chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old female patient. There was no information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications. On 25-JUL-2017, the patient was vaccinated with a dose of PROQUAD (therapy type: rHA, lot # N010247, expiry date: 25-SEP-2018) via subcutaneous route, for routine vaccination. She also received a dose of hepatitis a virus vaccine on the same day. Physician reported that 24 hours later vaccination, the patient developed a rash on her trunk and face. He mentioned that the patient's mother treated her with BENADRYL and a pharmacist recommended the patient with an antihistamine, VANACLEAR PD and PEDIAPRED by mouth. Outcome of the event was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Platelet transfusion, Thrombocytopenia
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old non pregnant  female patient. The patient's concurrent conditions, drug allergies or reactions, pertinent medical history and concomitant medications were not reported. In October 2016, the patient was vaccinated with a dose of GARDASIL 9 (dose, lot #, expiration date and route were not reported) for prophylaxis. On an unknown date, the patient experienced thrombocytopenia. In June 2017, the patient received "platelets" for thrombocytopenia. At the time of the report, the outcome of thrombocytopenia was unknown. Upon internal review, thrombocytopenia treated with platelets was determined to be medically significant. There was not product quality complain involved.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician via a field representative, refers to a female patient of unknown age. The patient's medical history was not reported. In approximately 2016, over a year ago, the patient was vaccinated with PNEUMOVAX 23 injection, at a dose 0.5 ml (Strength, frequency, anatomical location, lot/batch # and expiration date were not reported) intramuscularly for prevention of pneumococcal disease. There were no concomitant therapies reported. In approximately 2016, the day after the injection, the patient experienced pain at the injection site. There was no treatment given for the event of pain at the injection site. There was no product quality complaint involved. The outcome of the event, pain at the injection site was reported as recovered. The causality assessment was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On 01-AUG-2017, the patient was vaccinated with VAQTA of lot # M040421 with an expiry date of 26-MAY-2017 (Strength, dose, frequency and route was not reported) for prophylaxis. On 01-AUG-2017, the patient was administered an expired dose of VAQTA (Expired product administered). No adverse effects. There was no product quality complaint involved.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 18 year old patient. The patient's medical history was not reported. On 07-JUN-2017, the patient was vaccinated with PROQUAD, recombinant human albumin (rHA) or human serum albumin (HSA) (Strength, dose, frequency, route, lot/batch #, anatomical location was not reported) for prophylaxis (Drug administered to patient of inappropriate age). Other suspect therapies included sterile diluent (manufacturer unknown) which was administered on the same day. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received 01-AUG-2017 from a lawyer regarding a case in litigation concerning a female of unspecified age. It was claimed that this female plaintiff was inoculated with ZOSTAVAX on or about 04-JUN-2014 by a physician at a clinic as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed that the vaccine did not prevent shingles as intended, but rather caused the plaintiff to contract a persistent strain of herpes zoster. On or about 09-JUN-2014, the plaintiff was treated by the same physician that administered ZOSTAVAX, for the onset of a severe vesicular eruption accompanied by weakened immune symptoms which was diagnosed as herpes zoster or shingles, which developed within days of her vaccine. As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Day one post vaccination had soreness in left arm. On day four post vaccination developed redness, extreme soreness and fever at injection site down to just above left elbow. Saw MD 7/25/17, CBC was normal, put on KEFLEX for possible cellulitis. On 7/28/17, symptoms improved.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling (3.5 cm x 4.5 cm) and redness (9 cm x 5 cm) to (L) Deltoid. Onset: 7-29-2017.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Macule, Pyrexia, Rash, Skin hyperpigmentation, Urticaria
Clinical narrative: Urticaria Following HPV vaccine 7/27/17. Mild fever 7-26/17. Sx improved with BENADRYL. Rash on legs and back 1.5cm hyper pigmented macule R shoulder cap.
Age: 24.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 24-year-old male patient who received BEXSERO (batch number 159001, expiry date March 2018). Concurrent medical conditions included latex allergy. Concomitant products included GARDASIL. On 11th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 12th July 2017, 1 days after receiving BEXSERO, the patient experienced injection site pain. In July 2017, the patient experienced injected limb mobility decreased and injection site discomfort. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injected limb mobility decreased and injection site discomfort were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and injection site discomfort to be related to BEXSERO. Additional details were provided as follows: The patient received the 1st dose of BEXSERO in left deltoid and GARDASIL intramuscularly in right deltoid and experienced severe injection site pain in the next morning. It was reported that, 1 days after receiving BEXSERO the patient experienced injected limb mobility decreased and injection site discomfort. He could barely lift his arm, but since then, his pain gradually subsided and he had full range of motion now. He did not experience any injection site reactions in his right arm, where GARDASIL was given. However, 15 days later, he still had discomfort when there was pressure applied to the area.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Anxiety, Computerised tomogram head normal, Electrocardiogram normal, Fall, Lip injury
Clinical narrative: Patient was very nervous and anxious during the administration of the vaccines and after immunizations were given the patient advised to sit for 10-15 minutes. The nurse turned around and was going to walk out of the room and the patient feel from the exam table and lost consciousness. Patient came to consciousness within 10 seconds. Had blood coming from mouth which seemed to be from upper lip laceration. Pt was pale w/color returning over 10 minutes, AAO x3, PERRL. Pt denied h/a, blurry vision. Pt reports rining in ears. Pt slowly went from laying to sitting to standing without problem. Sent to ER for Eval.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Loss of consciousness, Mouth haemorrhage, Nervousness, Pallor, Tinnitus
Clinical narrative: Patient was very nervous and anxious during the administration of the vaccines and after immunizations were given the patient advised to sit for 10-15 minutes. The nurse turned around and was going to walk out of the room and the patient feel from the exam table and lost consciousness. Patient came to consciousness within 10 seconds. Had blood coming from mouth which seemed to be from upper lip laceration. Pt was pale w/color returning over 10 minutes, AAO x3, PERRL. Pt denied h/a, blurry vision. Pt reports rining in ears. Pt slowly went from laying to sitting to standing without problem. Sent to ER for Eval.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Head injury, Syncope, X-ray limb normal
Clinical narrative: Patient was very nervous and anxious during the administration of the vaccines and after immunizations were given the patient advised to sit for 10-15 minutes. The nurse turned around and was going to walk out of the room and the patient feel from the exam table and lost consciousness. Patient came to consciousness within 10 seconds. Had blood coming from mouth which seemed to be from upper lip laceration. Pt was pale w/color returning over 10 minutes, AAO x3, PERRL. Pt denied h/a, blurry vision. Pt reports rining in ears. Pt slowly went from laying to sitting to standing without problem. Sent to ER for Eval.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Face injury, Fall, Head injury, Immediate post-injection reaction, Limb injury
Clinical narrative: Patient was very nervous and anxious during the administration of the vaccines and after immunizations were given the patient advised to sit for 10-15 minutes. The nurse turned around and was going to walk out of the room and the patient feel from the exam table and lost consciousness. Patient came to consciousness within 10 seconds. Had blood coming from mouth which seemed to be from upper lip laceration. Pt was pale w/color returning over 10 minutes, AAO x3, PERRL. Pt denied h/a, blurry vision. Pt reports rining in ears. Pt slowly went from laying to sitting to standing without problem. Sent to ER for Eval.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Mouth injury, Syncope
Clinical narrative: Patient was very nervous and anxious during the administration of the vaccines and after immunizations were given the patient advised to sit for 10-15 minutes. The nurse turned around and was going to walk out of the room and the patient feel from the exam table and lost consciousness. Patient came to consciousness within 10 seconds. Had blood coming from mouth which seemed to be from upper lip laceration. Pt was pale w/color returning over 10 minutes, AAO x3, PERRL. Pt denied h/a, blurry vision. Pt reports rining in ears. Pt slowly went from laying to sitting to standing without problem. Sent to ER for Eval.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Received PNEUMOVAX 7/31/17 arm (inside) was painful, red, swelling 8/1/17 continued pain, red, swelling 8/2/17.
Age: 1.83
Sex: M
Vaccine: DTAP, HEP, VARCEL
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The thigh where he was vaccinated swelled, became red, hot and hard to touch.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, MNQ
Symptoms: Diarrhoea, Lethargy, Vomiting
Clinical narrative: Vomiting, diarrhea, lethargic.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Anxiety, Chest pain, Nausea, Respiratory rate increased, Tearfulness
Clinical narrative: Patient returned to clinic Urgent care 30 minutes after receiving vaccines. Complaints of anxiety, nausea and chest pain, patient tearful and rapid breathing. VS WNL noted heart murmur which is not a change for patient. Provider was able to calm patient down and symptoms improved. Patient released with no further treatment with instruction to return to ER if symptoms returned.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Pallor, Tremor
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pallor in a 12-year-old male patient who received BOOSTRIX (batch number 7Y29Z, expiry date 17th August 2019). Co-suspect products included MENVEO (batch number M16127, expiry date 31st July 2018) and GARDASIL (batch number N012093, expiry date 13th January 2020). On 25th July 2017, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml, the 1st dose of MENVEO (intramuscular) .5 ml and GARDASIL (intramuscular) .5 ml. On 25th July 2017, immediately after receiving BOOSTRIX and MENVEO, the patient experienced pallor, tremor, eye movement disorder and stiffness. On an unknown date, the outcome of the pallor, tremor, eye movement disorder and stiffness were recovered/resolved. It was unknown if the reporter considered the pallor, tremor, eye movement disorder and stiffness to be related to BOOSTRIX. It was unknown if the reporter considered the pallor, eye movement disorder and stiffness to be related to MENVEO. The reporter considered the tremor to be probably related to MENVEO. Additional details were reported as follows: The case was reported by nursing assistant. The patient received BEXSERO on left deltoid, MENVEO on right deltoid and GARDASIL into his right deltoid.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: I reconstituted the MENVEO with regular diluant. I am a new immunization nurse and I did not know that there was a liquid component to the vaccine.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Rash, Rash generalised
Clinical narrative: Foster Parent states Pt developed a rash on his trunk, that quickly spread to the rest of his body shortly after receiving vaccine. Pt also developed a high fever of 102 degrees F.
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Seizure like phenomena
Clinical narrative: Pt. was being monitored in ER as he reported a seizure after 2nd vaccine in ER 4 days prior which was not witnessed or reported. With screening pt at Public Health prior to 3 rd vaccine dose and his report of seizure, he was taken back to ER where vaccine was given by PH nurse. Pt observed by 2 PH nurses for 24 minutes when seizure like activity observed. ER Doctor and staff attended to pt.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cough, Erythema, Laboratory test, Nodule
Clinical narrative: Right arm pain, large hard nodule development, swelling, redness along with fever/chills, body aches and cough. Seen and treated by private physician with labs obtained and Antibiotics x 5 day course provided. Presently with overall reduction in symptoms of pain, swelling and size of nodule and resolution of symptoms of fever/chills, body aches and cough.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Right arm pain, large hard nodule development, swelling, redness along with fever/chills, body aches and cough. Seen and treated by private physician with labs obtained and Antibiotics x 5 day course provided. Presently with overall reduction in symptoms of pain, swelling and size of nodule and resolution of symptoms of fever/chills, body aches and cough.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: PT NOTICED SMALL BUMPS ON NOSE AND RIGHT SIDE CHEEK DAY AFTER VACCINE GIVEN ON 8/3/17. NO FEVER, SWELLING, SOB, OR CHEST PAIN NOTED.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Patient received vaccination at the end of a well visit where thorough medical history questions were asked. She was instructed by the medical assistant to remain on the exam table for at least 15 minutes, as per our office policy, due to likelihood of fainting. Pt got up after 5 minutes and wanted to go home, stating she "felt fine". Patient and mother left the room quickly and were asked by two other medical staff on their way out how she felt since she looked pale. Patient said she felt like she was going to faint. Mother stated the patient was "being dramatic." Patient proceeded to waiting room where she sat down and lost consciousness. She was lowered to the floor, pulse ox and BP were checked and were WNL. Feet were raised, head was cushioned. Pt was turned to side. Patient regained consciousness after approximately 45 seconds. Mother then stated that patient had multiple historical episodes of vasovagal syncope. This was new information to our staff. Patient was helped up slowly after about 10 minutes on the floor. No contusions, bruising, soreness, or injuries of any kind were noted.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Rash, Rash papular, Rash pruritic, Rash pustular
Clinical narrative: Patient presented to the Student Health Services at University at the Campus on 08-03-17. Patient states starting on 07-28-17 she developed an itchy rash on face, upper and lower extremities and abdomen; most significant is a cluster of lesions on the right abdomen. She is afebrile. The rash is not painful, but patient expressed discomfort. Pt reports new lesions have developed every day since then. Most are papular; however, the lesions on her right abdomen are pustular. A varicella culture was obtained and will be sent to a lab. She was sent home in quarantine and instructed to take Tylenol, Claritin and apply Caladryl lotion topically.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella virus test
Clinical narrative: Patient presented to the Student Health Services at University at the Campus on 08-03-17. Patient states starting on 07-28-17 she developed an itchy rash on face, upper and lower extremities and abdomen; most significant is a cluster of lesions on the right abdomen. She is afebrile. The rash is not painful, but patient expressed discomfort. Pt reports new lesions have developed every day since then. Most are papular; however, the lesions on her right abdomen are pustular. A varicella culture was obtained and will be sent to a lab. She was sent home in quarantine and instructed to take Tylenol, Claritin and apply Caladryl lotion topically.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fatigue, Pain, Pyrexia, Vomiting
Clinical narrative: Fever up to 102 starting at 6p, fatigue bodyaches and vomiting started at 1am.
Age: 21.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Syncope, Vision blurred
Clinical narrative: Fainting and syncope, blurred vision, dizziness.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Myalgia, Pain, Swelling
Clinical narrative: Local pain, swelling, redness, chills, and diffuse myalgias, worsening over 2 days.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Chest X-ray normal, Dizziness, Full blood count normal, Grip strength decreased, Heart rate abnormal
Clinical narrative: She had an episode of dizziness, right hand numbness, and right hand temporary paralysis. The numbness and paralysis lasted only about 30 seconds. The patient also reports persisting decreased grip strength bilaterally. In the ER she had a negative CXR, CBC and monospot. In our office the day of the vaccine she had a negative rapid strep screen with a negative follow up strep PCR. She did have a significant orthostatic change in HR when orthostatic BP and HR were checked in office the day following the event. Due to persisting grip strength concerns I have referred her to a neurologist.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Mononucleosis heterophile test negative, Monoplegia, Polymerase chain reaction, Streptococcus test negative
Clinical narrative: She had an episode of dizziness, right hand numbness, and right hand temporary paralysis. The numbness and paralysis lasted only about 30 seconds. The patient also reports persisting decreased grip strength bilaterally. In the ER she had a negative CXR, CBC and monospot. In our office the day of the vaccine she had a negative rapid strep screen with a negative follow up strep PCR. She did have a significant orthostatic change in HR when orthostatic BP and HR were checked in office the day following the event. Due to persisting grip strength concerns I have referred her to a neurologist.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration
Clinical narrative: I gave the IM shot in SQ on accident.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Oral herpes
Clinical narrative: Herpes stomatitis requiring hospitalization Valacyclovir, IV fluids.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The nurse reported than an expired dose of PROQUAD (lot # M002053, expiration date 11-JUL-2017) was administered to the patient on 13-JUL-2017 (route of administration not provided). The vaccine was reconstituted with sterile diluent (MSD) (unknown lot number and expiration date). No information was provided regarding the patient's past medical history, concurrent conditions, or other concomitant medication. No adverse effects. No further information to report. Lot number M002053 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 14-JUL-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The medical assistant reported that on an unknown date an unspecified patient was administered an improperly stored VARIVAX lot # M037642 expiration 01-SEP-2018, subcutaneous for prophylaxis reconstituted with correctly stored sterile diluent (STERILE DILUENT) lot # M035268 expiration 19-APR-2019. No adverse effects were reported. The vaccine was stored at a temperature of 15.8 degrees Fahrenheit for the time frame of 234 hours. There was no previous temperature excursion. The call was made due to a data logger.  Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information was received 14-JUL-2017 via a phone call from a female office manager who reported that an unspecified number of patients were vaccinated with improperly stored vaccines that underwent temperature excursion every day since May 2017. She also reported that the vaccines may also have had temperature excursions prior to May 2017. She was not able to provide the lot numbers and expiration dates or the details of the temperature excursions. The phone call was due to the use of a data logger. The vaccines involved in the temperature excursion are: GARDASIL 9, VAQTA, ROTATEQ and RECOMBIVAX HB. Follow-up information was received 24-JUL-2017 via a phone call from a physician who provided additional information about the administered vaccines that had undergone temperature excursions. For GARDASIL 9 lot numbers are: N003703 expiration 29-OCT-2019, M024261 expiration 31-JUL-2018, M018810 expiration 28-MAY-2018, L043214 expiration 30-AUG-2017. For VAQTA lot numbers are: N005746 expiration 26-MAY-2018, M047658 expiration 28-OCT-2017. For ROTATEQ lot numbers are: N003401 expiration 13-OCT-2018, M031553 expiration 19-MAR-2018, L046320 expiration 29-SEP-2017. For RECOMBIVAX HB lot numbers are N006321 expiration 08-NOV-2019, M037248 expiration 21-FEB-2019. These vaccines were stored at 32 to 35 degrees Fahrenheit for 25 hours and 47 to 77 degrees Fahrenheit for 55 hours. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. No further information was provided. Additional information was requested.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours. Previous temperature excursion: Yes, -9°C to +8°C for 5 hours. Data logger involved: Yes. This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 has been verified to be a valid lot number for VARIVAX. Additional information has been requested. Sender's Comments: US-009507513-1708USA000471: US-009507513-1708USA000472: US-009507513-1708USA000473: US-009507513-1708USA000474: US-009507513-1708USA000475.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 11-JUL-2017 from a medical assistant who reported that multiple unspecified patients received either VARIVAX or PROQUAD that were improperly stored (dates of vaccination, dose and lot#/expiration not reported). Temperature was 15 degrees F to 46 degrees F for a time frame of 24 hours. There had not been a previous temperature excursion. No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Nausea
Clinical narrative: Information has been received from a Medical Assistant concerning a 61 year old female patient.  The patient had an allergy to sulfa drugs. She did not have a pertinent medical history.  Concomitant medication use was not provided. On 11-JUL-2017 the patient was vaccinated with PNEUMOVAX 23, 1 DF, intramuscular, for prophylaxis (lot # N005597, expiration date 19-OCT-2018). "A few hours later" the patient developed shortness of breath. The patient returned to the physician's office on 12-JUL-2018 complaining of nausea and shortness of breath and was treated with an unspecified medication (NOS). The outcome of shortness of breath and nausea was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a other health professional refers to a 14 year old male patient. On 13-JUL-2017, the patient was vaccinated with VAQTA in the left deltoid for prophylaxis. Concomitant therapies included GARDASIL 9. In July 2017, the patient experienced injection site pain, injection site swelling, injection site warmth and injection site erythema. The outcome of injection site pain, injection site swelling, injection site warmth and injection site erythema was recovering.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours Previous temperature excursion: Yes, -9°C to +8°C for 5 hours Data logger involved: Yes This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 with expiration date 24-APR-2019 (reported as April 2019) has been verified to be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1708USA000472: US-009507513-1708USA000473: US-009507513-1708USA000474: US-009507513-1707USA004998: US-009507513-1708USA000475:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a nurse referring to a 67 year-old non-pregnant female patient. The patient's pertinent medical history and concomitant medications were not reported. The patient's drug reactions/allergies included allergy to ibuprofen(ADVIL) (patient gets double vision) and allergy to unspecified sulfa drugs (causes rash). The patient's concurrent conditions included allergy to latex (causes rash). On 31-JUL-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N004564 with expiration date 22-OCT-2018, for prophylaxis. On the same date, the patient developed cellulitis of the left arm. It was sated that she got edema, pain, swelling, redness and increased temperature in the left arm. The patient went to the clinic and received treatment for the adverse event (not specified). At the time of reporting the outcome of cellulitis of the left arm was reported as recovering. A product quality complaint was not involved. The causality assessment between cellulitis of the left arm and PNEUMOVAX23 was not provided. Upon internal review cellulitis of the left arm was determined to be medically significant.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a nurse referring to a 67 year-old non-pregnant female patient. The patient's pertinent medical history and concomitant medications were not reported. The patient's drug reactions/allergies included allergy to ibuprofen(ADVIL) (patient gets double vision) and allergy to unspecified sulfa drugs (causes rash). The patient's concurrent conditions included allergy to latex (causes rash). On 31-JUL-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N004564 with expiration date 22-OCT-2018, for prophylaxis. On the same date, the patient developed cellulitis of the left arm. It was sated that she got edema, pain, swelling, redness and increased temperature in the left arm. The patient went to the clinic and received treatment for the adverse event (not specified). At the time of reporting the outcome of cellulitis of the left arm was reported as recovering. A product quality complaint was not involved. The causality assessment between cellulitis of the left arm and PNEUMOVAX23 was not provided. Upon internal review cellulitis of the left arm was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information was received on 01-AUG-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 08-SEP-2013 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JAN-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with post herpetic neuralgia, a chronic condition of residual nerve pain and damage secondary to shingles. The patient has experience significant pain and complications from his shingles infections, which have spread to his eyes, scalp and face. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received on 01-AUG-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 08-SEP-2013 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JAN-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with post herpetic neuralgia, a chronic condition of residual nerve pain and damage secondary to shingles. The patient has experience significant pain and complications from his shingles infections, which have spread to his eyes, scalp and face. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient, their physician  and their pharmacists used the ZOSTAVAX vaccine in the manner in which it was intended. The patient was inoculated with a dose of ZOSTAVAX vaccine in October 2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about December 26, 2014, the patient was treated by his physician at a hospital, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about February 5, 2015, the patient received subsequent treatment from his physician for ongoing and worsening symptoms, diagnosed as post-herpetic neuralgia, a chronic condition of irreversible nerve pain and damage secondary to shingles. The patient has been prescribed gabapentin (manufacturer unknown), lidocaine (manufacturer unknown), and VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Patient described having pain in area of injection the started after the injection was given. Now the pain is radiating to the finger tips and to the neck.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV1, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Rotavirus vaccine was misadministered and injected rather than given orally.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Dizziness, Pyrexia, Urticaria
Clinical narrative: At 90 min post vaccine with weakness, dizziness, fever and chills. At 27 hours with generalized urticaria moderate to severe over ex tensor surfaces of all joints.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Pt. received ZOSTAVAX on 080117 - no complaints at that time. Pt. returned to Health Department on 080317 to have site checcked. RA noted to be red with induration and warmth. Redness and induration noted to be 7.5 cm in width and 5 cm in height. Referered client to MD for evaluation. Marked redness with ink pen. If it increases to ER ASAP.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: (L) thigh with redness, 2 cm induration. (Local reaction) - BENADRYL given.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Local reaction, Lymphadenopathy, Nausea
Clinical narrative: VARIVAX vaccine provided 7/27/17. One day later had localized RXN of redness/swelling. Pictured on her phone. Then nausea, sore throat, "swollen nodes" (pt. is an RN). Seen today 8/1/17 (Tues) with red pharynx, mildly reddened local area at inj. site. Glands positive or negative. Vitals WNL. HRR SM. Lungs clear - no wheezes. Does not have toxic appearance.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Pharyngeal erythema, Swelling
Clinical narrative: VARIVAX vaccine provided 7/27/17. One day later had localized RXN of redness/swelling. Pictured on her phone. Then nausea, sore throat, "swollen nodes" (pt. is an RN). Seen today 8/1/17 (Tues) with red pharynx, mildly reddened local area at inj. site. Glands positive or negative. Vitals WNL. HRR SM. Lungs clear - no wheezes. Does not have toxic appearance.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis
Clinical narrative: Patient has cellulitis with bullaes tx elevated arm, ice compress TYLENOL and return in 2 day.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Myalgia
Clinical narrative: Possible fever, muscle aches, and lethargy.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Asthenia, Blood pressure decreased, Cold sweat, Feeling cold
Clinical narrative: HPV #1 given to R Deltoid 3:09 PM R Deltoid 1 min after vaccine given, felt cold and clammy. Pt was actively talking c/o feeling weak, nausea and lower abdominal cramping. Patient was able to speak w/full conscience. B/P 64/42 dropped. Monitored for extended time.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea
Clinical narrative: HPV #1 given to R Deltoid 3:09 PM R Deltoid 1 min after vaccine given, felt cold and clammy. Pt was actively talking c/o feeling weak, nausea and lower abdominal cramping. Patient was able to speak w/full conscience. B/P 64/42 dropped. Monitored for extended time.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: LARGE RED RASH, HOT TO THE TOUCH, AND ITCHY.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: LARGE RED RASH, HOT TO THE TOUCH, AND ITCHY.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling, heat and pain located in the right arm. Swelling from the top of the arm down to the wrist getting progressively worse from 8/1 to 8/3. Pharmacy notified on 8/3. Parent advised to go to urgent care.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase, Injection site atrophy
Clinical narrative: Influenza Vaccine Quad Split GlaxoSmithKline contact primary care physician for exact vaccine. One was selected so the form could be completed, but unknown if it was a prefilled syringe or not.  Lipoatrophy resulted in area several months after the injection without weakness to the limb.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: Roughly five minutes after the vaccines were administered, the patient fainted. He was still seated in his chair in which the vaccines were administered. A pharmacy tech called 911 as I was tending to the patient. The patient was pale and sweaty and lost consciousness but regained within a few seconds. Blood pressure was 118/72 and pulse was 60 when I checked his vitals (with a few minutes of regaining consciousness). Paramedics checked him out and agreed that it was syncope.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site reaction, Rash macular
Clinical narrative: Patient received her tetanus booster on Monday, and last night noticed some red splotches on her upper arm near injection site. She also has had a headache, had a headache Tuesday, no headache Wednesday, and then the headache came back today. Patient spoke to PCP as well as Clinic Pharmacy staff and was given treatment advice. Will follow-up with Neurologist. Monitor closely for now, can try cold pack on upper arm, and splotches if they feel itchy or uncomfortable. Ibuprofen for headache. If headache or splotches persist tomorrow though, she will call back to check in.  08/3/2019 Seen in injections office. States that she is having no more effects from the vaccine.
Age: 59.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported to me over the phone tonight that she is experiencing swelling and extreme soreness in her left arm. She stated that her bicep area is swollen down to her elbow and that her arm is sore so that she cannot raise it above her head. She did not report any hives/rashes, trouble breathing, swelling of lips, tongue, throat, etc. I advised her to continue to watch for these signs/symptoms. I advised her to take TYLENOL for the pain.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Impaired work ability, Malaise, Nasopharyngitis
Clinical narrative: Cold, cough, chills, sore throat. Very....Very SICK. When I asked pharmacist about listed side effects before injection, very few were listed, and nothing like my reaction at all. I lost time off work and am a caretaker for my disabled sister. This was a terrible ordeal and my pharmacy feels bad.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: Cold, cough, chills, sore throat. Very....Very SICK. When I asked pharmacist about listed side effects before injection, very few were listed, and nothing like my reaction at all. I lost time off work and am a caretaker for my disabled sister. This was a terrible ordeal and my pharmacy feels bad.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Lethargy, Vomiting
Clinical narrative: Vomiting and lethargy. Normal pregnancy 36wk 4 day EDD 8/27/17.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose decreased, Confusional state, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient passed out a few minutes after receiving vaccine. She woke up a few seconds later was very pale, sweating and confused. Blood sugar was 50.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Infection, Insomnia, Pain in extremity
Clinical narrative: PATIENT HAD PAIN IN HER ARM AND A HEADACHE A COUPLE HOURS AFTER RECEIVING THE VACCINE. SHE LATER HAD TROUBLE SLEEPING AND HAD A RED AND SWOLLEN AREA ON HER ARM. SHE WENT TO THE EMERGENCY ROOM AS HER DR WAS UNABLE TO GET HER IN TO THE OFFICE THE NEXT DAY. THE ER TOLD HER SHE HAD AN INFECTION AND PRESCRIBED KEFLEX AND PREDNISONE.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: PATIENT HAD PAIN IN HER ARM AND A HEADACHE A COUPLE HOURS AFTER RECEIVING THE VACCINE. SHE LATER HAD TROUBLE SLEEPING AND HAD A RED AND SWOLLEN AREA ON HER ARM. SHE WENT TO THE EMERGENCY ROOM AS HER DR WAS UNABLE TO GET HER IN TO THE OFFICE THE NEXT DAY. THE ER TOLD HER SHE HAD AN INFECTION AND PRESCRIBED KEFLEX AND PREDNISONE.
Age: 46.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient stated that she experienced pain in her right arm after receiving the hepatitis vaccine and the pain continued for 2 months. She was advised to talk to her doctor because it is not normal to have pain for that long after a vaccination.
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism spectrum disorder, Brain injury, Gait inability, Seizure
Clinical narrative: Reaction next day, became completely mute, stopped walking, diagnosed with severe autism (permanent brain damage to child) immediate minor seizure.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Feeling abnormal, Generalised tonic-clonic seizure, Syncope
Clinical narrative: Syncope after ADACEL and MENACTRA. Still dizzy - 7-19-17. Then fine. 2:46PM, child was walking to the door after picking a sticker and fainted and has a small seizure for approximately 2 seconds. Patient was very alert after. She knew where she was, todays date, day. She knew her name and her age. She also had no problem reading. Her pulse was 86 however is was faint and steady. 2:51 PM add to notes- she did not hit her head. Another patient was coming the office and caught her head as she was falling. 5:07 PM Note being entered at end of day -fter patient received her shots, she felt fine and walked to the front of the office to leave. She was inspecting the stickers and there was a large spider nearby, though she said later that this did not bother her. She then started to take a few steps and had a brief syncopal episode. Another patient who arriving then caught her head before she hit the ground. She apparently had a very brief tonic clinic seizure-for a few seconds. I was called and found her already awake lying on the ground with mom. She was a little dazed at first but then immediately knew where she was, who I was, the date, events that are happening soon for her family that we discussed during her visit, etc. She had some water and fruit cup and stayed on the floor for a few minutes. Then we moved her to a chair, where she continued to drink and had fruit cup. I saw another patient and checked on her again, at which time she felt fine. We had her get up on her own and she was completely fine. Mom will call us if she has any concerns and I will check on her tomorrow. I advised mom that in the future, she should sit and relax for a while after she receives shots.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Conjunctival hyperaemia, Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: Pain at injection site, fever, malaise, muscle pain and conjunctival injection.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Dyskinesia, Pallor, Vaccination complication, Visual impairment
Clinical narrative: 911 was called today 1/19/2016 for the minor patient. Minor had a reaction due to the vaccines. Minor jerked back and her visions went blank for a few seconds after the vaccines were inserted. Visually minor looked really pale. Vaccines were stopped as soon as we saw that minor jerked back and 911 was called. When we asked minor how she was feeling she replied with "What's up?". Minor doesn't recall anything besides seeing all black.