chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The first 2 to 3 days after the vaccine felt like a normal vaccine. Pain and limited mobility from shoulder to elbow sometimes can feel pain in forearm has occurred since the vaccine. Pain is mainly from bicep down to elbow. Has been taking naproxen 500mg twice daily. has been feeling better since taking the naproxen but will be starting physical therapy on Friday 11.18.2016. Patient is not currently on any other medications.
Age: 7.0
Sex: M
Vaccine: JEV1
Symptoms: Erythema, Injection site pain, Pruritus, Skin warm
Clinical narrative: Per mom the actual date of onset was not known however 4-5 days ago child complained to dad about pain at injection site. Dad noticed a little redness at that time. Then on 11/15/16 in the evening the child complained that his pants were bothering the injection site. It was then that the parents noticed the redness was larger and hard warm to touch and painful for the child. Per mom she put cortisone cream on the site as the child also complained about itching. The parent called for an appointment with doctor and was seen in clinic. Bactrim antibiotic was prescribed by doctor on 11/16/16.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Fatigue, Feeling hot, Flushing
Clinical narrative: Lightheadedness, warm flushing feeling, general weakness. Patient sat down and had a snack as she had not eaten food all day. At 3:42 PM she reports her symptoms experienced and that all symptoms resolved other than weakness/tiredness which persist.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient has a dime sized bruise on arm and thinks it is from her flu shot.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: PATIENT STATES REDNESS AND SWELLING AT INJECTION SITE, DEEP PINK TO PURPLE COLORING WITH WHEELS AT INJECTION SITE,WITH SHIVERING CHILLS OF PROLONGED DURATION.
Age: 33.0
Sex: F
Vaccine: DTAP, FLU4, PPV
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: FEVER OF 102 F. RASH ON THE LEFT ARM. HARD LUMP ON THE LEFT ARM. ARM PAIN.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Widespread hives all over body, palms, scalp. Benadryl and Zantac taken at home, briefly relieved hives and itching but hives returned in the evening around 8 Pm. Second dose of Benadryl and zantac taken with little relief. Went to urgent care the next day around 9 AM and received IM solumedrol and RX for Medrol dosepak. Hives still present for two more days but not as severe. I am required to get the flu shot for work and have for the last several years. This is the first year I've had a reaction to it.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Muscle spasms, Skin warm
Clinical narrative: Patients arm is hot to touch, red. Complains of muscle cramping and burning sensation. Not at location of injection site.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised, red, warm, swollen area approximately 2 inches in diameter and 2 inches down the arm from the injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Swelling, Urticaria
Clinical narrative: Swelling and discoloration with welt.  Swelling, etc. continued to worsen up to day 3.  Swelling increased with welt to 6 inches.  Went to Pharmacy on 11/13/16 for follow-up.  Pharmacy said to take Benadryl and watch to make sure it did not continue and log a reaction.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever and Headache. Swelling and redness at injection site.
Age: 1.67
Sex: M
Vaccine: DTAP, FLU4, HEPA, IPV, MMRV, PNC13
Symptoms: Abdominal pain, Agitation, Anxiety, Decreased appetite, Diarrhoea
Clinical narrative: Fever, vomiting, diarrhea, rash, irrability, loss of appetite, visual issues, agitated, sleep disorder, tingling, anxiety, toxic diapers, bowel issues, abdominal pain.
Age: 1.67
Sex: M
Vaccine: DTAP, FLU4, HEPA, IPV, MMRV, PNC13
Symptoms: Functional gastrointestinal disorder, Irritability, Laboratory test, Liver function test abnormal, Liver injury
Clinical narrative: Fever, vomiting, diarrhea, rash, irrability, loss of appetite, visual issues, agitated, sleep disorder, tingling, anxiety, toxic diapers, bowel issues, abdominal pain.
Age: 1.67
Sex: M
Vaccine: DTAP, FLU4, HEPA, IPV, MMRV, PNC13
Symptoms: Paraesthesia, Pyrexia, Rash, Sleep disorder, Visual impairment
Clinical narrative: Fever, vomiting, diarrhea, rash, irrability, loss of appetite, visual issues, agitated, sleep disorder, tingling, anxiety, toxic diapers, bowel issues, abdominal pain.
Age: 1.67
Sex: M
Vaccine: DTAP, FLU4, HEPA, IPV, MMRV, PNC13
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, diarrhea, rash, irrability, loss of appetite, visual issues, agitated, sleep disorder, tingling, anxiety, toxic diapers, bowel issues, abdominal pain.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Abdominal pain upper, Back pain, Peripheral swelling
Clinical narrative: States she experienced swelling in arm, pain in 3 discs in her back, unable to walk, stomach pain, possible kidney damage. Hospitalized for 1 week then went back to hospital the following day after discharge.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Polymerase chain reaction positive, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Patient had VARIVAX on 8/15/16 documented in (R) lateral thigh and developed VZV (+) rash on (R) thigh on 11/11/16 after being diagnosed w/very high NTK leukemia at 14 mos of age (now s/p one month of chemo).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cytogenetic analysis normal, Electroencephalogram abnormal, Metabolic function test normal, Neurological examination, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Fever and seizure. Taken by ambulance. Started on KEPPRA then phenobarbital added. Neurology exam.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever and seizure. Taken by ambulance. Started on KEPPRA then phenobarbital added. Neurology exam.
Age: 0.17
Sex: M
Vaccine: DTAP, RV5
Symptoms: Adverse event, Respiratory arrest, Skin discolouration
Clinical narrative: Parents found him gray in color and not breathing. Infant was vaccinated with DTaP and Rota 3 days prior. Infant was hospitalized x 24h with BRUE.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Abasia, Guillain-Barre syndrome
Clinical narrative: 10-9-16 Pt unable to walk, ascending paralysis. Went to ER was admitted with Guillain-Barre.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 7-year-old male patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT 0.5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site rash and vomiting. On an unknown date, the outcome of the injection site rash and vomiting were recovered/resolved. It was unknown if the reporter considered the injection site rash and vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The exact date of the vaccination was unknown. The pharmacist believed it might have been Friday but she was not certain.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to clinic yesterday (L) deltoid was red, swollen and hot. He received Flu vaccine on 11/14/16 in that arm.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Erythematous maculopapular rash all over the body 2hrs post vaccination. Improved with BENADRYL PO.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Lip swelling, Pharyngeal oedema
Clinical narrative: Throat swelled, couldn't breathe, lips swelled up, red/pain at injection site. Took BENADRYL and that cleared it up after approximately 1-2 hours.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Injected limb mobility decreased, Muscle strain, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: 30 mins after vaccine, patient felt sore a few weeks later, pain increased and MRI performed. MRI showed inflammation and strain in affected area. Provided steroids and ibuprofen. Patient unable to raise left arm due to pain and swelling.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: 30 mins after vaccine, patient felt sore a few weeks later, pain increased and MRI performed. MRI showed inflammation and strain in affected area. Provided steroids and ibuprofen. Patient unable to raise left arm due to pain and swelling.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea, Eye pain, Injection site erythema, Injection site pain
Clinical narrative: About 1 hr after flu shot administration, trouble breathing, tongue swollen, back pain, eye pain, lips felt prickly, burning, red/sore at injection site. She took BENADRYL right after and felt better  but scared.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Oral discomfort, Paraesthesia oral, Swollen tongue
Clinical narrative: About 1 hr after flu shot administration, trouble breathing, tongue swollen, back pain, eye pain, lips felt prickly, burning, red/sore at injection site. She took BENADRYL right after and felt better  but scared.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEP, HEPA, MMRV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Round, redness to site of injections. No to nausea.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash
Clinical narrative: Patient received flu vaccine at school flu clinic 11/9/16. Several hours later developed 103 degree F fever, HR of 137 and rash on chest. Mother called to report this the following day 11/10/16. Mother states taking to PMD.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Cough, Wheezing
Clinical narrative: Pt experienced asthma exacerbation 2 days after receiving vaccine. Cough and wheeze noted. Pt started on steroids.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red, swollen area of upper arm. Tricep area sore into breast area and lower arm.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Urticaria
Clinical narrative: Hives, itchy throat.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Diarrhoea, Headache
Clinical narrative: Diarrhea for 1 1/2 day, headache, weak.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations
Clinical narrative: Patient reported having heart palpitations an hour after receiving the vaccine. She took her heart medication and was fine.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Laceration, Suture insertion, Syncope
Clinical narrative: Patient became dizzy, fainted and fell on floor several minutes after receiving vaccine. Assisted patient to exam table. Pressure to laceration on forehead. Monitored patient for 25 min. until dizziness subsided. Mother took patient to ER where she received sutures.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Fever of approx 103 degree F, chills, aches (body), rash - went away after 24 hrs.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Cheilitis, Erythema, Lip oedema
Clinical narrative: (R) side of lip (lower) became inflamed-4cm of lower lip. BENADRYL 50mg 920a. Face red. Sx subsided 1/2 hour color improved - lip edema decreased.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Pain in extremity, Spinal X-ray
Clinical narrative: Rec'd flu vaccine on 10-17-16. Arm was sore. Then on 10-21-16 left side of body started feeling strange. Extreme pain 10/10 mostly in left leg from knee to foot. Pain continued. Went to urgent care. They sent patient to ER. Pain moves up and down leg. Started on steroids. After 3 days of steroids pain came back. Pain has not gone away.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Swelling
Clinical narrative: Warm red rash left of injection site. Patient states she felt a bump. Verified she did not bump into any object.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Rash papular
Clinical narrative: Rash - raised, red, papular patches on thigh at and around injection site.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Injection site macule, Skin warm
Clinical narrative: Within 1-2 hrs after vaccination, area red and warm. Office visit: macular, pink-red inflamed area size approx 4 inches across left deltoid. No red streaks. Improving after 1 day. Ibuprofen and ice.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Cellulitis of the left lateral upper arm, started the day after her flu vaccine and was worse day 2. The area has warmth, erythema, and induration measuring approx. 6 x 7 cm. She was started on KEFLEX 250 mg/5 ml, 8 ml BID for 10 days.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: Received flu vaccine in left arm on 10/25/16. Welted almost immediately and redness progressed, arm became swollen and red to the touch.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Received influenza vaccine in right thigh on 10/25/16, leg became swollen from knee to groin, hard, red and warm to touch.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient received flu vaccine in right thigh on 10/25/2016, evaluated in clinic with localized redness (28cm x21cm) and swelling, firm to touch several cms around injection site.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Noticed rash on the bilateral distal arms.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Dysgraphia, Injection site pain, Joint range of motion decreased, Periarthritis, Tendonitis
Clinical narrative: Injection site very painful. Developed from shoulder, lost range of motion in right arm constant pain. Developed tendinitis, capsulitis of shoulder. Limited ability to write clearly and without pain.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient said that her arm has been hurting over a month since she received the flu vaccine. She went to a doctor about 3 wks after shot and got a steroid shot. It only helped a little bit.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Given out of age range (KINDRIX) no reaction at this time.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Spinal pain
Clinical narrative: Shoulder pain, sharp pains radiating to her spine started 3 days after administration.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe pain in arm and shoulder and neck.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 9 x 6 cm red, raised, sore, warm to (R) arm.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, slightly warm at site of injection Pt called MD0told to put cold compress. Pt doing well (MD not concerned per PT)
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Impaired work ability, Insomnia, Joint swelling, Peripheral swelling
Clinical narrative: Patient stated arm and shoulder swollen. Unable to sleep or work. He is in a lot of pain. This has not happened with flu shots in the past.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates multiple unspecified patients were administered improperly stored PNEUMOVAX 23 (lot # L018503, expired date 16-MAR-2017, or an unspecified lot# and expired date) (dose and frequency were unknown). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patients were each vaccinated with an improperly stored dose of  PEDVAXHIB (Lot number M032148, expiration date: 18-APR-2019). The vaccines were exposure to 32.4 Fahrenheit degree for 4 hours. There were no previous excursions. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to two unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L034367, expiration date 08-SEP-2017; dose and route were unknown). No adverse effects were reported. The excursion temperature was 9 Fahrenheit degree for 4 hours. Data logger was involved. There was no previous excursions. Product quality complaints was not involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On unknown dates in 2016 (reported as "unspecified dates since 29-SEP-2016"), the patients were vaccinated with doses of improperly stored PEDVAXHIB lot # M020101, expiration date 07-MAR-2019; lot # M010440, expiration date 09-DEC-2018 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 51.8 degrees Fahrenheit for 30 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 1 year old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 11-NOV-2016, the patient was vaccinated with a dose of PROQUAD (lot # M015695, expiry date: 26-SEP-2017) and a dose of VARIVAX (lot # M028551, expiry date: 07-JUN-2018) in the same office visit. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On unknown dates since 01-NOV-2016 (reported as "excursion started on 01-NOV-2016 and vaccination may have occurred since then"), the patients were vaccinated with unspecified doses in series of improperly stored doses of M-M-R II (which had the lot # L032182, expiration date 25-AUG-2017) (dose, route and vaccination site were not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 12.6 C. The time frame was 168 hours. There was not previous temperature excursion. The call was not because of the a "data logger". And there was not product quality complaint involved. A list of patients and actual dates of administration was not available. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a office manager refers to two patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 02-OCT-2016, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # M007764, 30-JAN-2018. No adverse effect was reported. Temperature was 74.3F for 28 hours and it was administered. There was no previous temperature excursion. This is one of the three cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On unknown dates since 01-NOV-2016 (reported as "excursion started on 01-NOV-2016 and vaccinations may have occurred since then"), the patients were vaccinated with unspecified doses in series of improperly stored doses of GARDASIL 9 (which had the lot # L024993, expiration date 17-OCT-2017) (dose, route and vaccination site were not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 12.6 C. The time frame was 168 hours. There was not previous temperature excursion. The call was not because of a "data logger". And there was not product quality complaint involved. A list of patients and actual dates of administration was not available. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This information has been received from a licensed practical nurse concerning a 2 year old patient of unspecified gender. On 19-SEP-2016, the patient was vaccinated with improperly stored (wistar ra 27-3) M-M-R II (lot # L036853, expiration date 24-SEP-2017) (dose#, dosage and route unspecified). The (wistar ra 27-3) M-M-R II  was exposed to temperature excursion potential of 72 F and 87.5 F on 17-JUN-216 and 22-JUL-2016 respectively. No adverse effects reported. No product quality complaint was involved. This is one of two reports from the same reporter. Additional information is not expected as no further information is available.
Sex: U
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Oedema
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, intramuscularly (dose, lot # and expiry date were not reported). The reporter stated that vaccine was administered too high in the deltoid. On an unknown date, the patient experienced oedema. The outcome of oedema was unknown. The relatedness between the event and the suspect therapy was not provided. Additional information is not expected, as there was no consent given to contact healthcare professional.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 3 month old patient of unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. It was reported that the patient received the first dose of ROTATEQ late (dosage schedule, lot #/expiration date were unknown) on 11-JUN-2016, the second dose of ROTATEQ (dosage schedule, lot #/expiration date were unknown) on 10-SEP-2016 and the third dose of ROTATEQ (dosage schedule, lot #/expiration date were unknown) on 22-OCT-2016, orally. There were no concomitant medications reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 16 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). The reporter stated that the patient received 2 doses. No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 6 months old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHI, lot # K015464 with expiration date 09-JUL-2017 (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 11 months old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # K015464 with expiration date 09-JUL-2017 (route administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 1 year old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # K015464 with expiration date 09-JUL-2017 (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 3 months old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # K015464 with expiration date 09-JUL-2017 (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 3 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # K015464 with expiration date 09-JUL-2017 (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of VAQTA lots # M031695, M022556, M036459, M032492 and M022924 with expiration dates 26-MAY-2017, 26-MAY-2017, 18-JAN-2018, 02-MAR-2018 and 24-JAN-2018 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. The doses of VAQTA were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of RECOMBIVAX HB lots# M018625, M020926, M007763 and L025377 with expiration dates 11-AUG-2018, 11-AUG-2018, 15-SEP-2017 and 15-APR-2017 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. The doses of RECOMBIVAX HB were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Inject site soreness. Red. Hot to touch blistered and itching.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with VARIVAX lot number reported as M005272, expiration date: 02-FEB-2018 (concentration, dose, frequency and via were not reported), which was improperly stored at 32.5 Fahrenheit degrees for 16 hours. No previous temperature excursion was reported and it was not detected due to a data logger. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies an concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of PNEUMOVAX 23 lots # M033086, Lo33707 and M020521 with expiration dates 05-MAY-2018, 18-MAY-2017 and 17-NOV-2017 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. The doses of PNEUMOVAX 23 were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown dates, the patients administered improperly stored doses of VARIVAX lot # M012992, expiration date 14-MAR-2018, (dosages and therapy routes were not provided). Concomitant therapies were not informed. The doses of VARIVAX were exposed to a temperature of 21.3C and were out of range for 1 hour. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB. No adverse effect was reported. Temperature was 74.3F for 28 hours and it was administered. There was no previous temperature excursion. This is one of the three cases received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Pain, Pyrexia, Swelling
Clinical narrative: Fever, erythema multiform and pain, swelling.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients were each vaccinated with a dose of improperly stored VAQTA (lot # M027879, expiration date 24-JAN-2018; lot # reported as M003611, expiration date 02-MAR-2018) (route and dose were not reported). The vaccines were stored at 34.7 degree Fahrenheit for 11 hours and 47 degree Fahrenheit for 45 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Lot number M003611 is an invalid lot number for hepatitis a vaccine, inactivated. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were each vaccinated with a dose of improperly stored GARDASIL 9 (lot #L026602, expiration date 19-OCT-2017) (dose and route unknown). The vaccine was exposed to 35.3 degree Fahrenheit for 240 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were each vaccinated with a dose of improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017 (dose and route unknown). The vaccine was exposed to 35.3 degree Fahrenheit for 240 hours. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information is not expected as there was no consent to contact physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were each vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L019836, expiration date 24-MAR-2017) (dose and route unknown). The vaccine was exposed to 35.3 degree Fahrenheit for 240 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to herself as a 72 year old female patient. The patient pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 15-DEC-2014, the patient was vaccinated with ZOSTAVAX. On 31-OCT-2016, the patient experienced Shingles. The patient sought medical attention by contacting the physician and received unspecified treatment. The outcome of Herpes zoster was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as the reporter does not want to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 31-OCT-2016 from a registered nurse. The nurse reported that one unspecified patient (age and gender unknown) received an improperly stored dose of PROQUAD (Lot # M014301, exp. 22-SEP-2017) subcutaneously on 27-OCT-2016. No adverse effects were reported. No further information was provided. The temperature was -7C for 2 hours, 35 minutes recorded on a data logger. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and a physician referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M008173 with expiration date 16-FEB-2018; dose and route were not reported). The doses of VARIVAX were exposed to 8.24 Fahrenheit for 15 days. There was no previous temperature excursion. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (dose, and route not reported) from lot # M009766 with expiry date of 23-FEB-2018. No adverse effects were reported. The vaccine was exposed to a temperature of 9.4 Fahrenheit for 283 hours and 21 minutes. Digital data logger was involved. The vaccine was also exposed to a temperature excursion previously. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and a physician referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II (lot # L036851 with expiration date 23-SEP-2017, lot # L040960 with expiration date 16-OCT-2017; dose and route were not reported). The doses of (wistar ra 27-3) M-M-R II were exposed to 8.24 Fahrenheit for 15 days. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 4 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M015698, expiry date: 26-SEP-2017; dose and route were not provided). The vaccine was improperly stored at a temperature of 11 degree Fahrenheit for 12 hours 35 minutes. No adverse effects were reported. This is one of two reports received from the same source. Additional information is not reported as no further information is available.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On unknown dates since 01-NOV-2016 (reported as "excursion started on 01-NOV-2016 and vaccinations may have occurred since then"), the patients were vaccinated with unspecified doses in series of improperly stored doses of PEDVAXHIB (which had the lot # M001813, expiration date 14-OCT-2018) (dose, route and vaccination site were not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 12.6 C. The time frame was 168 hours. There was not previous temperature excursion. The call was not because of a "data logger". And there was not product quality complaint involved. A list of patients and actual dates of administration was not available. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received on 21-OCT-2016 from a registered nurse regarding a case for GARDASIL 9 (MARRS# 1610USA012312). The registered nurse reported that on 17-OCT-2016 a male patient (age unknown) received an improperly stored dose of GARDASIL 9 (lot# M017983, expiration date 30-APR-2018). Temperature was 57.7F at time frame of 14 hours. Call was because of a data logger. There was no previous temperature excursion. No adverse effects reported. No further details provided. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On unknown dates since 01-NOV-2016 (reported as "excursion started on 01-NOV-2016 and vaccinations may have occurred since then"), the patients were vaccinated with unspecified doses in series of improperly stored doses of ROTATEQ (which had the lot # L048854, expiration date 31-AUG-2017) (dose and vaccination site were not informed) orally. Information regarding concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 12.6 C. The time frame was 168 hours. There was not previous temperature excursion. The call was not because of a "data logger". And there was no product quality complaint involved. A list of patients and actual dates of administration was not available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L045954, expiry date: 17-NOV-2017 and lot# L048465, expiry date: 02-DEC-2017 (route of administration was not reported). Temperature excursion details were reported as: temperature: 9C and time frame 204 hours and 26 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. Additional information is not expected, because there is no consent to contact the physician.
Sex: U
Vaccine: HEP, HPV4, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is an initial report received 02-NOV-2016 via a telephone call from a nurse practitioner. The nurse practitioner reported that an unknown number of patients may have been vaccinated with the following improperly stored vaccines: RECOMBIVAX, lot # M032653, expiration date 31-MAY2018, M-M-R-II, lot# M017346, expiration date 06-APR-2018, GARDASIL lot# K008621, expiration date 04-MAR-2017. It was reported that the storage temperature was 20 degrees C for 120 days (2,880 hours). It was reported the excursion dates were: 01-JUN-2016 through 30-AUG-2016. There was no previous temperature excursion. It was unknown if the vaccines were administered. No adverse events were reported. This telephone call report was because of a data logger. Additional information was requested.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Information has been received from a physician via a company representative referring to a currently 20 years old female patient. The patient's pertinent medical history, drug allergies and concomitant medications were unknown. On an unspecified date when the patient was 17 years old, she was vaccinated with GARDASIL or GARDASIL 9 (lot#, dose, frequency and route were not reported). On an unspecified date after vaccination, the patient began having "myalgia and neuromuscular weakness" and was being treated by an unspecified health care provider who got her hormones checked regularly for an unspecified reason. The outcome of the events was unknown. Additional information has been requested.