chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Erythema, Influenza like illness, Swelling
Clinical narrative: FLUZONE HD: chills, flu-like symptoms on late Friday 10-16-15 -> no treatment needed. PREVNAR 13: redness (size palm of hand), no pain, swollen start on Sat. 10-17-15 last 3-4 d.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Sensation of foreign body, Throat irritation, Urticaria
Clinical narrative: Itchy, scratchy throat; hives; coughing; "lump in throat". Seen in ER, BENADRYL, prednisone.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood pressure increased, Chest discomfort, Dizziness, Dysgeusia
Clinical narrative: Terrible taste in mouth after flu shot. Dizziness. Heavy chest, tight feeling in chest. Weaknessm shakiness. Nausea. Eleveated BP. Warm feeling skin very reddened. Seen in ER. Givent BENADRYL.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Nausea, Skin warm, Tremor
Clinical narrative: Terrible taste in mouth after flu shot. Dizziness. Heavy chest, tight feeling in chest. Weaknessm shakiness. Nausea. Eleveated BP. Warm feeling skin very reddened. Seen in ER. Givent BENADRYL.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: She received FLUARIX vaccine on 9/15/15 and by mistake another FLUARIX vaccine on 10/23/15. She has no symptoms - reporting for misadministration.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Nervous system disorder
Clinical narrative: Neurological side effects.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient noted redness of injection site, pain, swelling. since the shot (2nd day onwards). Didn't feel good. Slowly getting better but still with pain, redness and swelling. It is 7x10 cm area erythema, inch induration.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Wrong technique in product usage process
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received FLULAVAL QUADRIVALENT (batch number C92E7, expiry date 1st July 2016). On 13th October 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On 13th October 2015, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site swelling and wrong injection technique. On 15th October 2015, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovering/resolving and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to FLULAVAL QUADRIVALENT. Additional details were received as follows: On 15th October 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site warmth. The patient received FLULAVAL QUADRIVALENT, at four inches down from the acromium process, base of the deltoid, and the reporter was unsure of whether the route of administration was intramuscular, which led to wrong injection technique.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 51-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date 30th June 2016). On 7th October 2015, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 8th October 2015, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site redness, injection site swelling and contusion. On an unknown date, the outcome of the injection site redness, injection site swelling and contusion were recovering/resolving. The reporter considered the injection site redness, injection site swelling and contusion to be probably related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The reported injection site for FLULAVAL QIV vaccine was left arm. The patient experienced red, swollen arm (injection site) and bruising.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Formication, Injection site reaction, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a adult female patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date May 2016). On 7th October 2015, the patient received the 1st dose of FLULAVAL QUADRIVALENT .5 ml. On 7th October 2015, 15 min after receiving FLULAVAL QUADRIVALENT, the patient experienced pruritus. On 12th October 2015, the patient experienced injection site reaction. On 7th October 2015, the outcome of the pruritus was recovered/resolved. In October 2015, the outcome of the injection site reaction was recovered/resolved. The reporter considered the injection site reaction and pruritus to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient was also an employee of the facility. After the vaccination with FLULAVAL QIV vaccine, within fifteen minutes, the patient started to itch. The patient stated that itching was between her shoulders and felt like bugs were on her skin. The nurse stayed with the patient and provided BENADRYL for the itching. On 12th October 2015, 5 days after receiving the vaccine, the patient experienced injection site reaction. The patient was asked to contact the office if something like a reaction happened. Till the time of reporting, the patient had not contacted the facility.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Pertinent medical history and drug reactions/allergies were unspecified. Concomitant medications were reported as none. In 2008, the patient was vaccinated with ZOSTAVAX, (lot #, strength, dose and frequency not reported). On an unknown date (also reported as recently), the patient experienced an episode of shingles. The outcome of an episode of shingles was reported as recovered. Causality assessment was not provided. The patient sought medical attention. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Computerised tomogram abdomen abnormal, Herpes zoster, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This spontaneous report as received from a pharmacist and from the patient refers to a 64 year old female patient reporting on herself. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K014834 exp. 14-DEC-2015, (route and dose were not provided). Consumer states she also has history of Mitral valve prolapse, and high cholesterol. Concomitant medications included simvastatin (manufacturer unknown) 20 mg once daily, one baby aspirin daily, one multi vitamin daily, INDERAL 20 mg a day. The pharmacist stated that the patient came into the pharmacy recently and stated that she developed shingles on an unspecified recent date. In addition, the patient reported that she had gone to the local emergency rook on 03-OCT-2015, because she was in such severe pain radiating from her "belly to her back". They performed 2 Computerised Axial Tomography (CAT) scans looking for kidney stones but none found. The patient stated she was sent home with muscle relaxer and pain pills. Two days later, she went to an urgent care clinic, because she had such severe pain. They took 3 CAT scans and a nuclear magnetic resonance imaging (MRI). They found a urinary tract infection. Finally on 07-OCT-2015, she went to the urgent care clinic and got a prescription for the shingles. The shingles were located on her right lower stomach to her right back. The patient stated the health care provider told her that the size of the shingles was a manageable size and that may had been due to the fact she got vaccinated with ZOSTAVAX. The patient was prescribed NEURONTIN 200 mg three times a day, ZOVIRAX 80 mg five tablets by mouth once a day, and FLEXERIL once a day as needed. The patient stated that her husband also had ZOSTAVAX vaccine in December 2014, but he was not experiencing any adverse effects. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: This spontaneous report as received from a pharmacist and from the patient refers to a 64 year old female patient reporting on herself. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K014834 exp. 14-DEC-2015, (route and dose were not provided). Consumer states she also has history of Mitral valve prolapse, and high cholesterol. Concomitant medications included simvastatin (manufacturer unknown) 20 mg once daily, one baby aspirin daily, one multi vitamin daily, INDERAL 20 mg a day. The pharmacist stated that the patient came into the pharmacy recently and stated that she developed shingles on an unspecified recent date. In addition, the patient reported that she had gone to the local emergency rook on 03-OCT-2015, because she was in such severe pain radiating from her "belly to her back". They performed 2 Computerised Axial Tomography (CAT) scans looking for kidney stones but none found. The patient stated she was sent home with muscle relaxer and pain pills. Two days later, she went to an urgent care clinic, because she had such severe pain. They took 3 CAT scans and a nuclear magnetic resonance imaging (MRI). They found a urinary tract infection. Finally on 07-OCT-2015, she went to the urgent care clinic and got a prescription for the shingles. The shingles were located on her right lower stomach to her right back. The patient stated the health care provider told her that the size of the shingles was a manageable size and that may had been due to the fact she got vaccinated with ZOSTAVAX. The patient was prescribed NEURONTIN 200 mg three times a day, ZOVIRAX 80 mg five tablets by mouth once a day, and FLEXERIL once a day as needed. The patient stated that her husband also had ZOSTAVAX vaccine in December 2014, but he was not experiencing any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 04-OCT-2015, the patient was inadvertently administered with two doses of ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Fatigue, Flushing, Pruritus
Clinical narrative: Became flushed 10 min after receiving vaccine. Felt like hair standing on arms. Dizzy, chest pressure - 1 hour post vaccination - itching from nipple line up - no hives or rash - injection site fine - took CLARITIN - itching resolved. Legs fatigued after working shift and very fatigued this AM. Elbows itching this AM.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 81 year old female patient. Pertinent medical history included high blood pressure, high cholesterol, and hyperthyroidism. The patient had drug reactions/allergies to penicillin, PERCOCET, naproxen and IMITREX. Patient had taken unspecified concomitant medications. On 12-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L003188, expiry date 06-JUL-2016, 1 vial, intramuscularly in the left arm. The patient came into the physician's office on 14-OCT-2015 with redness, swelling, pain and warmth at the injection site, in her left arm. It was unspecified exactly when the symptoms started. Reporter requested the lot check PNEUMOVAX 23 single dose syringes. The patient was given 300 milligram (mg) Clindamycin and 25 mg Clindamycin (unspecified frequency and unspecified manufacturer). Lab diagnostics studies performed were reported as none. The outcome of the events was reported as recovering. Causality assessment was not provided. The patient sought medical attention (by office visit). No product quality complaint (PQC) was involved. No further information was given. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: UNK
Symptoms: Asthma, Dyspnoea, Wheezing
Clinical narrative: Asthma exascubation with dyspnea and wheezing.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer referring to her friend, a close to 70 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (route, lot# and dose were unknown). On an unknown date, about 4 to 5 years later the patient contracted shingles. The outcome of the event was unknown. The causality was not reported. Additional information is not expected as there was no reporter's contact information.
Age: 53.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Local pain, (L) deltoid (proximal/posterior) malaise from day #2 to day #9, low grade fever, body aches, joint pain.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a consumer (an account manager) of unknown age and gender via a company representative referring to himself/herself. Information about patient's concurrent conditions and medical history was not reported. On unknown dates the patient received at least one dose of (Merck) VARIVAX (lot#, dose and route not reported) and later, on an unspecified date the patient's titers showed negativity to the varicella virus. Outcome of the event was unknown. The causality was not provided. This is one of two reports from the same source (other linked case # 1510USA010832). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Patient called today; 10/19/15 and said she got little bruises and redness around the injection site about 1 inch per patient. No other system - no itch, no fever, no pain. I suggested if patient doesn't feel it is getting better, she can see doctor or if any sore, take TYLENOL.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Pt. experienced redness, inflammation et warmth to injection site. 2 days post injection site redness was 7 cm x 7 cm.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a female pharmacist (under 50 years old) via a company representative referring to herself. Information about patient's concurrent conditions and medical history was not reported. On unknown dates the patient was vaccinated with two doses of (Merck) VARIVAX (lot#, dose and route not reported). Concomitant medications were not provided. The patient reported that on an unspecified date after receipt of these vaccines, she had laboratory work conducted which showed negative titers for the varicella virus. Outcome of the event was unknown. The causality was not provided. This is one of two reports from the same source (other linked case # 1510USA010950). Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Rash approximately 6 inches by 5 inches at immunization site reported Oct 16, 2015.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Oedema, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm sore, hard to raise, (10-9) arm swollen and pink above elbow, (10-10) swelling below elbow - pink, sore, (10-11) swelling still present and pink swelling went down (10-12).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: 2 cm local reaction on (R) deltoid at the site of the injection. Patient advised to do OTC BENADRYL and Ibuprofen.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Heart rate decreased, Hypotension, Lethargy, Syncope
Clinical narrative: 10/15/15 Pt had syncopal episode approx 3 min after vaccine administered. Pt became hypotensive, 70/50; 2 min later 80/60. Pulse decreased 56; 2 min later P 80. Pulse Ox. 99. Pt was lethargic and weak for 5-10 min.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with (Merck) VARIVAX (lot # L012038, expiration date 07-APR-2017) (lot # was reported as L021215, expiration date 10-JUN-2017) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, warmth, swelling at injection site after injection. Treated with clindamycin. Area of erythema 8.5 x 6.5 cm left arm.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product reconstitution issue
Clinical narrative: Pt was here for MCV40. Pt was injected with diluent only. Vaccine was not mixed.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) (lot # L030592, expiration date 12-FEB-2017) (lot # L016395, expiration date 12-FEB-2017) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient reported bruising at injection site then hot, red, inflamed skin from site towards elbow. Patient saw doctor who administered a cortisone shot and an antibiotic (AUGMENTIN). Doctor didn't want to use BENADRYL due to a heart condition patient has.
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized erythema/swelling of injection site almost immediately after admin (L arm IM). Treating with ice and ibuprofen. No s/sx anaphylaxis.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, soreness, warm to touch at injection site.
Age: 1.13
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Pt developed redness and whelps around injection sites of MMR and varicella vaccines about 10 minutes after injections were given. Pt given 1.25 mL, Childrens BENADRYL 12.5,g/5mL orally. Approximately 15 minutes after medication given, redness and whelps had completely resolved.
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 patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot#L012838, expiration date: 10-MAR-2018, (dose, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Ran fever, had chills, lots of sweating (started) while sleeping. Gone next day. None, was gone by next morning.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, lot# K005402, expiration date: 07-NOV-2015, dose, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient has a red raised rash that was warm to the touch, probably infected, and was about 4 inches in diameter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ,  lot # K019372, expiration date: 16-JUL-2016 and lot# L000434, expiration date: 10-JUL-2016, orally, (dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus generalised
Clinical narrative: Pruritis, generalized.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, VIth nerve paralysis, Vision blurred
Clinical narrative: Felt unwell day 1-2 post vaccine then sudden onset blurred vision day 2-3 found to have (L) 6th nerve paralysis.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue, Inflammatory marker test, Laboratory test normal, Pain in extremity
Clinical narrative: Chronic persistent toe/knee/hand pain and fatigue aggravated by 3rd dose.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 21-OCT-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot# K009809, expiry date 16-MAY-2015), 0.5 ml intramuscularly. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. 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 nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, between 01-SEP-2015 and 30-SEP-2015, the patients were vaccinated with improperly stored doses in immunization series of (Merck) VARIVAX, lot # K001390, expiration date 29-JAN-2016 (strength, dose and route of administration were not provided). Concomitant therapy was not provided. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Erythema, Injection site mass
Clinical narrative: States started with lump at site Rt. upper arm. Approx 3 days ago notice large red area. Measures 17.5 cm x 11.5 cm red, not raised.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Papule, Rash, Urticaria
Clinical narrative: Pt developed small urticarial papules 1st on lower extremities and then spreading to torso within minutes of receiving vaccines. Pt was given BENADRYL and rash resolved.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unspecified dates, the patients were administered improperly stored (Merck) VARIVAX lot/batch # reported as L021212, expiration date 10-JUN-2017 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse Practitioner refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2014, the patient was vaccinated with first in the series of GARDASIL (dose, frequency, and route of administration not provided). On 15-AUG-2015, the second dose in the series was GARDASIL 9 administered. On 20-OCT-2015 (today), the third in the series dose was GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) administered. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. In approximately 2011 (reported as 4 years ago), the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose and route not reported). In approximately 2013 (reported as 2 years later), the second dose (lot#, expiration date dose and route not reported) and the third dose (lot#, expiration date dose and route not reported) were administered. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II, lot# K024035, expiration date: 26-NOV-2016 and lot# K014832, expiration date: 14-SEP-2016, (dose, route of administration, albumin status and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a Nurse Practitioner concerning an adult patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 13-OCT-2015, the patient was inadvertently administered a pediatric dose of RECOMBIVAX HB 5/0.5 mcrg/ml (lot # J007943, exp. date on 05-FEB-2016), (route of administration was not provided), 0.5 ml. There was no concomitant medication reported. No adverse effects reported. A product quality complaint was not involved. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Local redness and swelling.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown date during 2015, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# K001196 exp. 22-OCT-2015) (1 dose) and (lot# K0011948 exp. 07-JUN-2016) (5 doses) (dose was not reported) by oral route. There was no concomitant medication described. No adverse symptoms were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Influenza like illness, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Dizziness, fever and stiffened up, flu like symptoms.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 55-year-old male patient who received BOOSTRIX (batch number AG7KY, expiry date 20th May 2016). On 12th September 2015, the patient received BOOSTRIX .5 ml. On 26th September 2015, 14 days after receiving BOOSTRIX, the patient experienced nerve pain and numbness in fingers. On an unknown date, the outcome of the nerve pain and numbness in fingers were not recovered/not resolved. The reporter considered the nerve pain and numbness in fingers to be possibly related to BOOSTRIX. Additional details were received as follows: This case was previously reported to a doctor. On 26th September 2015, two weeks after vaccination, the patient experienced left arm nerve pain in forearm, elbow and shoulder and left hand numbness in thumb, index and middle fingers.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site nodule, Injection site pain, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 55-year-old male patient who received BOOSTRIX (batch number AG7KY, expiry date 20th May 2016). On 12th September 2015, the patient received BOOSTRIX .5 ml. On 26th September 2015, 14 days after receiving BOOSTRIX, the patient experienced nerve pain and numbness in fingers. On an unknown date, the outcome of the nerve pain and numbness in fingers were not recovered/not resolved. The reporter considered the nerve pain and numbness in fingers to be possibly related to BOOSTRIX. Additional details were received as follows: This case was previously reported to a doctor. On 26th September 2015, two weeks after vaccination, the patient experienced left arm nerve pain in forearm, elbow and shoulder and left hand numbness in thumb, index and middle fingers.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker - Certified Medical Assistant (CMA) on 13-OCT-2015 reported that unspecified patients received improperly stored PNEUMOVAX 23, MMR II (Reference MARRS # 1510USA006844), RECOMBIVAX HB (reported by CMA as RECOMBIVAX) (Reference MARRS # 1510USA011361), and GARDASIL (reported by CMA as GARDASIL (HPV-4)) (Reference MARRS # 1510USA009473 (Lot #, expiration date were provided for this case). Lot numbers and expiration dates of vaccines that were administered were not known. No adverse effects were reported. No further information was provided. on 15OCT2015, the healthcare worker - Certified medical assistant (CMA) called back to provide data as follows on administered dose: Patient (gender not reported, patient initials provided) received a dose of improperly stored PNEMOVAX 23 (Lot number 1005563 (as reported), expiration date 03NOV2016) on 12OCT2015. [Lot number 1005563 is an invalid lot number of PNEUMOVAX 23.] The healthcare worker did not report that any other products or doses were administered to patients as noted previously. (This is conflicting information. It is unclear if other patients had received a dose of improperly stored vaccine(s).) No adverse effects reported. No further information provided. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker - Certified medical assistant (CMA) on 13-OCT-2015 reported that unspecified patients received improperly stored GARDASIL (reported by CMA as GARDASIL, M-M-R II (Reference MARRS # 1510USA006844), RECOMBIVAX HB (Reference MARRS # 1510USA011361), and PNEUMOVAX 23 (Reference MARRS # 1510USA009474). Lot numbers and expiration dates of vaccines that were administered were not known. No adverse effects were reported. No further information was provided. On 15OCT2015, the healthcare worker - Certified medical assistant (CMA) called back to provide data as follows on administered dose: Patient (gender not reported, patient initials provided) received a dose of improperly stored GARDASIL  (Lot number K016966, expiration date 10MAY2017) on 12-OCT-2015. The healthcare worker did not report that any other products or doses were administered to patients as noted previously. (This is conflicting information. It is unclear if other patient had received a dose of improperly stored vaccine(s). No adverse effects reported. No further information provided. Additional information has been requested. This is one of several reports received from same source.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose and route not provided). Concomitant therapies were not provided. On an unspecified date, "two weeks" after receiving the dose of ZOSTAVAX; the patient developed an unspecified rash on an unspecified part of the body. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker - Certified medical assistant (CMA) on 13-OCT-2015 reported that unspecified patients received improperly stored RECOMVIBAX HB (reported by CMA as RECOMBIVAX), MMR II (Reference MARRS # 1510USA006844), GARDAIL (reported by CMA as GARDASIL (HPV-4)), and PNEUMOVAX 23. Lot numbers and expiration dates of vaccines that were administered were not known. No adverse effects were reported. No further information was provided. On 15OCT2015, the healthcare worker - Certified medical assistant (CMA) called back to provide data as follows on administered doses: GARDASIL (Lot number K016966, expiration date 10MAY2017) (Reference MARRS # 1510USA009473.) and PNEUMOVAX 23 (lot number 1005563 (as reported), expiration date 03NOV2016). [Lot number 1005563 is an invalid lot number for PNEUMOVAX 23] (Reference MARRS # 1510USA009474.) The healthcare worker did not report that any other products or doses were administered to patients as noted previously. (This is conflicting information. It is unclear if other patients had received a dose of improperly stored vaccine(s).) No adverse effects reported. No further information provided. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: HEP, HPV4, MMR, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker- Certified medical assistant (CMA) on 13-OCT-2015 reported that unspecified patients received improperly stored M-M-R II, RECOMBIVAX HB (reported by CMA as RECOMBIVAX (reference MARRS # 1510USA011361), GARDASIL (reported as GARDASIL (HPV-4)), and PNEUMOVAX23. Lot number and expiration dates of vaccines that were administered were not known. No adverse effects were reported. No further information was provided. On 15OCT2015, the healthcare worker- Certified medical assistant (CMA) called back to provide data as follows on administered doses: GARDASIL (Lot number k016966, expiration date 10MAY2017) (Reference MARRS # 1510USA009473.) and PNEUMOVAX23 (Lot number 1005563 (as reported), expiration date 03NOV2016). (Lot number 1005563 is an invalid lot number for PNEUMOVAX23 (Reference MARRS # 1510USA009474.) The healthcare worker did not report that any other products or doses were administered to patients as noted previously. (This is conflicting information. It is unclear if other patients had received a dose of improperly stored vaccine(s).) No adverse effects reported. No further information provided. Additional information has been requested. This is one of several reports received from same source.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with two improperly stored GARDASIL (lot# K006449 exp. 19-JUN-2016) and one dose of improperly stored GARDASIL (lot# L001442 exp. 04-NOV-2016). Concomitant therapy was not reported. No adverse effect was reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Diarrhoea, Nausea, Pain
Clinical narrative: Diarrhea; nausea; body aches; chills; 100.8 temp which lasted 24 hours.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Immediate post-injection reaction, Impaired work ability, Injection site pain, Myalgia
Clinical narrative: Very sore at site of injection immediately. Body aches began around 9 pm and progressively intensified until muscles of legs, back, arms, buttocks, and feet became very tender and painful.  Patient worked night shift at hospital and had difficulty walking and working due to pain. At 7:30 am on 10/23/15, took 400 mg of ibuprofen, 500 mg of Vit C, 5000 iu of vitamin D, and Zoloft 25 mg, and then went to sleep. Muscle aches had disappeared upon awakening at noon on 10/23/15.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Very sore at site of injection immediately. Body aches began around 9 pm and progressively intensified until muscles of legs, back, arms, buttocks, and feet became very tender and painful.  Patient worked night shift at hospital and had difficulty walking and working due to pain. At 7:30 am on 10/23/15, took 400 mg of ibuprofen, 500 mg of Vit C, 5000 iu of vitamin D, and Zoloft 25 mg, and then went to sleep. Muscle aches had disappeared upon awakening at noon on 10/23/15.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Flushing, Nausea
Clinical narrative: Flushing, blood pressure increase, nausea, faint feeling, warmth.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain
Clinical narrative: Achy pain in left shoulder. Injection site was high on the arm. Achiness comes and goes. The site of pain is a couple of inches below the injection site. I have this pain numerous times a day for up to an hour. It hurts to lift my arm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Violent chills and shaking followed by fever of 102. This lasted until about 5 AM.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized pain-moderate, and redness along with mild swelling.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Chills, Dyspnoea, Inflammation, Musculoskeletal pain, Pyrexia
Clinical narrative: Patient experienced shortness of breath, shoulder rash, fever, chills, as well as shoulder pain and inflammation.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Rash
Clinical narrative: Patient experienced shortness of breath, shoulder rash, fever, chills, as well as shoulder pain and inflammation.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Feeling cold, Immediate post-injection reaction, Musculoskeletal disorder, Pain in extremity
Clinical narrative: He felt very cold, shivering, felt too cold to walk. He was in a warm room at school at the time. His rectal temperature at about 3:45 PM was 101*. At 4:30 PM it was 103.2*. It was 99* at 10:00 PM. By the next morning, there was no fever and no more symptoms. In addition, his arm hurt badly enough immediately after getting the flu shot that he didn't use it for the rest of the first day.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: He felt very cold, shivering, felt too cold to walk. He was in a warm room at school at the time. His rectal temperature at about 3:45 PM was 101*. At 4:30 PM it was 103.2*. It was 99* at 10:00 PM. By the next morning, there was no fever and no more symptoms. In addition, his arm hurt badly enough immediately after getting the flu shot that he didn't use it for the rest of the first day.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Sore neck and neck area to upper shoulders.  Could barely move neck and it was terribly painful on 10/22, 10/23 and still is painful today.  Muscles in neck are still sore.
Age: 20.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Gave Tdap shot then immediately after giving the flu shot the patient loss consciousness.  She turned very pale.  No seizure and still breathing.  She regained consciousness before paramedics arrived and no treatment was given.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Depression, Emotional distress, Feeling abnormal
Clinical narrative: Crying, depressed unable to get out of bed (emotionally) reluctant to even speak. Monday afternoon I was well and happy and the following morning I woke up and felt like a freight train had hit me.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Patient reports developing a headache early the next morning after the immunizations. She also had a change in blood pressure medicine (from lisinopril to Benicar). She still has an off and on headache today, 10/24/15. Patient reports acetaminophen lessens the pain.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Blood test, Contusion, Epistaxis, Immune thrombocytopenic purpura, Oral mucosal eruption
Clinical narrative: Patient over night was covered in bruises and red dots all over her body and in her mouth and a bloody nose. I rushed her to the ER and she ended up being diagnosed with ITP a blood disorder that they said was brought on by a virus but I have now realized it was from a MMR vaccination she received.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Patient over night was covered in bruises and red dots all over her body and in her mouth and a bloody nose. I rushed her to the ER and she ended up being diagnosed with ITP a blood disorder that they said was brought on by a virus but I have now realized it was from a MMR vaccination she received.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Patient states she is itchy all over and has had this for a week.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Nodule, Tenderness
Clinical narrative: Redness, tenderness, warmth, small tender nodule.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Terrible burning pain on left arm (couldn't lift arm past waist-high) - then noticed significant swelling and redness (like sunburn) on upper left arm from the site of where injection of Pneumovax was administered to below elbow.  Tremendous pain prevented left elbow from bending.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Terrible burning pain on left arm (couldn't lift arm past waist-high) - then noticed significant swelling and redness (like sunburn) on upper left arm from the site of where injection of Pneumovax was administered to below elbow.  Tremendous pain prevented left elbow from bending.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Blood test, Erythema, Injection site erythema, Injection site infection, Malaise
Clinical narrative: Terrible burning pain on left arm (couldn't lift arm past waist-high) - then noticed significant swelling and redness (like sunburn) on upper left arm from the site of where injection of Pneumovax was administered to below elbow.  Tremendous pain prevented left elbow from bending.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Terrible burning pain on left arm (couldn't lift arm past waist-high) - then noticed significant swelling and redness (like sunburn) on upper left arm from the site of where injection of Pneumovax was administered to below elbow.  Tremendous pain prevented left elbow from bending.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Blood test, Erythema, Infection, Injection site erythema, Malaise
Clinical narrative: Terrible burning pain on left arm (couldn't lift arm past waist-high) - then noticed significant swelling and redness (like sunburn) on upper left arm from the site of where injection of Pneumovax was administered to below elbow.  Tremendous pain prevented left elbow from bending.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Fatigue, Malaise, Skin warm, Tenderness
Clinical narrative: 3 inch circle of red skin, tenderness, warmth, feeling of malaise, fatigue.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 24 hours after vaccine administration, patient's mom noticed that the vaccine site (left deltoid) was swollen. The patient is afebrile and does not appear to be in any distress. On examination, the patient's left arm (from Left pectorus to Left elbow joint) is diffusely swollen, tense, erythematous, warm, and mildly tender. There is slight limitation of range of motion due to pain. This appears to be an impressive hypersensitivity reaction rather than an infectious etiology such as cellulitis.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Approximately 24 hours after vaccine administration, patient's mom noticed that the vaccine site (left deltoid) was swollen. The patient is afebrile and does not appear to be in any distress. On examination, the patient's left arm (from Left pectorus to Left elbow joint) is diffusely swollen, tense, erythematous, warm, and mildly tender. There is slight limitation of range of motion due to pain. This appears to be an impressive hypersensitivity reaction rather than an infectious etiology such as cellulitis.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Chest pain, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Severe chest, back and neck pain. Swelling and pain at point of injection.