chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Dizziness, Dysgeusia, Immediate post-injection reaction, Nausea
Clinical narrative: Right after shot was given, patient experienced nausea (w/ salty and bloody taste), cold sweat, dizziness and his face got pale. He drank water and orange juice and with a little rest he got better. 911 was called but mom cancelled shortly after since he was getting better.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor
Clinical narrative: Right after shot was given, patient experienced nausea (w/ salty and bloody taste), cold sweat, dizziness and his face got pale. He drank water and orange juice and with a little rest he got better. 911 was called but mom cancelled shortly after since he was getting better.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a male consumer of unknown age, referring to himself. Current conditions and relevant medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous injection, strength, dose number, route, anatomical location, lot # and expiration date not reported). Concomitant medications were not reported. The consumer stated that on an unknown date developed a rash on various parts of his body after receiving ZOSTAVAX. The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information is not expected. because no contact details were provided.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 month old patient of unknown gender. Medical history and drug reactions/allergies were not reported. On 26-JUL-2014, the patient was vaccinated with an expired ROTATEQ lot # J002356 expiry date 17-JUL-2014, third dose, oral (dose not reported). Concomitant medication was not reported. No adverse effects reported. This is one of two reports from the same source (1408USA003108). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with GARDASIL which had been improperly stored (lot #, expiration date, frequency, dose and route were unknown). And no adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.61
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. Follow-up information as received from office manager refers to a 19 months old patient. On 05-APR-2014 the patient was vaccinated with a dose of improperly stored (Oka/Merck) (lot # J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with RECOMBIVAX HB which had been improperly stored (lot#, expiration date, frequency, dose and route were unknown). And no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On an unknown date the patient received a 4th dose of GARDASIL (lot #, dose, route not reported). Concomitant medications were not provided. No adverse symptoms were reported. This is one of several report received from the same reporter (other MARRS#1408USA007680). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The pharmacist informed that on 13-AUG-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 (dosage and route were not reported) injection lot # J009827 and that had expired on 10-AUG-2014. Concomitant therapy was not reported. No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: This spontaneous report was received from a health care worker that there was a daily news article in the 09-AUG-2014, refers to a 12 year old female patient with sore throat. Medical history was not reported. On 30-JUL-2014 the patient was vaccinated with HPV vaccine (MANUFACTURER UNKNOWN) (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The healthcare worker informed that the patient died after receiving an unspecified HPV vaccine (MANUFACTURER UNKNOWN). The health care worker stated that according to the article the patient was at an unspecified physician's office for a sore throat on 30-JUL-2014 at that visit the patient was given an unspecified HPV vaccine (MANUFACTURER UNKNOWN) and died later that day. It was unspecified if the autopsy was done. The cause of death was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Fall, Pulse absent, Respiratory arrest, Skin warm
Clinical narrative: This spontaneous report was received from a health care worker that there was a daily news article in the 09-AUG-2014, refers to a 12 year old female patient with sore throat. Medical history was not reported. On 30-JUL-2014 the patient was vaccinated with HPV vaccine (MANUFACTURER UNKNOWN) (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The healthcare worker informed that the patient died after receiving an unspecified HPV vaccine (MANUFACTURER UNKNOWN). The health care worker stated that according to the article the patient was at an unspecified physician's office for a sore throat on 30-JUL-2014 at that visit the patient was given an unspecified HPV vaccine (MANUFACTURER UNKNOWN) and died later that day. It was unspecified if the autopsy was done. The cause of death was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Somnolence, Vomiting
Clinical narrative: This spontaneous report was received from a health care worker that there was a daily news article in the 09-AUG-2014, refers to a 12 year old female patient with sore throat. Medical history was not reported. On 30-JUL-2014 the patient was vaccinated with HPV vaccine (MANUFACTURER UNKNOWN) (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The healthcare worker informed that the patient died after receiving an unspecified HPV vaccine (MANUFACTURER UNKNOWN). The health care worker stated that according to the article the patient was at an unspecified physician's office for a sore throat on 30-JUL-2014 at that visit the patient was given an unspecified HPV vaccine (MANUFACTURER UNKNOWN) and died later that day. It was unspecified if the autopsy was done. The cause of death was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a health care worker that there was a daily news article in the 09-AUG-2014, refers to a 12 year old female patient with sore throat. Medical history was not reported. On 30-JUL-2014 the patient was vaccinated with HPV vaccine (MANUFACTURER UNKNOWN) (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The healthcare worker informed that the patient died after receiving an unspecified HPV vaccine (MANUFACTURER UNKNOWN). The health care worker stated that according to the article the patient was at an unspecified physician's office for a sore throat on 30-JUL-2014 at that visit the patient was given an unspecified HPV vaccine (MANUFACTURER UNKNOWN) and died later that day. It was unspecified if the autopsy was done. The cause of death was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a health care worker that there was a daily news article in the 09-AUG-2014, refers to a 12 year old female patient with sore throat. Medical history was not reported. On 30-JUL-2014 the patient was vaccinated with HPV vaccine (MANUFACTURER UNKNOWN) (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The healthcare worker informed that the patient died after receiving an unspecified HPV vaccine (MANUFACTURER UNKNOWN). The health care worker stated that according to the article the patient was at an unspecified physician's office for a sore throat on 30-JUL-2014 at that visit the patient was given an unspecified HPV vaccine (MANUFACTURER UNKNOWN) and died later that day. It was unspecified if the autopsy was done. The cause of death was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Hypersomnia, Loss of consciousness, Resuscitation, Somnolence
Clinical narrative: This spontaneous report was received from a health care worker that there was a daily news article in the 09-AUG-2014, refers to a 12 year old female patient with sore throat. Medical history was not reported. On 30-JUL-2014 the patient was vaccinated with HPV vaccine (MANUFACTURER UNKNOWN) (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The healthcare worker informed that the patient died after receiving an unspecified HPV vaccine (MANUFACTURER UNKNOWN). The health care worker stated that according to the article the patient was at an unspecified physician's office for a sore throat on 30-JUL-2014 at that visit the patient was given an unspecified HPV vaccine (MANUFACTURER UNKNOWN) and died later that day. It was unspecified if the autopsy was done. The cause of death was unknown. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Cyanosis, Death, Mechanical ventilation
Clinical narrative: Patient was found blue in crib around 7:30 pm on the evening of July 2nd. 911 was call they got patient oxygen and was stabilized at hospital then was med flighted to another hospital where they put patient on a ventilator and he passed away July 4th around 845pm.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Diplopia, Headache, Lymphadenopathy, Musculoskeletal discomfort
Clinical narrative: Headache, chills, jaw pain, followed by swollen sublingunal gland, neck sensitivity, double vision, constant headache, neuropathy.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Neuropathy peripheral, Pain in jaw
Clinical narrative: Headache, chills, jaw pain, followed by swollen sublingunal gland, neck sensitivity, double vision, constant headache, neuropathy.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Diplopia, Headache, Laboratory test, Lymphadenopathy
Clinical narrative: Headache, chills, jaw pain, followed by swollen sublingunal gland, neck sensitivity, double vision, constant headache, neuropathy.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal discomfort, Neuropathy peripheral, Pain in jaw
Clinical narrative: Headache, chills, jaw pain, followed by swollen sublingunal gland, neck sensitivity, double vision, constant headache, neuropathy.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Abnormal behaviour, Back pain, Blood test, Breath holding, Electroencephalogram abnormal
Clinical narrative: Complained her back hurt and her legs hurt.  Gave Motrin then a few weeks later noticed strange activity.  In December noticed she was holding her breath during this strange activity.  Contacted doctor and they ordered eeg and mri eeg showed activity.  Referred to neurologist.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Complained her back hurt and her legs hurt.  Gave Motrin then a few weeks later noticed strange activity.  In December noticed she was holding her breath during this strange activity.  Contacted doctor and they ordered eeg and mri eeg showed activity.  Referred to neurologist.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash, Rash erythematous
Clinical narrative: Baby woke up with a red rash, some partly raised, covering approx. 80-85% of his torso and back. Some of it extended onto his buttocks, neck, and ears, but none on his face, lower legs, or arms. He was vaccinated in the arm. Baby did NOT exhibit any signs of breathing difficulty or discomfort with the rash; that is, he was not scratching or itching. He went to sleep the night prior at about 7:30 PM. He did not have any signs of the rash at that time. He awoke at approx 7:00 AM on Friday morning, and when I undressed him from his pajamas, that is when I discovered the rash.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 year old male patient. The nurse reported that on 01-AUG-2014 and 05-AUG-2014, the patient received a pediatric dose of VAQTA (injection, 25/0.5 (unit not reported) (lot # unknown) (dose/frequency, route unknown). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patients drug allergies and concurrent conditions were not reported. On 11-AUG-2014 the patient was vaccinated with expired does of ZOSTAVAX (Dose Frequency: 0.65 ml, Therapy Route: Subcutaneous) (lot # J011211, expiry date: 31-JUL-2014). No adverse effect was reported. No product quality complaint PQC was reported for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red and slightly bumps on her upper left arm extending to the left side of the neck. No blistering. I gave her a packet of diphenhydramine 25 mg and asked her to take one tablet every 6 hours around the clock for a couple of days and if symptoms does not resolve, she needs to see her PCP for possible corticosteroid therapy.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Alopecia, Asthenia, Emotional distress, Fatigue, Skin papilloma
Clinical narrative: This spontaneous report was received from patient's mother via company representative refers to a 11 year old male patient. Medical history was not reported. In September 2013 the patient was vaccinated with the first dose of GARDASIL the second dose was administered in November 2013 and the third dose was administered on 27-MAR-2014, the lot number, expiration date, strength and route were not reported for all of them. Concomitant therapy was not reported. The consumer informed that approximately on 10-APR-2014 (also reported as two weeks after the third dose) her son felt weak and fatigued and patches of his hair began to fall out. Also informed that she took her son to see a dermatologist who diagnosed her son with alopecia. A topical ointment was used on the patient's scalp to prevent further hair loss, therefore the patient began receiving shots in his scalp. The consumer also stated that on approximately August 2014, her son just got three warts on his hand and he was still tired, which was causing him significant distress. The reporter considered that the events caused significant disability or incapacity to the patient. The outcome of the events was not recovered. Additional information is not expected because the reporter refuse the contact with the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Since 25-JUL-2014, unknown number of vaccinated with M-M-R II (lot #, expiration date, route, frequency and dose were unknown) which had been improperly stored were administered to unspecified number patients. No adverse effects were reported. This one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 04-AUG-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 0.65 ml, subcutaneously (lot # K000995, expiry date: 16-MAR-2015 (reported as 06-MAR-2015); indication unspecified. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 04-AUG-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 0.65 ml injection, subcutaneously (lot # K000995, expiry date: 16-MAR-2015 (reported as 06-MAR-2015); indication unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Since 25-JUL-2014, the patients were vaccinated with PNEUMOVAX23 (lot #, expiration date, route, frequency and dose were unknown) which had been improperly stored. No adverse effects were reported. This one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 04-AUG-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J000443, expiration date 11-APR-2014, dose, route, frequency and strength were unknown). No adverse effects were reported. The outcome of the events was unknown.  Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient. The patients drug allergies and pertinent medical history was not reported. On 22-DEC-2011 the patient was vaccinated with first dose of M-M-R II (dose/frequency and route were not reported) when the patient was 6 months old. Concomitant medications were not reported. The second dose of M-M-R II was administered on 17-OCT-2012. No adverse effects reported. No product quality complaint (PQC) was reported for M-M-R II. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The pharmacist reported that on 29-JUL-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (injection) (lot#, dose/frequency and route unknown) (expiration date: 11-JUL-2014). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles post vaccine, Mumps, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from a medical assistant in physicians office via field representative refers to a male patient (medical assistants son). The patient's drug allergies were unspecified and the pertinent medical history included some birth problems and feet turned in wrong direction (worse braces to correct). On an unknown date the patient was vaccinated with M-M-R II (dose/frequency: standard milliliter (ml) one dose; Therapy Route: Unspecified and lot # and expiry date were unspecified) a few months prior to being 18 months of age. Concomitant medications were unspecified. The patient developed mumps and measles after receiving the M-M-R II around 18 months of age. The patient also received M-M-R II at 20 years of age approximately in August 2014 (reported as now 20 years) and then developed mumps and measles. The patient sought medical attention and treatment provided was unspecified. The outcome of developed mumps and measles, developed mumps and measles was reported as recovered on an unspecified date. The causality of measles and mumps was not reported. No product quality complaint (PQC) was reported for M-M-R II. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were not adverse effects reported.  It was unspecified wether the patients had sought any medical attention. There was no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call or fax information as it become available. Also reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time.  Follow-up information as received from a healthcare professional refers to a 2 years of patient. On 11-JUN-2014 the patient was vaccinated with a dose of improperly stored M-M-R II (lot # reported as J011332, expiration date 13-SEP-2015) (strength, dose, route and site of administration were not reported).  This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient received a 4th dose of GARDASIL (lot #, dose, route not reported). Concomitant medications were not provided. No adverse symptoms were reported. This is one of several report received from the same reporter (other MARRS#1408USA007763). Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back or fax information as it become available. Also report that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from office manager refers to a 12 months old patient. On 04-JUN-2014 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J012818, expiration date: 10-OCT-2015) (strength, dose, route and site of administration were not reported.  This is one of several reports from the same source. Additional information has been requested.
Age: 1.61
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were not adverse effects reported.  It was unspecified wether the patients had sought any medical attention. There was no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call or fax information as it become available. Also reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time.  Follow-up information as received from a healthcare professional refers to a 19 months old patient. On 03-JUN-2014 the patient was vaccinated with a dose of improperly stored M-M-R II (lot # reported as J011332, expiration date 13-SEP-2015) (strength, dose, route and site of administration were not reported).  This is one of several reports from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin mass, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The pharmacist stated that there was no record on patient of past history and medications and the patient had "never been a drug reaction".  On 05-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml once, lot# was not provided) subcutaneously. On 07-AUG-2014, the patient sought for medical attention by contacting the pharmacist and stated that she (patient) had a lump under her skin, swelling, redness but no pain. Pharmacist stated she advised patient to consider cold compresses to the area. No lab diagnostics studies were performed. The outcome of the events was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Herpes zoster
Clinical narrative: This spontaneous report as received from a 65 year old female consumer regarding herself as a patient with asthma. There were no drug reactions or allergies. In June or July 2013, the patient was vaccinated with ZOSTAVAX (one time vaccine, route reported as injection (lot and does not reported). Concomitant medication included an inhaler for asthma. On 23-JUL-2014, the patient experienced shingles. It started on the patient's face on whole right side of face and right ear. The patient sought for medical attention and was prescribed VALTREX and gabapentin (manufacturer unknown) for pain on face and ears. No lab diagnostics performed. The outcome of shingles was not reported.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No adverse effects.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pain
Clinical narrative: EMPLOYEE C/O OF NAUSEA AND BODY ACHING 6 HOURS AFTER IMMUNIZATION. MSA CALLED DR. AND SHE STATES IT COULD BE A NORMAL SIDE EFFECT TO THE IMMUNIZATION. EMPLOYEE STATES HE IS FEELING BETTER NOW (0900 8/15/14) EMPLOYEE ADVISED TO GO TO URGENT CARE IF SYMPTOMS GET WORSE.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Pruritus, Rash, Throat irritation
Clinical narrative: Symptoms rash, pruritus, scratchy throat, cough approximately 20 minutes after administration of Hepatitis B Vacccine. Treatment - Prednisone, Bendaryl, Zyrtec, Zantac.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date these unspecified patients were vaccinated with 4 doses of (Oka/Merck) PROQUAD (lot #, dose, route not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter (other MARRS#1408USA006719). Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender whom since 24-JUN-2014 have received (Oka/Merck) VARIVAX, subcutaneous (lot #, dose and route not reported) which went out of temperature range multiple times. These excursions were supported. No adverse effects were reported. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Age: 41.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 41 year old female patient with inappropriate dose of MMR II and RECOMBIVAX. On 17-JULY-2014, the patient was vaccinated with M-M-R II and RECOMBIVAX. On 23-JULY-2014, the patient inadvertently received another dose of RECOMBIVAX and M-M-R II.  No adverse effects were reported. No further information was provided. The outcome of extra dose of RECOMBIVAX and M-M-R II is unknown. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 4 cm raised, round, painful, itchy area - back of (L) arm.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Bowel movement irregularity, Decreased appetite, Irritability, Lethargy, Pyrexia
Clinical narrative: Fever for one and a half days, reaching 104.3 degrees; lethargy; fussiness; lack of appetite; no bowel movements for a day, reduced urination; treated with infant Motrin.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urine output decreased
Clinical narrative: Fever for one and a half days, reaching 104.3 degrees; lethargy; fussiness; lack of appetite; no bowel movements for a day, reduced urination; treated with infant Motrin.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Within 12 hrs temp > 103 during the night after IMM given. Mom had treated with ibuprofen. Next day temp 103 counselled pt to to to ER. Unable to speak with parents.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MNQ, TDAP
Symptoms: Erythema, Feeling hot, Localised oedema, Tenderness
Clinical narrative: Local erythema, local edema (moderate), warmth, mild pain to touch, at this time. Pt given prednisone 5 mg B.I.D. x 3 days per physician orders.
Age: 45.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out after receiving vaccines. Sometime had passed, then pt passed out.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test, Neuropathy peripheral, Polymyalgia rheumatica
Clinical narrative: Axillary neuropathy x4 mo - physical therapy. Polymyalgia rheumatica, ongoing. Tx: Prednisone.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Pyrexia, Rash, Rash erythematous, Tenderness
Clinical narrative: Patient came by this morning at 10:30 AM to notify us of fever which has been subsided after patient took Tylenol. Patient also has blister spots all over body. Per father, patient started having these blisters last evening. There were a couple of bigger ones (on index fingertip and sole of foot) that patient said are painful to the touch, but not itchy. I noticed a few more red spots on patient's forehead. Told the patient that the reaction might be from vaccine, to take a dose of Benadryl and call pediatrician as soon as possible.
Age: 14.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Electrocardiogram QT prolonged, Fatigue, Feeling abnormal, Feeling cold, Feeling hot
Clinical narrative: Patient fainted- unconscious for a few seconds, then became alert, but c/o tiredness, headache, nausea (no vomiting, didn't "feel right".  C/o feeling hot at first; later c/o feeling cold.  After laying in supine position she tried to sit up and c/o nausea and not feeling well.  She layed down again.  This happened 3 times.  Patient remained coherent.  Pulse strong and regular.  B/P 84/98, 90/50, and 100/60.  Transported to hospital by ambulance.
Age: 14.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Headache, Loss of consciousness, Malaise, Nausea, Syncope
Clinical narrative: Patient fainted- unconscious for a few seconds, then became alert, but c/o tiredness, headache, nausea (no vomiting, didn't "feel right".  C/o feeling hot at first; later c/o feeling cold.  After laying in supine position she tried to sit up and c/o nausea and not feeling well.  She layed down again.  This happened 3 times.  Patient remained coherent.  Pulse strong and regular.  B/P 84/98, 90/50, and 100/60.  Transported to hospital by ambulance.
Age: 49.0
Sex: M
Vaccine: DTAP, HEPA, MEN, YF
Symptoms: Musculoskeletal pain, Periarthritis
Clinical narrative: One week after vaccination I started to suffer from shoulder pain. I have visited health care professionals and attended physical therapy for Adhesive Capsulitis...pain still persists today.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMRV, PPV
Symptoms: Decreased appetite, Hypersensitivity, Induration, Miliaria, Pyrexia
Clinical narrative: My son got a hard lump in the arm where his shot was administered, he threw up twice three days after his shots (19th), He had no appetite until 12pm 07/25/2014. The morning of 7/27/2014 he had a rash appear on his arm by the lump that resembled ring worm. He got a sudden fever by 7pm and spiked up to 102 degrees by 8pm so I took him to the ER. They confirmed he had a allergic reaction to the MMRV shot (they took no tests). The fever lasted 14hrs only. On 7/28/2014 the rash on his arm was gone but a heat looking rash started on his neck. So I took him to his Dr., the Dr. said it was just a virus (he took no tests). The fever got worse when we got out in the heat to our car. By evening my son had a rash all over his face and his stomach, and back. The rash had small red pinpoint spots and eraser size spots. The rash lasted 3 days. He still has the lump in his arm. But otherwise he seems to be doing "better".
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMRV, PPV
Symptoms: Rash, Rash erythematous, Upper extremity mass, Viral infection
Clinical narrative: My son got a hard lump in the arm where his shot was administered, he threw up twice three days after his shots (19th), He had no appetite until 12pm 07/25/2014. The morning of 7/27/2014 he had a rash appear on his arm by the lump that resembled ring worm. He got a sudden fever by 7pm and spiked up to 102 degrees by 8pm so I took him to the ER. They confirmed he had a allergic reaction to the MMRV shot (they took no tests). The fever lasted 14hrs only. On 7/28/2014 the rash on his arm was gone but a heat looking rash started on his neck. So I took him to his Dr., the Dr. said it was just a virus (he took no tests). The fever got worse when we got out in the heat to our car. By evening my son had a rash all over his face and his stomach, and back. The rash had small red pinpoint spots and eraser size spots. The rash lasted 3 days. He still has the lump in his arm. But otherwise he seems to be doing "better".
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Skin burning sensation, Urticaria
Clinical narrative: Pt states he developed hives all over his body after FLUZONE HD shot. He stated his skin felt like it was burning. He took a CLARITIN and it resolved.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Hypotension, Leukocytosis, Local swelling, Pyrexia
Clinical narrative: Anaphylaxis with hypotension, fever, swelling of arm, leukocytosis
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Anaphylaxis with hypotension, fever, swelling of arm, leukocytosis
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Local reaction 4 x 4.5 cm; erythematous area with minimal tenderness around the injection site.
Age: 16.0
Sex: M
Vaccine: HPV2, MNQ
Symptoms: Drug administration error
Clinical narrative: Pt given vaccine GARDASIL which parent did not consent to on 8/14/14 at 1150.
Age: 18.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: on 8/3/14 - pt. reports not feeling well. 8/4/14 -> 8/8/14 Pt. reports fever of 102.9 degrees F. 8/9/14 -> 8/11/14 Pt. reports rash. 8/12/14 - Symptoms clear.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema-redness and warmth at injection site upper left outside arm.  Reports pain at site.  Approx 1.5inches wide and 2.5 inches long.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Atrial fibrillation, Blood thyroid stimulating hormone normal, Echocardiogram, Full blood count normal, Laboratory test normal
Clinical narrative: Sudden onset palpitations. Noted to have Afib with RVR of 150-160.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations
Clinical narrative: Sudden onset palpitations. Noted to have Afib with RVR of 150-160.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, and itching. On the morning of 8-14-14, the swelling increased. The child did not complain of pain. Treated with anti-itch cream. On the afternoon of 8-15-14, the swelling continued to increase and the area became "hot to the touch." Child was taken to a nurse practitioner who diagnosed cellulitis. Keflex 500mg, three times daily, 7 days prescribed.
Age: 68.0
Sex: F
Vaccine: TTOX
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Arm starting throbbing.  Pain shoots up right side of neck and down right arm to the finger tips.  The event happened in elsewhere but went to the doctor and his nursing assistant were we lived and said sometimes the pain lasts for weeks.  It is now over 2 months and the pain gets worse.  I take Tylenol daily.  My doctor referred me to an orthopedic doctor.  He said it was not a medical issue.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: Pt was given Peds Hep A (Havrix) & Gardasil (HPV) in Right arm. Pt then had syncope & passed out. He lost color in his face as well. Pt recovered well, walked around a bit, had some juice, waited around for a short time, then was given the other 3 vaccines he needed (Menactra, Boostrix, & Varivax). See next page for actual shots.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Sudden onset of severe muscle pain left deltoid.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, 3 in area of redness with increased warmth, itching, mildly tender - occurred just below site injection.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of upper arm at site of immunization.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Redness, pain, warmth, swelling and urticaria at vaccine site. Given halobetasol 0.05% cream and Prednisone 20 mg q 6 days PRN (if patient presenting respiratory symptoms of allergic reaction), treated today at 1400.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Pt was to be given the meningococcal (MCV40) and was given the Diluent only, vaccine and Diluent were not mixed.
Age: 0.53
Sex: F
Vaccine: RVX
Symptoms: Cough, Lethargy, Vomiting
Clinical narrative: Vomiting, Coughing, Lethargic.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain in thigh muscle at and around injection site. Hard, swollen, pink area measuring 4 inches diameter at injection site. Difficulty in walking due to the pain and swelling.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender, who received vaccines with incorrect product storage.   On an unknown date, an unspecified number of patients were vaccinated with PNEUMOVAX23. Other suspect therapies included VAQTA, RECOMBIVAX and ROTATEQ. On an unknown dates, an unspecified number of patients received improperly stored vaccines. PNEUMOVAX23, VAQTA, RECOMBIVAX, and ROTATEQ.  The outcome of an unspecified number of patients received improperly stored vaccines is Unknown. No further information was provided. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blood test, Constipation, Feeling abnormal, Gastrointestinal infection, Nervous system disorder
Clinical narrative: This spontaneous report as received from a consumer refers to an 82 year old female patient with drug reaction/allergy to many unspecified medications. On an unspecified date in September 2013 the patient was vaccinated with ZOSTAVAX (subcutaneous injection, in the arm, strength, dose, route, lot # and expiration date not reported). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (in the other arm, strength, dose, route, lot # and expiration date not reported). Concomitant therapies included unspecified medications for thyroid and cholesterol, atenolol and OCUVITE. On an unspecified date in 2013, a few dates after the vaccination the patient developed severely itchy patches on her skin starting on her back, legs, arms and breasts. She described them as "like patches of thick skin". Her itchy skin patches were diagnosed as prurigo. The patient also developed growths on her scalp that felt "like the head of a nail" that were diagnosed as "nerve endings". Most of them have gone away  but one or two will appear from time to time. The patient also reported that she felt "like there are needles going through her toes" and felt that there were "aliens in her body". Also, her intestines were infected as she had constipation. The patient was not diagnosed with shingles. The patient sought medical attention, and was treated for the patches with unspecified topical gel and unspecified shots, and for the constipation with colostrum powder. It was also reported that "blood tests" were performed on the patient (results and dates not provided). The outcome of the events was reported as not recovered / not resolved. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Paraesthesia, Prurigo, Pruritus, Skin hypertrophy
Clinical narrative: This spontaneous report as received from a consumer refers to an 82 year old female patient with drug reaction/allergy to many unspecified medications. On an unspecified date in September 2013 the patient was vaccinated with ZOSTAVAX (subcutaneous injection, in the arm, strength, dose, route, lot # and expiration date not reported). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (in the other arm, strength, dose, route, lot # and expiration date not reported). Concomitant therapies included unspecified medications for thyroid and cholesterol, atenolol and OCUVITE. On an unspecified date in 2013, a few dates after the vaccination the patient developed severely itchy patches on her skin starting on her back, legs, arms and breasts. She described them as "like patches of thick skin". Her itchy skin patches were diagnosed as prurigo. The patient also developed growths on her scalp that felt "like the head of a nail" that were diagnosed as "nerve endings". Most of them have gone away  but one or two will appear from time to time. The patient also reported that she felt "like there are needles going through her toes" and felt that there were "aliens in her body". Also, her intestines were infected as she had constipation. The patient was not diagnosed with shingles. The patient sought medical attention, and was treated for the patches with unspecified topical gel and unspecified shots, and for the constipation with colostrum powder. It was also reported that "blood tests" were performed on the patient (results and dates not provided). The outcome of the events was reported as not recovered / not resolved. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Medical history was not reported. The healthcare worker informed that on 11-AUG-2014 the patient was vaccinated with an improperly storage (Oka/Merck) PROQUAD injection, 0.5ml, subcutaneous, (lot number, expiration date were not reported). That was exposed to 36F for 13 hours. Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.