chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 43 year old non-pregnant female patient. The patient did not have pertinent medical history, drug reactions or allergies. On 01-FEB-2017, the patient was vaccinated with the first dose of VARIVAX (which had the lot # M002064, expiration date 12-JAN-2018), as routine varicella vaccination. There was no concomitant medication. The pharmacist reported that the patient called on 13-FEB-2017, to report that since 11-FEB-2017, the site was swollen, had a rash, and was painful to the touch "for the last couple of days". It was also reported that laboratory tests were not performed. The patient received treatment for the adverse events. And there was no product quality complaint involved. At the time of reporting, the outcome of vaccination site swelling, vaccination site pain and vaccination site rash was reported as not recovered. The causality assessment between the reported events and therapy with VARIVAX was not provided. 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 medical assistant and refers to unknown patients of unknown age and gender. There was no information regarding the patients' concurrent conditions, medical history and concomitant medications. On an unknown dates, the patients were vaccinated with five improperly stored doses of VARIVAX lot # M027343, expiration date 01-JUN-2018 (dose, route of administration were not reported) for prophylaxis. The vaccines were exposed to multiple above range, defrost cycles. The medical assistant did not have access to the temperature and time frame information at the time of the call. There was no previous temperature excursion. Digital data logger was involved. There was no adverse reaction. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012060:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse, who reported that on multiple unspecified dates, multiple unspecified patients were administered improperly stored VARIVAX (lot # M035687, expiration date 10-AUG-2018) (dosage and route of administration not provided). No adverse effects reported. No additional information provided. Temperature/Time frame: > 14°F but < 46°F for 3 hours.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA012015: US-009507513-1702USA012014: Original Case : 1702USA009271 US-009507513-1702USA012016:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 27-FEB-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 intramuscularly, lot # L014458, expiry date 11-FEB-2017 (anatomical location and dose were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 08-FEB-2017 (also reported as 09-FEB-2917), the patient was vaccinated with an improperly stored dose of ROTATEQ per oral, lot # M031650 with expiration date 16-MAR-2018, for prophylaxis (dose was not reported). The vaccine was exposed to a temperature between 5 and 25 Celsius degrees in 4 cycles. The cumulative time was 1.5 hours. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005482:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 08-FEB-2017 (also reported as 09-FEB-2917), the patient was vaccinated with an improperly stored dose of ROTATEQ per oral, lot # M031650 with expiration date 16-MAR-2018, for prophylaxis (dose was not reported). The vaccine was exposed to a temperature between 5 and 25 Celsius degrees in 4 cycles. The cumulative time was 1.5 hours. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005482:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 09-FEB-2017, the patient was vaccinated with an improperly stored dose of M-M-R II subcutaneously, lot # M025607 with expiration date 18-MAY-2018, for prophylaxis (dose was not reported). The vaccine was exposed to a temperature between 5 and 25 Celsius degrees in 4 cycles. The cumulative time was 1.5 hours. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005482:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 09-FEB-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly, lot # L048848 with expiration date 09-AUG-2018, for prophylaxis (dose was not reported). The vaccine was exposed to a temperature between 5 and 25 Celsius degrees in 4 cycles. The cumulative time was 1.5 hours. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005482:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse, who reported that on multiple unspecified dates, multiple unspecified patients were administered improperly stored PROQUAD (lot #M014302, expiration date 22-SEP-2017) (albumin status, dosage and route of administration not provided). No adverse effects reported. Temperature/Time frame: > 14°F but < 46°F for 3 hours. Previous temperature excursion (date unknown): > 14°F but < 46°F for 5 hours. No additional information provided. Additional information has been requested. Sender's Comments: US-009507513-1702USA012015: US-009507513-1702USA012016: US-009507513-1702USA009271.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse, who reported that on multiple unspecified dates, multiple unspecified patients were administered improperly stored LIQUID PEDVAXHIB (lot #M032150, expiration date 21-APR-2019) (dosage and route of administration not provided). No adverse effects reported. No additional information provided. Temperature/Time frame: > 46°F but < 77°F for 1.5 hours. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA009271: US-009507513-1702USA012016: US-009507513-1702USA012014:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse, who reported that on multiple unspecified dates, multiple unspecified patients were administered improperly stored ROTATEQ (lot #M031650, expiration date 16-MAR-2018) (dosage and route of administration not provided). No adverse effects reported. No additional information provided. Temperature/Time frame: > 46°F but < 77°F for 1.5 hours. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA012015: US-009507513-1702USA012014: US-009507513-1702USA009271:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unknown patients of unknown age and gender. There was no information regarding the patients' concurrent conditions, medical history and concomitant medications. On an unknown dates, the patients were vaccinated with eight improperly stored doses of ZOSTAVAX lot # M015925, expiration date 15-JUN-2017 and lot# M041510 expiration date: 27-JUL-2017 (dose, routes of administration were not reported) for prophylaxis. The vaccines were exposed to multiple above range, defrost cycles. The medical assistant did not have access to the temperature and time frame information at the time of the call. There was no previous temperature excursion. Digital data logger was involved. There was no adverse reaction. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007779:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (lot #, expiration date, albumin status, dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit (also reported as more than 46 but less than 77 degrees Fahrenheit) for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005340:
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Amnesia, Blood test, Bronchitis, Chest X-ray, Chronic obstructive pulmonary disease
Clinical narrative: Bbeathlessness/gasping for air, slight fever (~1 degree), flushing, amnesia reported for 3-4 days follow shot, eventually had to call 911 due to being unable to breath.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Flushing, Pneumonia, Pyrexia
Clinical narrative: Bbeathlessness/gasping for air, slight fever (~1 degree), flushing, amnesia reported for 3-4 days follow shot, eventually had to call 911 due to being unable to breath.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Death
Clinical narrative: None stated.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Pruritus, Rash, Varicella
Clinical narrative: My 71-year-old husband received the shingles vaccine on January 19, 2017 at the pharmacy. About 5 days later, chicken pox broke out all over his chest and back. Gradually the breakout spread to his lower back and legs, all the time accompanied by severe itching and discomfort which still continues now in late February. In addition, about two weeks ago at the beginning of February about a half dozen spots appeared on my abdomen and this week they are clearly appear as chicken pox with the stinking sensation of shingles, which I recognize because I had shingles when I was 19. I had the shingles vaccine probably a year ago but this did not prevent my catching this outbreak-albeit it small-from my husband.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: My 71-year-old husband received the shingles vaccine on January 19, 2017 at the pharmacy. About 5 days later, chicken pox broke out all over his chest and back. Gradually the breakout spread to his lower back and legs, all the time accompanied by severe itching and discomfort which still continues now in late February. In addition, about two weeks ago at the beginning of February about a half dozen spots appeared on my abdomen and this week they are clearly appear as chicken pox with the stinking sensation of shingles, which I recognize because I had shingles when I was 19. I had the shingles vaccine probably a year ago but this did not prevent my catching this outbreak-albeit it small-from my husband.
Age: 1.33
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Body temperature increased, Epilepsy, Febrile convulsion, Gaze palsy, Seizure
Clinical narrative: Patient was seen on Friday 2/17 for vaccines DTaP and PREVNAR. On Monday, 2/20 grandmother noticed a staring spell with an right upward gaze. 911 was called by family and ED diagnosed her with febrile seizure with temp of 103.0. Patient seen in clinic 2/21 as seizures were becoming more frequent and lasting up to 30 seconds. Oxygen was administered and patient was transported to hospital where she was for 7 days. Per family, Neurologist thought there could be a correlation between the vaccines and seizures, as the child never had them before. She is now diagnosed with epilepsy and is on medication.
Age: 1.33
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Staring
Clinical narrative: Patient was seen on Friday 2/17 for vaccines DTaP and PREVNAR. On Monday, 2/20 grandmother noticed a staring spell with an right upward gaze. 911 was called by family and ED diagnosed her with febrile seizure with temp of 103.0. Patient seen in clinic 2/21 as seizures were becoming more frequent and lasting up to 30 seconds. Oxygen was administered and patient was transported to hospital where she was for 7 days. Per family, Neurologist thought there could be a correlation between the vaccines and seizures, as the child never had them before. She is now diagnosed with epilepsy and is on medication.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Right upper arm at injection with pain redness and swelling, some itching, redness spread to 4x4 in circumference. Diagnosed cellulitis and allergic drug reaction.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Right upper arm at injection with pain redness and swelling, some itching, redness spread to 4x4 in circumference. Diagnosed cellulitis and allergic drug reaction.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse, concerning a 56 years old female patient. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 06-FEB-2017, the patient was vaccinated with a pediatric dose of VAQTA for prophylaxis (dose, frequency, route, lot # and expiration date were not reported) instead of the adult dose. No adverse effects were reported. No product quality complaint was involved (PQC).  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (LPN)referring to a female patient of unknown age. The patient's pertinent medical history, current conditions and concomitant therapies were not provided. On 17-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II (lot # K021952, expiration date 10-NOV-2016) subcutaneous. No adverse effect was reported. No further information was provided. Additional information was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a physician via a company representative  referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not reported. In approximately  2015 "reported as about a year or two ago",  the patient was vaccinated with ZOSTAVAX, (route of administration, strength, frequency, dose, lot# and expiration date were not provided) for shingles vaccine. On an unknown date, the patient that developed a very mild case of shingles. The physician had recommended husband and wife to be vaccinated; however, only one received the vaccine. (it could not be determinate which one received the vaccine). At the time of reporting, the outcome of shingles was unknown. It was unknown by the reporter if the patient sought medical attention. The relatedness between the events and ZOSTAVAX was not provided. This is one of two reports received from the same reporter MARRS: 1702USA011692. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011692:
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received on 21-FEB-2017 from a nurse who reported that on 01-FEB-2017, a 13-year-old patient (gender unknown) was administered a PROQUAD vaccination (Route and site of administration were not reported) for prophylaxis. Lot number reported as M032496. Expiration date reported as 02-JAN-2018. No adverse effects were reported. There was no quality complaint involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Inflammation, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Osteomyelitis
Clinical narrative: This spontaneous report has been received from a pharmacy student referring to a 15 year old female patient. The patient did not have pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies. On an unknown date, the patient was vaccinated with the first and second dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, the patient was vaccinated with a third dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, reported as "immediately after the third dose", the patient experienced in the vaccinated left arm and fingers pain and tingling for a month. The pain did not resolve and became worse. Therefore on an unknown date a nuclear magnetic resonance imaging (MRI) was performed  and "showed inflammation". The pharmacy student also reported that the "pain spiked to 10 out of 10" and the patient could not use her arm, the reporter suspected that the patient could have osteomyelitis. The patient went to the emergency room on an unspecified date and then on 19-FEB-2017 the patient was hospitalized in a local hospital for control the pain, the patient's treatment included TYLENOL, TORADOL and morphine. At the time of reporting the outcome of pain and tingling in her arm was not recovered and the outcome of osteomyelitis and inflammation was unknown. The reporter stated that the osteomyelitis, pain and tingling in the patient's arm cause disability. The relatedness between the events and GARDASIL was not reported. Upon internal review osteomyelitis was considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report has been received from a pharmacy student referring to a 15 year old female patient. The patient did not have pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies. On an unknown date, the patient was vaccinated with the first and second dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, the patient was vaccinated with a third dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, reported as "immediately after the third dose", the patient experienced in the vaccinated left arm and fingers pain and tingling for a month. The pain did not resolve and became worse. Therefore on an unknown date a nuclear magnetic resonance imaging (MRI) was performed  and "showed inflammation". The pharmacy student also reported that the "pain spiked to 10 out of 10" and the patient could not use her arm, the reporter suspected that the patient could have osteomyelitis. The patient went to the emergency room on an unspecified date and then on 19-FEB-2017 the patient was hospitalized in a local hospital for control the pain, the patient's treatment included TYLENOL, TORADOL and morphine. At the time of reporting the outcome of pain and tingling in her arm was not recovered and the outcome of osteomyelitis and inflammation was unknown. The reporter stated that the osteomyelitis, pain and tingling in the patient's arm cause disability. The relatedness between the events and GARDASIL was not reported. Upon internal review osteomyelitis was considered to be a medically significant event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: This spontaneous report was received through a company representative from a male pharmacist of unknown age referring to himself. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. On an unknown date an unspecified time after receiving the vaccine, the patient developed a red blister that looked like a shingles rash (herpes zoster) on an unspecified location. Then the patient recovered within 2 days on an unknown date. It was reported that there was not intervention to prevent serious criteria; that herpes zoster was not significant disability, incapacity or life threatening and that the patient was not hospitalized. The relatedness of herpes zoster with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported for a 65-year old female patient of an unspecified ethnicity started to receive bacitracin (UNKNOWN MANUFACTURER); NEOSPORIN; ibuprofen (UNKNOWN MANUFACTURER); Aspirin; BENADRYL; SUDAFED NON-DRYING SINUS; VERSED; and SENOKOT, all via unspecified routes of administration on unspecified dates at unknown doses for unspecified indications. The patient also received the following suspect vaccines: PREVNAR 13 and INFLUENZA VIRUS VACCINE, both were given via unknown routes of administration on unknown dates at a single dose for immunization. The patient's medical history included drug allergy to Cephalosporins. Concomitant medications were not reported. On unknown dates, the patient experienced allergies to Pneumococcal, Ibuprofen, Aspirin, Bacitracin, Influenza virus vaccine, SUDAFED Non Drying Sinus, NEOSPORIN, SENOKOT, VERSED, and BENADRYL. The action taken in response to the event for bacitracin was unknown; for gramicidin, neomycin sulfate, polymyxin b sulfate was unknown; for ibuprofen was unknown; for acetylsalicylic acid was unknown; for diphenhydramine hydrochloride was unknown; for guaifenesin, pseudoephedrine hydrochloride was unknown; for influenza vaccine was not applicable; for midazolam hydrochloride was unknown; for pneumococcal vaccine was not applicable; and for senna alexandrina was unknown. The clinical outcome for the event was unknown. Follow-up (26Apr2016): New information reported from the same contactable physician includes: Follow up attempts are completed. No further information is expected. Follow up (13Feb2017). New information reported from a contactable physician  included: patient' age. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : 2016197395 Legacy paper report number.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A 53-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at an single dose on an unspecified date for immunisation, guaifenesin via an unspecified route of administration from an unspecified date to an unspecified date for cough/cold /allergy, trazodone hydrochloride via an unspecified route of administration from an unspecified date to an unspecified date as antidepressant. The patient medical history and concomitant medications were not reported. The patient experienced allergy to trazodone HCl, PREVNAR 13, guaifenesin on an unspecified date with outcome of unknown.
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported a similar event for two patients. This is the first of two reports. A female patient of an unspecified age and race received for immunization TRUMENBA  via an unspecified route of administration on an unspecified date at single dose and other unknown vaccines.  The patient medical history and concomitant medications were not reported.  The patient fainted after being vaccinated.  The patient recovered quickly with no further complications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017081612 same reporter/suspect product/AE, different patient.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Abdominal rigidity, Disturbance in attention, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Initial unsolicited misuse report received from a Consumer on 16-FEB-2017. This case involves a 55 years old female patient who was intramuscularly vaccinated with a dose of TENIVAC (lot number: U5184CA, expiration date: 23-OCT-2017, dose, dose in series not reported) in left deltoid on 29-DEC-2015. It was reported that patient was bitten by a child, on the right arm and there is still a tender area at the site. The Illness at time of vaccination was reported as no and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as hypothyroidism, allergic to liquid iodine, Demerol, sulfa drugs. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On 12-JAN-2016, 14 days (reported as two weeks) following the vaccination patient had spasms in her arms and abdomen, difficulty in breathing, her legs swelled to 3x the regular size, severe headache. Patient had to stop her thyroid medication due to severe headache. On an unspecified date, post vaccination, patient had difficulty in concentrating, doesn't feel like herself and hasn't been able to work. It was also reported that the vaccine received by the patient was in a temperature excursion and was deemed unstable for use. This was also a case of incorrect product storage. The patient had not been seen by MD due to lack of medical insurance. Lab data was reported as none and corrective treatment was not reported. It was reported that some symptoms were resolved but was not specified. Patient continued to have a difficulty in concentrating, doesn't feel like herself, hasn't been able to work. Patient was recovered from headache as she started taking her thyroid medication again without headaches occurring. Patient was not yet recovered from other events. List of the documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Impaired work ability, Incorrect product storage, Muscle spasms, Peripheral swelling
Clinical narrative: Initial unsolicited misuse report received from a Consumer on 16-FEB-2017. This case involves a 55 years old female patient who was intramuscularly vaccinated with a dose of TENIVAC (lot number: U5184CA, expiration date: 23-OCT-2017, dose, dose in series not reported) in left deltoid on 29-DEC-2015. It was reported that patient was bitten by a child, on the right arm and there is still a tender area at the site. The Illness at time of vaccination was reported as no and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as hypothyroidism, allergic to liquid iodine, Demerol, sulfa drugs. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On 12-JAN-2016, 14 days (reported as two weeks) following the vaccination patient had spasms in her arms and abdomen, difficulty in breathing, her legs swelled to 3x the regular size, severe headache. Patient had to stop her thyroid medication due to severe headache. On an unspecified date, post vaccination, patient had difficulty in concentrating, doesn't feel like herself and hasn't been able to work. It was also reported that the vaccine received by the patient was in a temperature excursion and was deemed unstable for use. This was also a case of incorrect product storage. The patient had not been seen by MD due to lack of medical insurance. Lab data was reported as none and corrective treatment was not reported. It was reported that some symptoms were resolved but was not specified. Patient continued to have a difficulty in concentrating, doesn't feel like herself, hasn't been able to work. Patient was recovered from headache as she started taking her thyroid medication again without headaches occurring. Patient was not yet recovered from other events. List of the documents held by sender: none.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from health care professional via other company Pfizer on 16 Feb 2017. Manufacturer report number: 2017036187. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date (reported as 2005-2006). The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced high fever (type of reaction: allergic) and was hospitalized. Lab data and corrective treatment was not reported. The event outcome was not reported. List of documents held by sender: none. Sender's Comments: This is a poorly documented case in which patient experienced high fever after vaccination with INFLUENZA VACCINE. Time to onset is unknown. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: Initial unsolicited report received from health care professional via other company Pfizer on 16 Feb 2017. Manufacturer report number: 2017036187. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date (reported as 2005-2006). The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced high fever (type of reaction: allergic) and was hospitalized. Lab data and corrective treatment was not reported. The event outcome was not reported. List of documents held by sender: none. Sender's Comments: This is a poorly documented case in which patient experienced high fever after vaccination with INFLUENZA VACCINE. Time to onset is unknown. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 18.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash
Clinical narrative: He was vaccinated Feb 23 2017 he had a fever that night then on Feb 24 rashes appeared on his face and neck and still has fever. Today Feb 25 rashes spreads and he still has fever.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 10.22.16, no adverse reactions.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Patient received TDaP on 2/7/17 for cut on left toe while trying pedicure on self. Two days after vaccine onset of extreme pain at site with induration, itching, burning and tenderness.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen lump at injection site, hot to the touch.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Large redness around injection site.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV9, FLUX, HPV9
Symptoms: Dehydration, Dizziness, Headache, Lethargy, Lymphadenopathy
Clinical narrative: Lethargy, nausea, muscle spasm, continual headaches, dehydration, felt faint at time of injection, fever, swollen glands, leg pain, aching muscles, swollen glands armpit and face, dizziness. Had a headache since Jan 4 - 2017. Now easing up a bit. Recovering - easing up still headache.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV9, FLUX, HPV9
Symptoms: Muscle spasms, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Lethargy, nausea, muscle spasm, continual headaches, dehydration, felt faint at time of injection, fever, swollen glands, leg pain, aching muscles, swollen glands armpit and face, dizziness. Had a headache since Jan 4 - 2017. Now easing up a bit. Recovering - easing up still headache.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Gradual onset of severe shoulder pain with very limited ROM. Injection site tenderness, deep muscle ache,  nerve pain numbness and tingling in had and fingers.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Neuralgia, Pain, Paraesthesia
Clinical narrative: Gradual onset of severe shoulder pain with very limited ROM. Injection site tenderness, deep muscle ache,  nerve pain numbness and tingling in had and fingers.
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Rash
Clinical narrative: Rash on left leg 24 hours after immunization that was the size of a quarter.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Dyspnoea, Injection site inflammation, Injection site pain
Clinical narrative: Patient had pain and inflammation at the injection site. Shortness of breath and chest pain experienced as well. Treatment was observational.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Impaired work ability, Incomplete course of vaccination
Clinical narrative: She states dizzy, in shower and through out the day- "cold sweats" just felt "off" did go to work yet had occ episodes of "faint feeling of cold sweet"  next day she felt fine.. Did not receive second dose of Hepatitis B.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Seizure
Clinical narrative: +Spiked fever during routine enzyme infusion therapy to 102, (72 hrs after vaccine given) then had seizure.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased
Clinical narrative: Extremely high morning fasting sugar.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: PT WOKE UP WITH RED, WARM,1  INCH RED SPOT, BY AFTERNOON WAS 2 INCHES---ONE WEEK AFTER THE INJECTION.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased appetite, Influenza virus test negative, Pyrexia
Clinical narrative: Fever up to 103.5 late that night following vaccinations. Decreased appetite that evening into the next morning.  No signs of clinical dehydration.  Tylenol given for treatment of fever.  Flu test was negative.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Clonus, Eye movement disorder, Febrile convulsion, Pyrexia
Clinical narrative: 9 days after receiving MMR vaccine had an atypical febrile seizure - febrile, eyes rolled back and right arm had clonic movements.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, during the vaccination with a one dose of M-M-R II (exact dose, route of administration, lot #, therapy type and expiration date were not reported) and one dose of VARIVAX (exact dose, route of administration, lot # and expiration date were not reported), the patient moved his arm at the time of administration of one of the vaccines, resulting in an unknown portion of the unknown vaccine being deposited on the skin. The patient received only a partial dose of the vaccine. The reporter stated that it was unclear whether the incident occurred with the M-M-R II or VARIVAX. Revaccination was not performed at the time of the report. No product quality compliant was involved. Follow Up information has been received from  the reporting registered nurse on 14-FEB-2017 and stated that on an unknown date, the child was receiving a routine dose of M-M-R II and just before the entire dose was administered the child moved their arm  and  the needle came out of the skin and a very small amount of the dose squirted into the air. There were no adverse vaccine reactions. The nurse explained that she requested recommendation regarding if a repeat dose was needed and within what time frame. Subsequently, the child had received the repeat dose of M-M-R II. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia
Clinical narrative: This spontaneous report has been received from a pharmacist and referring to a currently 64-year-old female patient with no drug reaction or allergies. It was reported that the patient did not have any pertinent medical history. However, it was mentioned that the patient was taken "a few medications" as concomitant therapies. Approximately on an unknown date in 2007, reported as "over 10 years ago", the patient was vaccinated with a first dose of PNEUMOVAX 23 (strength, dose, frequency, route, anatomical location, lot number and expiration date were not provided). Subsequently, on 01-FEB-2017 (also reported as on an unspecified date, yesterday), a second dose of PNEUMOVAX 23 0.5 mL, intramuscularly, Lot number: M036161, expiration date: in May 2017 (strength, frequency, and anatomical location were not provided) for prophylaxis. Other suspect vaccines administered on the same date include: a high dose of FLUZONE (Lot number: UI682AZ, Expiration date: in April 2017) (anatomical location, lot number and expiration date were not provided). On an unknown date, the patient experienced joint pain and sought medical attention through a call made to her pharmacist. The patient did not undergo any laboratory tests or performed any treatment. At the reporting time, the outcome for the event of Arthralgia was unknown. The causal relationship between the adverse event and the therapy with PNEUMOVAX 23 was not provided. 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 medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reporter stated that improperly stored doses of VARIVAX, Lot number M025865, expiration date 24-MAY-2018 and M010483, expiration date 01-MAR-2018 (dose, route, and anatomical location were not reported), were administered to an unspecified number of patients on unspecified dates since 19-OCT-2016, for prophylaxis. The vaccine was exposed to a temperature of 10.8 Fahrenheit (F) for 4 hours and 56 minutes due to a data logger issue.  There was no previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001614:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a registered nurse concerning a 26 year old female patient who received the following altered dosing schedule for GARDASIL 9 intramuscularly (dosage not provided): First dose of GARDASIL 9, lot #M011117, expiration date 07-DEC-2017 administered on 13-SEP-2016. Second dose of GARDASIL 9, lot #L043214, expiration date 30-AUG-2017 administered on 14-DEC-2016. Third dose of GARDASIL 9, lot #M035486, expiration date 05-JUN-2019 administered on 14-FEB-2017. No adverse effects noted. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 06-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005376:
Sex: F
Vaccine: PNC13
Symptoms: Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age and race received PREVNAR 13 at single dose on unknown date for immunization. Relevant medical history and concomitant medication  were not reported. On unknown date the patient experienced significant swelling and pain. The outcome of the events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Contusion, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age received TRUMENBA via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at the injection site and a bruise below the injection site, on an unspecified date after vaccination, with unknown outcome.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable RN called on behalf of the provider at a doctor's office. A 85-year-old patient of an unspecified ethnicity and gender received PREVNAR 13 Lot R33239; Expiry Date 31Mar2018, via an unspecified route of administration on 16Feb2017 at 0.5 ml, single in Deltoid Right for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash around the injection site on the right shoulder on 21Feb2017 with outcome of unknown.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 9th of 10 cases. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 , via an unspecified route of administration on 27Jan2017 at 0.5 ml, single  Lot S15227 Expiry Date 01Feb2018 in Deltoid Left, for immunisation and  influenza vaccine  via an unspecified route of administration on 27Jan2017 at 1 DF single in Arm Right, for immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient experienced fever chills, swelling at the injection site  on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/drug, different patient and event.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 10th of 10 cases. A 78-years-old female patient of an unspecified ethnicity started to receive PREVNAR 13 Lot S15227 Expiry Date 01Feb2018, in Left deltoid, via an unspecified route of administration on 01Feb2017 at 0.5 ml, single for immunisation. Medical history included hypertension from an unknown date and unknown if ongoing High Blood Pressure. The patient's concomitant medications were not reported. The patient experienced bruising at the injection site, swelling at the injection site, small bumps at the injection site on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/drug, different patients/event.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 6th of 10 cases. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced the injection hurt a lot on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 Same reporter/drug/event, different patient.