chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Rash erythematous, Rash vesicular, Vaccination failure
Clinical narrative: This literature marketed report as received from the authors of the published article, refers to a 76 year-old male patient. His past medical history was significant for a recent episode of allergic contact dermatitis due to poison ivy, which was managed by his primary care physician with a short seven-day taper of oral methylprednisolone. On an unknown date, within a couple days of completing the methylprednisolone taper, the patient received the Zoster Vaccine Live (manufacturer unknown) (VZV vaccine) (medication error), which was administered subcutaneously into the left upper extremity (dose, lot # and expiration date were not provided). On an unknown date (reported as subsequently), he developed the vesicular rash seven days after receiving the vaccine. On an unknown date, the patient presented with a three day history of a vesicular rash localized to the left lateral neck, shoulder, and proximal upper extremity. The rash was not accompanied by pruritus, burning, or pain. Additionally, the patient denied experiencing prodrome symptoms, such as paresthesia, pain, burning, and/or pruritus, prior to developing the cutaneous eruption. Review of systems was unremarkable. On an unknown date, physical exam findings were significant for a confluent, erythematous, vesicular eruption in a dermatomal distribution on the left inferior/lateral neck, left clavicle, left shoulder and proximal upper extremity. These findings were consistent with herpes zoster (aka, shingles) (vaccination failure). The patient was immediately started on a seven-day course of oral valacyclovir. Since the rash was asymptomatic, no topical anti-inflammatory medications were prescribed. The patient reported improvement in the eruption within 2-3 days of starting oral valacyclovir. The rash remained asymptomatic. Of note, after starting valacyclovir, the patient indicated that he experienced mild, intermittent left-sided headaches, which resolved with over-the-counter ibuprofen. Otherwise, his review of systems remained unremarkable. Of note, no samples were collected from the rash to determine if the varicella zoster virus was derived from the vaccine versus a wild-type strain. The outcome of the event was considered to be recovering/resolving. The authors considered the event of herpes zoster to be related to the therapy with Zoster Vaccine Live (manufacturer unknown) as the herpes zoster developed shortly after vaccination. Follow up was received on 22-FEB-2016, which is prior to the previously submitted aware date 23-FEB-2016. Hence case # US-009507513-1602USA010954 is being deleted from our files and submitted under new case US-009507513-1603USA000296. Expiration date of the suspect product zoster vaccine live (manufacturer unknown) was reported to be 13-MAR-2016. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 12-JAN-2016 the patient was inadvertently administered improperly stored ZOSTAVAX (lot # L027321 with expiration date: 21-OCT02016 or lot # L035283 with expiration date: 15-DEC-2016, route and dose were unknown). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 12-JAN-2016 the patient was inadvertently administered improperly stored ZOSTAVAX (lot # L027321 with expiration date: 21-OCT-2016 or lot# L035283 with expiration date: 15-DEC-2016, route and dose were unknown)(incorrect product storage). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. No information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was reported. On an unknown dates in approximately 2014 (reported as "about two years ago"), the patient was vaccinated with the first and the second dose of GARDASIL (dose, lot #, expiry date, route of administration and anatomical location were not specified). On 29-FEB-2016, the patient would receive her third dose of GARDASIL. There were no known adverse effects. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' pertinent medical history or concurrent condition was not reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot #L035127, expiration date 14-SEP-2017, lot  #L008269, expiration date 11-MAR-2017, lot # reported as L032396, expiration date 26-AUG-2017, lot # L025208, expiration date 07-JUL-2017, lot # reported as L039093, expiration date 06-OCT-2017, dose, strength, route, frequency and indication were unknown). No adverse effects were reported. Temperature: 27F for 2 hours and 40 minutes Data logger: yes Was it administered (AE)? Yes Was it previous temperature excursion? No This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Follow up information was received on 12-FEB-2016, from health professional regarding a 5 year old male patient. On 25-JAN-2016, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016, from health professional regarding a 5 year old female patient. On 13-JAN-2016, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Follow up information was received on 12-FEB-2016, from health professional regarding a 5 year old female patient. On 25-JAN-2016, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 02-MAR-2016 the patient was administered an expired dose of M-M-R II (lot # K002527, expiration date 18-FEB-2016) (dosage, strength and route unknown). There was no concomitant medication reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 16-FEB-2016, the patient was vaccinated with a dose of GARDASIL (lot# K009482 and expiration date March 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L060586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a 77 year old female consumer referring to herself. She had the shingles virus sometime during 2013. On 02-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date were not reported) injection subcutaneously. Concomitant drug was not reported. On 27-FEB-2016, the patient developed a blister-like rash covering her shoulder blades down to her hips. She went to urgent care, where she was diagnosed with shingles, and was given treatment with VALTREX and another unspecified cream. Outcome of the event was reported as recovering. The causality was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 20-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (office manager) referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L044694, expiration date 04-FEB-2018; dose and route were unknown). No symptoms were reported. The vaccines were stored under 1 degree Centigrade for 6 days in November 2015, 1 degree Centigrade for 20 days in December 2015, 1 degree Centigrade for 16 days in January 2016, 1 degree Centigrade for 20 days in February 2016 (totally 62 days). No other excursions were involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (office manager) referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (lot # reported as L043209, expiration date 17-SEP-2017; dose and route were unknown). No symptoms were reported. The vaccines were stored under 1 degree centigrade for 6 days in November 2015, 1 degree centigrade for 20 days in December 2015, 1 degree centigrade for 16 days in January 2016, 1 degree centigrade for 20 days in February 2016 (totally 62 days). No other excursions were involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route), which was exposed to temperature outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and current conditions were not reported. On unspecified date in 2010, the patient was vaccinated with first dose of GARDASIL (Lot#, expiry date, route, dose and strength were not reported). On 23-FEB-2016, the patient received second dose in the series which was GARDASIL 9, Lot# L028083, expiry date: 03-SEP-2017 (route, dose and strength were not reported). No adverse effects were reported. No PQC involved. Outcome of the medication error was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (office manager) referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L039297, expiration date 19-JUN-2016; dose and route were unknown). No symptoms were reported. The vaccines were stored under 1 degree Centigrade for 6 days in November 2015, 1 degree Centigrade for 20 days in December 2015, 1 degree Centigrade for 16 days in January 2016, 1 degree Centigrade for 20 days in February 2016 (totally 62 days). No other excursions were involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: Incorrect route of drug administration, Loss of consciousness
Clinical narrative: Information has been received from a physician via a company representative, referring to a 12 year old non-pregnant female patient with no pertinent medical history or drug reactions/allergies. On 02-MAR-2016 the patient was vaccinated with 1 shot of GARDASIL 9 (lot# and expiration date were not reported) via subcutaneous route. There was no concomitant medication. On the same day, after receiving GARDASIL 9, the patient passed out. The patient was kept for about 25 minutes for observation and recovered. Her blood pressure was checked (result and unit were not reported) and she was given "PEDIALITE" before being sent home. It was reported that the patient had received two other vaccines, but GARDASIL 9 could not be ruled out as the cause. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker via a company representative referring to a female patient in her 60's, who had never had chickenpox. It was reported that on 17-FEB-2016 the patient was inadvertently vaccinated with ZOSTAVAX (lot # L035285, expiration date 15-DEC-2016, dose and route were unknown) instead of VARIVAX (Merck) (wrong drug administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 13-JAN-2016 the patient was inadvertently administered improperly stored ZOSTAVAX (lot # L027321 with expiration date: 21-OCT-2016 or lot# L035283 with expiration date: 15-DEC-2016, route and dose were unknown) (incorrect product storage). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (office manager) referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (lot # K010215, expiration date 05-MAY-2017; lot # L040459, expiration date 06-APR-2017; dose and route were unknown). No symptoms were reported. The vaccines were stored under 1 degree centigrade for 6 days in November 2015, 1 degree centigrade for 20 days in December 2015, 1 degree centigrade for 16 days in January 2016, 1 degree centigrade for 20 days in February 2016 (totally 62 days). No other excursions were involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a couple of unspecified patients of unknown age and gender. The patients' concurrent and historical conditions were not reported. On unknown dates the patients were vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were unknown). Concomitant therapies were not reported. On unknown dates the patients developed unspecified eye complications. The outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a Physician via a healthcare worker to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # L019835 and expiration date 23-MAR-2017) 0.5 ml, (dose number and route were not provided). Concomitant medications were not reported. On an unknown date, the patient experienced "severe reactions". Therefore, the patient visited an unspecified emergency room. The outcome of the adverse reaction was unknown. The primary reporter did not provide the causality between PNEUMOVAX 23 and the adverse reaction. This is one of two reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Injection site induration, Injection site mass
Clinical narrative: This spontaneous report was received from a Physician via a healthcare worker to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # L019835 and expiration date 23-MAR-2017) 0.5 ml, (dose number and route were not provided). Concomitant medications were not reported. On an unknown date, the patient experienced "severe reactions". Therefore, the patient visited an unspecified emergency room. The outcome of the adverse reaction was unknown. The primary reporter did not provide the causality between PNEUMOVAX 23 and the adverse reaction. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. The reporter stated that on 18-FEB-2016 or 19-FEB-2016, the unspecified patients were inadvertently administered stored doses of PROQUAD (Merck) (lot # L034932, expiration date: 03-MAR-2017, dos and route were not reported), on unspecified dates. No concomitant medication was reported. The storage temperature was -13 C degrees, the time frame was 10 min and there was no previous temperature excursion. No adverse effect was reported. This one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. The reporter stated that on 18-FEB-2016 or 19-FEB-2016, the unspecified patients were inadvertently administered improperly stored doses of VARIVAX (Merck) (lot # L028276, expiration date: 28-JUL-2017, dose and route not reported). No concomitant medication was reported. The storage temperature was -13 C degrees, the time frame was 10 min and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This initial spontaneous report was received from a 70 year old female consumer reporting on herself. The patient's concurrent conditions included hypertension, arthritis, tinnitus and penicillin allergy. On 28-FEB-2016, the patient was vaccinated with ZOSTAVAX 1 injection in the left arm (route and lot# were not provided). Concomitant therapies included XANAX and unspecified blood pressure medicine. On 29-FEB-2016, the patient experienced swelling and warmth around the injection site. She did not seek medical attention. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the events was unknown. The causality assessment was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: This initial spontaneous report was received from a 70 year old female consumer reporting on herself. The patient's concurrent conditions included hypertension, arthritis, tinnitus and penicillin allergy. On 28-FEB-2016, the patient was vaccinated with ZOSTAVAX 1 injection in the left arm (route and lot# were not provided). Concomitant therapies included XANAX and unspecified blood pressure medicine. On 29-FEB-2016, the patient experienced swelling and warmth around the injection site. She did not seek medical attention. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the events was unknown. The causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 19-FEB-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route) and with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route) which were exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from Physician via a Healthcare worker referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # L019835 and expiration date 23-MAR-2017) 0.5 ml, (dose number and route were not provided). Concomitant medications were not reported. No product quality complaint (PQC) was reported. On an unknown date, the patient experienced "severe reaction". The outcome of the adverse reaction was unknown. The primary reporter did not provide the causality between PNEUMOVAX 23 and the adverse reaction. This is one of two reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Lip injury, Suture insertion, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning an 11 year old male patient. The patient's medical history and concurrent conditions were not reported. On 05-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 0.65 ml (route of administration, lot # and expiration date were not reported) for prevention of HPV. No concomitant medication was reported. On the same date, on 05-FEB-2016, after being given GARDASIL 9, the patient fainted and when he did hit the counter and cut his lip. Therefore, on an unspecified date, the patient was brought to an unspecified emergency room (ER) where he got stitches for the cut and also to get a computerized tomogram (CT) scan. The reporting physician stated that there were no findings on the CT scan. It was unknown if the patient was admitted to the hospital. No product quality complaint was involved. It was reported that the patient got the stitches taken out on 17-FEB-2016. At the time of the report, the outcome for syncope was reported as unknown, and the outcome for lip injury was recovering. The relatedness between syncope and lip injury with GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 09-FEB-2016 the patient was inadvertently administered improperly stored ZOSTAVAX (lot # L027321 with expiration date: 21-OCT-2016 or lot# L035283 with expiration date: 15-DEC-2016, route and dose were unknown) (incorrect product storage). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Pain, Pneumonia, Pyrexia, Rash, Secondary transmission
Clinical narrative: This non valid spontaneous report as received from a consumer via Pfizer as a social media review refers to a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date the brother's patient was vaccinated with ROTATEQ oral (dose, frequency, route of administration, lot# and expiration date were not provided). On an unspecified date, it was reported that the ROTATEQ the brother's patient received gave the patient pneumonia. As she kissed her brother's neck she experienced secondary transmission. She also developed rash, bad pains and high fever for two weeks. The outcome of rash, bad pains, high fever and pneumonia was unknown. Additional information is not expected as no contact information was available.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Back pain, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Pt appeared light headed immediately after immunizations, which care was rendered, mom in attendance on 3/3/16. Next day mom called to report diarrhea, rash on bilat arms, fatigued, headache, poor appetite and not taking in fluids. Also with lower back pain. Sent to ER 3/4/16.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Headache, Immediate post-injection reaction, Rash
Clinical narrative: Pt appeared light headed immediately after immunizations, which care was rendered, mom in attendance on 3/3/16. Next day mom called to report diarrhea, rash on bilat arms, fatigued, headache, poor appetite and not taking in fluids. Also with lower back pain. Sent to ER 3/4/16.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Febrile convulsion, Generalised tonic-clonic seizure, Pyrexia, Rash
Clinical narrative: 7d post KINRIX and PROQUAD patient had generalized tonic-clonic seizure. No prior fever but fever noted afterwards. Seen in ER - dx febrile seizure. Also seen by PCP 2d after seizure and noted to have rash on trunk.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patient's pertinent medical history or concurrent condition was not reported. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L031603, expiration date 18-FEB-2017, lot # L034932, expiration date 03-MAR-2017, lot # L045678, expiration date 09-MAY-2017, lot # reported as L046509, expiration date 17-MAY-2017, lot # L030586, expiration date 10-FEB-2017, lot # K019102, expiration date 15-APR-2016, lot # L023112, expiration date 24-DEC-2016 dose, strength, route, frequency and indication were unknown). No adverse effects were reported. Temperature: 27F Time frame: 2 hours and 40 minutes Data logger: Yes Was it administered (AE)? Yes Was it previous temperature excursion? No This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red, warm area developed on (R) outer thigh; measures 5cm x 3.5 cm in size. No fever, area "itches" per patient but not painful. Noticed by parent(s) on 02/25/2016 and came to clinic on 02/26/2016.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Redness and warmth around injection site. Painful to touch. Most symptoms started 3/4/16. Pt c/o soreness same day as injection. Pt advised to use warm compresses and TYLENOL as needed. to call if not improving.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: CSF protein increased, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain-Barre Syndrome, Miller-Fisher Variant; Ophthalmoplegia, Facial palsy, Lower extremity weakness progressing to inability to ambulate, lower extremity pain and numbness, perioral numbness and tingling.  Areflexia to lower extremities. Lumbar puncture with elevated protein and elevated IgG consistent with Guillain-Barre.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Abasia, Areflexia, CSF immunoglobulin increased, CSF oligoclonal band absent, CSF protein increased
Clinical narrative: Guillain-Barre Syndrome, Miller-Fisher Variant; Ophthalmoplegia, Facial palsy, Lower extremity weakness progressing to inability to ambulate, lower extremity pain and numbness, perioral numbness and tingling.  Areflexia to lower extremities. Lumbar puncture with elevated protein and elevated IgG consistent with Guillain-Barre.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: CSF test normal, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Miller Fisher syndrome
Clinical narrative: Guillain-Barre Syndrome, Miller-Fisher Variant; Ophthalmoplegia, Facial palsy, Lower extremity weakness progressing to inability to ambulate, lower extremity pain and numbness, perioral numbness and tingling.  Areflexia to lower extremities. Lumbar puncture with elevated protein and elevated IgG consistent with Guillain-Barre.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal, Ophthalmoplegia, Pain in extremity, Paraesthesia oral
Clinical narrative: Guillain-Barre Syndrome, Miller-Fisher Variant; Ophthalmoplegia, Facial palsy, Lower extremity weakness progressing to inability to ambulate, lower extremity pain and numbness, perioral numbness and tingling.  Areflexia to lower extremities. Lumbar puncture with elevated protein and elevated IgG consistent with Guillain-Barre.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: Guillain-Barre Syndrome, Miller-Fisher Variant; Ophthalmoplegia, Facial palsy, Lower extremity weakness progressing to inability to ambulate, lower extremity pain and numbness, perioral numbness and tingling.  Areflexia to lower extremities. Lumbar puncture with elevated protein and elevated IgG consistent with Guillain-Barre.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT EXPERIENCED REDNESS AND ITCHING AT INJECTION SITE, INCLUDING A RED AREA THE SIZE OF A QUARTER.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Headache, tiredness progressing to nausea and vomiting.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Bad Sore throat, headache, fever, body aches, nausea.
Age: 24.0
Sex: M
Vaccine: YF
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, Achy, severe headache.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: After recieving the shot the patient started to pass out, his dad grabbed him and lowered him to the ground.  He then got up with help and sat in a chair for 10 minutes before leaving on his own.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Abnormal behaviour, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Day of vaccinations he had a small red knot under his leg that went away. Two weeks later (now) the knot has returned and continues to grow in size. It is very red and my son winces when it is touched. It appears to be very tender and bothersome. He will not sleep on that leg. He generally sleeps on his side. I believe it has been affecting his attitude as he has not been acting well since the knot has returned.  Treatment: Took him to see his primary doctor, and dismissed the spot as nothing to worry about.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Localized red rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Eructation, Flushing, Headache, Influenza like illness, Injection site rash
Clinical narrative: Had a mild headache and felt like I had a cold coming on for 2 days.  After that I felt flushed but had no fever.  I also felt fuzzy like you do with the flu, and have had a lot of nausea, and excessive belching.  I also still have a small rash at the injection sight.  Last night I had some blisters appear on the inside of my lower lip. I feel a little better today but not completely back to normal.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister, Nasopharyngitis, Nausea
Clinical narrative: Had a mild headache and felt like I had a cold coming on for 2 days.  After that I felt flushed but had no fever.  I also felt fuzzy like you do with the flu, and have had a lot of nausea, and excessive belching.  I also still have a small rash at the injection sight.  Last night I had some blisters appear on the inside of my lower lip. I feel a little better today but not completely back to normal.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Complex regional pain syndrome, Pain in extremity, Rash, Vaccination site pain, Vaccination site rash
Clinical narrative: Started with rash on lower forearm/wrists.  Within the next two days, developed rash on upper arm near site of vaccine with pain.  Eventually hospitalized the following week with severe pain in arm.  Eventually, developed chronic pain/CRPS.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Nausea, Neck pain, Pyrexia
Clinical narrative: Fever. Severe hip, back and neck pain. Headache. Nausea.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified Medical Assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 25-FEB-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L030160, expiration date- 11-AUG-2017. No adverse event reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified Medical Assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On February 2015 (as reported 29-FEB-2015) the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L030160, expiration date-11-AUG-2017. No adverse event was reported. The outcome of the event was unknown. No PWC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased
Clinical narrative: Customer came in 3/5/16 and stated that she suffered from immobility in her vaccinated arm. Stated it started gradually and got worse. Had to Dr for Xray/cortisone shots/therapy. Completed therapy 3/1/16 and is feeling better. Stated she was told IMZ should have been given in back of arm. Stated she couldn't raise her arm but had no pain or swelling.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Peripheral swelling, Pharyngeal oedema, Rash
Clinical narrative: 5:10 pm lightheaded, dizzy with subjective throat swelling. Exam showed dusky diffuse reticular rash over upper and lower extremities and left sided arm swelling.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient received PREVNAR 13 inj on 1/13/16, site became very painful 2 days later and continues to be painful almost 2 months later. Patient referred to primary care physician.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Thrombotic thrombocytopenic purpura, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: TTP, erythema, induration, warmth at vaccine site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: SIRVA- Pain in shoulder with and without use.  Taking nsaids pain is still occurring.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: Rash and fatigue.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Laboratory test, Premature labour
Clinical narrative: Preterm labor: contractions every 3-4 min for approx 1 hour requiring hospitalization and treatment.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Crying, Screaming
Clinical narrative: High pitch non-stop crying/scream that lasted from 11 PM - 6 AM. We called the nurse. She did not do anything or even check him. Around 4 AM, we called the nurse again, and she took him to the nursery, and she returned him an hour later, and he was still screaming.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Excessive eye blinking
Clinical narrative: MOMENTARY LOC PER VACCINATOR CHILD FLUTTERED EYES THEN OPENED THEM AGAIN LASTED FEW SECONDS ONLY THEN FULLY AWAKE....
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient reports a 4 by 5 inch red, painful area around the injection site and fever.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Left shoulder pain, pain with ROM, night shoulder pain, unable to move.
Age: 4.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red, hot area, 4 inch in diameter persisting for 2 or more days.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site nodule, Injection site swelling, Middle insomnia
Clinical narrative: 50-cent size hard knot and swelling around injection site. Increasing pain and loss of range of motion in left arm in days following. Dr. visit on 11/17/2015 prescribed Prednisone 10mg in a decreasing dose over 6 days between 11/17 through 11/22/15. Some pain relief while on the Prednisone but returned after med. was finished. Dr. visit on 12/1/15 with plan to start Physical Therapy to decrease pain and increase range of motion. Was referred for this and first visit on 1/15/2016 with visits continuing at this time. Have had some decrease of pain but wake up at night with pain in left arm. Have regained some range of motion but not to point of pre-vaccine. Having some loss of sensation in left hand and inability to always maintain a grasp/grip of items picked up.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 50-cent size hard knot and swelling around injection site. Increasing pain and loss of range of motion in left arm in days following. Dr. visit on 11/17/2015 prescribed Prednisone 10mg in a decreasing dose over 6 days between 11/17 through 11/22/15. Some pain relief while on the Prednisone but returned after med. was finished. Dr. visit on 12/1/15 with plan to start Physical Therapy to decrease pain and increase range of motion. Was referred for this and first visit on 1/15/2016 with visits continuing at this time. Have had some decrease of pain but wake up at night with pain in left arm. Have regained some range of motion but not to point of pre-vaccine. Having some loss of sensation in left hand and inability to always maintain a grasp/grip of items picked up.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PAIN, REDNESS AND SWELLING AT SITE OF INJECTION.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMR
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: HIGH FEVER AND SORE THROAT. TREATMENT: ACETAMINOPHEN, IBUPROFEN, BENADRYL.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria anterior thighs bilat, greater around injection sites, urticarial lower extremities, less on trunk/neck/face no vesicles, no ulcerations. No dyspnea.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Chills, Immediate post-injection reaction, Pyrexia, Vaccination complication
Clinical narrative: My child immediately had an adverse effect to the vaccine and continues. Immediately she had fever, chills and now constant stomach pain.
Age: 28.0
Sex: F
Vaccine: HEP, FLUX
Symptoms: Diarrhoea, Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: The night of vaccine donor c/o muscle aches on injection site. Woke up the next day w/immediate headache and nausea (0800). 2 hrs. later started vomiting and diarrhea. Visit a health clinic soon after; Dr stated she's having normal s/s of vaccination. Prescribed OTC TYLENOL and cough syrup. Donor stated continuing vomiting approx. x 3 times and diarrhea throughout the day (12 hrs). Woke up next day no s/s.
Age: 28.0
Sex: F
Vaccine: HEP, FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: The night of vaccine donor c/o muscle aches on injection site. Woke up the next day w/immediate headache and nausea (0800). 2 hrs. later started vomiting and diarrhea. Visit a health clinic soon after; Dr stated she's having normal s/s of vaccination. Prescribed OTC TYLENOL and cough syrup. Donor stated continuing vomiting approx. x 3 times and diarrhea throughout the day (12 hrs). Woke up next day no s/s.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-OCT-2015 16:14, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. The high temperature and low temperature were 4.6 and -3.0 respectively. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015 13:08, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 4.3 and -2.1 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.