chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLU3, PNC13, PNC13, PPV
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3 year old female patient who experienced pancake size red spot on leg and swollen leg. At 3 years of age, the patient received a dose on 22 Oct 2010. The patient also received a dose of PNEUMOVAX (Merck Sharp & Dome) on 22 Oct 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on 22 Oct 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced pancake size red spot on leg and swollen leg during the weekend following vaccination in Oct 2010. Outcome for swollen leg was recovered as of 25 Oct 2010. Outcome for pancake size red spot on leg was not recovered. No additional information was available at the time of this report. See related case (s): US WYE H1841116010 (adverse event, non expedited).
Sex: U
Vaccine: PNC13
Symptoms: Apnoea
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional via a sales representative regarding an unspecified number of patients who experienced apnea. The reporting healthcare professional stated that she obtained this information from an unknown journal. The patient received a dose on an unspecified date. The patient experienced apnea. Outcome was unknown. No additional information was available at the time of this report.
Age: 0.32
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Electroencephalogram normal, Seizure
Clinical narrative: Information regarding PREVNAR 13 (syringe pre filled) was received from a healthcare professional regarding a 3 month old female patient who experienced 40 minute seizure. At 3 months of age, the patient received the second dose on 01 Jun 2010. The patient also received a dose of Hib (manufacturer unknown) on 01 Jun 2010. The patient experienced a 40 minute seizure on 01 Jun 2010. She was taken to the hospital and may have received lorazepam. She was observed overnight and discharged on 02 Jun 2010. The patient experienced a second seizure on 20 Aug 2010. Again, she was hospitalized overnight for observation. Electroencephalogram was normal. On 13 Sep 2010, the patient experienced another seizure and was hospitalized. Treatment was unknown and no diagnosis has been made. As of 14 Sep 2010, the patient remains in the hospital and the outcome was unknown. The physician does not believe there is a causal relationship between the PREVNAR 13 and the seizures. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC13
Symptoms: Drug ineffective, Nasopharyngitis, Otitis media
Clinical narrative: This case was considered medically important. Additional information clarified the ear infection was an otitis media which updated the event and upgraded the event to serious for the medically important event of otitis media. Additionally reported were event details, recovery status and laboratory results. Information regarding PREVNAR 13 (syringe pre filled) was received from a healthcare professional regarding a male patient who experienced a cold and then developed otitis media/drug ineffective. The patient received a dose on an unspecified date. On an unspecified date in 2010, the patient experienced a cold and then developed otitis media. The patient recovered from the events. It was reported that the patient's mother believed that PREVNAR 13 caused the ear infection. No additional information was available at the time of this report.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumococcal bacteraemia, Streptococcus test positive
Clinical narrative: This is a spontaneous report from a contactable physician. A 2-year-old female patient received four doses of PREVNAR and one dose of PREVENAR 13 in May2010. Relevant history, past product history and concomitant medications were not reported. In Nov2010 (date not specified), the patient experienced culture confirmed pneumococcal bacteremia. The patient outcome was not reported.
Age: 0.3
Sex: U
Vaccine: PNC13
Symptoms: Bronchiolitis
Clinical narrative: This is a spontaneous report from a contactable Physician via sales representative. On an unspecified date, a 4-month-old patient (gender unspecified), received a second dose of PREVNAR 13. No relevant medical history or concomitant vaccines or medication were reported. No laboratory data was reported. On an unspecified date, the reporter was "managing an adverse reaction of bronchiolitis" considered a medically important event and stated "was noticed it happened within 3 to 4 days of a second dose of PCV 13, not as noticeable with PREVNAR". Treatment was not reported. The outcome of the event was unknown.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is an initial spontaneous report from a contactable Nurse. A Pfizer vaccine sales representative reported on behalf of a nurse who reported for her daughter. This 3 year old, female consumer received a single shot of PREVNAR 13 on an unknown date in Mar2011 at a dose of 0.5ml once intramuscularly. Previously the consumer included PREVNAR 7 since an unknown date at an unknown dose and frequency. The relevant medical history and concomitant medication included was unknown. The patient experienced pneumonia on an unknown date in Mar2011 after receiving PREVNAR 13 at 0.5ml once. The relevant laboratory tests included was unknown. In response to the reported event PREVNAR 13 was stopped on an unknown date in Mar2011. Therapeutic measures taken for the reported event included unspecified antibiotics. The consumer had recovered from the reported event on an unknown date at the time of report.
Age: 0.5
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Seizure
Clinical narrative: This is an initial spontaneous report by a contactable physician via Pfizer sales representative. A 6-month-old patient received PREVNAR 13 unknown dose unknown frequency at an unknown time at an unknown site of administration on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day included unspecified Flu vaccine. Vaccines taken within the last four weeks were unknown. On an unknown date while on PREVNAR 13 unknown dose unknown frequency patient experienced seizures. It was unknown if the patient had any siblings. Relevant lab data was unknown. At the time of the report, the clinical outcome of the above mentioned event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective, Otitis media, Streptococcus test positive
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer employee. A currently 24-month old female infant received PREVNAR 13 at an unknown anatomical site in Feb2011. Relevant medical history was unknown. Relevant past drug history included three doses of PREVNAR. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. On unknown date at an unknown time after the patient received the PREVNAR 13, the patient was diagnosed with otitis media and non-effectiveness of PREVNAR 13 was suspected. Relevant lab data included culture of otitis media carried on an unknown date which revealed 19A serotype. As of 13Apr2012, the clinical outcome of the otitis media was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Apnoea
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient (unknown age and gender) may have received a dose of PREVENAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unknown date a patient may have experienced apnea. The nurse queried the following: please advise as to the prevalence rate of apnea within the premature pediatric patient. The outcome of the event apnea was unknown. Follow-up (23May2012): Follow-up attempts completed. No further information expected.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Apnoea
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. This nurse reported similar events for this patient after the two month, four month and six month dose of PREVENAR 13. This is the six month report. A 6-month-old female patient was administered the third dose of PREVNAR 13 separately no an unspecified date. Relevant medical history and concomitant medications were not provided. Past product history included the first dose of PREVNAR 13 administered along with other unspecified vaccines on an unknown date at 2 months of age with apneic episode (not further specified). The patient received the second dose of PREVNAR 13, separate administration, on an unknown date at 4 months of age and within 48 hours the patient was found to be blue in her crib with an apneic episode. Subsequently, on an unknown date, the infant was then given her 6 month vaccine of PREVNAR 13 again given separately. Within 48 hours the apnea monitor alarmed, but she did not turn blue. The outcome of the event at the time of the report was unknown. Follow-up (21May2012): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report from a contactable nurse, who was the grandmother of the patient, via a Pfizer Sales Representative. A male patient (unknown age) received a dose of PREVNAR 13 on an unspecified date. It was reported that the patient missed the supplemental dose of PREVNAR 13. The patient also previously received an unknown number of doses of PREVNAR on an unknown date(s). Relevant medical history and concomitant medications were unknown. Vaccines given on the same day and taken within the last four weeks were unknown. On an unknown date, the patient experienced severe pneumococcal infection and pneumonia and was hospitalized for an unknown duration. Relevant lab data was unknown. At the time of the report, the patient had not recovered from the event.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pneumococcal sepsis
Clinical narrative: This is an initial spontaneous report by a contactable Physician. This Pfizer Sales Representative reported on behalf of a Physician. A 29-month-old male patient received a dose of PREVNAR 13 on 10Aug2010 (lot number E60220) (age 12-months). The patient had previously received 3 doses of PREVNAR 7 on 22Sep2009 (lot number D48927/first dose at age 2-months), 08Dec2009 (lot number D59304/second dose at age 4-months) and 09Feb2010 (lot number D59304/third dose at 6-months). Past vaccine history included 3 doses of Hepatitis B vaccine on 24Jul2009, 24Sep2009 and 09Feb2010; 3 doses of PENTACEL on 22Sep2009, 08Dec2009 and 09Feb2010 and 2 doses of ROTARIX on 22Sep2009 and 08Dec2009. Relevant medical history and relevant concomitant medications were unknown. Vaccines given on the same day (10Aug2010) included Hepatitis A vaccine, MMR and Varicella virus vaccine. Concomitant vaccines included 3 doses of FLUZONE administered on 26Oct2010, 14Dec2010 and 13Oct2011, a 2nd dose of Hepatitis A vaccine on 15Feb2011 and a 4th dose of PENTACEL on 26Oct2010. Vaccines taken within the last four weeks were unknown. On 12Jan2012, following vaccine administration, the patient experienced pneumococcal sepsis. Relevant laboratory data was unknown. Treatment included unspecified intravenous antibiotics. On 14Jan2012, the patient recovered from the event. The reporter commented: Causal Relationship: PREVNAR 7 and PREVNAR 13 did not prevent infection. Follow up (19Mar2012): New information reported from a contactable physician includes: Patient details (updated age), product details, concomitant vaccines and past vaccine history, event details including onset and recovery dates, treatment modalities, recovery status, and reporter comment.
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician, through a Pfizer sales representative. A female patient who was in late 70s was administered PREVNAR 13 unknown dose, route, at unknown time. Relevant medical history included high blood pressure and diabetes, still ongoing. Relevant concomitant medication was unknown. In 2012 at unknown time while on PREVNAR 13 she experienced severe rash at the site of injection and fever which was 103 degree for which she was hospitalized. Relevant lab data was unknown. At the time of report it was unknown if she was on PREVNAR 13. At the time of report the clinical outcome of all the above mentioned events was unknown. Follow-up (14Aug2012): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Seizure
Clinical narrative: This is a spontaneous report by a contactable medical assistant. This female medical assistant reported on behalf of a male patient who was administered with the second dose of PREVNAR 13 in thigh on 29Nov2012 at 10:15 am. Vaccines taken within the last four weeks were none. He had previously received the first dose of PREVNAR 13 in thigh, a dose of PENTACEL, and a dose of hepatitis A vaccine, on 27Aug2012. Relevant medical history included ongoing heart murmur. Relevant concomitant medications were none. On 29Nov2012, after vaccination, the patient experienced seizures. Relevant lab data was none. At the time of the report the clinical outcome of above mentioned event was unknown. Follow-up (28Jan2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On an unknown date these patients were vaccinated with improperly stored GARDASIL (lot # K011325, expiration date 08-APR-2017 or lot # K010574, expiration date: 08-APR-2017; strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient. There were no pertinent medical history and drug reactions or allergies. On 14-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose and route were unknown). There were not concomitant medications. On 15-SEP-2015, the patient reported to the pharmacist that she developed an unspecified fever and headache, ibuprofen (unspecified dose and frequency) was given for the events. No lab diagnostics studies were performed. The outcome of th events were unknown. The causality between the events and ZOSTAVAX were unspecified. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 17-SEP-2015 (also reported as today) the patient was vaccinated with an improperly stored dose of GARDASIL (dose, strength were unknown, lot # L011846, expiry date: 16-JUN-2016, intramuscular). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 17-SEP-2015 (also reported as today) the patient  was vaccinated with an improperly stored dose of GARDASIL (dose, strength were unknown, lot # L0118546, expiry date: 16JUN-2017; intramuscular). No adverse effects were reported. This is one of several cases received from the same source. 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 nurse and refers to a multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On multiple unspecified dates, the patients were vaccinated with an improperly stored doses of GARDASIL (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a multiple unspecified patients of unknown age and gender. No information about the patients pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. ON multiple unspecified dates, the patiens were vaccinated with an improperly stored doses of ROTATEQ route defaulted to oral (dose, lot# and expiration date were not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) referring to a female patient of unknown age. Concurrent condition and medical history were not reported. On an unspecified date, the patient was vaccinated with GARDASIL, (lot#, dose and route were not provided) as first dose in series. On 15-SEP-20165 ("today"), the patient was int he office and was to receive GARDASIL 9 (lot #, dose and route were not provided) as second dose in series. (interchange of vaccine products). No adverse effects were reported. 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 (certified medical assistant) referring to an unspecified number of patients of unknown ages and genders. Concurrent condition and medical history were not reported. On unspecified dates, the patients received improperly stored doses of RECOMBIVAX HB (lot # K008986, expired date 01-APR-2016, thimerosal status, strength, dose, frequency and route were not provided (incorrect product storage). No adverse effect was reported. This is one of two reports received from the same source. 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 (certified medical assistant) referring to an unspecified number of patients of unknown ages and genders. Concurrent condition and medical history were not reported. On unspecified dates, the patients received improperly stored doses of VAQTA (lot # K008254, expired date 12-NOV-2015, strength, dose, frequency and route were not provided) (incorrect product storage). No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a 1 year old child patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On 18-SEP-2015, the patient was vaccinated with ZOSTAVAX (unknown strength, route and dose) instead of (Oka/Merck) VARIVAX. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. on an unknown date these patients were vaccinated with improperly stored VAQTA (lot # K026529, expiration date: 02-JUN-2017 or lot # K019560, expiration date: 02-JUN02017; strength, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unknown date these patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K018180, expiration date: 17-SEP-2016 or lot # K020216. expiration: 17-SEP-2016; strength, dose and route unknown)(incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unknown date these patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # K025005, expiration date: 21-JUL-2017 or lot # K025006, expiration date: 22-JUL-2017 or lot #K016964, expiration date: 16-JUL-2017 or lot #K002747, expiration date: 09-DEC-2016 or lot #K008680, expiration date: 11-MAR-2017; strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 17-SEP-2015 (also reported as today) the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, strength were unknown, lot # L011846, expiry date: 16-JUN-2017, intramuscular). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (route of administration, lot # and expiration date not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 24-AUG-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally, lot # K020181, expiration date 24-JUN-2016 (strength and dose were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on 06-MAR-2015 the patient received the first dose of GARDASIL (strength, dosage, route and lot# were not reported), subsequently on 12-MAY-2015 the patient received the second dose of GARDASIL (strength, dosage, route and lot# were not reported) and finally in order to complete the series received the third dose of GARDASIL 9 (strength, dosage, route and lot# were not reported). Concomitant therapy was not reported. No adverse effects were reported. 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 registered nurse refers to multiple number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. ON an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (dose and route of administration not reported) lot # K026666, expiration date 22-OCT-2106, that were improperly stored. There were no adverse effects reported. 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: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medication and pertinent medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored unspecified doses of GARDASIL lot # K009482, expiry date: 06-MAR-2017 or lot# K023432, expiry date: 18-JUN-2016 or lot# K011325, expiry date: 08-APR-2017 or lot# K010574, expiry date: 08-APR-2017 or lot# K010215, expiry date: 05-MAY-2017, (dose, site and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Peripheral swelling, Urticaria
Clinical narrative: This spontaneous report was received from a 55 year old female patient with latex, shellfish and mold allergies, who was reporting on herself. The patient's medical history was not reported. On 12-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX in the left arm (lot #, dose and route of administration were not reported). No concomitant therapies were reported. On the same date, the patient developed a very large welt and swelling from armpit to elbow. The patient also reported that she did not feel well since the day after the vaccine was administered. The outcome of the events was reported as not recovered. The patient sought unspecified medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Headache, Neck pain, Pain in extremity
Clinical narrative: Following MENACTRA c/o HA, weakness and neck pain, arm soreness. No redness or warmth at injection site.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored (in temperature 34-35 unit unknown) unspecified doses of RECOMBIVAX HB lot # K023863, expiry date: 03-APR-2016 or lot # L009155, expiry date: 29-OCT-2016 or lot # L016959, expiry date: 12-MAR-2016 (dose, site and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a current 71 years old patient of unknown gender. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot# reported as L021367 with expiration date of 05-NOV-2016, dose, strength and route unknown) and less than 2 years later the patient was given a second dose of PNEUMOVAX 23 on an unspecified date. No adverse effects reported. 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 referring to a multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with incorrectly stored doses of (Oka-Merck) PROQUAD (dose and route of vaccination were not reported, lot # L017140 with expiration date: 13-NOV-2016, lot # K025760 with expiration date: 08-JAN-2016, lot # reported as L021599 with expiration date: 10-DEC-2016). No adverse effect reported. 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 registered nurse referring to a multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with incorrectly stored doses of (Merck) VARIVAX (dose and route of vaccination were not reported, lot # L001330 with expiration date: 13-JAN-2017, lot # L013395 with expiration date: 16-APR-2017). No adverse effect reported. 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 as received from a health care worker refers to a patient of unknown age and gender. Information regarding medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored (Merck) VARIVAX (lot # K007977 and expiry date 03-JUN-2015). No adverse effects were reported. Product quality complaint was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Rotator cuff syndrome, Swelling
Clinical narrative: Patient reported redness/swelling within 2 days of receiving shot followed by severe pain and rotator cuff issues. Went to ER for treatment.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Injection site induration, Injection site swelling, Nasopharyngitis
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to a 37 year old female patient with drug reactions/allergy to penicillin, sulfa drugs and LEVAQUIN. The patient was pregnant and she was currently at gestation week 38. The patient became pregnant with last menstrual period (LMP) of approximately 17-DEC-2014 and estimated delivery date (EDD) of approximately 23-SEP-2015. On 03-SEP-2015, the patient received a dose of GARDASIL injection or GARDASIL 9 injection (dose, lot# and expiration date were not reporter) instead of an unspecified Flu vaccine at her physician's office. The reporter was uncertain which vaccine was administered. The patient also experienced some injection site swelling and hardness which was not currently resolved. She had also developed "a cold". Pregnancy exposure was approximately at 37 weeks gestation age. The trimester of exposure was approximated to third. The pregnancy outcome and fetal outcome were unknown at the time of the report (the patient was still pregnant). No treatment was given for the adverse events. The outcome of the adverse events was reported as not recovered. The patient sought medical attention via office visit. The causality between the adverse events and reported vaccination was not provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative, Vaccination failure
Clinical narrative: This spontaneous report as received from a female consumer of unknown age, who was reporting on herself. No demographic information was provided for the patient or physician. No concurrent condition, medical history and concomitant therapy was reported. On an unknown date, the patient was vaccinated with M-M-R II (batch #, lot#, expiration date, dose, route of administration and indication were not reported). On an unknown date, reported as "recently", the patient had blood work done to check her titers. The patient's rubella titer showed, that she had no immunity. The outcome of the vaccination failure was unknown. The relatedness between the event of vaccination failure and the M-M-R II was not reported. Additional information is not expected, because the reporter declined to participate in answering questions within this report.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a multiple unspecified number of patients of unknown age. The nurse reported that multiple unspecified patients received on an unspecified date M-M-R II (confirmed Lot # K020188 and exp. 15OCT2016) that was improperly stored (dose and route of administration were not provided). No adverse effects or PQC were reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain (RT) upper arm. Treated w/doxycycline for cellulitis.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergie/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were administered with an unspecified number of improperly stored doses of GARDASIL injection (lot # L006549 with expiration date 06-APR-2017 and lot # K008931 with expiration date 04-MAR-2017; dose and route were not provided). There was no concomitant medication. It was unknown if the patients sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Cough, Headache, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Nasal congestion, sore throat, cough, fever, headache, body aches. Temp 98/3 (tympanic) Prescription for Z-pak given.
Age: 20.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Pyrexia
Clinical narrative: Nasal congestion, sore throat, cough, fever, headache, body aches. Temp 98/3 (tympanic) Prescription for Z-pak given.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Induration, Nodule, Skin warm, Swelling
Clinical narrative: (R) arm -( MENVEO) 11 x 6 cm  raised, indurated, warm flat - topped nodule. (L) arm (TDAP) 6 x 6 cm raised, indurated, warm flat - topped nodule.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Extra dose administered, Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Advised pt receiving pneumonia vaccinations prior to surgery. She received first PCV13 on 6/30/2015 (left arm) and was to get PPSV23 on 9/3/15 however she was given a 2nd dose of PCV13 instead (to left arm). She was called back and given PPSV23 on 9/9/2015 to same arm (left) reporting some site tenderness afterwards. Pt reported to go to ER on 9/11/2015 due to left arm pain - redness and swelling at injection site being given diagnosis of cellulitis and placed on antibiotics x 10 days. Pt/Pt husband reported she had immediate pain to vaccine site 9/9/2015 with dime size red splotch to area that progressed over the next 8-12 hours to include 1/2 her arm. Splotches went a few "inches" from injection site toward her elbow and she was unable to use left arm due to pain in arm/shoulder. She denied any fever, arm weakness, paresthesia, rash (other than site reaction), headache, or other systemic symptoms. An xray of arm 9/11/15 was normal. She advised it took 2 days on TYLENOL for pain to ease so she could use arm, and 3 days (9/14) on antibiotics before redness eased and another few days before all symptoms resolved. As of 9/18/2015 she is fine and skin left arm is normal with no pain.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pain in extremity, Rash macular
Clinical narrative: Advised pt receiving pneumonia vaccinations prior to surgery. She received first PCV13 on 6/30/2015 (left arm) and was to get PPSV23 on 9/3/15 however she was given a 2nd dose of PCV13 instead (to left arm). She was called back and given PPSV23 on 9/9/2015 to same arm (left) reporting some site tenderness afterwards. Pt reported to go to ER on 9/11/2015 due to left arm pain - redness and swelling at injection site being given diagnosis of cellulitis and placed on antibiotics x 10 days. Pt/Pt husband reported she had immediate pain to vaccine site 9/9/2015 with dime size red splotch to area that progressed over the next 8-12 hours to include 1/2 her arm. Splotches went a few "inches" from injection site toward her elbow and she was unable to use left arm due to pain in arm/shoulder. She denied any fever, arm weakness, paresthesia, rash (other than site reaction), headache, or other systemic symptoms. An xray of arm 9/11/15 was normal. She advised it took 2 days on TYLENOL for pain to ease so she could use arm, and 3 days (9/14) on antibiotics before redness eased and another few days before all symptoms resolved. As of 9/18/2015 she is fine and skin left arm is normal with no pain.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Wrong drug administered, X-ray limb normal
Clinical narrative: Advised pt receiving pneumonia vaccinations prior to surgery. She received first PCV13 on 6/30/2015 (left arm) and was to get PPSV23 on 9/3/15 however she was given a 2nd dose of PCV13 instead (to left arm). She was called back and given PPSV23 on 9/9/2015 to same arm (left) reporting some site tenderness afterwards. Pt reported to go to ER on 9/11/2015 due to left arm pain - redness and swelling at injection site being given diagnosis of cellulitis and placed on antibiotics x 10 days. Pt/Pt husband reported she had immediate pain to vaccine site 9/9/2015 with dime size red splotch to area that progressed over the next 8-12 hours to include 1/2 her arm. Splotches went a few "inches" from injection site toward her elbow and she was unable to use left arm due to pain in arm/shoulder. She denied any fever, arm weakness, paresthesia, rash (other than site reaction), headache, or other systemic symptoms. An xray of arm 9/11/15 was normal. She advised it took 2 days on TYLENOL for pain to ease so she could use arm, and 3 days (9/14) on antibiotics before redness eased and another few days before all symptoms resolved. As of 9/18/2015 she is fine and skin left arm is normal with no pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 74 year old female patient. Information regarding medical history and concurrent conditions were not reported. On 11-SEP-2015, the patient was vaccinated with 0.65 ml ZOSTAVAX vial 19400 PFU (lot # L006392 and expiry date 25-MAY-2016) subcutaneously in the left deltoid. On an unknown date in September 2015, the patient experienced little redness but no rash or blisters at the injection site. The reporting pharmacist did not know when the redness developed, but observed the patient's injection site on 16-SEP-2015. The patient stated that the redness not even bothering her. No lab diagnostics test was performed. The patient did not seek any medical attention. No product quality complaint was involved. The outcome of the event was reported as recovering. Causality assessment was not provided by the 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 health care worker regarding an unspecified number of patients of unknown demographics. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD lot # L005297, expiration date- 17-AUG-2016. No adverse effects reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. On 09SEP2015 the patient was vaccinated with incorrectly stored dose of ROTATEQ (dose and frequency were not reported, lot # K020181 with expiration date: 24JUN2016). No adverse effects reported. This is one of the several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant mediations were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored (Merck) VARIVAX lot # L002870 expiry date 27-JAN-2017, lot# L006386 expiry date 25-FEB-2017, lot# L013827 expiry date 21-APR-2017, lot# L012036 expiry date 07-APR-2017 (dose and route of administration unspecified). No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Contusion, Pain, Syncope, Tremor
Clinical narrative: Pt c/o bruised described as blood under the skin, starting day of injection. Then that went away quick, the c/o soreness for a couple day and muscle tremors 2 days after injection then pt had a syncope episode 2 days after injection.
Age: 22.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Cough, Nasal congestion, Nausea, Oropharyngeal pain, Vomiting
Clinical narrative: Sore throat, nasal congestion, cough, nausea, vomited x3. Temp 98.9 (tympanic).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: General malaise. Fever - 102. Injection site pain.
Age: 40.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Chills, Dry mouth, Headache, Nasopharyngitis
Clinical narrative: Dry mouth, sore throat, piercing headache, spinal pain, chills, cold symptoms; start 1/2 hour after injection with duration of one week. General weakness following day.
Age: 40.0
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain, Spinal pain
Clinical narrative: Dry mouth, sore throat, piercing headache, spinal pain, chills, cold symptoms; start 1/2 hour after injection with duration of one week. General weakness following day.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Fatigue, Hand-eye coordination impaired, Rash
Clinical narrative: Over several days: On Fri. 09/18/15 had rash in both armpits. Symptoms subsided. On 09/19/15 at 11:00 AM rash returned. At 3 PM rash spread to back. By 4 PM was on neck and wrists. By 4:30 rash spread to left breast and to face. At 5 PM patient went to ER. Rash was extremely itchy. By 5:30 rash had spread to hips. Took one ALLEGRA at 5:30 PM, helped with itching. Rash subsided temporarily, but later spread to more of back and stomach. At 9 PM ER administered PO diphenhydramine 25 mg and prednisone 40 mg. MD examined her at 10:30 PM and prescribed more prednisone and antihistamine shot in left buttock. Discharged at 11 PM. On 09/20/15 minor rash still present on left side of body and both knees. In left leg joints began to ache. And had no energy. At 1 PM rash reappeared on face and neck and palms of hands. At 1 PM took one 25 mg diphenhydramine and one 10 mg loratadine and 3 prednisone 20 mg tabs, as prescribed. Symptoms lessened. New rash appeared on stomach and returned to face at 6:20 PM. At 9 PM rash appeared on soles of feet. At 11 PM reappeared on back, as well as stomach, chest, neck, armpits, hips and continued to spread until 1 AM. Took one of each previously mentioned meds. At 6 AM took one BENADRYL. Rash had disappeared from all parts of body except back of legs and buttocks. At 12 noon took two 20 mg of prednisone, one loratadine and one BENADRYL. At 3:30 saw MD for follow up. Patient is exhausted and concerned. Is shaking and reports low hand-eye coordination.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic, Tremor
Clinical narrative: Over several days: On Fri. 09/18/15 had rash in both armpits. Symptoms subsided. On 09/19/15 at 11:00 AM rash returned. At 3 PM rash spread to back. By 4 PM was on neck and wrists. By 4:30 rash spread to left breast and to face. At 5 PM patient went to ER. Rash was extremely itchy. By 5:30 rash had spread to hips. Took one ALLEGRA at 5:30 PM, helped with itching. Rash subsided temporarily, but later spread to more of back and stomach. At 9 PM ER administered PO diphenhydramine 25 mg and prednisone 40 mg. MD examined her at 10:30 PM and prescribed more prednisone and antihistamine shot in left buttock. Discharged at 11 PM. On 09/20/15 minor rash still present on left side of body and both knees. In left leg joints began to ache. And had no energy. At 1 PM rash reappeared on face and neck and palms of hands. At 1 PM took one 25 mg diphenhydramine and one 10 mg loratadine and 3 prednisone 20 mg tabs, as prescribed. Symptoms lessened. New rash appeared on stomach and returned to face at 6:20 PM. At 9 PM rash appeared on soles of feet. At 11 PM reappeared on back, as well as stomach, chest, neck, armpits, hips and continued to spread until 1 AM. Took one of each previously mentioned meds. At 6 AM took one BENADRYL. Rash had disappeared from all parts of body except back of legs and buttocks. At 12 noon took two 20 mg of prednisone, one loratadine and one BENADRYL. At 3:30 saw MD for follow up. Patient is exhausted and concerned. Is shaking and reports low hand-eye coordination.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 19-SEP-2015, an expired sterile diluent (lot number reported as J006741; expiration date August 2015) (dose, frequency and route of administration were not reported) was used to reconstitute ZOSTAVAX (lot number, route of administration, dose and strength were not reported) and was inadvertently administered to a patient. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information is not expected because the reporter did not consent for new follow up attempts.
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report received from a health care worker refers to a patient of unknown demographics. No medical history was reported. On an unknown date the patient was vaccinated with an improperly stored  GARDASIL 9 (lot # L011846, expiry date: 16-JUN-2017, dose and route: unknown) and (Merck) VARIVAX (lot # L007224, expiry date: 03-MAR-2017, dose and route: unknown). No other concomitant therapy was reported. This case is linked to cases: # 1509USA011273 and # 1509USA007856. (Same reporter link). Additional information has been requested.