chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 31-AUG-2016, the patient received improperly stored dose of VARIVAX injection, lot # M004328, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 30-AUG-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This literature report was received from the authors of the published article title and concerns 317 patients of unspecified age and gender. On unknown dates, the patients were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (Dosing regimen, frequency, lot # and expiration date unknown) subcutaneous for prophylaxis. The author reported that greater than 97% of the patients received a 2-dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). A third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was recommended as a control measure. The authors conducted an investigation and identified that the patients had a mumps outbreak between 09-APR-2015 and 27-MAY-2016 despite being vaccinated with 2-dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). The patients were considered to be infectious from 2 days before until 5 days after the onset of parotitis. Among the 317 cases identified, at the time of parotitis onset, 50 mumps patients had received 3 doses of MMR vaccine, 232 had received 2 doses, 12 had received 1 dose, seven were unvaccinated, and 16 had unknown vaccination status. Forty-five of the 50 patients with a third dose received it during this outbreak, and five received it in prior years for reasons unrelated to this outbreak. Some of the 45 persons who received a third dose during this outbreak might have been exposed before vaccine-induced immunity was boosted. Eleven of the 45 patients had parotitis onset on the same day or within 2 weeks after receiving the third dose, six (13%) within 2-4 weeks, and 27 (60%) >4 weeks after. One (2%) patient received a third dose 3 days after parotitis onset. One hundred cases were laboratory confirmed by rRT-PCR, and 217 were classified as probable. Cases occurred in persons who ranged in age from 16-55 years, with a median age of 20 years. Two patients experienced orchitis, a recognized complication of mumps. No deaths were reported. All cases were epidemiologically linked to the university; 278 cases occurred in students, three in staff members, and 36 in persons not affiliated with the university, but who had contact with university students or the campus. Several sub-clusters occurred within the larger outbreak in certain academic programs, athletic facilities, and community workplaces. The outcome of the events was unknown. The reporter considered the events to be related to M-M-R II. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PPV, FLUX, PNC13
Symptoms: Influenza, Pneumonia
Clinical narrative: This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for herself. A 72-year-old female patient of an unspecified race received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunisation, XELJANZ XR, via an unspecified route of administration from an unspecified date at 11 mg, for an unspecified indication and influenza vaccine, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and the patient's concomitant medications were not reported. The patient experienced ended up getting the flu as well as pneumonia on an unspecified date with outcome of unknown. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in right arm, that goes down to my fingertips.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Anaemia, Blood alkaline phosphatase increased, Body temperature increased, Constipation, Crying
Clinical narrative: Temperature peaked on December 5th to 101 degrees F and then to 105.8 degrees F on December 6th and took to Emergency room. Crying, very irritable that day, fussy. The next day Dec. 7th, very lethargic, loss of appetite, didn't eat much also constipated and very gassy. Dec. 10th - emergency room visit. See attached paper.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Flatulence, Hepatomegaly, Irritability, Lethargy
Clinical narrative: Temperature peaked on December 5th to 101 degrees F and then to 105.8 degrees F on December 6th and took to Emergency room. Crying, very irritable that day, fussy. The next day Dec. 7th, very lethargic, loss of appetite, didn't eat much also constipated and very gassy. Dec. 10th - emergency room visit. See attached paper.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Vaccination error
Clinical narrative: None. Vaccine given inappropriate - not indicated.
Age: 25.0
Sex: M
Vaccine: FLU4, HEPA, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Due for Td; Tdap mistakenly given instead.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Axillary mass, Erythema, Tenderness
Clinical narrative: Client received FLULAVAL Quadrivalent vaccine 9-19-2016 in (L) deltoid. After playing baseball game noted a raised red lump approx. 10 mm in (L) axilla. Continues to remain reddened with increased tenderness since Monday pm - 9/19/2016.
Age: 1.67
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: .5 dose of FLUQ give to client instead of .25 dose of FLTQ.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Patient became very dizzy and lightheaded immediately after receiving the vaccine. Patient recovered after 15 min. Put head between legs, gave water, cool rag, and food. Pt left under care of husband.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient arrived at pharmacy to get pneumonia "Booster". Tech used screening tool to screen patient; and patient was given PREVNAR. Received PREVNAR 13 in 2015 already.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Patient arrived at pharmacy to get pneumonia "Booster". Tech used screening tool to screen patient; and patient was given PREVNAR. Received PREVNAR 13 in 2015 already.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chest discomfort, Crying, Decreased appetite, Depressed mood
Clinical narrative: Despondent, depressed, sad, crying a lot without cause, irritable, panicky, tight chest, upset stomach, loss of appetite.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Depression, Irritability, Panic reaction
Clinical narrative: Despondent, depressed, sad, crying a lot without cause, irritable, panicky, tight chest, upset stomach, loss of appetite.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Crying, Fall, Head injury, Headache, Musculoskeletal stiffness
Clinical narrative: Patient and mom walked out of exam room to head into room across hall where Sib was. Patient fainted and  fell backward hitting the back of his head on the floor, where he then went into a seizure like state. Non responsive, arms and legs stiffened and started to thrash. Then lost bladder control. Started to come to approx a minute-2 minutes after event, where he started crying for his mom, and also asking what had happened. PCP was present the entire time and kept him down due to head injury trying to keep him from moving his head. Patient c/o head hurting but was aware of surroundings.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Seizure like phenomena, Syncope, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Patient and mom walked out of exam room to head into room across hall where Sib was. Patient fainted and  fell backward hitting the back of his head on the floor, where he then went into a seizure like state. Non responsive, arms and legs stiffened and started to thrash. Then lost bladder control. Started to come to approx a minute-2 minutes after event, where he started crying for his mom, and also asking what had happened. PCP was present the entire time and kept him down due to head injury trying to keep him from moving his head. Patient c/o head hurting but was aware of surroundings.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Crying, Dyskinesia, Fall, Head injury, Musculoskeletal stiffness
Clinical narrative: Patient and mom walked out of exam room to head into room across hall where Sib was. Patient fainted and  fell backward hitting the back of his head on the floor, where he then went into a seizure like state. Non responsive, arms and legs stiffened and started to thrash. Then lost bladder control. Started to come to approx a minute-2 minutes after event, where he started crying for his mom, and also asking what had happened. PCP was present the entire time and kept him down due to head injury trying to keep him from moving his head. Patient c/o head hurting but was aware of surroundings.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal discomfort, Headache, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Location area of arm that received the administered vaccine sore, swelled, hard to move. Nausea, severe stomach trouble, headache.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea
Clinical narrative: Location area of arm that received the administered vaccine sore, swelled, hard to move. Nausea, severe stomach trouble, headache.
Age: 22.0
Sex: U
Vaccine: FLU3
Symptoms: Needle issue
Clinical narrative: The retractable needle did not retract but remained in the patient's arm. The pharmacist noticed it and removed it immediately. The patient was looking the other way and did not realize what happened.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: High fever 103 degrees. Sever debilitating headache for 4 days arm where shot was given (L) red and sore for 3 weeks. Flashing lights in eyes. Dizziness for 3 weeks. No appetite.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Photopsia, Pyrexia
Clinical narrative: High fever 103 degrees. Sever debilitating headache for 4 days arm where shot was given (L) red and sore for 3 weeks. Flashing lights in eyes. Dizziness for 3 weeks. No appetite.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Was given on 12-14-16 and was in office due to redness from elbow to clavicle on 12-16-16. Pediatric I.D. was notified, advised to start Clindamycin and BENADRYL. Pt was seen 12-17-16 and less redness.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Patient called and reported sweating, throwing up, swelling in injection site, and injection site was warm for 24 hours.
Age: 73.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Several days after receiving the flu vaccine, my upper arm and entire shoulder became painful, and this lasted approximately 10 days.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Body temperature increased, Hypersomnia, Seizure, Staring
Clinical narrative: Mom called next morning and stated her son was sleeping all day and had blank stare when he woke up and a temp. of 101. She was advised to take him to ER. He was diagnosed w/seizures he did on hospital follow up w/us on 7/21/16.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: Left arm swollen, hard, hot from shoulder to elbow. Arm discolored on day 3 (erythema).
Age: 68.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt developed cellulitis was seen by pts MD 12/31 got antibiotics and recovered. Cellulitis was at site of ZOSTAVAX injection.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of patients of unknown age and gender. No information regarding patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of PROQUAD (dose, route, lot # and expiry date were not reported) for prophylaxis. The vaccine was exposed to the temperature of -13 degrees Celsius for 5 hours. No previous temperature excursion and no adverse effects were reported. The data logger was not involved. This is one of several reports received from the same reporter. Follow up information was received on 14-OCT-2016. All telephone attempts to obtain follow-up information had been unsuccessful. Follow-up information was received on 04-JAN-2017 from the nurse. On 17-AUG-2016, it was reported that the improperly stored PROQUAD was not administered to the patients. On 04-JAN-2017, the nurse confirmed that multiple patients (unspecified number) received the improperly stored vaccine on unspecified dates. PROQUAD was exposed to the conditions which were previously reported. No symptoms were reported. Information on specific patients who were vaccinated would be provided upon authorization from the reporter's supervisor. No further information was provided. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1608USA010530: US-009507513-1608USA010527: US-009507513-1608USA010529: US-009507513-1608USA010528: US-009507513-1608USA010531: US-009507513-1608USA009023: US-009507513-1608USA010533: MERCK 1608USA010532:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # L048459 with expiration date 22-FEB-2018, lot # M004116 with expiration date 12-OCT-2017, lot # M007728 with expiration date 21-MAR-2018 and lot # L045700 with expiration date 22-FEB-2018 (dose and route of administration were not reported) for prophylaxis. The doses of vaccine were exposed to the temperature of 60 degrees Fahrenheit (F) for a time frame of 25 minutes. Data logger was not involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Follow-up information has been received on 28-DEC-2016, indicating that all telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA008310: US-009507513-1611USA001090: US-009507513-1611USA001092: US-009507513-1611USA001093: MERCK 1611USA001091:Mfr number.
Age: 1.25
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a physician referring to a 15 month old patient of unknown gender. The physician reported that on 12/09/2016 a fifteen month old was inadvertently administered the VARIVAX and PROQUAD instead of the VARIVAX and M-M-R II vaccines. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist via a Pfizer's company representative and refers to unspecified multiple patients, all of 65 years of age or older. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with single doses of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). The patients experienced redness at the injection sites after receiving the PNEUMOVAX 23 (unspecified dates). The outcome of the events and the relatedness between the events and PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59-year-old non-pregnant female patient. The patient's concurrent conditions included diabetes mellitus and an allergy to codeine. Information regarding concomitant therapies was not provided. On 17-DEC-2016, the patient received a dose of ZOSTAVAX subcutaneously (dose, lot # and expiration date were not reported) as a shingles vaccination at a pharmacy. On an unknown date in December 2016, the patient experienced an injection site redness larger than a silver dollar and darkness to an old scar. On 20-DEC-2016, the patient sought medical attention at the pharmacy. The outcomes of the events were reported as not recovered. No lab diagnostic studies were performed. The relatedness between the events and ZOSTAVAX was not provided.   Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 13 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 21-SEP-2016, the patients received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: After the soreness went away, I started experiencing severe pain raising my arm above my head. After 4 weeks saw a Dr and was told to report it. It's about 8 weeks since flu shot and I still have severe pain in my shoulder with raising above head or lifting anything. I found the injection to be way too high after I was injected, never had a flu shot injected there before.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Pain
Clinical narrative: After the soreness went away, I started experiencing severe pain raising my arm above my head. After 4 weeks saw a Dr and was told to report it. It's about 8 weeks since flu shot and I still have severe pain in my shoulder with raising above head or lifting anything. I found the injection to be way too high after I was injected, never had a flu shot injected there before.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Raised, mildly tender, erythematous rash on the left lateral thigh where Kinrix and Proquad were administered.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster, Rash
Clinical narrative: Herpes zoster diagnosis in a man previously vaccinated with zoster vaccine. diagnosed by, MD. Treated with PO acyclovir x11 days. Onset date 11/18/2016. Rash lasted less than 2 weeks. Rash on right face with eye involvement. Onset of bell's palsy on 1/1/2017.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Raised, mildly, tender erythematous rash on left lateral thigh.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site urticaria, Nausea, Pain in extremity, Pruritus
Clinical narrative: Patient reported having a high fever (101F), minor itching, feeling nauseous and having a headache. The patient also had an onset of hives on the right side of her arm from her elbow to her shoulder, with extreme arm pain. Patient reported onset of symptoms several hours after the vaccine was administered and reported these to the pharmacy on 1/5/17 at 1pm, at the time of which she still had arm pain and hives. She went to her doctor on 1/5/17 and received a prescription for prednisone for her hives.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient reported having a high fever (101F), minor itching, feeling nauseous and having a headache. The patient also had an onset of hives on the right side of her arm from her elbow to her shoulder, with extreme arm pain. Patient reported onset of symptoms several hours after the vaccine was administered and reported these to the pharmacy on 1/5/17 at 1pm, at the time of which she still had arm pain and hives. She went to her doctor on 1/5/17 and received a prescription for prednisone for her hives.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. The reporter stated that improperly stored doses of VARIVAX (lot number reported as M033905, exp. date 20-JUL-2018, Lot: M027347 Exp:01-JUN-2018, Lot: M022103 Exp: 04-MAY-2018, Lot: L020000 Exp:02-JUN-2017, and Lot: L013826 Exp:21-APR-2017) were administered to an unspecified number of patients in December 2016, following the initial excursion that was reported on 01-DEC-2016 and not following the most recent excursion that was reported on 07-DEC-2016. No adverse effects reported. A data logger was involved. Temperature was 13.8 Fahrenheit (F) for 13 hours, the previous excursion was of 9 F for 15 hours. This is one several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA002545.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB (lot # L033343 expiration date: 13-SEP-2017), the vaccines were exposed to 68.7 °F for 5 hours; also the vaccine with lot # L040458  expiration date: 04-FEB-2018 was exposed to 54.4 °F for 5 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010201: US-009507513-1612USA010217: US-009507513-1612USA010219: US-009507513-1612USA010220.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VARIVAX (lot # M000760 expiration date: 06-JAN-2018; lot # M009769 expiration date: 25-FEB-2018; lot # M010485 expiration date 01-MAR-2018; lot # M024702 expiration date: 18-MAY-2018; lot # M025871 expiration date: 24-MAY-2018, lot # M033213 expiration date: 13-JUL-2018). The vaccines were exposed to 30.2 °F for 5 hours, 30 minutes. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010201: US-009507513-1612USA010217: US-009507513-1612USA010218: US-009507513-1612USA010219.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 23-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L034724 expiration date: 09-DEC-2016) for prophylaxis (dose and route of administration were not provided). No side effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an unspecified health care professional, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX lot # M028552, expiration date 07-JUN-2018 and lot # M003440, expiration date 20-JAN-2018 (dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The vaccine had one temperature excursion of 7.1 Fahrenheit grades (F) for 1 hour and a previous excursion of 6.4 (F) for 3 hours; with a data logger involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted. Sender's Comments: US-009507513-1701USA001224: US-009507513-1612USA010151.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a 17 year old female patient reporting on herself. There was no concurrent conditions, medical history or concomitant medications. On 22-JUN-2016, the patient was vaccinated with a dose of GARDASIL (Dose, route, anatomical location, lot number and batch number were not provided). The consumer stated that in 2016, she was experiencing burning sensation and soreness at the site of GARDASIL injection. At the time of the report, the patient was not recovered/not resolved from the events. On 16-DEC-2016, the patient experienced burning sensation and soreness at the site of the insertion while was on NEXPLANON (MARRS:1701USA000855). The causality between burning sensation and soreness at the site of injection and GARDASIL was not provided. There was no product quality complaint issue involved. Additional information has been requested. Sender's Comments: US-009507513-1701USA000855.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. The reporter stated that improperly stored doses of PROQUAD (lot number reported as M035143, exp. date 30-JAN-2018, Lot: M033210 Exp:09-JAN-2018, Lot:M031566 Exp: 24-DEC-2017, Lot: M017335 Exp:05-OCT-2017 and Lot: M023932 Exp:09-NOV-2017) were administered to an unspecified number of patients in December 2016, following the initial excursion that was reported on 01-DEC-2016 and not following the most recent excursion that was reported on 07-DEC-2016. No adverse effects reported. A data logger was involved. Temperature was 13.8 Fahrenheit (F) for 13 hours, the previous excursion was of 9 F for 15 hours. This is one several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004071.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: 3" diameter red, hot, painful, swollen reaction at the injection site. Treated w/tylenol, advil, benadryl, ice. On 12/28/16, developed shoulder pain which was reported to provider on 1/3/16.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site infection
Clinical narrative: Infection at injection site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen warm red and itchy at injection site. He was advised to take ibuprofen and Benadryl and apply ice for 20 minute intervals. He was advised to call us or see his primary care physician if it worsened.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Began with pain, stiffness, swelling, warmth at injection site. Developed into redness, pain, swelling, warmth at injection site and fever.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Fatigue, Headache
Clinical narrative: 5:20 PM: Stomach pain, doubled over in pain, nausea, mumbling, pain at injection site, body aching, tiredness, lethargy. 7:15 PM: vomiting. 8:30 PM: excessive vomiting- 5 to 6 times in last hour. 100.4 temperature, edgy, flinching when touch body, sore all over. 10:45 PM fever of 101. 11 PM vomiting. 11:10 PM diarrhea. 1/5/17 12:15 AM vomiting, fever of 100.7. 7:45 AM fever of 100.9, same symptoms as above: nausea, stomach pain, tired, body aches. 8:20 AM complaining of numbness in body, pain all over body, everything hurts, headache, pain in abdomen between navel and waistline. 10:15 AM fever of 100.8. 1:05 PM fever of 99.7. 1:30 visit to pediatrician, told to watch my son and note any changes, doctor is reporting to VAERS.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Lethargy, Nausea, Pain
Clinical narrative: 5:20 PM: Stomach pain, doubled over in pain, nausea, mumbling, pain at injection site, body aching, tiredness, lethargy. 7:15 PM: vomiting. 8:30 PM: excessive vomiting- 5 to 6 times in last hour. 100.4 temperature, edgy, flinching when touch body, sore all over. 10:45 PM fever of 101. 11 PM vomiting. 11:10 PM diarrhea. 1/5/17 12:15 AM vomiting, fever of 100.7. 7:45 AM fever of 100.9, same symptoms as above: nausea, stomach pain, tired, body aches. 8:20 AM complaining of numbness in body, pain all over body, everything hurts, headache, pain in abdomen between navel and waistline. 10:15 AM fever of 100.8. 1:05 PM fever of 99.7. 1:30 visit to pediatrician, told to watch my son and note any changes, doctor is reporting to VAERS.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Speech disorder, Vomiting
Clinical narrative: 5:20 PM: Stomach pain, doubled over in pain, nausea, mumbling, pain at injection site, body aching, tiredness, lethargy. 7:15 PM: vomiting. 8:30 PM: excessive vomiting- 5 to 6 times in last hour. 100.4 temperature, edgy, flinching when touch body, sore all over. 10:45 PM fever of 101. 11 PM vomiting. 11:10 PM diarrhea. 1/5/17 12:15 AM vomiting, fever of 100.7. 7:45 AM fever of 100.9, same symptoms as above: nausea, stomach pain, tired, body aches. 8:20 AM complaining of numbness in body, pain all over body, everything hurts, headache, pain in abdomen between navel and waistline. 10:15 AM fever of 100.8. 1:05 PM fever of 99.7. 1:30 visit to pediatrician, told to watch my son and note any changes, doctor is reporting to VAERS.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Gastroenteritis, Myalgia
Clinical narrative: 5:20 PM: Stomach pain, doubled over in pain, nausea, mumbling, pain at injection site, body aching, tiredness, lethargy. 7:15 PM: vomiting. 8:30 PM: excessive vomiting- 5 to 6 times in last hour. 100.4 temperature, edgy, flinching when touch body, sore all over. 10:45 PM fever of 101. 11 PM vomiting. 11:10 PM diarrhea. 1/5/17 12:15 AM vomiting, fever of 100.7. 7:45 AM fever of 100.9, same symptoms as above: nausea, stomach pain, tired, body aches. 8:20 AM complaining of numbness in body, pain all over body, everything hurts, headache, pain in abdomen between navel and waistline. 10:15 AM fever of 100.8. 1:05 PM fever of 99.7. 1:30 visit to pediatrician, told to watch my son and note any changes, doctor is reporting to VAERS.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Vaccination complication, Vomiting
Clinical narrative: 5:20 PM: Stomach pain, doubled over in pain, nausea, mumbling, pain at injection site, body aching, tiredness, lethargy. 7:15 PM: vomiting. 8:30 PM: excessive vomiting- 5 to 6 times in last hour. 100.4 temperature, edgy, flinching when touch body, sore all over. 10:45 PM fever of 101. 11 PM vomiting. 11:10 PM diarrhea. 1/5/17 12:15 AM vomiting, fever of 100.7. 7:45 AM fever of 100.9, same symptoms as above: nausea, stomach pain, tired, body aches. 8:20 AM complaining of numbness in body, pain all over body, everything hurts, headache, pain in abdomen between navel and waistline. 10:15 AM fever of 100.8. 1:05 PM fever of 99.7. 1:30 visit to pediatrician, told to watch my son and note any changes, doctor is reporting to VAERS.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Headache, Pain, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 22-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot#M000592, expiry date: 12-OCT-2017 (dosing details were not reported) once, subcutaneously/intramuscularly for prevention of pneumonia. Approximately in 2016, the patient experienced redness, swelling, body aches, headache and tiredness after the vaccination. The patient did not seek any medical attention. No treatment was given for the events. The outcome of redness, swelling, body aches, headache and tiredness was reported as recovered. Causal relationship between the events and PNEUMOVAX 23 vaccinations was not reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. In addition, additional information has been received on 09-DEC-2016 from the registered pharmacist, who stated that he would find the patient identifiers and fax them in. Additional information has been requested. Sender's Comments: US-009507513-1610USA009296.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # reported as M024261, expiration date: 30-JUL-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Lot # M024261 is an invalid lot # for PEDVAXHIB. Additional information has been requested. Sender's Comments: US-009507513-1612USA012399: US-009507513-1701USA001262: US-009507513-1701USA001264: US-009507513-1701USA001265: US-009507513-1701USA001266: US-009507513-1701USA001267.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Influenza like illness, Skin warm
Clinical narrative: Patient experienced flu-like symptoms then felt better. A day or two later patients arm became red. The redness spread from shoulder to elbow and was a little warm to the touch.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abnormal behaviour, CSF test, Fatigue, Full blood count, Hypophagia
Clinical narrative: About 20 minutes after receiving the vaccines, the patient felt feverish and mom measured a rectal temperature of 103F. She gave the patient two doses of Tylenol throughout the day but he still had a fever of 102.7F. Mom states that the patient was not behaving like his typical self and was more sleepy and tired. He also had decreased po intake and urine output.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Somnolence, Urine analysis, Urine output decreased
Clinical narrative: About 20 minutes after receiving the vaccines, the patient felt feverish and mom measured a rectal temperature of 103F. She gave the patient two doses of Tylenol throughout the day but he still had a fever of 102.7F. Mom states that the patient was not behaving like his typical self and was more sleepy and tired. He also had decreased po intake and urine output.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Nausea, Respiratory tract congestion, Vomiting
Clinical narrative: Congested, felt tired, nausea by morning and vomited x1 after waking. Did not seek any treatment. Reports feeling better at 4:30PM on 01/05/2017.
Age: 45.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Patient is having chronic worsening pain at injection site over 2 months time after the injection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Localised infection, Peripheral swelling
Clinical narrative: Arms swelled and got infected
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Rash, Urticaria
Clinical narrative: Hives.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient had nausea for more than 3 days. Patient had soreness, redness and Swelling where the shot was given for more than 3 days.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Dyspnoea, Insomnia, Laboratory test
Clinical narrative: About 2-3 hours after getting a FLU shot, I began to experience dizziness, shortness of breath and sporadic shaking. The same night I developed insomnia and have had recurrent episodes until today. I continue to get feelings of fainting and confusion, which I've never hd before.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: About 2-3 hours after getting a FLU shot, I began to experience dizziness, shortness of breath and sporadic shaking. The same night I developed insomnia and have had recurrent episodes until today. I continue to get feelings of fainting and confusion, which I've never hd before.
Age: 0.58
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Body temperature increased, Malaise, Pyrexia
Clinical narrative: Fever, malaise.
Age: 0.58
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever, malaise.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Haematoma, Musculoskeletal pain
Clinical narrative: Shoulder pain, bruising to bicep and tricep area down to elbow. Patient presented to pharmacy on 1/2/17 with complaint of pain/bruising. Patient followed up with his medical provider on 1/3/17. His provider notated bruising to bicep/tricep, hematoma to upper posterior arm. No imaging was performed, no coumadin level was checked.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling
Clinical narrative: Slight swelling at the sight of injection (about 7mm in diameter). Redness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: ITCHING IN A 3 INCH BY 3 INCH WELT AT INJECTION SITE.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Erythema, Immediate post-injection reaction, Rash generalised, Urticaria, Wheezing
Clinical narrative: Persistent hives all over body (still going on a month after shot was given) and migrating rash all over body. Wheezing. Immediate huge red welt (size of silver dollar) an hour after shot was given.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Unable to raise left arm due to pain in left deltoid. Pain began in the evening after vaccine administered earlier the day - treated with analgesics, sling and light-duty at work.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site mass, Vaccination site warmth
Clinical narrative: Patient present with 6cm diameter of redness, lump and warmth to leg vaccine site.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient stated that she had hives all over her body after few hours of flu shot.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Hands and feet are itching the same night vaccine was given. Kind of on and off.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA, MNQ
Symptoms: Local swelling, Pain of skin, Swelling face
Clinical narrative: Patient received Hep A, MENACTRA, and flu vaccine in our office on 12-19-16. On 12-20-16 patient woke with swelling and skin tenderness of face and neck. Mom contacted physician and gave BENADRYL. No trouble breathing. Problem resolved.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint movement impairment, Injection site pain, Pain in extremity
Clinical narrative: Pain (R) shoulder at time of injection, has had persistent (R) shoulder, with radiation down side of (R) arm and decrease ROM of (R) shoulder.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Feeling cold, Hot flush, Nausea, Vomiting
Clinical narrative: Diarrhea, nausea, vomiting and hot/cold flashes.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Exposure during pregnancy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 17-year-old female subject who was vaccinated with HAVRIX 720 (GlaxoSmithKline), meningococcal acwy vaccine (non-gsk) and HPV vaccine (non-gsk). On 3 August 2009 at 09:00 the subject received 1st dose of HAVRIX 720 (unknown, left arm), 1st dose of Meningococcal ACQY vaccine  (Non-GSK) (unknown) and 1sr dose of HPV vaccine (Non-GSK) (unknown) and experienced vaccine exposure during pregnancy. The subject found out she was pregnant on 08 September 2009, she is in her second trimester. [Pregnancy Notes] On 04 January 2017, this case was considered as lost to follow-up.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Chest X-ray, Chest discomfort, Electrocardiogram, Laboratory test, Painful respiration
Clinical narrative: Approx, 1 hour after having vaccines - dad called and said patient was having tightness in her chest and it hurt to breathe - advised to go to ER after a delay dad brought her to ER for eval.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and itching at the injection and upper (L) arm. Pt. used hydrocortisone to help w/itching.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Cough, Dry throat, Throat tightness
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant (CMA) referring to a 17 year old male patient with coeliac disease and allergic rhinitis due to pollen. The patient had no known drug reactions or allergies. On 05-MAY-2016 the patient was vaccinated with the first dose of GARDASIL 9 (lot # M004116, exp date 12-OCT-2017), intramuscularly for prevention of HPV and the second dose of MENACTRA. Concomitant therapies included COLACE, PRILOSEC and MIRALAX. It reported that "within 5 minutes" after administration of both vaccines, while still in the physician's office, patient reported that his throat felt "dry and like it was closing up" and he developed a "repetitive dry cough." No treatment was given for the events. No lab diagnostic studies were performed. All symptoms resolved within 15 minutes on 05-MAY-2016. Follow up information has been received from the physician on 29-DEC-2016. The patient's concurrent condition included Lyme meningitis from an unknown date in June 2009. The suspect, GARDASIL 9 and the co-suspect, MENACTRA was administered in the right and the left arm respectively. It was reported that within five minutes of receiving GARDASIL 9, there was no visible facial, tongue or lip swelling, no hives. The chest was clear to auscultation and there was no tachycardia. The patient was doing fine. Reporter information, patient information, relevant history, suspect therapy, concomitant therapy and narrative were updated. Additional information has been requested. Sender's Comments: MERCK 1605USA006465:Mfr number.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-OCT-2016 from a medical assistant who reported that multiple unspecified patients received either VARIVAX (confirmed lot no. M028553, expiration 07-JUN-2018) M004330, 26-JAN-2018; M009766, 23-FEB-2018; M017290, 07-APR-2018; M024683, 18-MAY-2018), or PROQUAD (confirmed M006107, expiration 01-AUG-2017; M007962, 15-AUG-2017; M017337, 05-OCT-2017; M029599, 10-DEC-2017) that were improperly stored. No adverse effects reported. All fields pertain to all unspecified patients and all products. No further information was provided. This is one of two reports. All telephone attempts to obtain to follow-up information on 05-JAN-2017 have been unsuccessful. Additional information has been requested. Narrative was updated.; Sender's Comments:  US-009507513-1610USA008725:, MERCK 1610USA008744:Mfr number.