chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant via company representative regarding a 2 months old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported.On 05-AUG-2016, the patient received 2 dose of RECOMBIVAX HB 5/0.5 mcrg/ml injection (lot# M000442 and expiry date: 31-MAR-2018). No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a physician assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, while receiving GARDASIL 9, lot # L001312, expiry date 24-FEB-2107, parental, (dose, dose number unknown) the prefilled syringe leaked for an unspecified reason and the patient received half dose (underdose) The schedule of vaccination and dose number was not reported. No adverse effect was reported. This report was involved with a product quality complaint. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer referring to herself a 52 year old female patient with seasonal allergies. On 08-AUG-2016 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous. Concomitant therapies included CELEXA. On 10-AUG-2016, the patient reported that after receiving ZOSTAVAX, she experienced swelling at the injection site approximately 3 inches in diameter. The patient stated that the injection site was "really red, swollen with some itching". She called the physician but, no treatment was given nor lab diagnostic studies were performed. At the time of the reporting the outcome of the events was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant via a company representative referring to a patient of  unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, lot number and expiration were unknown) subcutaneously. On an unknown date, the patient contracted chicken pox after receiving VARIVAX. The outcome of the event was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV9
Symptoms: Decreased interest, Depression, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Patient's mother called clinic on 08/17/2016 and reported: "Patient had HPV shot early June and she had a reaction...daily dizziness, extreme fatigue, sleeping alot, lost interest in everything. She is doing better now and on the upswing after boosting her immunities & vitamin B..Mom wants noted in file that she had allergic reaction and wont be having shots 2&3. Is there someone that this gets reported? Manufacturer? Lot # etc? Please ck into". Nurse notified Dr. on call.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV9
Symptoms: Hypersomnia, Malaise, Personality change, Weight decreased
Clinical narrative: Patient's mother called clinic on 08/17/2016 and reported: "Patient had HPV shot early June and she had a reaction...daily dizziness, extreme fatigue, sleeping alot, lost interest in everything. She is doing better now and on the upswing after boosting her immunities & vitamin B..Mom wants noted in file that she had allergic reaction and wont be having shots 2&3. Is there someone that this gets reported? Manufacturer? Lot # etc? Please ck into". Nurse notified Dr. on call.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV9
Symptoms: Decreased interest, Dizziness, Fatigue, Hypersensitivity, Hypersomnia
Clinical narrative: Patient's mother called clinic on 08/17/2016 and reported: "Patient had HPV shot early June and she had a reaction...daily dizziness, extreme fatigue, sleeping alot, lost interest in everything. She is doing better now and on the upswing after boosting her immunities & vitamin B..Mom wants noted in file that she had allergic reaction and wont be having shots 2&3. Is there someone that this gets reported? Manufacturer? Lot # etc? Please ck into". Nurse notified Dr. on call.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient's mother called clinic on 08/17/2016 and reported: "Patient had HPV shot early June and she had a reaction...daily dizziness, extreme fatigue, sleeping alot, lost interest in everything. She is doing better now and on the upswing after boosting her immunities & vitamin B..Mom wants noted in file that she had allergic reaction and wont be having shots 2&3. Is there someone that this gets reported? Manufacturer? Lot # etc? Please ck into". Nurse notified Dr. on call.
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Dyspnoea, Hypoaesthesia, Panic attack
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016375919) on 11 August 2016. This case involves a female patient age reported as 16/17-year-old who was vaccinated with a dose of MENACTRA and a dose of Trumenba (batch number, expiration date, dose, site and route of administration were not reported for both vaccines) on an unspecified date. Patient received MENACTRA at age 11. It was reported that patient had no risk factors and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced had shortness of breath, numbness of arms, and sort of a panic attack. It was reported that patient required emergency room visit and was admitted to the hospital (last night) on an unspecified date. Lab data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Panic attack is unlisted with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE but dyspnea and numbness is listed. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 18.0
Sex: F
Vaccine: MENB, MENB, TDAP
Symptoms: Dizziness, Dysphagia, Dyspnoea, Nausea, Vision blurred
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 18-year-old female patient who received BEXSERO (batch number 156701, expiry date 31st August 2017). On 10th August 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 10th August 2016, 2 min after receiving BEXSERO, the patient experienced dizziness (serious criteria disability), nausea, blanching, shortness of breath and swallowing difficult. BEXSERO was discontinued (Dechallenge was positive). On 10th August 2016, the outcome of the dizziness, nausea, blanching, shortness of breath and swallowing difficult were recovered/resolved. The reporter considered the dizziness, nausea, blanching, shortness of breath and swallowing difficult to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was also reported by Novartis. The patient had no medical conditions and did not take any medications. On 10th August 2016, at 11:15 hours, the patient received the BOOSTRIX vaccine on the left deltoid. The physician found all vitals, blood pressure and blood glucose to be normal. The patient was seated and observed and started feeling better. The events were resolved after 50 minutes. No other vaccines were administered on that day. This case was not previously reported to anyone.
Age: 18.0
Sex: F
Vaccine: MENB, MENB, TDAP
Symptoms: Blood glucose normal, Dizziness, Dysphagia, Dyspnoea, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 18-year-old female patient who received BEXSERO (batch number 156701, expiry date 31st August 2017). On 10th August 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 10th August 2016, 2 min after receiving BEXSERO, the patient experienced dizziness (serious criteria disability), nausea, blanching, shortness of breath and swallowing difficult. BEXSERO was discontinued (Dechallenge was positive). On 10th August 2016, the outcome of the dizziness, nausea, blanching, shortness of breath and swallowing difficult were recovered/resolved. The reporter considered the dizziness, nausea, blanching, shortness of breath and swallowing difficult to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was also reported by Novartis. The patient had no medical conditions and did not take any medications. On 10th August 2016, at 11:15 hours, the patient received the BOOSTRIX vaccine on the left deltoid. The physician found all vitals, blood pressure and blood glucose to be normal. The patient was seated and observed and started feeling better. The events were resolved after 50 minutes. No other vaccines were administered on that day. This case was not previously reported to anyone.
Age: 18.0
Sex: F
Vaccine: MENB, MENB, TDAP
Symptoms: Pallor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 18-year-old female patient who received BEXSERO (batch number 156701, expiry date 31st August 2017). On 10th August 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 10th August 2016, 2 min after receiving BEXSERO, the patient experienced dizziness (serious criteria disability), nausea, blanching, shortness of breath and swallowing difficult. BEXSERO was discontinued (Dechallenge was positive). On 10th August 2016, the outcome of the dizziness, nausea, blanching, shortness of breath and swallowing difficult were recovered/resolved. The reporter considered the dizziness, nausea, blanching, shortness of breath and swallowing difficult to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was also reported by Novartis. The patient had no medical conditions and did not take any medications. On 10th August 2016, at 11:15 hours, the patient received the BOOSTRIX vaccine on the left deltoid. The physician found all vitals, blood pressure and blood glucose to be normal. The patient was seated and observed and started feeling better. The events were resolved after 50 minutes. No other vaccines were administered on that day. This case was not previously reported to anyone.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist, concerning a 65 years old female patient. There were no pertinent medical history of concurrent conditions. On 09-AUG-2016 the patient was vaccinated with ZOSTAVAX (lot # M020071, expiration date 18-JUL-2017, per subcutaneous route in the left arm (dosage was not reported). Concomitant therapies were not indicated. It was reported that the patient called the pharmacist on 11-AUG-2016 with reports of a "red rash on her arm";  Later on 11-AUG-2016 the patient went to the pharmacy and the pharmacist noted the ZOSTAVAX was administered "near the deltoid muscle and a warm red rash developed around the injection site". The pharmacist stated that he advised the patient to "take ibuprofen (manufacturer unspecified) or ice the area if there was any pain or swelling and BENADRYL if needed" as treatment for the rash. Packet was offered, but the pharmacist adamant about not receiving. The outcome of warm red rash around the injection site and red rash on her arm was reported as recovering as the patient reported the rash was subsiding at the time of the report. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1608USA009550). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Information has been received from a pharmacist, concerning a 65 years old female patient. There were no pertinent medical history of concurrent conditions. On 09-AUG-2016 the patient was vaccinated with ZOSTAVAX (lot # M020071, expiration date 18-JUL-2017, per subcutaneous route in the left arm (dosage was not reported). Concomitant therapies were not indicated. It was reported that the patient called the pharmacist on 11-AUG-2016 with reports of a "red rash on her arm";  Later on 11-AUG-2016 the patient went to the pharmacy and the pharmacist noted the ZOSTAVAX was administered "near the deltoid muscle and a warm red rash developed around the injection site". The pharmacist stated that he advised the patient to "take ibuprofen (manufacturer unspecified) or ice the area if there was any pain or swelling and BENADRYL if needed" as treatment for the rash. Packet was offered, but the pharmacist adamant about not receiving. The outcome of warm red rash around the injection site and red rash on her arm was reported as recovering as the patient reported the rash was subsiding at the time of the report. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1608USA009550). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness and swelling over left triceps.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Initial unsolicited report received from a healthcare professional on 11-Aug-2016. This case involves an 11 years old female patient who was vaccinated with first dose of MENACTRA (batch number: U5186AA, expiry date: 14 March 2017; route of administration was not reported) in the right deltoid and dose of BOOSTRIX (batch number, expiration date, route and site of administration was not reported) on 03-Aug-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies included latex, asthma and skin sensitivity. Concomitant medication was reported as none. 09-Aug-2016, 6 days following the vaccination, in evening, the patient developed hives across her upper back tops of arms and neck. On 10-Aug-2016, it was hot and red. Laboratory data was reported as none. Corrective treatment was not reported. On 10-Aug-2016, patient was recovered red and hot hives. Outcome of hives across her upper back tops of arms and neck was reported as unknown. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MENB, TTOX
Symptoms: Bacterial infection, Computerised tomogram, Fatigue, Headache, Laboratory test
Clinical narrative: Fever fatigue stiff neck headache-septic organ failure.
Age: 18.0
Sex: M
Vaccine: MENB, TTOX
Symptoms: Lumbar puncture, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Organ failure, Pyrexia
Clinical narrative: Fever fatigue stiff neck headache-septic organ failure.
Age: 18.0
Sex: M
Vaccine: MENB, TTOX
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Fever fatigue stiff neck headache-septic organ failure.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Acute kidney injury, Disseminated intravascular coagulation
Clinical narrative: Information was received from a physician via a company representative referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were unknown. On an unknown date, the patient was administered with a dose of PNEUMOVAX 23 (lot#, expired date, dose and route unknown). On an unknown date, the patient experienced acute renal failure and disseminated intravascular coagulation. Then the patient was admitted into the hospital due to the events. It was unknown if the patient received the treatment. The outcome of the events was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. The reporter considered the events to be life-threatening. Upon internal review, acute renal failure and disseminated intravascular coagulation were determined to be medically significant events. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Information was received from a medical assistant via a company representative referring to two female patients of unknown age. The patients' medical history, concurrent condition and concomitant therapy were unknown. On unknown dates, the patients received an unspecified dose of series with GARDASIL 9 injection (lot#, expired date, dose, dose number and route unknown) as recommended vaccine for their age. On unknown dates, the patients were both passed out within a couple of minutes of receiving GARDASIL 9. It was unspecified that if the treatment was given for the patient or how long it took for either patient to regain consciousness. The patients sought medical attention via speaking with the physician. The causality assessment between the event and GARDASIL 9 was not reported. Upon internal review, passed out was determined to be medically significant event. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Crying, Seizure
Clinical narrative: Patient cried out for mother, mother found patient convulsing. Patient taken by EMS to local hospital and treated, then transferred to hospital and treated there. No beds available for patient so patient was transferred to another hospital due to patient continuing to seize.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Seizure
Clinical narrative: Patient cried out for mother, mother found patient convulsing. Patient taken by EMS to local hospital and treated, then transferred to hospital and treated there. No beds available for patient so patient was transferred to another hospital due to patient continuing to seize.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Blindness, Blood test, Computerised tomogram, Drug screen, Electrocardiogram
Clinical narrative: Patient cried out for mother, mother found patient convulsing. Patient taken by EMS to local hospital and treated, then transferred to hospital and treated there. No beds available for patient so patient was transferred to another hospital due to patient continuing to seize.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Electroencephalogram, Haemoptysis, Lumbar puncture, Mental status changes, Nuclear magnetic resonance imaging
Clinical narrative: Patient cried out for mother, mother found patient convulsing. Patient taken by EMS to local hospital and treated, then transferred to hospital and treated there. No beds available for patient so patient was transferred to another hospital due to patient continuing to seize.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Pyrexia, Screaming, Seizure like phenomena, Sensory loss, Unresponsive to stimuli
Clinical narrative: Patient cried out for mother, mother found patient convulsing. Patient taken by EMS to local hospital and treated, then transferred to hospital and treated there. No beds available for patient so patient was transferred to another hospital due to patient continuing to seize.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Tues/Wed Fever, No fever on Thursday. Leg swollen w/redness. Thursday 8/18/16 approx. 7cm x 5cm. No treatment. Ice and monitor.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # L050910, expiration date 14-JUN-2017, therapy type: rHA; lot # M004894, expiration date 26-JUL-2017, therapy type: rHA, dose and route not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Tremor
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 13 year old non-pregnant female patient. There was no information regarding the patient's pertinent medical history, drug reactions or allergies provided. The patient did not take any concomitant medications. On 16-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # reported as K010215 (verified to be invalid), expiration date 05-MAY-2017; exact dose was not reported), frequency reported as 0, 2 and 6 months, intramuscularly. On the same day, when the patient was at the provider's office she felt hot and lightheaded. Subsequently, she passed out and began shaking. The patient received an unspecified treatment for the events, but she did not seek any medical attention. The outcome of the events was reported as recovered on an unspecified date in August 2016. The relatedness between the events and the GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ orally, lot # K022990 with expiration date: 26-JUN-2016 (dose was not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32.4 degree Fahrenheit for 95 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age and gender. No information regarding patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32. 4 Fahrenheit for 95 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RUB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified number of patents of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications were provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32.4 degree Fahrenheit for 95 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Contusion
Clinical narrative: Patient came to appointment with clinical pharmacist on 6/27/2106 at anticoagulation management clinic. Patient is taking warfarin. Pharmacist noted patient had left shoulder bruise from pneumococcal vaccine that was given 5 weeks prior to this appointment. Pharmacist was surprised to still see a bruise from vaccine administration. Patient declined referral to PC or UC for further evaluation. Pharmacist added reaction into patient's chart.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Information has been received from an approximately 89 years old female patient referring to herself. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unspecified date in July 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported) subcutaneously in her left arm. On an unspecified date in January 2015, the patient experienced extreme pain in her left arm and saw her physician. It was reported that there was no visual evidence of a rash or blisters. The patient was told by the physician that she had shingles. Treatment was given for the events. At the reporting time, the patient still experienced pain in her left arm. The outcome of the events was reported as not recovered. The causality between the events and ZOSTAVAX was not reported. Additional information is not expected as the physician doesn't want to be contacted.
Age: 0.58
Sex: F
Vaccine: PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from an assistant head nurse referring to a 7 month old female patient. The patient had no known medical allergies. On 31-MAY-2016 when the patient was 32 weeks and 1 day, the patient was vaccinated with ROTATEQ (lot # L042214, expirations date 14-APR-2017, 2 ml, oral). Concomitant therapy included PREVNAR 13. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified number of patents of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications were provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of VAQTA (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32.4 degree Fahrenheit for 95 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On an 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 not reported). The vaccine was exposed to temperature of -13 degree Celsius for 5 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Irritability, Occult blood positive
Clinical narrative: Had ROTAVIRUS vaccine on 8/18/16 and developed blood stools (hemoccult (+)) - was fussy but it resolved-symptoms started 8/19/16
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: did not give consent to follow-up. This spontaneous report was received from a nurse referring to unspecified number of patents of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications were provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32.4 degree Fahrenheit for 95 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. Pertinent medical histories, drug reactions, allergies and concomitant medications were not provided. on 14-AUG-2016 the patient was vaccinated with M-M-R II lot # L024266 and expiry day 01-JUL-2017 (dose, frequency and route of administration were not reported) and therapy for unknown reason which were improperly stored (incorrect product storage). No symptoms reported (no adverse event). There were no previous excursion of temperature. Temperature was 48 F, time frame was 72 hours and no data logger was there. The outcome of incorrect product storage was unknown. This case is linked to case WAES1608USA009124 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored dosed of RECOMBIVAX HB (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32.4 degree Fahrenheit for 95 hour. No previous temperature excursion was reported and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 05-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU (lot # L012478, expiration date 10-JUL-2016, dose and route not reported). No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood test normal, Electrocardiogram normal, Electroencephalogram normal, Fall, Nuclear magnetic resonance imaging normal
Clinical narrative: Mom called and stated that child was diagnosed with orthostatic intolerance on 8-16-16 by cardiologist. Mom also stated that child started falling after receiving vaccines on 8-5-15. Child has been under the care of pediatrician, and has been seen by neurologist and another cardiologist.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Orthostatic intolerance
Clinical narrative: Mom called and stated that child was diagnosed with orthostatic intolerance on 8-16-16 by cardiologist. Mom also stated that child started falling after receiving vaccines on 8-5-15. Child has been under the care of pediatrician, and has been seen by neurologist and another cardiologist.
Age: 31.0
Sex: F
Vaccine: HEPAB, IPV, TYP
Symptoms: Alopecia, Alopecia areata, Blood thyroid stimulating hormone normal, C-reactive protein normal, Full blood count normal
Clinical narrative: Hair loss in patches (alopecia areata).  Treating with topical steroid.
Age: 31.0
Sex: F
Vaccine: HEPAB, IPV, TYP
Symptoms: Metabolic function test normal
Clinical narrative: Hair loss in patches (alopecia areata).  Treating with topical steroid.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pox started in the evening on July 6 before bath.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red raised area quarter size where vaccine was given.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red raised area quarter size at site of injection.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown demography. Pertinent medical histories, drug reactions, allergies and concomitant medications were not provided. On an unknown date in August 2016, the patients were vaccinated with (wistar ra 27-3) M-M-R II lot # L024266 (dose, frequency and route of administration were not reported) and therapy for unknown reason which were improperly stored (incorrect product storage). No symptoms reported (no adverse event). There were no previous excursion of temperature. Temperature was 48 F, time frame was 72 hours and no data logger was there. The outcome of incorrect product storage and no adverse event were unknown. This case is linked to case WAES1608USA010175 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history drug reactions or allergies were not reported. On 26-JUL-2016 at the same time, the patient was vaccinated with PROQUAD, 0.5 ml, lot # L0510899, expiration date: 17-JUN-2017 and with VARIVAX, 0.5 ml, lot # M005973, expiration date: 02-FEB-2018 (route of administration not reported). Albumin status for PROQUAD, lot # L051099 has been verified as recombinant human albumin (rHA). Concomitant medications were not reported. No adverse effects were reported. Addition information had been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant referring to a 16 year old female patient. The pertinent medical history and concomitant therapy were not reported. On 15-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as M009773, expiration date: 17-MAY-2017 (dose and route unspecified), instead of VARIVAX (lot #, expiration date unspecified). No adverse effects reported. The patient's vaccination history included first dose of VARIVAX (lot information not provided) om 01-JUN-2001, second dose of VARIVAX (lot information not provided) on 23-JUL-2007 and M-M-R II (lot information not provided) on 12-AUG-2016.  Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 10-AUG-2016 the patient was vaccinated with PROQUAD (rHA) (lot # L007230, expiration date 03-SEP-2016, 0.5 ml, once, subcutaneous). No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 13 year old patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 02-AUG-2016, the patient was vaccinated with a first dose of PROQUAD, therapy type: rHA, lot # L046508 (expiry date: 17-MAY-2017) at a dose of 0.5 ml, subcutaneously. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Blister, Dermatitis, Impetigo, Pyrexia, Staphylococcal infection
Clinical narrative: Child's mom reported low fever since day of immunizations.  Multiple blisters behind one ear noticed by mom 3 days after immunizations received. Child seen by physician 8/11/16 and was DX and treated for Staph infection, dermatitis and impetigo. 8/22/16 - Mom reported all symptoms have resolved.
Age: 27.0
Sex: M
Vaccine: HEP, TD, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Started as a bump then more started coming then went to bed woke up with them on hands and legs it keeps spreading.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Had a flu shot on 8/20 at 3:40 pm, 102.6 Fever at 8:30 pm on 8/20/2016 until 6:00 PM on 8/21/2016.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-AUG-2016, the patient was vaccinated with improperly stored PROQUAD injection (lot # M015695, expiration date 26-SEP-2017 and 0.5 ml/once) subcutaneously. The administered dose experienced a temperature excursion of 56.8 degree Fahrenheit for 22 hours 47 minutes from 15-AUG-2016 to 16-AUG-2016. No adverse effects were reported. It was reported that the safety committee may speak to the registered nurse if there are any questions or concerns. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, severe headache, aches, nausea for 2 days symptomatic treatment at home - mom requested VAERS report be filed as this did not occur with previous 2 vaccines.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain
Clinical narrative: 4hrs after vaccine chills, pain, redness of arm 15x15cm. Tx: meloxicam, TYLENOL, compresses.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: 17 yo patient with redness, swelling at site of BEXSERO injection. Erythema approx 10cm diameter with swelling/lump approximately 3cm size. Pt otherwise well - Supportive care with Ibup, Ice.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored (-0.2C for 116 hours, 24 minutes and the data logger was involved) doses of GASDASIL 9 (dose, frequency and route were unknown, lot # M011117, expiration date 07-DEC-2017, another lot # L026602, expiration date 19-OCT-2017. The GARDASIL 9 didn't have previous excursions and currently backed in range. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Bilateral significant Herpes Zoster.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Cerebral disorder, Computerised tomogram head normal, Dizziness, Electroencephalogram abnormal, Fall
Clinical narrative: 4/27/16 - pt. seen and given 2nd HPV vaccine and 2nd Hep A. 4/30/16 - pt c/o numbness at inj. site, dizziness, tripping, not able to lift one leg without falling, and feeling very tired. Sent to ER - normal CT of brain; Strep (+) treated with an antibiotic. 5/2/16 - seen in office c/o tiredness, vomiting - (+) Mono Spot; mom feels due to vaccine. 5/5/16 ER - sore throat, fatigue, emesis, unsteady gait; admitted with Dx: Sydenham's chorea and Rheumatic fever.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fatigue, Gait disturbance, Injection site hypoaesthesia, Mononucleosis heterophile test positive, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 4/27/16 - pt. seen and given 2nd HPV vaccine and 2nd Hep A. 4/30/16 - pt c/o numbness at inj. site, dizziness, tripping, not able to lift one leg without falling, and feeling very tired. Sent to ER - normal CT of brain; Strep (+) treated with an antibiotic. 5/2/16 - seen in office c/o tiredness, vomiting - (+) Mono Spot; mom feels due to vaccine. 5/5/16 ER - sore throat, fatigue, emesis, unsteady gait; admitted with Dx: Sydenham's chorea and Rheumatic fever.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Oropharyngeal pain, Rheumatic fever, Streptococcus test positive, Sydenham's chorea, Vomiting
Clinical narrative: 4/27/16 - pt. seen and given 2nd HPV vaccine and 2nd Hep A. 4/30/16 - pt c/o numbness at inj. site, dizziness, tripping, not able to lift one leg without falling, and feeling very tired. Sent to ER - normal CT of brain; Strep (+) treated with an antibiotic. 5/2/16 - seen in office c/o tiredness, vomiting - (+) Mono Spot; mom feels due to vaccine. 5/5/16 ER - sore throat, fatigue, emesis, unsteady gait; admitted with Dx: Sydenham's chorea and Rheumatic fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dysgeusia, Headache, Pain
Clinical narrative: Aches and pains, metallic to site, no energy, no appetite, headache had vaccine on 8-11-16-started w/sx Aug 15. Spoke to her MA, said couldn't be sure if sx are due to vaccine. Came in 8/22. Still has some sx.
Age: 1.34
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism spectrum disorder, Diet refusal, Encephalopathy, Lethargy
Clinical narrative: Loss of speech, regression from previous milestones, a light went out from child's eyes, fever, lethargy, refusing to eat, encephalopathy.
Age: 1.34
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Sensory processing disorder
Clinical narrative: Loss of speech, regression from previous milestones, a light went out from child's eyes, fever, lethargy, refusing to eat, encephalopathy.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Feeling abnormal, Injection site reaction, Pain, Upper extremity mass
Clinical narrative: "Weird feeling in whole right arm" Then localized in right upper arm. Lump developed on 8/18/16 and continued pain, stinging. Mild erythema.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Initially with burning sensation at injection site similar burning sensation now migrating in other location. At first arm of injection site-deltoid for 1 week ipsilateral thigh then contralateral thigh then (R) forearm. Currently (R) eye. One month duration.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Pt tired and achy all over body. Displaying flu like symptom. Been taking APAP for pain.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Infantile spitting up, Underdose
Clinical narrative: This spontaneous report was received from a healthcare worker via the company representative regarding an unspecified number of infant patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with ROTATEQ, oral (dose, dose number, lot # and expiration date unknown). On unknown dates, unspecified number of patients "regurgitated or spit up" doses of ROTATEQ (infantile spitting up, incomplete dose administered) and these doses were repeated on unknown dates (Inappropriate schedule of vaccine administered). No product quality issue was involved. The outcome of infantile spitting up was unknown. Causality was not provided by the reporter. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Strong local reaction to INFANRIX in left thigh, redness 8x8cm slightly tender.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Diarrhoea, Pyrexia, Somnolence, Vomiting, Wrong drug administered
Clinical narrative: Vaccine ordered was Hep B - Hep A was given. Not discovered until entering into WIR that wrong vaccine given and mom called that night to state patient had a fever; then vomiting and diarrhea and "drowsy" for next 3 days.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Pt had urticarial rash on upper extremities initially then to buttocks back and lower extremities. Vitals-stable. Playful. Given BENADRYL P.O. No progression of symptoms.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dehydration, Headache, Nausea, Vomiting
Clinical narrative: 08/05/2016 Severe headache, nausea, and vomiting leading to dehydration and ER visit.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site pain, Paraesthesia, Syncope
Clinical narrative: (L) deltoid pain immediately after. 11 hours later syncopal event at home X2, c/o tingling in arm. Worsening arm pain 72 hours after dose.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Bursal fluid accumulation, Drug administered at inappropriate site, Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: Pt developed severe pain in (L) shoulder a few hours after Tdap injection. Pain limits ROM and makes it difficult for pt to pick up infant daughter. MRI showed fluid in subdeltoid bursa, likely b/c injection was given to high. Pt treated with subacromial bursa injection of KENALOG and physical therapy.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warmth around the injection site on left arm.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Warm, red welts on arm, below where vaccine was given.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Crying, Hallucination, auditory, Muscle contractions involuntary, Pain, Pyrexia
Clinical narrative: Auditory hallucinations, muscle seizures (clenched fists repetitive stretching), fever, restlessness, whimpering pain for 8 hours.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Restlessness
Clinical narrative: Auditory hallucinations, muscle seizures (clenched fists repetitive stretching), fever, restlessness, whimpering pain for 8 hours.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Computerised tomogram head normal, Concussion, Head injury, Loss of consciousness
Clinical narrative: 2 min after TRUMENBA pt with LOC resulting in post head injury and concussion. Head CT WNL, LOC for 60-90 seconds.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Concussion, Fall, Head injury, Syncope
Clinical narrative: 2 min after TRUMENBA pt with LOC resulting in post head injury and concussion. Head CT WNL, LOC for 60-90 seconds.