chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Limb discomfort, Pyrexia, Skin warm
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a 16-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st DECEMBER 2016). In JUNE 2016, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site induration, injection site warmth, fever and injection site erythema. On an unknown date, the outcome of the injection site induration, injection site warmth and fever were recovered/resolved and the outcome of the injection site erythema was recovering/resolving. The reporter considered the injection site induration, injection site warmth, fever and injection site erythema to be related to BEXSERO. Additional details were provided as follows: The vaccination date was unclear, it could be 20th JUNE 2016 or 30th JUNE 2016. In 2016, the patient experienced fever, warm to touch, erythema and an induration at the injection site (left deltoid). the side effects resolved 1 week later. The healthcare professional wanted information on administering the second dose. The call was transferred to medical information system (MIS).
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a 16-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st DECEMBER 2016). In JUNE 2016, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site induration, injection site warmth, fever and injection site erythema. On an unknown date, the outcome of the injection site induration, injection site warmth and fever were recovered/resolved and the outcome of the injection site erythema was recovering/resolving. The reporter considered the injection site induration, injection site warmth, fever and injection site erythema to be related to BEXSERO. Additional details were provided as follows: The vaccination date was unclear, it could be 20th JUNE 2016 or 30th JUNE 2016. In 2016, the patient experienced fever, warm to touch, erythema and an induration at the injection site (left deltoid). the side effects resolved 1 week later. The healthcare professional wanted information on administering the second dose. The call was transferred to medical information system (MIS).
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was vaccinated with three doses of GARDASIL on 31-DEC-2012, 08-MAR-2013 and 30-JUL-2013. Then on an unknown date the patient received fourth dose of GARDASIL 9, 0.5 ml, subcutaneously, with lot# L044475 and expiry date: 12-APR-2017. No adverse effects were reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patient completed the series GARDASIL 9 (lot # , dose and route were not reported). On 22-JUL-2016, the patient was inadvertently administered a fourth dose of GARDASIL 9 (extra dose administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-FEB-2016, the patient was administered with STELARA and approximately on 15-FEB-2016 (reported as "approximately 2 weeks after having STELARA), the patient developed shingles. Then on 25-MAY-2016, the patient was vaccinated with ZOSTAVAX (dosing details not provided) after having shingles (inappropriate schedule of drug administration). No further information provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site induration, Injection site pain, Injection site warmth, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient medical history included gastrointestinal (GI) upset with amoxicillin and tetracycline (manufacturer unspecified) and depression with benzodiazepines (manufacturer unknown). Pharmacist reported that these reactions were listed as patient's allergy on patient profile. The patient had allergy to nickel. On 07-JUL-2016, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included simvastatin (manufacturer unknown) and vitamin D (unspecified). Pharmacist reported that patient received a dose of ZOSTAVAX but dose was inadvertently administered intradermally rather than subcutaneously. Pharmacist also reported that during administration, very small amount of ZOSTAVAX leaked out from needle and patient might not have received full 0.65 ml. On 07-JUL-2016, shortly after vaccination, indurated area (about 9 x 6 centimeters) around injection site and indurated area was tender and warm to touch. Pharmacist recommended for patient to take ibuprofen and use heat and gentle massage to manage adverse effects patient experienced. Patient followed up with her primary care physician, on 11-JUL-2016 and patient was told to continue with ibuprofen, heat and gentle massage. The outcome of the events and the relatedness between the events and ZOSTAVAX were not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a company representative refers to his wife, a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On 30-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX in the fatty part of her arm (arm unspecified), which reporter "thought" was subcutaneous (strength, exact dose, frequency, lot# and expiration date were not provided). No concomitant therapy was reported. On unknown dates in 2016, the patient experienced warmth and "a little" pain and  "a little" swelling at the ZOSTAVAX injection site. Then the patient developed redness at the ZOSTAVAX injection site (also on an unspecified date). The outcome of reported events was recovering/resolving at the time of the report, as the reporter stated that his wife's injection site where ZOSTAVAX was administered "looked better". Product quality complaint was not involved. The reporter did not provide a casual relationship between the reported events and vaccination with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to two patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017, dose and route of administration were not reported) which were improperly stored. Administered doses of vaccine experienced the temperature excursion of 74 degrees Fahrenheit for 164 hours. No adverse effects were reported. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions and drug reactions or allergies was reported. On 25-JUL-2016, the patient was inadvertently vaccinated with VARIVAX injection, (lot # L019124, expiry date 27-MAY-2017, dose, route of administration and anatomical location were not specified) instead of an intended dose of ZOSTAVAX. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Crying, Pruritus, Urticaria, Vomiting
Clinical narrative: Mom reported hives with itching, throwing up and continued crying.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Injection site hypersensitivity, Injection site rash, Limb discomfort, Paraesthesia
Clinical narrative: This is a 58yo F with history of thyroid cancer. She underwent routine pre-travel assessment with PCP in 2006. She was found to be varicella non-immune. Vaccination was advised. She ultimately proceeded to varicella #1 L deltoid 7/1/2016. There was possible local site reaction, self-limited, improved with benadryl. I saw her in follow-up 7/29 (28d after varicella #2). Risks/benefits discussed. We proceeded to varicella #2 in the R deltoid that day. The following day she appreciated RUE rash and discomfort/tingling, localized. No lesions elsewhere. rash emanating from injection site. there is a well-circumscribed and stable dark erythematous patch. no vesicles. distally there is a minimally erythematous patch. there is discomfort to light touch. no palpable collection, no fluctuance. examination is not consistent with cellulitis. there is some hypersensitivity at the site. onset was associated with chills. no fever. improved with benadryl. has no trialed any other medications. seen today 8/1 for acute visit attention complaints. the more proximal, darker patch remains stable. the associated lighter patch waxes and wanes, maximally 5"x 2", but otherwise stable. treatment with po benadryl and topical emollient (e.g. sarna) advised.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Tenderness
Clinical narrative: This is a 58yo F with history of thyroid cancer. She underwent routine pre-travel assessment with PCP in 2006. She was found to be varicella non-immune. Vaccination was advised. She ultimately proceeded to varicella #1 L deltoid 7/1/2016. There was possible local site reaction, self-limited, improved with benadryl. I saw her in follow-up 7/29 (28d after varicella #2). Risks/benefits discussed. We proceeded to varicella #2 in the R deltoid that day. The following day she appreciated RUE rash and discomfort/tingling, localized. No lesions elsewhere. rash emanating from injection site. there is a well-circumscribed and stable dark erythematous patch. no vesicles. distally there is a minimally erythematous patch. there is discomfort to light touch. no palpable collection, no fluctuance. examination is not consistent with cellulitis. there is some hypersensitivity at the site. onset was associated with chills. no fever. improved with benadryl. has no trialed any other medications. seen today 8/1 for acute visit attention complaints. the more proximal, darker patch remains stable. the associated lighter patch waxes and wanes, maximally 5"x 2", but otherwise stable. treatment with po benadryl and topical emollient (e.g. sarna) advised.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Mobility decreased, Pain, Pyrexia
Clinical narrative: On 08/01/2016, employee reported she "had a not so good reaction to (the 1st in series of 2).  I had to call off work because of it.  Horrible body aches, fever, chills, and couldn't get out of bed for a day.  I read the reactions and it was all of those."
Age: 19.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a physician who refers to a 19 year old female patient. The patient's medical history and/or concurrent conditions were unknown. On 01-JUL-2016, the patient was vaccinated with the first dose of GARDASIL. Other suspect therapies included GARDASIL 9. The physician reported that he did not know if the patient was given GARDASIL or GARDASIL 9. Concomitant medications were unknown. The physician reported, an anonymous patient experienced headaches, felt light headed and felt like she was going to faint on 15-JUL-2016. The patient called her doctor but it was unknown if treatment was given for the adverse events. It was unknown if lab diagnostic studies were performed. The physician did not know the patient's present status. The outcome of the events were unknown. No further information was provided. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 27-JUL-2016, the patient was inadvertently vaccinated with a dose of adult formulation of VAQTA injection, lot # M003025, expiry date 26-MAY-2016 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown dates, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) injection (dose, lot #, expiry date, route of administration and anatomical location were not specified). On an unknown date, after receiving the entire series of hepatitis b vaccine (recombinant) (manufacturer unknown), the patient's blood was drawn and did not show any titer for hepatitis B. The outcome of the event and the causality assessment were not provided. Additional information is not expected as no further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nursing assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot# K004204, expiration date 31-JAN-2017 (dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 05-JUL-2016, the patient received an expired dose of VARIVAX (injection, lot # K00798 with expiration date of 03-JUN-2016) (exact dose and route of administration were not reported). No concomitant therapy was reported. The reporter stated that the VARIVAX did not have any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 month old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 29-JUL-2016, the patient was vaccinated with a dose of PROQUAD, dose 0.5 ml, subcutaneously, lot # L031600, expiration date: 18-FEB-2017, (dose number and injection site were not reported) and a dose of VARIVAX, (dose, dose number, injection site, route of administration, lot number and expiration date were not provided) (overdose). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information had been requested.
Age: 19.0
Sex: F
Vaccine: MMRV
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 19-year-old female patient. The patient's concurrent conditions and medical history were not reported. The patient had no concomitant medication, no drug reactions and no allergies. On an unknown date in 1998, the patient was vaccinated with the first dose of M-M-R II (dose, lot#, expiration date and route of administration were not reported). On an unknown date in 2002, the patient was vaccinated with second dose of M-M-R II (dose, lot#, expiration date and route of administration were not reported). On an unknown date, the patient developed chickenpox. On 13-JUN-2016, titers were drawn and the results were positive for varicella. On 29-JUN-2016, the immunity test was performed with a positive result for mumps and rubella and negative result for measles. According to negative result for measles, the patient was supposed to be administered the third dose of M-M-R II but was inadvertently administered a dose of PROQUAD lot# L024497 with expiration date: 01-JAN-2017, via subcutaneous route (dose was not reported). No third dose of M-M-R II was ultimately administered. Product quality complaint (PQC) was not involved. The outcome of the chickenpox and the patient was negative for immunity to measles was not reported. The relatedness between the chickenpox and the patient was negative for immunity to measles was not reported. The relatedness between the chickenpox and the patient was negative for immunity to M-M-R II was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified nurse assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored ROTATEQ, orally, lot # L038536, expiry date 19-AUG-2017 (strength and dose were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # L001311 with expiration date: 06-JUL-2016 (dose and route of administration were not reported). No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Syncope, Urinary incontinence
Clinical narrative: Patient had syncope immediately after Hep B vaccine. When he regained consciousness he vomited and had urinary incontinence. Again began to feel faint, then had another episode of emesis. 911 called due to slow recovery at 12:15pm - EMS arrived at 12:23pm Transported to hospital 12:51PM. Patient was given 3rd Hepatitis B vaccine in R.D. Immediately patient became pale and began to faint. Ammonia Inhalant activated under patient's nose and he opened his eyes. A cold compress was applied to the back of his neck. No respiratory distress. Patient then had an episode of emesis and began to feel faint again. Ammonia Inhalant again used. Pt became more alert but again had an episode of emesis and urinary incontinence. Vital signs taken. 6-24-16 phone call to patient's mother. She states that when they arrived at the hospital patient had something done to see if he had an enlarged heart. Heart tested fine-no problems. Patient is home today-No complaints.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Patient had syncope immediately after Hep B vaccine. When he regained consciousness he vomited and had urinary incontinence. Again began to feel faint, then had another episode of emesis. 911 called due to slow recovery at 12:15pm - EMS arrived at 12:23pm Transported to hospital 12:51PM. Patient was given 3rd Hepatitis B vaccine in R.D. Immediately patient became pale and began to faint. Ammonia Inhalant activated under patient's nose and he opened his eyes. A cold compress was applied to the back of his neck. No respiratory distress. Patient then had an episode of emesis and began to feel faint again. Ammonia Inhalant again used. Pt became more alert but again had an episode of emesis and urinary incontinence. Vital signs taken. 6-24-16 phone call to patient's mother. She states that when they arrived at the hospital patient had something done to see if he had an enlarged heart. Heart tested fine-no problems. Patient is home today-No complaints.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Anxiety, Syncope
Clinical narrative: Syncope that lasted greater than 30 mins after getting listed immunizations. Sent to ER via EMS for observation/treatment. F.U. with ER: Nurse reported client was treated for anxiety and discharged.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia
Clinical narrative: On 7/23 and 24 -  ran a high fever of 101 to 102. 25th got 4 pox.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Axillary pain, Dizziness, Erythema, Immediate post-injection reaction
Clinical narrative: Immediate redness, swelling, itching, feeling woozy. Took 2tsp Benadryl. By evening painful & swollen armpit & lymph nodes. Very painful shoulder joint - could not raise my arm. Took more Benadryl & applied ice pack. 72 hours later still red painful & swollen- will see doctor.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Mobility decreased, Oedema peripheral, Pruritus
Clinical narrative: Immediate redness, swelling, itching, feeling woozy. Took 2tsp Benadryl. By evening painful & swollen armpit & lymph nodes. Very painful shoulder joint - could not raise my arm. Took more Benadryl & applied ice pack. 72 hours later still red painful & swollen- will see doctor.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Immediate redness, swelling, itching, feeling woozy. Took 2tsp Benadryl. By evening painful & swollen armpit & lymph nodes. Very painful shoulder joint - could not raise my arm. Took more Benadryl & applied ice pack. 72 hours later still red painful & swollen- will see doctor.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pruritus, Rash
Clinical narrative: Immediate redness, swelling, itching, feeling woozy. Took 2tsp Benadryl. By evening painful & swollen armpit & lymph nodes. Very painful shoulder joint - could not raise my arm. Took more Benadryl & applied ice pack. 72 hours later still red painful & swollen- will see doctor.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Peripheral swelling, Rash erythematous, Urticaria
Clinical narrative: Began noticing rash/red bumps, hands and bottoms of the feet began to swell. Hives and swelling still apparent.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None noted or reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Hypotonia, Immediate post-injection reaction, Muscle twitching, Unresponsive to stimuli
Clinical narrative: 10:25 AM After HPV vaccination and immediately after MENVEO pt started to go limp and did not respond to name. Twitched, laid pt down on table. Within a minute the patient opened eyes and became alert. Pt admitted to feeling dizzy prior to episode. Provider immediately notified and came in to assess pt. BP 98/40, pt drank water and ate and advised to wait in office 15 mins. After 15 min pt left with mother and stated felt better.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash erythematous, Rash macular
Clinical narrative: Rec'd. 12 mo. shots in office on 7/14/16. Per Mom on 7/30/16 at return visit, pt with developed rash (patch) to (RT) shoulder (resolved within 30 min) on 7/20/16. Pink macular rash began 7/30/16 - AM - rash to scalp, trunk and extremities. Afebrile. (Went to fair with animals 7/29/16 - pm). No vesicles; No pruritus.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of syncope in a 18-year-old patient who received BEXSERO (batch number 154101, expiry date 31st May 2017). This case was associated with a product complaint. In July 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In July 2016, 5 min after receiving BEXSERO, the patient experienced syncope (serious criteria disability), nausea (serious criteria disability), fever (serious criteria disability), injection site erythema (serious criteria disability), injection site rash (serious criteria disability), injection site pain (serious criteria disability), and injection site swelling (serious criteria disability). On an unknown date, the patient experienced pharmaceutical product complaint. BEXSERO was discontinued. On an unknown date, the outcome of the syncope, nausea, fever, injection site erythema, injection site rash, injection site pain, injection site swelling and pharmaceutical product complaint were unknown. The reporter considered the syncope, nausea, fever, injection site erythema, injection site rash, injection site pain and injection site swelling to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at vaccinations for the patients were not reported. The registered nurse reported to the sales representative that she had 10 single packaged doses of BEXSERO with the same lot number and 8 doses were administered to the patients. Out of the 8 patients who received the vaccine, 6 patients (3 female, 2 male, 1 unknown), approximately 18 years of age, experienced a range of side effects including syncope, fever (greater than 101 degrees F), nausea and injection site reactions including erythema (size of a silver dollar), swelling, redness, rash and pain. One female patient experienced syncope 5 minutes after vaccination with BEXSERO. This patient had also experienced syncope after vaccination with GARDASIL in the past. Limited information was provided by the sales representative from the nurse, as the nurse did not have the patients charts and was unable to provide specific information about the events experienced by the patients. The nurse believed there was something wrong with the lot number. The nurse refused to use the last two doses and wanted the product to be tested. If something was found wrong with the vaccine, then she requested credit for the two remaining doses and she would return the product. The nurse reported to sales representative that the vaccine was kept in the refrigerator, not frozen and nothing unusual was noted about the product or packaging. The nurse also informed that an entire dose was administered to each patient.
Sex: U
Vaccine: MENB
Symptoms: Product quality issue, Pyrexia, Syncope
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of syncope in a 18-year-old patient who received BEXSERO (batch number 154101, expiry date 31st May 2017). This case was associated with a product complaint. In July 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In July 2016, 5 min after receiving BEXSERO, the patient experienced syncope (serious criteria disability), nausea (serious criteria disability), fever (serious criteria disability), injection site erythema (serious criteria disability), injection site rash (serious criteria disability), injection site pain (serious criteria disability), and injection site swelling (serious criteria disability). On an unknown date, the patient experienced pharmaceutical product complaint. BEXSERO was discontinued. On an unknown date, the outcome of the syncope, nausea, fever, injection site erythema, injection site rash, injection site pain, injection site swelling and pharmaceutical product complaint were unknown. The reporter considered the syncope, nausea, fever, injection site erythema, injection site rash, injection site pain and injection site swelling to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at vaccinations for the patients were not reported. The registered nurse reported to the sales representative that she had 10 single packaged doses of BEXSERO with the same lot number and 8 doses were administered to the patients. Out of the 8 patients who received the vaccine, 6 patients (3 female, 2 male, 1 unknown), approximately 18 years of age, experienced a range of side effects including syncope, fever (greater than 101 degrees F), nausea and injection site reactions including erythema (size of a silver dollar), swelling, redness, rash and pain. One female patient experienced syncope 5 minutes after vaccination with BEXSERO. This patient had also experienced syncope after vaccination with GARDASIL in the past. Limited information was provided by the sales representative from the nurse, as the nurse did not have the patients charts and was unable to provide specific information about the events experienced by the patients. The nurse believed there was something wrong with the lot number. The nurse refused to use the last two doses and wanted the product to be tested. If something was found wrong with the vaccine, then she requested credit for the two remaining doses and she would return the product. The nurse reported to sales representative that the vaccine was kept in the refrigerator, not frozen and nothing unusual was noted about the product or packaging. The nurse also informed that an entire dose was administered to each patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Eye swelling, Facial paralysis, Hypoaesthesia oral, Nuclear magnetic resonance imaging
Clinical narrative: For approximately 2 weeks prior eyes felt swollen and thought I needed new glasses. July 27, I went to ER, thought because of numbness in mouth thought I was having a stroke. After CT, MRI, with and without contrast determined it was Bells Palsy.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal X-ray
Clinical narrative: For approximately 2 weeks prior eyes felt swollen and thought I needed new glasses. July 27, I went to ER, thought because of numbness in mouth thought I was having a stroke. After CT, MRI, with and without contrast determined it was Bells Palsy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Rec'd 5yr shots in office on 7/26/16. Seen 7/27/16 for c/o redness to Rt deltoid (5x6cm) and 4x3 cm to Lt deltoid. Both with warmth and c/p discomfort and pruritis. Afebrile. (No Hx RXN). TX with cold packs; Ibuprofen. To return if S/S increase.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant who refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with PROQUAD (lot # L030585, expiration date: 10-FEB-2017) and (lot # M007964, expiration date: 15-AUG-2017), subcutaneous. Other suspect therapies included VARIVAX (Lot # L037559, expiration date: 29-SEP-2017), (refer to MARRS # 1608USA000350). The medical assistant reported that multiple unspecified patients received either VARIVAX or PROQUAD that were improperly stored. No adverse effects reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to PROQUAD. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant regarding a case involving PROQUAD (MARRS # 1607USA002225) who refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX (Lot # L037559, expiration date: 29-SEP-2017). Other suspect therapies included PROQUAD (lot # L030585, expiration date: 10-FEB-2017) and (lot # M007964, expiration date:18-AUG-2017, not valid), subcutaneous. The medical assistant reported that multiple unspecified patients received either VARIVAX or PROQUAD (MARRS # 1607USA002225) that were improperly stored. No adverse effects reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to VARIVAX. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pain, Skin warm
Clinical narrative: Redness, tenderness at site, warmth, soreness.
Age: 5.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Client was at the clinic on 7/26/16 w/mother. Mother mentioned he has chickenpox due to the PROQUAD vaccine. I mentioned she would need to take him to his pediatrician to confirm. Client was w/a few blisters on side of face/arms (mom reported no fever for previous days and no itchiness).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, soreness, redness and warmth at site.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site papule, Pyrexia
Clinical narrative: Patient received PENTACEL on (L) thigh and PREVNAR on (R) thigh on 7-26-2016. Patient developed low grade fevers and papules around site of vaccine on both thighs on 7-28-2016.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Urticaria
Clinical narrative: Mother reports child was febrile 7/22-7/23/16 with 101 degree-102 degree fever, then 7/24 fev. blister-type/hives of extremities which opened-numerous hives approximately 50 noted of all extremities, today-fever resolved.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None reported.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Seizure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of seizure in a patient who received BOOSTRIX. Co-suspect products included MENACTRA. Concurrent medical conditions included autism (underlying neurological disorder). On an unknown date, the patient received BOOSTRIX .5 ml and MENACTRA at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced seizure (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the seizure and fever were unknown. It was unknown if the reporter considered the seizure and fever to be related to BOOSTRIX. Additional details were received as follows: the age at vaccination was not reported. the reporter stated that, the patient received a dose of BOOSTRIX along with MENACTRA and experienced the events. the reporter did not have any patient information or lot number and expiry date of the product.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Injection site pruritus
Clinical narrative: Local rash with Pruritis to left upper arm - T: 99.5 Tx: BENADRYL
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Musculoskeletal pain, Myoglobin urine absent, Neck pain
Clinical narrative: Left neck and left upper back pain radiating down to left buttock. Began after vaccination; IBP PO has helped, bending worsens.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash generalised, Rash morbilliform
Clinical narrative: Redness at injection site (large red circle) - measles- like bumps/rash on her body.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Headache, Malaise, Pallor
Clinical narrative: Vaccine given at 4 pm. Fine until 3 am - fever, headache, malaise, dizziness, vomiting, weakness. Dizzy, pale, orthostatic in office. Some improvement with ibuprofen and ZOFRAN. Sent home with instructions to go to ER if worsening/persistent symptoms.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vaccine given at 4 pm. Fine until 3 am - fever, headache, malaise, dizziness, vomiting, weakness. Dizzy, pale, orthostatic in office. Some improvement with ibuprofen and ZOFRAN. Sent home with instructions to go to ER if worsening/persistent symptoms.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: On 7/28/16 at approximately 2000, LPN reported to this writer that it was discovered that PEDIARIX Lot # 22J73, with an expiration date of 10/09/15 were inadvertently given to patient by LPN on 5/31/16, 4/5/16, and 1/26/16. All 3 were signed out by LPN.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Right arm red, swollen, itchy, warm to touch x 5 days. Mother had done BENADRYL. States BENADRYL helps.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Impaired driving ability, Muscular weakness, Nausea
Clinical narrative: Nausea, legs felt like jelly, weakness, unable to drive herself home from college class.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash pruritic
Clinical narrative: Erythema at injection site the following day, then a pruritic rash developed over the next 3 days, then lessened with benadryl per Dr  (patient's PCP).
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Full blood count normal, Metabolic function test normal
Clinical narrative: The day after vaccinations he developed chest pain and fever.  EKG showed ST elevation at a local urgent care. He was hospitalized where his labwork, including cardiac enzymes, were normal.  He was discharged home the next day after observation.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Myocardial necrosis marker normal, Pyrexia
Clinical narrative: The day after vaccinations he developed chest pain and fever.  EKG showed ST elevation at a local urgent care. He was hospitalized where his labwork, including cardiac enzymes, were normal.  He was discharged home the next day after observation.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Induration, Mass, Pain, Secretion discharge
Clinical narrative: Immediate burning pain, pain worsened the next day with swelling. Developed an indurated mass that ruptured during showering and oozed clear fluid. Swelling and pain resolved. Minor soreness now. No treatment provided.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Immediate burning pain, pain worsened the next day with swelling. Developed an indurated mass that ruptured during showering and oozed clear fluid. Swelling and pain resolved. Minor soreness now. No treatment provided.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Aggression, Asthenia, Confusional state, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Administer Hep A vaccine in Rt deltoid, immediately after pt had LOC, with arms and legs rigid. Episode last approx. 20-30 secs. Kept pt in lying position. Upon waking pt appeared confused and jump up yelling "where am I" "What happened?" Pt mildly combative, but easy to calm/reassure. Pt became weak again and was sat in a chair with assistance. MD notified. held in office for observation x 15 min.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored dose of GARDASIL 9 (dosing details were not reported) (lot # M005714, with expiry date of 30-OCT-2017). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Hypotension, Pallor, Pulse abnormal, Syncope
Clinical narrative: 15 y/o female had fainting spells and syncope 5 seconds after administration of vaccines. Client was very pale, diaphoretic, hypotensive BP 93/ pale, thready pulse responsive to verbal commands.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Adverse event, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 17 year old female patient. The patient's pertinent medical history and concomitant medications were reported as none. The patient was allergic to clindamycin. On 22-JUL-2016 the patient was at 5 weeks gestation was vaccinated with first dose of GARDASIL 9 (dosing details were not reported) intramuscularly. The reporter stated that the patient was with an adverse event while on GARDASIL 9 therapy. The reporter stated that patient after receiving her first dose of GARDASIL 9 injection today, 22-JUL-2016 after which she discovered that she was pregnant. The LMP (last menstrual period) and EDD (estimated date of delivery) were not known. The outcome of pregnancy was not known. Patient sought medical attention. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (dosing details were not reported) (lot # L028645 expiry date: 25-MAY-2017) and (lot # L039141 expiry date: 16-AUG-2017). No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received on 19-JUL-2016 from a registered nurse who refers to an anonymous female patient. The patient's medical history and/or concurrent conditions and concomitant medications were unknown. In May 2015 the patient was vaccinated with one dose of GARDASIL. The patient then received one dose of GARDASIL 9 in March 2016. No further doses of either vaccine were administered. No symptoms were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of unspecified patients (ages unknown). Starting on or after 01-JUN-2016 the patients were vaccinated with GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017) or with ROTATEQ (lot # L033545, expiration date 30-MAY-2017) that was improperly stored at 34 degrees F for 72 hours. No adverse events were reported. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Large area of redness at injection site, pain at injection site, and a hard spot at the injection site.  Area is still red and hard spot is still there as of 8/1/16 at 140pm.  Pain resolved on Saturday 7/30/16.  No treatment provided.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient fainted and experienced minor jerking motions for about 10 seconds immediately following MENACTRA vaccination.  She then regained consciousness and stopped jerking.  Patient felt dizzy afterward.  After resting for 10-15 minutes, patient felt ok to go home with mother.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swilling and redness at the site, fatigue x 2 days, headache, and fever.
Age: 35.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Circumstance or information capable of leading to medication error, Exposure via direct contact, Eye irrigation
Clinical narrative: Administered MMRV to her daughter, daughter moved and part of the vaccine went into mothers right eye.  Right eye was irrigated with eye wash. Client instructed to report if develops any s/s and seek medical treatment for s/s.
Age: 35.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Accidental exposure to product, Exposure via direct contact, No adverse event
Clinical narrative: Administered MMRV to her daughter, daughter moved and part of the vaccine went into mothers right eye.  Right eye was irrigated with eye wash. Client instructed to report if develops any s/s and seek medical treatment for s/s.
Age: 14.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Administered Zostavax in error, should have been Varivax.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Hives. RN gave Benadryl.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported redness and soreness around injection sight that presented on 8/1/2016.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: INJECTION SITE REACTION. RED, HARD, PAINFUL AND SOFTBALL SIZE AT INJECTION SITE.
Age: 23.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: PATIENT BROKE OUT IN FULL BODY HIVES.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Loss of consciousness, Nervousness, Unresponsive to stimuli
Clinical narrative: Patient passed out. She felt shaky and was sweating. Was alert but not responsive.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Malaise, Nausea, Seizure, Syncope
Clinical narrative: My daughter complained of not feeling well after being administered the vaccination. She then fainted and had convulsions. After feeling better for ten minutes she felt ringing in ears, nausea, and felt faint again. Waited one hour to leave office.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Tinnitus
Clinical narrative: My daughter complained of not feeling well after being administered the vaccination. She then fainted and had convulsions. After feeling better for ten minutes she felt ringing in ears, nausea, and felt faint again. Waited one hour to leave office.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Eed, hot, swollen, pain.