chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a physician assistant refers to about 17 years old, non-pregnant female patient. Patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, Expiry date, dose, route were not reported) (dose number unspecified). Concomitant medications were not reported. Subsequently on an unknown date, the patient experienced seizures. The patient sought medical attention- she went office visit. The outcome of seizures was not reported. The relatedness between the event and GARDASIL was not reported. It was reported that therapy was not discontinued. Upon internal review the event "seizures" was considered to be medically significant. This one of two reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Immediate post-injection reaction, Loss of consciousness, Memory impairment
Clinical narrative: Patient immediately slumped over and then fell off the table. Patient landed on his head and started experiencing tonic clonic movements. Patient urinated on himself. When patient stopped having the tonic clonic movements and came to, he was unaware of the events that had happened leading up to him passing out. He did not know how he got on the floor. 911 was called immediately. Paramedics arrived and patient was transported.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Tonic clonic movements, Urinary incontinence
Clinical narrative: Patient immediately slumped over and then fell off the table. Patient landed on his head and started experiencing tonic clonic movements. Patient urinated on himself. When patient stopped having the tonic clonic movements and came to, he was unaware of the events that had happened leading up to him passing out. He did not know how he got on the floor. 911 was called immediately. Paramedics arrived and patient was transported.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Craniocerebral injury, Fall, Fatigue, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient immediately slumped over and then fell off the table. Patient landed on his head and started experiencing tonic clonic movements. Patient urinated on himself. When patient stopped having the tonic clonic movements and came to, he was unaware of the events that had happened leading up to him passing out. He did not know how he got on the floor. 911 was called immediately. Paramedics arrived and patient was transported.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Nausea, Posture abnormal, Syncope, Tonic clonic movements, Urinary incontinence
Clinical narrative: Patient immediately slumped over and then fell off the table. Patient landed on his head and started experiencing tonic clonic movements. Patient urinated on himself. When patient stopped having the tonic clonic movements and came to, he was unaware of the events that had happened leading up to him passing out. He did not know how he got on the floor. 911 was called immediately. Paramedics arrived and patient was transported.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a physician assistant refers to about 17 years old, non-pregnant female patient. Patient's medical history and concurrent condition were not reported. In approximately 2014 ("about a year ago"), the patient was vaccinated with a third dose of GARDASIL (lot number, Expiry date, dose, route were not reported). Concomitant medications were not reported. Subsequently on an unknown date, the patient experienced seizures. The patient sought medical attention- she went office visit. The outcome of the event was not reported. The relatedness between the seizures and GARDASIL was not reported. Upon internal review the event "seizures" was considered to be medically significant. This one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to two unidentified patients of unknown age and gender. On unknown dates (range between 18-FEB-2015 to 30-MAR-2015) the patients were possibly vaccinated with one dose of improperly stored PROQUAD (Merck) (lot # K007799, expiration date 29-NOV-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of PROQUAD (Merck), (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the PROQUAD (Merck) lot # was J011330 with expiration date: 13-MAR-2015 and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of PROQUAD (Merck) vaccinations. The office was in the process of contacting the patients revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Blister, Rash generalised, Urticaria
Clinical narrative: This spontaneous report as received from a nurse via company representative, refers to a 12 year old male patient. On 30-MAR-2015, the patient was vaccinated with his second dose of GARDASIL 0.5 ml intramuscularly in the left arm (lot # K008931, expiration date: 04-MAR-2017). On an unspecified date in 2015, the patient developed widespread rash, hives and blisters. The symptoms resolved on 02-APR-2015 without requiring medical treatment. The patient sought medical attention - phone call was placed to the office by patient's mother. The nurse also stated, that the patient developed a similar reaction while taking penicillin on an unspecified date in the past. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender whose medical history and concurrent conditions were not reported. Since 22-JAN-2015 the patients had been vaccinated with doses of (Oka/Merck) VARIVAX, which were exposed to temperatures outside of the recommended range (dose, route of administration and lot # were not reported). No adverse effects had been observed or reported. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of RECOMBIVAX HB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that RECOMBIVAX HB the lot # was 0021AE with expiration date: 30-AUG-2014 and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of RECOMBIVAX HB vaccine. The office was in the process of contacting the patient for revaccination. The correspondence process was reviewed and reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old female patient. Information about patient's medical history was not provided. On 02-APR-2015 also reported as "today", the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose: 0.5 ml, frequency, route of administration and indication were not specified) (lot # K001504, expiration date: 28-MAR-2015). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected, as no consent was give to follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 07-APR-2015 the patient was vaccinated with ROTATEQ (oral, dose 1,2 ml; lot no. unknown). The nurse reported that the vaccine was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB inj 40 interchangeably with ENGERIX-B totaling 4 doses. No adverse effects reported. NO Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid rash, Injection site erythema, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had no drug reactions or allergies. On 29-MAR-2015 the patient was vaccinated with ZOSTAVAX (subcutaneous, 0.65 ml in the left arm, lot # K023624, EXP 19-FEB-2016) for routine vaccination. On 31-MAR-2015, the patient developed a red rash on both eyelids and on both eyebrows (rash) and redness around the injection site. The patient sought medical attention (seen at pharmacy) but received no treatment. No lab diagnostic studies were performed. The outcome of injection site erythema and rash was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dysarthria, Fatigue, Headache, Lip injury, Loss of consciousness
Clinical narrative: Passed out after receiving vaccines, while sitting on exam table. Had 48 hours of headache, nausea, fatigue, malaise, slurred speech, Rt arm pain, lower lip laceration; monitored by phone daily and seen in follow up 4/10/15 by CRNP.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Malaise, Nausea, Pain in extremity
Clinical narrative: Passed out after receiving vaccines, while sitting on exam table. Had 48 hours of headache, nausea, fatigue, malaise, slurred speech, Rt arm pain, lower lip laceration; monitored by phone daily and seen in follow up 4/10/15 by CRNP.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to two unidentified patients of unknown age and gender. On unknown dates (range between 18-FEB-2015 to 30-MAR-2015) the patients were possibly vaccinated with one dose of (Oka/Merck) VARIVAX (lot # J014228, expiration date 08-NOV-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Administration site swelling, Dizziness, Fatigue, Injection site pain
Clinical narrative: Site of adminstration tenderness, swelling, dizziness, fatigue.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Pyrexia, Rash
Clinical narrative: Child had immediate erythematous reaction on posterior left upper arm after receiving varicella vaccine. 10 days later developed a maculopapular rash surrounding the erythematous area and spread rapidly to trunk and face. Also had fever of 102.9. Diagnosed with Varicella on 4/11/15. Treated with Acyclovir.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular, Varicella post vaccine
Clinical narrative: Child had immediate erythematous reaction on posterior left upper arm after receiving varicella vaccine. 10 days later developed a maculopapular rash surrounding the erythematous area and spread rapidly to trunk and face. Also had fever of 102.9. Diagnosed with Varicella on 4/11/15. Treated with Acyclovir.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccination with unknown number of doses of PROQUAD, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the PROQUAD lot # was K002483 with expiration date: 18-AUG-2015 (also reported as 08-AUG-2015) and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of PROQUAD vaccinations. The office was in the process of contacting the patients for revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 11-year-old female patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 18-OCT-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). On 11-FEB-2011, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). The reporter stated that the patient received the third dose of GARDASIL too soon, on 29-APR-2011 (dose, route of administration, anatomical location, lot# and expiration date were not reported). The patient did not report or demonstrate any adverse events. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia
Clinical narrative: Woke up with severe joint pain.
Age: 37.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia, Blood pressure fluctuation, Fatigue, Liver function test abnormal, Musculoskeletal pain
Clinical narrative: Woke up with severe joint pain.
Age: 37.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Pain, Pain in extremity, Serum sickness
Clinical narrative: Woke up with severe joint pain.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly storage MMR II (dose, route of administration, lot# and expiration date not reported). There was no adverse effects reported. Additional information is not expected. This is one of several reports received from the same reporter.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a healthcare worker/medical assistant and refers to a currently 60 years old female patient with codeine and morphine hypersensitivity. The patient's medical history included Hepatitis C. On 01-APR-2015, the patient was vaccinated with PNEUMOVAX23 (route of administration, dose were not reported, arm, lot number: K009874, expiry date: March 2016). Concomitant therapies included LOTREL, LEXAPRO, hydromorphone, diazepam (manufacturer unknown) and atenolol. On approximately April 2015, the patient experienced pain, redness and swelling that spanned over the entire injection arm. The patient sought medical attention (phone call to the physician). No lab diagnostic test was performed. The patient was advised to apply ice to her arm and call back if the patient would experience fever. It was reported that the patient did not call back. The patient's outcome was not reported. The relatedness between the therapy with PNEUMOVAX23 and the adverse events was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a healthcare worker/medical assistant and refers to a currently 60 years old female patient with codeine and morphine hypersensitivity. The patient's medical history included Hepatitis C. On 01-APR-2015, the patient was vaccinated with PNEUMOVAX23 (route of administration, dose were not reported, arm, lot number: K009874, expiry date: March 2016). Concomitant therapies included LOTREL, LEXAPRO, hydromorphone, diazepam (manufacturer unknown) and atenolol. On approximately April 2015, the patient experienced pain, redness and swelling that spanned over the entire injection arm. The patient sought medical attention (phone call to the physician). No lab diagnostic test was performed. The patient was advised to apply ice to her arm and call back if the patient would experience fever. It was reported that the patient did not call back. The patient's outcome was not reported. The relatedness between the therapy with PNEUMOVAX23 and the adverse events was not reported. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A second shot of PREVNAR 13 was administered to patient on 4/9/15 after she got one on 1/14/15. No adverse effects were reported by the patient.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist refers to a 72 year old female patient without medical history or drug reactions/allergies. The patient had received a dose of FLUZONE HD injection on unspecified date in September 2014 and did not have "any problems" after receiving the flu shot. On 07-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K020801, expiration date: 31-JAN-2016, dose unknown) subcutaneous. Concomitant therapies included calcium with vitamin D, benazepril hydrochloride, amlodipine, desmopressin and NEXIUM. On 08-MAR-2015 the patient developed itchiness, warmth to touch, erythema and swelling "about the size of golf ball" at the injection site after receiving ZOSTAVAX. The patient applied ice to the injection site on 10-MAR-2015. The patient went into pharmacy and spoke with the pharmacist on 11-MAR-2015. No lab was performed. The outcome of the events was reported as recovering. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient medical history and drug allergies were not reported. On an unknown date, an unspecified number of patients received improperly stored VARIVAX lot number: K020756, exp date: 30-APR-2016 (invalid lot) (dose, strength and route were not reported). No concomitant medications were reported. No adverse effects were reported. Lab tests were reported as unspecified. The outcome of the event was unknown. There was no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 16-MAR-2015, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (lot #, dose, frequency and route were not reported) that was expired on 25-FEB-2015. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to two unidentified patients of unknown age and gender. On unknown dates (range between 18-FEB-2015 to 30-MAR-2015) the patients were possibly vaccinated with one dose of improperly stored GARDASIL (lot # J010668, expiration date 29-APR-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's concurrent or historical conditions were not reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K01569 exp. date 23-JUN-2016 and lot# J006278 exp. date 22-MAY-2015) (dose, frequency and route were not reported). Concomitant therapies 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient medical history and drug allergies were not reported. On an unknown date, an unspecified number of patients received improperly stored PROQUAD lot number: K020750, exp date: 30-APR-2016 (dose, strength and route were not reported). No concomitant medications were reported. It was reported that all of the remaining doses of the improperly stored PROQUAD from the office stock were administered to an unspecified number of patients on unspecified dates. No adverse effects were reported. Lab tests were reported as unspecified. The outcome of incorrect product storage was unknown. There was no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored GARDASIL (dose, route of administration, lot# and expiration date not reported). There was no adverse effects reported. Additional information is not expected. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of VARIVAX (Merck), (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the VARIVAX (Merck) lot # was J003705 with expiration date: 27-MAR-2015 (also reported as 12-OCT-2015) and indicated that the VARIVAX (Merck) lot # was J003706 with expiration date: 27-MAR-2015 (also reported as 12-OCT-2015) and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of VARIVAX (Merck) vaccinations. The office was in the process of contacting the patients for revaccination. The correspondence process was review and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of (Oka/Merck) VARIVAX, (strength, dose, route, anatomical location, lot number and expiration date were not reported) which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was receiving from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manger who indicated that the (Oka/Merck) VARIVAX lot # was H018758 with expiration date: 11-OCT-2014 (also reported as 31-JAN-2015) and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of (Oka/Merck) VARIVAX vaccinations. The office was in the process of contacting the patients for revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of RECOMBIVAX HB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that RECOMBIVAX HB the lot # H020605 with expiration date: 31-MAR-2015 (also reported as 13-MAR-2015) and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of RECOMBIVAX HB vaccine. The office was in the process of contacting the patients for revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored ROTATEQ orally (dose, lot# and expiration date not reported). There was no adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of (Oka/Merck) VARIVAX, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the (Oka/Merck) VARIVAX lot # was J001177 with expiration date: 31-JAN-2015 (also reported as 27-MAR-2015) and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of (Oka/Merck) VARIVAX vaccinations. The office was in the process of contacting the patients for revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. Since 19-FEB-2015, approximately in February 2015, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot number K007979; expiration date not reported) that had been improperly stored in a temperature excursion but that were deemed stable according to stability data (dose and route were unknown). Concomitant medications were unspecified by reporter. No adverse effects were noted. This case is linked to the cases MARRS # 1502USA010291, 1502USA010390 and 1504USA005759 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of children of unknown age. Pertinent medical history was unknown. Since 19-FEB-2015, approximately in February 2015, the children were vaccinated with doses of VARIVAX (Merck) (lot number K007972; expiration date not reported) that had been improperly stored in a temperature excursion but that were deemed stable according to stability data (dose and route were unknown). Concomitant medications were unspecified by reporter. No adverse effects were noted. This case is linked to the cases MARRS # 1502USA010291, 1502USA010390 and 1504USA005760 (same reporter link). 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 healthcare worker refers to an unspecified number of children of unknown age and gender. No medical history and current conditions were reported. On an unknown date the patients were vaccinated with oral, ROTATEQ lot # K009900, expiry: 04-MAY-2016 (dose and route was unknown), which was improperly stored. No adverse effects were reported. No product quality complaint was involved. The outcome of the events was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site vesicles, Irritability, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist and a 58 year old female patient reporting on herself who was allergic to codeine and cough syrup and with no pertinent medical history. On 28-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, anatomical location, lot number and expiration date not reported). On the night of the same day, she did not feel well (Malaise) and was irritable. On 29-MAR-2015 the injection site had a red, pus filled blister the size of 4 inches by 2.5 inches and patient still did not feel well. By the evening of that day, her right hand and thumb had developed blisters and as of 30-MAR-2015 she had developed more blisters on her right hand and the fingertips on her right hand were very red so she visited her physician, who prescribed Acyclovir. The patient was not recovered from the events at the time of the report, Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: <24hrs fine papular rash eruption upper torso arms pruritic slightly.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Swelling
Clinical narrative: Redness and inflammation around injection site. Vaccine given on 3/22. Redness and swelling occurred on 3/30 better on 3/31 and even better on 4/1/15. Patient did take BENADRYL 25 mg.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Vaccine given 4/1/15 in pm - by late afternoon fever 99.0, red, warm, firm area site of injection. 4/3/15 area still red, soft, warm - 11cm-10cm.
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Injection site swelling
Clinical narrative: Muscle aches and pain, including headache, lightheadedness, swelling at injection site, weakness, loss of appetite, and brief loss of awareness.
Sex: F
Vaccine: PNC13
Symptoms: Loss of consciousness, Myalgia
Clinical narrative: Muscle aches and pain, including headache, lightheadedness, swelling at injection site, weakness, loss of appetite, and brief loss of awareness.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Neuralgia
Clinical narrative: 2 days after immunizations he experienced significant neuralgia in the area of his old spinal cord injury: mid-trunk, both front and back x 1 1/2 weeks. Has never reacted to a flu shot. We suspect the HPV shot.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was receivd from a pharmacist and refers to unspecified number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown date, the patients were administered ZOSTAVAX post supported temperature excursion (0.65ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to two unidentified patients of unknown age and gender. On unknown dates (range between 18-FEB-2015 to 30-MAR-2015) the patients were possibly vaccinated with one dose of improperly stored PNEUMOVAX 23 (lot # J011045, expiration date 15-MAY-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to two unidentified patients of unknown age and gender. On unknown dates (range between 18-FEB-2015 to 30-MAR-2015) the patients were vaccinated with one dose of improperly stored M-M-R II (lot # J013316, expiration date 22-OCT-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Blister, Herpes dermatitis, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a healthcare worker and a nurse practitioner referring to a 60 year old female patient with rheumatoid arthritis (medication error), osteopenia, vitamin D deficiency and degenerative joint disease. The patient had no drug reactions. On 25-FEB-2015, the patient was vaccinated with a single dose of ZOSTAVAX vial, 0.65 ml, subcutaneous (lot number and expire date not reported). Concomitant therapies included REMICADE (medication error), prednisone (manufacturer unknown) (medication error), celecoxib, methotrexate (manufacturer unknown) (medication error), vitamin D (unspecified), vitamins (unspecified), calcium (unspecified) (+) vitamin D (unspecified), omega-3 marine triglycerides, folic acid and zinc (unspecified). On 23-MAR-2015, the patient developed lesions on her left temporal area, right side of her neck and chest, right upper back, right breast and right hand. The lesions were further described as a maculopapular rash which was "significantly" painful, and none of the lesions looked like vesicles. The patient sought medical attention by visiting the office. A punch biopsy was performed of one of the lesions, which came back as herpetic dermatitis. The patient was treated with oral acyclovir, but the patient continued to develop new lesions, and some lesions had "crusted over". At the time of the report, the patient was not recovered from the herpetic dermatitis. The nurse practitioner felt all of the herpetic dermatitis occurred due to the administration of ZOSTAVAX specifically while the patient was receiving REMICADE. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin lesion
Clinical narrative: Information has been received from a healthcare worker and a nurse practitioner referring to a 60 year old female patient with rheumatoid arthritis (medication error), osteopenia, vitamin D deficiency and degenerative joint disease. The patient had no drug reactions. On 25-FEB-2015, the patient was vaccinated with a single dose of ZOSTAVAX vial, 0.65 ml, subcutaneous (lot number and expire date not reported). Concomitant therapies included REMICADE (medication error), prednisone (manufacturer unknown) (medication error), celecoxib, methotrexate (manufacturer unknown) (medication error), vitamin D (unspecified), vitamins (unspecified), calcium (unspecified) (+) vitamin D (unspecified), omega-3 marine triglycerides, folic acid and zinc (unspecified). On 23-MAR-2015, the patient developed lesions on her left temporal area, right side of her neck and chest, right upper back, right breast and right hand. The lesions were further described as a maculopapular rash which was "significantly" painful, and none of the lesions looked like vesicles. The patient sought medical attention by visiting the office. A punch biopsy was performed of one of the lesions, which came back as herpetic dermatitis. The patient was treated with oral acyclovir, but the patient continued to develop new lesions, and some lesions had "crusted over". At the time of the report, the patient was not recovered from the herpetic dermatitis. The nurse practitioner felt all of the herpetic dermatitis occurred due to the administration of ZOSTAVAX specifically while the patient was receiving REMICADE. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Laboratory test abnormal, Pain, Rotator cuff syndrome
Clinical narrative: Patient received vaccine on 3 November 2014, reported to medical facility on 19 Nov 2014 with left shoulder pain when lifting arm over head X two weeks. Physician states left shoulder impingement.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Measles antibody positive, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 19 year old female patient non pregnant. Concurrent conditions or medical history were not reported. The licensed practical nurse stated that on 02-DEC-1996, the patient was vaccinated with a first dose of M-M-R II (lot #, expiration date and route of administration unspecified). Later, on 03-OCT-2000, the patient was vaccinated with a second dose of M-M-R II (lot #, expiration date and route of administration unspecified). On 26-MAR-2015 was administered in error a booster dose of M-M-R II (Lot #: J014876 Expiration date: 21-NOV-2015) (dose not specified) third dose, intramuscular in the left arm in the deltoid. As concomitant drugs, unspecified oral contraceptives were reported. The nurse stated that the patient received the booster dose of M-M-R II due to titers, which were collected on 17-MAR-2015 as a part of pre-employment physical examination, where the antiviral tests showed immunity to measles and rubella but non-immunity to mumps. At the time of this report, the primary reporter was not aware of any adverse event of adverse effects concerning the patient, and she stated that the patient was otherwise healthy. She also stated that she did not had an extensive health history of the patient, therefore other details about patients history could not be provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 06-APR-2015, the patient was inadvertently vaccinated with expired dose of ZOSTAVAX (dose and route were not reported) (lot # J008528 and expiration date 19-OCT-2014 also reported as 12-OCT-2015) after the labeled expiration date. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Raised welt that grew from a quarter size to a 2" x 3" pink 1/2" size.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to seven unspecified patients of unknown age and gender. On an unknown dates, the patients received improperly stored VARIVAX (Merck) (dose and route were not reported, lot # K005177, expiration date: 10-APR-2016), exposed to -9.5 C for 20 hours. No adverse effects were reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Condition aggravated
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient with asthma who is allergic to penicillin. Approximately on 09-MAR-2015, reported as 3 weeks ago, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, anatomical location, route, lot number and expiration date not reported). Concomitant therapies included: SYMBICORT, unspecified albuterol inhaler, meloxicam (manufacturer unknown) and simvastatin (manufacturer unknown). On 25-MAR-2015, the patient was prescribed prednisone (manufacturer unknown), by an unspecified physician, for the treatment of asthma. The pharmacist stated that the asthma is an existing condition and stated that the prednisone may have been prescribed for an exacerbation of asthma symptoms. Outcome of asthma was unknown at the time of the report. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling left upper arm 9cm long and 7cm wide. Redness, warm to touch, induration. Ibuprofen 2-3 tablets every 6-8 hours as needed for pain and swelling. Cool Compress. Return to clinic for s/s infection.
Age: 59.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Fever, sweating.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a male patient of unknown age, regarding himself. No medical history and current conditions were reported. On an unknown date in 2012 (reported as 2-3 years ago) the patient was vaccinated with ZOSTAVAX, 1 vaccine (dose, route and lot number was unknown). No concomitant medications were reported. On an unknown date in February 2015 the patient thinks he has shingles after receiving ZOSTAVAX (2 or 3 years ago) and also experienced itchiness with a small rash on his back and severe pain on his left side. It was reported that the rash never developed into blisters and also reported that unspecified pain medications does not really help. No product quality complaint was involved. The outcome of the events shingles, itchiness with a small rash on his back and severe pain on his left side was unknown. The reporter causality was not provided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Pain, Tenderness
Clinical narrative: 6-8 hours later severe pain on shoulder started. Couldn't move area for about 36 hours so could hardly get out of bed. Still is sore, tender to touch, painful to rotate backwards. Put ice and tried taking TYLENOL but did not help. Nurse put it high in shoulder.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: On 4/7/15 patient received upper LA Tdap and lower LA MCV4. After +/- 2 hours noted swelling of arm, pain increase over 2 days, today mild decrease. 12 x 8 cm. No signs of infection.
Age: 1.07
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Blood lead, Haematocrit, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: (+) hive like skin lesion noted after administration to injection site-proximal, given BENADRYL-checked site after. Hct and Lead done in lab-site now just erythematous, firm, no other hives noted.