chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: 66 YO female with PMH significant for T2DM received PNEUMOVAX 23 vaccine on (L) deltoid from clinic on 8/11/14. That evening, pt began to experience increased swelling in (L) arm with warmth, tenderness, limited movement, and reported neck/arm pain of 4/10. Pt took 1 APAP 325mg tablet that night and another dose the next morning but symptoms did not improve. Pt contacted the clinic on 8/12/14 and PCP instructed pt to apply warm compress 20-30 mins 4-6x/day and NSAID as directed per OTC label. Pt came to clinic for evaluation: no further information about symptom resolution.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Injection site induration, Injection site swelling
Clinical narrative: Swelling/induration of tricep area from injection site to elbow, chills, sweats. Diphenhydramine 50 mg TID.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Urticaria, pruritus and injection site itching, pain, redness, and swelling. Diphenhydramine 25 mg PRN, ibuprofen 600 mg prn.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Urticaria, pruritus and injection site itching, pain, redness, and swelling. Diphenhydramine 25 mg PRN, ibuprofen 600 mg prn.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood glucose, Dizziness, Nausea, Nervousness
Clinical narrative: Patietn felt shaky, throat felt "funny"- stomach pain-nauseated dizzy.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Throat irritation
Clinical narrative: Patietn felt shaky, throat felt "funny"- stomach pain-nauseated dizzy.
Age: 16.0
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Back pain, Hypoaesthesia
Clinical narrative: Returned to office with abdominal pain - Rt leg numbness and Rt back pain - resolved after resting 40 min.
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a male patient who received Hepatitis B vaccine. Previously administered products included Hepatitis B vaccine (2 full series). On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was not recovered/not resolved. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional information: a doctor did not respond to receipt of 2 full series' of Hepatitis B vaccine. The blood work was pulled 1-2 months after each series as recommended.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, heat, swelling. Treatment - cephalexin
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to two unspecified patients of unknown age and gender. On unspecified dates the two patient were inadvertently administered VARIVAX (Merck) (lot#, expiration date, dose and route not reported) that had been improperly stored. No adverse effects were reported. Additional information is not expected as the reporter asked not to be contacted.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Erythema, Local reaction, Nausea
Clinical narrative: Local pain, swelling, redness. Patient reported only local rxn. to MD. Additional symptoms reported to pharmacist nausea, coughing, difficulty breathing, fever x 4 days. Pt. did not seek medical attention at time of reaction. Reported symptoms to RPh on 2/23/15 and Dr. on 2/25/14.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Local pain, swelling, redness. Patient reported only local rxn. to MD. Additional symptoms reported to pharmacist nausea, coughing, difficulty breathing, fever x 4 days. Pt. did not seek medical attention at time of reaction. Reported symptoms to RPh on 2/23/15 and Dr. on 2/25/14.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia, Vaccination failure
Clinical narrative: This spontaneous report was received from 36 year old white male patient as part of market research program regarding himself. Concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dose, route of administration, anatomical location and lot number was unspecified by reporter). No concomitant medication was reported. On an unknown date, the patient got pneumonia only after having taken the PNEUMOVAX 23 (vaccination failure). The outcome of the event was unknown. The causal relationship between the events and PNEUMOVAX 23 was unknown. This is one of 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a consumer via market research program regarding unspecified number of patients. Concurrent conditions and medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with PNEUMOVAX23 (dose, route of administration, anatomical location and lot number was unspecified by reported). No concomitant medication was reported. On an unknown date, unspecified number of patients got pneumonia only after having taken the PNEUMOVAX23. The outcome of the events was unknown. The causal relationship between the events and PNEUMOVAX23 was unknown. This is one of 2 reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt developed localized redness, warmth at left deltoid injection site. Area 2.25 in x 3.5 inch. Given BENADRYL.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 04-MAR-2015, the patient was inadvertently administered a dose of expired ZOSTAVAX, 0.65 ml dose, subcutaneous, lot # J011211 and expiration date on 31-JUL-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a non practicing pharmacist referring to an unspecified number of patients of unknown ages and gender. On unknown dates the patients were vaccinated with ZOSTAVAX (strength, dosage, frequency and route unknown). On unknown dates the patients experienced hand pain after receipt of the vaccine. The outcome of hand pain was unknown. Additional information is not expected since contact information was not provided.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: MENACTRA was previously administered on 8/16/13.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse via a company representative referring to a female patient of unknown age. Patient's current conditions and pertinent medical history were not provided. "Last week", on an unspecified date of 2015, the patient was vaccinated with her first dose of GARDASIL (injection, lot # K005881, dose, route and expiry date were not provided). Concomitant therapies included MENACTRA. While receiving the vaccination in the physician's office, the patient experienced fainting. The treatment given to the patient was allowing the patient to lie down after the fainting episode. The reporter stated that the patient had not eaten a meal in approximately four hours when receiving the injection of GARDASIL. The reporter also stated that the patient's blood pressure was measured at 109/71 and pulse rate at 91 BPM (date unspecified, in approximately 2015). The outcome of the event was not provided. The reporter stated that the adverse event is pertaining to GARDASIL containing four strains and not GARDASIL 9. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Pruritus
Clinical narrative: Patient came to pharmacy on 3-2 showed me her arm and around injection site it was round whelp. She stated the night after shot (2/27) she began itching before bed. She said she did not use ice pack, MOTRIN, TYLENOL, or BENADRYL but I instructed her to before shot and also when she showed be on 3-2.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Pruritus
Clinical narrative: Patient called 3/3 and wanted to know if she was contagious because she said her arm where I gave her the shot was red and she had been itching  (2/27 - 3/3) and was worried that she had shingles (2/27). B/C had flu-like symptoms (3/3).
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 24 year old female patient. On 12-FEB-2015 the patient was vaccinated with GARDASIL lot # K007828, expiration date was unknown, third dose, intramuscularly. First dose was administered on 07-AUG-2014, dose number 2 administered 18-NOV-2014. Lot numbers and expiration dates not available for doses 1 and 2. The patient became pregnant on unknown date. No treatment was given for adverse event. The LMP and EDD was not known. The pregnancy outcome was pending. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a pharmacist and described the occurrence of possible overdose in a female subject of unspecified age who was vaccinated with HAVRIX adult (GlaxoSmithKline). On an unspecified date the subject received a dose of HAVRIX adult (unknown details) and experienced possible overdose and possible inappropriate age at vaccine administration. It was unclear from the reporter what dose of HAVRIX the subject received. The exact date of administration of HAVRIX was not reported and it was unclear if the subject was 18 or 19 years old at the time of vaccination. Based on the lot number the subject was administered the HAVRIX adult. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: Information has been received from an unknown age female patient concerning herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot # and route were not reported). On an unknown date, the patient experienced cold-like symptoms that involved mucus in the back of the throat after receiving ZOSTAVAX. Outcome of the event was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Bradycardia, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Epstein-Barr virus antibody negative
Clinical narrative: Injection given 2/18/15-mom brings child to office 2/23/15 for lightheaded, arm pain at injection site, body aches since injection on 2/18/15.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Laboratory test normal, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Injection given 2/18/15-mom brings child to office 2/23/15 for lightheaded, arm pain at injection site, body aches since injection on 2/18/15.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated post supported temperature excursion with VARIVAX (Merck) 0.5 ml, subcutaneous, lot # reported as K0007974 with expiration date 30-JUN-2015 and lot #K010339 expiration date 22-JUL-2016. No adverse effects noted. Lot number K0007974 is an invalid lot number for VARIVAX (Merck). 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 health care worker refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with PROQUAD (Merck) vaccine, 0.5 ml, subcutaneously (strength, lot number and expiry date were not reported), which were improperly stored. No concomitant medication was reported. The PROQUAD (Merck) vaccines were exposed to a maximum of 9.9 degree F for a total of 188.5 hours, on multiple occasions. No adverse effects were reported. The outcomes of the events were unknown. A product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with (Merck) VARIVAX vaccine (strength, dose, route, lot number and expiry date were not reported), which were improperly stored. No concomitant medication was reported. The (Merck) VARIVAX vaccines were exposed to a maximum of 9.9 degree F, for a total of 188.5 hours, on multiple occasions. No adverse effects were reported. The outcomes of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Vaccine appeared to be administered IM below the deltoid. Area is very red inflamed and painful with a 3 inch diameter. Pt referred to physician.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of wrong vaccine administered in a 16-year-old subject of unspecified gender who was vaccinated with HAVRIX adult (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of HAVRIX adult (0.5 ml, unknown route and injection site, batch number not provided) instead of HAVRIX Junior. No adverse event was reported.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of expired vaccine used in a 27-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 13 February 2014 the subject received a dose of HAVRIX (.5 ml, unknown details) and experienced expired vaccine used. The nurse reported that the subject "inadvertently received an expired HAVRIX." The expiry for HAVRIX was 10 February 2014.
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure to product, Anxiety, Exposure via direct contact, Eye irritation, Nausea
Clinical narrative: Information has been received from a healthcare worker referring herself. Healthcare worker reported on 23-FEB-2015 when she was administering a dose of PNEUMOVAX 23 (lot# was not reported) to patient, the needle separated from syringe and most of PNEUMOVAX 23 (lot# was not reported) dose spilled out before administration could be completed. A couple of drops of PNEUMOVAX 23 got into her eye and mouth and she experienced little bit of burning in her eye and nausea from anxiety which she was having about topical exposure. The outcome of the adverse events was not reported. This is one of the reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Syringe issue
Clinical narrative: Information has been received from a healthcare worker referring herself. Healthcare worker reported on 23-FEB-2015 when she was administering a dose of PNEUMOVAX 23 (lot# was not reported) to patient, the needle separated from syringe and most of PNEUMOVAX 23 (lot# was not reported) dose spilled out before administration could be completed. A couple of drops of PNEUMOVAX 23 got into her eye and mouth and she experienced little bit of burning in her eye and nausea from anxiety which she was having about topical exposure. The outcome of the adverse events was not reported. This is one of the reports from the same source. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Contusion
Clinical narrative: This spontaneous report as received from a nursing student via a company representative refers to an 80 year old male patient (the reporter's father). On 19-FEB-2015 the patient was vaccinated with PNEUMOVAX23 (route, dose, frequency and lot # not reported). On an unknown date, approximately in February 2015 the patient developed very bad bruising on an unspecified location. The outcome of the event was unknown. The patient sought medical attention and went to an unspecified urgent care. The relatedness between the event and PNEUMOVAX23 was not reported. 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 Register Nurse refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated post supported temperature excursion with VARIVAX (Merck) 0.5 ml, subcutaneous, lot # reported as K0007974 with expiration date 30-JUN-2015 and lot # K010339 expiration date 22-JUL-2016. No adverse effects noted. Lot number K0007974 is an invalid lot number for VARIVAX. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to a multiple unspecified patients of unknown age and gender. No information regarding concurrent condition and medical history was reported. On an unknown date the multiple unspecified patients were vaccinated with PEDVAXHIB (strength, dose, unit, lot number, expiry date and route were unknown) which was stored improperly. No concomitant therapy was reported. No adverse event was reported. The outcome of event was unknown. No further information was provided. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a female patient of unknown age concerning herself. There were no current or historical conditions reported. On an unknown date the patient was vaccinated with ZOSTAVAX. There were no concomitant medications reported. In approximately FEB-2015, "a little over a week ago" the patient woke up with a rash on her leg from her knee up to her hip. She visited her physician and the shingles was confirmed. The outcome of shingles was unknown. The patient requested a refund for medical costs and the pain and suffering. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, erythema, swelling.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth, Headache, Infection, Nausea, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 79 year old male patinet without pertinent medical history or drug reaction/allergies. On 18-JAN-2015 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # K015308, expiration date 17-DEC-2015), subcutaneously. Concomitant therapies included CELEBREX, sertraline hydrochloride, lansoprazole and hydrochlorothiazide. On 28-JAN-2015 or 19-JAN-2015, the patient developed a headache, a fever of 102, nausea, dry mouth, and an ulcer "90 degrees" away from the injection site on the interior side of his unspecified bicep after receiving ZOSTAVAX. The pharmacist stated that the patient was seen by his physician on 01-FEB-2015 and the physician diagnosed the patient with an unspecified infection. The pharmacist reported that she saw the ulcer on the same day and she reported it looked like a scab. The patient was prescribed cephalexin by his physician as treatment on that day. The pharmacist reported that the patient informed her on the same day that prior to the scab, the ulcer "oozed up and busted open" on an unspecified date. The outcome of events was not resolved. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab, Secretion discharge, Ulcer
Clinical narrative: Information has been received from a pharmacist referring to a 79 year old male patinet without pertinent medical history or drug reaction/allergies. On 18-JAN-2015 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # K015308, expiration date 17-DEC-2015), subcutaneously. Concomitant therapies included CELEBREX, sertraline hydrochloride, lansoprazole and hydrochlorothiazide. On 28-JAN-2015 or 19-JAN-2015, the patient developed a headache, a fever of 102, nausea, dry mouth, and an ulcer "90 degrees" away from the injection site on the interior side of his unspecified bicep after receiving ZOSTAVAX. The pharmacist stated that the patient was seen by his physician on 01-FEB-2015 and the physician diagnosed the patient with an unspecified infection. The pharmacist reported that she saw the ulcer on the same day and she reported it looked like a scab. The patient was prescribed cephalexin by his physician as treatment on that day. The pharmacist reported that the patient informed her on the same day that prior to the scab, the ulcer "oozed up and busted open" on an unspecified date. The outcome of events was not resolved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Headache, Pyrexia
Clinical narrative: Patient's mother called said he had a 100.5 fever and giving TYLENOL. Also he has back pain and a headache.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. There were no current or historical conditions provided. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route not reported). There were no concomitant medications reported. On an unknown date the patient had a rash after receiving the vaccination of ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Cough, Ear infection, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: Fine papular exanthem on trunk and back that progressed to a morbilliform, blanching and more diffuse rash. Of note, patient treated for otitis media with amoxicillin and still on antibiotic at the time of rash development.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash morbilliform, Respiratory tract congestion
Clinical narrative: Fine papular exanthem on trunk and back that progressed to a morbilliform, blanching and more diffuse rash. Of note, patient treated for otitis media with amoxicillin and still on antibiotic at the time of rash development.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pallor, Rash, Rash morbilliform, Rash papular
Clinical narrative: Fine papular exanthem on trunk and back that progressed to a morbilliform, blanching and more diffuse rash. Of note, patient treated for otitis media with amoxicillin and still on antibiotic at the time of rash development.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Erythema, Fatigue, Flushing, Nasal congestion
Clinical narrative: Rhinorrhea, nasal congestion, red/flushed face, generalized rash, low grade fever, fatigue and joint pain.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: Rhinorrhea, nasal congestion, red/flushed face, generalized rash, low grade fever, fatigue and joint pain.
Sex: M
Vaccine: HEP
Symptoms: CD4 lymphocytes increased, Hepatic enzyme increased, Hepatitis B, Hepatitis B virus test positive, Liver function test abnormal
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Hepatitis B in a male patient who received Hepatitis B vaccine. Co-suspect products included TRIUMEQ tablet for HIV-1 infection. Previously administered products included Hepatitis B vaccine (in 2011 office records show the patient had immunity to Hepatitis B because of previous vaccination) and TRUVADA (the patient was previously on a TRUVADA regimen for his HIV, which has anti HepB activity, so it could have controlled or hidden any active HepB infection). Concurrent medical conditions included HIV infection. In 2011 (or before), the patient received Hepatitis B vaccine. In 2014, the patient started TRIUMEQ (oral) at an unknown dose once daily. In 2014, unknown after receiving Hepatitis B vaccine and an unknown time after starting TRIUMEQ, the patient experienced Hepatitis B (serious criteria GSK medically significant). TRIUMEQ was continued with no change. On an unknown date, the outcome of the Hepatitis B was unknown. It was unknown if the reporter considered the Hepatitis B to be related to Hepatitis B vaccine and TRIUMEQ. Additional details provided: The patient was vaccinated with Hepatitis B vaccine sometime in 2011 or before according to physician. During routine blood work in the past year, the physician noted elevated LFTs. Further tests diagnosed the patient with active Hepatitis B infection. The physician does not know if TRIUMEQ contributed to the HepB infection. The patient was still on TRIUMEQ and will be starting HepB therapy. The patient's labs have normalized as of the most recent lab work. Patient's viral load was undetectable, and he has had a good increase in CD4 count. The patient was sexually active. Patient was on other medications, but the health care professional did not provide the names. The reporting physician stated that he did not want any follow-up.
Sex: M
Vaccine: HEP
Symptoms: Viral load undetectable
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Hepatitis B in a male patient who received Hepatitis B vaccine. Co-suspect products included TRIUMEQ tablet for HIV-1 infection. Previously administered products included Hepatitis B vaccine (in 2011 office records show the patient had immunity to Hepatitis B because of previous vaccination) and TRUVADA (the patient was previously on a TRUVADA regimen for his HIV, which has anti HepB activity, so it could have controlled or hidden any active HepB infection). Concurrent medical conditions included HIV infection. In 2011 (or before), the patient received Hepatitis B vaccine. In 2014, the patient started TRIUMEQ (oral) at an unknown dose once daily. In 2014, unknown after receiving Hepatitis B vaccine and an unknown time after starting TRIUMEQ, the patient experienced Hepatitis B (serious criteria GSK medically significant). TRIUMEQ was continued with no change. On an unknown date, the outcome of the Hepatitis B was unknown. It was unknown if the reporter considered the Hepatitis B to be related to Hepatitis B vaccine and TRIUMEQ. Additional details provided: The patient was vaccinated with Hepatitis B vaccine sometime in 2011 or before according to physician. During routine blood work in the past year, the physician noted elevated LFTs. Further tests diagnosed the patient with active Hepatitis B infection. The physician does not know if TRIUMEQ contributed to the HepB infection. The patient was still on TRIUMEQ and will be starting HepB therapy. The patient's labs have normalized as of the most recent lab work. Patient's viral load was undetectable, and he has had a good increase in CD4 count. The patient was sexually active. Patient was on other medications, but the health care professional did not provide the names. The reporting physician stated that he did not want any follow-up.
Age: 27.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Fatigue, Injection site rash, Lip swelling, Mouth swelling
Clinical narrative: Rash on left arm bicep region where shot was given. Weeks later I had a fever, with fatiguing and wooziness. Week after that there was hives on my buttocks, swelling of the hands, feet, and face (Mouth, lips, and jaw line). All symptoms have gone away except for the hives and swelling of the hands, feet, and mouth.
Age: 27.0
Sex: M
Vaccine: HEPAB
Symptoms: Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Rash on left arm bicep region where shot was given. Weeks later I had a fever, with fatiguing and wooziness. Week after that there was hives on my buttocks, swelling of the hands, feet, and face (Mouth, lips, and jaw line). All symptoms have gone away except for the hives and swelling of the hands, feet, and mouth.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Pyrexia, Retching
Clinical narrative: 3/4 6:30 PM started with head ache day of vaccine. 3/5 following day progressed with necking stiffness, severe headache, nausea, fever 101, vomiting/dry heaves. Did not notify health nurse until following morning. Did not seek medical attention. 3/6 720 am called health phone and left message. 915 health nurse returned phone call. Stated decreased nausea, decreased head ache. Feeling better, holding down fluids, refused medical treatment. Did not want to continue with MMR course or second MMR in 1 month. Noted in employee chart. Employee had a low measles titer upon hire.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: 3/4 6:30 PM started with head ache day of vaccine. 3/5 following day progressed with necking stiffness, severe headache, nausea, fever 101, vomiting/dry heaves. Did not notify health nurse until following morning. Did not seek medical attention. 3/6 720 am called health phone and left message. 915 health nurse returned phone call. Stated decreased nausea, decreased head ache. Feeling better, holding down fluids, refused medical treatment. Did not want to continue with MMR course or second MMR in 1 month. Noted in employee chart. Employee had a low measles titer upon hire.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Angioedema, Eye swelling, Immediate post-injection reaction, Injection site reaction, Rash papular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of papular rash in a 4-year-old female patient who received KINRIX (batch number A75B7, expiry date 3rd September 2016). Co-suspect products included MMR (batch number K007974, expiry date 3rd June 2016) and VARIVAX (batch number K002036, expiry date 10th February 2016). On 8th January 2015, the patient received KINRIX .5 ml, MMR and VARIVAX. On 8th January 2015, immediately after receiving KINRIX, the patient experienced papular rash. On an unknown date, 2 days after receiving KINRIX, the patient experienced eye swelling and giant urticaria (serious criteria GSK medically significant). On an unknown date, the outcome of the papular rash, eye swelling and giant urticaria were not recovered/not resolved. It was unknown if the reporter considered the papular rash, eye swelling and giant urticaria to be related to KINRIX. Additional information received: Patient experienced papular rash in the buttock area and in the leg area. The patient's giant urticaria was everywhere. Physician recommended patient to go to emergency room.
Sex: M
Vaccine: YF
Symptoms: Adverse reaction, Apparent death
Clinical narrative: Initial unsolicited report was received from a pharmacist on 25 February 2015. A male patient (date of birth not reported) with a history of a slight reaction after dose 1 of YF-VAX and multiple allergies except no egg allergy, had received on an unspecified date dose two of YF-VAX (Sanofi Pasteur lot number, route and site of administration not reported) and an unspecified amount of time later, experienced a "severe reaction", was hospitalized for one week and "nearly died". According to the reporter, she did not remember the patient name or other information since it was received so long ago (reported as six years). The patient has additional events captured in cases 2015SA026087 and 2015SA026088. Documents held by sender: none.
Age: 1.06
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Wrong technique in drug usage process
Clinical narrative: Pentacel was reconstituted with Merck & CO sterile diluent instead of the diluent that is provided with the vaccine.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Blood test abnormal, Diarrhoea, Pneumonia, Sepsis
Clinical narrative: Vomiting and diarrhea. Transferred by EMS to local hospital.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Vomiting and diarrhea. Transferred by EMS to local hospital.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: PATIENT DIAGNOSED WITH CELLULITIS. PRESCRIBED DOXYCYLINE HYCLATE 100MG 2 TIMES A DAY FOR 7 DAYS.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Pruritus, Skin warm, Swelling
Clinical narrative: Redness and rash around injection site that continued to spread over next few days, itching unrelieved with cortisone cream, mild swelling, warm to touch.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness
Clinical narrative: Patient complains of extreme lightheadedness when rising from a seated or supine position. Symptoms last for a few seconds and then pass. Pt denies being dehydrated. Denies other symptoms.
Age: 1.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febile seizure called 911 and was taken by ambulance to the emergency room, when they got to the er the fever was gone and he was not having a seizure.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood test, Herpes zoster, Myalgia, Polymyalgia rheumatica
Clinical narrative: Pt developed shingles rash and PMR--polymyalgia rheumatica, lots of joint and muscle pain.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Pt developed shingles rash and PMR--polymyalgia rheumatica, lots of joint and muscle pain.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Pt developed shingles rash and PMR--polymyalgia rheumatica, lots of joint and muscle pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site hot/tender. Thurs chills fever 103 itching in random areas, Site hard, swollen, painful. Friday little sleep, painful.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Pruritus, Pyrexia
Clinical narrative: Injection site hot/tender. Thurs chills fever 103 itching in random areas, Site hard, swollen, painful. Friday little sleep, painful.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: PER LPN LEFT DELTOID WITH REDNESS, INDURATION OF 40MMX25MM, WARM AND PAIN TO THE TOUCH. ALSO MOTHER DECLINED FEVERS. DR. INSTRUCTED PATIENT TO PLACE ICE ON DELTOID AREA AND MOM TO MONITOR IF REDNESS AND INDURATION SPREAD TO TAKE CHILD TO ER.
Age: 1.32
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Blepharospasm, Eye movement disorder, Fatigue, Muscle twitching, Unresponsive to stimuli
Clinical narrative: Pt was rear facing in her car seat. Mother noticed," facial twitching on the right side with her mouth drawing towards her ear, along with eye twitching and her eyes were rolling, and her face flopped the other way." She would not respond to her name, mom did not notice her extremities. She returned to our office and was found to be slightly tired, but otherwise normal acting. Referred to make apt with neurology.
Age: 1.32
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: VIIth nerve paralysis
Clinical narrative: Pt was rear facing in her car seat. Mother noticed," facial twitching on the right side with her mouth drawing towards her ear, along with eye twitching and her eyes were rolling, and her face flopped the other way." She would not respond to her name, mom did not notice her extremities. She returned to our office and was found to be slightly tired, but otherwise normal acting. Referred to make apt with neurology.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Pain in extremity, Swelling
Clinical narrative: Patient reports swelling and redness (heat). Also, states that his arm hurt when moving. Informed patient to use Benadryl, Motrin, and Cold compresses for 15 min per day, several times a day.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat, quarter sized lump at injection site. Started on antibiotics.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Differential white blood cell count normal, Fatigue, Full blood count normal, Lymphadenopathy, Malaise
Clinical narrative: Fever, malaise. Then flat, non-pruritic rash to abdomen and lymphadenopathy and fatigue.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, malaise. Then flat, non-pruritic rash to abdomen and lymphadenopathy and fatigue.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction: extreme redness and swelling at injection site that was most severe 3/2 and 3/3 getting better over time.  Redness and swelling still present on 3/6. Patient to follow up with MD.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abasia
Clinical narrative: Patient could not walk after the vaccine lasted for 2 days.
Age: 42.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Injection site pain, Pain, Toothache
Clinical narrative: Toothache on left side (worse on teeth with pre-existing caps). General soreness at injection site and slight body soreness.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Pain in upper arm-questionable hematoma vs. muscle bruise after vaccination administration.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Axillary pain, Culture wound, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: 16 Feb 15 Pt had a hard time sleeping, woke up feeling tender and swollen left arm (from shoulder to elbow) and armpit. Pt went to ER, was told to take Benadryl, and was discharged.  17 Feb 15, Pt woke up with Left arm further irritated with red streaks fro vaccine site to armpit, returned to the ER to receive IV antibiotics and RX for Amoxicillin- clavulanate 875-125mg bid for 10 days.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site streaking, Injection site swelling, Insomnia, Oedema peripheral, Smear test
Clinical narrative: 16 Feb 15 Pt had a hard time sleeping, woke up feeling tender and swollen left arm (from shoulder to elbow) and armpit. Pt went to ER, was told to take Benadryl, and was discharged.  17 Feb 15, Pt woke up with Left arm further irritated with red streaks fro vaccine site to armpit, returned to the ER to receive IV antibiotics and RX for Amoxicillin- clavulanate 875-125mg bid for 10 days.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Culture wound, Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: 16 Feb 15 Pt had a hard time sleeping, woke up feeling tender and swollen left arm (from shoulder to elbow) and armpit. Pt went to ER, was told to take Benadryl, and was discharged.  17 Feb 15, Pt woke up with Left arm further irritated with red streaks fro vaccine site to armpit, returned to the ER to receive IV antibiotics and RX for Amoxicillin- clavulanate 875-125mg bid for 10 days.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Insomnia, Local swelling, Smear test, Tenderness
Clinical narrative: 16 Feb 15 Pt had a hard time sleeping, woke up feeling tender and swollen left arm (from shoulder to elbow) and armpit. Pt went to ER, was told to take Benadryl, and was discharged.  17 Feb 15, Pt woke up with Left arm further irritated with red streaks fro vaccine site to armpit, returned to the ER to receive IV antibiotics and RX for Amoxicillin- clavulanate 875-125mg bid for 10 days.
Age: 0.38
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Hypotonia, Respiratory arrest
Clinical narrative: I woke up to find my baby not breathing.  He was completely flaccid and I had to stimulate him awake.  I don't know how long he hadn't been breathing prior to me waking up.  It took me 3-5 minutes to get him breathing again.
Age: 1.28
Sex: M
Vaccine: MMR, PPV
Symptoms: Abnormal behaviour, Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: Lack of Appetite, diarrhea, vomiting. Called Dr. on call. Dr told me to keep an eye on him, not give him food and if he continued throwing up after a few hours to take him in. He threw up 5 times total. I gave him water and watched him during the night. On the morning of 3/6/2015, he breastfed a little, but would only eat small amounts. Took two 3.5 hour naps and is currently sleeping again. I do not know that he has recovered yet, since he is still not acting normally. I am continuing to keep an eye on him.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness postural, Gait disturbance, Immunology test, Mobility decreased, Weight decreased
Clinical narrative: Barely able to walk, cannot bend, cannot stand without getting dizzy, losing weight.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Body temperature increased, Decreased appetite, Irritability
Clinical narrative: 103.1° rectal temp taken at 1930 (7:30 PM), fussiness, loss of appetite. Dressed her down, fluids, rest (will administer infant Tylenol if she wakes up later).
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on stomach, back and neck, gradually got worse for 2 more days. Gave Benadryl but didn't go away. Had a low grade fever of 100.5 to 101.5 for 2 days prior with no symptoms until the rash.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain upper, Constipation, Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Patient has had a belly ache And mild fever for the past 5 days.  He has been lethargic and not eating well and has been constipated.
Age: 50.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Injection site induration
Clinical narrative: Headache, body ache, fatigue, pain, redness, hard knot at injection site.  Fever 102 degrees.  Flu like symptoms for two days so far.
Age: 50.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Injection site nodule, Pain, Pyrexia
Clinical narrative: Headache, body ache, fatigue, pain, redness, hard knot at injection site.  Fever 102 degrees.  Flu like symptoms for two days so far.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Cough, Dyspnoea, Influenza like illness, Malaise
Clinical narrative: Father presented with pt to clinic on 3/4/15 stating that after pt received flu vaccine on 2/26/15 he began experiencing "flu like symptoms". He began with "cough" and "not feeling well." C/O having fever on and off since 2/28/15 and feeling shortness of breath at night and feels "something in his throat". Father took pt to ED on 3/3/15 and diagnosed with chest pain. Pt admitted to hospital 3/4/15 due to his complaints. F/U call to father/grandmother stated father did not take patient to hospital.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Sensation of foreign body
Clinical narrative: Father presented with pt to clinic on 3/4/15 stating that after pt received flu vaccine on 2/26/15 he began experiencing "flu like symptoms". He began with "cough" and "not feeling well." C/O having fever on and off since 2/28/15 and feeling shortness of breath at night and feels "something in his throat". Father took pt to ED on 3/3/15 and diagnosed with chest pain. Pt admitted to hospital 3/4/15 due to his complaints. F/U call to father/grandmother stated father did not take patient to hospital.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received Tdap and MVO in LD on 03-03-2015. Client c/o headaches and LD swollen, red, and warm to touch. Client was seen at HD at 2:30 pm 3-5-15.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Left shoulder pain where needle was inserted going down arm to thumb; up thru nite with pain.
Age: 39.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Contusion, Muscular weakness
Clinical narrative: Bruise, arm weakness, none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle twitching
Clinical narrative: Shoulder pain (L) and reduced range of motion. Muscle twitching in (L) forearm. Saw primary care doctor on 11/12/14, who advised naproxen and gentle exercise. Took two courses of naproxen but symptoms continue to date. (Muscle twitching subsided, though).
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Impaired work ability, Pain, Swelling
Clinical narrative: On 12/2/2014 flu vaccine was placed on (R) top shoulder. He felt pain and fairly quickly swelled up. Pain keeps him from much work over shoulder level. He was sent to therapy.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Haematoma, Injection site nodule, Skin lesion
Clinical narrative: She received her annual flu vaccine 12/2/14. She had a little knot at the injection site (L) deltoid for a couple of days and then it went down but then it came back. It has persisted since that time she had similar bumps on her arm in the past but they've always gone away in few days. Not this one. Since she has a previous history of Lipoma, an ultrasound of the deltoid has been order to confirm that the lesion is indeed hematoma.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Aspiration bone marrow abnormal, Myalgia, Nausea
Clinical narrative: 7 Feb about noon started to feel nauseous, 9 Feb right knee pain started to increase. 10-14 Feb nausea continues, knee pain increasing. 15 Feb nausea continues, knee pain increasing, muscle, and joint pain. 16 Feb continued nausea, and knee pain increasing, full body muscle, and joint pain. 17 Feb Pain level 8/9+. 18 Feb Went to Dr. X-ray and ultra sound. Rx NARCO. 19 Feb Pain level 8/9+. 20 Feb Went to Hospital drained Rt knee and cortisone shot. 22 Feb Released from Hosp. 22Feb- 2 Mar pain level 4/5.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received influenza vaccine in left deltoid on 9/25/2014. Patient still experiencing arm soreness in March 2015.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received influenza vaccine in left deltoid on 9/25/2014. Patient still experiencing arm soreness in March 2015.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 03-MAR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneously (dose, strength, frequency and lot number were not provided) which was improperly stored. Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.