chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 12-AUG-2013, one patient was vaccinated with an improperly stored dose of PEDVAX (lot # H022058 expiration date 10-OCT-2015) (dose and route not specified), that was exposed to 31F for 72 hours, which is an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA008790), another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA009656), another patient was vaccinated with improperly stored ROTATEQ (MARRS 1308USA009659), and another one was vaccinated with improperly stored GARDASIL (Intramuscular injection) (MARRS1308USA009658). This is one of several reports from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash pruritic, Rash pustular, Scab, Skin lesion
Clinical narrative: This spontaneous report as received from a consumer mother refers to her 23 year old daughter with lactose intolerance, mittelschmerz no drug reaction/allergies. The patient's medical history included chickenpox when young but her titers tested low and she had to get the vaccine before starting school. On 16-JUN-2013 and 15-JUL-2013 the patient was vaccinated with VARIVAX (Merck) dose 1 and dose 2, respectively (doses, route and lot numbers not provided). Concomitant medication included birth control therapy (unspecified). On 22-JUL-2013, reported as 1 week after second dose of VARIVAX (Merck), the patient developed a rash with itchiness, lesions like red "bug bites" and pustules. The patient had not seen a doctor or sought medical attention. No lab diagnostic tests were performed. The patient used calamine lotion as a treatment for the events. The patient rash was beginning to scab over. The outcome of pustules and lesions like red "but bites" was unknown. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown ages. On unknown dates in 2013, the patients might have received unspecified doses of VARIVAX (Merck) (lot # 670184/0412AA, expiration date 16-MAR-2013) (strength and total daily dose not reported). No adverse effects were reported. It was unspecified whether the patients sought for medical attention. The outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 23 year old male patient. On 06-JUL-2010 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route and indication unknown). The patient received the second dose of GARDASIL late (date, dose and route unspecified). No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to a 12 years old female patient with no drug reaction/allergies. On 15-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot# H021346, expiration date: 01-OCT-2015) of series of three intramuscular (dose unspecified) at unspecified location, a dose of VARIVAX (Merck) (lot# unspecified), unspecified route and dose at unspecified location, a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and meningococcal vaccine (unspecified) (manufacturer unknown) during the routine check up. On 15-JUL-2013, the patient experienced syncope while receiving the first dose of GARDASIL. The nurse reported that she lied the patient down after the patient experienced syncope, and it took the 15 seconds for the patient to wake up. The patient had sought medical attention, the patient was in the doctor's office when the adverse reaction happened. No treatment was given. None lab diagnostics studies was performed. On 15-JUL-2013, the patient recovered from syncope. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot#, expiration date and route not reported) that underwent unsupported temperature excursions and no adverse effects reports. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash pruritic, Rash pustular, Scab, Secondary transmission
Clinical narrative: This spontaneous report as received from the consumer's mother refers to her daughter of unknown age. The patient's medical history included chickenpox in childhood. On 16-JUN-2013 and on 15-JUL-2013 the patient's sister was vaccinated with first and second doses of VARIVAX (merck) respectively (dose, route and lot number not provided). A couple days later, on approximately July 2013 the patient experienced rash with itchiness, lesions like red "bug bites" and pustules the same rash as her sister had. The patient went to a doctor who prescribed halobetasol propionate cream (manufacturer unknown) which helped itch only. The patient's rash was beginning to scab over. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from the consumer's mother refers to her daughter of unknown age. The patient's medical history included chickenpox in childhood. On 16-JUN-2013 and on 15-JUL-2013 the patient's sister was vaccinated with first and second doses of VARIVAX (merck) respectively (dose, route and lot number not provided). A couple days later, on approximately July 2013 the patient experienced rash with itchiness, lesions like red "bug bites" and pustules the same rash as her sister had. The patient went to a doctor who prescribed halobetasol propionate cream (manufacturer unknown) which helped itch only. The patient's rash was beginning to scab over. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with VAQTA (lot#, expiration date and route not reported) that underwent unsupported temperature excursions and no adverse effects reported. No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with GARDASIL (lot#, expiration date and route not reported) that underwent unsupported temperature excursions and no adverse effects reported. No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 19-AUG-2013 the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular. The nurse reports that patient received her first dose of GARDASIL (injection, 0.5 ml, intramuscular) in July 2011 and the patient was in the office presently(19-AUG-2013) to receive her second dose of GARDASIL (injection, 0.5 ml, intramuscular). No adverse effect was reported. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, strength and injection site were not reported) subcutaneous. On an unknown date the patient experienced shingles. The patient transmitted shingles to his wife after he received ZOSTAVAX. The outcome and action taken was not provided. This is one of several reports received from the same source with Patient/Partner link to case 1308USA008550. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Secondary transmission
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The patient's medical history included chickenpox in childhood. On 16-JUN-2013 and on 15-JUL-2013 the daughter of a friend of the patient was vaccinated with first and second doses of VARIVAX (merck) respectively (dose, route and lot number not provided). This weekend, in approximately August 2013 the patient developed bumps. The outcome of the event was unknown. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Secondary transmission
Clinical narrative: This spontaneous report as received from a consumer refers her husband of unknown age. The patient's medical history included chickenpox in childhood. On 16-JUN-2013 and on 15-JUL-2013 the patient's daughter was vaccinated with first and second doses of VARIVAX (Merck) respectively (dose, route and lot number not provided). This weekend, in approximately August 2013 the patient saw bumps on his arm, similar to his daughter's. The outcome of the event was unknown. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 13-AUG-2013, one patient was vaccinated with an improperly stored dose of GARDASIL (lot #H015555 expiration date 13-APR-2015) (dose and route not specified) that was exposed to 31F for 72 hours, which is an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS1308USA008790) another patient was vaccinated with improperly stored PEDVAX (MARRS1308USA009657), another patient was vaccinated with improperly stored ROTATED (MARRS1308USA009659) and another one was vaccinated with improperly stored VAQTA (MARRS1308USA009656). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 12-AUG-2013, one patient was vaccinated with an improperly stored dose of ROTATEQ (lot # reported as H012979 expiration date 06-FEB-2014) (dose and route not specified), that was exposed to 31F for 72 hours, which is an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA008790), another patient was vaccinated with improperly stored PEDVAX (MARRS 1308USA009657), another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA009656), and another one was vaccinated with improperly stored GARDASIL (MARRS 1308USA009658). This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient's husband was vaccinated with ZOSTAVAX (lot number, dose, strength and injection site were not reported) subcutaneous for prevention of shingles. On an unknown date the patient's husband was transmitted shingles to her after he received ZOSTAVAX. The patient was going through chemotherapy treatments when shingles were transmitted to her. The outcome and action taken was not provided. This is one of several reports received from the same source with Patient/Partner Link to case 1308USA008132. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Underdose, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 8 week old female patient. On 19-AUG-2013 the patient was vaccinated with "about half" of a dose of ROTATEQ (lot number unspecified) orally. The patient then vomited immediately following the administration. The outcome of adverse event was unknown. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Myalgia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the third dose of GARDASIL (injection, dose and lot # were unknown). On an unknown date the patient suffered from fatigue and myalgia after receiving the third shot of GARDASIL. The outcome of events was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 20 year old female patient with penicillin allergy. There was no pertinent medical history. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified) when she was a child. On 13-AUG-2013 (two days ago), the patient was vaccinated with the second dose of, 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date reported as H018758 and 11-OCT-2014 respectively), subcutaneously. There were no concomitant medications. On 15-AUG-2013 (today), the patient visited the pharmacy. Approximately on an unknown date in August 2013, the patient experienced redness, a ring around the point of injection, itchiness, swelling, hot and a hard spot at the site of injection. Patient also called her unspecified physician who advised the patient to go to an unspecified emergency room as a result of the injection site reaction. It was unknown if the patient actually visited an unspecified emergency room or if she was admitted to an unspecified hospital. It was unspecified if any treatment was provided. The patient was not recovered from redness, a ring around the point of injection, itchiness, swelling, hot and a hard spot at the site of injection. The relatedness for redness, a ring around the point of injection, itchiness, swelling, hot and a hard spot at the site of injection was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypersensitivity, Malaise, Throat tightness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient with Macrodantin allergy, latex allergy, peanuts allergy and statin allergy. The patient had no pertinent medical history. On 14-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J001007, exp. date 24-APR-2014) 0.65 ml, subcutaneous. Concomitant medications were not reported. Pharmacist stated that on 14-AUG-2013, 3 hours after receive ZOSTAVAX, patient felt dizzy. Pharmacist stated patient continued "not feeling well" at 8 hours post vaccination and experienced throat tightness. Pharmacist stated patient reported she went to unspecified urgent care clinic where it was diagnosed as "a sort of allergic reaction" and patient was given unspecified antihistamines. Pharmacist stated patient "was fine" on 19-AUG-2013. No lab diagnostics studies were performed. The relationship between ZOSTAVAX and the allergic reaction was not reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 72 year old male patient with diabetes, allergic rhinitis, high cholesterol and elevated (prostatic specific antigen) PSA, the patient also had a history of gastrointestinal bleed and gastrointestinal upset after using ibuprofen on an unspecified date. On 18-JUL-2013 the patient was vaccinated with ZOSTAVAX lot number and expiration date not reported (subcutaneous, dose not reported). No other suspect therapies were reported. Concomitant medications included Metformin and fluticasone nasal spray. The reporter stated that on "about 19-JUL-2013" the patient developed a rash on the back and the right side of the torso. On 22-JUL-2013, he went to the emergency room at an unspecified hospital. On 25-JUL-2013 he went to see a physician, the patient was given VALTREX and NORCO. The patient recovered on an unspecified date (also reported as recovering). The reporting medical assistant did not assess the causality between ZOSTAVAX and rash on the back and the right side of the torso. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 72 year old male patient with diabetes, allergic rhinitis, high cholesterol and elevated (prostatic specific antigen) PSA, the patient also had a history of gastrointestinal bleed and gastrointestinal upset after using ibuprofen on an unspecified date. On 18-JUL-2013 the patient was vaccinated with ZOSTAVAX lot number and expiration date not reported (subcutaneous, dose not reported). No other suspect therapies were reported. Concomitant medications included Metformin and fluticasone nasal spray. The reporter stated that on "about 19-JUL-2013" the patient developed a rash on the back and the right side of the torso. On 22-JUL-2013, he went to the emergency room at an unspecified hospital. On 25-JUL-2013 he went to see a physician, the patient was given VALTREX and NORCO. The patient recovered on an unspecified date (also reported as recovering). The reporting medical assistant did not assess the causality between ZOSTAVAX and rash on the back and the right side of the torso. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: HEP, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Somnolence
Clinical narrative: High pitched inconsolable screaming following vaccination that continued until 5.5 months (had shots again at 4 mo. and it got worse). Also had 18+ loose stools every day with mucous in them and extremely foul smelling.
Age: 0.17
Sex: F
Vaccine: HEP, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal faeces, Crying, Culture stool negative, Diarrhoea, Frequent bowel movements
Clinical narrative: High pitched inconsolable screaming following vaccination that continued until 5.5 months (had shots again at 4 mo. and it got worse). Also had 18+ loose stools every day with mucous in them and extremely foul smelling.
Age: 0.17
Sex: F
Vaccine: HEP, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mucous stools, Radioallergosorbent test negative, Screaming, Vaccine positive rechallenge
Clinical narrative: High pitched inconsolable screaming following vaccination that continued until 5.5 months (had shots again at 4 mo. and it got worse). Also had 18+ loose stools every day with mucous in them and extremely foul smelling.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Lip swelling
Clinical narrative: Hoarseness at 02:00 PM and continuing; cough beginning at 3:00 PM; lip swelling beginning at 08:00 PM; treated by urgent care physician (reporting) at 08:45 PM.
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: Initial report was received from a healthcare professional on 12 August 2013. A female patient (age and date of birth not reported) had received a dose 3 injection of DTaP (Manufacturer Unknown) on 26 April 2002 (lot number, route, site, and side of administration not reported). On the same day, the patient experienced a seizure and had to be taken to the emergency room. The pediatrician who administered the vaccine was deceased. A note in the chart from the current physician stated the patient experienced a "fever reaction" and was not to receive any vaccine containing pertussis. The patient had a history of receiving DTaP, manufacturer unknown, on 18 January 2001 and 16 July 2001 (lot number, route, site and side of administration not reported). The patient's outcome was recovered. Documents held by sender: None.
Age: 1.52
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 13 August 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 18-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL (lot number not reported) on 18 February 2011, 20 April 2011, and 20 June 2011, and 1 dose of DAPTACEL (lot number C4035AA) on 22 June 2012. The subject developed a cough on 12 July 2013, approximately 1 year after the last dose, and a paroxysmal cough without a whoop on 12 July 2013. The subject also developed cold like symptoms on 10 July 2013. Laboratory testing included positive PCR on 23 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 23 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 30 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 206 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 13 August 2013. These 206 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 1.52
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction
Clinical narrative: Initial report received on 13 August 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 18-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL (lot number not reported) on 18 February 2011, 20 April 2011, and 20 June 2011, and 1 dose of DAPTACEL (lot number C4035AA) on 22 June 2012. The subject developed a cough on 12 July 2013, approximately 1 year after the last dose, and a paroxysmal cough without a whoop on 12 July 2013. The subject also developed cold like symptoms on 10 July 2013. Laboratory testing included positive PCR on 23 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 23 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 30 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 206 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 13 August 2013. These 206 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 83.0
Sex: M
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from an 83 year old male consumer refers himself. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX (dose, route, indication not reported) in the upper left arm. Other suspect therapies included influenza virus vaccine (brand and manufacturer unspecified) (dose, route, indication not reported). Concomitant therapies included PRILOSEC. Both shots were administered in his left arm and one in his shoulder area, the patient did not distinguish which shot was given to him in a specific location. There was no pertinent medical history or drug reactions/allergies. Approximately in July 2013 (a couple days) the patient experienced itching in a 4" diameter around the injection site with a hardening pimple in the center of the injection area. He also began to get soreness from the first injection site location to the second location in his shoulder. He subsequently returned to the physician's office where he was told it was a cyst. To date the itching has subsided, but the soreness remained in his upper left arm going up to his shoulder. The patient did not recovered from cyst. There was not treatment given for the event. No lab diagnostics studies performed. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Acne, Injection site cyst, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from an 83 year old male consumer refers himself. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX (dose, route, indication not reported) in the upper left arm. Other suspect therapies included influenza virus vaccine (brand and manufacturer unspecified) (dose, route, indication not reported). Concomitant therapies included PRILOSEC. Both shots were administered in his left arm and one in his shoulder area, the patient did not distinguish which shot was given to him in a specific location. There was no pertinent medical history or drug reactions/allergies. Approximately in July 2013 (a couple days) the patient experienced itching in a 4" diameter around the injection site with a hardening pimple in the center of the injection area. He also began to get soreness from the first injection site location to the second location in his shoulder. He subsequently returned to the physician's office where he was told it was a cyst. To date the itching has subsided, but the soreness remained in his upper left arm going up to his shoulder. The patient did not recovered from cyst. There was not treatment given for the event. No lab diagnostics studies performed. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from an 83 year old male consumer refers himself. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX (dose, route, indication not reported) in the upper left arm. Other suspect therapies included influenza virus vaccine (brand and manufacturer unspecified) (dose, route, indication not reported). Concomitant therapies included PRILOSEC. Both shots were administered in his left arm and one in his shoulder area, the patient did not distinguish which shot was given to him in a specific location. There was no pertinent medical history or drug reactions/allergies. Approximately in July 2013 (a couple days) the patient experienced itching in a 4" diameter around the injection site with a hardening pimple in the center of the injection area. He also began to get soreness from the first injection site location to the second location in his shoulder. He subsequently returned to the physician's office where he was told it was a cyst. To date the itching has subsided, but the soreness remained in his upper left arm going up to his shoulder. The patient did not recovered from cyst. There was not treatment given for the event. No lab diagnostics studies performed. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Body temperature increased, Malaise, Nausea, Pain
Clinical narrative: Pt. reports was running approx. 6pm 08/20/2013 suddenly "felt sick" and weak after 1 mile and had to go home and lie down. Temp was 99. On 08/21/2013 developed nausea most of day. 08/21 PM noted rash only on back, was resolved with Benadryl cream. Temp still 99.  Woke 08/22/2013 am with arm of injection "painful to raise", "tingling into hand". Denied pain, redness, or swelling at injection site left arm. Was instructed to discuss with primary MD.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia, Rash
Clinical narrative: Pt. reports was running approx. 6pm 08/20/2013 suddenly "felt sick" and weak after 1 mile and had to go home and lie down. Temp was 99. On 08/21/2013 developed nausea most of day. 08/21 PM noted rash only on back, was resolved with Benadryl cream. Temp still 99.  Woke 08/22/2013 am with arm of injection "painful to raise", "tingling into hand". Denied pain, redness, or swelling at injection site left arm. Was instructed to discuss with primary MD.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth and pain around left uper arm injection site. Redness measures 12cm x7.5 cm. Treated with 7 days of Augmentin for cellulitis.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Gait disturbance, Musculoskeletal pain, Neck pain
Clinical narrative: Pt states pain started in left leg around 3pm and became "excruciating" and by 9pm could not walk unassisted. Days later started in right leg and also spread to neck wrist and shoulder. Pt also had lightheadedness off and on during this time.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt states pain started in left leg around 3pm and became "excruciating" and by 9pm could not walk unassisted. Days later started in right leg and also spread to neck wrist and shoulder. Pt also had lightheadedness off and on during this time.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Patient broke out with shingles 7 days after it was administered. No treatment provided. Mom wanted this reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Oropharyngeal blistering, Pharyngeal erythema, Pharyngeal oedema, Urticaria
Clinical narrative: Swollen throat, hives on neck, red blisters on back of throat, headache.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: Patient was administered Immunizations by nurse and within a couple of minutes patient became pale, faint and sick to his stomach. Nurse assisted patient with a cool wash cloth and fan and two nurses assisted patient from chair to exam table with legs elevated.  Patient stated he did not have lunch today.  Mother present during fainting episode and support provided and monitored for 25 minutes prior to going home.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Mild redness.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Urticaria
Clinical narrative: Small raised red hives on face, started near eyes. Did not spread to anywhere else on body. 5 mL Children's Diphenhydramine given.
Age: 63.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Chest pain, Injection site pain
Clinical narrative: 45 minutes after the immunization, pt experienced gradual pain from the injection site (left arm) and spread to left chest area. Pt states that pt has not been gone since and have been to ER twice.
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Diarrhoea, Malaise, Nausea
Clinical narrative: On 8/7/13 RN was notified by employee that one day after starting oral typhoid she experienced bodyaches, generalized malaise, slight nausea, diarrhea, and a low grade fever. Symptoms ceased approx 2 days after completing vaccine. The day after completing the vaccine she went to a work physical and it was noted she had an increased WBC, AST, ALT labs.
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Pyrexia, White blood cell count increased
Clinical narrative: On 8/7/13 RN was notified by employee that one day after starting oral typhoid she experienced bodyaches, generalized malaise, slight nausea, diarrhea, and a low grade fever. Symptoms ceased approx 2 days after completing vaccine. The day after completing the vaccine she went to a work physical and it was noted she had an increased WBC, AST, ALT labs.
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Chest X-ray normal, Febrile convulsion, Pyrexia
Clinical narrative: Fever up to 103 degrees went to ER for suspected febrile seizure.
Age: 14.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Client very nervous prior to receiving shots. After receiving the 2 vaccines, she was alert, talking, color slightly pale. Suddenly, about 2 minutes after vaccination, clients eyes. Fluttered, color pale and began to slump in chair - completely fainted. Revived with seconds with smelling salts. After resting and sipping H20 x 15 min, client left facility to sit in car before leaving > 15 min later.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Serum sickness, Skin lesion, Urticaria
Clinical narrative: 8-19-13 Urticaria - CLARITIN QD. 8-20-13 Serum sickness - fever 101, diffuse hives widespread with wheals and coalescent lesions.
Age: 1.59
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Pinkish red firm tissue measuring 3 cm x 5 cm non tender, raised on (R) thigh.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Bacterial test, Chlamydia test, Incorrect dose administered, Loss of consciousness
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old female patient with sulfa and peanuts allergy. Patient had no pertinent medical history and did not use concomitant medication. On 19-AUG-2013 the patient was vaccinated with GARDASIL lot # H021608 (expiry date 13-AUG-2013) dose 4, 0.5 ml, intramuscular in the left arm. Patient's mother stated the GARDASIL series had been completed at an unspecified time in the past and this was fourth dose to be received by patient. Nurse stated that there was no information available about the prior doses of GARDASIL. The patient passed out after fourth dose was administered on 19-AUG-2013. Unspecified staff monitored blood pressure prior to allowing patient to leave office. Patient experienced no other symptoms and patient was doing fine then. Furthermore, it was reported that the patient did not seek medical attention. It was also reported that the patient had a sexually transmitted disease (STD) screening for gonorrhea and chlamydia. Upon internal review the case was assessed as medically significant. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Blister, Erythema, Skin warm, Swelling
Clinical narrative: Redness and slight swelling 5 in x 4.5 inches center area slight vesicle area. Center area slight warm but pt denies pain.
Age: 0.03
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Pt developed varicella vaccine induced chicken pox confirmed by dermatologist.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: Rash to ankles, legs, cheek fluid filled vesicles.
Age: 1.55
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Pruritus, Urticaria
Clinical narrative: Broke out in hives, itching for 3 days. Had diarrhea 1 day. Rubbed cortisone ointment on body, gave orally Benadryl.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Mother of pt called clinic today, 8/22/13, to report a local reaction on patient's R arm. Vaccines administered on R arm on 8/19/13, were Varicella and Menveo. Mother reported she called CDC and was advised by CDC to call us and report VAERS. Mother described the site as red, warm, diameter of about 5 cm, worse today. Advised to seek MD care today, fluids and home treatment to ease discomfort. Mother reported except for local reaction, child active, normal, afebrile, eating well. Mother stated will make MD appt today.
Age: 19.0
Sex: M
Vaccine: MNQ, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse effects.
Age: 0.35
Sex: M
Vaccine: DTAP, IPV, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Baby had high pitch screaming for 2 hours.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness and itching and burning sensation at site of injection within 10 minutes of administration of Varicella vaccine. Went to ER - got Decadron 8 mgm by mouth in ER and took Benadryl at home 8/12/13. Fully recovered.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt's wife called stating the day after pt. got TDap that he developed a 3-4" area of redness, hard bump and heat at site L deltoid. Pt. also having fever and chills. Instructed to use ice at site and Tylenol or Ibuprofen for fever and chills. Instructed to call or come and be seen if something persist or worsen. Recovering-better doay 3 days later.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Pt's wife called stating the day after pt. got TDap that he developed a 3-4" area of redness, hard bump and heat at site L deltoid. Pt. also having fever and chills. Instructed to use ice at site and Tylenol or Ibuprofen for fever and chills. Instructed to call or come and be seen if something persist or worsen. Recovering-better doay 3 days later.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Client noticed itching and swelling at injection site over 24 hours later. Cont today (8-22-13) with same. States feels warm and has redness the size of a 50 cent piece. No systemic symptoms, no fever. Advised to see PCP if getting worse instead of better.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5, 6VAX-F, PPV, RV5
Symptoms: Death
Clinical narrative: He received vaccines 8-20-13 at 11:30 AM in the office and was notified by Coroner's office he had expired 8-21-13 by fax.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Electroencephalogram, Presyncope, Syncope, Tremor
Clinical narrative: Had syncopal episode with shaking (seizure?) episode and vasovagal reaction.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Oedema mouth, Swelling face, Swollen tongue
Clinical narrative: Patient experienced swelling in facial cheeks, mouth, and tongue.  Did not seek medical treatment.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Sharp stabbing pain from top of arm down to ventral forearm of left arm; dull ache in left posterior shoulder; limited range of motion due to pain; brief red streaks down arm.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Culture, Irritability, Pyrexia, Rash, Skin lesion
Clinical narrative: Rash, herpetic like lesions, fever, fussy.
Age: 21.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Accidental exposure to product
Clinical narrative: Patient was recieving a MMR injection when she pulled after feeling the injection going in. At that point a small droplet shot in my eye. After that I reported to my immediate chain of command and was treated via protocol.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 11-12 year old male patient. On an unknown date the patient was vaccinated with GARDASIL (lot # not reported) (dose 1, intramuscular, dose as indicated, strength and total daily dose not reported). Concomitant therapies included MENACTRA and TDAP. The patient experienced syncope after receiving the first dose of GARDASIL. The patient fainted in office during the visit and sought for unspecified medical attention by being attended to office. No treatment was given. The patient recovered in office. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with prednisone allergy and hypertension. On 05-AUG-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J002242, expiration 21-MAY-2014), 19400 PFU, subcutaneously. Concomitant therapies included CATAPRES and BENECARDIN. On 14-AUG-2013, the patient experienced an itchy, red, rash on the side of her face, and around the eye, which went down the patient's neck. The patient sought medical attention via visit to pharmacy. Patient had not yet seen physician and no treatment had been given at this time No lab diagnostic studies performed. At the time of report, the event outcome was reported as not recovered. VZVIP packet faxed to pharmacist. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to an unknown age female patient. The patient had no past medical history. On 13-AUG-2013 the patient had a syncopal episode immediately after receiving her 3rd dose of GARDASIL (lot# H020002, expiration date: 08-AUG-2015), intramuscularly at unspecified location. The patient was sitting down as indicated and this episode occurred as the needle was being removed from the injection site. The patient was physically supported until symptoms resolved which was approximately 15 seconds. The patient was sitting on the exam room table with her feet 'dangling' when this occurred. No concomitant therapies reported. The patient had sought medical attention. No lab studies were performed. On 13-AUG-2013, the patient recovered from syncopal episode. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Full blood count normal, Metabolic function test normal, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 32 year old female patient with no medical history and no drug allergies/reactions. The patient who was pregnant (had her last menstrual period on 15-JUN-2013) was vaccinated with a dose of VARIVAX (Merck) lot # H020248, expiration date 08-NOV-2014, 0.5 ml, subcutaneous on 19-JUL-2013. No additional adverse effects reported. There was no concomitant medication. Laboratory studies performed included "Normal metabolic panel and normal CBC". Patient sought medical attention by contacting physician. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 11-12 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (lot # not reported) (dose 1, intramuscular, dose as indicated, strength and total daily dose not reported). Concomitant therapies included MENACTRA and TDAP (unspecified). The patient experienced syncope after receiving the first dose of GARDASIL. The patient fainted in office during the visit and sought for unspecified medical attention by being attended to office. No treatment was given. The patient was recovered in office. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown ages. On unknown dates the patients were vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). It was reported that an unknown number of vials of ZOSTAVAX underwent unknown excursions, which might not be supported. Pharmacist reported that it was possible that some of these vials of ZOSTAVAX might have been administered to the patients. No adverse effects were reported. It was unspecified whether the patients sought for medical attention. The outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient (who is the granddaughter of one of her pharmacy technicians) of unknown age. On 20-AUG-2013, the patient was vaccinated with 2 doses of GARDASIL, (lot numn). It was unspecified if the patient was administered any previous dose of GARDASIL. No adverse effect was reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old male patient. On 05-AUG-2013, the patient was vaccinated with a first dose of GARDASIL, 0.5 ml injection, intramuscularly, lot number # H017698, exp.date 02-JUL-2015. The reporter stated that GARDASIL was exposed to 31.5 Fahrenheit degrees for 75 minutes which was not supported. No adverse effects were reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gait disturbance, Laboratory test normal
Clinical narrative: This spontaneous report was received from an 83 years old female consumer refers to herself with thyroid and high cholesterol problems. The patient had no pertinent medical history and drug reaction/allergies. On 07-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified), one time injection, route and location unspecified. Concomitant therapies were taken for thyroid and high cholesterol. On Sunday, 11-AUG-2013 the patient started feeling light headed and unsteady on her feet. No treatment was given for feeling light headed and unsteady on her feet. The patient did not seek medical attention. In May 2013, the patient had lab work everything was good. Therapy with ZOSTAVAX was reported as continued. At the time of report, the outcome of feeling light headed and unsteady on her feet was unknown. Additional information is not expected.