chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3, PPV, VARZOS
Symptoms: Condition aggravated, Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via the publicist representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, indication not reported), dose and frequency reported as one shot dose, route reported as injection, a dose of influenza virus vaccine (manufacture unknown) (lot#, expiration date, dose, frequency, route and indication not reported) and a dose of PNEUMOVAX 23 (lot#, expiration date, dose frequency, route and indication not reported) at the same time by the pharmacist manager. She first injected the patient in an unspecified arm with influenza virus vaccine (manufacture unknown). Then in the same arm, the patient was injected with ZOSTAVAX (but not in the same injection site as influenza virus vaccine (manufacture unknown)). Then on the other arm, the patient was injected the PNEUMOVAX 23. On the same day, on the arm that was injected with the influenza virus vaccine (manufacture unknown) and the ZOSTAVAX, the patient developed an injection site reaction or the patient already had a rash there previously and now it had worsened because of the vaccines being given. The patient sought medical attention and spoken with the pharmacist. The outcome was unknown. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient. On 07-SEP-2013 the patient was vaccinated with a dose GARDASIL (lot #, expiration, dose and route unspecified) instead of PEDVAXHIB. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a currently approximately 38 years old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dosage, dose number and lot number unknown). The nurse stated the patient was less than 60 years old. No adverse effects reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Nerve injury, Throat irritation
Clinical narrative: Case number PHHY2013US097652 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 495856) on 05 Sep 2013, with a follow up report received from the Quality Assurance department (QA ref: 251531) on 14 Oct 2013: This report refers to a 39-year-old female patient. The patient was on no other prescriptions for anything and was healthy prior to receiving vaccine. No prior adverse reactions to any vaccines were reported. She was vaccinated with FLUVIRIN (batch number: 11074P) intramuscularly in to the right arm on 17 Oct 2011. On the same date, immediately after vaccination, she experienced itchy throat and reddening of entire arm. She was sent to the employee health, then immediately to Emergency Room (ER) where "IV" (unspecified) was administered to counteract the effects. This caused cellulitis and subsequent persistent blood clots from wrist to crease in the forearm. Inability to diffuse blood clots with several rounds of daily injectable blood thinners caused permanent left arm nerve damage as verified by two doctors, one of them was an independent doctor for the hospital. The health authority assessed the seriousness of this case was permanent disability. Final outcome of the events was reported as not yet recovered as on 03 Jul 2013. Causality of the events was not assessed. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 11074P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 14 Oct 2013: Updated batch review report.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Thrombosis
Clinical narrative: Case number PHHY2013US097652 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 495856) on 05 Sep 2013, with a follow up report received from the Quality Assurance department (QA ref: 251531) on 14 Oct 2013: This report refers to a 39-year-old female patient. The patient was on no other prescriptions for anything and was healthy prior to receiving vaccine. No prior adverse reactions to any vaccines were reported. She was vaccinated with FLUVIRIN (batch number: 11074P) intramuscularly in to the right arm on 17 Oct 2011. On the same date, immediately after vaccination, she experienced itchy throat and reddening of entire arm. She was sent to the employee health, then immediately to Emergency Room (ER) where "IV" (unspecified) was administered to counteract the effects. This caused cellulitis and subsequent persistent blood clots from wrist to crease in the forearm. Inability to diffuse blood clots with several rounds of daily injectable blood thinners caused permanent left arm nerve damage as verified by two doctors, one of them was an independent doctor for the hospital. The health authority assessed the seriousness of this case was permanent disability. Final outcome of the events was reported as not yet recovered as on 03 Jul 2013. Causality of the events was not assessed. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 11074P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 14 Oct 2013: Updated batch review report.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Disability, Erythema, Immediate post-injection reaction, Nerve injury
Clinical narrative: Case number PHHY2013US097652 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 495856) on 05 Sep 2013, with a follow up report received from the Quality Assurance department (QA ref: 251531) on 14 Oct 2013: This report refers to a 39-year-old female patient. The patient was on no other prescriptions for anything and was healthy prior to receiving vaccine. No prior adverse reactions to any vaccines were reported. She was vaccinated with FLUVIRIN (batch number: 11074P) intramuscularly in to the right arm on 17 Oct 2011. On the same date, immediately after vaccination, she experienced itchy throat and reddening of entire arm. She was sent to the employee health, then immediately to Emergency Room (ER) where "IV" (unspecified) was administered to counteract the effects. This caused cellulitis and subsequent persistent blood clots from wrist to crease in the forearm. Inability to diffuse blood clots with several rounds of daily injectable blood thinners caused permanent left arm nerve damage as verified by two doctors, one of them was an independent doctor for the hospital. The health authority assessed the seriousness of this case was permanent disability. Final outcome of the events was reported as not yet recovered as on 03 Jul 2013. Causality of the events was not assessed. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 11074P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 14 Oct 2013: Updated batch review report.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat irritation, Thrombosis
Clinical narrative: Case number PHHY2013US097652 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 495856) on 05 Sep 2013, with a follow up report received from the Quality Assurance department (QA ref: 251531) on 14 Oct 2013: This report refers to a 39-year-old female patient. The patient was on no other prescriptions for anything and was healthy prior to receiving vaccine. No prior adverse reactions to any vaccines were reported. She was vaccinated with FLUVIRIN (batch number: 11074P) intramuscularly in to the right arm on 17 Oct 2011. On the same date, immediately after vaccination, she experienced itchy throat and reddening of entire arm. She was sent to the employee health, then immediately to Emergency Room (ER) where "IV" (unspecified) was administered to counteract the effects. This caused cellulitis and subsequent persistent blood clots from wrist to crease in the forearm. Inability to diffuse blood clots with several rounds of daily injectable blood thinners caused permanent left arm nerve damage as verified by two doctors, one of them was an independent doctor for the hospital. The health authority assessed the seriousness of this case was permanent disability. Final outcome of the events was reported as not yet recovered as on 03 Jul 2013. Causality of the events was not assessed. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 11074P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 14 Oct 2013: Updated batch review report.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative concerning a 71 year old female patient who on 18-SEP-2013 was vaccinated with one dose of ZOSTAVAX, 0.65 ml, subcutaneous (dose and lot # not provided). The pharmacist stated that next day on 19-SEP-2013 the patient experienced red welt on the back of her left arm at the injection site which was 3 inches in diameter, raised and swelling. Pharmacist noted to the company representative that follow up was made with the patient on 20-SEP-2013, and the swelling and redness had gone done. The outcome of red welt on the back of her left arm at the injection site was unknown. The patient sought medical attention contacting unspecified physician. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative concerning a 71 year old female patient who on 18-SEP-2013 was vaccinated with one dose of ZOSTAVAX, 0.65 ml, subcutaneous (dose and lot # not provided). The pharmacist stated that next day on 19-SEP-2013 the patient experienced red welt on the back of her left arm at the injection site which was 3 inches in diameter, raised and swelling. Pharmacist noted to the company representative that follow up was made with the patient on 20-SEP-2013, and the swelling and redness had gone done. The outcome of red welt on the back of her left arm at the injection site was unknown. The patient sought medical attention contacting unspecified physician. Additional information has been requested.
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Mass
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of AFLURIA, (lot number R55608, expiry date was unknown) intramuscular in the right arm. Other suspect therapies included PNEUMOVAX23 (lot number N010916, expiry date was unknown) intramuscular in the right arm. On an unknown date, about 2 or 3 hours after receiving the vaccine the patient noticed nickel sized pump on left cheek. No other signs were reported. It was not bothering the patient at all. The reporter stated that it was not sure if the event was related to the vaccines. There was no illness at the time of this report. There was no preexisting condition reported. The outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of AFLURIA, (lot number R55608, expiry date was unknown) intramuscular in the right arm. Other suspect therapies included PNEUMOVAX23 (lot number N010916, expiry date was unknown) intramuscular in the right arm. On an unknown date, about 2 or 3 hours after receiving the vaccine the patient noticed nickel sized pump on left cheek. No other signs were reported. It was not bothering the patient at all. The reporter stated that it was not sure if the event was related to the vaccines. There was no illness at the time of this report. There was no preexisting condition reported. The outcome of the event was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4, HPV4
Symptoms: Convulsion, Seizure like phenomena
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 15 year old male patient with BACTRIM allergy and LORTAB allergy. The patient's medical history included one time seizure activity in 3rd grade. On 10-JUN-2013, the patient was vaccinated with first dose of GARDASIL (lot #, dose, and route not provided). On 16-OCT-2013, the patient was vaccinated with second dose of GARDASIL lot # J006236 (dose and route not provided). Concomitant therapies included CONCERTA, LEXAPRO and amoxicillin. Nurse report patient became pale and did not look good right after GARDASIL was administered and he started having seizure like activity which lasted about 45 seconds. After seizure like activity ended, patient was still not completely coherent and was little agitated. Patient was observed in the office and within 30 minutes of administration of GARDASIL, patient came back to normal and was sent home. The patient did not receive any treatment for adverse event. Labs diagnostics were not performed. Patient's brother experienced exactly same reaction and it is reported in (MARRS # 1310USA008417 SR 1-905963156). The outcome of adverse events was reported as recovered on 16-OCT-2013. No additional information provided. Upon internal review the event seizure like activity was considered to be an medically significant event. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4, HPV4
Symptoms: Agitation, Immediate post-injection reaction, Incoherent, Pallor, Seizure like phenomena
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 15 year old male patient with BACTRIM allergy and LORTAB allergy. The patient's medical history included one time seizure activity in 3rd grade. On 10-JUN-2013, the patient was vaccinated with first dose of GARDASIL (lot #, dose, and route not provided). On 16-OCT-2013, the patient was vaccinated with second dose of GARDASIL lot # J006236 (dose and route not provided). Concomitant therapies included CONCERTA, LEXAPRO and amoxicillin. Nurse report patient became pale and did not look good right after GARDASIL was administered and he started having seizure like activity which lasted about 45 seconds. After seizure like activity ended, patient was still not completely coherent and was little agitated. Patient was observed in the office and within 30 minutes of administration of GARDASIL, patient came back to normal and was sent home. The patient did not receive any treatment for adverse event. Labs diagnostics were not performed. Patient's brother experienced exactly same reaction and it is reported in (MARRS # 1310USA008417 SR 1-905963156). The outcome of adverse events was reported as recovered on 16-OCT-2013. No additional information provided. Upon internal review the event seizure like activity was considered to be an medically significant event. Additional information has been requested.
Age: 0.31
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Crying, Depressed level of consciousness, Dysphemia, Fatigue, Food allergy
Clinical narrative: Baby began to cry when the nurse administered the shot, which was expected. After nurse had left the room, mother tried to nurse baby to comfort and calm baby, but baby refused and continued to cry inconsolably. Mother drove child home and child continued to cry and scream inconsolably for approximately 90 minutes, refusing multiple attempts to breastfeed baby. After 90 minutes of crying, baby nursed and fell asleep soundly. Baby continued to sleep upwards of 4 hours. Mother had difficultly waking baby to breastfeed. Baby seemed uncharacteristically tired and sluggish during feedings and fell promptly back into deep sleep. Mother anticipated child would be awake more than usual during night hours as a result of the extensive sleeping after the baby finally calmed down. Baby did not wake on his own (had to be woken for feedings, and was sluggish and slow to respond to stimulus as described) through the entire duration of the night. Baby continued pattern of sleeping very deeply and requiring waking and stimulation to keep awake long enough to feed. Mother contacted Pediatrician due to concerns for baby's inconsolable crying and excessive sleepiness. Mother was informed that baby's 'symptoms' were 'within the range of normal reactions' to a vaccination and that nothing further needed to be done unless baby's symptoms changed or increased in severity. Baby was shown to have a sensitivity to eggs when tested using alternative methods so eggs were not introduced until well after 1 year old, and even then, only small amounts mixed into baked goods such as breads/muffins. At 2.5 years of age, child had a serving of scrambled eggs and within an hour began stuttering severely. Child had never stuttered previously and within 4 hours, stuttering was so severe child would repeat initial sound of the first word of a sentence 6+ times before being able to move onto the next portion of the word. Child was previously developmentally within the normal range for speech prior to this. Mother immediately began to withhold all traces of egg from child's diet and child's stuttering gradually decreased and was completely gone within 10 days. Food allergy to eggs may have been caused by egg protein found in vaccines. Child is still allergic to eggs nearing age 4.
Age: 0.31
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Hypersomnia, Hyporesponsive to stimuli, Screaming, Sluggishness
Clinical narrative: Baby began to cry when the nurse administered the shot, which was expected. After nurse had left the room, mother tried to nurse baby to comfort and calm baby, but baby refused and continued to cry inconsolably. Mother drove child home and child continued to cry and scream inconsolably for approximately 90 minutes, refusing multiple attempts to breastfeed baby. After 90 minutes of crying, baby nursed and fell asleep soundly. Baby continued to sleep upwards of 4 hours. Mother had difficultly waking baby to breastfeed. Baby seemed uncharacteristically tired and sluggish during feedings and fell promptly back into deep sleep. Mother anticipated child would be awake more than usual during night hours as a result of the extensive sleeping after the baby finally calmed down. Baby did not wake on his own (had to be woken for feedings, and was sluggish and slow to respond to stimulus as described) through the entire duration of the night. Baby continued pattern of sleeping very deeply and requiring waking and stimulation to keep awake long enough to feed. Mother contacted Pediatrician due to concerns for baby's inconsolable crying and excessive sleepiness. Mother was informed that baby's 'symptoms' were 'within the range of normal reactions' to a vaccination and that nothing further needed to be done unless baby's symptoms changed or increased in severity. Baby was shown to have a sensitivity to eggs when tested using alternative methods so eggs were not introduced until well after 1 year old, and even then, only small amounts mixed into baked goods such as breads/muffins. At 2.5 years of age, child had a serving of scrambled eggs and within an hour began stuttering severely. Child had never stuttered previously and within 4 hours, stuttering was so severe child would repeat initial sound of the first word of a sentence 6+ times before being able to move onto the next portion of the word. Child was previously developmentally within the normal range for speech prior to this. Mother immediately began to withhold all traces of egg from child's diet and child's stuttering gradually decreased and was completely gone within 10 days. Food allergy to eggs may have been caused by egg protein found in vaccines. Child is still allergic to eggs nearing age 4.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Intensive care
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 84 year old male patient with hypertension and chronic ischemic heart disease. On 08-OCT-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 25/0.5 Y (lot # H014561, expiration date 21-MAR-2014, dose, route not reported in the left arm). Concomitant therapies included FLUZONE in the right arm on 08-OCT-2013. There was no drug reactions/allergies. On 08-OCT-2013, the patient experienced cellulitis of his left arm and later hospitalized in the intensive care unit. The patient sought medical attention via contacted pharmacist. The outcome of the event reported as recovering. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Papule, Peripheral T-cell lymphoma unspecified, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse refers to a 33 year old male patient with no pertinent medical history and no drug reactions/allergies. The nurse reports that her son received two doses of VARIVAX (merck). The first on 24-AUG-2012 and the second on 30-OCT-2012 (dosing information and route were not provided). No concomitant medication. She reports that two weeks after VARIVAX (merck) administration, he developed red, raised, itchy rash on his left pelvic bone which spread down to his peri area, over his right pelvic bone, and began in his axillary region as well. She stated that the papules in the axilla are lighter, a peachy color and look "like chickenpox". The patient was seen at an unspecified clinic on 26-DEC-2012, and was diagnosed with tinea cruris. He was given Nystatin, which was ineffective. On 25-APR-2013 he was given Ketoconazole which was ineffective and a Typhoid vaccine. In May 2013 he was given DIFLUCAN and Clotrimazole, which were ineffective at treating the rash. On 07-OCT-2013 a biopsy was performed and he was diagnosed with subcutaneous T cell lymphoma. He is having a secondary biopsy done and is currently being treated with a "steroidal cream" and they are considering light therapy. The outcome of tinea cruris and T-cell lymphoma was reported as not recovered/not resolved. No reporter causality provided. Upon internal review T-cell lymphoma was considered medically significant. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Subcutaneous biopsy abnormal, Tinea cruris
Clinical narrative: This spontaneous report as received from a nurse refers to a 33 year old male patient with no pertinent medical history and no drug reactions/allergies. The nurse reports that her son received two doses of VARIVAX (merck). The first on 24-AUG-2012 and the second on 30-OCT-2012 (dosing information and route were not provided). No concomitant medication. She reports that two weeks after VARIVAX (merck) administration, he developed red, raised, itchy rash on his left pelvic bone which spread down to his peri area, over his right pelvic bone, and began in his axillary region as well. She stated that the papules in the axilla are lighter, a peachy color and look "like chickenpox". The patient was seen at an unspecified clinic on 26-DEC-2012, and was diagnosed with tinea cruris. He was given Nystatin, which was ineffective. On 25-APR-2013 he was given Ketoconazole which was ineffective and a Typhoid vaccine. In May 2013 he was given DIFLUCAN and Clotrimazole, which were ineffective at treating the rash. On 07-OCT-2013 a biopsy was performed and he was diagnosed with subcutaneous T cell lymphoma. He is having a secondary biopsy done and is currently being treated with a "steroidal cream" and they are considering light therapy. The outcome of tinea cruris and T-cell lymphoma was reported as not recovered/not resolved. No reporter causality provided. Upon internal review T-cell lymphoma was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a consumer refers to a patient (the consumer's friend) of unknown age and gender. On an unknown date in 1991 (about 22 years ago), the patient was vaccinated with a dose of M-M-R II (dose, lot number and route of administration were not reported). On an unknown date the patient experienced seizures. The outcome of seizures was unknown. The relatedness between the seizures and M-M-R II was not reported. Upon internal review the seizures were considered to be medically significant. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Case number PHEH2013US021639 is an initial spontaneous report received from a health care professional on 11 Oct 2013. This report refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number: A1105, expiry date: 30 Apr 2014) at a dose of 0.5 ml intramuscularly on 07 AUG 2013. It was reported that before vaccination, MENVEO vials had reached 32 Fahrenheit on two occasions; therefore, he received MENVEO that went below the recommended temperature range (reporter stated that crystallization might have occurred, which destroyed the vaccine). After vaccination, he complained of injection site reactions and was taken to the clinic. He had increased redness in the arms, hot to touch and pink area of the upper arm that did not help with ibuprofen. Finally he was diagnosed with cellulitis at the injection site, on an unspecified date and was prescribed with BACTRIM. Outcome of the reactions was reported as resolved. No seriousness and causality was reported for the events.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: This spontaneous report as received from a 58 year old male consumer and a pharmacist refers to the patient. The patient had diabetes, a history of having a stroke, triple bypass surgery and an implant in the heart. The patient had no drug allergies. On 24-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot # 0709AE, expiration date 04-JAN-2014) (total daily dose not reported) in the arm. Other suspect therapies included FLUZONE (lot # not reported) (total daily dose not reported) vaccinated in another arm. Concomitant therapies included COUMADIN, insulin pump, cilostazol, furosemide (manufacturer unknown), simvastatin (manufacturer unknown), finasteride (manufacturer unknown), tamsulosin, omeprazole (manufacturer unknown), KLOR-CON, metoprolol, gabapentin, calcium, vitamin D, dapsone, folic acid, Men's Ultravitamin, aspirin (manufacturer unknown), fluticasone and VICODIN. The patient stated that on 25-SEP-2013, he developed red "spot" at the both of the injection sites after receiving the dose of PNEUMOVAX23 on one arm and FLUZONE on the other arm. Both of the red spots disappeared after 2-3 days but the purple mark appeared where he received the PNEUMOVAX23. He still had the purple mark and it seemed to be spreading. He did not feel pain at the purple site. The patient sought for medical attention by seeing the physician. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Mass, Pain
Clinical narrative: Lump pain redness in 1 hour numbness pain persist 10/21/13.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Iritis, Ocular hyperaemia, Ophthalmological examination
Clinical narrative: 24 hrs. post vaccine - bloodshot eyes worsened over next 2 days. Dx - Iritis prescribed eye drops.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372; 1310USA008373, 1310USA008374; 1310USA008375; 1310USA008376; 1310USA008377; 1310USA008378; 1310USA008379; 1310USA008380; 1310USA008381; 1310USA008382; 1310USA008383; 1310USA008384; 1310USA008385; 1310USA008386; 1310USA008388; 1310USA008389; 1310USA008390; 1310USA008391; 1310USA008392; 1310USA008393; 1310USA008394; 1310USA008395; 1310USA008396; 1310USA008397; 1310USA008398; 1310USA008399; 1310USA008400; 1310USA008401; 1310USA008402; 1310USA008403; 1310USA008404; 1310USA008405; 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372; 1310USA008373, 1310USA008374; 1310USA008375; 1310USA008376; 1310USA008377; 1310USA008378; 1310USA008379; 1310USA008380; 1310USA008381; 1310USA008382; 1310USA008383; 1310USA008384; 1310USA008385; 1310USA008386; 1310USA008387; 1310USA008389; 1310USA008390; 1310USA008391; 1310USA008392; 1310USA008393; 1310USA008394; 1310USA008395; 1310USA008396; 1310USA008397; 1310USA008398; 1310USA008399; 1310USA008400; 1310USA008401; 1310USA008402; 1310USA008403; 1310USA008404; 1310USA008405; 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372; 1310USA008373, 1310USA008374; 1310USA008375; 1310USA008376; 1310USA008377; 1310USA008378; 1310USA008379; 1310USA008380; 1310USA008381; 1310USA008382; 1310USA008383; 1310USA008385; 1310USA008386; 1310USA008388; 1310USA008389; 1310USA008390; 1310USA008391; 1310USA008392; 1310USA008393; 1310USA008394; 1310USA008395; 1310USA008396; 1310USA008397; 1310USA008398; 1310USA008399; 1310USA008400; 1310USA008401; 1310USA008402; 1310USA008403; 1310USA008404; 1310USA008405; 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372; 1310USA008373, 1310USA008374; 1310USA008375; 1310USA008376; 1310USA008377; 1310USA008378; 1310USA008379; 1310USA008380; 1310USA008381; 1310USA008382; 1310USA008383; 1310USA008384; 1310USA008385; 1310USA008387; 1310USA008388; 1310USA008389; 1310USA008390; 1310USA008391; 1310USA008392; 1310USA008393; 1310USA008394; 1310USA008395; 1310USA008396; 1310USA008397; 1310USA008398; 1310USA008399; 1310USA008400; 1310USA008401; 1310USA008402; 1310USA008403; 1310USA008404; 1310USA008405; 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372; 1310USA008373, 1310USA008374; 1310USA008375; 1310USA008376; 1310USA008377; 1310USA008378; 1310USA008379; 1310USA008380; 1310USA008381; 1310USA008382; 1310USA008384; 1310USA008385; 1310USA008386; 1310USA008387; 1310USA008388; 1310USA008389; 1310USA008390; 1310USA008391; 1310USA008392; 1310USA008393; 1310USA008394; 1310USA008395; 1310USA008396; 1310USA008397; 1310USA008398; 1310USA008399; 1310USA008400; 1310USA008401; 1310USA008402; 1310USA008403; 1310USA008404; 1310USA008405; 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On unknown dates the patient was vaccinated with GARDASIL. On 07-OCT-2013 ("now") the patient was is the office to receive a third dose of GARDASIL which was off-schedule. No adverse events were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with codeine allergy. On 10-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J004267, expiration date: 12-JUL-2014, subcutaneously. (dose not reported). Concomitant medications included "unspecified number of medications". On 11-OCT-2013, patient experienced silver dollar size rash around injection site which was painful, swollen, warm to touch and tender. The patient called pharmacy. No treatment was given for the events. No laboratory diagnostics studies performed. The outcome the events was reported as recovering. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 58 year old male patient. On 08-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot#, dose and frequency not reported), subcutaneous. The treating physicians office manager explained that on 09-OCT-2013 the patient developed redness at the injection site after receiving ZOSTAVAX. The outcome of the event was reported as recovering/resolving. The patient had sought medical attention by office visit. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a 23 years old female patient with none medical history and no drug reactions/allergies refers to herself. On 11-OCT-2013 the patient was vaccinated with the first dose of GARDASIL dose, route and lot # not provided. There were no concomitant medication. The patient was 18 weeks pregnant at the time of vaccination. The patient's doctor was aware that she was pregnant. The estimated last menstrual period (LMP) was 24-MAY-2013, the date of conception 07-JUN-2013 and estimated due date (EDD) 28-FEB-2014. The pregnancy outcome was outcome pending. On an unknown date in October 2013, after receiving GARDASIL, the patient experienced pain in stomach. The patient sought medical attention by her doctor's visit. There were no lab diagnostics performed. There was no treatment given. The outcome of pain in stomach was unknown. The relatedness between pain in stomach and GARDASIL was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot # and indication not reported). On an unknown date the patient lost his hair after having had GARDASIL. The outcome of lost his hair was unknown. The patient spoke with the FDA for medical attention. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old patient. On 11-JUL-2013, the patient was vaccinated with first dose of ROTATEQ (lot number, expiry date and route was unknown). On 14-SEP-2013, the patient was vaccinated with second dose of ROTATEQ (lot number, expiry date and route was unknown). No adverse symptoms reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse refers to some patients (also reported as female) of unknown demographics. On an unknown date the patients were vaccinated with doses of GARDASIL (lot#, expiration date and route not reported) after an interruption in the GARDASIL vaccination schedule. On an unknown date the patients complained of "burning and that the injection site hurts". The outcome of the events were unknown. The patients sought medical attention as these events happened in the office. Causality was not reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: PNC13
Symptoms: Convulsion
Clinical narrative: Had seizures.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367,  1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399,1310USA008400,  1310USA008401, 1310USA008402, 1310USA008403,1310USA008404,  1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient had suffered from recurring shingles outbreaks. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). On an unknown date, the patient experienced another outbreak of shingles. The outcome of outbreak of shingles was unknown. The relatedness between adverse event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients (also reported as female) of unknown demographics. On an unknown date the patients were vaccinated with doses of GARDASIL (lot#, expiration date and route not reported) after an interruption in the GARDASIL vaccination schedule. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker who reported that approximately 71 individuals had been administered expired ZOSTAVAX vaccine, Lot # H011430, Expiration 12-SEP-2013 (dose and route were unknown), between the dates of 13-OCT-2013 and 15-OCT-2013. There were no reported adverse effects to any patient. The patients did not sought medical attention. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a office manager(registered nurse) refers to a 28 year old male patient. On  an unknown date the patient was supposed to receive PNEUMOVAX23, but accidentally received GARDASIL instead. Lot# and administration route were not reported. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with allergy to B12 and B6. On 09-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J005719, expiration date 13-AUG-2014 0.65 ml one dose, subcutaneous in the arm). There were no oncomitant medication. On 11-OCT-2013, the patient experienced itching, swelling, a hard knot and redness at the injection site area but was also spreading around and back of the patient's arm. The patient also experienced a fever and one blister that popped up near the patient's wrist in the same arm where ZOSTAVAX injection was received. The patient was given cold compress, hydrocortisone ointment and ALLEGRA for treatment. No lab diagnostics studies performed. The patient sought medical attention via contact pharmacist. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with allergy to B12 and B6. On 09-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J005719, expiration date 13-AUG-2014 0.65 ml one dose, subcutaneous in the arm). There were no oncomitant medication. On 11-OCT-2013, the patient experienced itching, swelling, a hard knot and redness at the injection site area but was also spreading around and back of the patient's arm. The patient also experienced a fever and one blister that popped up near the patient's wrist in the same arm where ZOSTAVAX injection was received. The patient was given cold compress, hydrocortisone ointment and ALLEGRA for treatment. No lab diagnostics studies performed. The patient sought medical attention via contact pharmacist. The outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Over a year ago, on an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB 10 (dose, route and lot number were not reported). In approximately September 2013 (about one month ago), the patient received the second dose of RECOMBIVAX HB 10 (dose, route and lot number were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1310USA009449 via same reporter link. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. On 09-OCT-2013 the patient was vaccinated with ZOSTAVAX vial (subcutaneous, dosage unknown, lot # J004267 exp 12-JUL-2014). On 10-OCT-2013, the patient reported a silver dollar size rash around injection site, which is painful, swollen, tender and warm to the touch. The patient sought for medical attention (called pharmacy). No lab diagnostics studies were performed. The outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Registered nurse reported that on unknown dates, unspecified patients had been administered RECOMBIVAX HB (strength, dose and lot numbers were not reported) outside of the prescribing recommendations. Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1310USA005428 via same reporter link. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Nasal congestion, Paraesthesia, Pyrexia
Clinical narrative: Patient reports onset approximately 3 hours after received vaccine. He had extreme difficulty breathing, chest and nasal congestion, fever of 101-102 degrees F, teeth hurt, tingling sensation on skin, chills 12-13 hours later- patient reports no fever, breathing better, some congestion remains.