chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-APR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot#I023386, expiration date 25-JUN-2017, dose and route unknown) and an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 22-APR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot#I023386, expiration date 25-JUN-2017, dose and route unknown) and an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: About four hours after getting the Pneumococcal polysaccharide vaccine, the patient experienced severe pain in her shoulder and had problems moving her arm. This lasted about 24 hours before some relief and could move my arm.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local reaction, Skin warm
Clinical narrative: Large local reaction, redness, induration 9cm, warmth.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 27-APR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot#I023386, expiration date 25-JUN-2017, dose and route unknown) and an improperly stored dose of VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: On 13-APR-2016 the patient was vaccinated with an improperly stored (at 14.9 Celsius degree for 280 hours) doses of VARIVAX (lot# reported as l04688, expiration date 23-NOV-2017, dose and route unknown). There was no out of range before. No adverse events were reported. Lot number l04688 is an invalid lot number for VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-APR-2016 the patient was vaccinated with an improperly stored (at 14.9 Celsius degree for 280 hours) dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 19 patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 17-MAR-2016 an unspecified number of GARDASIL 9 were under 31.1 F for 16 hours without previous temperature excursion. It was because of a data logger and the temperature were back in range. On unknown dates in 2016, the patients were vaccinated with the improperly stored GARDASIL 9 (lot# L019297, expiration date 18-AUG-2017,  route, dose and strength were not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male patient. The patient had no relevant medical history, concomitant medications, or past drug history. About a month ago (in April) in 2016, the patient was vaccinated with ZOSTAVAX (dose, route and lot # unknown) for shingles. On 13-MAY-2016, the patient received another dose of ZOSTAVAX 0.5 mL (lot #L040442, Expiration Date 15-JAN-2017) by mistake. The pharmacist reported the patient hadn't had any adverse reactions. It was unknown if any relevant lab work had been done. As of 13-MAY-2016, it was unknown if the patient would continue on the ZOSTAVAX, and the outcome of receiving another dose by mistake was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Psoriasis
Clinical narrative: This spontaneous report was received from a 72 year old female patient regarding herself. The patient's medical history and concurrent conditions were not reported. On 23-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot # J012660; expiry date: 10-JAN-2015). The patient's concomitant medications included unspecified medications. The patient reported that she experienced an outbreak of psoriasis immediately (unspecified date in OCT-2014) after receiving ZOSTAVAX. No other symptoms were reported. The patient saw physician and treated with unspecified topical cortisone cream. Therapy with ZOSTAVAX was continued. The outcome and causality of the events were not reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Medication error
Clinical narrative: Information has been received from a pharmacist referring to a 38 year old female patient. No relevant medical history or concurrent conditions were reported. On 31-AUG-2015 (reported as 256 days ago), the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). The reporter stated that, according to an unspecified doctor, the titers were not significantly increased (antibody test negative) (event onset date was not reported). The outcome of the event antibody test negative was not reported. Causality between antibody test negative and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. Follow up information has been received from medical assistant on 26-APR-2016 via a phone call. On 14-MAR-2016, patient was vaccinated with improperly stored GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested. Onset date, start date of product, patient demographics and the narrative was updated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L007230, expiry date: 03-SEP-2016) (route, dose# and site of administration not reported). Concomitant medication was not mentioned by the nurse. The vaccine was stored at -2.0 degree Centigrade for a time frame of 12 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. The call was a result of a "data logger". No adverse effects were reported. No additional information was provided. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the three reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L034736, expiry date: 09-DEC-2016) (route, dose# and site of administration not mentioned by the nurse. The vaccine was stored at -2.0 degree centigrade for a time frame of 12 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. The call was a result of a "data logger". No adverse effects were reported. No additional information was provided. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the three reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. Follow up information has been received from medical assistant on 26-APR-2016 via a phone call. On 12-MAR-2016, patient was vaccinated with improperly stored GARDASIL 9 (Therapy type: Digital Data Logger). This is one of several reports received from the same reporter. Additional information has been requested. Onset date, start date of product, patient demographics and the narrative was updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. No concurrent or historical conditions were reported. On or after 27-APR-2016 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L048468, expired date 02-DEC-2017; lot # M000760, expired date 06-JAN-2018) (strength, dose, route unknown). Concomitant medication was not reported. The vaccines were stored under 31F for unspecified duration. No previous temperature excursions. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. The registered nurse reported that the patient had a measles, mumps, and rebella titer drawn on 10-MAY-2016 which showed low immunity to mumps. The nurse was unsure if the patient ever received M-M-R II (strength, dose, route and lot # unknown) prior to the titer. At the time of reporting, the outcome was unknown. The causality was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB intramuscular injection (lot # K018180, expiration date 17-SEP-2017, dose and frequency not provided). The RECOMBIVAX HB was exposed to the following conditions: 34 Fahrenheit (F) for a total time of 65 hours. The previous temperature excursions included 33 F for 13 hours and 47 F for 13 hours. No adverse symptoms reported. This is one of several report received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old male patient. There were no drug reactions/allergies, pertinent medical history and concomitant medication. The patient received unspecified doses of MMR II (strength, dose, route and lot # unknown) as a child at unspecified date. The nurse stated that the patient had titers drawn for MMR II on 23-APR-2013, "which was required for employment" and the titer showed no immunity to rubella or mumps. The nurse stated that the patient was administered a dose of MMR II on 07-MAR-2016 (rHA, lot #K016154, Expiration Date 24-SEP-2016, 0.5ml, subcutaneous) due to the titer showing no immunity to rubella or mumps. The nurse stated that the patient had titers drawn for MMR on 27-APR-2016 and the titer showed that the patient did have immunity to measles, mumps and rubella. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to three patients of unknown age and gender. These patients' medical history and current condition were not reported. On unknown dates all three patients were vaccinated with doses of improperly stored ROTATEQ (lot # L029617 with expiration date as, dose and dose number were unspecified) orally. Concomitant therapy was not reported. The nurse reported that the vaccine was improperly stored at 33 F temperature (temperature excursion) with duration as less than 14 hours. There was no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
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. The patient's concurrent conditions and medical history were not provided. The patient, who completed 3-dose of GARDASIL, inadvertently received another dose of GARDASIL 9 (Lot# L016429, expiry: 09-AUG-2017) on 02-MAY-2016 (dose, route and site of administration not reported). Concomitant medications were not mentioned by the reported. Patient received first dose of GARDASIL on 20-AUG-2008, second dose of 09-DEC-2008 (inappropriate schedule of drug administration) and third dose on 18-NOV-2010 (inappropriate schedule of drug administration) (route, site of administration and lot# not reported). No adverse effects reported. No additional information provided. Product quality complaint was not filed. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) concerning multiple unspecified patients of unknown age and gender. No concomitant condition, medical history and concomitant therapies were reported. On multiple unspecified dates, unspecified doses of (Oka/Merck) VARIVAX (dosage and route not reported) which were improperly stored under 12.5 F for 20 hours were administered to multiple unspecified patients. The lot # of the (Oka/Merck) VARIVAX included: L039093 with expiration date 06-OCT-2017, L048464 with expiration date 02-DEC-2017, L046884 with expiration date 23-NOV-2017. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 17-MAY-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ, orally, lot # K010224, expiration date: 13-MAY-2016, (exact dose was not provided). There were no concomitant medications reported. No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Dyskinesia, Eye movement disorder, Syncope
Clinical narrative: Syncope approximately 2 min after admin. Pt's eyes rolled, mouth wide open, and arms flailed sporadically approximately 15 s. Went to grab phone for 911 or EpiPen. By time returned (about 15 s later), pt began regaining consciousness. Gave pt BENADRYL and monitored for about 45 minutes. Gave OJ and crackers due to pt potentially being hypoglycemic. Full recovery about 20 minutes.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Administered 2nd Hep A vaccine off schedule. Initial vaccine on 4/13/16.
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Lymph node pain, Lymphadenopathy, Nasal congestion, Pain
Clinical narrative: Patient indicates about 2 days after vaccine had onset of swollen tender lymph nodes in back of neck, head and groin. Patient also had stuffy nose and achy, lasted about 1 week. No treatment sought.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red bump on injection site, per patient about 4 cm across.
Age: 18.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified nursing assistant regarding a 18 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. ON 16-MAY-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (dose and route were not reported, lot # M003435, expiration date 19-JUL-2017), that was outside the recommendations per prescribing information. There was no adverse event reported. Additional information is not expected s the reporter did not wish to be contacted.
Age: 37.0
Sex: U
Vaccine: PPV, TDAP
Symptoms: Injection site pain
Clinical narrative: Excessive soreness and tenderness at sight of injection 5 days after administration.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Feeling hot, Local swelling, Pruritus
Clinical narrative: Localized swelling, hot, itchy.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Autism, Disturbance in social behaviour, Pyrexia, Speech disorder
Clinical narrative: Child suffered fever after receiving MMR vaccine. Child thereafter stopped talking or saying his favorite word. Child vocal skills regressed, as did his social behavior.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electroencephalogram abnormal, Infantile spasms, Seizure cluster, Unresponsive to stimuli
Clinical narrative: Not Responsive. Having Convulsions. Prolonged. Clusters.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Chills, Dizziness, Eye swelling, Fatigue
Clinical narrative: Extreme fatigue x 1 week, dizziness, body aches, headache, 3 days after vaccination there were rashes around both eyes with swelling, rash on back of thigh and under arm, GI upset, headache & chills lasting for approximately three days. Still have rash around eyes and nares.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Pain, Rash
Clinical narrative: Extreme fatigue x 1 week, dizziness, body aches, headache, 3 days after vaccination there were rashes around both eyes with swelling, rash on back of thigh and under arm, GI upset, headache & chills lasting for approximately three days. Still have rash around eyes and nares.
Age: 61.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Electromyogram, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Anger, Asthenia, Balance disorder, Blindness, Blood pressure fluctuation
Clinical narrative: Just 7 minutes after vaccine diarrhea started, threw up in the parking lot. Had problems with balance, comprehension, vision loss like glasses don't work, scared to drive. Weak, lost 20-30 pounds. Everything that pt eats tosses it up or has diarrhea, hallucinations, blood pressure issues that couldn't be controlled goes from 60/90 -> 210/126, depressed, very angry/mood swings, can't think. Symptoms worse for first 2 months but have leveled off. Had to start smoking to help bring BP back up. Stopped taking vitamin. Has had 7 doctor visits and 1 ER visit, 2 CAT scans, 4 MRIs, 1 EEG. Quit taking vitamins. Had bad infection on teeth. Teeth loose and had pus pockets so 2 teeth were pulled given azithromycin. 3/18 prescribed CIPRO and then prednisone and then stopped. 4/1 started tamsulosin for enlarged prostate.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Cognitive disorder, Computerised tomogram, Condition aggravated, Depression, Diarrhoea
Clinical narrative: Just 7 minutes after vaccine diarrhea started, threw up in the parking lot. Had problems with balance, comprehension, vision loss like glasses don't work, scared to drive. Weak, lost 20-30 pounds. Everything that pt eats tosses it up or has diarrhea, hallucinations, blood pressure issues that couldn't be controlled goes from 60/90 -> 210/126, depressed, very angry/mood swings, can't think. Symptoms worse for first 2 months but have leveled off. Had to start smoking to help bring BP back up. Stopped taking vitamin. Has had 7 doctor visits and 1 ER visit, 2 CAT scans, 4 MRIs, 1 EEG. Quit taking vitamins. Had bad infection on teeth. Teeth loose and had pus pockets so 2 teeth were pulled given azithromycin. 3/18 prescribed CIPRO and then prednisone and then stopped. 4/1 started tamsulosin for enlarged prostate.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Electroencephalogram, Gingivitis, Hallucination, Impaired driving ability, Loose tooth
Clinical narrative: Just 7 minutes after vaccine diarrhea started, threw up in the parking lot. Had problems with balance, comprehension, vision loss like glasses don't work, scared to drive. Weak, lost 20-30 pounds. Everything that pt eats tosses it up or has diarrhea, hallucinations, blood pressure issues that couldn't be controlled goes from 60/90 -> 210/126, depressed, very angry/mood swings, can't think. Symptoms worse for first 2 months but have leveled off. Had to start smoking to help bring BP back up. Stopped taking vitamin. Has had 7 doctor visits and 1 ER visit, 2 CAT scans, 4 MRIs, 1 EEG. Quit taking vitamins. Had bad infection on teeth. Teeth loose and had pus pockets so 2 teeth were pulled given azithromycin. 3/18 prescribed CIPRO and then prednisone and then stopped. 4/1 started tamsulosin for enlarged prostate.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Mental impairment, Mood swings, Nuclear magnetic resonance imaging, Prostatomegaly, Tobacco user
Clinical narrative: Just 7 minutes after vaccine diarrhea started, threw up in the parking lot. Had problems with balance, comprehension, vision loss like glasses don't work, scared to drive. Weak, lost 20-30 pounds. Everything that pt eats tosses it up or has diarrhea, hallucinations, blood pressure issues that couldn't be controlled goes from 60/90 -> 210/126, depressed, very angry/mood swings, can't think. Symptoms worse for first 2 months but have leveled off. Had to start smoking to help bring BP back up. Stopped taking vitamin. Has had 7 doctor visits and 1 ER visit, 2 CAT scans, 4 MRIs, 1 EEG. Quit taking vitamins. Had bad infection on teeth. Teeth loose and had pus pockets so 2 teeth were pulled given azithromycin. 3/18 prescribed CIPRO and then prednisone and then stopped. 4/1 started tamsulosin for enlarged prostate.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Tooth extraction, Tooth infection, Vomiting, Weight decreased
Clinical narrative: Just 7 minutes after vaccine diarrhea started, threw up in the parking lot. Had problems with balance, comprehension, vision loss like glasses don't work, scared to drive. Weak, lost 20-30 pounds. Everything that pt eats tosses it up or has diarrhea, hallucinations, blood pressure issues that couldn't be controlled goes from 60/90 -> 210/126, depressed, very angry/mood swings, can't think. Symptoms worse for first 2 months but have leveled off. Had to start smoking to help bring BP back up. Stopped taking vitamin. Has had 7 doctor visits and 1 ER visit, 2 CAT scans, 4 MRIs, 1 EEG. Quit taking vitamins. Had bad infection on teeth. Teeth loose and had pus pockets so 2 teeth were pulled given azithromycin. 3/18 prescribed CIPRO and then prednisone and then stopped. 4/1 started tamsulosin for enlarged prostate.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: After having patient to wait 15-20 minutes before leaving, she complained of feeling dizzy. She fainted briefly. The provider reassessed her found no injuries. No treatment required.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (certified medical assistant) refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. The reporter stated that, the patient was inadvertently vaccinated with an expired dose of MMR II lot # K005574, expiry date 17-APR-2016 on 23-APR-2016 (dose, strength, vaccination site, route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 'newborn infant' patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-MAY-2016 at 07:00, the patient was vaccinated with RECOMBIVAX HB lot # L038018, exp. 13-SEP-2017, 0.5 ml, intramuscularly and then another dose of RECOMVIVAX HB lot # L038018, exp. 13-SEP-2017 intramuscularly at 07:45 on 05-MAY-2016 (coded as overdose). There was no adverse event reported. The outcome of the event was not reported. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer, a male patient of unknown age reporting for himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-OCT-2015, the patient was either vaccinated with GARDASIL 9 or GARDASIL, dose 1, intramuscular (dose unknown). The patient could not confirm which vaccine he had received. Approximately in December 2015, the patient had received second dose of vaccination which was after two and half months of receiving first dose (inappropriate schedule of vaccine administered) and the patient had received final dose (dose 3) of vaccination on 14-APR-2016. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to five patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. ON an unknown dates, the patients were vaccinated with improperly stored (temperature minimum 30F, 32.F, 92.5 Hours, because of date logger) GARDASIL, lot# L040459, expiry date 06-APR-2017, (dose, frequency and route of administration not reported). Previous temperature excursion was reported as no. No adverse events reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to eight patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature minimum 30F, 32.7F, 33F, 92.5 hours, because of data logger) RECOMBIVAX HB lot # L019298, expiry date 22-JUN-2017 (dose, frequency and route of administration not reported). Previous temperature excursion was reported as no. No adverse events reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to 6 patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature minimum 30F, 32.7F, 33F, 92.5 Hours, because of data logger) VAQTA lot # L004743, expiry date 01-JUN-2017, (dose, frequency and route of administration not reported). Previous temperature excursion was reported as no. No adverse events reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a back office lead refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JAN-2017, dose reported as 1 mg, intramuscularly, in deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 29 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Patient received a vaccine that was later discovered not to be in range due to equipment malfunction.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Patient received a vaccine that was later discovered not to be in range due to equipment malfunction.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Patient received a vaccine that was later discovered not to be in range due to equipment malfunction.
Age: 4.0
Sex: M
Vaccine: HEP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient presents to Health Department with parents to let nurse evaluate (L) arm. Mother states noted redness about 24 hrs. after vaccine given. (L) upper arm warm to touch and slightly red from top of (L) shoulder to mid arm, parents have given no treatment to child.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Medication error
Clinical narrative: Patient received a vaccine that was later discovered not to be in range due to an equipment malfunction.
Age: 73.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 73 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 13 year old female patient. No pertinent medical history or concurrent conditions were reported. On an unknown date in December 2015, the patient was vaccinated with the second dose of GARDASIL. On an unknown date, the patient experienced hair loss after vaccination. The outcome of hair loss was reported as not recovered. The reporter did not assess the causality of hair loss with GARDASIL. Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 48 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 52 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date 26-JUN-2017, dose reported as 1 mg, intramuscularly, in left deltoid (dose number was not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 46 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information have been requested.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 week old female patient. The patient has no pertinent medical history and drug reactions or allergies. On 25-Mar-2016, the patient was vaccinated with VAQTA lot # L036300, expiration date 04-NOV-2016, 0.5ml, intramuscularly. At the same visit on 25-MAR-2016, the patient received PENTACEL, PREVNAR 13 and ROTATEQ orally (dose, lot# and expiration date were not reported). On 25-MAR-2016, later on the day, the patient experienced a fever, temperature of 100 degrees (units not provided). The patient received Tylenol for the treatment for the experience. There were no lab diagnostic studies performed except body temperature. The outcome of pyrexia was unknown The relatedness between the event and suspect therapies were not reported. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 54 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Testicular disorder
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a male patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. Approximately in 2001 (reported as "15 years ago"), the patient was vaccinated with a dose of M-M-R II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. On an unknown date, the patient experienced an unspecified problem with his testicle. The patient was remitted to an urologist. The outcome of testicular disorder was unknown at the time of this report. The reporter did not provide a causality assessment between the event and therapy with M-M-R II. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received TDAP vaccine in the left arm on the afternoon of 4/25/16. On 4/28/16, patient called complaining of symptoms: redness, swelling, warm to touch, tender to touch, feels like huge knot, entire left arm is very sore. Patient reported symptoms began the morning of 4/27/16. Patient instructed to continue putting ice on arm, take OTC pain medicine for pain and inflammation, and to go to ER if experiencing trouble breathing, swelling in throat, chest pain, confusion, fever, etc. Patient presented to ER late evening of 4/28/16 complaining of pain, swelling, and itching of left arm. ER noted 12x8 cm area of redness and swelling. Patient did not have fever or other indication of cellulitis/infection. Patient discharged home and instructed to take cetirizine and avoid TDAP in the future. Swelling, Erythema, Pruritus.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: Patient received TDAP vaccine in the left arm on the afternoon of 4/25/16. On 4/28/16, patient called complaining of symptoms: redness, swelling, warm to touch, tender to touch, feels like huge knot, entire left arm is very sore. Patient reported symptoms began the morning of 4/27/16. Patient instructed to continue putting ice on arm, take OTC pain medicine for pain and inflammation, and to go to ER if experiencing trouble breathing, swelling in throat, chest pain, confusion, fever, etc. Patient presented to ER late evening of 4/28/16 complaining of pain, swelling, and itching of left arm. ER noted 12x8 cm area of redness and swelling. Patient did not have fever or other indication of cellulitis/infection. Patient discharged home and instructed to take cetirizine and avoid TDAP in the future. Swelling, Erythema, Pruritus.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Client reported nausea, headache, fatigue, and diarrhea starting at 6PM and extending through today. Client reports taking tums and ibuprofen last night with some relief. Reports some improvement today (5/18/2016) but continues to have fatigue and headache.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Dizziness
Clinical narrative: Woke up this morning and was very dizzy and weak.  Mom encouraged fluids, still dizzy and weak, but improving.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, swelling, pain, warmth, not sure of the onset.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Injection site induration, Injection site pain
Clinical narrative: Headache, diffuse body aches, fatigue, malaise, nausea, difficulty sleeping, low grade fevers, chills.  Right arm where vaccine administered painful, swollen and firm.  He has had difficulty moving his right hand.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Insomnia, Malaise, Mobility decreased, Nausea
Clinical narrative: Headache, diffuse body aches, fatigue, malaise, nausea, difficulty sleeping, low grade fevers, chills.  Right arm where vaccine administered painful, swollen and firm.  He has had difficulty moving his right hand.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, diffuse body aches, fatigue, malaise, nausea, difficulty sleeping, low grade fevers, chills.  Right arm where vaccine administered painful, swollen and firm.  He has had difficulty moving his right hand.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Dizziness, Ear pain
Clinical narrative: Dizziness, headache with pain into left ear, diarrhea with upset stomach and no appetite.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Full blood count normal, Headache, Metabolic function test, Urine analysis normal
Clinical narrative: Dizziness, headache with pain into left ear, diarrhea with upset stomach and no appetite.
Age: 0.85
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: Fever over 100 degrees, no desire to eat.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dyskinesia, Eye movement disorder, Heart rate decreased, Hyperhidrosis, Pallor
Clinical narrative: Patient experienced syncope with jerky movements of arms and eye rolling reported by mother. Patient appeared pale and diaphoretic. Vital signs normal; heart rate slightly low, but returned to normal.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient experienced syncope with jerky movements of arms and eye rolling reported by mother. Patient appeared pale and diaphoretic. Vital signs normal; heart rate slightly low, but returned to normal.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Per mother -> red, swollen, softball size local allergic reaction to right arm on 5/11 the day vaccines were given. Took BENADRYL and applied ice pack.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Vision blurred
Clinical narrative: Got ZOSTAVAX on Sunday, right eye felt discomfort on Monday 5/16. It felt blurry, pain, discomfort. Did not get better from Mon through Tues. She has history of blepharitis and thinks it may be due to that also. I told her to follow up with her MD.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Pruritus, Rash, Urticaria
Clinical narrative: Patient received vaccine on 03/23/2016 at CBOC. He called CBOC reporting symptoms and presented for nursing appointment on 3/25.  Rash, Urticaria, Pruritus and Diarrhea.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness to site with warmth. Tender to palpation full range of motion. No fever chills or vomiting. Redness localized to injection site with no streaking
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient got vaccines Tdap and MCV4#1 on right arm at his 11 year well child check on 05/16/2016. Called office 05/18/2016 morning to report that arm had been swollen and red. No fever or other symptoms, just arm pain and redness/soreness. Patient was seen at clinic on 05/18/2016 by Doctor and diagnosed with cellulitis. He was placed on antibiotics Cephalexin for 10 days.