chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2012US111817, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 468533) website on 04 Dec 2012 with follow-up received from Quality Assurance department (QA ref: 209816) on 18 May 2014. This report refers to a 46-year-old female patient. The patient had the seasonal flu vaccine for the following years: 2009/10, 2010/11 and 2011/12 and had reactions (unspecified) from flu vaccine. She was vaccinated with FLUVIRIN (batch number: 1205001) intramuscularly to her left arm on 05 Oct 2012. Vaccine was administered at the place of employment. On 09 Oct 2012, four days after vaccination, the patient had an allergic reaction to the flu shot. She was feeling weak, body aches and fainted at the Doctor's office with a blood pressure of 70/40. Her "PCP" recommended hospitalization for those symptoms and including a rash she was developing. It was also reported that the patient was being hospitalized due to reactions. Outcome of the events were reported as not recovered. Based on the investigation performed by the QA department, it was confirmed that FLUVIRIN batch number 1205001 was manufactured in accordance with the effective company procedure and was in compliance with corporate quality requirements. Non-significant follow-up received from QA department on 11 Feb 2013: Updated QA reference number as 209816. Follow-up received from QA department on 18 May 2014: Updated batch review report.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Joint dislocation, Joint swelling, Local swelling, Pain in extremity
Clinical narrative: Case number PHHY2012US116422, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 468597) web site on 04 Dec 2012 with a follow up information received from quality assurance department (reference number: 209813) on 18 May 2014. This report refers to 64 year old male patient. His medical history included pacemaker user and stent insertion, high blood pressure, prostate BPH, depression, liver (very bad liver) and kidney problem. Concomitant medications included NEXIUM, IMDUR, hydrochlorothiazide, CELEXA, PLAVIX, Aspirin, FLOMAX, MTV (multivitamins), fish oil, FERGON, vitamin D and E and Folic acid. He was vaccinated with FLUVIRIN (batch number: 1205301) intramuscularly in to his left arm and PNEUMOVAX (batch number: 0556AE) intramuscularly into his right arm on 08 Oct 2012. On the same day the patient developed painful right arm and cannot move his arm and this happened the night after the shot. His fingers, arms, neck and shoulder were also swollen. He described the pain as 12 on a scale of 1-10. The patient felt like shoulder was dislocated. The patient had to visit the ER due to the events. The outcome of the events was condition unchanged. Seriousness and causality assessment was not reported. Upon follow up received from the quality assurance department (reference number: 209813) on 18 May 2014: Based on batch review performed, it was concluded that the concerned FLUVIRIN (batch number: 1205301) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from quality assurance department on 18 May 2014: Batch summary updated.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope, Urticaria
Clinical narrative: Case number PHHY2012US111648, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 469198) website on 04 Dec 2012 with a follow up report received from the Quality Assurance department (QA reference number: 209996) on 18 May 2014. This report refers to 16 year old male patient. He was allergic to penicillin. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1206701, expiry date: Jun 2013) intramuscularly into right arm on 08 Oct 2012. The patient fainted about 5 minutes after the administration of the flu shot. He was taken to the hospital where he was treated. The next day (about 24 hours later) he broke out in hives and was given a MEDROL dose pack. The final outcome of the events was recovered. Seriousness and causality assessment was not reported. Based on the review performed, it was concluded that this batch of FLUVIRIN, batch no: 1206701 was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 209996): The expiry date of FLUVIRIN, EMEA labeling and the batch review report were updated.
Age: 7.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pneumonia, Pyrexia, White blood cell count increased
Clinical narrative: Case number PHHY2013US000549 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 469633) on 02 Jan 2013 with a follow up report received from the Quality Assurance department (QA reference number: 209503) on 18 May 2014. This case refers to a 07 year old female patient. The patient's medical history included orthotopic heart transplant, pneumonia episodes in the past and asthma. Her concomitant medications included of RAPAMUNE 1 mg/mL oral solution 0.4 milliliters (0.40 mg) by mouth daily, amlodipine besylate (compounded) 1 mg/ml oral 2 milliliters (2 mg) by mouth every 12 hours, FLOVENT HFA 110 mcg/actuation aerosol inhaler 2 puffs twice a day. He was vaccinated with FLUVIRIN (batch number: 1204301, expiry date: 31 May 2013) intramuscularly into her left arm on 11 Oct 2012. On the same day she was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H012650) intramuscularly into her left arm. In the evening of 11 Oct 2012 she had fever of 102.3 degree C. Fever came down to 101 with acetaminophen and got as high as 103.4. On 11 Oct 2012 her WBC level was at 7.3 (no units reported). She was admitted to hospital on 13 Oct 2012 with evidence of pneumonia. On 13 Oct 2012 her WBC level was at 21.8 (no units reported). The seriousness of these events was reported as life threatening. The patient had recovered completely from the events on an unspecified date. The causality was not reported. No other information was available. Based on the review performed, it was concluded that this batch of FLUVIRIN was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 209053) on 18 May 2014: The expiry date, and the batch review report were updated.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary pain, Musculoskeletal pain
Clinical narrative: Case number PHHY2013US097276 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494593) website on 05 Sep 2013 with a follow up report received from the Quality Assurance department (QA reference number: 263430) on 19 May 2014. This report refers to a 53-year-old male patient. His current illness included degenerative joint disease. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 123433) intramuscularly in the left arm on 14 Dec 2012. On 01 Jan 2013 two weeks after vaccination, he developed shoulder and armpit pain. It was reported that the pain was better but not resolved even six months after receiving the shot. The outcome of the events was reported as condition improving as on 19 Jun 2013. The seriousness and causality were not reported. Based on the review performed, it was concluded that this batch of FLUVIRIN was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 263430) on 19 May 2014: The EMEA labeling and the batch review report were updated.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Asthma, Chest X-ray abnormal, Condition aggravated, Feeling abnormal
Clinical narrative: Case number PHHY2014US045973 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 521693) web site on 14 Apr 2014, with the follow-up received from Quality Assurance Department (reference number: 295406) on 21 May 2014. This report refers to a 55 year old female patient. Her current condition included asthma and her concomitant medications included ADVAIR DISKUS at a dose of "100 to 50", FLONASE, ZYRTEC, VENTOLIN when needed, Albuterol sulfate at a dose of 2.5mg via nebulizer and BENADRYL as per need at night at a dose of 1/2 tablet. Her vaccination history included a monovalent influenza vaccine (batch number: not reported) which caused severe wheezing in the past (see case number: PHHY2014US046070). On 17 Feb 2014, she was vaccinated with FLUVIRIN (batch number: 11162401) via intradermal route into left arm. On 24 Feb 2014, her asthma symptoms escalated and maintenance medications could not relieve symptoms. She was unable to rest at night, felt terrible and became weaker while waiting for the next physician appointment. She was taken to emergency room. On 03 Mar 2011, chest X-ray was performed and the nurse (practitioner) told that the findings were consistent with chronic obstructive pulmonary disease (COPD) which was disturbing. On 15 Mar 2011, pulmonary function study was performed and it ruled out the previous diagnosis of COPD. The final outcome of the events was reported as complete recovery. The consumer believed that her asthma reacted to the flu shot and assessed the events as serious due to life threatening condition. Based on the batch investigation performed, QA department stated that, the FLUVIRIN (batch number: 11162401) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 295406) on 21 May 2014: Updated batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pulmonary function test abnormal, Restlessness
Clinical narrative: Case number PHHY2014US045973 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 521693) web site on 14 Apr 2014, with the follow-up received from Quality Assurance Department (reference number: 295406) on 21 May 2014. This report refers to a 55 year old female patient. Her current condition included asthma and her concomitant medications included ADVAIR DISKUS at a dose of "100 to 50", FLONASE, ZYRTEC, VENTOLIN when needed, Albuterol sulfate at a dose of 2.5mg via nebulizer and BENADRYL as per need at night at a dose of 1/2 tablet. Her vaccination history included a monovalent influenza vaccine (batch number: not reported) which caused severe wheezing in the past (see case number: PHHY2014US046070). On 17 Feb 2014, she was vaccinated with FLUVIRIN (batch number: 11162401) via intradermal route into left arm. On 24 Feb 2014, her asthma symptoms escalated and maintenance medications could not relieve symptoms. She was unable to rest at night, felt terrible and became weaker while waiting for the next physician appointment. She was taken to emergency room. On 03 Mar 2011, chest X-ray was performed and the nurse (practitioner) told that the findings were consistent with chronic obstructive pulmonary disease (COPD) which was disturbing. On 15 Mar 2011, pulmonary function study was performed and it ruled out the previous diagnosis of COPD. The final outcome of the events was reported as complete recovery. The consumer believed that her asthma reacted to the flu shot and assessed the events as serious due to life threatening condition. Based on the batch investigation performed, QA department stated that, the FLUVIRIN (batch number: 11162401) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 295406) on 21 May 2014: Updated batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Asthma, Chest X-ray abnormal, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Case number PHHY2014US045973 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 521693) web site on 14 Apr 2014, with the follow-up received from Quality Assurance Department (reference number: 295406) on 21 May 2014. This report refers to a 55 year old female patient. Her current condition included asthma and her concomitant medications included ADVAIR DISKUS at a dose of "100 to 50", FLONASE, ZYRTEC, VENTOLIN when needed, Albuterol sulfate at a dose of 2.5mg via nebulizer and BENADRYL as per need at night at a dose of 1/2 tablet. Her vaccination history included a monovalent influenza vaccine (batch number: not reported) which caused severe wheezing in the past (see case number: PHHY2014US046070). On 17 Feb 2014, she was vaccinated with FLUVIRIN (batch number: 11162401) via intradermal route into left arm. On 24 Feb 2014, her asthma symptoms escalated and maintenance medications could not relieve symptoms. She was unable to rest at night, felt terrible and became weaker while waiting for the next physician appointment. She was taken to emergency room. On 03 Mar 2011, chest X-ray was performed and the nurse (practitioner) told that the findings were consistent with chronic obstructive pulmonary disease (COPD) which was disturbing. On 15 Mar 2011, pulmonary function study was performed and it ruled out the previous diagnosis of COPD. The final outcome of the events was reported as complete recovery. The consumer believed that her asthma reacted to the flu shot and assessed the events as serious due to life threatening condition. Based on the batch investigation performed, QA department stated that, the FLUVIRIN (batch number: 11162401) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 295406) on 21 May 2014: Updated batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Insomnia, Pulmonary function test normal, Restlessness
Clinical narrative: Case number PHHY2014US045973 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 521693) web site on 14 Apr 2014, with the follow-up received from Quality Assurance Department (reference number: 295406) on 21 May 2014. This report refers to a 55 year old female patient. Her current condition included asthma and her concomitant medications included ADVAIR DISKUS at a dose of "100 to 50", FLONASE, ZYRTEC, VENTOLIN when needed, Albuterol sulfate at a dose of 2.5mg via nebulizer and BENADRYL as per need at night at a dose of 1/2 tablet. Her vaccination history included a monovalent influenza vaccine (batch number: not reported) which caused severe wheezing in the past (see case number: PHHY2014US046070). On 17 Feb 2014, she was vaccinated with FLUVIRIN (batch number: 11162401) via intradermal route into left arm. On 24 Feb 2014, her asthma symptoms escalated and maintenance medications could not relieve symptoms. She was unable to rest at night, felt terrible and became weaker while waiting for the next physician appointment. She was taken to emergency room. On 03 Mar 2011, chest X-ray was performed and the nurse (practitioner) told that the findings were consistent with chronic obstructive pulmonary disease (COPD) which was disturbing. On 15 Mar 2011, pulmonary function study was performed and it ruled out the previous diagnosis of COPD. The final outcome of the events was reported as complete recovery. The consumer believed that her asthma reacted to the flu shot and assessed the events as serious due to life threatening condition. Based on the batch investigation performed, QA department stated that, the FLUVIRIN (batch number: 11162401) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 295406) on 21 May 2014: Updated batch review report.
Age: 41.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging, Oropharyngeal pain
Clinical narrative: Case number PHHY2014US046006, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522377) website on 14 Apr 2014, with a follow-up received from Quality Assurance Department (reference number: 295399) on 21 May 2014. This report refers to a 41-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 12261P) on 24 Oct 2012. On 25 Nov 2012, he experienced sore throat and GBS (Guillain-Barre Syndrome). He underwent electromyogram, nuclear magnetic resonance imaging and lumbar puncture tests (results: not provided). The patient was hospitalized due to the events for duration of 60 days (reported as prolonged hospitalization). The outcome of the events was reported as not recovered. The causality of the events was not reported. Based on the batch review report, it was concluded that the concerned FLUVIRIN (batch number: 12261P) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 21 May 2014: Updated batch review report.
Age: 29.0
Sex: M
Vaccine: HEP, MMR, MMR
Symptoms: Blood test, Fatigue, Headache, Rash
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 29 year old male patient with no medical history and no drug reactions. On 25-APR-2014 the patient was vaccinated with a 0.5 ml dose of M-M-R II (lot # J013315, exp date 18-OCT-2015), subcutaneous. There was no concomitant medication. The patient developed widespread lesions on 05-MAY-2014. The patient was evaluated in the office in 07-MAY-2014, and was diagnosed with measles. Blood count ordered was completed on the same day. The patient was prescribed loratadine (manufacturer unknown) and an unspecified topical cream. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: HEP, MMR, MMR
Symptoms: Blood count, Measles post vaccine, Skin lesion
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 29 year old male patient with no medical history and no drug reactions. On 25-APR-2014 the patient was vaccinated with a 0.5 ml dose of M-M-R II (lot # J013315, exp date 18-OCT-2015), subcutaneous. There was no concomitant medication. The patient developed widespread lesions on 05-MAY-2014. The patient was evaluated in the office in 07-MAY-2014, and was diagnosed with measles. Blood count ordered was completed on the same day. The patient was prescribed loratadine (manufacturer unknown) and an unspecified topical cream. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAP, RVX
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report was received from a Nurse via a field representative refers to a 60 year old female patient. The patient's medical history was not reported. On 05-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # not provided), 1 injection, subcutaneous. On 11-MAY-2014, 6 days after the patient was given the vaccine, she presented with paralysis on one side of her face and the appearance of her face seeming "droopy", as described with someone showing the indications of Bell's Palsy. The outcome of the event was not reported. The relationship between the event and ZOSTAVAX was not reported. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: TD, TDAP, VARCEL
Symptoms: Autoimmune thrombocytopenia, Haemorrhagic disorder
Clinical narrative: This spontaneous report as received from a physician refers to a 12 or 13 years old female patient. No pertinent medical history or drug reactions were provided. Concomitant therapies included Tdap (manufacturer unknown) or Td Absorbed. The physician reported that, on an unknown date over 20 years ago, he had an unspecified female patient who received her 1st dose of VARIVAX (Merck) injection (dose, route, lot#, expiry date unspecified) as she required vaccination at that time. It was reported that 2 weeks later she developed an immune thrombocytopenic purpura, ITP and a bleeding disorder. The patient sought medical attention, she contacted physician. The reporter stated that the patient made a full recovery (date unspecified) and was a normal adult at the time of report. Physician also stated that he reported one of the two cases that were documented years ago, concerning this ITP condition after subsequent administration of VARIVAX (Merck) (date not provided). No other information was provided for the other case. Physician stated that he reported this incident over 20 years ago, but he was unable to find documentation. Upon internal review the immune thrombocytopenic purpura was considered to be medically significant. The relatedness between event and VARIVAX (Merck) was unknown. This is the one of several report received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and minor swelling at site.
Sex: U
Vaccine: VARCEL
Symptoms: Autoimmune thrombocytopenia
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, over 20 years ago the patient was vaccinated with a subsequent dose of VARIVAX (Merck) (dose, strength, route, lot # and expiry date not reported). On an unknown date, after receiving VARIVAX (Merck) the patient experienced ITP (Immune thrombocytopenic purpura). The outcome of the event was unknown. The relatedness between the event and VARIVAX (Merck) was not reported. Upon internal review the immune thrombocytopenic purpura was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.48
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of the left thigh around the vaccination site.
Sex: U
Vaccine: HPV4
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. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 17-MAR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 month old male patient. On 07-FEB-2014 the patient was vaccinated with LIQUID PEDVAXHIB dose 2. The nurse reported that the patient received LIQUID PEDVAXHIB that was improperly stored and was determined in to be unsupported by in-house stability. Nurse also reported that the patient received the first dose of LIQUID PEDVAXHIB on 06-DEC-2013. It was reported that the patient needs to be revaccinated for his second dose. No adverse symptoms were reported. No PQC. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 01-APR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a nurse refers to a 46 year old female patient. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. The nurse stated that the patient was incorrectly vaccinated today (on 07-MAY-2014). The nurse stated that she reconstituted the M-M-R II (lot # 1505AA, batch #H018945; expiration date 21-MAR-2015, also reported as 18-OCT-2014) and the MENVEO and then mixed them together in the same syringe and administered it to the patient, in her left arm (route of administration was not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via field employee refers to a male patient about 50 years old. On an unknown date the patient was vaccinated with ZOSTAVAX (dose not reported, one single shot). No concomitant medications were reported. On an unknown date the patient developed mild case of shingles. The outcome of the event was unknown. The patient sought medical attention - saw the doctor. It was not reported if the patient was given a treatment for the event. The relatedness between mild case of shingles and ZOSTAVAX was not reported. This report is linked with a case MARRS#1405USA008299 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via field employee refers to a female patient about 80 years old. On an unknown date the patient was vaccinated with ZOSTAVAX (dose not reported, one single shot). No concomitant medications were reported. On an unknown date the patient developed mild case of shingles. The outcome of the event was unknown. The patient sought medical attention - saw the doctor. It was not reported if the patient was given a treatment for the event. The relatedness between mild case of shingles and ZOSTAVAX was not reported. This report is linked with the case MARRS#1405USA007471 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. The patient was vaccinated with PNEUMOVAX 23 (dose, route and site of administration not reported) lot # H014283 and expiration date 17-APR-2014 on 01-MAY-2014. There was no adverse reaction reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified numbers of patients of unknown demographics. On an unknown date an unspecified number of patients may have received PNEUMOVAX 23. The PNEUMOVAX 23 was exposed to 47 F for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011937, 1405USA011938 and 1405USA009508 (same reporter link). Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Discomfort, Dizziness, Gait disturbance
Clinical narrative: Weak, dizzy, sleepy, body overall discomfort. Got worse over time. Slept 14 hours and stumbled around and just rested for that day. Next day woke with severe back pain like shingles probably feels. Suffered greatly. Heat on back helped reduce terrible pain. After about 60 hours from time of shot symptoms diminished mostly.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersomnia, Somnolence
Clinical narrative: Weak, dizzy, sleepy, body overall discomfort. Got worse over time. Slept 14 hours and stumbled around and just rested for that day. Next day woke with severe back pain like shingles probably feels. Suffered greatly. Heat on back helped reduce terrible pain. After about 60 hours from time of shot symptoms diminished mostly.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Fatigue, Pyrexia, Somnolence
Clinical narrative: Significant fatigue, low fever, required 2 days away from work to sleep (have never had this type or degree of reaction before).  Significantly impaired ability to perform normal daily tasks.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients may have received GARDASIL. The GARDASIL was exposed to 47 F for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011939, 1405USA011938 and 1405USA009508 (same reporter link). 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 health care worker refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients may have received MMR II. The MMR II was exposed to 47 F for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011937, 1405USA011938 and 1405USA011939 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. The patient was vaccinated with PNEUMOVAX 23, (dose, route and site of administration not reported) lot # H014283 and expiration date 17-APR-2014 on 05-MAY-2014. There was no adverse reaction reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients may have received PEDVAXHIB. The PEDVAXHIB was exposed to 47 F for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011939, 1405USA011937 abd 1405USA009508 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 02-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 14-MAR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 04-APR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA0082972, 1405USA008203, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or alleriges were not specified. On 02-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, one, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982).
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 63 year old patient. On 14-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # J013451, Expiry: 24-JAN-2015, 0.65 ml, subcutaneous. The pharmacist reported that post vaccination he asked about the history of shingles. The patient reported that he/she has shingles now. It was also reported that there is no adverse effects. The outcome of shingles was unknown. The causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient (demographic data not provided). On 16-MAY-2014, the patient was vaccinated improperly stored dose of RECOMBIVAX HB (thimerosal status: not provided) (lot #, expiration date: unspecified). No adverse events were reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Swelling, Tenderness
Clinical narrative: Tdap 5/19, 5/20 now lge, red and hard. 5/31 reddened tender swollen 50 x 76 mm.
Age: 32.0
Sex: F
Vaccine: FLUX, HEPAB, HIBV, IPV, PNC13, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, heat, hardness at injection site on Right arm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Convulsion, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient received TDAP AND meningococcal vaccines. Waited for 15 minutes after vaccine. Pt was fine when released. Mother discussing insurance with facility workers and suddenly pt fell back/fainted. His skin became pale and his body became stiff. It seemed as if he may have had a brief seizure for about 10-15 seconds (maybe shorter) (the parent seemed to think he was also having a seizure), and he then started to become conscious again. Once conscious the pt felt weak, but knew his surroundings, name, dob etc. He then was taken to the School Nurse for further evaluation. When falling, the student did seem that he may have hit his head on the wall when falling backward. Vaccines administered at a prescheduled school vaccination event. LVN was present as well as School Nurse, and three Medical Assistants to assist with incident.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Patient received TDAP AND meningococcal vaccines. Waited for 15 minutes after vaccine. Pt was fine when released. Mother discussing insurance with facility workers and suddenly pt fell back/fainted. His skin became pale and his body became stiff. It seemed as if he may have had a brief seizure for about 10-15 seconds (maybe shorter) (the parent seemed to think he was also having a seizure), and he then started to become conscious again. Once conscious the pt felt weak, but knew his surroundings, name, dob etc. He then was taken to the School Nurse for further evaluation. When falling, the student did seem that he may have hit his head on the wall when falling backward. Vaccines administered at a prescheduled school vaccination event. LVN was present as well as School Nurse, and three Medical Assistants to assist with incident.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised
Clinical narrative: Generalized rash for 2 days (possible generalized vaccinia). Not itchy but bumpy. No treatment given. Reassurance that the patient is ok.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient got a fever.  At school on 05/23/2014 the fever went up to 102.1.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Convulsion, Dizziness, Musculoskeletal stiffness, Syncope
Clinical narrative: Pt received Tdap and Meningococcal vaccines. Pt felt dizzy and weak almost immediately after receiving injections. Pt remained seated and was monitored for 15 minutes or more. Once the pt was feeling better, she was released. Once released, she tool about 5-7 steps and fainted. When fainting occurred, the pts body became stiff, and seemed she may have had some brief seizure activity. She was attended to by the LVN who administered the vaccines, as well as assessed by the School Nurse. Once the student became fully conscious she was taken by wheel chair to the School Nurse's office, where she remained until released by school officials.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 15-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (dose, frequency, lot # not reported) which temperature fell outside the temperature parameters in the prescribing information, but was supported by in house stability data. There was no adverse effects and PQC reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with VAQTA (dose, dosage schedule and route of administration were not provided). On an unknown date VAQTA vaccine was improperly stored and administered to unknown number of patients. The vaccine was exposed to 9 degrees C for total of 60 hours. No adverse effects reported. This is one of 5 reports received from the same reporter (case # 1405USA006316, 1405USA009350, 1405USA009348, 1405USA009347). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness felt at injection site in evening on 04/03/14. Then noticed redness at site injection site approximately size of a half dollar. No other symptoms as of yet.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Aphagia, Discomfort, Headache, Nausea, Pyrexia
Clinical narrative: The severity of headache increased following the vaccinations, mild nausea (unable to eat dinner evening of vaccinations) also stated fever was present. Client may have received OTC pain reliever medicine on 5/21/14, unknown. Family memebers instructed client to rest. Upon awakening the morning of 5/22/2014, client felt warm to the touch (no thermometer to measure temp) and unable to eat, still c/o of severe headache; clt received 200 mg ibuprofen client stayed home from school on 5/22/2014. On 5/23/2014, client still complaining of headache but of lesser intensity; fever has subsided related to use of fever reducing medication; client missed a second day of school. No report on whether appetite returned; on Right arm 4 inch diameter swelling that is red and blotchy in appearance; that area is warm to the touch. Left arm only has mild discomfort if touched. Client has not sought other medical attention at this point.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Rash macular, Skin warm, Swelling
Clinical narrative: The severity of headache increased following the vaccinations, mild nausea (unable to eat dinner evening of vaccinations) also stated fever was present. Client may have received OTC pain reliever medicine on 5/21/14, unknown. Family memebers instructed client to rest. Upon awakening the morning of 5/22/2014, client felt warm to the touch (no thermometer to measure temp) and unable to eat, still c/o of severe headache; clt received 200 mg ibuprofen client stayed home from school on 5/22/2014. On 5/23/2014, client still complaining of headache but of lesser intensity; fever has subsided related to use of fever reducing medication; client missed a second day of school. No report on whether appetite returned; on Right arm 4 inch diameter swelling that is red and blotchy in appearance; that area is warm to the touch. Left arm only has mild discomfort if touched. Client has not sought other medical attention at this point.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blood glucose increased, Computerised tomogram, Dizziness, Fall, Laceration
Clinical narrative: Patient complained of sore arm.  Went into the bathroom and did not feel well.  Got lightheaded and dizzy and then fell. Patient called an ambulance and went to the ER. Patient has a small laceration on her forhead and her right arm continues to be sore.  Patient was admitted to the hospital for observation.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Malaise, Pain in extremity, White blood cell count increased
Clinical narrative: Patient complained of sore arm.  Went into the bathroom and did not feel well.  Got lightheaded and dizzy and then fell. Patient called an ambulance and went to the ER. Patient has a small laceration on her forhead and her right arm continues to be sore.  Patient was admitted to the hospital for observation.
Age: 1.26
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Mother states redness, tenderness, and irritation started on left outer thigh where vaccines were given. Mother states increased in last 3 days. Seen today and put on antibiotics, instructed to do warm compresses, go to ER if worsening symptoms and return to clinic in 1 week for re-evaluation.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Anion gap, Band neutrophil percentage increased, Blood chloride normal, Blood potassium increased, Blood sodium normal
Clinical narrative: Fever, anorexia, weight loss.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Carbon dioxide normal, Decreased appetite, Differential white blood cell count abnormal, Eosinophil percentage increased, Full blood count
Clinical narrative: Fever, anorexia, weight loss.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Lymphocyte percentage, Monocyte percentage increased, Neutrophil percentage decreased, Platelet count normal, Pyrexia
Clinical narrative: Fever, anorexia, weight loss.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Red blood cell morphology normal, Weight decreased
Clinical narrative: Fever, anorexia, weight loss.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus
Clinical narrative: This spontaneous report as received from a male patient of approximately 67 years old referring to himself with high blood pressure and sulfa-antibiotics allergy. On 31-OCT-2012, the patient was vaccinated with ZOSTAVAX, 0.65 ml/one dose, injection. Concomitant therapies included metoprolol and lisinopril. On an unknown date in May 2014 (also reported as week and a half ago), the patient developed shingles on the left side of his face. The shingles was in his mouth, ear, and everywhere else that is on the left side of the face. On an unknown date in May 2014 (also reported as same day he started to develop the shingles), the patient went to the hospital to seek medical attention and was admitted and he was not released until 20-MAY-2014. Patient was treated with unspecified intravenous (IV) antibiotics at the hospital. The patient stated that, pharmacy could be contacted to find the lot information for the ZOSTAVAX. The outcome of shingles on the left side of his face and the shingles is in his mouth, ear, and everywhere else that is on the left side of the face was reported as not recovered. Causality between ZOSTAVAX and the events were not reported. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Anuria, Pyrexia, Vomiting
Clinical narrative: Fever x 2 days, vomiting, did not urinate for 8 hours - seen in ED - No IV fluids, returned to baseline 2-3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Muscle spasms
Clinical narrative: Tuesday- received ZOSTAVAX. 20 minutes after she left, muscle in front of arm started cramping. Arm is swollen (not itching or burning). Still cramping.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching at injection site.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Rubella antibody negative
Clinical narrative: Vaccinated 4/28/14 with MMR after negative rubella titer of 4/17/14. 5/14 Developed ache in both hands and (R) ankle. 5/23 Ache and numbness intermittent persists in both hands.