chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: Swelling, hard lump at the sight of injection. Bright red circle rash 2 by 3 inches, with a second lighter red circle rash 6 by 6 inches. Itching at sight.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Urticaria
Clinical narrative: Hives on the face and headache.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Somnolence, Tremor
Clinical narrative: During administration pt became shaken, pale and drowsy. Parents indicated reaction to sight of blood/injections. Pt recovered after 1-2 min, but was kept in lobby for 10 min for observation before being released to parents.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Injection site reaction which include pain, redness, swelling and hard lump.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Injection site reaction which include pain, redness, swelling and hard lump.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Pt. complaining of a red swollen arm.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (Lot # not reported), injection, single standard dose (dose not reported0 for prevention of shingles. No other co suspects were reported. No concomitant therapy was reported. The patient reported that shortly after the administration of ZOSTAVAX and the following day, the patient experienced a low-grade fever, body aches and chills. By the second morning following administration, these symptoms had resolved. No rash or blisters occurred. Treatment was not given for the events. The patient sought medical attention, she saw the physician. The outcome of the patient experienced chills, the patient experienced low grade fever and body aches was reported as recovered/resolved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Pt complaining of red mark on her arm.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Pt. complaining of red mark on arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction, Pain in extremity
Clinical narrative: Pt presented with a bright red localized reaction on left upper arm and stated her arm was causing her pain.
Age: 0.5
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old infant who received MMR II, VARIVAX (Merck), 0.5 ml, subcutaneous and VAQTA on 09-DEC-2013. No adverse effect reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day following vaccine she developed malaise, myalgias swelling, redness, heat, pain at injection site and fever to 101 orally. The next day neck pain; head pain and cervical and axillary lymphadenopathy. Sx all resolving on day 6.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Malaise, Myalgia, Neck pain, Pyrexia
Clinical narrative: Day following vaccine she developed malaise, myalgias swelling, redness, heat, pain at injection site and fever to 101 orally. The next day neck pain; head pain and cervical and axillary lymphadenopathy. Sx all resolving on day 6.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Day following vaccine she developed malaise, myalgias swelling, redness, heat, pain at injection site and fever to 101 orally. The next day neck pain; head pain and cervical and axillary lymphadenopathy. Sx all resolving on day 6.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a male nurse refers to himself. The patient had no pertinent Medical History and Drug Reactions/Allergies. On 20-JUN-2001, when the patient was 14 year old, the patient was vaccinated with his first dose of VARIVAX (Merck) (lot #, dose and therapy route was unspecified). On 26-OCT-2007, the patient was vaccinated with his second dose of VARIVAX (Merck) (lot # 658407/1176U, Exp date: 24-JUL-2009) 0.5 ml, intramuscularly. Concomitant Medication was not reported. On 19-NOV-2013, the patient had a negative vzv antibody titer with a result of 0.6 (units unspecified). No treatment was given for the events. The outcome of the event was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling at sight of injection.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from an unspecified source regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) lot # J003536, expiration date 25-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination was unknown. Follow-up information was received. The VARIVAX (Merck) was exposed to unknown temperatures for 5 hours during interoffice transport. The patient was revaccinated on an unknown date. No symptoms were reported. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Redness, warmth, and slight firmness in area of vaccination. Tx- Cephalexin 500 mg BID x 100, BENADRYL.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) lot # H006462; expiry date 08-MAR-2014 dose unknown. No concomitant medications were reported. It was reported that VARIVAX (Merck) lot # H006462 was exposed to -2.5C for 252 hours and as was administered to unspecified number of patients. No adverse effects were reported. This case is linked to case # 1312USA011848 and 1401USA000286 (same reporter link). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Self reported flat rash developed 12/28/13. Rash with itching reported on shoulders, neck and trunk. On 1/2/14, pt reports rash has resolved. Denies use of medication or other treatment to rash.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Chills, Erythema, Pyrexia, Tenderness
Clinical narrative: This spontaneous report as received from a nurse refers to approximately a 67 year old patient. The patient concurrent condition included drug reactions/allergies to penicillin. On 13-DEC-2013 the patient was vaccinated with PNEUMOVAX23 lot # J004332, expiry date reported as August 2014, and 0.5 ml once, intramuscular. Concomitant medications included unspecified topical cream. Approximately on December 2013 the patient experienced redness from the elbow up into axillary, it was tender, had chills and low grade fever for 2 days. The patient sought medical attention and contacted the office. The nurse stated that the physician advised patient to use ice and take BENADRYL. The outcome of redness from the elbow up into axillary, it was tender and chills are unknown. The outcome of low grade fever for 2 days was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date the patient was vaccinated with MMRV lot number J005178; expiry date 03-NOV-2014 and lot number J004174; expiry date 08-OCT-2014. No concomitant medications were reported. The nurse reported that MMRV lot number J005178; expiry date 03-NOV-2014 and lot number J005178; expiry date 03-NOV-2014 and lot number J004174; expiry date 08-OCT-2014 was exposed to -2.5C for 252 hours and was administered to unspecified number of patients. No adverse effects were reported. This case is linked to case # 1401USA000286 and 1401USA000288 (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 unspecified number of patients of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose unknown. No concomitant medications were reported. The nurse reported that GARDASIL was exposed to -1.5C for 48 hours and it was administered to unspecified number of patients. No adverse effects were reported. This case is linked to case # 1312USA011848 and 1401USA000288 (same reporter link). Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Hypersensitivity, Pharyngeal oedema
Clinical narrative: Employee was given flu shot by Employee Health nurse.  Employee suffered an allergic reaction 15 minutes after the immunization was given.  She complained of throat starting to swell.  Voice was hoarse.  Employee was given Benadryl 25 mg po at 1725 and Epinephrine 0.3 mg SQ at 1730.  Started feeling better by 1745.  V.S. at 1755 were T. 36.5, BP 149/71, SaO2 100%.  Employee Health physician was in house and came to evaluate.  Ordered repeat Benadryl 25 mg po.  It was given at 1812.  Employee sent home at 1833.  SaO2 99%, P 87, BP 138/80.  Continued to use Benadryl through the night.  Stayed home from work the next day.  Was back to work on Monday with no residual effects.
Sex: F
Vaccine: HEP
Symptoms: Hearing impaired, Visual impairment
Clinical narrative: Vision problems around 1 1/2 months old.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives first developed on turso, spread to back and buttocks, inner thigh, arms and back of hands. Treated with low dose oral steroids for 6 days - during treatment hives subsided but came back after steroids finished.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported RECOMBIVAX HB, (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013. The nurse practitioner reported that GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS # 1401USA000269), 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13 (MARRS#1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13 (MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13 (MARRS# 1401USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 0/25/2013. PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013 (MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 43.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 43 year old patient. On 20-DEC-2013 the patient was vaccinated with PROQUAD (Merck). No concomitant medications were reported. The pharmacist reported that the patient was vaccinated with PROQUAD (Merck) instead of M-M-R on 20-DEC-2013. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 61 year old male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (strength, dose, lot number and expiration date not provided). On an unknown date the patient experienced bilateral diffuse and rash across his upper chest and arms after receiving ZOSTAVAX. The patient sought medical attention - saw the doctor. The outcome of bilateral diffuse and rash across his upper chest and arms was reported as not recovered/not resolved. The relatedness between therapy with ZOSTAVAX and bilateral diffuse and rash across his upper chest and arms was not reported.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a 54 year old male nurse regarding himself. The patient's medical history included migraines. On 30-DEC-2013 the patient was vaccinated with ZOSTAVAX single dose for prevention of shingles. No concomitant medications were reported. On 20-DEC-2013, 1 to 2 hours post vaccination the patient experienced ongoing headache. The outcome of ongoing headache was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 01-APR-2013 the patient was vaccinated with GARDASIL dose 1. No concomitant medications were reported. The patient received dose 2 of GARDASIL lat on 21-OCT-2013 and on 20-DEC-2013 the patient received dose 3 of GARDASIL. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. On 27-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number unknown, expiry date 10-DEC-2013) dose unknown. No concomitant medications were reported. The physician reported that the patient was vaccinated with expired ZOSTAVAX, expired on 10-DEC-2013 on 27-DEC-2013. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse Practitioner, who reproted that GARDASIL, RECOMBIVAX HB, VAQTA, PEDVAXHIB, went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse Practitioner reported that PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013, 1 unspecified patient on 10/25/2013 (MARRS#1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS#1401USA000280). The Nurse Practitioner also reported GARDASIL (Lot#J003727, expiration date 11/07/2015) was administered to 3 unspecified patients on 10/25/13 (MARRS#1401USA000268) and 1 unspecified patient on 10/26/2013 (MARRS#1401USA00027_). VAQTA (Lot#J008090, expiration date 08/23/2105) was administered to 1 unspecified patient on 10/17/2013 (MARRS#1401USA000279) and 1 unspecified patient on 10/25/2013. RECOMBIVAX (Lot#H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013 (MARRS#1401USA000277). PEDVAXHIB (Lot #J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013 (MARRS1401USA000275), 1  unspecified patient on 10/25/2013 (MARRS1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS1401USA000280). No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report has been received from a consumer, who was referring to her husband, currently 74 year old male patient with no drug reactions or allergies. The patient's medical history included heart surgery (date unspecified) and one bout of shingles before getting the shot of ZOSTAVAX (date unspecified). In 2012, reported as sometime in early fall 2012, the patient was vaccinated with ZOSTAVAX vial, (lot #, dose, strength, route, frequency not reported) to prevent shingles. Concomitant therapies included metformin, metoprolol, CRESTOR, ALLOPURINOL, lisinopril (manufacturer unknown) and tamsulosin hydrochloride. It was reported that since getting the vaccine the patient experienced two bouts of Shingles. On an unknown date, soon after getting the vaccine, the patient experienced a bout of shingles. At the to date of the report, reported as right now the patient had a second bout of shingles (adverse events onset date in approximately 2013). It was reported that he had a rash on his stomach and his back. The patient was treated with unspecified medication. The patient was seeking medical attention by visiting physician. No diagnostic laboratory tests were performed. The outcome of first bout of shingles was unknown. The outcome of a second bout was reported as not recovered. Relatedness between the events and ZOSTAVAX was not assessed by the reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with Parkinson's, migraines, penicillin allergy, codeine allergy, darvon allergy and shingles. On an unknown patient had drug allergy or drug reaction with penicillin, codeine, darvon. The patient's medical history included cracked vertebrae from a fall. On 31-DEC-2013 at 9:00 AM, the patient was vaccinated with ZOSTAVAX (dose number, dose units, route, lot number and expiry date unknown) to prevent shingles. It was reported patient was on many unspecified medications. On 31-DEC-2013 by 10:00 AM, the patient experienced headache and it got worse by 2:00pm. She took a hydrocodone bitartrate and acetaminophen (manufacturer not specified). It was also reported that patient did not sought medical attention no treatment was given for adverse event. She feels that it was getting better now, but she still has a headache. The outcome of headache and headache got worse by 2:00pm was reported as not recovered/not resolved. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown demographics. On 26-DEC-2013, the patient was vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneously instead of ZOSTERVAX 19400 PFU as prescribed. No adverse effects were reported. Outcome of the event and causality assessment was not provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 63 year old female patient. On 21-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J011212, expiry date 29-AUG-2014) dose 1, subcutaneous in the right arm. No concomitant medications were reported. On 22-NOV-2013, the patient experienced redness at injection site, warmth at injection site and pain at injection site. The outcome of pain at injection site and warmth at injection site was reported as recovered. It was reported that the patient still had a 2 inch diameter area of redness at the injection site. The outcome of redness at injection site was reported as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. 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 Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse Practitioner, who reproted that GARDASIL, RECOMBIVAX HB, VAQTA, PEDVAXHIB, went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse Practitioner reported that PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013, 1 unspecified patient on 10/25/2013 (MARRS#1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS#1401USA000280). The Nurse Practitioner also reported GARDASIL (Lot#J003727, expiration date 11/07/2015) was administered to 3 unspecified patients on 10/25/13 (MARRS#1401USA000268) and 1 unspecified patient on 10/26/2013 (MARRS#1401USA00027_). VAQTA (Lot#J008090, expiration date 08/23/2105) was administered to 1 unspecified patient on 10/17/2013 (MARRS#1401USA000279) and 1 unspecified patient on 10/25/2013. RECOMBIVAX (Lot#H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013 (MARRS#1401USA000277). No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to an adult patient (exact age not specified). On 01-JUL-2013 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose and lot # not reported). On 30-DEC-2013 the patient was vaccinated with a second dose of RECOMBIVAX HB (dose and lot # not reported). The patient experienced no adverse symptoms. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from an unspecified source regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) (lot# J003221, expiration date 25-MAR-2015 (reported as expiration date of 15-AUG-2015), which had been improperly stored. Follow up information has been received from the nurse who called and stated all patients (who received VARIVAX (Merck) that was exposed to unknown temperatures for 4 hours) have been revaccinated. No symptoms reported. This is one of several reports from the same source (linked MARRS#: 1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA0014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA004866, 1310USA014868, 1310USA015422, 1310USA015165. 1311USA000069. 1310USA015424, 1311USA000058, 1311USA000064, 1311USA000021. 1311USA000020, 1311USA000022. 1310USA015101, 1310USA014853. 1311USA000075, 1310USA004895, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065. 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637. 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000022, 1311USA000002, 1310USA014897, 1309USA011086). Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Community Nursing Services and refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of PROQUAD lot # H021358, expiry date 29-MAY-2014. Dosing information and route of administration were not provided. On an unknown date, the PROQUAD had been stored improperly. Follow up information as received from the nurse who stated that the vaccine was exposed to unknown temperature for 5 hours during interoffice transport and the patient ws revaccinated and no symptoms reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from an unspecified source regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) lot # J003221, expiration date 15-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination is unknown. Follow up information was received from a nurse indicating that the patient had been revaccinated. No symptoms reported. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to an 86 year old female patient. On 20-DEC-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml , intradermal in the right forearm. There were no concomitant medications. Approximately on an unknown date in December 2013 the patient experienced some redness and swelling at the site of administration in the right forearm. The patient sought unspecified medical attention. The physician was called up for follow up. No treatment was provided. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Approximately on an unknown date in December 2013 (reproted as sometime in the last week) the patient was vaccinated with ZOSTAVAX dose unknown. No concomitant medication was reported. Approximately on an unknown date in December 2013 the patient experienced red area that has developed around the injection site. The patient also had reported as well a round the injection site. The outcome of the events was reported as not recovered/not resolved. The patient sought medical attention and called pharmacy. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from an unspecified health professional regarding a patient (demographics unknown), who on an unknown date, was vaccinated with VARIVAX (Merck), lot # J003539, expiration date 25-MAR-2013, which had been improperly stored. Follow up information has been received from the nurse who called and stated all patients (who received VARIVAX (Merck) that was exposed to unknown temperatures for 4 hours) had been revaccinated. No symptoms reported. This is one of several reports received from the same source (linked MARRS#:1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853,  1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268,  1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000032, 1311USA000002, 1310USA014897, 1309USA011086. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported that PEDVAXHIB Lot# J005670, expiration 12/17/2015 was administered to 1 unspecified patient on 10/15/2013 (MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). The Nurse practitioner also reported GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS# 1401USA000269, 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13 (MARRS#1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13 (MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13 (MARRS# 1401USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 0/25/2013. RECOMBIVAX (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013 (MARRS# 1401USA000277). No adverse effects reported. No further information was provided. 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 Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAXHIB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported that PEDVAXHIB Lot# J005670, expiration 12/17/2015 was administered to 1 unspecified patient on 10/15/2013 (MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000276) and 1 unspecified patient on 10/29/2013. The Nurse practitioner also reported GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS # 1401USA000269), 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13 (MARRS#1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13 (MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13 (MARRS# 1401USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 0/25/2013. RECOMBIVAX (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013 (MARRS# 1401USA000277). No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Computerised tomogram head normal, Computerised tomogram normal, Dysaesthesia, Dysstasia
Clinical narrative: Admitted on 12/20/13 with markedly weakened feet/ankles and tingling dysesthesia in same. The patient underwent laparoscopic cholecystectomy on 12/12/13 and received influenza vaccination on the same date prior to DC. The patient developed a cough productive of greenish purulent sputum on 12/20. He reports one other member of his family with an acute URI in the home enviornment. Symptoms: and numbness and tingling in feet, inability to stand. Treatment: Globulin, Immune 72 GM every day.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Face and mouth X-ray normal, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Paraesthesia
Clinical narrative: Admitted on 12/20/13 with markedly weakened feet/ankles and tingling dysesthesia in same. The patient underwent laparoscopic cholecystectomy on 12/12/13 and received influenza vaccination on the same date prior to DC. The patient developed a cough productive of greenish purulent sputum on 12/20. He reports one other member of his family with an acute URI in the home enviornment. Symptoms: and numbness and tingling in feet, inability to stand. Treatment: Globulin, Immune 72 GM every day.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Skin degenerative disorder, Spinal X-ray abnormal, Spinal osteoarthritis, Sputum discoloured
Clinical narrative: Admitted on 12/20/13 with markedly weakened feet/ankles and tingling dysesthesia in same. The patient underwent laparoscopic cholecystectomy on 12/12/13 and received influenza vaccination on the same date prior to DC. The patient developed a cough productive of greenish purulent sputum on 12/20. He reports one other member of his family with an acute URI in the home enviornment. Symptoms: and numbness and tingling in feet, inability to stand. Treatment: Globulin, Immune 72 GM every day.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Licensed Practical Nurse refers to a 28 year old female patient with none drug reactions/allergies. The patient's medical history included adenocarcinoma. On 26-DEC-2013 the patient was inadvertently vaccinated with a dose of GARDASIL, 0.5 ml, intramuscularly. There was none concomitant medications. The patient was pregnant with last menstrual period (LMP) of around 21-JUN-2013 and estimated due date (EDD) of 28-MAR-2014. To confirm pregnancy urine pregnancy test was performed on an unknown date. Initial exposure to GARDASIL was at 27 week(s), also reported that patient was around 28 weeks pregnant. The pregnancy outcome was outcome pending. There were no known drug effects. The patient sought medical attention in the office where she was given GARDASIL. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, Tendonitis
Clinical narrative: Left shoulder pain onset 3 hrs post vaccine admin. Pain radiates to upper arm, neck and posterior shoulder persisting x 2 mos. Doctor suspects tendonitis secondary to local pain from immunization. Referred to Physical Therapy.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information was received from a registered nurse regarding a 46 year old female patient, who on 18-OCT-2013 was vaccinated with M-M-R II, Albumin status HSA, lot #670210/0447AA, expiration date 28-MAR-2013, 0.5 ml, intramuscular. The patient received an expired of M-M-R II on 18-OCT-2013. No adverse effect reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Pt developed blisters around injection site and redness all around the back of her arm. Pt saw dr and they diagnosed it as an injection site drug reaction.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Local swelling, Pain, Rash
Clinical narrative: Raised rash on legs. Swollen feet and hands. Achy body. Doctor advised not to take any further doses.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autism, Rash, Thermal burn
Clinical narrative: Severe burns - skin rash on both sides of cheek.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Pt. noticed tingling in his L arm. Tingling got progressively worse and discussed this with his private physician by phone on 11/18/13. Pt. called health dept. with symptoms 12/20/13.
Age: 0.49
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Seizure like phenomena
Clinical narrative: He had involuntary facial responses for 20 minutes. He looked like he was having a seizure. I took him to the walk-in clinic. They did not report this OR give my pediatrician the information as requested.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Developed redness and swelling at injection site that evening. 12/25 developed fever of 103 degrees, poor appetite and vomiting. Continued to have fever off and on through 12/31 ranging from 101-103. Poor appetite and vomiting only lasted 24 hours. No other symptoms noted. Redness and swelling at site resolved by 12/31.
Age: 86.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Rash
Clinical narrative: Rash (cellulitis) high fever. Hospitalization two days after injection.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature increased, Headache, Injection site infection, Injection site swelling, Local swelling
Clinical narrative: Both FLUVIRIN 0.5ml and PNEUMOVAX 0.5 were administered in the same arm. 24 hours later severe temperature (104 degrees), vomiting, headache, swollen and infected arm where the shot was. Admitted into hospital 48 hours later as fever would not go down. Stayed in hospital for 3 days with fever.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Both FLUVIRIN 0.5ml and PNEUMOVAX 0.5 were administered in the same arm. 24 hours later severe temperature (104 degrees), vomiting, headache, swollen and infected arm where the shot was. Admitted into hospital 48 hours later as fever would not go down. Stayed in hospital for 3 days with fever.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Infection, Local swelling, Pyrexia, Vomiting
Clinical narrative: Both FLUVIRIN 0.5ml and PNEUMOVAX 0.5 were administered in the same arm. 24 hours later severe temperature (104 degrees), vomiting, headache, swollen and infected arm where the shot was. Admitted into hospital 48 hours later as fever would not go down. Stayed in hospital for 3 days with fever.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: After 11 days, the IZ still big purple bruising on the injection site.
Age: 0.77
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Hepatitis A given to early.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Neuralgic amyotrophy
Clinical narrative: Ten days after receiving flu shot, severe pain in left shoulder with limited movement numbness in hands/fingers. Persists as of this date. Physical therapy continuing. Dx Parsonage Turner Syndrome.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Ten days after receiving flu shot, severe pain in left shoulder with limited movement numbness in hands/fingers. Persists as of this date. Physical therapy continuing. Dx Parsonage Turner Syndrome.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt had MMRV on 12/20 with swelling, see dr. At 1217 spoke with mom. Noticed some swelling of pts arm last night. Mom states swelling is large, area is red, larger than an inch. Denies red streaking/fever. Arm is itchy. Bartin Schmitt protocol used, call nurse back if symptoms worsen, and make appointment for today. Barton Schmitt protocol given: immunization reaction.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Injection site reaction, Skin reaction
Clinical narrative: Received hib and PREVNAR immunization (1st dose of each). Prolonged crying and skin reaction at site of PREVNAR. Treatment advised was acetaminophen/cool - cold pack and observation. No adverse reaction on the next day.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Immediate post-injection reaction, Injection site reaction, Rash, Urticaria
Clinical narrative: Immediately after administration, the site of injection developed a welt about 1/2 the size of a golf ball, a rash developed, and patient felt warm. 911 was called, EMT evaluated patient and deemed her to be well.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at site, fever 102.
Age: 1.4
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Fatigue, Irritability, Urticaria, Vomiting
Clinical narrative: 2 days after vaccine - throwing up, very fussy, tired, no appetite. 12/17 - Patient broke out in hives over entire body (this has never happened before and she did not eat new food).
Age: 1.67
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Lip swelling
Clinical narrative: Swelling around (L) eye and upper lip. Swelling and redness (L) upper arm at site immunization and (L) thigh at site immunization. Does not appear to have urticaria. Will refer to allergist for testing parent prefers to hold on antihistamines.
Age: 36.0
Sex: F
Vaccine: MMR, TD
Symptoms: Erythema, Skin warm
Clinical narrative: The client returned to clinic on this date showed her (R) arm which was very red warm to touch and measured 3 in and 2.5 inches in diameter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a health professional regarding an unknown age and gender patient. Medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) lot # J003539, expiration date 25-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination was unknown. This is a corrected report. On 23-SEP-2013, information was received from a registered nurse concerning the unknown age and gender patient. It was reported that VARIVAX (Merck) was exposed to unknown temperatures for 5 hours during interoffice transport. The patient was revaccinated. No adverse symptoms reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age and gender. On 14-JUN-2013 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose, frequency and route unspecified) when she was suppose to receive ZOSTAVAX. No adverse symptoms reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Pain in extremity, Tenderness
Clinical narrative: Painful arm, sore to move and touch. Light redness around injection site and a small patch of light redness 3-4 inches down from injection site. Appeared to look like "Red Arm Syndrome".
Age: 58.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased
Clinical narrative: Today 01/02/14 approximately 10:00 patient reported to staff of health services severe (L) shoulder upper arm pain and decreased strength and range.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site abscess sterile, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Doc thinks sterile abscess 1/3/2014 warm, swollen, painful whole left upper arm.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Hypotonia, Increased bronchial secretion, Injection site pain, Loss of consciousness, Muscle spasms
Clinical narrative: Administered vaccine patient stated pain at site given, held head, pt pale went limp, held pt. gently got pt. to ground. pt. did not respond, fist clinched, muscle spasms, gurgling noise. Pt. responded <3-4 minutes. Rested 20-40 minutes. Mother and pt. left. Contacted pt 1-3-13 AM and pat stated she passed out when getting up this morning. She called her doctor and would follow up w/him.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Administered vaccine patient stated pain at site given, held head, pt pale went limp, held pt. gently got pt. to ground. pt. did not respond, fist clinched, muscle spasms, gurgling noise. Pt. responded <3-4 minutes. Rested 20-40 minutes. Mother and pt. left. Contacted pt 1-3-13 AM and pat stated she passed out when getting up this morning. She called her doctor and would follow up w/him.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: CSF test normal, Chest X-ray normal, Computerised tomogram head normal, Delusion, Disorientation
Clinical narrative: Initial fever, then dizziness, disorientation, and delusional thinking.  No treatment given to date.  Neurology specialty evaluation pending.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Full blood count normal, Laboratory test normal, Pyrexia, Urine analysis normal
Clinical narrative: Initial fever, then dizziness, disorientation, and delusional thinking.  No treatment given to date.  Neurology specialty evaluation pending.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bacterial test, Body temperature increased, Chest X-ray, Heart rate increased, Pain
Clinical narrative: Groggy & temperature of 103.2.  Had given Advil an hour earlier for pain.  Called pediatrician and they said to take him to the ER.  Temperature was 103.5 when we got there.  His heart rate jumped up to over 220.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Somnolence, Viral test negative
Clinical narrative: Groggy & temperature of 103.2.  Had given Advil an hour earlier for pain.  Called pediatrician and they said to take him to the ER.  Temperature was 103.5 when we got there.  His heart rate jumped up to over 220.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Abortion spontaneous, Haemorrhage, Ultrasound abdomen
Clinical narrative: Bleeding in pregnancy, miscarriage at 9 weeks. Eventual D&C.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pyrexia
Clinical narrative: I don't know if it was the vaccine or I have the flu, but I have flu symptoms and a fever which started Friday. Can barely make it out of bed.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort, Mobility decreased
Clinical narrative: Upper arm discomfort and limited arm use because of discomfort.