chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to an unspecified patient of unknown age. On 06-FEB-2015 the patient was vaccinated with two 0.65ml dose of ZOSTAVAX, subcutaneous for one dose and intramuscularly for the second dose instead of receiving an unspecified Hepatitis B vaccine which the pharmacist could not confirm if it was RECOMBIVAX. No adverse effect was reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX, (lot # not reported, expiration date: 20-SEP-2014) 0.65 ml, subcutaneous. The ZOSTAVAX was supported and properly stored. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 30-JAN-2015, the patient was inadvertently administered a dose of improperly stored VARIVAX (Merck) 0.5 ml, (lot number and expiry date were not reported), subcutaneously. No adverse effects reported. This is one of two reports received from the same reporter (linked to 1502USA004548). Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: High fevers.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a adult unk patient who received HAVRIX pediatric (batch number UNKNOWN, expiry date unknown). On an unknown date, the patient received HAVRIX pediatric 2 dosage form (s). On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information: Nurse reports that two doses of the pediatric HAVRIX vaccine were administered to an adult patient on the same day. She did not have any additional information about the event.
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received HAVRIX. On an unknown date, the patient received HAVRIX (intramuscular). On an unknown date, an unknown time after receiving HAVRIX, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to HAVRIX. Additional information: An adult female patient reports that her nurse may not have injected into her deltoid in her arm. She reports that the injection site looks like it is more forward on her arm, rather than towards the middle. The patient noted that the nurse who gave her the injection insists it was done correctly.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a infant patient who received ENGERIX B pediatric. On an unknown date, the patient ENGERIX B pediatric at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse reported that approximately 38 infants were vaccinated at birth with ENGERIX  that was stored out of recommended temperatures for approximately 1 month. Nurse did not have any further information at this time.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vaccine underdose in a 91-year-old female patient HAVRIX 720 (batch number UNKNOWN, expiry date unknown). On an unknown date, the patient received HAVRIX 720. On an unknown date, an unknown time after receiving HAVRIX 720, the patient experience vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. Additional information: A pediatric dose was inadvertently given to an adult patient. Was unable to collect addition information. Contact phone number provided by reporter not working.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX (batch number LK94M, expiry date 5th September 2015), (batch number 4233K, expiry date 5th September 2016) and (batch number 43gM4, expiry date 30th August 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information 6 patients received PEDIARIX that was exposed to temperature of 30.4F Three Lot Numbers LK94M exp 9/5/2015, 4233K exp 9/5/2016; 43GM4 exp 8/30/2016. This is one of the 6 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received HAVRIX (batch number N4341, expiry date 19th February 2016). On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. One patient received HAVRIX that was exposed to temperature of 30.4F.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX (batch number 4233K, expiry date 6th September 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. Six patients received PEDIARIX that was exposed to temperature of 30.4F Three lot numbers LK94M exp 05Sep2015 or 4233K exp 05Sep2016 or 43GM4 exp 30Aug2016.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 case reported by the same reporter for the same vaccine.
Age: 0.71
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Differential white blood cell count, Full blood count, Pyrexia, Streptococcus test
Clinical narrative: Fever up to 103 on the night of vaccination and continued until day of office visit 2/16/15.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dyskinesia, Streptococcus test negative, Syncope, Trismus
Clinical narrative: Syncope, patient fainted, had jerking movement, his jaw locked. MCV4.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Impaired healing, Injection site reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Unable to move left arm in certain positions. Throbbing pain throughout arm. Unhealed spot near injection site after 5 months.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Lethargy, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, loss of appetite, lethargy.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Vaccination complication
Clinical narrative: Small red areas on body, adverse reaction to varicella suspected.
Age: 0.35
Sex: M
Vaccine: HIBV, IPV, PNC13, TDAP
Symptoms: Rash erythematous, Rash generalised, Rash macular, Urticaria
Clinical narrative: Red rash upper arms bilat, back and chest, rash is macular generalized, few urticarial lesions.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Cough, Haematocrit normal, Haemoglobin normal, Pyrexia, Rash
Clinical narrative: Vaccinated 1/6, on 1/14 started with a fever-103 and on and off over the weekend, slight runny nose and cough. Sunday afternoon noticed a slight rash-on 1/14 move on face and trunk and then spread to back of arms-fever broke evening on 1/19.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Rhinorrhoea, White blood cell count increased
Clinical narrative: Vaccinated 1/6, on 1/14 started with a fever-103 and on and off over the weekend, slight runny nose and cough. Sunday afternoon noticed a slight rash-on 1/14 move on face and trunk and then spread to back of arms-fever broke evening on 1/19.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Measles post vaccine
Clinical narrative: Vaccinated 1/6, on 1/14 started with a fever-103 and on and off over the weekend, slight runny nose and cough. Sunday afternoon noticed a slight rash-on 1/14 move on face and trunk and then spread to back of arms-fever broke evening on 1/19.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Cough, Croup infectious, Irritability, Ocular hyperaemia, Otitis media
Clinical narrative: 2/11/15 - started with red eyes per mom, 2/12 - started Kw/ runny nose, cough and fever 101.5 that AM, very grumpy (told had B/L OM-started on ZITHROMAX and dexamethasone for croup. 2/15 - started with red rash on neck, torso and has spread - fever broke 2/15. 2/16 - rash got worse. 2/17 - rash spread to arms and legs.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash erythematous, Rhinorrhoea
Clinical narrative: 2/11/15 - started with red eyes per mom, 2/12 - started Kw/ runny nose, cough and fever 101.5 that AM, very grumpy (told had B/L OM-started on ZITHROMAX and dexamethasone for croup. 2/15 - started with red rash on neck, torso and has spread - fever broke 2/15. 2/16 - rash got worse. 2/17 - rash spread to arms and legs.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 30-JAN-2015, the patient was inadvertently administered a dose of improperly stored PROQUAD 0.5 ml, (lot number and expiry date were not reported), subcutaneously. No adverse effects reported. This is one of two reports received from the same reporter (linked to 1502USA000768). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via field employee referring to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, lot number, expiry date, route and dose were not reported). On an unknown date, after receiving the ZOSTAVAX vaccine, the patient experienced shingles. The outcome of shingles was unknown. The patient visit unspecified person for medical attention. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX (batch number LK94M, expiry date 5th September 2015), (batch number 4233k, expiry date 5th September 2016) and (batch number 43GM4, expiry date 30th August 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information.  Patients received PEDIARIX that was exposed to temperature of 30.4F Three Lot Numbers LK94M exp 9/5/2015, 4233K exp 9/5/2016; 43GM4 exp 8/30/2016. This case is one of the 6 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-FEB-2015 the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneously) that underwent two temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 04-FEB-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (0.5 ml, subcutaneously) that underwent two temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-JAN-2015 the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneously) that underwent two temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old female patient. The patient's medical history was not reported. On 16-FEB-2015, the patient was vaccinated with the expired dose of PROQUAD lot # J008572, expiration date 12-JAN-2015, second dose, 0.5 ml, subcutaneously (site of vaccination was not reported). No concomitant medication was reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. The patient medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II, 0.5 ml (route, lot # and expiration date were not provided). Concomitant medication was not provided. On an unknown date, the patient had negative titers for measles and the physician believed the patient was a non-responder. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. The physician also mentioned that she had seen unspecified patients that were administered an unspecified flu vaccine on unspecified dates and the unspecified patients contracted the flu virus. The physician believed this was vaccine failure of the most recent unspecified flu vaccine. This is one of several reports received from the same source. Additional information is not expected. The physician did not authorize to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 29-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose number was not reported), lot # J013449, 0.65 ml, subcutaneous route, which was expired on 24-JAN-2015. No adverse effect reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a consumer via other company and refers to eighteen patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, therapy route and anatomical location were not reported; lot # K011239, exp. date 11-JUN-2016) which was exposed to temperatures outside of the required temperature range. The reporter stated that the efficacy of the product outside the temperature range was not established. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On unknown dates since 23-JAN-2015, the patients were vaccinated with doses of LIQUID PEDVAXHIB (route, lot # and expiration dates were not provided). Concomitant medication information was not provided. On unknown dates since 23-JAN-2015, the patients had been administered LIQUID PEDVAXHIB which underwent supported temperature excursions. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On unknown dates since 23-JAN-2015, the patients were vaccinated with doses of PNEUMOVAX 23, intramuscularly (lot # and expiration dates were not provided). Concomitant medication information was not provided. On unknown dates since 23-JAN-2015, the patients had been administered PNEUNOVAX 23 which underwent supported temperature excursions. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On unknown dates since 23-JAN-2015, the patients were vaccinated with doses of GARDASIL (route, lot # and expiration dates were not provided). Concomitant medication information was not provided. On unknown dates since 23-JAN-2015, the patients had been administered GARDASIL which underwent supported temperature excursions. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain, Dehydration, Diarrhoea, Dizziness, Nausea
Clinical narrative: Received vaccine 2/12/15. Later developed N/V then diarrhea progressed to dizziness, incr. fluid loss over several hours w/ abd pain. Seen in E.R. for IV fluids - discharged home that day.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Vomiting
Clinical narrative: Received vaccine 2/12/15. Later developed N/V then diarrhea progressed to dizziness, incr. fluid loss over several hours w/ abd pain. Seen in E.R. for IV fluids - discharged home that day.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain, Asthenia, Chills, Decreased appetite, Dehydration
Clinical narrative: Received vaccine 2/12/15. Later developed N/V then diarrhea progressed to dizziness, incr. fluid loss over several hours w/ abd pain. Seen in E.R. for IV fluids - discharged home that day.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Diarrhoea, Fatigue, Nausea, Pain in extremity, Respiratory rate increased
Clinical narrative: Received vaccine 2/12/15. Later developed N/V then diarrhea progressed to dizziness, incr. fluid loss over several hours w/ abd pain. Seen in E.R. for IV fluids - discharged home that day.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Tremor, Vomiting
Clinical narrative: Received vaccine 2/12/15. Later developed N/V then diarrhea progressed to dizziness, incr. fluid loss over several hours w/ abd pain. Seen in E.R. for IV fluids - discharged home that day.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 02-FEB-2015 the patient was inadvertently vaccinated with ZOSTAVAX (dose and frequency were not reported) (lot # J011333 and expiry date: 13-DEC-2014) which passed expiry date. No adverse effects were reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 10-FEB-2015 the patient was inadvertently vaccinated with ZOSTAVAX (dose and frequency were not reported) (lot # J011333 and expiry date: 13-DEC-2014) which passed expiry date. No adverse effects were reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles, Measles antibody negative, Secondary transmission
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. The patient medical history and concurrent conditions were not provided. On an unknown date, a different patient was vaccinated with a dose of M-M-R II, (route, lot # and expiration date were not provided). On an unknown date, the patient, whose age and gender was unknown, experienced secondary transmission and measles described by the physician as the patient contracted vaccine associated measles from the patient that had received the M-M-R II. It was unknown if medical attention was sought. At the time of the report, the patient status was unknown. The physician also mentioned that she had seen unspecified patients that were administered an unspecified flu vaccine on unspecified dates and the unspecified patients contracted the flu virus. The physician believed this was vaccine failure of the most recent unspecified flu vaccine. This is one of several reports received from the same source. Additional information is not expected. The physician did not authorize to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a physician refers to a 53 year old (reported as around 53 to 55 years old) female patient. The patient's medical history included fever blisters. On 27-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The physician reported that on 04-FEB-2015, a patient developed a fever blister on an unspecified location of her body after she received ZOSTAVAX. At the time of the report the outcome of fever blister was reported as not recovered. The physician reported the patient called her dermatologist and the dermatology office referred the patient to reach out to her primary care physician who was the reporter. The patient did not receive treatment for the fever blisters. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneous that expired on 10-JAN-2015. The lot number was not available to provide at the time of the report. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) referring to 3 patients of unknown age and gender. On 09-FEB-2015, 3 doses of improperly stored VARIVAX (Merck) (lot number, dose, frequency and route not reported) had been administered to the patients. No adverse effects were reported. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: DTOX, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: Information was received from published article. This literature marketed report refers to 9 year old male patient. The patient medical history was significant for glaucoma, conductive hearing loss and hemivertebrae, with a clinical diagnosis suggestive of Marden Walker syndrome. He had mild persistent asthma and was atopic with multiple allergies. The patient developed hives and coughing immediately after eating salmon and tuna on separate occasions. The patient also developed nasal congestion with dust mite exposure, and latex exposure caused hives. The patient developed a facial rash minutes after eating beef and has been avoiding the food for years. The patient medical history included spinal operation (8 years prior). The patient presented to the allergy/immunology service after intraoperative anaphylaxis during removal of segmental spinal instrumentation for worsening kyphosis. Anesthesia was induced with propofol, fentanyl, and rocuronium (manufacturer unknown) and the patient was continued on rocuronium (manufacturer unknown) and remifentanil infusions. One hour later, the patient was given tobramycin and cefazolin, and surgery commenced. Sixty minutes into the procedure, FLOSEAL was injected into the screw holes. Within minutes, the patient became tachycardic with an increase from baseline of 80 beats/min to 105 beats/min, and hypotensive, with mean arterial pressure dropping from 75 mmHg to 45 mmHg. The patient was placed supine, given a 0.5 microgram/kg (10 mcg) intravenous bolus of epinephrine 4 times, followed by intravenous atropine twice, subcutaneous terbutaline, and inhaled albuterol via a metered-dose inhaler. Despite these interventions, the patient became pulseless and required chest compressions for 1 minute before regaining pulses. He then was started on epinephrine and vasopressin infusions. It was determined that, during a spinal operation 8 years prior, the patient had an episode of less-severe anaphylaxis. On an unknown date, the patient was vaccinated with MMR (manufacturer unknown) (dose, frequency and route were not reported), VARIVAX (Merck) (manufacturer unknown) (dose, frequency and route were not reported), diphtheria and poliovirus vaccines (dose, frequency and route were not reported). Concomitant therapies were not reported. On an unknown date, the patient experienced an allergic reaction to gelatin component in vaccines resulting in episode of anaphylaxis. The outcome of allergic reaction to gelatin component in vaccines resulting in episode of anaphylaxis was unknown. The reporter considered allergic reaction to gelatin components in vaccines resulting in episode of anaphylaxis to be related to MMR (manufacturer unknown), VARIVAX (Merck) (manufacturer unknown), diphtheria and poliovirus vaccines. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered adult dose of vaccine instead of pediatric dose.
Age: 52.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood pressure decreased, Limb injury, Loss of consciousness, Rash generalised
Clinical narrative: On 2/19/15, patient states she, "passed out at work after having injured fingers." States she took her BP at home and it was low, unsure of exact reading. On 2/11/15 she woke up with raised rash covering arms, trunk, legs, and it was scattered in her face. Followed up on 2/17/15 and she said took BENADRYL for 2 nights and rash completely resolved.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F. Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage od drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016 and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient reecived BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two lot numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30/4F Two lot numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX (batch number 4233K, expiry date 6th September 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information, 6 patients received PEDIARIX that was exposed to temperature of 30.4F. Three lot numbers LK94M exp 05Sep2015, 4233K exp 05Sep2016, 43GM4 exp 30Aug2016.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX (batch number 4233K, expiry date 6th September 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. Ten patients received BOOSTRIX that was exposed to temperature of 30.4F. Two lot numbers 3P9CL exp 15Apr2016 or HM4FY exp 06Dec2016.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX (batch number 4233K, expiry date 6th September 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. Six patients received PEDIARIX that was exposed to temperature of 30.4F. Three lot numbers LK94M exp 05Sep2015, 4233K exp 05Sep2016, 43GM4 exp 30Aug2016.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Urticaria
Clinical narrative: Hives on face reported by Mon > post 20 min imm. Hives cleared before patient was seen by provider.
Age: 54.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Underdose
Clinical narrative: Patient was given 720 units of HAVRIX (pediatric dose) and had to be given an additional shot of 720 units (same day) to give correct dose.
Age: 68.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Abasia, Arthralgia, Asthenia, Cast application, Fall
Clinical narrative: Severe pain in shoulder for six weeks. Pain and weakness in feet and ankle and difficulty walking lasting several months and recurring with ankle pain, foot brace, boot, unsatisfactory improvement after twenty months.
Age: 68.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Joint swelling, Orthosis user, Pain in extremity, Peripheral swelling, Walking aid user
Clinical narrative: Severe pain in shoulder for six weeks. Pain and weakness in feet and ankle and difficulty walking lasting several months and recurring with ankle pain, foot brace, boot, unsatisfactory improvement after twenty months.
Age: 68.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Arthralgia, Asthenia, Gait disturbance, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Severe pain in shoulder for six weeks. Pain and weakness in feet and ankle and difficulty walking lasting several months and recurring with ankle pain, foot brace, boot, unsatisfactory improvement after twenty months.
Age: 68.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Orthosis user, Pain in extremity, Swelling
Clinical narrative: Severe pain in shoulder for six weeks. Pain and weakness in feet and ankle and difficulty walking lasting several months and recurring with ankle pain, foot brace, boot, unsatisfactory improvement after twenty months.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Nausea
Clinical narrative: Extreme fatigue, upset stomach for 4 days. Bright red mark on arm (injection site) 4 inches x 1/2" long. Muscle soreness or nerve pain on left side. Pale red mark still exists to present.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Fatigue, Injection site erythema, Myalgia, Neuralgia
Clinical narrative: Extreme fatigue, upset stomach for 4 days. Bright red mark on arm (injection site) 4 inches x 1/2" long. Muscle soreness or nerve pain on left side. Pale red mark still exists to present.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 67 year old female patient. Pertinent medical history included: asthma. Drug Reactions/Allergies: DEMEROL allergy, codeine allergy, penicillin allergy and allergy to sulfa. On 30-JAN-2015 the patient was vaccinated with ZOSTAVAX (lot # K009810; 10-OCT-2015), Dose: 0.65 ml, subcutaneous in the right arm. Concomitant therapies included levothyroxine sodium (manufacturer unknown), FLONASE and hydrochlorothiazide (manufacturer unknown). On 01-FEB-2015, the patient reported swelling and redness at the injection site on her right arm and also had swelling, redness, tenderness, pain and warmth at the base of her neck. Patient went to the emergency room because of the neck pain on 04-FEB-2015. Treatment given was: KEFLEX, VALTREX, VICODIN and gabapentin. Sought medical attention was reported as-patient had an office visit and emergency room visit. The outcome of swelling, redness, tenderness, pain and warmth at the base of her neck and swelling and redness at injection site was reported as recovering. Causality assessment was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local swelling, Neck pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 67 year old female patient. Pertinent medical history included: asthma. Drug Reactions/Allergies: DEMEROL allergy, codeine allergy, penicillin allergy and allergy to sulfa. On 30-JAN-2015 the patient was vaccinated with ZOSTAVAX (lot # K009810; 10-OCT-2015), Dose: 0.65 ml, subcutaneous in the right arm. Concomitant therapies included levothyroxine sodium (manufacturer unknown), FLONASE and hydrochlorothiazide (manufacturer unknown). On 01-FEB-2015, the patient reported swelling and redness at the injection site on her right arm and also had swelling, redness, tenderness, pain and warmth at the base of her neck. Patient went to the emergency room because of the neck pain on 04-FEB-2015. Treatment given was: KEFLEX, VALTREX, VICODIN and gabapentin. Sought medical attention was reported as-patient had an office visit and emergency room visit. The outcome of swelling, redness, tenderness, pain and warmth at the base of her neck and swelling and redness at injection site was reported as recovering. Causality assessment was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 67 year old female patient. Pertinent medical history included: asthma. Drug Reactions/Allergies: DEMEROL allergy, codeine allergy, penicillin allergy and allergy to sulfa. On 30-JAN-2015 the patient was vaccinated with ZOSTAVAX (lot # K009810; 10-OCT-2015), Dose: 0.65 ml, subcutaneous in the right arm. Concomitant therapies included levothyroxine sodium (manufacturer unknown), FLONASE and hydrochlorothiazide (manufacturer unknown). On 01-FEB-2015, the patient reported swelling and redness at the injection site on her right arm and also had swelling, redness, tenderness, pain and warmth at the base of her neck. Patient went to the emergency room because of the neck pain on 04-FEB-2015. Treatment given was: KEFLEX, VALTREX, VICODIN and gabapentin. Sought medical attention was reported as-patient had an office visit and emergency room visit. The outcome of swelling, redness, tenderness, pain and warmth at the base of her neck and swelling and redness at injection site was reported as recovering. Causality assessment was not reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Induration, Injection site rash, Peripheral swelling, Urticaria
Clinical narrative: 2-3-2015 - Local reaction - pink with mild swelling. No tx. Symptomatic. 2-7-2015 - Intermittent urticaria started.
Age: 10.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Erythema, Local reaction, Swelling, Urticaria
Clinical narrative: 2-3-2015 - Local reaction - pink with mild swelling. No tx. Symptomatic. 2-7-2015 - Intermittent urticaria started.
Age: 30.0
Sex: F
Vaccine: JEV1
Symptoms: Dizziness, Hypertension, Nausea, Pruritus, Sensation of foreign body
Clinical narrative: Dizziness, pruritis of the face and neck, globus sensation, nausea / vomiting, hypertension.  Treated with 50mg Diphenhydramine IM, patient's symptoms subsided within 15 minutes of administration.
Age: 30.0
Sex: F
Vaccine: JEV1
Symptoms: Vomiting
Clinical narrative: Dizziness, pruritis of the face and neck, globus sensation, nausea / vomiting, hypertension.  Treated with 50mg Diphenhydramine IM, patient's symptoms subsided within 15 minutes of administration.
Age: 0.35
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Increased appetite, Irritability, Poor quality sleep, Sleep disorder
Clinical narrative: Became very fussy; wanting to nurse non-stop; not sleeping well at all; continued for 2 weeks; developed odd hand movements that have tapered but still occurs 5 months later.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Chronic fatigue syndrome, Laboratory test
Clinical narrative: Chronic Fatigue Syndrome, gradual onset over several months and next 3 years.
Age: 1.1
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Death, Peripheral coldness
Clinical narrative: Received first vaccines 2/13/15, no apparent problems that afternoon or evening, found dead in crib following AM - cold, likely died hours before. Complex PMH following anoxic/ischemic brain injury at birth. Hx seizures, weaned off anticonvulsants - 2m ago after EEG normal.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Acne, Blister, Herpes zoster, Hyperaesthesia, Hypoaesthesia
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered.