chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. Since on an unknown date in March 2015, the unspecified patients were vaccinated with improperly stored doses of GADASIL (lot # J011272 and expiry date: 21-APR-2016) (dose and frequency were not reported). No adverse effects were reported. No product quality complaint was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. Since on an unknown date in March 2015, the unspecified patients were vaccinated with improperly stored, oral, ROTATEQ (lot# K007246 and expiry date: 17-MAR-2016) (dose and frequency were not reported) for an unknown indication. No adverse effects were reported. No product quality complaint was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified nunber of patients of unknown age and gender. On an unknown date the patients were vaccinated subcutaneously with 0.65 ml single dose of ZOSTAVAX (lot # K010628, expiration date: 30-OCT-2015) that were improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test abnormal, Feeling abnormal, Hypersomnia, Hypokalaemia, Immediate post-injection reaction
Clinical narrative: Immediate symptoms - I have limited recall - immediate sensation of vaccine flooding through my system.  I have no memory of driving home.  I must've gone to bed immediately - slept 24 hours.  Called P.A. who told me to go to hospital.  I didn't think I could drive there, but no friends were available, so I did - very carefully.  Emergency room did blood tests; only found potassium deficiency.  Went home and slept 10 more hours.
Age: 68.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Memory impairment
Clinical narrative: Immediate symptoms - I have limited recall - immediate sensation of vaccine flooding through my system.  I have no memory of driving home.  I must've gone to bed immediately - slept 24 hours.  Called P.A. who told me to go to hospital.  I didn't think I could drive there, but no friends were available, so I did - very carefully.  Emergency room did blood tests; only found potassium deficiency.  Went home and slept 10 more hours.
Age: 68.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood potassium decreased, Feeling abnormal, Hypersomnia, Hypokalaemia, Immediate post-injection reaction
Clinical narrative: Immediate symptoms - I have limited recall - immediate sensation of vaccine flooding through my system.  I have no memory of driving home.  I must've gone to bed immediately - slept 24 hours.  Called P.A. who told me to go to hospital.  I didn't think I could drive there, but no friends were available, so I did - very carefully.  Emergency room did blood tests; only found potassium deficiency.  Went home and slept 10 more hours.
Age: 68.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Impaired driving ability, Memory impairment
Clinical narrative: Immediate symptoms - I have limited recall - immediate sensation of vaccine flooding through my system.  I have no memory of driving home.  I must've gone to bed immediately - slept 24 hours.  Called P.A. who told me to go to hospital.  I didn't think I could drive there, but no friends were available, so I did - very carefully.  Emergency room did blood tests; only found potassium deficiency.  Went home and slept 10 more hours.
Age: 1.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash generalised
Clinical narrative: 3/20: Injection site was swollen and red, approx. 3x1". 3/21: PM: Rash started on trunk and cheeks. 3/22, AM: Rash darkened and spread, approx. 80% of body covered. 3/20, PM: Fever of 103.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unkown date in March 2015 (also reported as "the last month"), the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # K01022, expiration date 12-MAY-2016 (dose and dose number were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected because reporter refused additional contact.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 26-year-old female patient received who received ENGERIX B adult (batch number FB3A3, expiry date 28th January 2016). Previously administered products included ENGERIX B adult (dose 1). In January 2014, the patient received the 2nd dose of ENGERIX B adult 20 ug. In January 2014, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.
Sex: U
Vaccine: TDAP
Symptoms: Neurological symptom
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of neurologic reaction in a unk patient who received DTPa (batch number UNKNOWN, expiry date unknown). On an unknown date, the patient received DTPa (subcutaneous). On an unknown date, an unknown time after receiving DTPa, the patient experienced neurologic reaction. On an unknown date, the outcome of the neurologic reaction was unknown. It was unknown if the reporter considered the neurologic reaction to be related to DTPa. Additional details were provided as follows: The product brand was not specified as BOOSTRIX. The patient had suffered a neurological reaction following administration of TDAP vaccine. It was unknown whether the vaccine was administered at the hospital or at a satellite clinic. No other information was available at this time.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Off label use
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site swelling in a elderly female patient who received Influenza vaccine. Previously administered products included influenza vaccine (swelling, pain, warmth and redness at the injection site dose 1). On an unknown date, the patient received the 2nd dose of Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site swelling, injection site warmth, injection site erythema, injection site pain, off label use and wrong injection technique. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema, injection site pain, off label use and wrong injection technique were unknown. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site pain to be related to the Influenza vaccine. Additional information: The doctor divided this second flu shot into 1/5th of the actual dose so he could try and mitigate any reactions to the shot itself. However, the same events occurred with this reduced flu shot dose. This case is linked with cases US2015057042 and US2015GSK061625 as same patient.
Sex: F
Vaccine: FLU3
Symptoms: Wrong technique in drug usage process
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site swelling in a elderly female patient who received Influenza vaccine. Previously administered products included influenza vaccine (swelling, pain, warmth and redness at the injection site dose 1). On an unknown date, the patient received the 2nd dose of Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site swelling, injection site warmth, injection site erythema, injection site pain, off label use and wrong injection technique. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema, injection site pain, off label use and wrong injection technique were unknown. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site pain to be related to the Influenza vaccine. Additional information: The doctor divided this second flu shot into 1/5th of the actual dose so he could try and mitigate any reactions to the shot itself. However, the same events occurred with this reduced flu shot dose. This case is linked with cases US2015057042 and US2015GSK061625 as same patient.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date in March 2015 (also reported as "the last month"), the patient was vaccinated with an improperly stored dose of VAQTA, lot # K012457, expiration date 04-JUN-2017, (dose, dose number, route and anatomical location were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected because reporter refused additional contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date in March 2015 (also reported as "the last month"), the patient was vaccinated with an improperly stored dose of ROTATEQ lot # K004795, expiration date 11-FEB-2016, (dose and dose number were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected because reporter refused additional contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date in March 2015 (also reported as "the last month"), the patient was vaccinated with an improperly stored dose of GARDASIL, lot # K005881, expiration date 14-JAN-2017, (dose, dose number, route and anatomical location were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected because reporter refused additional contact.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Scab, Skin lesion
Clinical narrative: Baseball sized, swollen lesion. Painful felt like shingles. Scabbes. Severe pain, chills, fever x 3 days following.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Baseball sized, swollen lesion. Painful felt like shingles. Scabbes. Severe pain, chills, fever x 3 days following.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patient of an unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 01-MAY-2015, the patient was vaccinated with one improperly stored doses of (Oka/Merck) VARIVAX (dose, route and lot number were not provided) as prophylaxis by default. Concomitant medicattions were not provided. The nurse reported that no adverse events were experienced by the patient. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This spontaneous report was received from a physician via a company representative regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On an unknown dates, the patient was vaccinated with the complete series of GARDASIL injection (dose, route and lot numbers were not provided). Concomitant medication was not provided. On an unknown date, after completed the GARDASIL series, the patient came down with an HPV infection. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
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. Concurrent conditions, medical history and allergies were not reported. On 30-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml once, subcutaneous, (lot # K003600, expiration date: 10-MAR-2015 (also reported as 19-MAR-2015), inadvertently which was expired. No adverse effect was reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient has arm pain since vaccination. (approximately 4 weeks). She uses are less now and finds the pain worse at night.
Age: 14.0
Sex: F
Vaccine: FLU4, HEP, HPV4, IPV, MMRV, TD
Symptoms: Exposure during pregnancy
Clinical narrative: Child received vaccines during pregnant state on 9/19/14, 10/20/14 and 12/19/14. We were notified of this today on 5/8/15, when she came in to receive immunizations due. Stated she was not aware of pregnant state until 7+ months into it. Reports her baby was born on 4/5/15 and both her and baby are well. States babys dr is aware she received vaccines while pregnant. Reports baby is healthy with zero problems noted at birth or now. At time of immunizations received on 12/19/14, client would have been about 4 months pregnant.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth, Rash papular
Clinical narrative: (R) thigh 3.5 x 2.5 in red, warm area of skin 3-4 papulo/vesicular lesions within the red area. Varicella and Hep A given in this leg. (R thigh cellulitis).
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling, Ultrasound Doppler
Clinical narrative: Swelling, rash, next day sl. better day next day was referred to covering MD. Was seen, 5-1-15 by dr. Treated with AUGMENTIN 875-125 mg 2 times daily/or 10.
Age: 44.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Client's right arm became swollen and red and tender later in the evening on 5/28/2015.  Client's sister noticed the arm had not reduced in size of redness and was also tender to touch on Friday, May 1, 2015. Sister took client to the hospital ED where client was seen and oral ATB was prescribed (client does not remember the name of the ATB).  When client came in to the health department 5/11/2015 for a TB skin test read, I checked her upper right arm and it was still noticeably warm and slightly swollen larger than upper left arm. Noted in immunization charting client had both MMR and V subcutaneous vaccines in the upper right arm.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: No known adverse effects. The child received an expired Pentacel dose.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site oedema
Clinical narrative: Patient reports she awoke with numbness to her left arm (the injection site was to the left deltoid muscle). The donor reports complete resolution of the numbness within 6 hours. There is also a 3 cm hardening under the skin at the injection site today, 05/11/15. The patient reports the lump was approximately 5 cm on 05/07/15.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives all over pt's body, including her head started almost 24 hrs after receiving the vaccine.  Went to urgent care.  Tx with Prednisone dose pack.
Age: 39.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: VERY HOT RED SWOLLEN AREA OVER SITE WHERE MMR AND VARICELLA WERE GIVEN WHICH PERSISTED MORE THAN 72 HOURS. REPORTS HE USED ICE TO TRY AND REDUCE SWELLING. HE WAS UNABLE TO REACH THE PEOPLE WHO GAVE IT SO CAME TO SHOW IT TO THE LOCAL HEALTH DEPARTMENT.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles, Staphylococcus test negative, Varicella virus test
Clinical narrative: Left upper arm rash with red base and vesicles overlying.  Area circular and measures approximately 6.5 x 5.5 cm.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Injection site pain, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Pain at injection site,  right deltoid, for 3 days and as this started to dissipate...on day 5 a very warm red/pink pruritic rash developed and increased in size.  Pt came into office on Day 7 after injection. No shortness of breath or chest pain.  No coughing.  No fever, nausea, vomiting.  No diarrhea or constipation.  Since on qd Claritin for good control of allergies and edges of rash becoming more faint, I added ranitidine as adjuvant to Claritin to stop pruritis. To return if no better in 3 days.  BP was elevated but pt had a lot of stressors which were discussed.  Follow up visit planned in 4 days.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Stress
Clinical narrative: Pain at injection site,  right deltoid, for 3 days and as this started to dissipate...on day 5 a very warm red/pink pruritic rash developed and increased in size.  Pt came into office on Day 7 after injection. No shortness of breath or chest pain.  No coughing.  No fever, nausea, vomiting.  No diarrhea or constipation.  Since on qd Claritin for good control of allergies and edges of rash becoming more faint, I added ranitidine as adjuvant to Claritin to stop pruritis. To return if no better in 3 days.  BP was elevated but pt had a lot of stressors which were discussed.  Follow up visit planned in 4 days.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness and swelling at injection site.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Compression fracture, Computerised tomogram normal, Generalised tonic-clonic seizure, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Pt received Tdap (Adacel) 2/11/15. Grand Mal seizure, witnessed. Sustained compression fx T7 during seizure. Since then has had 2 more. Negative CT, 2 MRIs.
Age: 1.01
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area where injection placed was swollen, hot to touch, and reddened. There was a bump 2 inches wide and 1 1/2 inches long at this site as well.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Few minutes after vaccination-- pale, sweaty, lightheaded and passed out for a few seconds- responded after a few seconds- ems took vitals and all BP, O2 and bs were normal- breathing fine but threw up after about 20 minutes. Spoke to mom and doing fine so far- still dizzy but much better- will continue to monitor.
Age: 1.79
Sex: M
Vaccine: DTAP
Symptoms: Crying, Gait disturbance, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Started with crying uncontrollably at sitters then she said he did not want to be touched and cried all day. I picked him up and he had a limp and was still crying. I noticed his left thigh was very swollen from hip to knee and was very hot to touch. I gave him some pedia care and put a cold compress on it and his crying had calmed down from when I picked him up at sitter. He went to sleep and woke up to a still swollen leg the next day. I dropped him off at sitter again and picked him up and she said that his leg was streaking and red now and still swollen. He did not have as bad of a limp as the day before though. I called the nurse hotline that night and the on call Dr called me said that I should be ok to come in tomorrow morning. I gave him some Benadryl and the next morning I took him to Dr and it was still swollen but redness had about gone away. Dr said that best to not give him the 5th dose when he turned 4. But it looked to be clearing up so everything should be fine.
Age: 1.79
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth, Tenderness
Clinical narrative: Started with crying uncontrollably at sitters then she said he did not want to be touched and cried all day. I picked him up and he had a limp and was still crying. I noticed his left thigh was very swollen from hip to knee and was very hot to touch. I gave him some pedia care and put a cold compress on it and his crying had calmed down from when I picked him up at sitter. He went to sleep and woke up to a still swollen leg the next day. I dropped him off at sitter again and picked him up and she said that his leg was streaking and red now and still swollen. He did not have as bad of a limp as the day before though. I called the nurse hotline that night and the on call Dr called me said that I should be ok to come in tomorrow morning. I gave him some Benadryl and the next morning I took him to Dr and it was still swollen but redness had about gone away. Dr said that best to not give him the 5th dose when he turned 4. But it looked to be clearing up so everything should be fine.
Age: 89.0
Sex: F
Vaccine: FLUX, MNQ, TTOX, FLUX, MNQ, TTOX
Symptoms: Injection site urticaria, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Cluster of Hive like eruptions around the site of the vaccination. Arm was extremely painful and stiff to move during first two days after Vac.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Aspiration, Muscle spasms, Pyrexia, Respiratory arrest, Seizure
Clinical narrative: Child had full body single spasms and fast spiking fever for 12 hrs leading up to event. About 30 hrs after shot, child had a seizure. Sitting the seizure she aspirated saliva and stopped breathing. 911 was called and within three minutes she was breathing again.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Local reaction, Reaction to drug excipients, Rhinorrhoea, Wheezing
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 5 year old female patient with allergy to peanuts, tree nuts, milk and eggs. Also reported as none drug reactions/allergies. On 23-JUL-2008, the patient was vaccinated with a dose of M-M-R II (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. The patient experienced a "large local reaction", wheezing and a runny nose, immediately after receiving a dose of M-M-R II. An ambulance was called to the physician's office, in which the patient was administered an EPIPEN, and patient was taken to an unspecified emergency room, seeking medical attention; it was unspecified whether patient was admitted to the hospital. The reaction was thought to be an allergic reaction to the gelatin content of M-M-R II. Patient's family was advised not to continue the M-M-R II series due to the reaction (also reported as the therapy was discontinued). The outcome of local reaction, reaction to drug excipients, wheezing and rhinorrhoea was reported as recovered (unspecified date). The reporter considered the reaction to drug excipients to be related to M-M-R II. Relatedness between the therapy with M-M-R II and the events: local reaction, wheezing and rhinorrhoea was not reported. Local reaction, reaction to drug excipients, wheezing and rhinorrhoea were considered to be medically significant by the Registered Nurse. Wheezing was considered to be life threatening by the Registered Nurse. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain-Barre syndrome, paralysis.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Patient received vaccines. Mom stated within fifteen minutes that patient had redness appear on arms with small circular white patches.
Age: 1.26
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Blister, Body temperature increased, Injection site vesicles, Rash, Varicella post vaccine
Clinical narrative: Pt with rash onset 5/10/15 and temp 100.0 range last night. Pt. had varicella vaccine 5/1/15. No recent travel. Water filled vesicles on red base of face, trunk, genitals, and extremities noted on 5/11/2015 office visit. Dx: Varicella s/p vaccine.
Age: 0.15
Sex: M
Vaccine: FLU3, HIBV, PNC13, RV1
Symptoms: Wrong drug administered
Clinical narrative: A FLUARIX vaccine was given instead of a PEDIARIX.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Approximately 15 lesions of varicella developed starting 20 days after VARIVAX.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a 14 year old female patient. Pertinent medical history, drug reactions or allergies were unspecified. On 23-APR-2015 the patient was vaccinated with a second dose of GARDASIL, intramuscular, (dose, anatomical location, lot number and expiration date were not reported). Concomitant therapies were unspecified. That day, after receiving the vaccine, the patient experienced syncope (reported as "fainted"). The physician reported that the patient woke up in the office and was sent home after an unknown period of time. Treatment given for the adverse event and laboratory diagnostic studies performed were unspecified. The outcome of syncope was reported as recovered on the same day, 23-APR-2015, after an unspecified period of time. The relatedness between syncope and GARDASIL was not reported. 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 Registered Nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with post excursion doses of VARIVAX (Merck) lot K021934 Expiry date 20-NOV-2016, lot K026385 Expiry date 15-DEC-2016, lot K021485 Expiry date 03-NOV-2016, lot L001326 Expiry date 13-JAN-2017 (dose and route were not reported). There was no concomitant medication provided. No adverse effects reported and no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) concerning a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored GARDASIL (dose, strength and route were not reported, lot # J006850, expiry date: 31-MAR-2016). No adverse symptoms were reported. The temperature excursion for GARDASIL was found to be supported with in-house stability data. Additional information has been requested.
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 49 year old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (19400 plaque forming unit (PFU), lot#, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Doses of ROTATEQ (dose, frequency, lot# and route were not reported) which were exposed to temperatures outside of the recommended range, were administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse experience had been observed or reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Doses of PNEUMOVAX 23 (dose, frequency, lot# and route were not reported) which were exposed to temperature outside of the recommended range, were administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse experience had been observed or reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No current condition and medical history was reported. On 13-APR-2015, the patient was not vaccinated with full dose of ZOSTAVAX (lot # K020187, Exp. 27-JAN-2016, dose and route not reported) which was draw up into a plastic syringe and the needle leaked. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This information has been received from a medical assistant referring to two patients of unknown age and gender. On 13-APR-2015 two patients were vaccinated with improperly stored GARDASIL (dose, strength, lot# and route not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Doses of RECOMBIVAX HB (dose, frequency, lot# and route were not reported) which were exposed to temperatures outside of the recommended range, were administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse experience had been observed or reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Doses of GARDASIL (dose, frequency, lot# and route were not reported) which were exposed to temperatures outside of the recommended range, were administered to unspecified patients for prophylaxis on unspecified date since 09-APR-2015. No adverse experience had been observed or reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Doses of VAQTA (dose, frequency, lot# and route were not reported) which were exposed to temperatures outside of the recommended range, were administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse experience had been observed or reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: 2 days fever, H/A, (L) arm pain. Persistant pain (L) arm.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fall, Fear
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning an 11 year old female patient. It was reported that on an unspecified date previously to the vaccination with GARDASIL, the patient had an allergic reaction to Hepatitis A Vaccine, (manufacturer unspecified). It was not specified if the patient had any other known drug allergies or reactions. In late April 2015 the patient was vaccinated with her first dose of GARDASIL (dose, route and lot# not provided) for HPV Prevention. The patient experienced syncope when under physician supervision at the clinic directly after having received the dose of GARDASIL. The patient was treaged at the clinic by being seated, having a blood pressure reading taken, and by being monitored for 30 minutes. There were no laboratory tests or diagnostic studies performed. It was not known if the patient will continue her GARDASIL series. At the time of the report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning an 11 year old female patient. It was reported that on an unspecified date previously to the vaccination with GARDASIL, the patient had an allergic reaction to Hepatitis A Vaccine, (manufacturer unspecified). It was not specified if the patient had any other known drug allergies or reactions. In late April 2015 the patient was vaccinated with her first dose of GARDASIL (dose, route and lot# not provided) for HPV Prevention. The patient experienced syncope when under physician supervision at the clinic directly after having received the dose of GARDASIL. The patient was treaged at the clinic by being seated, having a blood pressure reading taken, and by being monitored for 30 minutes. There were no laboratory tests or diagnostic studies performed. It was not known if the patient will continue her GARDASIL series. At the time of the report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Ear pain, Eye discharge, Eye irritation, Eye pain, Eye swelling
Clinical narrative: The patient is a 26 yo female who received smallpox vaccine on 22 APR 2015 (lot# ACA VV04-003A). She was evaluated by provider on 01 May 2015 for ear pain and eye discomfort, with edema and drainage to her eye lids, matting to lashed, swollen post auricular lymph node and she was diagnosed with otitis media and conjunctivitis and given SEPTRA and topical ophthalmic antibx. On 03 May she developed a vesicular lesion below her brow, worsened edema, conjunctival injection, blurred vision, headache. She was seen again by provider on 04 May, and the health agency was contacted. A photograph was sent to health agency demonstrating a vesicular lesion inferior to her lateral left brow with crusting to her lashes. The Patient to be seen ASAP by ophthalmology and started on viroptic; antibacterials were stopped. There was no evidence of keratitis. PCR was collected and sent to CDC and vaccinia was confirmed. Her symptoms have improved with VIROPTIC only; she was not required VIG.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Insomnia, Laboratory test, Ocular hyperaemia, Photophobia
Clinical narrative: The patient is a 26 yo female who received smallpox vaccine on 22 APR 2015 (lot# ACA VV04-003A). She was evaluated by provider on 01 May 2015 for ear pain and eye discomfort, with edema and drainage to her eye lids, matting to lashed, swollen post auricular lymph node and she was diagnosed with otitis media and conjunctivitis and given SEPTRA and topical ophthalmic antibx. On 03 May she developed a vesicular lesion below her brow, worsened edema, conjunctival injection, blurred vision, headache. She was seen again by provider on 04 May, and the health agency was contacted. A photograph was sent to health agency demonstrating a vesicular lesion inferior to her lateral left brow with crusting to her lashes. The Patient to be seen ASAP by ophthalmology and started on viroptic; antibacterials were stopped. There was no evidence of keratitis. PCR was collected and sent to CDC and vaccinia was confirmed. Her symptoms have improved with VIROPTIC only; she was not required VIG.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Conjunctival hyperaemia, Conjunctivitis, Ear pain, Eye discharge, Eyelid margin crusting
Clinical narrative: The patient is a 26 yo female who received smallpox vaccine on 22 APR 2015 (lot# ACA VV04-003A). She was evaluated by provider on 01 May 2015 for ear pain and eye discomfort, with edema and drainage to her eye lids, matting to lashed, swollen post auricular lymph node and she was diagnosed with otitis media and conjunctivitis and given SEPTRA and topical ophthalmic antibx. On 03 May she developed a vesicular lesion below her brow, worsened edema, conjunctival injection, blurred vision, headache. She was seen again by provider on 04 May, and the health agency was contacted. A photograph was sent to health agency demonstrating a vesicular lesion inferior to her lateral left brow with crusting to her lashes. The Patient to be seen ASAP by ophthalmology and started on viroptic; antibacterials were stopped. There was no evidence of keratitis. PCR was collected and sent to CDC and vaccinia was confirmed. Her symptoms have improved with VIROPTIC only; she was not required VIG.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Eyelid oedema, Headache, Lymphadenopathy, Ocular discomfort, Orthopoxvirus test positive
Clinical narrative: The patient is a 26 yo female who received smallpox vaccine on 22 APR 2015 (lot# ACA VV04-003A). She was evaluated by provider on 01 May 2015 for ear pain and eye discomfort, with edema and drainage to her eye lids, matting to lashed, swollen post auricular lymph node and she was diagnosed with otitis media and conjunctivitis and given SEPTRA and topical ophthalmic antibx. On 03 May she developed a vesicular lesion below her brow, worsened edema, conjunctival injection, blurred vision, headache. She was seen again by provider on 04 May, and the health agency was contacted. A photograph was sent to health agency demonstrating a vesicular lesion inferior to her lateral left brow with crusting to her lashes. The Patient to be seen ASAP by ophthalmology and started on viroptic; antibacterials were stopped. There was no evidence of keratitis. PCR was collected and sent to CDC and vaccinia was confirmed. Her symptoms have improved with VIROPTIC only; she was not required VIG.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Otitis media, Polymerase chain reaction positive, Rash vesicular, Vaccinia virus infection, Vision blurred
Clinical narrative: The patient is a 26 yo female who received smallpox vaccine on 22 APR 2015 (lot# ACA VV04-003A). She was evaluated by provider on 01 May 2015 for ear pain and eye discomfort, with edema and drainage to her eye lids, matting to lashed, swollen post auricular lymph node and she was diagnosed with otitis media and conjunctivitis and given SEPTRA and topical ophthalmic antibx. On 03 May she developed a vesicular lesion below her brow, worsened edema, conjunctival injection, blurred vision, headache. She was seen again by provider on 04 May, and the health agency was contacted. A photograph was sent to health agency demonstrating a vesicular lesion inferior to her lateral left brow with crusting to her lashes. The Patient to be seen ASAP by ophthalmology and started on viroptic; antibacterials were stopped. There was no evidence of keratitis. PCR was collected and sent to CDC and vaccinia was confirmed. Her symptoms have improved with VIROPTIC only; she was not required VIG.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Discomfort, Headache, Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Skin Reaction; mild headache.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Skin irritation
Clinical narrative: Skin Reaction; mild headache.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Headache, Skin reaction
Clinical narrative: Skin Reaction; mild headache.
Age: 2.2
Sex: U
Vaccine: MMR, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a 26 month old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 07-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.5 ml, subcutaneous, (anatomical location, lot number and expiration date were not reported), instead of VARIVAX (Merck). No adverse experienced was reported. Additional information has been requested.
Age: 2.2
Sex: U
Vaccine: MMR, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a 26 month old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 07-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.5 ml, subcutaneous, (anatomical location, lot number and expiration date were not reported), instead of VARIVAX (Merck). No adverse experienced was reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: Swelling under tongue.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Pneumococcal 23-valent vaccine (MFR Merck Co, Inc.; LOT K021881; EXP 07/30/2016) administered via intravenous injection (IV push) into left hand peripheral IV, rather than intramuscular injection (IM).  No reactions/adverse events documented in the medical record or reported to pharmacy by nursing.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test
Clinical narrative: Fever, sore throat.
Age: 66.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Chills, Pruritus, Pyrexia, Rash macular
Clinical narrative: TX for dog bite on 4/8 on anbx IV/PO for hand bite. On 5/5 #1 Rabies given, 5/8 #2 Rabies given after 1 hr complained of rash-blotches, chest, arms, back, itchy, chills, joint pain, fever. Call received 5/11 to see primary.
Age: 1.24
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. No pertinent medical history was reported. On 15-APR-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 (Inj 10 vials of 1) (lot # K005957 and expiration date 08-MAR-2015) 0.5 ml, intramuscular. No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information about the patient's relevant medical history or concomitant medications was not reported. Since May 2015 (for both vaccines reported as since 08-MAY-2015), the patients were vaccinated with improperly stored doses of ROTATEQ (route default as oral, dose, lot# and expiration date were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored, oral, ROTATEQ (lot # K016314 and expiry date: 05-JUN-2016). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On 25-FEB-2015, oral, ROTATEQ of lot # K006458, expiry date 24-FEB-2016 and lot number K006805, with expiry date 24-MAR-2016 was improperly exposed to 21.72F for 40 minutes for 1 cycle. On unspecified date after this, in approximately 2015, an unspecified number of patients may have received this improperly stored ROTATEQ, oral. There were no known adverse effects. The vaccine was however, given via the correct route as per the prescribing information. The outcome of the incorrect product storage was unknown. This is one of the 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 healthcare worker refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On 29-APR-2015, the patient were vaccinated with improperly stored ZOSTAVAX (dose, route, lot # and expiration date were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. 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 registered nurse refers to unspecified number of patients of unknown age and gender. On 25-FEB-2015, LIQUID PEDVAXHIB of lot # K008878 with expiry date 23-MAR-2017 was improperly exposed to 21.72F for 40 minutes for 1 cycle. On unspecified date after this, in approximately 2015, an unspecified number of patients may have received this improperly stored PEDVAXHIB. There were no known adverse effects. The vaccine was however, given via the correct route as per the prescribing information. The outcome of the incorrect product storage was unknown. This is one of the several reports received from the same source. Additional information has been requested.