chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On an unspecified date, an unknown number of patients were vaccinated with an improperly stored dose of VARIVAX (lot# M048203, expiration date 07-DEC-2018) (dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at a temperature excursion of 18.6F for 22 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from an office manager from the physician's office via a company representative and refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 injection in the back of the thigh instead of deltoid muscle of the arm (dose, lot number and expiration date were not reported). The patient did not have any adverse effects. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in jaw, Swelling face
Clinical narrative: This spontaneous report was received from a physician and refers to a 12-year-old male patient with allergies to penicillin and peanuts. On 14-AUG-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N012093 with expiration date on 13-JAN-2020, intramuscular injection in the left deltoid. Concomitant therapies included ADDERALL XR 25 mg. On 15-AUG-2017, the patient experienced right sided jaw swelling and pain. The patient's mother was recommended to treat the events with warm compresses to the site. The mother took the patient to an urgent care who suggested that this might be a reaction to the vaccination with GARDASIL 9. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # n005274 with expiry date: 03-APR-2018 (dosing details, anatomical location, route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32F to 35F (35F) for 4 minutes; 32F to 35F (34.7F) for 11 minutes and 32F to 35F (35F) for 4 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011663: US-009507513-1708USA011662:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On an unknown date in 2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # and expiration date were unknown). In April 2017, the patient was vaccinated with the second dose of GARDASIL 9 (lot # and expiration date were unknown). In June 2017, the patient was vaccinated with the third dose of GARDASIL 9, lot # N003703 with expiration date on 29-OCT-2019. The patient had an altered dosing schedule of GARDASIL 9. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age. On 18-AUG-2017, 20-AUG-2017 and 21-AUG-2017, the patients were vaccinated with improperly stored doses of Other suspect therapies included PROQUAD for prophylaxis, which were reconstituted with properly stored sterile diluent (MRK). No adverse events reported. The vaccines were exposed to a temperature excursion -14°C to -10°C, during a time frame of 4 hours and 30 minutes. There was no previous temperature excursion. Sender's Comments: US-009507513-1708USA010604.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age.  First dose of ZOSTAVAX was administered to the patient in approximately 2016. On 23-AUG-2017, the patient was vaccinated with ZOSTAVAX dose 2, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent. On 23-AUG-2017, the patient experienced extra dose administered. No adverse effects were reported. The outcome of extra dose administered and no adverse event was unknown.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot#M045653 with expiry date: 03-JUL-2018 (dosing details, anatomical location, route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32F to 35F (35F) for 4 minutes; 32F to 35F (34.7F) for 11 minutes and 32F to 35F (35F) for 4 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1708USA009622: US-009507513-1708USA009622: US-009507513-1708USA011663:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M045545 with expiry date:10-JUN-2018 (dosing details unknown) orally for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32F to 35F (35F) for 4 minutes; 32F to 35F (34.7F) for 11 minutes and 32F to 35F (35F) for 4 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1708USA009622: US-009507513-1708USA011662:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M019643 with expiration date of 20-APR-2018 or lot#M038857 with expiration date of 14-SEP-2018 for prophylaxis. Other suspect therapies included sterile diluent(manufacturer unknown). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to sterile diluent(STERILE DILUENT) and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and sterile diluent (STERILE DILUENT). Additional information has been requested.; Sender's Comments:  US-009507513-1708USA007660:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested.; Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA011858: US-009507513-1708USA011859: US-009507513-1708USA008820: US-009507513-1708USA011857:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PEDVAXHIB for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB. Additional information has been requested. Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA011858: US-009507513-1708USA011859: US-009507513-1708USA011856: US-009507513-1708USA008820.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA008820: US-009507513-1708USA011859: US-009507513-1708USA011856: US-009507513-1708USA011857.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II. Additional information has been requested. Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA011858: US-009507513-1708USA008820: US-009507513-1708USA011856: US-009507513-1708USA011857.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ, oral for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1708USA008820: US-009507513-1708USA011858: US-009507513-1708USA011859: US-009507513-1708USA011856: US-009507513-1708USA011857.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. A 17-year-old patient of an unspecified ethnicity and gender received the first dose of TRUMENBA at single dose for immunisation. The medical history and concomitant medications were not reported. The patient received the first dose vaccination and had a fever of 103 degree F. Event outcome was unknown.
Sex: M
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This is a spontaneous report from contactable physician via Pfizer Sales Representative. An 18-years-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose in left arm for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe pain in left arm and neck stiffness on an unspecified date after receiving meningococcal group b rlp2086. Event outcome was unknown.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Cold sweat, Malaise, Pyrexia, Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for daughter. A 18-years-old female patient received first dose of TRUMENBA, via an unspecified route of administration on 21Aug2017 at single dose for preventative measure. Patient had no medical history. There were no concomitant medications. The patient experienced chills, fever, fainted, felt clammy, general malaise/not feeling well, all on early morning of 22Aug2017 and received treatment of TYLENOL. Outcome of events was recovered.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician (a pediatrician). A 26-year-old female patient received the first dose of TRUMENBA (Lot R56655, Expiration date Jan2019), via an unspecified route of administration on 02Jun2017 at 0.5 ml, single for immunisation. Medical history was none. There were no concomitant medications. No other vaccines were administered on the same day. The patient experienced 103 degree fever after vaccination. The outcome was recovered on unspecified date. The second dose of meningococcal group b rlp2086 was not yet given.
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A (Age: 50s-60s; Unit: Unknown) male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced soreness on an unspecified date. The outcome of the event was unknown.
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited report received from a healthcare professional (medical assistant) on 17-Aug-2017. This case is linked with: 2017SA152905 (same reporter). This case involves a male patient (age not reported), who was vaccinated with first dose of QUADRACEL via intramuscular route (batch number: C5222AA; expiry date: 20-Jun-2019, dose and site of administration were not reported) on an unknown date of Aug-2017 (one patient got it on 11-Aug-2017 and other on 14-Aug-2017) and VARICELLA VACCINE (LIVE) via intramuscular route (manufacturer: Merck) (batch number, expiry date, dose and site of administration were not reported) MEASLES, MUMPS AND RUBELLA VACCINE (MMR) via intramuscular route (batch number, expiry date, dose and site of administration were not reported) on an unknown date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Illness at time of vaccination was none. Concomitant medication was not reported. Any other vaccinations within 4 weeks of vaccinations was unknown. On an unspecified date, following the vaccination patient experienced redness and swelling at the injection site and was seen (emergence room/doctor visit) in the office and disgnosed with superficial cellulitis. No laboratory investigation was there. Corrective treatment included BENADRYL and warm soaks. Outcome of the events were unknown. Upon internal review the case was considered as serious because of important medical event: superficial cellulitis. List of the documents held by sender: none. Sender's Comments: The patient experienced cellulitis and vaccination site redness and swelling post vaccination with QUADRACEL. Time to onset was not available and the event cellulitis is not listed with the vaccine. The patient received vaccination with VARICELLA (UNK MFR) and MMR (OTHER MFR). Site of vaccination and reactions was not provided and it could be possible that the vaccination site reaction occurred at the site of other vaccine. Cellulitis indicates infectious etiology which needs to be investigated and patients pre-existing conditions need to be looked into. Based upon reported information the role of the vaccine cannot be assessed.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash generalised
Clinical narrative: Baseball sized warm, raised and red are on skin at site of injection with red, warm blotchy rash from cheeks on her face throughout entire body including her arms, buttocks, thighs, legs, ankles and feet. Rash mildly itchy. Sight of injection tender. Today marks day 3 of rash. Rash is not worsening at this time.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Rash macular, Rash pruritic, Skin warm
Clinical narrative: Baseball sized warm, raised and red are on skin at site of injection with red, warm blotchy rash from cheeks on her face throughout entire body including her arms, buttocks, thighs, legs, ankles and feet. Rash mildly itchy. Sight of injection tender. Today marks day 3 of rash. Rash is not worsening at this time.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Rash, Skin warm
Clinical narrative: Swelling, redness, heat, rash on lower arm and elbow. Pain. Symptoms gradually subsided over the course of 2 weeks.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and raised area to the right of the injection site on the left arm. Drew a border around the arm with a ball point pen as a point of reference. Followed up (08/27/2017) with the patient and she stated swelling and redness has gone down.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Non-viable due to temperature excursion of refrigerator and vaccine was too warm. It was not reported right away and that is why the bad vaccine was given. All the pt.'s have been found, told, and awaiting either the 1 month or 6 month return for repeat vaccine. No actual adverse events reported.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Blister, Rash generalised, Rash papular
Clinical narrative: Patients father called and said that the child developed a rash with red papules all over and he took the child to several different Doctors (6 times in all) with multiple different diagnosis  from Bug bites to poison Ivey to scabies he has had several topical ointments to apply. Stating he never applied for more that 2-3 days as they showed no improvement. Stated that the physician gave a steroid shot at one point with no help. Now the child has developed blisters 3 blister just broke out about a week ago  1 on leg 2 in head. They all sleep in the same bed. No other children have the rash or blister or bug bite.  Father thinks that this was a reaction to the polio vaccination. Although I informed him that this is not a symptom that I have ever known polio vaccine to cause the child could be having an allergic reaction to something. I suggested an allergy specialist or Dermatologist, and told him that I would enter his complaint as a VAERS however I really think unlikely due to this being the 5 time the child has received this vaccine.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Non-viable vaccine d/t temperature excursion too warm.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Patient was only give the HIB portion of Pentacel. Contacted Sanofi Pasteur because the HIB was reconstituted with a MERCK Diluent for MMR & Varicella. The nurse from Sanofi states that it would need to be readministered due to the fact that the DTAP-IPV could not be administered standalone. Patient was called and is scheduled to have the PENTACEL readministered.
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Non-viable vaccine d/t temperature excursion too warm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 10 cm area that is bright pink on the left lateral thigh with very mild induration, 5-6 cm diameter bright pink area in the left inguinal area surrounding a approximately 1 cm lymph node.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Blood gases normal, Culture urine negative, Cyanosis, Diarrhoea, Febrile convulsion
Clinical narrative: My daughter started with a fever in the am (Day 8 from vaccine), at 5pm received a text that my daughter's temp had returned and was 101.9 and TYLENOL was going to be given. No other symptoms with fever. At around 6 pm daughter started seizing. It presented as a seizure to start but then my daughter lost consciousness, stopped breathing and was turning blue around her mouth and chin. At that point I was unsure if it was a seizure or choking or what so began first response measures (check airway, back blows, rescue breaths) and 911 was called. She was unresponsive and not breathing for 2-4 minutes but by the time the paramedics arrived she had started breathing on her own. She still was unresponsive and limp. Ended up taking a ride to the hospital via ambulance and upon arrival she started to respond to stimulus. During the ride oxygen was given. Ran a number of test at the ER, Simple Febrile Seizure was diagnosis and we were discharged that evening. Fever continued through the next day, seemed to break for 12 hours and then returned. Finally ending day 11. She did have some diarrhea after the fever started (after ER) but assuming it was then related to higher temps. Was not runs multiple times a day but loose stool when she went regularly.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Hypotonia, Laboratory test, Loss of consciousness, Pyrexia, Respiratory arrest
Clinical narrative: My daughter started with a fever in the am (Day 8 from vaccine), at 5pm received a text that my daughter's temp had returned and was 101.9 and TYLENOL was going to be given. No other symptoms with fever. At around 6 pm daughter started seizing. It presented as a seizure to start but then my daughter lost consciousness, stopped breathing and was turning blue around her mouth and chin. At that point I was unsure if it was a seizure or choking or what so began first response measures (check airway, back blows, rescue breaths) and 911 was called. She was unresponsive and not breathing for 2-4 minutes but by the time the paramedics arrived she had started breathing on her own. She still was unresponsive and limp. Ended up taking a ride to the hospital via ambulance and upon arrival she started to respond to stimulus. During the ride oxygen was given. Ran a number of test at the ER, Simple Febrile Seizure was diagnosis and we were discharged that evening. Fever continued through the next day, seemed to break for 12 hours and then returned. Finally ending day 11. She did have some diarrhea after the fever started (after ER) but assuming it was then related to higher temps. Was not runs multiple times a day but loose stool when she went regularly.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Resuscitation, Seizure, Unresponsive to stimuli
Clinical narrative: My daughter started with a fever in the am (Day 8 from vaccine), at 5pm received a text that my daughter's temp had returned and was 101.9 and TYLENOL was going to be given. No other symptoms with fever. At around 6 pm daughter started seizing. It presented as a seizure to start but then my daughter lost consciousness, stopped breathing and was turning blue around her mouth and chin. At that point I was unsure if it was a seizure or choking or what so began first response measures (check airway, back blows, rescue breaths) and 911 was called. She was unresponsive and not breathing for 2-4 minutes but by the time the paramedics arrived she had started breathing on her own. She still was unresponsive and limp. Ended up taking a ride to the hospital via ambulance and upon arrival she started to respond to stimulus. During the ride oxygen was given. Ran a number of test at the ER, Simple Febrile Seizure was diagnosis and we were discharged that evening. Fever continued through the next day, seemed to break for 12 hours and then returned. Finally ending day 11. She did have some diarrhea after the fever started (after ER) but assuming it was then related to higher temps. Was not runs multiple times a day but loose stool when she went regularly.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Blood culture negative, Blood gases abnormal, Blood glucose increased, Febrile convulsion, Glucose urine present
Clinical narrative: My daughter started with a fever in the am (Day 8 from vaccine), at 5pm received a text that my daughter's temp had returned and was 101.9 and TYLENOL was going to be given. No other symptoms with fever. At around 6 pm daughter started seizing. It presented as a seizure to start but then my daughter lost consciousness, stopped breathing and was turning blue around her mouth and chin. At that point I was unsure if it was a seizure or choking or what so began first response measures (check airway, back blows, rescue breaths) and 911 was called. She was unresponsive and not breathing for 2-4 minutes but by the time the paramedics arrived she had started breathing on her own. She still was unresponsive and limp. Ended up taking a ride to the hospital via ambulance and upon arrival she started to respond to stimulus. During the ride oxygen was given. Ran a number of test at the ER, Simple Febrile Seizure was diagnosis and we were discharged that evening. Fever continued through the next day, seemed to break for 12 hours and then returned. Finally ending day 11. She did have some diarrhea after the fever started (after ER) but assuming it was then related to higher temps. Was not runs multiple times a day but loose stool when she went regularly.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Glycosylated haemoglobin, Metabolic function test, Protein urine present, Pyrexia, Urine ketone body present
Clinical narrative: My daughter started with a fever in the am (Day 8 from vaccine), at 5pm received a text that my daughter's temp had returned and was 101.9 and TYLENOL was going to be given. No other symptoms with fever. At around 6 pm daughter started seizing. It presented as a seizure to start but then my daughter lost consciousness, stopped breathing and was turning blue around her mouth and chin. At that point I was unsure if it was a seizure or choking or what so began first response measures (check airway, back blows, rescue breaths) and 911 was called. She was unresponsive and not breathing for 2-4 minutes but by the time the paramedics arrived she had started breathing on her own. She still was unresponsive and limp. Ended up taking a ride to the hospital via ambulance and upon arrival she started to respond to stimulus. During the ride oxygen was given. Ran a number of test at the ER, Simple Febrile Seizure was diagnosis and we were discharged that evening. Fever continued through the next day, seemed to break for 12 hours and then returned. Finally ending day 11. She did have some diarrhea after the fever started (after ER) but assuming it was then related to higher temps. Was not runs multiple times a day but loose stool when she went regularly.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient had a 2 inches long and 1 inch wide red spot on her arm and slightly raised.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with VARIVAX lot # M046926 with expiration date of 28-NOV-2018, 0.5 ml, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). On 17-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information is not expected because there is no consent to contact the reporter. Sender's Comments: US-009507513-1708USA011918.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M036296 with expiration date of 14-NOV-2017. Concomitant therapies included sterile diluent (manufacturer unknown). On 17-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information is not expected because there is no consent to contact the reporter. Sender's Comments: US-009507513-1708USA009124.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: KINRIX ordered and given by mistake.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient had a shingles outbreak approximately 1 month (July 30, 2017) after receiving the vaccine. She woke up the morning of July 30, 2017 with what she thought were spider bites over one side of her back. She went to her doctor a couple of weeks later for an unrelated issue and was diagnosed with shingles at that time.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pruritus
Clinical narrative: Red area greater than 5 inches, itching.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Autopsy, Death neonatal, Gestational hypertension
Clinical narrative: Patient unexpectedly passed away on 8/22/17. EDD: 7/3/17, Birth weight: 3.27kg. Mother's Hx--Gravida: 4, Full Term Preg: 1, Preterm Preg: 1, Abortions: 1, Living Children: 2. Pregnancy complicated by HTN (non-medicated), CDX2, HSV, learning disability (FAS), tobacco use, asthma, anemia, PTSD, anxiety, depression, scoliosis, HA's, GERD.
Age: 8.0
Sex: F
Vaccine: IPV, MMRV, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Fever up to 101 started on 8/22/17 and last through 8/24/17; Rash started on face, torso and back on 8/26/17 and still currently has rash.
Age: 20.0
Sex: M
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Rash, Rash generalised, Rash pruritic
Clinical narrative: Skin rash all over body starting that night of receiving the vaccine, itchy, tolerable with BENADRYL. No anaphylactic symptoms. Presents to clinic for care on 8/28/17 with the rash. Photos taken. Advised to continue BENADRYL and monitor.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HIBV, MMR, PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction, patient was to receive DTap-Hep B-IPV vaccine and was given DTap-Hib-IPV vaccine, no treatment needed, mother was notified of the incident, states no reactions.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Aggression, Communication disorder, Cough, Disorientation
Clinical narrative: I made several attempts to wake patient, which is very uncharacteristic for her. She struggled to wake up, and when I finally was able to wake her, she was disoriented and struggled to communicate. Her struggles continued throughout the day. When she arrived home from school, she had developed a congested cough, appeared very distracted and unable to communicate as she normally would. She was very verbally and physically aggressive, had multiple meltdowns (uncharacteristic of her), and became very flushed at random points throughout the evening.  She was very irritable, unwilling to cooperate with anything I prompted her to do, and required full assistance with self-grooming tasks that she can normally perform independently.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Distractibility, Emotional distress, Flushing, Irritability, Loss of personal independence in daily activities
Clinical narrative: I made several attempts to wake patient, which is very uncharacteristic for her. She struggled to wake up, and when I finally was able to wake her, she was disoriented and struggled to communicate. Her struggles continued throughout the day. When she arrived home from school, she had developed a congested cough, appeared very distracted and unable to communicate as she normally would. She was very verbally and physically aggressive, had multiple meltdowns (uncharacteristic of her), and became very flushed at random points throughout the evening.  She was very irritable, unwilling to cooperate with anything I prompted her to do, and required full assistance with self-grooming tasks that she can normally perform independently.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Respiratory tract congestion, Somnolence
Clinical narrative: I made several attempts to wake patient, which is very uncharacteristic for her. She struggled to wake up, and when I finally was able to wake her, she was disoriented and struggled to communicate. Her struggles continued throughout the day. When she arrived home from school, she had developed a congested cough, appeared very distracted and unable to communicate as she normally would. She was very verbally and physically aggressive, had multiple meltdowns (uncharacteristic of her), and became very flushed at random points throughout the evening.  She was very irritable, unwilling to cooperate with anything I prompted her to do, and required full assistance with self-grooming tasks that she can normally perform independently.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Acute sinusitis, Adverse event following immunisation, Discomfort, Head discomfort, Pain
Clinical narrative: Adverse reaction to IM Influenza vaccine occurred 8/23/17. Employee had pain and pressure of left side of body, pressure in back of head. Seen by ER and diagnosed with Acute Sinusitis.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: Swollen about the size of a golf ball, erythromatous, intense itching, painful on palpation, warm to touch.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Woke up the next morning with chills, body aches, and low-grade fever. Sick for only 1 day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Deltoid was red and hard.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 19 year old female patient. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. In July 2016, the patient was vaccinated with GARDASIL 9 (dose 1, dose, route and lot # not reported) for prophylaxis. The series of GARDASIL 9 should be completed by July 2017. But on 27-JUL-2017, the patient was in the office to receive the second dose of GARDASIL 9 (lot # N013695, expiration date 21-MAR-2019) (inappropriate schedule of vaccine administered). No adverse effects reported.
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Measles antibody negative, Vaccination failure
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 33 year old female patient. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. It was unknown if the patient had any drug reactions or allergies. On an unknown date, when the patient was younger, she was vaccinated with two doses of M-M-R II injection (dose, unit, route, lot# and expiration date were not reported) for prophylaxis. Since the patient did not have any documentation of the first two doses, on an unspecified date in 2009, the patient was vaccinated with additional two doses of M-M-R II injection (dose, unit, route, lot# and expiration date were not reported) as it was required for nursing school (inappropriate schedule of drug administration). On an unspecified date (after the two doses in 2009), the patient had titres which showed that the patient had immunity. On an unknown date in February 2017, the patient was seen by an unspecified gynecologist who performed unspecified test as a precaution for pregnancy. The unspecified test showed that the patient was not immune to measles (vaccination failure). On 18-AUG-2017, the patient was vaccinated with another dose of M-M-R II injection, intramuscularly (dose number 5; dose, units, lot# and expiration date were not reported) for prophylaxis (extra dose administered). The outcome of the events was unknown. No product quality complaint was involved. Causality for the event vaccination failure was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients received improperly stored PROQUAD lot # N012616 expired on 18-OCT-2018 for prophylaxis (strength, dose and route of administration were not reported). The sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. No adverse effect was reported. The vaccines were stored at 6.3°F for 20 minutes. Previous temperature excursions reported were: 5.4°F for 10 minutes, 5.4°F for 10 minutes, 5.7°F for 10 minutes, 5.4°F for 20 minutes, 5.5°F for 20 minutes, 5.4°F for 10 minutes, 5.5°F for 10 minutes, 5.4°F for 20 minutes, 6.4°F for 1 hour, 5.9°F for 40 minutes and 5.7°F for 10 minutes. It was reported that the call was because of a data logger. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1708USA011980.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients received improperly stored vaccinated with VARIVAX lot # M041080 expired on 06-OCT-2018 for prophylaxis (strength, dose and route of administration were not reported). The sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. No adverse effect was reported. The vaccines were stored at 6.3°F for 20 minutes. Previous temperature excursions reported were: 5.4°F for 10 minutes, 5.4°F for 10 minutes, 5.7°F for 10 minutes, 5.4°F for 20 minutes, 5.5°F for 20 minutes, 5.4°F for 10 minutes, 5.5°F for 10 minutes, 5.4°F for 20 minutes, 6.4°F for 1 hour, 5.9°F for 40 minutes and 5.7°F for 10 minutes. It was reported that the call was because of a data logger. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1708USA010711.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Altered state of consciousness, Dizziness, Nausea, Palpitations
Clinical narrative: Initial unsolicited report received from nurse on 17-Aug-2017. This case involves a 17-year-old female (reported as 18 years) patient who was vaccinated with a MENACTRA (batch number: U5712AA, expiry date: 11-Oct-2018) via intramuscular route on 11-Aug-2017. Illness at time of vaccination reported as no. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): Allergic to sulfa, Allergic rhinitis. Concomitant medications was not reported. On 11-Aug-2017, shortly after the vaccination, the patient began feeling lightheaded, feeling as if she would pass out, having palpitations and nausea. Symptoms have continued to occur for one week now. The patient required ER/doctor visit. The patient's laboratory data was reported as unknown. Corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Urticaria
Clinical narrative: Headache and hives.
Age: 0.42
Sex: M
Vaccine: DTAP, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Reported to have fallen asleep very soon after immunization during the car ride home; parent tried to stimulate him to wake up but he did not respond; they were very concerned, pulled over, and mom tried to stimulate him with no response; then took him out of car seat, and he appeared to 'wake up.'    From then on seemed at baseline.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient given Zoster vaccine IM instead of Sub Q. Patient informed to pay close attention for adverse reactions. No symptoms or signs noted at time of vaccination.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Anxiety, Arthralgia, Headache, Hyperventilation
Clinical narrative: Anxiety, hyperventilation, headache, hip girdle pain within 1-2 hours of vaccine administration.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Varicella post vaccine
Clinical narrative: Pt has developed fever and has now broken out in varicella rash all over body.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to pharmacy on 8/28/17 reporting redness, swelling, and heat at injection site following ZOSTAVAX vaccination. She reported using several doses of BENADRYL and that symptoms have improved but are still present. She was told this is a common side effect and as long as symptoms don't worsen or change, it should completely resolve soon. She was told if symptoms worsen or change to contact provider.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Cold sweat, Dizziness, Pallor, Syncope
Clinical narrative: At approximately 1540 pt received Tdap, HPV, and MENACTRA. 1542 Post vaccine pt appears to have a syncope episode. Pt had body enclosed to herself and was violently shaking for approximately 20 seconds. 1543 Pt becomes pale and clammy to the touch. 1544 Nurse and staff place the patient in a back leaned sitting position. 1545 Pt vomits. Approximately 1/2 a cup with food chunks from a previous snack. 1547 An ice pack is placed behind her neck and the nurse and staff continue to talk to her and fan her to keep the pt from falling asleep/passing out. At approximately 1540 pt recieved Tdap, HPV, and MENACTRA. 1542 Post vaccine pt appears to have a syncope episode. Pt had body enclosed to herself a
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tremor, Vomiting
Clinical narrative: At approximately 1540 pt received Tdap, HPV, and MENACTRA. 1542 Post vaccine pt appears to have a syncope episode. Pt had body enclosed to herself and was violently shaking for approximately 20 seconds. 1543 Pt becomes pale and clammy to the touch. 1544 Nurse and staff place the patient in a back leaned sitting position. 1545 Pt vomits. Approximately 1/2 a cup with food chunks from a previous snack. 1547 An ice pack is placed behind her neck and the nurse and staff continue to talk to her and fan her to keep the pt from falling asleep/passing out. At approximately 1540 pt recieved Tdap, HPV, and MENACTRA. 1542 Post vaccine pt appears to have a syncope episode. Pt had body enclosed to herself a
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: REPORTED RASH AND ITCHING. BEGAN EVENING OF INJECTION.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Nausea, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Reaction to GARDASIL 9 vaccine, dose #1; 2:50 PM HPV #1 vaccine administered to LD. C/O of feeling tired and nausea. Dad instructed to call staff for assistance. 2:52 patient fainted and unresponsive, body shaking for a few seconds while sitting on chair. No harm done. 2:53 Staff and Dad present, B/P 102/65 pulse 66 resp 20 patient felt better and was placed laying position and felt better. Good skin color, warm to touch, clinic assessed patient. 3:00 PM 93/64 RA P- 89 3:28 PM 97/64 RA P- 96 warm to touch and feeling better without dizziness and responding well. Good skin color.
Age: 1.75
Sex: M
Vaccine: HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on left and right arms and thighs, and right cheek and neck. Vaccination was given at approximately 11:15 am, I saw the reaction at approximately 12:30. (He had a sweater and pants on so it could've started sooner.)
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Musculoskeletal stiffness, Peripheral swelling, Pruritus
Clinical narrative: Patient received 2 vaccines on Saturday (2 days ago). Those 2 vaccines were FLUZONE HD and PNEUMOVAX 23. Both vaccines were administered in the same arm. Patient stated later that evening she noticed her arm getting red and swelling, but did not think it was an emergency. She came in today (Monday around 10:30 am) to show a pharmacist the reaction she is having. She was not complaining of any pain. I noticed her arm was swollen and red. The patient stated it was a little itchy and stiff. I asked her if it felt warm and she said it felt a little warm. I recommended she seek medical attention right away or see her primary care physician. She seemed to agree, but she didn't seem to urgent about it. I tried to call her around 5:15pm to see what has happened, but I was not able to reach her. She did call me back today after 6pm. She stated she did not go to her physician's office. She is continue with compresses and feels her arm is getting better.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Joint swelling, Local swelling, Mobility decreased, Peripheral swelling
Clinical narrative: SWELLING AND REDNESS FROM SHOULDER TO ELBOW, DIFFICULTY IN  MOVING SHOULDER AND ARM. STARTED 08/25, PT STILL HAS SOME SWELLING AND REDNESS AROUND ELBOW AREA. AS OF 8/28/2017, SHE WENT TO HOSPITAL AND GIVEN RX FOR AUGMENTIN.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Injection site warmth, Nausea, Vomiting
Clinical narrative: Patient called pharmacy 8-28-2017 stating that she has been experiencing severe dizziness, nausea & vomiting since she received the vaccine on the 22nd of August and that the symptoms were the worst on 8-27-2017. She also states that the injection site and surrounding area feel "Hot" but there is no redness or any changes in appearance. She stated that she went to emergency room but left before being seen by any medical professional. She is following up with her PCP in a month.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Per patient, she got headache and nausea for 4 days, and fever for 2 days following vaccination.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Amnesia, Arthralgia, Gastric disorder, Headache, Hypoaesthesia
Clinical narrative: Joint pain all over body, throwing up, headache, eye sensitivity, rashes, stomach issues, numbness around joints, memory loss.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Photophobia, Rash, Rheumatic fever, Rheumatoid factor, Systemic lupus erythematosus
Clinical narrative: Joint pain all over body, throwing up, headache, eye sensitivity, rashes, stomach issues, numbness around joints, memory loss.