chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLU3, MENB, MNQ, FLU3, MENB, MNQ, MNQ
Symptoms: Erythema, Inflammation, Pain, Petechiae, Swelling
Clinical narrative: Fever, rash headache, itching, pain in the arm, redness on the site of the vaccine administration (right arm) and redness in the left arm.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Dysstasia, Nausea, Vomiting
Clinical narrative: About 10 minutes after administered vaccine, patient felt a little dizzy and wasn't able to stand up. She eventually felt very nauseated, threw up in the office, but felt almost immediately better after she vomited.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Glossodynia, Pyrexia, Swollen tongue
Clinical narrative: Awoke with a fever of 100.3 tongue was swollen and sore.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Chromatopsia, Visual impairment
Clinical narrative: Patient described visual disturbances in left eye, with "orange" appearance. Re-evaluated patient with vital check; all within normal limits, provider did eye exam, no abnormalities noted on exam. Advised if continues, to schedule office visit with eye doctor. Follow-up via phone to parent the next afternoon; patient's visual disturbance had resolved and no other issues.
Sex: F
Vaccine: MMR
Symptoms: Abasia, Gait disturbance
Clinical narrative: Information has been received from SPMSD (manufacturer control# was not reported) on 04-AUG-2016. Information has been received from a nurse referring to her daughter of unknown age via a video. On an unknown date the patient was vaccinated with MMR II (lot#, strength, dosage, frequency and route unspecified). On an unknown date, following the vaccine administration, the patient had difficulty walking and was unable to walk. The outcome of the events was unknown. The causality was not reported. This is one of two reports from the same TV program. Upon internal review, the event of "unable to walk" to be medically significant. Additional information is not expected since no contact information is provided.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Cold sweat, Dizziness, Dyskinesia, Pallor
Clinical narrative: After receiving the Men B Vaccine client began exhibiting jerky movements. She was swaying forward and almost fell into the wall and forward. The nurse caught her and placed her on a bed. The client was pale, skin was moist and clammy and BP was 90/60. After compress were applied and water was give the BP was reassessed and was 100/68. The client felt better and had dizziness or light headiness.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Neck pain, Pyrexia
Clinical narrative: Dizzy, nausea, fever, neck pain.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Menveo inadvertently given subcutaneously.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray, Chest pain, Feeling hot, Malaise, Pain
Clinical narrative: Body aches, chest pain, feeling hot, malaise. Diagnosed with pericarditis in ER.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Pericarditis
Clinical narrative: Body aches, chest pain, feeling hot, malaise. Diagnosed with pericarditis in ER.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Constipation, Myelitis transverse, Urinary retention
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of myelitis transverse in a 29-year-old female patient who received ENGERIX B adult (batch number Y9424, expiry date unknown). On 1st June 2016, the patient received the 2nd dose of ENGERIX B adult. On 29th June 2016, 28 days after receiving ENGERIX B adult, the patient experienced myelitis transverse (serious criteria GSK medically significant and other: serious as per reporter) and urinary retention (serious criteria GSK medically significant). On an unknown date, the patient experienced constipation. On an unknown date, the outcome of the myelitis transverse, urinary retention and constipation were recovering/resolving. The reporter considered the myelitis transverse, urinary retention and constipation to be probably related to ENGERIX B adult. Additional details were provided as follows: In 2016, less than a year after vaccination, the patient experienced constipation. The healthcare professional did not have expiry date of the vaccine.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Lumbar puncture normal, Myelitis transverse, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Nuclear magnetic resonance imaging thoracic abnormal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of myelitis transverse in a 29-year-old female patient who received ENGERIX B adult (batch number Y9424, expiry date unknown). On 1st June 2016, the patient received the 2nd dose of ENGERIX B adult. On 29th June 2016, 28 days after receiving ENGERIX B adult, the patient experienced myelitis transverse (serious criteria GSK medically significant and other: serious as per reporter) and urinary retention (serious criteria GSK medically significant). On an unknown date, the patient experienced constipation. On an unknown date, the outcome of the myelitis transverse, urinary retention and constipation were recovering/resolving. The reporter considered the myelitis transverse, urinary retention and constipation to be probably related to ENGERIX B adult. Additional details were provided as follows: In 2016, less than a year after vaccination, the patient experienced constipation. The healthcare professional did not have expiry date of the vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Alopecia, Condition aggravated
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of alopecia in a 17-year-old female patient who received BEXSERO. The patient's past medical history included alopecia (experienced on and off, since the patient was 6). Previously administered products included prednisone (the alopecia got resolved after treatment). On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, 28 days after receiving BEXSERO, the patient experienced alopecia (serious criteria other: serious as per reporter). The patient was treated with prednisone. On an unknown date, the outcome of the alopecia was unknown. The reporter considered the alopecia to be unrelated to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient's mother reported to a field representative that her daughter experienced alopecia 4 weeks after receiving a BEXSERO vaccine. For this latest bout of alopecia the patient had seen her trained dermatologist, who did not think it was related to BEXSERO. The alopecia was being treated the same way as it was in the past. The reporter did not want any of her information to be shared.
Sex: F
Vaccine: MENB
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the second of four reports. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced cellulitis, huge rash probably like a whole foot long, swelling, very red and warm to touch, severe pain at the injection site that went all the way up to the back of their neck and all the way down to their hands. The events were described as cellulitis, pain at the injection site, large redness and swelling with hotness, radiating pain both to the neck and all the way down to the hands. The patient went to the Emergency Room where she was diagnosed with cellulitis and they put her on antibiotics. The outcome of events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Injection site warmth, Neck pain, Pain in extremity, Rash, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the second of four reports. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced cellulitis, huge rash probably like a whole foot long, swelling, very red and warm to touch, severe pain at the injection site that went all the way up to the back of their neck and all the way down to their hands. The events were described as cellulitis, pain at the injection site, large redness and swelling with hotness, radiating pain both to the neck and all the way down to the hands. The patient went to the Emergency Room where she was diagnosed with cellulitis and they put her on antibiotics. The outcome of events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the second of four reports. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced cellulitis, huge rash probably like a whole foot long, swelling, very red and warm to touch, severe pain at the injection site that went all the way up to the back of their neck and all the way down to their hands. The events were described as cellulitis, pain at the injection site, large redness and swelling with hotness, radiating pain both to the neck and all the way down to the hands. The patient went to the Emergency Room where she was diagnosed with cellulitis and they put her on antibiotics. The outcome of events was unknown.
Age: 17.0
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Dyspnoea, Hypoaesthesia, Panic attack
Clinical narrative: This is a spontaneous report from a contactable physician assistant (PA) via Pfizer-sponsored program. A 16/17 year-old female patient of an unspecified ethnicity received a single dose of TRUMENBA along with MENACTRA, on an unspecified date. The patient medical history and concomitant medications were not reported. Previously at age 11, she received a dose of MENACTRA. On an unspecified date, the patient experienced numbness of arms, shortness of breath and sort of a panic attack: she was seen in emergency room and due to the events she was admitted to the hospital. The outcome of the events was unknown.
Age: 14.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-JUN-2016, the patient was vaccinated with M-M-R II, once, subcutaneously, lot # L049316, expiry date 03-DEC-2016 (strength, dose and site of administration were not reported). At the time of report, the patient was found to be 5 weeks pregnant. The last menstrual period (LMP) was on 23-JUN-2016 and estimated date of delivery (EDD) was of 30-MAR-2017. The pregnancy outcome was pending and the fetal outcome was unknown. The patient sought medical attention and called the physician's office. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates the patients were administered improperly stored doses of GARDASIL (lot # K010574, expired on 08-APR-2017) (dose and route unknown). The vaccines were exposed under 48 Fahrenheit degree (F). There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This solicited report as received from a Pharmacist via Company Representative refers to a multiple patients of unknown ages and genders enrolled in a Patient Support Program. The patient's pertinent medical histories, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot number and expiration date were not provided). No other suspect medications or concomitant therapies were reported. On an unknown date that multiple unspecified patients experienced a case of Herpes zoster after receiving a dose of ZOSTAVAX. The outcome of the event and the causality between the event and the therapy with ZOSTAVAX were unknown. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. The physician heard about the event reported below from the media, possibly from the Internet. On an unknown date, the patient was vaccinated with an unspecified GARDASIL or GARDASIL 9 could not be ruled out (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date after receiving the unspecified HPV vaccine, the patient was hospitalized due to an unknown reason. The outcome of the event was unknown. The relatedness between the event and the suspect vaccine was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Eye swelling, Fatigue, Joint swelling, Laboratory test abnormal, Rheumatoid arthritis
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of rheumatoid arthritis in a 17-year-old female patient who received BEXSERO. Concurrent medical conditions included acne and anxiety disorder. Concomitant products included CYMBALTA and Acne Medication. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, 14 days after receiving BEXSERO, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant and other: serious as per reporter), swollen joints, fatigue and eye swelling. On an unknown date, the outcome of the rheumatoid arthritis, swollen joints, fatigue and eye swelling were recovering/resolving. The reporter considered the rheumatoid arthritis, swollen joints, fatigue and eye swelling to be unrelated to BEXSERO. Additional details were provided as follows: The age at vaccination was not provided. The patient's mother reported to a field representative that her daughter experienced swollen knuckles, swollen eyes and fatigue starting at least 2 weeks after receiving BEXSERO. The patient had seen her pediatrician and she was tested for rheumatoid arthritis since there was a family history. it was also decided to discontinue her acne medication. The rheumatoid arthritis (RA) titer came back mild, but the patient would be seeing a rheumatologist. The patient was an equestrian and the mother was going to insist that she needs to be tested for Lyme disease. The reporter did not want any of her information to be shared.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rheumatoid factor positive
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of rheumatoid arthritis in a 17-year-old female patient who received BEXSERO. Concurrent medical conditions included acne and anxiety disorder. Concomitant products included CYMBALTA and Acne Medication. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, 14 days after receiving BEXSERO, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant and other: serious as per reporter), swollen joints, fatigue and eye swelling. On an unknown date, the outcome of the rheumatoid arthritis, swollen joints, fatigue and eye swelling were recovering/resolving. The reporter considered the rheumatoid arthritis, swollen joints, fatigue and eye swelling to be unrelated to BEXSERO. Additional details were provided as follows: The age at vaccination was not provided. The patient's mother reported to a field representative that her daughter experienced swollen knuckles, swollen eyes and fatigue starting at least 2 weeks after receiving BEXSERO. The patient had seen her pediatrician and she was tested for rheumatoid arthritis since there was a family history. it was also decided to discontinue her acne medication. The rheumatoid arthritis (RA) titer came back mild, but the patient would be seeing a rheumatologist. The patient was an equestrian and the mother was going to insist that she needs to be tested for Lyme disease. The reporter did not want any of her information to be shared.
Age: 79.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site pain, Peripheral swelling, Pyrexia, Tremor
Clinical narrative: Patient experienced severe pain in her upper arms near injection site, high fever and shaking and both arms swollen.
Age: 79.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site pain, Tremor
Clinical narrative: Patient experienced severe pain in her upper arms near injection site, high fever and shaking and both arms swollen.
Age: 1.25
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Aphasia, Blood immunoglobulin G decreased, Cyst, Dysarthria, Methylenetetrahydrofolate reductase gene mutation
Clinical narrative: High fever, chickenpox outbreak on leg, golf ball size cyst that stayed for 3 months, total cessation of speech. Lost all words. No more babbling sounds. It sounded like garbled slurring.
Age: 1.25
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: High fever, chickenpox outbreak on leg, golf ball size cyst that stayed for 3 months, total cessation of speech. Lost all words. No more babbling sounds. It sounded like garbled slurring.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Induration, Pallor, Pruritus, Rash erythematous
Clinical narrative: Itchy and slightly swollen was noted by patient on Monday 8/8/2016.    Patient was seen on 08/11/2016 and right arm has an area of warmth and confluence over 10x8 cm with irregular borders and small clear fluid blisters. Central induration with pallor in a 2x2 cm with irregular borders as noted by Dr. Patient has been placed Keflex 500 mg orally 4 times per day for 10 days and OTC diphenhydramine can be used for the itching.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Swelling
Clinical narrative: Itchy and slightly swollen was noted by patient on Monday 8/8/2016.    Patient was seen on 08/11/2016 and right arm has an area of warmth and confluence over 10x8 cm with irregular borders and small clear fluid blisters. Central induration with pallor in a 2x2 cm with irregular borders as noted by Dr. Patient has been placed Keflex 500 mg orally 4 times per day for 10 days and OTC diphenhydramine can be used for the itching.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Seizure
Clinical narrative: Patient had two seizures, one at 9:30 AM and another at 5:55 PM.  Patient has known seizures, and Mom states that the seizures were different.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea, Feeling cold, Haematochezia, Headache, Mucous stools
Clinical narrative: Fever, chills, headache, diarrhea.  Diarrhea progressivel worsened in the next 48 hours with blood and mucous present.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, diarrhea.  Diarrhea progressivel worsened in the next 48 hours with blood and mucous present.
Age: 18.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Pt's mother reported his right arm at the injection sites began swelling and turning red.  On the morning of 8/11/16 he woke up and the swelling had enlarged, patient is lethargic, with a fever of 102. "Feels awful".
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unknown number of patients of unknown age and gender. On unknown dates incorrectly stored doses of GARDASIL (lot # L038135, Exp date: 27-MAY-2017 could have been administered. It was reported that, on an unknown date, the refrigerator was out of range for 22 hours with a highest temperature of 48.6 F. Temperature was back in range at the time of call. The Registered Nurse reported that vaccines could have been administered before the excursion was identified. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (route, dose, lot # and expiry date not reported) instead of a dose of VARIVAX. No adverse effects reported. It was verified that it was not product confusion. No further information provided. 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 healthcare worker (office manager) refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccination with improperly stored VARIVAX subcutaneously, lot # L026407, expiration date 15-JAN-2017 (dose was not reported). There was no adverse effect reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Mydriasis, Palpitations, Syncope
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 20 year female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 27-JUL-2016, the pharmacist administered dose 2 of RECOMBIVAX HB strength 10/1.0 microgram/ml, 1 ml intramuscularly ( lot # L042846, expiration date 15-SEP-2017) to the patient. Immediately after administration, the patient fainted, while still at the pharmacy. The patient regained consciousness and her eyes were dilated. She also stated that her heart was "palpitating". The patient recovered from the events while she was still at the pharmacy and did not require any treatment. The patient said that she had not eaten all day prior to vaccination. The causality assessment between the events and RECOMIBVAX HB was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-AUG-2016, the patient was vaccinated with improperly stored VARIVAX (dose: 0.5 ml, lot # M003441, expiry date: 19-JAN-2018) via subcutaneous route. Nurse reported that the vaccine was exposed at 28.2 degree Fahrenheit for 1 hour 15 minutes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ (lot# L042215, expired on 02-JUN-2017; lot# L048854, expired on 31-AUG-2017 (dose unknown) orally. The vaccines were exposed under 48 Fahrenheit degree (F) for undetermined time frame and was back in range. There was no previous temperature excursion. Digital data logger was involved. No adverse events was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received rom a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II (dose, route, lot# and expiry date not provided). On an unknown date the patient had unknown titers drawn, which showed the patient was immune to measles and rubella, however, was not immune to mumps. The reporter could not clarify if the patient had received a dose of M-M-R II prior to the titers being drawn. The outcome of the event and causality assessment was not provided. No product quality complaint (PQC) involved. No further information provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Arthropod bite, Blister, Burning sensation, Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a currently 11 years old male patient. The patient's medical history included a "bad reaction" with a flu vaccine (unknown strength/dosage/manufacturer). The patient's concurrent conditions included asthma and eczema. On 06-JUL-2016, the patient was vaccinated with first dose of GARDASIL via intramuscular route (right arm). Concomitant therapies included albuterol. After receiving the first dose of GARDASIL, the patient had an adverse reaction. The reported stated that the reaction started out as a "small red spot" on his foot "just like if someone took a marker and just tapped it on the skin." Then the reaction spread from the feet, to the ankles, to the lower arms, to the chest, and then to the back. It then turned into "blisters with a crust on top of them." The reaction itched and burned for the patient. The patient was taken to the emergency room at the hospital on 10-JUL-2016. The "medics" at the emergency room felt that the reaction was caused by "bug bites". The reporter then stated she had taken the patient to their primary physician on an unspecified date and the physician felt that it might be "hoof and mouth disease." No treatment was given for the adverse events. The patient's present status was reported as recovered. The reporter felt that the reaction was related to GARDASIL. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Scab
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a currently 11 years old male patient. The patient's medical history included a "bad reaction" with a flu vaccine (unknown strength/dosage/manufacturer). The patient's concurrent conditions included asthma and eczema. On 06-JUL-2016, the patient was vaccinated with first dose of GARDASIL via intramuscular route (right arm). Concomitant therapies included albuterol. After receiving the first dose of GARDASIL, the patient had an adverse reaction. The reported stated that the reaction started out as a "small red spot" on his foot "just like if someone took a marker and just tapped it on the skin." Then the reaction spread from the feet, to the ankles, to the lower arms, to the chest, and then to the back. It then turned into "blisters with a crust on top of them." The reaction itched and burned for the patient. The patient was taken to the emergency room at the hospital on 10-JUL-2016. The "medics" at the emergency room felt that the reaction was caused by "bug bites". The reporter then stated she had taken the patient to their primary physician on an unspecified date and the physician felt that it might be "hoof and mouth disease." No treatment was given for the adverse events. The patient's present status was reported as recovered. The reporter felt that the reaction was related to GARDASIL. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blister, Burning sensation, Erythema, Pruritus, Scab
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a currently 11 years old male patient. The patient's medical history included a "bad reaction" with a flu vaccine (unknown strength/dosage/manufacturer). The patient's concurrent conditions included asthma and eczema. On 06-JUL-2016, the patient was vaccinated with first dose of GARDASIL via intramuscular route (right arm). Concomitant therapies included albuterol. After receiving the first dose of GARDASIL, the patient had an adverse reaction. The reported stated that the reaction started out as a "small red spot" on his foot "just like if someone took a marker and just tapped it on the skin." Then the reaction spread from the feet, to the ankles, to the lower arms, to the chest, and then to the back. It then turned into "blisters with a crust on top of them." The reaction itched and burned for the patient. The patient was taken to the emergency room at the hospital on 10-JUL-2016. The "medics" at the emergency room felt that the reaction was caused by "bug bites". The reporter then stated she had taken the patient to their primary physician on an unspecified date and the physician felt that it might be "hoof and mouth disease." No treatment was given for the adverse events. The patient's present status was reported as recovered. The reporter felt that the reaction was related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored doses of PNEUMOVAX23 (lot# L019836, expired on 24-MAR-2017) (dose and route unknown). The vaccines were exposed under 48 Fahrenheit degree (F) for undetermined time frame and was back in range. There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB (lot# L04048, expired on 04-FEB-2018; lot# M010212, expired on 21-JAN-2019) (dose and route unknown). The vaccines were exposed under 48 Fahrenheit degree (F) for underdetermined time frame and was back in range. There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored doses of VAQTA injection (lot# M009377, expired on 17-JUN-2017; lot# M011116, expired on 17-JUN-2017; lot# M003011, expired on 15-NOV-2017) (dose and route unknown). The vaccines were exposed under 48 Fahrenheit degree (F) for undetermined time frame and was back in range. There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: Patient received vaccine and later that night symptoms of swelling started. This is a new problem. The current episode started 3 to 5 days ago. The problem occurs constantly. The problem has been gradually worsening since onset. The problem is moderate. Associated with: received pneumonia immunization and symptom started on the night. The exposure occurred at home. Swelling location: present on the axillary area, left side. Past treatments include ibuprofen. The treatment provided mild relief.
Age: 26.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral, Tenderness
Clinical narrative: Patient received vaccine and later that night symptoms of swelling started. This is a new problem. The current episode started 3 to 5 days ago. The problem occurs constantly. The problem has been gradually worsening since onset. The problem is moderate. Associated with: received pneumonia immunization and symptom started on the night. The exposure occurred at home. Swelling location: present on the axillary area, left side. Past treatments include ibuprofen. The treatment provided mild relief.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Dx with chicken pox.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site discharge, Injection site discolouration, Injection site erythema, Injection site pustule, Injection site warmth
Clinical narrative: Inj. site red, hot and had a "purple like" sore that broke and drained pus like drainage. Area was a little better but now red and warm again. Area has been bothering Pt since receiving vaccine. Past 2-3 days hot to touch, developed white head, picked it a green and white drainage.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness, swollen, and run down area toward hand.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Hypoaesthesia, Injection site paraesthesia, Injection site reaction
Clinical narrative: Mother called next day after immunization that daughter experiencing headache, arm numbness, tingle at site. No fever. Advised urgent care center but did not go.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Mother called reported child has red whelped area where injection was given on left arm. Child denies pain but itches a little at the site. Mom denies fever, nausea or any other symptoms. Mother gave ibuprofen and BENADRYL this am. Recommended taking to MD but client said if worsen will take MD or ER. She said gave BENADRYL  and MOTRIN and will watch area.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Injection site hypoaesthesia, Limb discomfort, Pain, Rash
Clinical narrative: Patient had numbness in the arm that was injected, heavy arm, swelling, soreness, rash. Symptoms last for 5 days. on 3rd day she developed cough, lasted for a week.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient had numbness in the arm that was injected, heavy arm, swelling, soreness, rash. Symptoms last for 5 days. on 3rd day she developed cough, lasted for a week.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Localised infection, Musculoskeletal pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient received vaccine on 8/4. On 8/5 patient started getting shoulder pain and fever greater than or equal to 101 degrees F, redness swelling of arm. Went to MD and was concerned patients arm was infected. Received cefadroxil 500 mg antibiotic.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: 3 days after receiving ZOSTAVAX patient developed a blister about 10 inches away from vaccination location.
Age: 0.31
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Mom called 7/30/16 to report dime-size local reaction to site of PCV13 vaccine given 7/29/16. No fever. No fussiness. Just red spot. Mom didn't notice until 7/30/16 AM.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rhinalgia
Clinical narrative: 2 days after 7/31, patient experienced pronounced pain on area below the bridge of nose to halfway down nose for 1 week she took ibuprofen but didn't respond to it. She thinks pain may have started on 7/30 but wasn't too noticeable.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Hot rash with increasing size started 8/8/16 no pain. No airway obstruction. Started on Prednisone 10 mg taper pack on 8/10/16. Started on Hydroxyzine HCL 25mg PRN for pruritis.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Large, hot, red swollen upper arm the next morning after vaccine admin.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching, warmth, redness and pain at injection site approximately 48 h after administration, then followed by shortness of breath/"labored breathing".
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Swelling, itching, warmth, redness and pain at injection site approximately 48 h after administration, then followed by shortness of breath/"labored breathing".
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Hypoaesthesia, Injection site joint movement impairment, Injection site pain, Neck pain
Clinical narrative: Limited active range of motion initially (L) shoulder. Pain base of (L) neck, (L) trapezius radiating to upper back, pain (L) shoulder, pain (L) upper extremity. Numbness/tingling (L) upper extremity.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Limited active range of motion initially (L) shoulder. Pain base of (L) neck, (L) trapezius radiating to upper back, pain (L) shoulder, pain (L) upper extremity. Numbness/tingling (L) upper extremity.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 (lot# L024993, expired on 17-OCT-2017 (dose and route unknown). The vaccines were exposed under 48 Fahrenheit degree (F). There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Throat tightness
Clinical narrative: This spontaneous report as received from a nurse via a company representative, refers to a 22 year old female patient with drug reaction/allergy to penicillin. There was no patient's pertinent medical history. On 05-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly (strength, dose, lot number and expiration date were unknown). Concomitant therapies included a birth control pill. Then, after she left, the patient called into the office and reported that experienced some tightening of throat. No product quality complaint was involved. The outcome of throat tightness was reported as recovered. The causality between throat tightness and GARDASIL 9 was not provided. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received on 18-JUL-2016 from a physician via a company representative referring to a male patient of unknown age. The physician reported "about 6 months ago" the patient was vaccinated with the first dose of GARDASIL 9. A few seconds after the first dose of vaccine the patient experienced two episodes of syncope, one right after the other. The patient fully recovered while still in the office. The causality of two episodes of syncope was not reported. No further information was reported. Additional information habeen requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Within 4 hours after administration patient had vomiting, diarrhea, intractable abdominal pain for 48 hours.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On 08-AUG-2016, the patient was vaccinated with dose 4 of RECOMBIVAX HB (dosing details not provided via intramuscular route, (extra dose administered). Physician reported that the patient received rest of the 3 vaccine doses on 03-FEB-2016, 11-MAR-2016 and 18-JUL-2016, respectively. There were no known adverse effects. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: SWOLLEN AT INJECTION SITE FOR 4 DAYS, HURT BACK OF ARM FROM SITE OF SHOT TO ELBOW.
Age: 0.83
Sex: M
Vaccine: IPV, PNC
Symptoms: Medication error
Clinical narrative: No s/s of adverse event. Just inappropriately administered dose.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, TDAP
Symptoms: Unevaluable event
Clinical narrative: None known.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient claims she got shingles from the vaccine. She previously had shingles for the past few months, and came in for the vaccine after she said she had no active lesions.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored doses of M-M-R II (lot# L020189, expired on 03-JUN-2017; lot# L032181, expired on 25-AUG-2017; lot# L036853, expired on 24-SEP-2017 (dose and route unknown). The vaccines were exposed under 48 Fahrenheit degree (F). There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Urticaria - 12 y/o boy - known controlled allergic rhinitis, intermittent asthma and ADHD. Daily meds: FLONASE, Montelukast, Vyvanse. GARDASIL 9 #1 on 06/07/16. # 2 on 08/09/16. On am of 08/10/16 - diffuse urticaria from waist up. Rx with oral BENADRYL.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: The pt had vaccine 8/4/16 and on 8/5/16. Started w/Sever muscular and joint pains. Difficult to move. No fever, no swelling or redness. Upper back, fingers, knees and buttocks involved.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Headache, Hypertension, Injection site erythema, Injection site pain
Clinical narrative: Generalized malaises, headache, body aches with heavy feeling in legs. "Foggy feeling". Localized reaction in deltoid area with swelling, redness, warmth, pain. All above signs/symptoms were reported by patient. Pt declined treatment.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Limb discomfort, Local reaction, Malaise
Clinical narrative: Generalized malaises, headache, body aches with heavy feeling in legs. "Foggy feeling". Localized reaction in deltoid area with swelling, redness, warmth, pain. All above signs/symptoms were reported by patient. Pt declined treatment.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Generalized malaises, headache, body aches with heavy feeling in legs. "Foggy feeling". Localized reaction in deltoid area with swelling, redness, warmth, pain. All above signs/symptoms were reported by patient. Pt declined treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 08-JUN-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 plaque forming units (PFU) (lot # L036823 with expiration date 24-DEC-2016, dose and route were not reported). The vaccine was improperly stored at 12 degree Fahrenheit for 4 months. There was no previous temperature excursion and no data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a currently 5 years old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies. On 09-MAR-2012, the patient was vaccinated with M-M-R II injection, lot # reported as 0400A (dose, route of administration, anatomical location and expiry date were not specified). Other suspect therapies included VARIVAX injection, lot # reported as 0469AA (dose, route of administration, anatomical location and expiry date were not provided) administered on the same day. On an unknown date in 2016 (reported as "recently"), the patient experienced upper respiratory tract infection. The patient sought medical attention and visited the physician's office. During the visit, the patient was prescribed 5 course day of prednisone (manufacturer unknown). No lab diagnostics studies were performed. The outcome of the event and the causality assessment were not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 04-MAY-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 plaque forming units (PFU) (lot # L036823 with expiration date 24-DEC-2016; dose and route were not reported). The vaccine was improperly stored at 12 degree Fahrenheit for 4 months. There was no previous temperature excursion and no data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dry skin, Urticaria
Clinical narrative: Pt wait 15min after vacc given. Pt left returned an hour later with hives. Pt seen by provider. Dx with dry skin note states doubt significant allergy or shot reaction. No treatment given.