chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 01-JUL-2020, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA002536: US-009507513-2007USA003651: US-009507513-2007USA003645: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
I received the shot on 3/23. On 4/23 I had flu symptoms for 24 hours. On 4/29 my taste and smell became distorted. Most foods now taste like metal coins mixed with ammonia, same with some smells. It has changed my quality of life because eating has now become a chore. I still have taste/smell distortion as of 4/13.
no adverse event; a patient was administered PROQUAD that was reconstituted with an expired STERILE DILUENT; This spontaneous report was received from a nurse, regarding a patient of unknown age and gender.   Their medical history, concurrent condition, and concomitant therapies were not reported.  On 07-JUL-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant human albumin (PROQUAD) 0.5, subcutaneously, valid lot# U002530, expiration date 24-JUL-2022 (dosage regimen and anatomical location were not provided) that was reconstituted with an expired sterile diluent 0.7 ml, Lot# S037038, expiration date 05-JUL-2022 (Expired product administered). Lot Number S037038 is not valid for sterile diluent and does not match any company product. No adverse event was reported.
This spontaneous report as received from a physician via a company representative refers to a 65 year old female patient. There was no information about the patient's concurrent conditions or medical history provided. On 13-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M000592, expiration date 12-OCT-2017 (dose and route of administration were not reported). Concomitant therapies included an unspecified flu shot, administered on the same day in her left arm. On 14-DEC-2016, 24 hours later, the patient experienced arm cellulitis, swelling and redness in her right medial arm. The deltoid area was also tender to the touch and the area affected was approximately 3 cm by 6 cm. The patient did not receive any treatment. There were no lab diagnostic studies performed. She did not seek medical attention. The outcome of the events was reported as recovered/resolved on an unknown date. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of arm cellulitis was considered to be medically significant. Additional information has been requested.
This spontaneous report as received from a medical assistant via a company representative refers to a 13-year-old female patient. The patient's concurrent condition included unspecified allergies (hypersensitivity). On 25-AUG-2018, the patient was vaccinated with her second dose of GARDASIL 9 (Lot # and expiry date was not reported) for prophylaxis. The patient's concomitant therapies included BENADRYL. On 25-AUG-2018, the patient became pale, had lower blood pressure and felt like she was going to throw up. The patient received treatment with oxygen for the events and was transported to an unspecified hospital. The outcome of pallor, hypotension and nausea were unknown. The medical assistant also reported that the patient did not pass out or throw up and according to the patient's mother the patient had not eaten anything that day and took an unspecified dose of BENADRYL for unspecified allergies that morning. The reporting medical assistant did not provide the causality assessment for the events. There was no product quality complaint involved. Upon internal review, the events pallor, hypotension and nausea was determined to be medically significant due to oxygen therapy.
Was vaccinated for 4 strains of HPV 7 years ago. Was negative for HPV at the time. I am positive for HPV now.
received two fluzone hd qiv, the second dose was within an hour of the first with no reported adverse event; Initial information was received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 79 years old female patient who received two influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] the second dose was within an hour of the first with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Oct-2023, the patient received a 0.7 ml,once dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot UT8157AA, expiry date: Jun-2024, strength: unknown) via intramuscular route in the left deltoid for Immunization and received two fluzone hd qiv, the second dose was within an hour of the first with no reported adverse event (extra dose administered) (Latency: same day).  Reportedly, The caller believed that the patient thought she was getting another COVID vaccine. They have their clinics set up where patients can get both flu vaccines and COVID vaccines. They believe the patient became confused and received two FLUZONE HD QIV  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine administered 3/2/06 at 11:45 a.m.  Patient had onset of symptoms at 6:30 p.m. on 3/2/06 consisting of difficulty breathing like asthma; body muscle aches and weakness; chest heaviness; cough; and chills.  She did not take her temperature.  Symptoms resolved by 10:00 p.m. and she felt completely well by 11:30 p.m.  Patient did not seek medical attention and did not take any medications.  On 3/3/06 she developed bilateral ear itching at 11:15 a.m. and reported this at 11:45 a.m. at which time she was given Benadryl 25 mg p.o. and was told to report summary of events to her family doctor, which she did.  At 12:30 p.m. 3/3/06, she now reports she has had chest heaviness since her ears started to itch at 11:15 a.m.  The itching of the ears has resolved with Benadryl.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure abnormal, esophageal acid reflux and blood cholesterol abnormal. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd May 2018, 3 days after receiving SHINGRIX, the patient experienced injection site abrasion. On 4th May 2018, the patient experienced injection site warmth, injection site itching and injection site erythema. On an unknown date, the patient experienced pain in arm. On 7th May 2018, the outcome of the injection site warmth, injection site itching, injection site abrasion and injection site erythema were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm, injection site warmth and injection site erythema to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site itching and injection site abrasion to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a physician. The patient's concomitant medication included blood pressure medication, cholesterol medication and acid reflux medication. The patient received SHINGRIX on the right upper arm. In 2018, less than a week after vaccination, the patient's upper arm was sore for 3 days. On 3rd May 2018, the patient scratched the right arm. On 4th May 2018, the patient noticed that her arm just below the area of the injection was hot to touch, red and itchy which were lasted for 3 days. On 7th May 2018, the redness faded away and all other symptoms were resolved. It was the patient's choice to get the vaccine and was not ordered by an healthcare professional (HCP). The patient was not sure whether to take the follow up shot or not. The patient stated, no one seemed to have heard about this reaction. The patient denied permission to contact their physician and did not have additional information pertaining to these adverse events.
Patient presented 24 hours after flu shot with a headache, fever of 100.6 and myalgia.
My right leg near my knee began to burn; Then hives developed. My stomach also developed hives.; My left leg also had pressure in it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 13:15 (Lot number: FD8448) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known_allergies:broccoli" (unspecified if ongoing); "known_allergies:shrimp" (unspecified if ongoing); "known_allergies:peanuts" (unspecified if ongoing); "known_allergies:coconut" (unspecified if ongoing); "known_allergies:corn, wheat" (unspecified if ongoing); "known_allergies:gluten" (unspecified if ongoing). Concomitant medication(s) included: VITAMINS NOS. The following information was reported: BURNING SENSATION (non-serious) with onset 27Aug2021 13:30, outcome "recovering", described as "My right leg near my knee began to burn"; URTICARIA (non-serious) with onset 27Aug2021 13:30, outcome "recovering", described as "Then hives developed. My stomach also developed hives."; LIMB DISCOMFORT (non-serious) with onset 27Aug2021 13:30, outcome "recovering", described as "My left leg also had pressure in it". Therapeutic measures were not taken as a result of burning sensation, urticaria, limb discomfort.  Prior to vaccination, was the patient was not diagnosed with COVID-19.Since the vaccination, patient has not been tested for COVID. No treatment received, case assessed as non serious  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Multiple joints developed pain and swelling, including both wrists, thumb and finger joints, low back pain, ankle pain.  Pain and swelling lasted about three days.  Symptoms recurred on August 5, with same joints painful and swollen, and left foot developed swelling, redness, warmth and tenderness.  Saw PA at my doctor's office August 11.  Was treated with antibiotic and prednisone.  All symptoms except back pain subsided, but developed bilateral buttock, thigh and leg pain.
my right arm gets a tingling feeling that I have not had before; just has this weird feeling/ At times this feeling spreads up the side of my neck/ This feeling comes and goes/ like when your foot, arm, etc goes to sleep; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (my right arm gets a tingling feeling that I have not had before) and FEELING ABNORMAL (just has this weird feeling/ At times this feeling spreads up the side of my neck/ This feeling comes and goes/ like when your foot, arm, etc goes to sleep) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (my right arm gets a tingling feeling that I have not had before) and FEELING ABNORMAL (just has this weird feeling/ At times this feeling spreads up the side of my neck/ This feeling comes and goes/ like when your foot, arm, etc goes to sleep). At the time of the report, PARAESTHESIA (my right arm gets a tingling feeling that I have not had before) and FEELING ABNORMAL (just has this weird feeling/ At times this feeling spreads up the side of my neck/ This feeling comes and goes/ like when your foot, arm, etc goes to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
BUD date 04/07/2022 administered on 4/22/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended revaccination
Horrible headaches and body aches.  Swollen glands.  Fatigue.
I got laryngitis then a little bit of a cough. Then fatigue and fever set in that lasted a couple of days. The cough was on and off. The fever subsided and the cough is still here and I'm getting my energy back but not completely over it. The doctors thought it was an asthmatic bronchitis. I did not test positive for COVID-19.
Very lethargic. Boosted in very high fever that lasted 36 hours. Still congested. No appetite. Second booster was given a year later from first shot instead of 6 months later.
Slightly swollen; Itchy; Big red splash; Hot; covid arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Slightly swollen), PRURITUS (Itchy), ERYTHEMA (Big red splash), FEELING HOT (Hot) and VACCINATION COMPLICATION (covid arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced SWELLING (Slightly swollen), PRURITUS (Itchy), ERYTHEMA (Big red splash), FEELING HOT (Hot) and VACCINATION COMPLICATION (covid arm). At the time of the report, SWELLING (Slightly swollen), PRURITUS (Itchy), ERYTHEMA (Big red splash), FEELING HOT (Hot) and VACCINATION COMPLICATION (covid arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Reporter reported that patient was taking other medication.
Woke up sore with a mild fever with chills, slightly nauseous and improved as the day went on, mostly back to normal by the day after.
Pt received flu shot at works on Friday. That evening, pt began having hives and also chest pain. Pt eventually admitted for chest pain to r/o cardiac and GI events. No other changes in meds or food except this flu shot. Pt has had flu shot previously with no adverse effects. An event occurred that contributed to or resulted in temporary harm to the pt and required treatment or intervention.
33 year old male received his first dose AVA on 7/23/03. He developed headache later that day. By 7/31/03 the headache had become increasingly worse. Other symptoms included photophobia, vomiting, diarrhea and fever. Patient went to clinic on 7/31/03 and again on 8/1/03. He was kept for several hours observation and treated with IV fluids, tigan and demerol. Vitamin B-12 and Vitamin C shots were also administered. Patient was told he had an infectious process, possibly flu and sent home on Keflex 500mg TID, Motrin 500mg for headache. Patient went to hospital 8/4/03 for continued headache, nausea/vomiting, and fever. CT scan and spinal tap performed. Patient admitted with diagnosis of viral meningitis. Treated with IV fluids and symptom management. Discharged 8/8/03. The hospital and clinic physicians told patient and family that the events were not related to the vaccine. On 8/12/03 and 8/15/03 the patient returned to his physician for unresolved nausea and headache and was given IV fluids and dietician consult for vitamin supplementation. Patient returned to work 8/18/03 - still with slight headache and stiff neck, also some stomach upset. Patient reported that tests for West Nile virus were negative. Patient continues on Keflex 500mg TID and Motrin PRN. Follow up on 10/31/2003: "Additional information received 10/14/2003: Patient fully recovered and did not have any adverse events with subsequent anthrax vaccinations. "
On 2/2/00, pt recv'd MMR,Varicella, Hib, & IPV.  On 2/10/00, pt recv'd DTaP. Within 1 hr, pt beame fussy & dvlped fever.He also began vomiting, dvlped lethargy and some "jerking".Also noticed hive-like spots around DTaP inject site. Follow up information states that child had loose cough for about 1 month post episode and rash for 6-8 weeks. Now resolved. 60 day follow-up dated 07/24/00 provided no additional data.
vaccination had been given and then it was found to be 3 months expired with no reported adverse event; Initial information received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 59-year-old female patient for whom IPV (VERO) [IPOL] vaccination had been given and then it was found to be 3 months expired [expired product administered].   The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  On 02-Jul-2021, the patient received a 0.5 mL 3rd dose of suspect IPV (VERO) [lot number not reported and expiry date: 13-Mar-2021] via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to expired product administered [Latency: on the same day].  It was reported that, they realized later that this was an expired vial of Ipol they used.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Information has been received from a consumer, for the Pregnancy Registry for GARDASIL vaccine, concerning his 25 year old wife general anesthesia allergy who was vaccinated 3 doses of GARDASIL vaccine (Lot # not reported) prior to becoming pregnant.  Concomitant therapy included heart medication.  Consumer's wife is the patient in this case.  Consumer reported that his wife had completed the GARDASIL vaccine series approximately six months to becoming pregnant with their first child.  Consumer reported that they learned at 17 weeks gestation that his wife had lost their baby around 12 weeks of gestation.  Laboratory test was performed previous to pregnancy and during pregnancy.  Consumer reported that his wife will call back with more specific dates and information.  Upon internal review, abortion spontaneous was determined to be an other important medical event.  Additional information has been requested. 11/13/09 Medical records received for date 11/10/09. DX: PID, UTI, dysmenorrheal. Presented with pelvic pain x1 month abrupt onset. Pt states intermittent cramps. Assessment: WNL, cervical/uterus exam WNL, pt signed out before external genitalia exam. Pt signed out AMA.
Red bump; Red bump; Feels strange; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-SEP-2023, the patient received the 1st dose of Shingrix (right arm). On 21-SEP-2023, 1 days after receiving Shingrix, the patient experienced local swelling (Verbatim: Red bump), erythema (Verbatim: Red bump) and weird feeling (Verbatim: Feels strange). The outcome of the local swelling and erythema were resolving and the outcome of the weird feeling was unknown.   It was unknown if the reporter considered the local swelling, erythema and weird feeling to be related to Shingrix.     It was unknown if the company considered the local swelling, erythema and weird feeling to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter reported that the patient received Shingrix vaccine and felt strange. The reporter stated that he had one little red bump that appeared on his left arm opposite his elbow area that looks like it was going away now. The reporter consented to follow up.
I26.99 - Subacute massive pulmonary embolism (CMS/HCC) I26.99 - Other pulmonary embolism without acute cor pulmonale
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 10-JUL-2016 to 09-SEP-2016 the patients were vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # L044475, expiry date: 12-MAY-2017), which was stored at a temperature of 25 degree Fahrenheit, for a time frame of 4 days 1 hour 45 minutes there was no previous temperature excursions reported, (lot # M020103, expiry date: 15-FEB-2018), which was stored at a temperature of 25 degree Fahrenheit for a time frame of 15 minutes. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.