chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash and itching at injection site 8 days later after injection; nerve pain/burning sensation in right leg/right ankle 8 days after injection that lasted 3 days. Ocular migraine 8 days later after injection...lasted 15 minutes.
My arm started to hurt about 5 min after vaccine. Got a little better after 10 min. Last night the pain to progressed to severe and still very painful.
about a week after shot developed severe facial pain, felt to have trigeminal neuralgia got temporal artery biopsy negative develop FUO hospitalized 4/8 to present
6 month old baby girl vomited; Possible underdose; This case was reported by a physician via call center representative and described the occurrence of vomiting in a 5-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3N4R7, expiry date 1st May 2022) for prophylaxis.   On 9th October 2020, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 9th October 2020, 1 hr after receiving Rotarix lyophilized formulation, the patient experienced vomiting. On an unknown date, the patient experienced underdose. On an unknown date, the outcome of the vomiting and underdose were unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation.  Additional details were reported as follows: The patient vomited, 1 hour after receiving 2nd dose of Rotarix.  The reporter asked did the dose needs to be repeated which led to possible underdose. The reporter consented to follow up. This case was considered as medication error with harm.
day p/vax pt c/o soreness at the site. swelling & warmth also.temp 101f
She had a episode of vasovagal syncope laid Pt Flat and Immediately got better and ox was at 98%
Chills, low fever, malaise, and headache beginning ca. 5 hours after second injection; symptoms subsided with use of Advil and Tylenol. Persisted 36 hours
Mom called the following day to report that pt had a GARDASIL shot at his PE and was fine afterwards. He had eaten a snack before the shot as well. About 45 minutes later he felt dizzy and fainted in the car. When he got home he had a fever and stayed home the next day. He didn't seem sick at all per mom.
This spontaneous case, initially received from a nurse on 07-Dec-2017, concerning a 58-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November through first December (unspecified year) with the lowest 27.5 degrees F. On 01-Dec-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.
Suspected vaccination failure; shingles, extremely mild case; itching; blister; RASH; pain for 10 days; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and tofacitinib citrate (Xeljanz) for ulcerative colitis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, the patient received the 2nd dose of Shingrix and Xeljanz (oral) 10 mg twice daily (20 mg daily). On an unknown date, unknown after receiving Shingrix and less than 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus, blister and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). The action taken with Xeljanz was unknown. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and blister were unknown and the outcome of the pain was recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus, blister and rash to be related to Shingrix and Shingrix.  Additional details were received as follows: The patient received Shingrix vaccine, on the same day as starting xeljanz therapy.  The patient reported that, after starting the therapy everything was good, she felt good and things were flowing.  The patient then developed shingles, an extremely mild case. She was unsure of start date for shingles symptoms. The patient had pain for 10 days prior to itching and formation of blister.  The physician started valtrex prescription about 6 days ago of the reporting date but rash was still present. The patient received last dose of xeljanz on 10th February 2020. No additional information provided. This case was considered as suspected vaccination failure, since the details regarding time to onset and laboratory confirmation for herpes zoster were not provided.
Information has been received from a physician concerning a 16 year old female who on unspecified date was vaccinated with first dose of Gardasil given with MENACTRA and passed out. It was noted she has a fear of shots. Unspecified medical attention was sought. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information has been requested. 07/08/08 Follow-up information indicated request for no further contact. No additional information available.
I still had swelling from my second dose, but the swelling in my neck and elbow got bigger after my booster dose. I am still dealing with this at this time.
Hives.  I continue to break out in hives daily for more than 7 days after vaccination.
back of her neck started to burn like someone poured acid on her. It burns and her skin bubbles up but doesn't blister.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jul2021 (Lot number: EW0167) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Hypothyroidism" (unspecified if ongoing), notes: Verbatim: Hypothyroidism; "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "Verbatim: allergies" (unspecified if ongoing), notes: Verbatim: allergies. Concomitant medication(s) included: ALBUTEROL HFA; BUDESONIDE; LISINOPRIL taken for blood pressure measurement; LORATADINE. The following information was reported: SKIN BURNING SENSATION (non-serious) with onset 16Jul2021, outcome "recovering", described as "back of her neck started to burn like someone poured acid on her. It burns and her skin bubbles up but doesn't blister.".  Additional information: The reporter has had sun poisoning before, but this was 40-50 years ago. This was how the reporter felt after having the vaccine. The reporter was not outside for very long and then the back of her neck started to burn like someone poured acid on her. It burns and her skin bubbles up but doesn't blister. This lasted about 3 days and sometimes she would only be outside for a few seconds, and it would start, and it would calm down after a while. It had been 2 weeks since the caller had the shot and every once in a while, it starts, and it doesn't ease off. The reporter has had both shots; she didn't had this after the first one. The reporter hasn't had any reaction for years and then all the sudden for it to happen and the timing with the shot concerned the reporter. It was reported that controlled by the foods that the reporter eats. The reporter had been taking her regular medications for a good period of time. patient had not attended Emergency Room and Physician Office. No follow-up attempts are possible. No further information is expected.
He had fever for 2 days and it went away; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He had fever for 2 days and it went away) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391C20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (He had fever for 2 days and it went away). On 11-Feb-2021, PYREXIA (He had fever for 2 days and it went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported by the reporter.   This case was linked to MOD-2021-283961 (Patient Link).
Later in the evening- pain in arm, restless sleep, body aches, inc. temp; nausea, severe swelling at injection site; hot to touch; itching; nausea.
This spontaneous report was received from a nurse and refers to a female patient of an unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date (reported as many years ago), the patient was vaccinated with M-M-R II (dose, frequency, lot# and expiration date were not reported) for prophylaxis, reconstituted with DILUENT MRK INJ (lot# and expiration date were not reported). On an unknown date, the patient experienced rash and general malaise, which lasted for a day or two and resolved without intervention. No treatment was given to treat adverse events. The relatedness between the events and M-M-R II was not reported.
7/23/12 AM Pt awoke with "tennis ball" size erythema and induration accompanied by tenderness at (L) delt. 7/24/12 AM area improving.
Patient received 0.5 mL (50 ?g) dose instead of 0.25 mL (25 ?g) dose that is authorized by the EUA for ages 6-11.
Extreme fatigue, red raised patch on arm (3"x4") & serious vertigo.
Patient phoned on 11/20/22 and left voice mail stating they are feeling musculoskeletal aches after Jynneos vaccine received on 11/19/22.    At the time of vaccination patient stated they had a moderate reaction consisting of muscle aches after COVID vaccinations.    Patient was a staff/host at the vaccine clinic on 11/20/22 and was under direct observation for approximately 2 hours post vaccination.    They complained of mild muscle tightness or discomfort in the sternal area during that time   No signs of allergic reaction. Denied shortness of breath. No wheezing. Able to carry on conversations and walk about the clinic space engaging with others in the room.    States they have ongoing problems with and receive care for musculoskeletal pain and costochondritis.   On the day of clinic, discussed use of otc if approved by their primary care provider.    Responded to voice mail on 11/21/22 - recommended follow up with primary care provider regarding ongoing muscle aches, activate reporting system if they have not already done so.
I had the usual cold-like symptoms a couple of days post-vaccination. Over the month following, I began gradually gaining irregular weight of about 25lbs since receiving the vaccine. At the same week, my physician changed the medications I was prescribed as well. I feel a lot of swelling and bloating in my stomach area since the vaccine. I've tried to drink more water, exercise more and everything, but nothing is helping. I have an appointment scheduled on 05/23/2022 with my PCP for further diagnosis and testing.
Erythema and rash extending down about 2-3" from injection site, tender upon touch.
Vertigo; Nausea; Dizziness; This is a spontaneous report from contactable consumer (patient).   A 61-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0176 or EW0178, Expiration date: 31Aug2021) on 11May2021, at 16:00, at single dose, in the left upper arm, for COVID-19 immunisation. Relevant medical history included allergies to codeine. The patient previously, on an unspecified date, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0164, Expiration date: 31Aug2021) 0.3 ml, single dose, in left upper arm, for COVID-19 immunisation. Concomitant medications included topical steroid-name unknown, stopped 2 days before this report. Medic said to not be concerned because it was a topical cream. On 11May2021, the patient experienced dizziness after getting the vaccine. Sat there a few minutes and felt better, got up and walked to the sitting area. She sat for 30 minutes, got up and drove home. She had seen the medic prior to getting the shot because she has allergies to codeine. On 12May2021, around 02:00 am, the patient developed severe dizziness, vertigo and nausea. Treatment was none. The patient did not recover from vertigo, while clinical outcome of the other events was unknown. Seriousness criteria was not reported for the events.   No follow-up attempts are needed. No further information is expected.
J96.00 ACUTE RESPIRATORY FAILURE 6/24/2022 HYPERLIPIDEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2022 HYPERLIPIDEMIA R09.02 HYPOXIA 6/24/2022 HYPERLIPIDEMIA J96.00 ACUTE RESPIRATORY FAILURE 6/24/2022 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2022 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 6/24/2022 ATHEROSCLEROSIS OF AORTA
This spontaneous report as received from a healthcare worker refers to a 14 year old male patient. Healthcare worker reported that approximately on 30-APR-2013 the patient was vaccinated with first dose of GARDASIL (lot # and expiration date unspecified) injection, (dose, route and anatomical location unspecified) for vaccination. Healthcare worker reported that on 30-APR-2013 the patient complained of being very tired 15 minutes after receiving the first dose of GARDASIL last week. The patient went to an emergency room and was released without finding the cause. The patient went to a different emergency room and was released still without finding the cause. The patient went home and planned to see a neurologist. At the time of the report the outcome of tiredness was reported as not recovered. Additional information is not expected.
Pancytopenia; Bone marrow biopsy consistent with aplastic anemia; This spontaneous case was reported by a physician and describes the occurrence of PANCYTOPENIA (Pancytopenia) and APLASTIC ANAEMIA (Bone marrow biopsy consistent with aplastic anemia) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concomitant products included ACETAZOLAMIDE SODIUM (DIAMOX [ACETAZOLAMIDE SODIUM]), ALPRAZOLAM (XANAX), AMLODIPINE BESILATE (NORVASC), AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), EMPAGLIFLOZIN (JARDIANCE), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LATANOPROST (XALATAN), METFORMIN, MULTIVITAMIN [VITAMINS NOS], METOPROLOL, OMEPRAZOLE, ROSUVASTATIN CALCIUM (CRESTOR) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCYTOPENIA (Pancytopenia) (seriousness criteria hospitalization and medically significant) and APLASTIC ANAEMIA (Bone marrow biopsy consistent with aplastic anemia) (seriousness criteria hospitalization and medically significant). At the time of the report, PANCYTOPENIA (Pancytopenia) and APLASTIC ANAEMIA (Bone marrow biopsy consistent with aplastic anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy bone marrow: consistent with aplastic anemia (abnormal) consistent with aplastic anemia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included OTC vB12.  No treatment drug information provided.  Patient presented to hospital on 24-Aug-2021.  Physician reported that the patient had normal counts several months ago. Patient was previously also under the care of a nephrologist and blood counts were normal then as well.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Administer Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided. The vaccines were stored in freezer, they take out one to two vials and placed in fridge each day as needed.
Patient, Pharmacist, received Boostrix (Tetanus-diphtheria-acellular-pertussis) on 5/20 around 4:45pm. She was administered the vaccine via intramuscularly route in her right arm by pharmacist. About 5-10 minutes after receiving vaccine, patient states difficulty breathing, heat sensation to head, and heart pounding ie...palpitations. Her hands begin to shake and she ask pharmacist to give her Benadryl liquid per immunization kit in pharmacy. Pharmacist assist patient with receiving 1&1/2 teaspoonful of Benadryl liquid. Patient continues to complain of heat sensation to head and heart pounding in chest. Pharmacist and Technican call 911 and paramedics arrive within 15 minutes of phone call to store pharmacy. Pharmacist alerts, Management for further information and to alert spouse of patient. Patient, Pharmacist, is assisted by paramedics to hospital. She later contacts Pharmacist and states to alert pharmacy team she is feeling much better after leaving emergency room.
We received the following information from a consumer via the agency on 12 MAR 2009: A 58-year-old female patient, was vaccinated with FLUVIRIN i.m. in October 2008. Immediately after vaccination she felt dizzy. 48 hours after vaccination she lost consciousness for 1 hour. Further, she complained about exacerbation of chronic health problems since vaccination i.e. weight loss, pain and concentration problems. The patient has a history of "toxicity problems", weight loss, reaction to mercury poisoning, high arsenic level, pain and concentration problems. At time of report, the patient had not recovered. She refused information on treating MD and did not want her MD contacted. Concomitant medication: Phenobarbital, TENORMIN , Lisinopril, AVINZA, Simvastatin. Company assessment : Seriousousness criterion: medically significant. Causality: insufficient data. No medical information/confirmation provided. Expectedness assessment according to label: The reported symptoms are not expected after vaccination with FLUVIRIN. No change in benefit-risk ratio. No measures necessary. Med Com no. NA09-000772
This case was reported by a physician and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX. The subject had no concomitant medications, relevant medical history or adverse events following previous vaccinations. Previous and/or concurrent vaccination included DAPTACEL; Sanofi given on an 20 January 2009. On 20 January 2009 the subject received 1st dose of ROTARIX (1ml, oral). On 24 January 2009, 4 days after vaccination with ROTARIX, the subject experienced intussusception. It was attempted to resolve the intussusception with enemas twice and then the subject did have to undergo bowel surgery. The subject was in the hospital for four to five days and has since been released. The physician saw the subject on 02 February 2009 and stated that the subject was "recovering nicely". The physician did not think he will use ROTARIX again. The physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the event was improved. The physician considered the event was probably related to vaccination with ROTARIX.  4/13/09 MR received for DOS 1/25-28/2009 with d/C DX:  Intussusception of intestine. Pt presented with 2 day hx of emesis, bloody stool and lethargy with intermittent fussiness. PE (+) for abd distention.  IS dx by US.  Attempted reduction by BE only partially successful. Unable to fully reduce so pt to OR for Ex lap with reduction of IS and incidental appy. Improved on d/c.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 10-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Symptom: sore arm and shingles  Signs: long rash with blisters on left abdomen. Tingling and burning sensation mainly around hip, sometimes on upper abdomen, arms, neck and upper thigh.  Time: Almost 48 hours after second shot.  Treatment: Prescribed VALACYCLOVIR (1 gram tablet) Outcome: TBA