chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the 2nd dose I had a red and swollen area on my arm around the injection site. A week later I started getting a headache, muscle pains, joint pains, and heart palpitations. My heart rate goes up to 130 or 140 then go back down to my normal resting heart rate. The heart palpitations come and go, on and off. I had an incident in October 2021 where I went to lay down. Then I had a heart palpitation, and it caused partial vison loss in my right eye. My doctor told me to follow up at the ER, but by the time I was going to go to the ER it had passed. When I went to see my doctor he told me I was having some right side facial drooping. I have a referral to see a cardiologist. My heart palpitations usually last for 5 or 10 minutes.
bruising at injection site developed day after immunization, redness developed 2 days after injection w/expansion on the 3rd day post injection w/associated tenderness, started on keflex for associated cellulitis given rapid extension and tenderness.
feeling achy; This is a spontaneous report received from a contactable consumer reporting for a patient. An 80-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 26Feb2021 14:00 at the age of 80-years-old as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 27Feb2021, the patient experienced feeling achy, a day after receiving her first Pfizer Covid19 vaccine shot. It was unknown if the patient received treatment for adverse event. Adverse event resulted in none of the above. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
See attached sheet. Gave patient flu shot - pt stated that he had the flu shot many times before. I gave him his shot in the right arm. Pt then immediately had a syncopal episode when he fell from the chair and hit his face on the floor. Pt was unconscious for approximately 10 seconds. When he awoke he said that he felt like he was dreaming. I called 911 immediately and stayed with the pt until EMS arrived.
Began feeling weak yesterday, daughter came to check on her today and had trouble lifting her. Vaccinated for covid, currently oxygenating well on room air. Remdesivir x3 days, D5% 0.45% NaCl + KCl 20mEq/L 100/hr
Immediately after receipt of intramuscular influenza vaccine, child fainted--eyes closed, head rolled to side, arms flacid--while still sitting in chair. Assisted child to floor whence she immediately regained consciousness with orientation to person, place, event. Allowed to lie still for 1 minute. Assisted to a chair, observed for 15 minutes with no further issues. Accompanied to classroom by school nurse.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (dose: 0.5 ml, lot # K011325, expiration date 08-APR-2017, route and a vaccination series were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash around the injection site. Redness, some swelling, a bit of itching. Noticed 8 days after injection.
student reports fever 102.7 1 wk p/vax w/sweats & chills & h/a which lasted approx 6 hrs;
Pt had a vasal vagal episode.  She was sitting upright in the chair and assisted to the floor, elevated pt's legs and patient immediately felt better was able to communicate without difficulty  Pt placed on cot and given water and chips.  Pt was able to ambulate to the bathroom without help.  Explained to the mother and patient why is event occurred.  Pt and mother understood.  Pt will increase her salt and water intake the night before  and the day of the next vaccination shot.  Pt Dcd home with mother  Pt and mother given instruction to do deliberate position changes with 30 to 60 seconds waiting period in between. RN PHN
adverse reaction to Pfizer Covid vaccine--neurologic--obtain asap MRi  of brain with contrast and crp/esr and start on prednisone 40mg and f/u  on Thursday, sooner if having  proplems or go to ER. advised not to drive for  now. and avoid drugs and alcholol
Narrative: 1/31/2021 Patient presented to Hospital Emergency Department for evaluation following a fall at home. The patient was admitted to the facility that day for failure to thrive and evaluation for placement in rehabilitation facility for strengthening. Urinalysis on 2/1/2021 indicates urinary tract infection. Symptoms: & Hospitalization for failure to thrive Treatment:
Information has been received from a registered nurse concerning a 12 year old male who in approximately 1999, at the age of 5-years-old was vaccinated with Varivax. On an unspecified date, the patient experienced "breakthrough varicella rash". It was reported that the patient had "more than 50 rashes on upper parts of the body including scalp, face, shoulder and back". At the time of this report, the outcome of the event was unknown. It was reported that the patient had a 11 year old brother, who at the age of 5-years-old was vaccinated with varicella virus vaccine at a different place and different time and subsequently experienced "breakthrough varicella rash" (MSD, WAES# 0607USA02437). Additional information has been requested.
ED to hospital admission for diabetic ketoacidosis. She was given IVF and insulin drip started, soon transitioning off the insulin drip onto her home insulin regimen. Discharged home. This visit was within 6 weeks of receiving the COVID vaccine.
decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain starting on 12/24/20 which has gradually improved with only rare episodes of numbness as of today 1/8/20.  No weakness, back pain or injury.
Took Vivotif 45 minutes after eating raspberries; Spontaneous report received on 18DEC2019.  A consumer reported that she "took Vivotif 45 minutes after eating raspberries" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis. On 18DEC2019, the consumer took the first dose of Vivotif 45 minutes after eating raspberries. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif dose 45 minutes after eating raspberries" (Product administration error). Considering the case information, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took Vivotif dose 45 minutes after eating raspberries" (Product administration error). Considering the case information, the causality of the event is assessed as not related to Vivotif.
facial flushing ONLY;   denies any other S/S whatsoever.    TX - removal of mask, fresh air;  drank water.  waited total of 25 mins; drove off - felt comfortable doing so.
having thoughts of suicide; I Instantly became very emotional, I thought it was relief but my emotions have been off the chart for two weeks.; I had an abundance of energy the first week into to try to get rid of some of the energy I went for a very long walk.; I've been very argumentative; have been crying a lot; high depression; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205), via an unspecified route of administration administered in arm left on 01Mar2021 11:45 at single dose for covid-19 immunisation.  Medical history included high blood pressure. Concomitant medications included lisinopril; pseudoephedrine; chloramphenicol (UNISON). There was no other vaccine in four weeks. The patient previously took codeine and experienced reaction to codeine.  The patient instantly became very emotional, she thought it was relief but her emotions had been off the chart for two weeks. She had an abundance of energy the first week into to try to get rid of some of the energy she went for a very long walk. Since then been very argumentative, having thoughts of suicide, and had been crying a lot. Before the vaccine she did not have thoughts of suicide or high depression. Adverse event start date was 01Mar2021 at time of 11:45 am. No treatment received. No Covid prior vaccination. Covid was not tested post vaccination. The outcome of events was not recovered.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: Positive. Patient had no known allergies. Patient received Paxlovid from 05Oct2023 to 10Oct2023 for COVID 19 Treatment.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5], has been requested and will be submitted if and when received.
No additional AE,; temperature excursion, caller disclosed that multiple doses of MMRlI were administered to multiple patients; This spontaneous report as received from an office administrator refers to a 13-month-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.    On 08-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status rHA) 0.5 ml injection,"once", lot # S012944 was confirmed to be valid, expiration date 28-APR-2021 (route and site of administration were not reported) for prophylaxis. There were previous excursions reported. The digital data logger was involved. No additional adverse events were reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2012USA012763:Same Reporter Link US-009507513-2101USA000854:Same Reporter Link US-009507513-2101USA000853:Same Reporter Link
5/16/21 Pt presented to a free standing ED with complaints of cough, body aches, nasal congestion and otalgia that started around 5/11/21. In the ED she had audible wheezing, mild tachypnea (RR19) and her RA pulse ox was 88-943%. She was placed on oxygen and found to be positive for SARS-CoV-2. CXR showed possible pneumonia and she was transferred to a tertiary care facility for admission. She was discharged on 5/21/21  Acute hypoxic respiratory failure, resolved Covid-19 Virus Infection Date of onset of symptoms: Approximately 7 days prior (5/15/2021) Symptoms present on admission: Nasal congestion, myalgias, productive cough of yellow-green sputum, diarrhea Date of covid positive test: 5/16 Vaccination status: vaccinated, received only first dose Imaging: CXR with lobar pneumonia Oxygen requirements on admission: 2 L Current oxygen requirements: None Medical therapy:  Oral prednisone, not a candidate for remdesivir Inflammatory markers: CRP 18.1, ferritin 111, D-dimer 0.62, LDH 174   Community-acquired pneumonia Given lobar appearance on CXR and productive cough of green/yellow sputum I do feel it prudent to cover the patient for community-acquired pneumonia Treated with Azithromycin, Augmentin     Acute on chronic kidney disease Baseline serum creatinine approximately 1.1-1.2, presenting serum creatinine 1.94 Prerenal versus intrinsic renal 2/2 infection Creatinine trending down to 1.24 at time of discharge   COPD with acute exacerbation IV Solu-Medrol initially, transition to oral prednisone  Schedule bronchodilators Started Symbicort per hospital formulary, and held home Flovent while hospitalized Antibiotic coverage as above
Shoulder pain; Tenderness under the biceps; This is a spontaneous case, initially received from other health professional on 20-Nov-2018, concerning a 29-year-old, adult, female patient.  The patient had no medical history and concomitant medications.  On 26-Oct-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252663 and expiry date: 31-May-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On an unspecified date in 2018 (a few days later as reported), the patient experienced tenderness under the biceps and pain in the shoulder. The patient had no redness and swelling. The patient went to doctor and prescribed with Medrol (methylprednisolone) dose pack.  At the time of this report, the patient had not recovered from the events.  The reporter assessed this case as non-serious.  This case is linked to 201805709, due to same reporter.; Reporter's Comments: A 29-year-old, female patient developed shoulder pain and tenderness on an unspecified date after administration of Flucelvax QIVc vaccine. The company assessed the causality of the events as unassessable due to lack of information regarding the event onset date and onset latency between the event and the suspect vaccine. The case will be further assessed upon receipt of follow up information.
This spontaneous case was initially received on 05-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 26 year old female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received ALFURIA on 05-NOV-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular: Dose: 0.6 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) outcome: On 05-NOV-2015 08:45, after starting/treatment with AFLURIA the patient experienced AFLURIA pre-filled syringe that was left out for 9 hours and reached room temperature (first excursion) was administered (non serious outcome: Unknown). On an unknown date, after starting/treatment with ALFURIA the patient experienced AFLURIA pre-filled syringe that was left out for 8  hours and reached room temperature (first excursion)/Temperature excursion occurred (non serious, outcome: Unknown). Reporter's assessment: Not reported.
Immediately after the vaccine, I felt pain at the injection site. The pain went all the way to my breast. It is so painful that I can not lift arms up and limited range of motion. It is very weak and is worse at nights. It is painful to the touch. Eventually the pain went away from breast area. I went to my doctor and waiting for approval from my insurance to get x-rays. The pain still continues to this day.
Debilitating chills and headaches lasting the entirety of November 12, 2021. Chills weren't treated by bundling up warmly or moving around. Felt significantly better the next day by November 13, 2021.
1st event- he came home at about noon from school the day following his vaccination with a terrible headache and very pale and feeling nauseous. Once he got home he started vomiting and I gave him some Zofran. I had also stocked up on Gatorade and saltines just in case, but he was unable to eat or drink those. He threw up until 8-9PM until he fell asleep. Threw up about 30 times and had an absolute awful headache the entire time. When he woke up in the morning on 01/29/2022, he felt tired but fine. 2nd event- took place on 02/09/2022. The school called at about noon and said that he had a terrible headache and wasn't feeling well so I went and picked him up. When I got him home, it was the same thing, terrible headache, pale and feeling nauseous. He threw up pretty much nonstop until 5PM. He had some vision issues, numbness in his left hand. I called the doctor earlier in the day and asked if it would be okay to give him Zofran again and they said it should be okay. I also called hospital later and asked what I should be doing, and they said I should bring him in. At that point, his vision was okay but he was on the ground in pain because of the headache and I couldn't get him to stop vomiting even with the Zofran. So that's when I took him to hospital. Once we got there, they said he needed to go to the ER and quickly start an IV for fluids, head pain and nausea. We were there until 10PM administering that and he missed school the following day as well with a relatively mild headache and exhaustion.
Starting about 11 hours after my second dose, in quick succession, I became exhausted, had a headache, low grade fever, nausea, all over body aches with extra pain at the injection site.  I took Tylenol and went to bed, but couldn?t sleep.  Around 6 am (21) hours after vaccination, I took a bath with Epsom salts and more Tylenol.  Except for the injection site pain and light headed ness, the other symptoms subsided by 7 am 5/13
Nurse was administering MPOX ID vaccine in forearm when pt jerked arm away, causing leakage and incomplete administration. Upon assessment of the situation, no vaccine content was administered, OK to readminister subQ. Pt education given and pt agreed to receive another proper dose.
Severe diarrhea from 6am on 10/24/03 until 8am on 10/25/03.
9 days after my first vaccine, I got a 4-inch rash on my arm at the injection site.  The rash went away after 36 hours. However, the soreness in my arm came back with the rash, and my arm is still sore two weeks later. I get my second injection in 5 days.
The patient was given the Pfizer Monovalent vaccine instead of the Pfizer Bivalent vaccine. The patient had no adverse signs or symptoms.
Vaccine given on 10/11/16. Mother noted redness at injection site on 10/12/16. Redness on R thigh between hip and spreading down to knee. Pt states is sore and has a slight limp. Mother gave MOTRIN med.
My 1st flu shot made me feel drugged all winter, Head in a bucket feel; Initial information was received on 29-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who reported that my 1st flu shot made me feel drugged all winter, head in a bucket feel  (head discomfort), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, patient reported that my 1st flu shot made me feel drugged all winter, head in a bucket feel  (head discomfort)(unknown latency), following the administration of INFLUENZA VACCINE.   Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
Flu-like. Low-grade fever 99.3. Chills. All over body aches.
Pt developed a red, warm, swollen arm. Stated it was painful to move. Discovered pt actually had same vaccine in 9/2003 but didn't remember. No problems then but maybe the close proximity of the next shot caused reaction. Told pt to take BENADRYL and ibuprofen and to see dr.
Pain in left deltoid  that radiates into shoulder and neck      Mobic 15 mg at bedtime and Cyclobenzaprine  5 mg  twice a day and warm compresses and Tiger balm twice a day as needed
On 06/12/21 patient received the Janssen COVID-19 vaccine at the mass vaccine event approximately 15 hours prior to arrival to the ED.  Patient reports at approximately 2300 hours (12 June 21) she awoke with hives around her mouth; however, went back to sleep.  Just PTA to the ED (0358 hours) she reports awakening with dyspnea, facial swelling with worsening facial rash into her hairline, throat feeling tight and difficulty swallowing.  Patient arrived to ED where she received Epi 0.3 mg SQ, Benadryl 50 mg IV, Solu-Medrol 125 mg, Famotidine 20 mg IVPB with improvement in symptoms.  Patient was observed for greater than 4 hours in the ED without sequela or further intervention required.  D/C with RX: Benadryl, Zyrtec, Prednisone taper, and an Epi Pen and instructions to f/u on Monday 14 June 21.
Vaccine administered that went under temperature excursion for 15 minutes at the site; Vaccine administered that went under temperature excursion for 15 minutes at the site; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (Dose 1) on 28-Jan-2021, Pfizer (Dose 2) on 18-Feb-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The data logger at the clinic was not set with correct parameters and temperature excursion happened with the vial.  Number of doses/vials that were administered from that lot was 2 (1 punctured and 1 not punctured).  The vial was previously stored in fridge.  The vial was moved from freezer to refrigerator on 15-Jun-2022.  The vial was first punctured on 15-Jun-2022 at 9.15 AM.  The vial was stored in portable fridge post puncture.  The vial underwent temperature excursion for about 15 minutes having minimum temperature of 1.9 degree Celsius and maximum temperature of 6.4 degree Celsius. The dose was administered to the patient within less than 12 hours post puncture.  Proposed desired use by date and time of the vial was 15-Jun-2022 (afternoon).  The vial was returned to fridge and quarantined after administration.  Treatment information was not provided.