chrisvoncsefalvay/vaers-outcomes huggingface dataset:
102 fever; aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 15:00 (Lot number: FH8020) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies: Morphine". No other vaccine in four weeks. There were unspecified medications in two weeks. With both doses, patient had 102 fever and aches. The following information was reported: PYREXIA (disability) with onset 2021, outcome "not recovered", described as "102 fever"; PAIN (disability) with onset 2021, outcome "not recovered", described as "aches". The patient underwent the following laboratory tests and procedures: body temperature: 102, notes: had 102 fever. Therapeutic measures were not taken as a result of pyrexia, pain. There was no covid prior vaccination. COVID was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
13cmx11cm red, swollen, painful area left upper arm where DTaP and IPV injection given. Give Motrin and/or Benadryl per doctor.
However after the second shot he had flu like symptoms for 24 hours; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. This consumer (patient's daughter) reported.   A 85-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd, dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received first dose of Pfizer COVID vaccine and had no symptoms. On an unspecified date 2021, after second shot, patient experienced flu like symptoms for 24 hours and then itself resolved. The outcome of the event was recovered on an unspecified date 2021.   No follow-up attempts are possible. Information about lot/Batch cannot be obtained.
Right arm swollen, pain, red symptoms began 5 days after injection. Advised warm compress and NSAIDS.
A 25-year-old male subject, with no relevant medical history, developed chest pain 5 years after receiving an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on March 2009. On 18 April 2014, the subject developed pleuritic chest pain, associated with deep inspiration. He experienced 3 episodes of pleuritic chest pain. The severity of chest pain was reported as mild. No shortness of breath, no interference with his activities and no other symptoms associated with myopericarditis were noted. Electrocardiogram and rapid troponin test (<0.10 ng/mL) done on 22 April 2014 were normal. The subject had no pain at visit 2 but recurrence of the symptoms was reported. The subject did not take any medications to treat the SAE. No action was taken. The subject was referred for appropriate evaluation. The subject's outcome was reported as not recovered. The relationship was assessed as remote by the investigator. Documents held by sender: None.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 25-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Patient had some swelling and redness at the injection site along with a rash around the site. Patient also complaining of tenderness at the site.
Having a small amount of diarrhea; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 35-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 26Jul2021 13:30 as dose 1, single (age at vaccination: 35 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date Jul2021, it was reported that it was not serious as of now but after a week of taking that shot, I am noticing that I am having a small amount of diarrhea. They did not gave me the lot number, they told me that this was my first dose and then they said the second dose would be on the 16Aug (not clarified). Consumer stated that I started these symptoms like on Saturday morning, that was only as I took the Pfizer. It was stated that see your vaccination card when you get the first dose then you get the vaccine card that tell you when to return for your second dose of Pfizer Vaccine Covid-19, bring your vaccination card and the attention information that if you require visit the website or call the cell phone number provided, my first vaccine it was fine. The clinical outcome of the event was unknown.    Information on the Lot/batch number has been requested.
I wasn't feeling well all winter, I couldn't feel good but I have been anemic so I got an IV infusion. My sodium bottomed out and I ended up in the hospital. My sodium was normal prior to the booster. We spent Christmas out of the area and I was having memory lapses. On April 2 I had a small fall and April 3 I was in a car accident. April 5 I went to the ER. Right before the holiday I went back in. I was an emergency admit again. Everything was off, white count, red count, and I see all kinds of specialists. I left my job because I couldn't think anymore.
3:30 PM: Muscle aches (had to take breaks from standing while baking) 5:30 PM: Muscle aches continue to get worse and fatigued (feeling lethargic) 99 degree body temp 7:00 PM :  Start to get a headache  7:30 PM: Chills, headache, muscle aches, 100 degree body temp.  8:30 PM symptoms increase throughout the night,  10:00 PM temp 102.8  2:00 AM Vomiting and taste changes (my water tasted like I pored sweeter in it)  2:00-8:00 AM continued to have headache, bodyaches, chills,  8:30 Am : Symptoms decrease start to feel better Next day liquids taste like sweeter is added
Pt reported that flu shot was given too high and that she has experienced arm pain and difficulty lifting arm above shoulder since the day following the injection on a subsequent visit to the pharmacy about a month later. She states she "felt it in her fingertips" when the injection was administered as though a nerve was struck, but did not say anything at the time. She has not pursued any treatment beyond ice, rest, and ibuprofen.
Throat swelling, voice hoarse, constant coughing (couldn't hold conversation). Called family member who is a nurse. She suggested BENADRYL.
12/23/2020 sharp pain left lower breast, chest constriction lasted approx for 2 days on and off. 12/26/2020 swollen left armpit, resolved 01/04/2020. Antibiotic  prescription provided.
On 12-8-05 Patient informed office that she had been having pain at injection site since 12-4-05.  Dr. diagnosed cellulitis prescribe antibiotics.  By 12-22-05 cellulitis resolved.
Within an hour and a half after vaccination my skin was flush and red and I developed hives. I work at this facility and was sent to the ER where I was monitored for two hours and received IV Benadryl, solumedrol, and Pepcid. The redness was gone within an hour and the hives disappeared after having to take an additional 25mg Benadryl pill after 6 hours. The next day I experienced fatigue, severe muscle pain, chills and this continued for an additional 2 days.
Patient reported severe vertigo, nausea and vomiting, and brain fog  that have not subsided since injection in late august
I received the flu vaccination on 10/23/2019 during one of the flu clinic's that Occupational Health offered to employees. After speaking with my manager, about the symptoms, sickness, and the way that I have felt since the vaccine, I think I may have had a reaction to this specific flu vaccine. Manager had also filed a report because of the way he has felt since receiving the shot. BACKGROUND INFORMATION: On Monday, October 14, 2019, I went to my Primary Care physician's office and saw Staff. I presented with a very bad cough. Staff prescribed me prednisone 20mg to take orally once per day for 7 days and amoxicillin-clavulanate 875 mg-125mg to take every 12 hours for 10 days. I completed the prednisone medication on October 20, 2019 and seemed to be better with still a little bit of a cough (which I thought it would still taper off since I had the full dose in my system). I completed the amox medication on October 23, 2019. This was the day that I received the Flu Shot. I felt completely normal and the cough had stopped. I received the shot around 2 PM in the room where Occupational Health was giving shots. (Please see attachments section for further details about vaccine). The next day, I felt extremely tired. I was nauseous and felt like I needed to sleep. I had felt like I was sweating but my body was cold. I have had a similar episode to a flu shot (the day after) in the past, so I just thought that maybe the vaccine needed to 'get into my system and I would be fine.' Throughout the next few weeks, leading up to Thursday, November 14, I could barely sleep. This has NEVER been an issue for me. I was waking up from a sweat some nights and felt like I had plenty of energy at 3 AM. I also noticed that my vision was a little more blurry than normal. I was wearing my glasses throughout the day vs. how I generally only wear these at night or when driving. On Thursday, November 14, I made an appointment with Staff at my Primary office because I was not feeling any better. He sent me to the imaging center to have a chest x-ray because the cough was back and worse. He also prescribed me prednisone again. On November, 19, I was at a Site Visit with my co-worker. I started to feel extremely lethargic and dizzy. I had ate my normal breakfast and I always try and drink plenty of water. Co-worker noticed that I started to be very pale. I started not to be able to feel my legs and felt as if I would pass out. Co-worker got a wheelchair to wheel me out of the office. My mother came to pick me up from the clinic to take me home. I reported this to my primary care office and they asked if I needed to come in. I tried to sleep for a little while to see if I felt better, and I did after sleeping and getting more food on my stomach. After telling all of this to Manager, he had mentioned that he experienced very similar things. This prompted me to do this report. I am not sure if it is just a series of unfortunate events of sickness or if it was the vaccine. Dr. and I did not talk about this being a allergic reaction because I think that never really crossed my mind until last week after talking with Manager!
expired Immunization was not pulled out of stock on Friday  8/6/21 (expiration date) and was given to this pt on Monday 8/9/21 No problems - mom notified will re-do
Lymph node swollen near neck area, pain radiates to injection site. With 2nd vaccine lymph node swollen with pain that radiates to injection site. Felt chills and night sweats that night. Fever reached 103.4 for over 24 hours then went to 101. 4 with the use of ibuprofen. Finally got it to come down to 99.2 that Friday. Was seen by doctor through virtual. Felt fatigued muscle aches through our body. Pounding headache. Had Sob and wheezing heard when I went in person to doctor on Friday. Was prescribed steroids and albuteral. Seen primary doctor on Monday she went over my chest X-ray and noticed infiltration on lungs was dx with pneumonia. Prescribed antibiotics with steroids! Have to go for another chest X-ray in 2wks. Also referred to have a Pulmonary capacity test done.
Patient presented to clinic on 4.30.2015 with lesions on limbs-arms and legs. Lab test done on 5.6.15 confirming patient had the chickenpox-zoster virus despite 2 doses of varicella vaccine.
Within 12 hrs of injection, I became severely weak, dyspneic, fever/chills and body aches without appetite and almost nausea. These symptoms lasted X 48 hrs. 5 weeks later, I developed a non covid viral upper respiratory cold that lasted approximately 2 weeks. During this time I developed severe dyspnea and increased exertional effort. I was hospitalized 1/15/2022 with unprovoked bilateral PE with r sided heart strain. I was covid negative X 2 and negative for all/ any other viral response.  I am now informed, because of such profound response, I will be on lifetime eloquis because of the severity of response. Previous, I have been without any major previous illnesses or high risk health. I am upset.
4/21/2022-Presents to ED chest pain. Covid - test. Admit OBS Chest pain r/o AC. Intial trop 0.20 and EKG NSR. 4/23/2022-Cardiac Cath completed. Severe restenosis of the LAD stents.  4/26/2022- Coughing, chills, sore throat and congestion. T-101.5  Covid + test. Creatnine 1.4 AKI. Given bebtelovimab.  4/28/2022-Afebrile. Maintaining spo2 on RA.  4/29/2022- D/C and transfer to hospital possible cardiac transplant.
Unable to lift left arm which the vaccine was given in.  Extreme headache  Nausea
No lot number. Fatigue, 1 day headache, 5 days muscle pain, joint pain, chills, itchy, rash on arm, rapid heart beat.
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 40-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 11May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Relapse of COVID19 symptoms, notes: Relapse of COVID 19 symptoms (congestion, headache, fatigue, night sweats) following 14 days from initial onset of symptoms. I had recovered, and was symptom-free by day 4 of disease onset. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2weeks was reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Triage - presents with red rash onset 1/17/15 - back/chest - arms, ankles - c/o itching - pt antib ointment and triamcinolone cream- with no results - seen 1/9/15 with URI - given AUGMENTIN and prednisone taper - no change in soaps/detergents/no new foods. SOLUMEDROL 125 mg IM right D.G. without problems - instructed to use Aveeno bath and baking soda for itching - but OTC BENADRYL 50 every 6 hrs as needed for itching - do no drive- will make sleepy - verb understanding.
Patient 9 wks pregnant. Got PF flu shot. She had a flu shot last yr & no problem. Patient passed out outside, but doesn't remember anything. She got scraps on her knee & lip.
B/P 152/102 increased heart rate, headache, eyes irritated. Saw nurse at ER told to give pt Tylenol. Did not see MD.
WHEN THE 15 MINUTE OBSERVATION PERIOD ENDED, PATIENT NOTED SCATTERED BLOTCHY RED RASH ACROSS HER UPPER CHEST/FRONT SHOULDER AREA.  RASH ALSO NOTED OVER L SCAPULAR AREA.  SKIN IS CLEAR ON THE  REMAINDER OF BACK, ADBOMEN, EXTREMITES, BLOTCHES ARE NOT RAISED OR  PRURITIC. FACE FLUSHED. PATIENT STATES SHE GETS THIS RASH WHEN SHE IS ANXIOUS.   NO DIFFICULTY BREATHING, NO TIGHTNESS IN THROAT OR CHEST, NO NUMBNESS,SWELLING  OR TINGLING OF LIPS/TONGUE.  PATIENT REMOVED JACKET LAYERS OF CLOTHING AND MASK, GIVEN WATER AND CRAKERS (ALSO HAD NOT EATEN FOR SEVERAL HOURS). LUNGS ARE CLEAR TO AUSCAULTATION. BP 130/91, PULSE OX 100%, PULSE 93.   RASH BEGAN TO SUBSIDE ABOUT 5-10 MINUTES AFTER PATIENT FIRST NOTED IT, AND WAS COMPLETELY GONE WITHIN 20-30 MINUTES.  PATIENT STATED SHE FELT WELL, HAD NO FURTHER COMPLAINTS.
rash developed with a raised, red appearance and filled with fluid; Rash developed around neck, shoulders, butt, arms, chest, and legs; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0176) via an unspecified route of administration on 09May2021 at 11:30 (at the age of 40-years-old) in right arm as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was reported as none and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (Lot number: EW0169) on 18Apr2021 at 10:30 in right arm as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine in four weeks. Patient not had any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 28May2021 at 12:00, about 3 weeks after the second dose, patient had a rash developed with raised, red appearance and filled with fluid. Rash developed around neck, shoulders, butt, arms, chest, and legs. The event was assessed as serious (medically significant). It was reported patient consulted with four clinicians (two internal medicine and two dermatologists) and none of them could diagnose conclusively the cause of the rash, though all four commented that the reaction could be caused by the covid vaccine. The patient was treated with creams and medications (steroids) and they did not help to improve the symptoms or severity. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Device date was reported as 04Jul2021. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Aching of knuckle joints of left hand on awakening (next morning about 13.5 after vaccine.
lethargic, can't walk more than a mile; soreness throughout body; soreness in shoulder, hips; soreness in buttocks; soreness in legs, thighs; burning when given/injected; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age (reported as age: 84; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced burning when given/injected on 02Mar2021, soreness in shoulder, buttocks, hips/legs, thighs on 03Mar2021. It was reported to went away on 04Mar2021. On 05Mar2021, the patient experienced soreness throughout body, and still sore. The patient was also "lethargic, can't walk more than a mile" on an unspecified date. It was reported that it was annoying because the patient was an active person. Patient was querying why he was sore when he get up. The outcome of the events burning when given/injected , soreness in shoulder, buttocks, hips/legs, thighs was recovered on 04Mar2021 (reported as went away), outcome of event soreness throughout body was not recovered and outcome of event "lethargic, can't walk more than a mile" was unknown. The patient was also querying if he can get COVID from the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021272981 Same reporter and product, similar events; different patients.
This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength reported as 19400 PFU) lot # J013138, expiration date 17-JAN-2015, 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reported that ZOSTAVAX was stored at 40F for 90 days and was administered to a patient on 06-JUN-2014. No adverse effects reported. Additional information has been requested. These is one (1) of two (2) reports from the same reporter (MARRS 1406USA007864 and 1406USA007871).
About 24 hours after shot- experienced severe arm pain. Pain radiated from lymph nodes in the armpit area all the way down left arm into hand/wrist. Ice/heat was alternated for approximately 18 hours. acetaminophen taken before bed with little to no affect.   Slight headache which decreased with acetaminophen. Diarrhea for approximately 3 days however, no stomach cramping.
Severe local swelling with skin vesicle formation, pain, fever with erythema developing 24 hours after injection.  Treated with Bactrim and Benadryl with significant improvement at 48 hours.
Warmth and red swelling at site developing over 2 days. Pt hs hx of other allergies. TX was Benadryl PO and topical. Pt has Epi Pen available if needed. Pt records updated to poss. allergic rxn to Neomycin or Poly mix.
menopause symptoms; A throbbing headache; her brain is not working properly; This is a spontaneous report from a Pfizer sponsored program, via a Non-contactable consumer (patient, self-reported).  A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included estrogen replacement therapy. Concomitant medications were not reported. The patient reported that she received the Covid-19 vaccine 9 days ago. It had completely interfered with her estrogen replacement therapy and she was experienced menopause symptoms, a throbbing headache and her brain was not working properly on an unspecified date. The patient wanted to know how long did this last and why weren't we telling people about this. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Subject is a 32 y/o male who approx. 5 minutes after receiving Johnson & Johnson vaccine experienced Grand Mal seizure activity lasting approx. 30 seconds.
Patient reported itchiness in throat, no signs of respiratory distress, oxygen saturation was 98-99%. 25 mg of benadryl oral was given at 1511, patient reported itchiness resolved at 1530.
Pain and joint swelling in hands, numbness and tingling (B) arms, is improving.