chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching redness around injection site. BENADRYL 50mg given orally, ice applied. Primary MD updated and agreed in treatment and to monitor.
low grade fever 99.2; Headache.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: We 8731), via an unspecified route of administration on 16Apr2021 at 16:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep 6955), via an unspecified route of administration in the left arm on 22Mar2021 at 12:30 (at the age of 55- years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 17Apr2021 at 12:00, the patient experienced a low-grade fever of 99.2 (unspecified units) for more than two weeks since the second shot which was accompanied with an occasional headache. The patient reported that her normal temperature was 97.8 (unspecified units). On 17Apr2021, the patient underwent a body temperature measurement and result was found to be 99.2 (unspecified units). The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of all the events low grade fever and headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a mother concerning her 14 month old son with no known drug allergies and no past medical history who was vaccinated with a dose of MMR II. There was no concomitant medication. Subsequently the pt's stool irritated his skin. The mother felt that the stool irritation was related to the ingredients of the MMR II which was excreted in his stool and irritated his skin. The pt sought unspecified medical attention. Additional info is not expected.
Patient received multiple immunizations in clinic on 01/13/12. The morning of 1/14/12, the patient's sister witnessed her having a seizure. Patient transported to ER via ambulance. Fever 39.3 degrees. Patient given MOTRIN & IV fluids. Sent home stable.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant) all with onset 17May2022, outcome "unknown" and all described as "I have all the Pfizer shots, booster but ended up contracting COVID, tested positive on Tuesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Contracting COVID, tested positive on Tuesday. Clinical course: Caller stated, "I have all the Pfizer shots, booster but ended up contracting COVID, tested positive on Tuesday, I started having symptoms late Sunday night in the Monday morning. I'm trying to get this, I tried yesterday and the doctor's office told me that I'm outside of my window for this antiviral pill to work. I spoke to a nurse on our hotline and she said that I should still be within my window to use antiviral pill." Caller asked, "can you tell me yes or no whether it would help if I got this or not?" Caller wanted to know if Paxlovid would still be helpful for him if he get this today. Caller knew that the medication is being given within 5 days. Caller clarified that he tried to get the Paxlovid yesterday and finally got back to him today. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received full dose instead of half dose for booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received full dose instead of half dose for booster dose) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson&Johnson COVID-19 vaccine (Primary dose) in May 2021. Past adverse reactions to the above products included No adverse event with Johnson&Johnson COVID-19 vaccine.    On 16-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient received full dose instead of half dose for booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Patient received full dose instead of half dose for booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Patient who received a primary dose of Johnson and Johnson in May-2021 was mistakenly given the full dose of the Moderna COVID 19 vaccine instead of the booster dose. She thought the patient was receiving the COVID-19 vaccine for the 1st time.  Treatment information was not provided.
Mom reports pt. started w/faint red spots on lower limbs on 11/23/09, spots spread only from waist down, reports weakness and swelling in hands and feet/legs.  12/03/09 MR received for DOS 11/28/09. DX: Pt c/o rash, purpura, painfull swelling in joints. Tx: prednisone. DX: HenochSchönlein purpura.  12/14/09 Vaccine record received for 11/17/09.  12/14/09 MR received for 11/25/09. Pt was seen in clinic for rash, bilateral rash in legs, muscle weakness. Pt was alert in examination. Systems review: negative.
Nauseous, lightheaded,  Itching at injection site, red, swollen, hot, lump like "a plum"  painful to touch "down to elbow"
This spontaneous case reported by a consumer, describes the occurrence of dyspnea (shortness of breath), pain in extremity (sore arm), peripheral swelling (swollen arm), pyrexia (low-grade fever) and headache in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Patient was negative for past history of COVID-19 diagnosis. On Mar 16, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient experienced dyspnea (shortness of breath), pain in extremity (sore arm), peripheral swelling (swollen arm), pyrexia (low-grade fever) and headache. The patient was treated with ibuprofen at an unspecified dose and frequency. At the time of the report, dyspnea (shortness of breath), pain in extremity (sore arm), peripheral swelling (swollen arm), pyrexia (low-grade fever) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications were provided by the reporter.
1-2 hr p/vax 11JUN96 began to scream-far away look-eyes glassy;mom gave APAP as directed & placed cold cloth on legs;took pt to ER about 12JUN96 1030PM;APAP w/cod given;24hr later t102, pt did not seem to know mom during rxn;
This is a spontaneous report from a contactable consumer or other non-health care professional ( patient). A 75-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not report-ed), via an unspecified route of administration (at the age of 75-years), on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included ongoing Dercums. I am 75 years, have a rare disease, Dercums, for info if unaware see Dr. research doc, it is progressive with no cure. It was a doozie Last winter I sent an email to the CDC about your shot as this virus would send those of us with DD straight to heaven, we are so compromised. Nice note back, stating they were comfortable with the Pfizer shot.90% of us wanted the shot. The patient concomitant medications were not reported. On an unspecified date, the patient stated that after getting the first shot was great, arm got sore, no swelling or side effects. Except I felt great, many of my other problems stopped. weakness, pain, brain fogs, digestive. Lasted just over 2 weeks then poof. Others but not enough for (withheld). But she was interested. Second shot just fine but the good stuff didn't come back. No more room, those with strong immunity. Did not get sick from shot. The 2 I know of that got the virus before the shot was available. they are both lucky to be alive, however, both have now got the Delta strain. Both very sick. Enter the reason I call (withheld). You know the old saying out of the horses mouth to get answers. I want answers you can not give probably. How much protection will we have against Delta, are you thinking about a booster, what added things do we look for in Delta anything diff. This is info I wanted to take back to the people who are really scared, and a heads up to all. I will move on to the shot, glad-ly fill in any further questions as needed. Took almost a year. To get it and I had to go to the hospital for that. Let me say because of this DD I keep my immune system pretty strong with herbs and fruits. The clinical outcome for the events was reported as recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101017357 same reporter/drug, different patient/AE
tingling on my right fingers; numbing on my right cheek & lip; numbing on my right cheek & lip; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 15:00 (Lot number: EW0161) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Meniere's disease" (unspecified if ongoing); "Tree nut allergy" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing); "Dust mites allergy" (unspecified if ongoing); "Cats allergy" (unspecified if ongoing). Concomitant medication(s) included: DIURETIC [HYDROCHLOROTHIAZIDE]; NORTREL [ETHINYLESTRADIOL;NORETHISTERONE]; POTASSIUM. Vaccination history included: Bnt162b2 (dose 1, single, Lot number: ER8734, Administration time: 01:15 PM, Vaccine location: Left arm), administration date: 26Mar2021, when the patient was 44 years old, for Covid-19 Immunisation, reaction(s): "tingling in the my fingers and cheeks", "Tingling in lips", "heavy cheek", "Sore arm". The following information was reported: PARAESTHESIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "tingling on my right fingers"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "numbing on my right cheek & lip"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "sore arm". Therapeutic measures were taken as a result of paraesthesia, hypoaesthesia, hypoaesthesia oral, pain in extremity.  Additional Information: The vaccine was administered at a hospital. The patient did not receive other vaccine in four weeks. The patient reported that she was instructed to take diphenhydramine (BENADRYL) right before receiving the second shot. It was further reported that the patient did have tingling on her right fingers, but not nearly as bad as the first one and not as soon. She waited there for 30-40 minutes. The patient then felt numbing on her right cheek & lip, but not as bad as last time & not tingling. After the patient left she felt the numbing move to the left side of her upper lip. The patient's nurse friend told her to take another diphenhydramine (BENADRYL). After a nap, about 5:00 that evening the patient's face & fingers were fine but the sore arm persisted for a few days.  No follow-up attempts are possible. No further information is expected.
Gave TD and Meningococcal vaccines and after giving Meningococcal, pt's eyes rolled to back and he was jerking in extremities. Immediately awakened and alert and oriented.
Pt came to our office on 2/2/04 complaining of a hard eccymotic nodule tender to the touch on her L mid-outer arm measuring approx 10mm. No redness, swelling or fever. Full range of motion with L arm. I referred her to see the doctor at clinic.
Mild Nausea; Moderate Upper Back/ Chest Pains; Moderate Upper Back/ Chest Pains; Partial memory loss after the dose injection; Feverish 'hot' feeling; Elevated Temperature; Severe to Moderate Chills/shaking; Severe to Moderate Chills/shaking; Moderate Muscle Soreness/Aches; Sharp but Mild Joint Pains; Mild Headache; Mild Sweating; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 20Aug2021 12:00 as dose 2, single for covid-19 immunization. The patient did not had any medical history and concomitant medications were not reported. On 20Aug2021, after receiving the vaccine on around 19: 00, the patient had feverish hot feeling which for 108 hours, elevated temperature for 36 hours, severe to moderate chills/shaking for 4.5-5 hours, moderate muscle soreness/aches for 60 hours, sharp but mild joint pains for 36 hours, mild headache for 2-4 hours, intermediate and rare, partial memory loss and mild sweating for 96-108 hour. On 22aug2021 in the afternoon, patient experienced moderate upper back/ chest pains for 6 hours and on 24Aug2021, patient had mild nausea for 4 hours, intermittently. The outcome of the events was recovered.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
On the third day after vaccination, I started to get a Migraine. It was localized Migraine on the left side of my face which was the same side as I was vaccinated on. I have never had a Migraine before. The migraine lasted for three days I got the second dose and had felt like I had the flu with  a fever for 14 hours but no Migraine.
Patient received Janssen dose 0.05ml instead of the 0.5ml recommended dose.  The pt was re-vaccinated with the appropriate Janssen 0.5ml dose on 9/8/2021. No adverse events.
Soreness at shot location, flu-like symptoms on day following vaccination (achiness, headache, fatigue), took Tylenol, slept for 5 hours, felt improved by evening and fine by following day (2 days after vaccination)
At about 4:00 or 4:30, I broke out in hives on my arms, inner thighs - legs, back, stomach - I called my health care provider and she had me take a Benadryl, on Sunday these were going away. At 5:00 pm, I got out of work, I went straight home because I felt so weak and my eyes got watery (didn't go to work out afterward) and I got the chills and my bones started to hurt, I went to bed and slept all - my bones were in horrific pain - especially in my back. Saturday morning, I felt the same -I took OTC med for the pain - no fever; body aches, watery eyes and I was very weak. I drank orange juice and I took some Zinc; vitamin C - and I hurt all that day - bones still achy but not quite as much. Sunday morning, I wasn't normal but better and by Sunday noon I was better; not weak anymore. On a scale from one to 10, I felt like a ten when it was bad. My injection site was sore for a good four days. I took it on a Friday but Tuesday the arm was good to go.
SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight fever. This report was non-serious.
cellulitis with induration erythema and pain at injection site 5cm by 9 cm
rash on her left elbow which is spreading on her both arms; chest tightness; dizzy; elevated blood pressure; anxiety; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash on her left elbow which is spreading on her both arms), CHEST DISCOMFORT (chest tightness), DIZZINESS (dizzy), BLOOD PRESSURE INCREASED (elevated blood pressure) and ANXIETY (anxiety) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history is provided and concomitant drugs are provided.  Concomitant products included LORATADINE (CLARITINE) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced RASH (rash on her left elbow which is spreading on her both arms), CHEST DISCOMFORT (chest tightness), DIZZINESS (dizzy), BLOOD PRESSURE INCREASED (elevated blood pressure) and ANXIETY (anxiety). At the time of the report, RASH (rash on her left elbow which is spreading on her both arms), CHEST DISCOMFORT (chest tightness), DIZZINESS (dizzy), BLOOD PRESSURE INCREASED (elevated blood pressure) and ANXIETY (anxiety) outcome was unknown.
approx 10 hrs p/vax devel fever, malaise, myalgia & severe chills, treated self w/Advil, lot of blankets & early retirement for the noc;
Expired vaccine administered.  Vaccine expiration date was 6/30/2020., vaccine administered on 10/14/2020. Patient denied negative reaction after administration, no signs/symptoms of a reaction.  Per  recommendation of  a website, repeat vaccine should be administered.  Based on that recommendation the visit provider will contact the patient to disuss/ arrange repeat clinic visit for a second vaccine..   What should we do if a dose of expired vaccine is given to a patient?  The dose should be repeated. If the expired dose is a live virus vaccine, you should wait at least 4 weeks after the previous (expired) dose was given before repeating it. If the expired dose is not a live vaccine, the dose should be repeated as soon as possible. If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, mumps, rubella, varicella, and hepatitis A).
hurt; just like covid/ chills; just like covid /exhausted; just like covid/ temp; just like covid/ stomach; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain, chills, exhaustion, fever and gastric disorder. On an unknown date, the outcome of the injection site pain, chills, exhaustion, fever and gastric disorder were unknown.   It was unknown if the reporter considered the injection site pain, chills, exhaustion, fever and gastric disorder to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd shot of Shingles vaccines and stated short truly hurt and also symptoms from 2nd shot was just like Covid. The patient also experienced chills, exhausted, temperature and stomach issue. The patient was glad that both the shots were done. The patient stated that then others said they had nothing, only she had symptoms. The follow-up could not be possible as no contact details were available. The case was linked with case US2021AMR203450 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203450:same reporter
Fever - occurred about 24 hours after vaccine and lasted for 4 hours; high temp 101.4 Fatigue - occurred about 18 hours after vaccine and lasted for 12 hours Pain/swelling at injection site - occurred about 12 hours after vaccine and lasted 36 hours Congestion - occurred about 18 hours after vaccine and lasted about 12 hours
Suffered from side effects with the primary series; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Suffered from side effects with the primary series) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Suffered from side effects with the primary series). At the time of the report, IMMUNISATION REACTION (Suffered from side effects with the primary series) outcome was unknown.            Patient was taking Excedrin.   This case was linked to MOD-2022-560254 (Patient Link).   Reporter did not allow further contact
1st dose -- 1/20/21 Following day experienced very sort Left arm and Left eye sensation of looking through a ring shape (last about 15 seconds) On/about 2/7 noticed onset of tinnitus in Left ear. Saw Dr. on 2/9/21 and began prednisone regiment at 20 mg for 7 days then 10 mg for 3 then back to my 3 mg for PMR. 2nd dose -- 2/24/21 Note --completed the previous prednisone regiment one day prior to this dose. Following day extreme reactions with chills/shaking for several hours, head fullness to feeling of explode, sleeping all day. Within 2 days extreme tinnitus in Left ear.  (Note: with menieres disease in right ear and in burn out phase I ONLY have 1 good ear (left) Started another longer regiment of prednisone and taper. Completed the prednisone regiment and the tinnitus in left ear back with a vengeance on 3/20/21.  Back on 20 mg prednisone and working with both hearing doctor and my rheumatologist.
8 hours after administration patient complained of "severe" total body aches and lethargy, fever "over 102" and "uncontrollable emotional lability". Pt self administered Tylenol. Symptoms resolved completely by 8/11/07.
1/6 vaccination couple hours later, I couldn't see, close and far away. No fever. I couldn't make cognitive sense. BP 150/90. I didn't have strength in legs; couldn't walk. Fatigue in body.  1/7 medical attention. Dr. tested for UTI; negative. Dr. stated was due to vaccination. Dr recommended not having second vaccine but needed to because work with homeless and prisons. Felt needed to have the second vaccine.
Day 1: Body aches, left leg pain, headache, nausea? resolved without treatment  Day 7: left axillary lymph node palpable and painful  Day 9: 4x3 red area, itchy.  Day 12: red area itchy and took Zyrtec, resolved.
Patient reported tingling and a twitch in vaccine administered arm ~3 weeks after Pfizer dose 1. It was a single episode that resolved after a few hours.