chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8732), in left arm, on 04May2021 as dose 2, single (Lot number: EW0167), in left arm and on 21Nov2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Jun2022 as dose 4 (booster), single (Lot number: 054A22A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (08Nov2022) Negative; (09Nov2022) Negative; (12Nov2022) Positive; (12Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was used for treatment of COVID-19 from 03Nov2022 to 07Nov2022.
Tingling sensation throughout vaccinated arm off and on for 24 hours - treated with hot shower and trying to remain still; chronic headache with no prior history of chronic headaches - treated with tylenol
Extremely heavy blood flow menstruation, had to change pads every hour and double up on pads. Clotting the size of 3 golf balls at a time, lasted 6 days.  This was not a normal period for me.  Every period since has been like this-July and August 2021, even though my OBGYN put me on Norlyda in June 2021 to prevent me from having a period at all.
Itching all over, headache the day after the vaccine, cold sore on her mouth, burning in her mouth and tongue.
On 8/27/21, at approximately 9:25am my son had his second Pfizer vaccine. He returned to school and was fine the duration of the day. At approximately 10:30/45pm my son went to bed with no symptoms. At approximately 3:30am 8/28/21, I checked on him and he was under his comforter and very hot and sweating a little. I took the comforter off and covered him with only his sheet. When I did this, he woke groggy and said he had vomited but was ok. I told him to rest more, he went back to bed and at approximately 5:25am I heard an agonizing loud drawn out yelling moan. I ran into my son?s bedroom and he was convulsing in his bed having a seizure. I got in his bed, held his head and assured him I was with him, then called his father and  911 at 5:28am. SEIZURE OBSERVATIONS: His tongue was limply hanging out the left side of his mouth, eyes rolled back, he was gasping for air, his right hand was stretched up and latched onto his light cord, right side of body was rigid and convulsing. I was on hold with 911, the call took a total of 5minutes. Half way through the 911 call, while answering the dispatchers questions about my son ie: is he responsive, does he know his name -while he was seizing and couldn?t talk, my son's convulsions lessened and his eyes came back to a resting state. I asked him his name again and he was responsive but with slurred speech. My son was seizing for approximately 5min from start to finish (appx. 5:25 - 5:30am) . POST SEIZURE: His head laid in my hands, he was limp, weak, exhausted, sweaty, out of breath and disoriented. He didn't know what happened.  He said he had a headache and his left leg was aching. He had to use the bathroom but couldn?t get up, and released in the bed (urinated). The whole left side of his face was drooping and speech was slurred for about 20minutes after he started being responsive. The FD  (and his father) arrived at approximately 5:45am. They checked his vitals. All vitals were fine except the FD mentioned something about his blood sugar was a little high/low(?) at 127. We drove our son to emergency, where he was checked and all vitals were confirmed to be fine. He was discharged and rested the remainder of the day. We had a follow up appointment with his pediatrician on 8/31/21 scheduled for 10:45am.
Child did not have adverse reaction at time of imm. Had positive blood cultures for pneumoccus on 4/14/03 post receiving 4 doses Prevnar. Had high fever 4/14/03.
Hemochromatosis; they throw hers (blood) away because it has too much iron; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hemochromatosis in 2021, they throw hers (blood) away because it has too much iron in 2021. Patient reported, She has hemochromatosis, where she has too much iron in her blood, and having that going on she has been going to the Haematologist twice a month for the last month. You know how you go to donate blood; well, they throw hers (blood) away because it has too much iron. They got it down to a safe level and she went to get the shot. After she got the shot and went to have another blood test, in between this to make sure it's going down. She got the Covid shot and a week later got the blood test because it was time for her to go back for a blood withdraw and the results since the shot have gone up again. Her blood levels have gone up again and now she is scared to get the other shot and does not want the blood level to go up even more. Again, mentions that her condition is called Hemochromatosis. The patient underwent lab tests and procedures which included blood iron was too much iron in her blood in 2021, blood test was done, and her blood levels have gone up on 2021. The outcome of event was unknown.  Description of complaint: Declines to provide further report details. Has hemochromatosis and they got her blood levels to a safe level. She got the Covid shot and a week later got the blood test because it was time for her to go back for a blood withdraw and the results since the shot have gone up again. Her blood levels have gone up again and now she is scared to get the other shot and does not want the blood level to go up even more. States she only had the first Covid shot and blood draw was done in between.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A 9-year-old girl came to the pharmacy on 2/4/2022 for 1st dose of the COVID-19 vaccine. We accidentally gave her COVID-19 vaccine for 12-year-old and above, instead of pediatric COVID-19 vaccine for 5 to 11-year-old. We notified the parent and MD, we gave the wrong vaccine. We will also follow-up with patient in a couple of days. Patient's parent claim she had soreness at injection site and low-grade fever.
Reported tightening in face/jaw after vaccine. Subsided on its own with no treatment.
Rt leg upper thigh 1.5/1.5 lesion on scar tissue.
Patient received vaccine on 12/7/14. Two days later she began to have pain at the injection site that radiated up through her shoulder and shoulder blade on her right side. It also caused a tingling sensation in her right hand. She went to the E.R. on 1-3-14 for treatment.
No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant information was reported. It was reported that the dosage was changed to 0.5 ml. For the past month, nurse had been given 0.25 ml to 19 patients who received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022. No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2022-662961, MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-662973:Same reporter MODERNATX, INC.-MOD-2022-662961:Same reporter
At 0932, RRT was initiated for a 45 y/o M with c/o feeling dizzy, nauseous, and clammy. He also vomited about 50 cc of yellowish emesis. Vaccinated on the L arm at 0923. Vitals: BP - 128/58, HR ? 62, RR ? 18. Head-to-toe assessment completed. After vomiting, client states he felt so much better. He stated, ?I probably did not eat enough.? He has no PMH, NKA, and did not take any medications today. He has not experienced a reaction with any other vaccine, medication, or food product. Throughout monitoring period, client?s condition improved. By the end of monitoring period, client was in stable condition and did not experience dizziness or nauseousness anymore. He was no longer clammy. Client left vaccination clinic at 0948, accompanied by his family, ambulatory, in stable condition.
I was given the flu shot in two doses, one half on 10/5 and the other half on 10/9.  The first shot I had a sore arm and burning which I reported to the nurse when I came back for the second dose.  When I had the second dose, I began to experience burning under my nose and a woozy feeling at about the 15 minute mark after the shot was administered.  My blood pressure elevated and I felt like my heart was going to come out of my chest. I was in the doctors office when this happened as the PA had me stay after the shot.  The PA and nurse monitored my symptoms and when my blood pressured lowered I was able to leave the office.  After the adverse event at the office, I began to experience pain and burning in both arms and across my upper torso.  Those symptoms are still bothering me as of today.  The PA had me take Benadryl initially and then I changed to Allegra after e-mailing the doctor and getting his permission.  I am still on 2 Allegra a day.  I take one rapid release Tylenol in the morning and at night on the days when the burning and pain in my arms and torso is more bothersome.  On those days, I also have a raspy voice.  I also got cold symptoms a few days after the second injection.
Left arm was twitching. Started the evening that the vaccine was given, and still persists presently,24 hours after vaccine administration. The patient received a adult tetanus vaccine in the left arm.
4hr post shot:arm pain .10hr post shot:chills and shivering. 12-19hr post shot: constant chills, shakes, body aches, muscle cramps, vomiting,  20-32hr post shot: body aches, lethargic and fever of 100,7F.  60hr post shot: 3 cold sores on lip.  12 days post shot: 1 cold sore on lip and probable  Shingles (herpes zoster) on left leg.
Losing much more hair than normal the last 4 days.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 15:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the patient experienced losing much more hair than normal the last 4 days, to the point that the patient must clean the brush 2-3 times while brushing the hair when the patient generally only lost a few strands. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event losing much more hair than normal the last 4 days was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Onset on 04/18/2002 with hot and swollen to touch. 4 1/2 x 6" area red and raised.
Bruise at injection site with a warm flat rash extending down arm and curving under arm. Patient had no fever.
(L) deltoid became swollen, red and warm in a 2" x 3" area at injection site. Saw her MD and was prescribed a 10 day course of AUGMENTIN. She fully recovered.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, dose number 1, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date in APR-2022, patient initially was tested negative for covid but had covid symptoms (confirmed covid-19 infection) and started on Paxlovid. The patient additionally received non-company co-suspect Paxlovid (form of admin not reported, oral, batch number: unknown, expiry: unknown) dose was not reported, administered from 23-APR-2022 to 28-APR-2022 for treatment of COVID-19. No concomitant medications were reported. On 02-MAY-2022, 5 days after finishing the treatment with Paxlovid patient experienced tiredness, fatigue, covid positive and confirmed clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0.20220518635-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related..
very sick after second dose; headache after second dose; fever 100°F after second dose; nausea after second dose; threw up after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick after second dose), HEADACHE (headache after second dose), PYREXIA (fever 100°F after second dose), NAUSEA (nausea after second dose) and VOMITING (threw up after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick after second dose), HEADACHE (headache after second dose), PYREXIA (fever 100°F after second dose), NAUSEA (nausea after second dose) and VOMITING (threw up after second dose). At the time of the report, ILLNESS (very sick after second dose), HEADACHE (headache after second dose), PYREXIA (fever 100°F after second dose), NAUSEA (nausea after second dose) and VOMITING (threw up after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degree f (High) 100 degree F.         No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-367283 (Patient Link).
Rheumatoid arthritis flare up; Swelling; Pain aggravated;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4242523-00 (AbbVie).  An adult female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2020 (Batch/Lot number: unknown) to 2021 at citrate free and second regimen subcutaneous since Dec2021 (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up"; SWELLING (non-serious), outcome "recovering", described as "Swelling"; PAIN (non-serious), outcome "recovering", described as "Pain aggravated". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of swelling increased, pain increased and flare up of rheumatoid arthritis joint pain with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Causality for BNT162B2: The reporter's causality for the event(s) of swelling increased and pain increased with BNT162B2 was not reported. Flare up of rheumatoid arthritis joint pain with BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - Rheumatoid arthritis,  pain, swelling, and the suspect drug "BNT162B2" cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Next day post vax, the pt experienced severe left arm pain. The pt went to the ER. The pain was so severe that she was crying, thought she was having a heart attack, and she lost the use of her arm. She also experienced nausea and vomiting. The pt was administered Demerol and an anti-emetic in the ER. She was sent home with her arm in a sling.
Initial and follow-up information has been received from a physician concerning a 11 year old female who was vaccinated with a first dose of GARDASIL (Lot #654535/0960F). Concomitant therapy included MENACTRA, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid) and VARIVAX at the same visit separate sites. Immediately after receiving the GARDASIL injection the patient developed a headache, dizziness, and urticaria at the injection site described as a rash with welts and dermatographism. The patient was given 50 mg of BENADRYL her blood pressure was recorded as 118/70. The patient was then observe for thirty minutes and then released and considered recovered. She was sent for an allergy referral. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On FEB-2017 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On FEB-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.    Additional information has been requested.; Sender's Comments: US-009507513-1707USA000480: US-009507513-1706USA005951: US-009507513-1707USA000479:
The patient received the Pfizer adult dose instead of a Pfizer 5-11 dose. No adverse reactions noted or reported by the parents.
12/31/2021:  Onset of symptoms (fever 100-101, muscle aches, fatigue, sore throat) and positive COVID home test.  1/1/2022 - 1/2/2022: fever 100-101, muscle aches, chills, fatigue, sore throat. 1/3/2022 - 1/5/2022:  no fever, much reduced symptoms 1/6/2022 - 1/8/2022: low fever 99, fatigue; positive COVID test on 1/7/2022  1/9/2022: negative COVID test no fever.   1/9/2022 - 1/10/2022:  Lingering fatigue.
Same day post vax, the pt experienced a very sore left arm and was unable to move it. No treatment was given.
Patient said received flu shot then had regular check up with doctor and 10 minutes later was done. When patient was ready to leave 15 minutes after the flu shot said felt funny. Then when she got home 30 minutes later could not breathe, tongue had swollen in back of throat. Called ambulance who administered IV BENADRYL then was taken to ER where she was told she had a mild reaction to the flu shot and administered an IV steroid. She was sent home 3 hours later with some ibuprofen. She has severe arm pain still and is afraid of taking any medication due to thinking her throat might close.
Fever of 101.8, extreme muscle cramping, joint pain (hips, fingers, shin)
Pain day after injection, and it has never gone away.  Noticed swelling last night. Nearly 4 weeks. Hurts to abduct the shoulder, less with flexion. No fever. No redness. Never reacted to immunizations before. Objective:  There is mild enlargment of the midportion of the L deltoid muscle compared with the Right.  Not red or warm. No fluctuance. No nodule. No lymph nodes. Shoulder ROM is normal. No loss of power.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The reporter stated that a dose of RECOMBIVAX HB, inj (lot# not provided) (dose not reported), that expired on 07-SEP-2014, was administered to a patient today (reported as on 18-SEP-2014), for prophylaxis. Additional information has been requested.
Pt recvd vax & 9 or 10 days following vax pt devel optic neuritis; No further details were provided;
I was scheduled for surgery and had concerns about it following the vaccine, but my doctor said that it should be fine, do I had the surgery. After a few weeks, a blood clot was found in my breast. On May 11, 2021, I had to have another surgery to clean the blood clot from the area.