chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
This spontaneous report was received from a registered nurse and refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 24-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 13 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Swelling and rash all over upper body (arms included). Received steroid dose pack. She just received treatment today. Recovery is expected.
Fever as high at 102.4, nausea, aches and pains, chills and hot flashes / sweating, headache, dizziness, shaking, sore arm all the way to my finger tips.
pt  vax'd w/1st dose of hepatitis B & inadvertently given 3mls instead of 1ml.
Developed petechial rash within few days of receiving 2nd dose on bilateral lower legs. Also had complaints of tremor, weak voice and cough with deep inspiration. Appeared to be developing cellulitis to bilateral lower extremities- treated with oral antibiotic. Oxygen level was good in office, advised to monitor for worsening.
Shoulder, neck, upper arm pain in right side only starting 1 day after vaccine (2/20/21) which has not resolved as of today 3/5/2021
Case previously recorded as MA2009-3668. We received via MedCom the following information on 03 NOV 2009: A 38-year-old female patient, was vaccinated with SOIV FLUVIRIN i.m. on 30 OCT 2009. The patient was pregnant during vaccine exposure (gestational age 6.5 months). No adverse event was reported. MedCom ref. no. NA09-007512.
I got my Pfizer booster shot last Monday; started breaking out head to toe with the rash again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Knee replacement", start date: Apr2021 (unspecified if ongoing), notes: in Apr2021 I had 'knee' replacement done. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (2nd dose, Now they put me on prednisone(Intent Treatment) and I was on prednisone for like two or three months to be honest with you. They couldn't figure out they can't figure out what's wrong with me), administration date: 2021, for Covid-19 immunization, reaction(s): "shortness of breath", "head to toe rash". The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "I got my Pfizer booster shot last Monday"; RASH (non-serious) with onset 2021, outcome "not recovered", described as "started breaking out head to toe with the rash again".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Got covid although he was vaccinated; Got covid although he was vaccinated; This is a spontaneous report from a contactable consumer or other non hcp.  An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), both as single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that the patient got covid in Sep2021 although he was vaccinated . It was informed that he said it was like having a cold. Since the vaccination, the patient been has tested for COVID-19. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
At 25 minutes patient reported finger tingling, chest tightening. Observed for additional 15 minutes and patient began to report sensation of chest tightness and lightheadedness. Transported to ED without epinephrine administration.  BP164/88 pulse 96. O2 sat normal at ED triage station.
Pt. states that after receiving the 2nd Moderna shot 04/24/2021, 04/28/2021 started experiencing shortness of breath with difficulty walking. Wheezing with coughing productions. Still continuing to experience daily. 07/22/2021 planned Primary visit.
On Tues, 1/12 I started feeling like I was getting a cold  because I got the chills when I got home, but not the flu because I had my flu shot in Oct.2020     Wednesday 1/13 I left work because I started with vomiting, diarhhea , a light headache and my arm was real sore.  That continued on through that night and into the next morning.  So I had to call in at work that morning 1/14.  I finally started feeling better by friday night, 1/15.  The headache was gone and the chills were only slight and I could finally keep some toast down.  Before that I could only slightly keep liquids down.
Severe itching and bullseye red hive-like rash from injection site circumference almost as large as shoulder area. Developed low grade fever of 99.9  and chills but the rash area had 102.9  fever for almost 4 days. Took Tylenol , put cold towels on shoulder, and rested. Couldn't take Benadryl because of adverse reaction to Benadryl. Resolved after about 10 days. Shoulder is still very sore after 18 days.
Extremely red,  hot to touch,  area very swollen Pain where I can barely lift my arm  Tylenol 325 2 tablets every 6 hours  Ice pack every 15 minutes
Patient recd Hep B 2nd dose on 10-10-12. 10-12-12 pt presents with raised red bumps at injection site. No cellulitis noted. Advises completing VAERS.
The patient started experiencing joint pain in both of his knees starting on 6/9. The pain is worse in the morning.  They have tried taking acetaminophen and ibuprofen with no significant relief. Recommended trying diclofenac gel and rest, ice, and elevation. If no significant relief in a few days, recommended going to urgent care as patient does not have a primary doctor.
After my 2nd COVID-19 vaccine, I had some fevers post vaccination. I also had some nausea with nonbloody nonbilious emesis followed by 4-5 episodes of frankly bright red hematemesis with clots. Got admitted in ER by myself on  May 16th 2021 evening.  Next day, 5/17/2021, doctor did EGD - CONTROL BLEEDING.  On May 19th 2021 afternoon got discharged from the hospital.
Starting 14 hours after the vaccine was administered I became dizzy, nauseous, my body was aching, I had a pounding headache and I maintained a temperature of 103 for about 15 hours.
Evening of shot arm swelling began.  By 6pm following evening vomiting (6 times) and diarrhea began and lasted until 6am.
Pt. developed eyes swelled shut, red, itching, Pt. complained of nose hurting, short of breath. Liquid BENADRYL given. 911 notified - transported to Emergency Room.
Day after vaccine was given when I would drink or eat anything I would throw up within 1-or 2 minutes. This went on for 9 days. Was able to eat drink on 10-26-23 without vomiting.  dehydration - I.V. to get Liquid in body 2 injections to help with nausea on two ocasions
patient presented to the pharmacy on 3/20/2023 with a red rash on his arm below the injection site of the shingrix vaccine  patient stated the feeling in his arm started about 3 days after the vaccine was admininstered and said the rash was very itchy, he self treated with benadryl capsules at bedtime, stated he received some relief from the itching.  Rash started on 3/15/23 pt presented on 3/20/2023 to the pharmacy stated the rash seemed to be improving.
severe local reaction after 24 hours, patient's right arm was red, swollen and extremely sore,patient to take diphenhydramine and go to ER if have SOB, patient went to MD and got RX(unknown) and he is doing much better, swelling is almost gone
A pharmacist reported that a male received an injection of Tetanus Toxoid 25 to 30 years ago and developed an unspecified reaction. He recovered. No further info was available at the date of this report.
Dose 1 given 2/12/2021 Moderna 024M20A  Patient was hospitalized for Covid 19
No reach action; Administered Booster dose earlier than 5 months by at least 2 days. She presented and requested Pfizer vaccine and had a Pfizer form that had received Pfizer vaccine on 10/06/2022 so was registered for her 2nd Pfizer vaccine; we discussed and after administered Pfizer vaccine voiced that her she left her other form which was her first vaccine; as she is reporting her 2nd Pfizer vaccine was given on 10/06/2022 and I administered what I thought was her 2nd but really was her Booster dose of Pfizer.  Therefore she received it 6 days before 5 months  (or 2 days is use grace period).
VACCINE DOSE ADMINISTERED WAS 6 DAYS EXPIRED. NO ADVERSE EVENTS RECORDED.
Infection; Fibromyalgia; Neck pain; Back pain; Kidney disorder; Pain; Difficulty breathing; Pain stomach; Weird feeling; Headache; Rheumatoid arthritis; bedridden; Pneumonia; This spontaneous case was reported by a physician and describes the occurrence of PNEUMONIA (Pneumonia), RHEUMATOID ARTHRITIS (Rheumatoid arthritis), BEDRIDDEN (bedridden), INFECTION (Infection), FIBROMYALGIA (Fibromyalgia), NECK PAIN (Neck pain), BACK PAIN (Back pain), RENAL DISORDER (Kidney disorder), PAIN (Pain), DYSPNOEA (Difficulty breathing), ABDOMINAL PAIN UPPER (Pain stomach), FEELING ABNORMAL (Weird feeling) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (Oral) at an unspecified dose. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization prolonged and medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criteria hospitalization and medically significant), BEDRIDDEN (bedridden) (seriousness criterion hospitalization prolonged), INFECTION (Infection) (seriousness criterion hospitalization), FIBROMYALGIA (Fibromyalgia) (seriousness criterion hospitalization), NECK PAIN (Neck pain) (seriousness criterion hospitalization), BACK PAIN (Back pain) (seriousness criterion hospitalization), RENAL DISORDER (Kidney disorder) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Pain stomach) (seriousness criterion hospitalization), FEELING ABNORMAL (Weird feeling) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA (Pneumonia), RHEUMATOID ARTHRITIS (Rheumatoid arthritis), BEDRIDDEN (bedridden), INFECTION (Infection), FIBROMYALGIA (Fibromyalgia), NECK PAIN (Neck pain), BACK PAIN (Back pain), RENAL DISORDER (Kidney disorder), PAIN (Pain), DYSPNOEA (Difficulty breathing), ABDOMINAL PAIN UPPER (Pain stomach), FEELING ABNORMAL (Weird feeling) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt was due for Hepatitis B vaccines but HIB was inadvertently pulled and given.
left arm on 25Mar big red spot abd bruise abd hot; left arm on 25Mar big red spot abd bruise abd hot; left arm on 25Mar big red spot abd bruise abd hot; Arm Swelling Reaction; left arm got a large round rash; very painful; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207, Expiry date: Jul2021) intramuscularly administered in Arm Left on 24Mar2021 15:45, as dose 2, single (at the age of 60-years-old) for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, Expiry date: Jun2021) via Intramuscularly administered in Arm Left on 03Mar2021 15:00 for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus, pre-diabetes and hypertension from an unknown date and unknown if ongoing, COVID-19 from 09Mar2021 taken to physician office patient was treated with inhaler Albuterol, patient recovered on 04Apr2021. Concomitant medications included acyclovir sodium (ACYCLOVIR SODIUM) taken for an unspecified indication, start and stop date were not reported; dulaglutide (TRULICITY) taken for Pre-Diabetes from an unspecified start date and ongoing; hctz (HCTZ) taken orally for High Blood Pressure from an unspecified start date and ongoing; lisinopril (LISINOPRIL) taken orally from an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken orally from an unspecified indication from an unspecified start date and ongoing. On 24Mar2021 the Patient experienced arm swelling reaction. On 25Mar2021, the patient experienced left arm on 25mar big red spot abd bruise abd hot. On unspecified date in Mar2021 patient experienced left arm got a large round rash, very painful. The patient went to physician office for the events arm swelling reaction, left arm on 25mar big red spot abd bruise abd hot and it was unknown if treatment was received for these events. It took 4-5 days to diminish. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on 09Mar2021. Patient didn't receive any treatment for event arm swelling reaction. The outcome for arm swelling reaction was recovered on unspecified date of Mar2021, for left arm on 25mar big red spot abd bruise abd hot, left arm got a large round rash, very painful was recovering.  Follow-up attempts are completed. No further information is expected.
few muscle aches; Patient was tired, nothing dramatic; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (few muscle aches) and FATIGUE (Patient was tired, nothing dramatic) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced MYALGIA (few muscle aches) and FATIGUE (Patient was tired, nothing dramatic). At the time of the report, MYALGIA (few muscle aches) and FATIGUE (Patient was tired, nothing dramatic) had resolved.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-379581 (Patient Link).   Reporter did not allow further contact
Client called 3/14/06 2 or 3 days past receiving Twinrix vaccine c/o joint pain, fatigue, loss of appetite + 30lb wt loss in 1 month. Client reports he did go to ER on 2/22/06 and had lab work done at hospital and that all lab work done was normal.
Patient developed shingles on right buttock and leg on 1/20/07, was started on acyclovir.  2 days later she developed meningeal signs and a spinal tap was done.  Her CSF had varicella virus present.  She completed a 10 day course of acyclovir.  4/10/07 Received medical records from hospital which consisted only of LP & CT scan reports.  ER exam on 1/24/07  revealed photophobia, nuchal regidity & positive Kernig & Brudzinski signs.  Rapid PCR was + for varicella zoster virus in CSF.  CSF culture was neg.  CT scan was WNL. FINAL DX: Varicella meningitis.
Sickness; He had joint pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004151.  A male patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Joint pain". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sickness"; ARTHRALGIA (non-serious), outcome "not recovered", described as "He had joint pains".  Additional information: It was reported the patient experienced six months of joint pain after the second dose. He experienced adverse reactions again after the Pfizer booster dose. He had joint pains, sickness and it reportedly lasted for a long time. At the time of reporting, the patient still had those joint pains.  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-PV202200109361 Same patient/drug, different AE, different dose of vaccine;
Pain in extremity; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in extremity). At the time of the report, PAIN IN EXTREMITY (Pain in extremity) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment information were reported   This case was linked to MOD-2021-162188 (Patient Link).
The patient came to the pharmacy to complain from pain in the injection site from the last injection of the ENGERIX-B that was administered on 01/03/2018. The patient denied having any swelling or redness now but only the vague pain. I advised the patient and husband to consult a doctor and we will start our documentation of the event.
Tinnitus both ears one week post injection. Audiology exam and ENT exam 2 1/2 weeks post injection to determine other illness or injury.  None detected.
Seizure like activity, 10 episodes since receiving vaccines 1/7/20@11:35am onset appox.; pt referred to neuro, labs ordered
This is a vaccine error report. The patient received a booster vaccine 8 weeks after the primary series. He came to clinic without a card. His vaccine status was verified in database.
pt recvd vax & screamed high pitch crying x 3 hrs; seen by MD; t101;
Weakness, shortness of breath, became COVID positive after the 1st dose of vaccination, IV meds, blood thinner, chest x-ray, staff member was hospitalized
Hives, pruritis, rash. Treated with prednisone, Benadryl and decadron. 24 hrs after treatment rash still spreading.  No f/u since.
Pt received a dose of pneumovax 23 prior to the dose of prevnar 13 after 65 years old. (incorrect order of immunization.
High fever of any where from 100.1 103.2, screaming fits for hours while throwing his head and body backwards, a rash on his back and abdomen, he is very grumpy and whiny, he is also having what appear to be spasm's in both feet. He was treated with 3.5mls of motin at night.
rectal pain crack of butt; unable to get up form bed; daughter had to help get me to the toilet and get up; very heavy pain felt like carry steel; feels like child bearing pain; fever 100.5; chills; fatigue; arm pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 12-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PROCTALGIA (rectal pain crack of butt), HYPOKINESIA (unable to get up form bed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (daughter had to help get me to the toilet and get up), PAIN IN EXTREMITY (arm pain) and PAIN (very heavy pain felt like carry steel) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016CZ1A and 016BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, LOSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE, COLECALCIFEROL (VITAMIN D3), ALLOPURINOL, METOPROLOL, GABAPENTIN and METFORMIN for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 08-May-2021, the patient experienced PROCTALGIA (rectal pain crack of butt), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (daughter had to help get me to the toilet and get up), PAIN (very heavy pain felt like carry steel), PAIN (feels like child bearing pain), PYREXIA (fever 100.5), CHILLS (chills) and FATIGUE (fatigue). 08-May-2021, the patient experienced HYPOKINESIA (unable to get up form bed). On 12-Apr-2021, PAIN IN EXTREMITY (arm pain) had resolved. On 08-May-2021, PYREXIA (fever 100.5) and CHILLS (chills) had resolved. On 10-May-2021, PROCTALGIA (rectal pain crack of butt), HYPOKINESIA (unable to get up form bed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (daughter had to help get me to the toilet and get up), PAIN (very heavy pain felt like carry steel), PAIN (feels like child bearing pain) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Action taken with mRNA-1273(Modern covid-19 vaccine) was not applicable Treatment drug used is tylenol