chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAINFUL RIGHT BREAST; RIGHT BREAST FEELS HEAVY; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-APR-2021, the subject experienced painful right breast. On 02-APR-2021, the subject experienced right breast feels heavy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the painful right breast and right breast feels heavy was not reported. This report was non-serious.
6/20/12 mom called office because pt had blood in stool. No treatment necessary. Adv to start neocate or elecare formula if continued. *Recommended by nutritionist.
Reaction: sore arm, fever,  body aches, fatigue. Treatment: Ibuprofen and rest. Resolved with in 48 hours.
tender sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender sore arm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tender sore arm). At the time of the report, TENDERNESS (tender sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided.  No Treatment medication was provided.   This case was linked to MOD-2021-314581 (Patient Link).
I had a burning sensation in my lungs and shortness of breath that lingered for several weeks. I had muscle aches and bouts of brain fog. I had like an internal vibration or tremors at times. Like a racing heart and feeling winded. There were a lot of symptoms to when I had COVID-19, be that vaccine. It was symptoms that I felt came back. I would say now, I have occasional lung issues. I had an issue with the burning lungs and called my doctor and I had a telehealth visit, that determined that I watch and wait until anything got worse. I have been having a severe pain in my ankle for no reason. It was swelling inside of the foot right below the ankle, after three hours of icing the foot and it was over the next morning. Also, after I had some blurry vision return. For a month or so there was a feeling like my brain was too big for my skull, I could feel my eyes moves. It was a strange sensation. There was numbness and tingling in my face and hands. There are times when there were mini shocks going through my body.
MODERNA VACCINE-received vaccine and immediately felt hot, fanning with papers, vitals: BP normal , HR 105, complaining of feeling hot and throat feeling tight. Given 25 mg Benadryl liquid, took to ED, second dose of Benadryl given, discharged
I had a constant allergy and uncontrolled asthma; I was having a hard time breathing.
Seizure-like tremors during the night time. Significant fever, shaking, sweating, teeth chattering.  Took Tylenol and drank fluids and symptoms eventually faded
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 30-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) and ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Severe joint pain; Body aches; Diarrhea; Headache; This is a spontaneous report from a contactable Other Health Care Professional (reported for him-self). A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 25Jan2021 15:45, (at the age of 33-years-old) as un-known, single for COVID-19 immunization. Medical history included post-traumatic stress disorder, hypertension both from an unknown date and unknown if ongoing. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT); amlodipine (AMLODIPINE) both taken for an unspecified indication, start and stop date were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. On 26Jan2021 06:00, patient experienced severe joint pain and body aches, diarrhea and headache. Patient did not received any treatment for the adverse event. The outcome of the events was recovering.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
85 recruits were vaxed w/Td & Yellow fever @ the same time; pts exp swelling & erythema surrounding vax site to a greater extent thatn was prev exp;
On Oct 17 I was dx with an embolic stroke. Intermittent symptoms of word finding difficulty first started on Oct 11.
This spontaneous report as received from a female patient of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). On an unknown date the patient developed a rash at the injection site after receiving ZOSTAVAX. Action taken with ZOSTAVAX was unknown. The outcome of rash at the injection site was unknown. The relatedness between the event and ZOSTAVAX was not specified. Additional information is not expected as the patient did not wish to provide any information and there was no mention of a physician in this case.
Rash; Tenderness; Redness and tenderness to touch along my right side; This case was reported by a consumer and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2019).   On 25th September 2019, the patient received the 2nd dose of Shingrix. On 30th September 2019, 5 days after receiving Shingrix, the patient experienced rash, tenderness and erythema. On an unknown date, the outcome of the rash, tenderness and erythema were unknown.   The reporter considered the rash, tenderness and erythema to be possibly related to Shingrix.  Additional case details were provided as follows: The patient received 1st dose, 6 months prior o reporting date.  On Wednesday, the patient received Shingrix.  The patient initially stated, she had rash and upon further clarification she stated on the last night (before the reporting date), she developed redness and tenderness to touch along her right side like dermatomal pattern. She was wondering if this was related to the vaccine.
Complained of Rt. arm soreness.  States unable to raise arm 3 inches away from body.  MD visited on 8/25/11.  Pt. given Rx for muscle relaxers and anti-inflammatory meds.
By 8/9 I was feverish, exhausted, had headaches, sore throat and was coughing so hard I ached all over. Finally on 8/18 I went to Dr. He took chest x-ray and told me I had pneumonia, took azithromycin for 5 days.
Patient fainted immediately after giving 2nd vaccine. (Fluarix).  Her head went straight back over the top of the chair and she gasped 2 times.  I assumed her airway was restricted.  In the meantime, her mother came over and sat next to her and asked if she had a seizure.  I said that I did not believe she had a seizure.  Mother also said she had no history of seizures or fainting.  Just about then the young lady popped up totally alert and able to answer questions from her mother.  Her mother said she felt like she had a fever and wanted to sit there for a while.  She asked if I could take her blood pressure and I told her I did not believe we had a monitor.  They left after about 10 minutes.
body ache especially at the back; eyes burn; bloodshot eyes; joint soreness; arm soreness; feverish; looks when he is sick; felt miserable; A spontaneous report was received from a consumer concerning a 60 year-old, male patient participating in the mRNA-1273 Emergency Use Program and experienced body ache (especially at the back), eyes burn, bloodshot eyes, joint soreness, arm soreness, feverish (no fever), looking sick and felt miserable.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, approximately 2-3 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced body ache (especially at the back), burning eyes, bloodshot (red) eyes, joint soreness, and arm pain. It was reported that the patient was feverish but had no fever. The reporter described that the patient "looks the way he looks when he is sick", felt miserable, but denied chills. Treatment for the events included ibuprofen, 2 or 3 times to alleviate the pain, but it did not seem to really help.   Action taken with mRNA-1273 in response to the events was not reported.   The events, body ache (especially at the back), eyes burn, bloodshot eyes, joint soreness, arm soreness, feverish (no fever), looking sick and felt miserable, were considered recovering/resolving.  The reporter did not provide assessment of the events in relation to study drug.; Reporter's Comments: This case concerns a 60 year old male who experienced non-serious unexpected events of body ache, eyes burn, bloodshot eyes, looking sick and felt miserable and non-serious expected events of arthralgia, arm soreness, and pyrexia.  The events occurred with 2-3 hours after first dose of mRNA-1273 administration.  Treatment for the events included ibuprofen, and all events were resolving at the time of this report. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JAN-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J000493, expiration date 14-APR-2014, 0.65 ml/ once, subcutaneous). No adverse effect was reported. Additional information has been requested.
Itching, redness, hard, about 3 inches horizontal and 2 inches vertical
Pt vaccinated at 11:05 am with COVID-19 Moderna, 1st dose. While waiting in her car at the observation station of the drive-thru site, pt began to feel anxious, described hand shaking. Alert and talking, no distress noted. VS  Pulse 86 bpm, Respirations 16 per minute, O2 sat 98%.  Pt given ice pack to apply to neck. Pt reported hx of anxiety in the past. Staff stayed with pt until she felt better. Pt was discharged to home via her own car she was driving at 11:40.
This is a spontaneous report received from a contactable consumer (reporter's mother) case number: 01873713. A 68-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 20, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient was sore, fatigued and very tired on unknown date. The outcome of the events: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Continued Left shoulder pain.; This is a spontaneous report from a contactable Health care professional, patient qualified nurse. A 45-years-old female patient received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot No: unknown) via an unspecified route of administration, administered on the left arm on Jan2021at 08.00 am (at the age of 45-years old) as a single first dose for COVID-19 Immunization. The second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot No: unknown) via an unspecified route of administration, administered on the left arm on Jan2021at 08.00 am (at the age of 45-years old) as a single first dose for COVID-19 Immunization. Medical history and concomitant medications were not reported and did not have any allergies to food medication or other product. The patient was not pregnant at the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the covid-19 vaccination and other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Left shoulder pain on 29Jan2021 at 9.00pm which continued. Therapeutic measures were taken for the adverse event which included Steroid shot on an unknown date. The clinical outcome of the event Left shoulder pain was reported as not recovered. Information about lot/batch number cannot be obtained. No further information is expected
About four hours after the shot I noticed some sensitivity down in my vaginal area I initially thought it was a hair bump within 24 hours it was swollen bigger than the size of a quarter within 48 hrs even bigger, tenderness and sensitive I went to the doctor she lanced what she initially thought was a boil on Thursday, May 6 and then I returned to her the swelling had returned and on May 7  she determine it was a cyst and proceeded to remove the cyst in her office. I have had to return to her again on Monday, May 10 . Future Appts for May 11 , 14 and 17 so she said that she could continue to pack the hole where the cyst was removed and because of the vicinity of the cyst I?m not able to do any work or look for work because of potential re- infection
Almost immediately, within 5 minutes of injection got metal/burning sensation & taste in throat. Turned into kind of a sore throat within the hour, persisting a couple more hours. Sore arm within an hour (much quicker to start being sore than on dose #1). Fatigue already setting in, just 8 hours later.
Pt recieved 2nd dose of pfizer vaccine on 4/14.  on 4/15 pt had fever up to 103. Pt has had ongoing fevers since. On 4/20 pt became confused and displayed s/s of stroke.  Brought to hospital by EMS and evaluated for stroke like sx.  Pt was treated for stroke- given TPA and placed in ICU.  CT showed show evolving subacute infarct.  Pt has word difficulty, confusion, diaphoresis. Currently still in ICU.
10 doses of Moderna COVID-19 vaccine left past 6 hours They kept it in the refrigerator. accidently they gave 2 doses to two patients; A spontaneous report from was received from a healthcare Professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the Potential expired doses administered to two patients .    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05-MAR-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 05-MAR-2021, It was reported that 10 doses of Moderna COVID-19 vaccine were left past 6 hours. They kept it in the refrigerator.The Potential expired doses were administered to two patients.   Laboratory details if provided.  Treatment details if provided or No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event is considered as resolved.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273.  There were no reported adverse events associated with this case.
Dry cough; Running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "Dry cough"; RHINORRHOEA (non-serious), outcome "not recovered", described as "Running nose".  Additional information: Patient just received Prevnar 20 vaccine. About 12 hours after, patient had a dry cough and running nose. This is still occurring; if it doesn't get better, the patient willl contact the doctor.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Caller called stating that he got his vaccine on 04/05/2021 to the left arm and on 04/06/2021 he woke up with swolen lymph nodes to his left arm pitt. He states that they're tender to touch and the swelling is getting worse. He denies any other symptoms.
Fever, body aches, exteme fatigue, sore airm where shot was given, chills
Local Symptoms: Pain-discomfort, General Symptoms: Nausea, light-headed, numb lips, bad taste. Narrative:
shock type rxn started w/feeling warm temp 100ax-APAP;started vomit 10min later vomit x 5;staring into space, would look @ parents;taken to hosp-still staring described as postictal-fluids;
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 52 year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8727), at the age of 52, intramuscularly, in right arm, on Mar 27, 2021, at 16:45, single dose, for COVID-19 immunisation. Medical history included back pain, start date: Nov 2020 (unspecified if ongoing). The patient's concomitant medications not reported. The patient had pain in extremity (with the first COVID-19 vaccine, he had some pain in his left arm), onset Mar 2021, with outcome of recovered (2021). No follow-up attempts possible. No further information expected.
After the shot on Dec. 4, normal side effect (sore arm) faded in 24 h. However, a tingling sensation in the left body persisted that has never happened after the previous shots. The sensation then became body pain with numbness on the left rib area and Tylenol has to be taken to have a good sleep. By Dec. 10, rashes started showing up on the lower left back suspected to be shingles. Went to urgent care on Dec 11, and confirmed it to be shingles. Prescribed Valacyclovir HCl for one week. More painful rashes have developed on the left side abdomen during the treatment. The shingles have nearly cleared as of today.
Patient had swelling, redness induration pain on left arm site injection with a fever.  Patient was treated with Keflex and Benadryl told to apply warm compression.  Recheck scheduled.
Delayed reaction; Localized raised area at the injection site; A spontaneous report was received from a physician concerning  a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced localized raised area at the injection site and delayed reaction.  The patient's medical history was not provided. No concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed localized raised area at the injection site and delayed reaction. The treatment information was not provided. The reporter stated that the patient was doing fine and had no fever.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events localized raised area at the injection site  and delayed reaction were considered resolved.  Reporter causality for the events was not provided.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious expected events of injection site reaction and injection site swelling.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
she has heart complications; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Pfizer Sponsored Program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "she has heart complications".  Additional Information: Caller [withheld], mentioned that she and her son were due to get the second dose today which was 08Apr2021 at 3:30 PM and she would also have a Doctor's appointment because she has heart complications. Caller wants to know if she can reschedule her appointment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The first night after the shot I woke up with chills so bad that I couldn?t stop shaking for an hour. The day after the shot I had a constant headache, full body soreness, a fever, nausea, loss of appetite, and chills. 2 days after the shot I have developed a cough, have full body soreness, a headache, and nausea. I am colder but have not experienced the chills anymore. I have also experienced strained vision due to the severe headaches.
Narrative:  Patient received two doses of covid vaccine. death over a month after last dose. Unclear documentation of cause of death and no further investigation documented. PMH includes lung SCC, hypothyroidism, carotid artery disease.
Patient arrives via EMS for post cardiac arrest CPR per EMS, patient was at work and received a flu shot from Pharmacist, Immediately after vaccine was administration patient collapsed and went unresponsive, EMS states initial rhythm on their arrival was VFIB, patient was shocked and rhythm was then Torsades, EMS states the patient was shocked 5 additional times, 2 grams magnesium IVPB given, 300mg amiodarone, and 2mg Narcan given by EMS prior to arrival at Hospital Emergency Room. Patient arrives with IO to right lower distal Tib Fib and nasal trumpet in place being bagged by EMS. Patient has a history of hypertension (taking hydralazine), EMS brought flu vaccine information that was being administered by the pharmacist at the patient's place of employment.