chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 25 minutes after receiving the dose, patient complained of itching on her chest and also a sensation of itching and tightness in her lungs.   Has had this sensation before with allergy to mold.   Gave 50mg of benedryl and monitored.   Sensation did begin to improve about 30 minutes after benedryl, and continued to improve,
fully vaccinated and boosted 22Oct2021, all Pfizer, and just recovered from Covid (probably omicron).; fully vaccinated and boosted 22Oct2021, all Pfizer, and just recovered from Covid (probably omicron).; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant) with onset 22Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "fully vaccinated and boosted 22Oct2021, all Pfizer, and just recovered from Covid (probably omicron).". It almost certainly mitigated his symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Had a reaction to the Covid Vaccine, both arms are going numb and I am concerned, wondered and scared about that; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, had a reaction to the Covid Vaccine, both arms are going numb and I am concerned, wondered and scared about that on unknown date. Consumer stated, I would like for somebody to know that I got this vaccination 16 hours ago and my arms were numb and I am scared. The outcome of the event was reported as unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional (Medical Assistant) via other company (Pfizer) under Manufacturer Report Number: 2018359728. This case involves a 18 years old male patient who experienced shortness of breath, while he received vaccines HEPATITIS A VACCINE, TRUMENBA and MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications, were not provided. On 27-Aug-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U58338A via unknown route. On 27-Aug-2018, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot 560256 via unknown route. On 27-Aug-2018, the patient received a dose of suspect HEPATITIS A VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route. On 28-Aug-2018, the patient developed a non-serious shortness of breath 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, TRUMENBA and HEPATITIS A VACCINE. Lab test was not reported. Final diagnosis was shortness of breath. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered/Resolved on an unknown date for shortness of breath.
Administered expired vaccine to patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter's address updated.
Muscle soreness; This spontaneous case was received on 18-Sep-2020, from other non-health professional (consumer) via Agency (reference number: SEQW20-01990) and concerned a female patient of unreported age.   The patient had no relevant medical history.  The patient's concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for protection against seasonal influenza. The batch number was not reported.  On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced muscle soreness. No corrective treatment was applied for the event.  On an unspecified date, the patient recovered from muscle soreness.   The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Case updated on 25-Nov-2020: Correction made to information received on 18-Sep-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. Narrative and company comment amended accordingly  Company comment: Event of muscle soreness is considered as related to influenza virus vaccine polyvalent.; Sender's Comments: Event of muscle soreness is considered as related to influenza virus vaccine polyvalent
Patient referred from PCP office for abnormal EKG. Patient reportedly fell on the ice and has been having chest pain since then. Case was discussed with cardiology who recommended to discharge patient home. ACS was ruled out and per cardiology, the pain was likely due to the fall. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Seizure like activity. Daughter has a prolonged startle and her eyes roll up into her head you can not get her to stop while the event is taking place
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown by the reporter. On an unknown date (reported as "as a teenager"), the patient was vaccinated with an unspecified number of doses of hepatitis b vaccine (recombinant) (manufacturer unknown) injection (exact dose, route of administration, lot # and expiry date were not reported), however she did not complete the three dose series. Then, on unknown dates, (reported as "as an adult"), the patient was administered the complete series of hepatitis b vaccine (recombinant) (manufacturer unknown) injection (exact dose, route of administration, lot # and expiry date were not reported). Subsequently, on an unknown date, the patient had titers drawn, which were negative. Due to these negative titers, on an unknown date, the patient began another series of hepatitis b vaccine (recombinant) (manufacturer unknown) injection (exact dose, route of administration, lot # and expiry date were not reported), however the nurse who was administering hepatitis b vaccine (recombinant) (manufacturer unknown) injection pulled the needle out of the patient's arm too soon and the liquid vaccine spilled down the patient's arm, possibly leading to a less than administered dose. No adverse effects were reported. It was not specified how many doses of hepatitis b vaccine (recombinant) (manufacturer unknown) injection the patient received in total. The outcome of the event of negative titers and causality between the event and hepatitis b vaccine (recombinant) (manufacturer unknown) were not provided. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 16 Dec 2021 and administered on 18 Feb 2022) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 16 Dec 2021 and administered on 18 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 16 Dec 2021 and administered on 18 Feb 2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported- received 1/2 booster dose. The vial didn't undergo any temperature excursions. No concomitant drug reported. No treatment information was provided by the reporter.
Pt developed very large raised, hot, red reaction over (R) deltoid area following administration of 2008 Flu vaccine and Pneumovax at adjacent sites. Also had severe headache with nausea and vomiting.
Having hot flashes; Early menopause; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 40 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset Jan2022, outcome "unknown", described as "Having hot flashes"; PREMATURE MENOPAUSE (non-serious) with onset Jan2022, outcome "unknown", described as "Early menopause". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the Pfizer Covid booster in Dec2021 and started having hot flashes in early Jan2022. She had hormones tested the week of 17Jan2022 and will have to start hormone therapy for early menopause.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient presents to the emergency department secondary to fever and weakness.  Patient does have dementia and cannot participate in history, wife at bedside gives history.  Patient recently hospitalized for a colonic abscess.  He was treated medically.  Today he was noted to have nausea rigors and a fever.  He did complain of abdominal pain
Muscle and joint pain, headache, vomiting (could be from the headache), fatigue, shortness of breath.
Patient unable to provide any other vaccine information but states that they are fully vaccinated. Patient diagnosed with COVID after being fully vaccinated
After the first shot I had random quick intense pain,  a sensation like somebody punched me hard with their knuckle out.  I would come and go quickly.  Intense, then go away.  It was on my lower right breast, left side of my head, on my right leg near my upper quad.  It lasted throughout the day.  After the second shot, the first hours after were fine.   Woke up at 6am and the pain that was quick come and go with the first shot, now the pain was just as intense, but did not go away.  So under my breast, my leg, my head, the pain was intense and did not go away.  Then the intensity of the pain grew and spread throughout the day.  By 8pm I could barely walk, my legs were so pained and  my back, everywhere it was so incredibly painful.  I went to bed, and woke up around midnight and the pain had subsided.
Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose of Prevnar. The physician stated that there was an error on the part of the office. Specifically, 70 doses of Pneumovax 23 were ordered instead of Prevnar because both products were next to each other on the order form. It was reported that 40 doses were administered with the belief that they were Prevnar. It was reported that there was no confusion in regards to product packaging. The physician stated that the problem had been corrected at the office and did not foresee any future problems. On an unspecified date, the patient returned to the physician's office and was vaccinated with a fourth dose of Prevnar. There were adverse experienced reported. Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted. Additional information is not expected.
I was feeling really sick and so I took a COVID-19 Home Test my significant other had just tested positive as well. For about ten days I had issues with upper chest congestion and like a really bad cold. I was put on Paxlovid and it was that tenth day that I felt better. I did end up with a rebound case with the same symptoms of congestion and headache and they were worse.
On Wednesday, I noticed two nickel sized bumps on my arm. I had a root canal at the dentist Friday and they put me on an antibiotic. Saturday, I noticed my arm was getting red and swollen. I went and saw urgent care Sunday and they said that I had cellulitis. I ended up going to the hospital and they did some blood work. I saw my doctor Monday morning and he put me on another type of antibiotic. I had a follow up appointment on Thursday. The swelling had gone down by then and it was feeling fine. I asked him if I should get my 2nd vaccine and he said that I should. On March 7th, I went to get my 2nd dose of my vaccine. The person that checked me in said that someone else had the same thing happen to them. I am now not having any kinds of problems. I am doing much better.
Information has been received from a physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of PNEUMOVAX.  Concomitant medication was not reported.  Subsequently on an unspecified date, the patient experienced a large, swollen and red area at the injection site.  Unspecified medical attention was sought.  Subsequently on an unspecified date, the patient recovered from a large, swollen and red area at the injection site.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report was received from a consumer via company representative regarding a 1-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD and a dose of VARIVAX, (dose, route, anatomical location, lot number and expiration date were not reported for both vaccines above described) both vaccines for prophylaxis. Additional information has been requested. It has been determined that case US-009507513-1702USA008643 was sent to distribution with an incorrect aware date. Therefore, case # US-009507513-1702USA008643 is being deleted from our files and the cases are consolidated into case # US-009507513- 1703USA000332.
Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed tinnitus and was hot, flushed, and diaphoretic. He felt very cold and "wobbly" after other symptoms subsided. He had sharp pains in the joints on the side of injection which continued through 1/1/21 later that day. He was tired and had a minor headache 12/29/2020-12/31/2020. Patient had a bout of severe depression and "not caring about anything" beginning 12/29/2020 and lasting about 16 hours. He has no history of depression. He awoke 1/1/2021 and the depression was gone. Patient states all these symptoms disappeared when his arm pain resolved. He developed a "strained" throat on 1/1/2021 which is the only symptom that has continued to the day of this report.
4 days after I had the 1st shot I had an optic nerve stroke in my right eye with complete and permanent vision loss
Both arms hurt but was expected.  Went to bed about 9:00 p.m.  Woke up around 1:00 a.m. and felt like I had been hit by a train. My head hurt so bad I couldn't stand it.  I got up and too two extras strength tylenol.  When I finally got up around 8 am for good with hardly no sleep my head hurt soooooo bad and I hurt so bad.  All I could do is cry it all hurt so bad.  Then I began to get really dizzy as the day went on.  I could just move my eyes or my head and I could hear like banging in my head and I was very dizzy.  I was running a temperature of 100
Dizziness,   Vertigo and tinnitus in right ear  Nausea
An expired dose of ENGERIX B was given; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 10-day-old female patient who received HBV (Engerix B) (batch number J7H4D, expiry date 23rd March 2022) for prophylaxis.   On 12th April 2022, the patient received Engerix B. On 12th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-APR-2022 Reporter's comment: Physician who called in to report that on the day of reporting (today) an expired dose of Engerix- B was given to a patient.  No other symptoms reported.  The reporter provided information on dosing schedule and warm transferred to medical information and provided medical information agent with case number. Consented to follow up. Additional Supportive Information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Large red swelling occured 6 hours after injection.  Given Benadryl and ice pack applied.  By next day swelling was improved size decreasing from 8x8 cm to 7x7 cm.  Warmth decreasing.  Axilla free from nodes no sign of purulence.
Pain/weakness of arms and legs, SOB, laryngitis, numbness of both arms.
I woke up the morning after my COVID 19 vaccine and i was very sluggish and couldn't hardly move. My muscles were hurting and I noticed a big red spot on my arm where the injection was given. I stated getting nauseous also. Then I started noticing a red rash on my neck and it was painful and itchy I took Benadryl and called my Doctor and went in to see him to make sure it wasn't Shingles and he noticed that the rash was on both sides of my neck so it wasn't Shingles.
pt devel fever of 106 ax & R 4 hrs p/vax; also had vague red dots; called hosp advised to give APAP & baths; 10JUL @ 12N t102 take to hosp t106; pt shook a lot & eyes rolled; dx ear infection; also rash worsened head to toe & lasted 3 days;
Very red rash on sun-exposed areas after her DTaP vaccine, resolved on it own.
3/4 hours after receiving the vaccine my heart started racing causing a massive anxiety attack. I had chills, nausea, lost of appetite, and muscular aches. I felt tired and fatigued. I got sweaty hands and experienced reduced amount of saliva in my mouth. Ten hours after the injection I also had diarrhea and cramps. Today is day 2 and I am still experiencing tiredness and anxiety. I didn't take anything, just waited for the side effects to pass.
Patient developed red splotches all over left and right arm. There was one splotch on the face and leg. The left arm was warm to the touch. The rash did not hurt or itch. It began to subside about 24 hours later. Patient began taking BENADRYL on the evening of the 23rd.
pentacel was administered and expired 3 days prior with no reported adverse event; Initial information received on 20-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves an unknown age and unknown gender patient who experienced pentacel was administered and expired 3 days prior with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect  diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t)(PRP/T) vaccine(unknown batch lot number, dosage, strength, formulation) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed non-serious event of  pentacel was administered and expired 3 days prior with no reported adverse event (expired product administered) ( latency :same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event pentacel was administered and expired 3 days prior with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
AFTER MODERATE MUSCLE AND JOINT PAIN, AND INCREASED TIREDNESS THE FIRST 45 HOURS AFTER THE VACCINE SYMPTOMS BECAME LOCALIZED TO PRE-EXISTING INJURY LOCALS (HIP/BACK).  AT APPROXIMATELY 1930 HOURS ON THE 5TH DAY AFTER VACCINATION I BEGAN TO HAVE SEVERE INTESTINAL DISCOMFORT LEADING TO DIARRHEA.  SHORTLY THEREAFTER MY ENTIRE BODY BROKE OUT IN A NON-ANAPHYLACTIC ALLERGIC REACTION RASH.  MY ENTIRE BODY WAS BRIGHT RED, WARM AND EDEMIC TO THE TOUCH, AND ITCHED.  I BEGAN TO HAVE THE CHILLS AND EXPERIENCED SEVERE CHILL TREMORS.  MY BODY WENT INTO MILD SHOCK WITH NO CAPILLARY REFILL ON MY FINGERS OR TOES.   I TOOK TWO  FULL DOSES OF 25MG BENADRYL (SPLIT TABLETS- 50MG TOTAL) AND 1 DOSE ALLEGRA-D [60MG FEXOPHENADINE HCL/120MGPSEUDOEPHEDRINE HCL] (IN ADDITION TO THE 24 HR ALLEGRA [180MG FEXOPHENADINE HCL] DOSE TAKEN AT 14OO HOURS) WITHIN 20 MINUTES OF ONSET.  AFTER THE SHOCK PASSED AND THE FIRST DOSAGE OF BENADRYL WORE OFF I TOOK ANOTHER 50MG AT 0030 HOURS AND AGAIN AT 0530 HOURS DUE TO A RECURRANCE OF REDNESS, ITCHING, AND LOCALIZED EDEMA.  25MG DOSE OF BENADRYL AND 1 24 HR ALLEGRA TAKEN AT 1300 HOURS AND ANOTHE BENADRYL AT 1900 HOURS THE FOLLOWING EVENING.