chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No Adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 05-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) 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 WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    Concomitant medications were not reported.   The route of administration of suspect Moderna bivalent was reported as BI.  No treatment information was provided by the reporter.
while waiting the 30 minutes after the injection. i started feeling sharp pain in the heart area and asked the nurse if this was normal. they took my pressure and vitals and had me sit longer to see how i felt. The sharp pain went away but i felt pressure on the left chest area. I thought i was fine since the shooting pain was gone. The nurse said to go to the ER if the sympotms persisted. I felt tired the following 2 days with pressure on the chest. Monday 4/5 i felt more pressure and pain on the left neck and left upper back shoulder and called the triage nurse and said go to the E.R not urgent care.
severe ulcerative colitis flare up; vomiting greater than 7 times; gray skin pallor; slightly jaundiced; This is a spontaneous report from a non-contactable nurse. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 81 years of age), dose 2 intramuscular, administered in arm right on 19Feb2021 17:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypertension and hyperlipidaemia. The patient's concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, first dose at 81 years of age, intramuscular in the right arm on 28Jan2021 for COVID-19 immunisation. The patient was not pregnant. The patient had not received other vaccines in four weeks. The patient had no COVID prior to vaccination nor was she tested post vaccination. She had no known allergies. The patient experienced a severe ulcerative colitis flare up starting within 24 hours of the 2nd vaccine. Initially, as a exceptionally private and stubborn person, she did not report her progressing symptoms to her family and only after she "felt as if she was actively dying" did she reach out for help (01Mar2021). Additional symptoms included severe burning pain across her lower abdomen, vomiting greater than 7 times, persistent diarrhea, gray skin pallor and she appeared slightly jaundiced. Patient refused repeated offers from daughters to be taken to hospital. On 01Mar2021, contact was made with her gastroenterologist and in the morning of 02Mar2021, she was restarted on her UC treatment, which was oral budesonide (unsure of dose). Outcome was improving. She was now able to intake food and liquids and her UC symptoms are resolving. She was up and active again. The events started on 20Feb2021 with outcome of recovering. Therapeutic measures were taken as a result of the events.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Based on data provided and temporal association, the reported events are assessed as possibly related to BNT162B2. 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.
Urticaria and intense itching of scalp, cheeks, neck, chest, back, and belly. Zyrtec was needed every evening and hives would spread and become more intense if not taken within 22-24 hours of previous nighttime dose. Benadryl used at night and about 3 days per week during the daytime if urticaria was distracting from daily activities (happened often). This more serious reaction last about the first 3 week at the start of symptoms (which occurred ~2 weeks after Moderna Booster shot).  Symptoms improved slowly but lasted 12 weeks. I had no reactions to 1st and 2nd dose of Moderna Covid vaccine, only the booster.
01/04/07 pt started getting sick around 2pm, her face was warm and flush, no recorded fever, threw up one time. Fell asleep until 5pm woke up ate a little dinner went back to sleep until next morning.
Breakthrough case admission after 4 vaccines Pfizer 1/26/21 Lot# EL9264;  Pfizer 2/16/21 Lot# EN6200;  Pfizer 8/26/21 Lot# FC3182;  Pfizer 4/4/22 Lot# FK9894
Received Td 2/27/03. On 2/28 developed rash, temp of 102.6, HA, dizziness, sinus congestion, clear mucus, sore throat. Rash gone 3/7. Fever gone 3/4. Sick with rest S/S x 1 week.
received a dose of expired Menveo; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA462A, expiry date 31st October 2021) for prophylaxis.   On 1st November 2021, the patient received Menveo. On 1st November 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided are as follows: The age at vaccination was not reported. Nurse reported that the patient received a dose of expired Menveo, which led to expired vaccine used. The reporter declined to provide the patient demographics. The reporter consented to follow-up.
rash that started 2 days after vaccine - initial spot on right foot, then behind her left knee, then multiple spots on left arm developed on 3/28; sites are itchy but not painful
Had the Pfizer COVID vaccine booster in Nov2021; Day afterwards his arm was sore; Thinks that he had a fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 19 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 19 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 (Unknown manufacture), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Had the Pfizer COVID vaccine booster in Nov2021"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "Day afterwards his arm was sore"; PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "Thinks that he had a fever".  Additional information: The caller mention that patient had the Pfizer COVID vaccine booster in Nov2021 and the day afterwards his arm was sore and the caller thinks that he had a fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
History of Present Illness  34-year-old male with history of end-stage renal disease secondary to lupus nephritis (dx 2018) on MWF dialysis, morbid obesity, CHF with EF 45%, htn, SLE, who presents to the ED for shortness of breath and hemoptysis. Patient states that he has been missing dialysis for around 12 days. He does still make urine around 1/2L daily. He was brought into the ED by his uncle who he lived with. His uncle just got back to town and noticed that Javone had difficult time breathing, thus, brought him to the ED. Patient reports that he also has been having diarrhea, hemoptysis, fever, and shortness of breath for the past 2-3 days. He had Covid vaccination on 5/01 and 5/22.  In the ED, he was found to be at 75% oxygen on 10L in the ED, improved to 84% on 15L non-rebreather. He was quickly started on BiPAP. VBG was significant for metabolic acidosis with respiratory compensation pH 7.304, pCO2 27.2, and HCO3 13.1. Labs were notable for Hgb 10.9, K 5.5, Cr 22.3, trop 60, and BNP 7281. Patient was admitted  for acute hypoxic respiratory failure suspect secondary to fluid overload 2/2 missed dialysis vs Covid pneumonia.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vaccine was placed in refrigerator on 04-Nov-2021. The vaccine did not go any temperature excursion and does not experience adverse event. No treatment information was provided.
swelling about 4 1/4 x 3 3/4" at site of immunization (varivax)
Fever of 100 degrees. Chills & sweating. Headache. Achiness, weakness, and fatigue.
Patient was administered Prevnar-13 on 612/2019 and injectionsite was red, warm and swollen. Asked her to take ibuprofen and apply cold compress every   minutes
Medication Error - Hepatitis B vaccine was ordered for the patient and Prevnar-13 vaccine given by staff. No adverse reaction noted and the Physician spoke to patient's parent.
Is a 54-year-old female who presents today with nausea vomiting and diarrhea as well as body aches and a fever after taking her first Covid vaccination 2 days ago.  She went to urgent care at first and they transfer her to the ER here.  She has been out of her insulin for at least 3 weeks.  She has had a refill of her glipizide and has not picked up a refill.  She denies any chest or abdominal pain.  She has had times where she is short of breath.  She has had 3 episodes of nausea and vomiting and 3 episodes of diarrhea since midnight or in the last 19 hours.
Patient given Pfizer COVID-19 booster too early. Received 2nd dose 01/21/2022. Got the booster on 03/03/2022. I followed protocol and notified Pfizer. I was told at this time we do not need to repeat the dose. Patient also notified of provided information. The patient is doing well. Denied any symptoms or complications.
PAIN UPON INJECTION; This spontaneous report received from a consumer/other non health professional concerned a patient of unspecified age and gender. 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, intramuscular, batch number: unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced pain when receiving injection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain upon injection was not reported. This report was non-serious. This case, from the same reporter is linked.
a loss of taste; sore at the injection site; fatigued; drowsy; sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsy), SLUGGISHNESS (sluggish), AGEUSIA (a loss of taste), VACCINATION SITE PAIN (sore at the injection site) and FATIGUE (fatigued) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced SOMNOLENCE (drowsy), SLUGGISHNESS (sluggish), VACCINATION SITE PAIN (sore at the injection site) and FATIGUE (fatigued). On 23-Mar-2021, the patient experienced AGEUSIA (a loss of taste). At the time of the report, SOMNOLENCE (drowsy), SLUGGISHNESS (sluggish), AGEUSIA (a loss of taste), VACCINATION SITE PAIN (sore at the injection site) and FATIGUE (fatigued) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
low grade fever; chills; felt like crap; possible food poisoning; I did not want to eat; sick; nausea; vomiting; diarrhea; normal soreness in arm; I feel more tired and 'not rested' now; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 17Mar2021 (at the age of 59-years-old) as dose 1, single for covid 19 immunization. The patients medical history include Food poisoning (that was only cured by going to the hospital). The patients concomitant medications were not reported. On 17Mar2021, patient received the first dose of the Pfizer Biontech COVID 19 vaccine. After the first dose, she had normal soreness in arm and the pain went away after 24 hours. Currently, on unspecified date in Mar2021 she feel more tired and not rested now as compared to the first 3 days after the injection. she went out on Saturday, 20Mar2021, for her birthday and had no side effects from the vaccine besides a hang over the next morning since her grandkids were buying her so many alcoholic shots. On Sunday, 21Mar2021, she went to a casino, ate around 5:30-6 PM and was feeling fine. There was something she had not eaten so took that home and ate that at 8 PM and a couple of hours after that, 10:30 PM she started getting sick: had nausea, vomiting, diarrhea. The vomiting and diarrhea lasted until 2 AM; then she fell asleep after that. The nausea continued the next day (22Mar2021) because she did not want to eat. On Monday night, 22Mar2021, she had low grade fever (99.4 F at 10:30 PM), chills and felt like crap. This morning she was feeling better but still feel chills; she was only eating soup and crackers. So the possible food poisoning only lasted 24 hours. As of this morning on 23Mar2021, she had no temperature. Outcome of events normal soreness in arm recovered on unspecified date in Mar2021, vomiting, diarrhea recovered on 22Mar2021 02:00 AM, low grade fever and possible food poisoning recovered on 23Mar2021, I feel more tired and not rested now, sick, nausea, I did not want to eat, chills, felt like crap, was unknown   No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Stuffy nose; Severe shakes; Fever; Exhaustion; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), CHILLS (Severe shakes), PYREXIA (Fever), FATIGUE (Exhaustion) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced NASAL CONGESTION (Stuffy nose), CHILLS (Severe shakes), PYREXIA (Fever), FATIGUE (Exhaustion) and HEADACHE (Headache). On 09-Jun-2021, NASAL CONGESTION (Stuffy nose), CHILLS (Severe shakes), PYREXIA (Fever), FATIGUE (Exhaustion) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jun-2021, Body temperature: 103 (High) Fever of 103.         No Concomitant Medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Redness and swollen 13 x 9 round at left side. Loratadine, BENADRYL, heat and ice packs.
Patient's OB/GYN notified patient that she has a clinically significant red blood cell antibody, anti-D, identified in the plasma.  The titer of this antibody is 64, above the critical cut-off for patients at risk for hemolytic disease of the fetus and newborn.  Patient with no history of transfusion.  Patient with no history of prior pregnancy.  The source of this antibody cannot be determined.  The only recent medical intervention was vaccination of Yellow Fever (Lot number UH672AA) for travel outside of the county.  Patient denies needle stick, IVDU, tattoo, or other known blood exposure.  This antibody has placed the patient and her developing fetus at risk for hemolytic disease of the fetus/newborn (HDFN).
At approximately 11:15 pt complained of dizziness and confusion. Bp 128/84, hr 72,  O2 sats 100%, blood glucose 105. Pt given water and chips. 11:43 pt reports feeling better, bp 126/84,hr 68, O2 sats 99%. Pt discharged.
?Covid arm? Rash on arm that was vaccinated.  Currently 29 weeks pregnant. Expected due date SEP 7.
No reaction other than left arm pain with the first 4 shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Lot number: ER8731) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV+" (unspecified if ongoing), notes: HIV+; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: DOVATO; ALENDRONATE SODIUM; CALCIUM+D3. Past drug history included: Penicillin (augmentin), reaction(s): "Allergy Penicillin (Augmentin)", notes: Known allergies: Penicillin (Augmentin). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "No reaction other than left arm pain with the first 4 shots". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "No reaction other than left arm pain with the first 4 shots". Therapeutic measures were not taken as a result of pain in extremity.  Additional information : The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: Left arm pain that evening. No reaction other than left arm pain with the first 4 shots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201167373 same patient, vaccine, event, different dose;
5 minutes after vaccination, patient reports heart pain, chest palpitations, shortness of breath, and shakes that patient attributes to anxiety from possible reaction.
Patient has not received 2nd dose.; tested positive for COVID19 on 21-Jul-2021; Had COVID19 symptoms; Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.; This spontaneous case was reported by a consumer and describes the occurrence of FOOD ALLERGY (Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.), SARS-COV-2 TEST POSITIVE (tested positive for COVID19 on 21-Jul-2021), COVID-19 (Had COVID19 symptoms) and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced FOOD ALLERGY (Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.). On 18-Jul-2021, the patient experienced COVID-19 (Had COVID19 symptoms). On 21-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID19 on 21-Jul-2021). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose.). The patient was treated with AZITHROMYCIN for Adverse event, at an unspecified dose and frequency. At the time of the report, FOOD ALLERGY (Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.), SARS-COV-2 TEST POSITIVE (tested positive for COVID19 on 21-Jul-2021) and COVID-19 (Had COVID19 symptoms) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient administered a steroid shot due to allergic reaction experienced due to food she ate not from the vaccine on 14Jul2021.
Racing heart for about 3 hours post vaccination.  Heart stopped racing, but turned into a severe headache, fever, vomitting, nausea, full body aches and dizziness.  This has been going on for 24 hours.
VACCINE ADMINISTERED UNDER PUBLIC HEALTH. VACCINE GIVEN TOO EARLY. NO ADVERSE REACTIONS, PER PATIENTS MOTHER.  VAERS REPORT FILED.
Within the 15 minute waiting period I got and had a weird taste in my mouth the lasted through that evening.  10/26-10/27=Arm very sore/Feeling off, a queasy sickness.  10/28-10/29=Felt a little better but headaches  10/30=Very dizzy, light-headed, nauseous, headaches. Taking a Bonine motion sickness pill helped but it didn't go away.  11/6-current = intermittently lightheaded, headaches, queasy/nausea feeling.