chrisvoncsefalvay/vaers-outcomes huggingface dataset:
retinal occlusions due to high blood pressure; Sore and achy left arm at injection site; Fever; Chills; Irregular heart rhythm; High Blood Pressure; Dizziness; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in left arm on 01Feb2021 at (14:30- 15:00) (at the age of 75-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included high blood pressure (HBP 10 years ago and was under control with medications), SVT's (diagnosed 17 years ago), and COPD (diagnosed 6 years ago). The patient's concomitant medication(s) included diltiazem hydrochloride (DILTIAZEM [DILTIAZEM HYDRO-CHLORIDE]) taken for supraventricular tachycardia started taking10 years ago, atorvastatin for blood pressure high started taking 10 years ago, and ezetimibe (ZETIA). Family history of heart problems. On 01Feb2021 at 14:30, the patient experienced dizziness and blurred vision. On 01Feb2021 at 14:50, they called EMS and took blood pressure 20 minutes later, and the patient experienced high blood pressure, at 15:10 irregular heart rhythm and at 21:00, the patient had fever and chills. It was suggested that she go to the Emergency room after they did the blood pressure and EKG. On 02Feb2021 at 09:00, the patient reported sore and achy left arm at injection site, and on 11Feb2021, she found out about retinal occlusion due to high blood pressure at her eye check-up and she will see a specialist on Monday. Her eye doctor said it was due to high blood pressure. It caused the blood vessels to bursts in her left eyeball. The patient under-went lab tests and procedures which included blood pressure: 171/107 on 01Feb2021 at 14:50, EKG: right bundle block on 01Feb2021 (She showed it to cardiologist and he said this might be regular for you, but it is irregular). The patient consulted cardiologist and he said this might be regular for you, but it was irregular and patient has a right bundle block and nothing that needs to be done about it and it was present prior to vaccine. No ER or physician's office required. The outcome of event dizziness, blurred vision, fever, chills and ore and achy left arm at injection site as recovering and irregular heart rhythm, hypertension, and retinal occlusions due to high blood pressure as not recovered.  Follow-up attempts completed. No further information expected.
Did not sleep well. Woke up at 5:30am. He is achy and has the chills, fever of 102.7, and a bad headache.  I?ve given Motrin and he still has the symptoms.
This spontaneous report has been received from a physician referring to a patient of age and gender unknown. No concurrent or historical condition was reported. On 07-JUL-2015 the patient was vaccinated with improperly stored dose of RECOMBIVAX HB dose, route, frequency, Lot number and anatomical location were unknown and on the same date the patient also was vaccinated with an improperly stored dose of ROTATEQ; unknown route, frequency, lot number and anatomical location. No adverse event was reported. This is one of several cases from the same source. Additional information has been requested.
Erythema multiforme major (OMIC). 3/17/06 Per f/u with vaccine provider, IPV was also given on 3/10/06. Other additions-corrections made as indicated. 3/21/06 Added Stevens Johnson Syndrome per FDA researcher request. Review of medical record confirms diagnosis of erythema multiforme triggered by recent vaccines or Amoxicillin.  Follow-up: See note (scanned medical records).
Lower upper arm is very swollen and hard after receiving Shingle vaccine.  Red circle approximately four inches in length is present.  Some itchy.  Very painful at site and over the entire arm/shoulder area.
agitated; She didn't get the 2nd dose a month later because the family was concerned about her reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AGITATION (agitated) and INTENTIONAL PRODUCT USE ISSUE (She didn't get the 2nd dose a month later because the family was concerned about her reaction) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had covid in December 2020) in December 2020 and Encephalitis in December 2020.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGITATION (agitated) and INTENTIONAL PRODUCT USE ISSUE (She didn't get the 2nd dose a month later because the family was concerned about her reaction). At the time of the report, AGITATION (agitated) and INTENTIONAL PRODUCT USE ISSUE (She didn't get the 2nd dose a month later because the family was concerned about her reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter. Starting the day after the first dose, she was agitated. It lasted less than a week and she was acting like a typical elderly patient with a UTI, which she did not have.   This case was linked to MOD-2021-303462 (Patient Link).
Pt came to hospital post mechanical fall with sepsis related to covid. Dexamethasone, remdesivir, and baricitinib given along with 2-3L of oxygen used. Pt discharged.
Vaccine got on patient's arm during immunization. Pt stated that she is doing okay and had half or more of the dose. Our Clinical Research Team, spoke with Moderna. Per Moderna as long as half or more of the dose was provided into the patient the dose does not need to be readministered.
pt recv vax 30JUN98;pt seen again for well check up & on 21SEP98 varivax was given again by mistake;pinpoint red rash & fever 100.6 to 102.2 noted on 30SEP98;pt to be seen in office viral rash not related possible enterovirus per MD;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from start date 25May2022 to end date=29May2022.  Clinical Information: The patient did not received other medication in 2 weeks. The patient received COVID 19 Treatment (Paxlovid) from 25May2022 to 29May2022 for the Treatment of COVID-19.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Soreness in arm where vaccine was given. Painful and hard to lift at time. Tried using heat and ibuprofen.
Patient reported swelling and warmth the next day after receiving vaccine. Patient applied cool compresses to the site, and swelling and warmth have decreased. She is also still experiencing headache and nausea. I contacted her physician and was informed to have patient come to office if symptoms worsen.
Weird taste in mouth; This is a spontaneous report from a contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 05:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was calling because he/she wanted to know as he/she looked up the side effect of the COVID vaccine and he/she got it on the 4th and then he/she noticed this weird taste in his/her mouth and he/she just wanted to know if that is kind of a side effect of the vaccine. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Headache, shivers, tiredness, nausea. From about 12 hours after dose to 30 hours after dose
Had immunizations on 7/29/13 developed headaches wed. 7/31-8/1 and 8/2/13 and awoke 8/3/13 in AM repeating words, stuttering and brief periods of confusion.  Diagnosis Seizures, Epilepsy. Abnormal EEG, Normal MRI, Now taking seizure medication Keppra.
Pt states approx 6 days after shot she developed rash on back, mouth sores, swollen throat, fever of approx 100.5 for 2 days.  Pt sought medical attention  and was informed it was possibly allergic reaction to shot.
Patient with apparent anaphylactic shock was received. Patient had cyanosis, hypoactivity and bradycardia. Patient was treated with Heart Association protocol for cardiopulmonary resuscitation. He was transferred in critical condition to Hospital. Patient was delivered with vital signs but in critical condition.
MS symptoms; Tingling; Pain; Felt like crap; Constantly tired; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS symptoms) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (MS symptoms) (seriousness criterion medically significant), PARAESTHESIA (Tingling), PAIN (Pain), MALAISE (Felt like crap) and FATIGUE (Constantly tired). At the time of the report, MULTIPLE SCLEROSIS (MS symptoms), PARAESTHESIA (Tingling), PAIN (Pain), MALAISE (Felt like crap) and FATIGUE (Constantly tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication Adalimumab is temporarily with held for next six weeks. No treatment information was provided.  Very limited information regarding the events have been provided at this time. No Further information is expected.   This case was linked to MOD-2021-139280 (Patient Link).; Sender's Comments: Very limited information regarding the events have been provided at this time. No Further information is expected.
Sore throat no voice painful ears joints ache hurts to swallow shortness of breath weakness
Patient was given incorrect covid-19 vaccine. She is only 16 years old and was given the  MODERNA covid vaccine, which is NOT approved to be given to anyone under 17 years of age. She asked why she wasn?t given the Pfizer covid vaccine and the nurse stated, ?Oh, crap.? Two nurses told her she is okay and to just go home. She didn?t know she wasn?t supposed to get the moderna vaccine until she tried to get the second dose and the county clinic told her they ?didn?t have that vaccine? and told her to go to another clinic. They did NOT admit their fault and she was a minor with her parent who do NOT speak or read the language. She was part of a medical error from the staff at the county run covid vaccination site that was not taken accountable or action for. She is only 16!
Additional information was received from the reported on 17-Sep-2003 providing diagnosis, duration of hospitalization and treatment therapy. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare profession regarding a 29-month-old male patient who experienced drug ineffective, streptococcal pneumonia and streptococcal bacteremia. At 25 months of age, the patient received the first dose of Prevnar on an unspecified date. Medical History: The physician stated that the "child had no underlying medical conditions." Product Details: Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was one dose. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experienced drug ineffective (drug ineffective), streptococcal pneumonia (pneumonia streptococcal) and streptococcal bacteremia (streptococcal bacteraemia) in June 2003. The child was hospitalized for 2 days and diagnosed with right lower lobe pneumonia and bacteremia. He was treated with Rocephin and Augmentin. Test results: Blood culture (results: Positive for streptococcal pneumonia) was done on 02-June-2003. Note: the physician reported this event to the CDC and completed a VAERS form.
Patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 27th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's comment: HCP (Health Care Professional) reported that the patient received an expired Havrix. No reactions were reported. The reporter consented to follow-up by email. Additional Supportive Information: The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
When I had the vaccine I developed a red spot, I been feeling better able to walk more and I had been hammering on my deck I felt like sprained my elbow and wrist and about 2 weeks later I  had been working out in yard and on the outside of my wrist I had a terrible bruise about 2 inches and it did not hurt at all I didn't hit anything , it was red and slightly purple . Then it started happening on my other hand and my toes and my knees, sometimes they would last days to only a few hours, and I remember having this at beginning of pandemic when my daughter was ill possibly with Covid.
At 9 pm I had an attack of Raynauds in my right index finger.  I left upper arm was sore. At 11:00 when I retired to bed, I had chills (very cold, shivering, teeth chattering), headache, nausea, full body aches, dizziness, confusion (brain fog), restless, could not sleep at all, very exhausted.  When i got up at 8 a.m. next morning, I had a red butterfly rash across my cheeks and bridge of nose and felt very uncomfortable (body aches had dissipated), achy, restless, headache, warm face, aching eyeballs.  At 3:00 pm redness still persisting and my face felt warm so I took my temperature and I am running a 2-degree fever.
according to the patient her Sjorgens syndrome has reoccur like dryness of mouth and eyes
Patient came in for COVID vaccine accompanied by son. She was a little anxious about getting the vaccine but son was here to support her. About two minutes after injection she said she felt dizzy. We brought water to her. We tried to get a BP could not get a reading. We attached pulse oximeter and her HR was 41 BPM and she was 96% SpO2 on RA. Within two minutes she was in and out of consciousness and could not hold herself up in chair. We notified the IC and brought a wheelchair so that we could transport her down. Son said she was hydrated today and that she took all of her medications. Son did say she was recently put on Paroxetine and Aldactone. Son stated that she has hx of seizure and this is how she acts when it happens.
Drop in blood sugar; Chills; Fever; SWEATING; headache; body aches; nauseas; Drop in Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (SWEATING), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nauseas) and BLOOD PRESSURE DECREASED (Drop in Blood Pressure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus syndrome, Diabetes, Sciatica, Arthritis and Drug allergy (BACTRIM).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced HYPERHIDROSIS (SWEATING), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nauseas) and BLOOD PRESSURE DECREASED (Drop in Blood Pressure). On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (Drop in blood sugar), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, HYPERHIDROSIS (SWEATING), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nauseas), BLOOD PRESSURE DECREASED (Drop in Blood Pressure), BLOOD GLUCOSE DECREASED (Drop in blood sugar), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional info
flushing, tingling/numbness neck and face. Evaluated by EMS-Cleared
Fever for 1 wk, acted "dazed" not smiling or eating well. No prolonged crying. Unk temp degree. Advised to wait until older for further vaccines.
COUGHED UP BLOODY PHLEGM; MILD SORE THROAT; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, seasonal allergy, and tree pollen allergy. The patient experienced drug allergy when treated with nifedipine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced slight headache. On 15-APR-2021, the subject experienced coughed up bloody phlegm. On 15-APR-2021, the subject experienced mild sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughed up bloody phlegm, and mild sore throat on 15-APR-2021, and slight headache on 13-APR-2021. This report was non-serious.
Vaccine was stored in the fridge on 24Jan2023; no adverse event; Moderna Bivalent vaccine was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023) and NO ADVERSE EVENT (no adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023).    No concomitant medications were reported. No treatment details were reported. It was reported that patient had not reported any side effects post vaccination.
the patient reported that after he received his second done he stated experiencing numbness and tingling in his face and his legs feel "funny" and get swollen from time to time
BODY WAS KILLING; LEGS ARE KILLING; HEAD WAS KILLING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced body was killing, legs are killing, and head was killing. The action taken with covid-19 vaccine was not applicable. The outcome of the legs are killing, head was killing and body was killing was not reported. This report was non-serious.
Pox-like reaction over torso and extremities. Presented as patches of intact blisters. Pt endorsed itch but no pain. Ongoing symptoms for 3-4 days at time of report. No respiratory reaction or other allergic reactions.
The pt became irritable the evening of the vax, also the pt experienced diffuse macular rash next morning.
Fever 103, limp & groggy; no loss of consciousness; lasted few minutes; exam was nl;
Localized redness, itching, pain and warm to the touch at the injection site. Zostavax administered at 9:15 am. 9:20 am the patient was scratching at the site and it was red and painful. Ice pack applied and the patient was monitored for 30 minutes. No systemic reaction noted. Local reaction itching, pain, redness and warmth subsided.
Approximately 2 weeks after the vaccine, I experienced joint pain all over my body. I even had bone pain in my chin. I went to my PCP on 8/25/2021 and blood work was preformed. The blood work indicated inflammation. I was prescribed EFFEXOR that did not help symptoms. I have constant pain since then until now. I am an alcoholic and I did quit drinking the day before vaccination. I do have another appointment set up for next week.