chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable nurse reported that a male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, 2 days after taking his first vaccine, the patient tested positive. Event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile.
Swelling, erythema, pain at site. MEDROL prescribed 3d later & Antihistamines.
1st dose on FEB 2021 and received her 2nd dose on 20-MAY-22; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2021).   On 20th May 2022, the patient received the 2nd dose of Shingrix. On 20th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporters comment: The patient self-reported the case.  The patient called in for information for information on Shingrix.  She received the first dose of Shingrix in February 2021 and second dose on 20th May 2022.  Provided medical advice disclaimer and information per content on alternative dosing schedules. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Pt developed severe lower back pain several minutes after receiving a pneumococcal polyvalent 23 vaccine lot# J009833, exp: 1/25/15, NDC 0006-4943-01.  Back pain radiated up to her head.  Pt started sweating & was starting to pass out before being revived with ammonia inhalants.  MD applied oxygen & cold compress before pt was transported to ER for evaluation.
About 42 hours after my Covid Booster, I woke up with an itchy right eye. Then I started sneezing, so I took an Allegra. About 30 mins after waking up, I went to the bathroom and noticed the right side of my face was swollen. I then called the 24/7 hotline from my insurance to speak with a nurse. At that point, I started having trouble swallowing and my breathing was laborious. The nurse suspected I could be having a delayed reaction to the booster shot, and I should call an ambulance to take me to the hospital. I mentioned I was staying with my parents, and had access to an EpiPen since my dad has a severe shellfish allergy. The nurse advised me to administer the Epipen, but still call for an ambulance and go to the ER. I was subsequently monitored at the ER and discharged, with instructions to see an Allergist and follow up with my Primary Care doctor. I have never before experienced an allergic reaction of the magnitude and haven't had any other symptoms since. The Allergist as well as my parents, who are physicians, and their colleague who specializes in infectious diseases, all feel that this was a reaction to the booster.   I did not have any significant symptoms from the first vaccine dose, but I did have side effects from the second, including flu-like symptoms about 12-24 hours later. Symptoms from the booster shot were similar to the second shot, but started after about 4-6 hours and including wheezing, which I did not previously experience.
Aches, fever, fatigue, headache. Had to leave work and tried pushing fluids and sleeping. Ongoing symptoms at 9:40PM.
My daughter got shingles within the first 3 months following the vaccine. She didn?t have a skin rash but the virus caused inflammation in her brain and impaired her vision and hearing on one side. It is likely that she will have permanent hearing loss. She thought she had a sinus infection and let it go for nearly two months. If at the time of vaccination she would have been told this is a possibility she would have been more aware of the symptoms and would have sought treatment much sooner.  She also had previously gotten covid so she had natural immunity but due to public pressure went forward with a vaccine that has now caused permanent hearing loss. She is being treated for shingles now.
The subject was in clinic for day 180 on 03 October 20005. Pre-injection vitals were normal with blood pressure (BP) of 114/84. The subject did not have any complaints. About 15 minutes after received the injection the subject experienced mild nausea, lightheadedness dizziness with blurred vision. He was not diaphoretic and head not experienced these or any other symptoms on earlier injection day (was previously given injections on two separate occasions for this study). The subject had not eaten since 2100 the night before (injections given at 1200). The subject was given orange juice to drink and the lightheadedness, dizziness and nausea were resolved with in a few minutes. Blurred vision was resolved within 15 minutes. He is not a known diabetic and was on no Anti-retroviral (ARV) medications. A physical exam was performed and BP was taken lying down, which was 110/710. About five minute later, while sitting it as 140/100 and standing it was 140/100. Heart sounds were normal. After speaking to the subject later that day, he remained without the above symptoms. The following day his only complaints were slight headache and sluggishness. The reporting physician (PMD) deems this was possibly related to study treatment.
I was on vacation when I contracted COVID. We returned on 06/12/2022 and I tested positive on 06/13/2022. I contacted my Dr. that day and she ordered PAXLOVID. I started that on Tuesday Morning. I am feeling much better and by Tuesday afternoon I felt a little better and was surprised. I see an improvement on a daily basis. It started out as a head cold and my husband and I thought it was allergies. I had some slight chest tightness at the start of taking PAXLOVID and now only have minimal nasal congestion (more like sinus drainage). As of today, this is day 3 of the PAXLOVID treatment.
Redness, edema, local rxn w/tenderness @ inject site lt deltoid; no fever;
Light headed; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed) and DIZZINESS (Dizzy) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Light headed) and DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Light headed) and DIZZINESS (Dizzy) outcome was unknown.            Treatment information not reported. No concomitant medications reported.
Developed mild cough immediately after shots then after 2-3 hours developed increased cough itching feet, abdomen, swollen lips, generalized urticaria. Also reaction at site of MMR injection (Right Deltoid)
No additional AE details were provided; AThe HCP also reported that both doses were administered intramuscularly instead of subcutaneously; The HCP reports that the patient was inadvertently administered both PROQUAD and VARIVAX at the same time; This spontaneous report has been received from a Medical Assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 04-NOV-2022, the patient was inadvertently vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection (lot number: U029323, which was determined to be valid with an expiration date on 19-MAR-2023) and varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (lot number: U039722, which was determined to be valid with an expiration date on 15-DEC-2023); both at a dose of 0.5 milliliters intramuscularly as prophylaxis at the same time (Accidental overdose, Inappropriate route of vaccination). No additional adverse events were reported.
Shorter than recommended interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old male patient who received HAV (Havrix) (batch number 2Y29Z, expiry date 12-JUL-2023) for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On 22-MAY-2023, the patient received the 2nd dose of Havrix. On 22-MAY-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Shorter than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 A public health nurse called in to report that a patient accidentally received a dose of Havrix before 6 months had elapsed since the first dose, which led to shortening of vaccinations schedule. Call was escalated to second line. Information about patient, vaccine and event were collected. The reporter consented to follow up. the vaccine administration facility is the same as primary reporter. The second line agent did not answer call.
I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 AORTIC VALVE STENOSIS I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 AORTIC VALVE STENOSIS I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 ACUTE NON ST ELEVATION MI I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 ACUTE NON ST ELEVATION MI I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 CHF EXACERBATION, UNSPECIFIED I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 CHF EXACERBATION, UNSPECIFIED I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 ISCHEMIC CARDIOMYOPATHY W SYSTOLIC HEART FAILURE STAGE C I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 ISCHEMIC CARDIOMYOPATHY W SYSTOLIC HEART FAILURE STAGE C I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 6/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 6/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY
Patient should have been administered Hepatitis A vaccine but was inadvertently administered a Hepatitis B vaccine.
Pt. returned to the clinic a few wks. after the injection reporting her arm was still sore distal to the injection site. She described the pain as being similiar to the pain she experiences on her other arm secondary to rotator cuff injury.
I experienced a breakthrough case of COVID-19 with needing to clear my throat a lot and then I start to feel a fever of 101 with body aches and upper respiratory congestion, coughing, fatigue and it took me 10 days to recover from my symptoms.
adverse effects; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced  adverse effects (not specified).  No lab data was provided.  Treatment details was unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events-adverse effects was considered to be unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Vomiting (with blood), Cannot raise arm above shoulder, miss school  Twin brother had same adverse  event  - Lot number FF2587
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: notify that a patient received a 3rd dose of covid vaccine before due time
Fever from 101-102 over 24-48 hours from 10/8 to 10/10. Mild-moderate maculopapular rash on trunk from 10/11-10/16, almost complete resolution of that rash, then recurrence of maculopapular rash, but moderate-severe, most concentrated in trunk. Very abundant papules in trunk, back, face with presence, but more scattered on arms and legs. No confluence. No vesicles. No fever with the recurrence of rash. Second rash began 10/17 with significant worsening 10/18 through 10/19.
Sore arm near injection site, body aches, nausea.  11/18/2013: elevated blood glucose, elevated blood pressure, elevated temperature,  severe body shaking, repeated vomiting, HEARTRATE 120/MIN lasting about 16 hours.
8pm night of the vaccine - chills (Fri . night and Saturday) weakness, fatigue, headache, extremely soar arm (more than the initial doses), Low grade fever Sunday morning - Headache, overall feeling of blah
I had two of my patients lose their eyes due to central retinal vein thrombosis after the second dose of the Pfizer BioNTech COVID-19 vaccine; This is a spontaneous report received  from a contactable physician. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on an unknown date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unknown date. The physician reported that, two of my patients lose their eyes due to central retinal vein thrombosis after the second dose of the Pfizer-biontech covid-19 vaccine. Outcome of event was unknown.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event retinal vein thrombosis. 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.
Patient complaint of pain in (L) arm since HPV injection. Doctor found no tenderness, no swelling, difficulty with full extension of (L) arm. No s/s of infection.
flu like symptoms; Body aches; fever; lethargic; chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 13Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that I took the 2nd dose of the Pfizer vaccine yesterday (Monday 13Sep2021) and on an unspecified date of Sep2021 I have flu like symptoms. Body aches, fever, lethargic and chills. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
noticed a mild rash here and there on my arms and legs and back a few days after  the first shot - but assumed it might be from food - did not connect with the shot - thought it might be from eating shrimp cocktail - it subsided and went away after a couple of weeks  after the second shot - I began to get much more of a rash beginning at the injection site and gradually spreading in small patches and isolated bumps to my lower arm and leg on my left side (site of shot) with wild itching - which slowly spread to my right side in the same areas and the same amount - I tried Benedryl which seemed to help some - but didn't make it go away - I have not seen a doctor - once I decided it was definitely a reaction - it was
sore arm, temp 101.7 F (oral), shortness of breath necessitating supplemental oxygen for approximately 2 hours (2L)
feels like burning; it hurts on the ribs and back so much; it hurts on the ribs and back so much; fever of 38.3°C/ is very difficult to lower/ 39.8°C/ 38.1°C; the head ache is more intense/ it feels like if it's going to explode; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (feels like burning), MUSCULOSKELETAL CHEST PAIN (it hurts on the ribs and back so much), BACK PAIN (it hurts on the ribs and back so much), PYREXIA (fever of 38.3°C/ is very difficult to lower/ 39.8°C/ 38.1°C) and HEADACHE (the head ache is more intense/ it feels like if it's going to explode) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included ACETAMINOPHEN and IBUPROFEN for an unknown indication.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (feels like burning), MUSCULOSKELETAL CHEST PAIN (it hurts on the ribs and back so much), BACK PAIN (it hurts on the ribs and back so much), PYREXIA (fever of 38.3°C/ is very difficult to lower/ 39.8°C/ 38.1°C) and HEADACHE (the head ache is more intense/ it feels like if it's going to explode). At the time of the report, BURNING SENSATION (feels like burning), MUSCULOSKELETAL CHEST PAIN (it hurts on the ribs and back so much), BACK PAIN (it hurts on the ribs and back so much), PYREXIA (fever of 38.3°C/ is very difficult to lower/ 39.8°C/ 38.1°C) and HEADACHE (the head ache is more intense/ it feels like if it's going to explode) outcome was unknown.            Treatment Acetaminophen 500 mg each 4 hours Ibuprofen towels with cold water and vinegar to lower the temperature   This case was linked to MOD-2021-118472 (Patient Link).
Quantity flu shot: .5, Quantity Moderna Covid-19 vaccine shot: .25 Noticed slight nausea today (11/10/2021) and slight painful lymph node reaction with small lump on right side of neck.
POST VACCINE, C/O DIZZINESS AND NAUSEA, LAYED ON FLOOR AND PLACED FEET ON CHAIR, THEN ASSISTED TO WC AND TAKEN TO OBS TO LAY DOWN. ASSISTED TO STRETCHER, PLACED IN TRENDELENBERG, STATES SOME RELIEF AFTER A FEW MINUTES. STATED SOME RELIEF. SAT UP ON STRETCHER, DRANK SOME WATER, S/S IMPROVING PER PATIENT REPORT. ONCE S/S RESOLVED, ESCORTED TO EXIT WITH NO ISSUES WHERE HUSBAND WAITING IN CAR/IS DRIVING PATIENT HOME, AT 1100. ORTHOSTATIC VSS THROUGHOUT EPISODE. 1025 LYING BP 123/82 HR 68 RR 20 SATS 98% RA 1048 SITTING BP 131/89 HR 60 RR 20 SATS 98% RA 1055 STANDING BP 122/84 HR 64 RR 20 SATS 98% RA
High fever up to 104F for about 1 day was treated w/APAP;
Hard lump became apparent the day after the injection. Lump and surrounding area were red and warm to the touch. Redness and pain receded after 3 days. Lump remains at 7 days, and pain is present if the lump or surrounding area is touched.
only two patients were tested positive for COVID-19 infection/one 46 days after the second dose; only two patients were tested positive for COVID-19 infection/one 46 days after the second dose; This is a literature report for the following literature source(s): "Antibody response to 2-dose SARS-CoV-2 mRNA vaccination in pediatric solid organ transplant recipients", Journal of Transplantation, 2021.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "only two patients were tested positive for COVID-19 infection/one 46 days after the second dose". The patient underwent the following laboratory tests and procedures: investigation: unknown results; sars-cov-2 test: positive. Additional information: In a study, assessing the effectiveness of Pfizer in 12 -18-year-old adolescents, among 57 participants, only two patients were tested positive for COVID-19 infection, one patient before receiving the second dose and another one 46 days after the second dose.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration. ,Linked Report(s) : US-PFIZER INC-202200200766 Same article/drug/ event and different patient.
Patient began having dizzy spells after the vaccine and light headedness. She fainted in front of me and I tried to catch her, but because of the lack of room in our bathroom, she still managed to hit her head on the tub, She was taken to the ER and given fluids. She ultimately saw the cardiologist where she was diagnosed with POTS along with her twin sister after receiving the HPV vaccine.
High Fevers for 3 days; cough, sore throat, body aches.
Patient developed facial hives approximately 3 minutes after receiving Varivax.  Occurred in the Am on 10/11/07.  Recieved Benadryl 12.5 mg po.  resolved within 15 minutes
A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving Nasal FLUMIST (Intranasal). FLUMIST (Intranasal) started on 14-Mar-2014. The patient was administered FLUMIST on March 14th, 2014, past expiry date which started on 14-Mar-2014. The outcome of the event of a patient was administered FLUMIST on March 14th, 2014, past expiry date is unknown. the report was considered to be non-serious.
Information has been received from a medical assistant concerning a 6-year-old male with no medical history or no known allergies who on 23-MAR-2001 was vaccinated with a dose of Varivax. There was no concomitant therapy. The medical assistant reported that on 01-JUL-2006 (also reported as 05-JUL-2006), the patient developed a red itchy rash. Unspecified medical attention was sought and BENADRYL was recommended. No laboratory/diagnostic tests were performed. At the time of this report, the patient's red itchy rash persisted. The medical assistant also reported that the patient's sibling experienced an adverse event after being vaccinated with Varivax (WAES #0609USA03175). Additional information has been requested.
c/o dizziness, h/a, generalized body aches, and chills after receiving 2nd dose of Moderna COVID vaccine yesterday AM. Pt has not taken any measures of self-care.  Able to ambulate without difficulty.
Pain in left arm, heaviness in chest, weakness, discomfort in abdomen, loss of appetite, sleeplessness, restless, sporadic trembling and shivering.