chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a lot of coughing, really tired, slight fever for 2 days, postnasal drip, and headache for a day. I tested positive for COVID-19 at home. But I had symptoms days before that and was testing negative. I spoke to a doctor and gave me a prescription for benzonatate. I had really bad coughing for 3 days and trouble sleeping. After that I gradually started feeling better.
No adverse effects were reported; the patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 09-APR-2019, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly, lot # N020501 with expiration date 03-MAR-2019, for prophylaxis (anatomical location was not provided). No adverse effects were reported.
I have been  having body ache moving around my joints, bloating; causing stomache ache that extends to my pelvic area like a labor pain and making me uncomfortable when i sit.
This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with VARIVAX lot number reported as M005272, expiration date: 02-FEB-2018 (concentration, dose, frequency and via were not reported), which was improperly stored at 32.5 Fahrenheit degrees for 16 hours. No previous temperature excursion was reported and it was not detected due to a data logger. No adverse effect was reported. Additional information has been requested.
The employee health nurse called to inform the pharmacy that the patient passed out at work and was coming to the ER.
Moderate- severe Occipital  headache since receiving the headache, it will be 2 weeks tomorrow, no relief. It is accompanied w nausea when it is severe.
He felt as though his heart rate slowed, he developed chest pain and lightheadedness. He was pale. We received the rest.
Covid positive again 8 days after last paxlovid pills; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid positive again 8 days after last paxlovid pills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid positive again 8 days after last paxlovid pills). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Covid positive again 8 days after last paxlovid pills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Covid positive.         No concomitant medications were reported.  Company comment: This spontaneous case concerns a 46 year old male patient, with no relevant medical history, who experienced the unexpected non serious of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient tested positive for COVID-19 and took Paxlovid for 5 days. About 8 days after the last dose of paxlovid, he tested positive for COVID-19 again. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 46 year old male patient, with no relevant medical history, who experienced the unexpected non serious  of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient tested positive for COVID-19 and took Paxlovid for 5 days. About 8 days after the last dose of paxlovid, he tested positive for COVID-19 again. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt recv vax;c/o tingling/numbness in lt arm;no soreness at site of inject;stated was like he had a cold in neck & shoulder;c/o severe pain & tingling sensation in lt arm,muscles in forearm are tight & burning;to chiropractor;
This case was reported by a pharmacist and described the occurrence of human immunodeficiency virus test positive in a female subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of FLULAVAL TETRA (unknown route and injection site, batch number not provided). In February 2014, less than one year after vaccination with FLULAVAL TETRA, the subject was tested positive for Human Immunodeficiency Virus. At the time of reporting, the outcome of the event was unspecified. The pharmacist wondered if FLULAVAL TETRA could cause false-positive readings for HIV.
On 03/25/2023 I had fatigue and nasal congestion. I took a home COVID-19 test and it was positive. I went to urgent care to get a prescription of PAXLOVID and a PCR test which was positive as well. My symptoms lasted for about 4 days. I still have mild congestion but am feeling a lot better.
Before my symptoms began, on Saturday May, 7, my wife and I had gone out of town for an art event. At the dinner for the event, there was not a lot of mask wearing. We drove back on Sunday. By Monday, my wife was feeling mild symptoms, so she took an at home Covid test on Tuesday 5/10 which came back positive. We then both went to a local urgent clinic, where we were tested. Her test was positive while mine was negative. They advised that I isolate with her as well. By that Friday, 5/13/22 I was feeling some sinus like symptoms so I took an at home Covid test which came back negative. I tested again on 5/14 and was negative. That Monday, I had a doctor's appointment so I wanted to test before that and it was positive, so I canceled that appointment and have still been isolating.
hives all over the body; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number B4527, expiry date 2nd May 2022) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   On 2nd September 2020, the patient received Shingrix and PNEUMOVAX. On 2nd September 2020, less than a day after receiving Shingrix, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were not recovered/not resolved.   It was unknown if the reporter considered the hives and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Neumovax both on same day and experienced hives all over the body and rash, not recovered at the moment they reported it. The reporter consented to follow up. It was unknown if the reporter considered the hives and rash to be related to PNEUMOVAX.
34 weeks pregnant first time, Due date 2/18/2018. 1/3/2018 - Received TDAP vaccination during third trimester. 1/4/2018 - Slight raised swelling by the evening, sore and tenderness in arm Overnight - Body Aches, muscle pain, trouble sleeping. 1/5/2018 - Unable to work, flu like symptoms, extreme tiredness, body aches, upper right arm swollen and HOT (width of tennis ball). 1/6/2018 - Out at a store, felt like I may faint, shortness of breath. Went home, headache followed by nausea, fatigue, upper right arm swollen and HOT (width of softball). 1/7/2018 - Muscle/arm still sore, felt physically better but by late afternoon fatigue kicked in and felt "off". Upper right arm swollen and HOT (size of my hand). 1/8/2018 - Feeling physically better, still swollen and HOT. 1/9/2018 - OBGYN appt, did not like how swollen the site was and asked me to submit the symptoms to VAERS.
SOB, tightness in chest, difficulty breathing, rapid pulse. ER MD gave - epinephrine and BENADRYL.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because the facility was unable to download the digital data logger, would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. No adverse reactions were reported by any patients.  No treatment medication was provided.
Anxiety, seeing spots, ringing in ears, lightheaded.  Ate breakfast but no lunch.  No previous reactions to vaccine injections.  Discharged home at 3:35PM after eating granola bar, drinking water and assessment by MD.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.            Patient had allergic reaction to Unspecified drug. Concomitant medication was not reported. Patient had Rebound COVID-19 on 02-Jun-2022 which was recovering. The patient taking was not taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. Device Date :03-Jun-2022.  Company comment: This spontaneous case concerns a 63-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 10-may-2022 to 14-may-202. She was tested positive (rebound covid-19) again 19 days after the treatment with Paxlovid. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 10-may-2022 to 14-may-202. She was tested positive (rebound covid-19) again 19 days after the treatment with Paxlovid. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pfizer-BioNtech COVID-19 Vaccine EUA. Swollen lymph  node,s in the same side as the vaccine was applied, in the lower neck and perhaps armpit.
Adverse event: Immediately after injection at 1642, PT c/o feeling "faintness" and presented with diaphoresis. PT would later report that she felt like she "went black" immediately after injection. No LOC noted. PT assisted to cot/curtained room.  Aid called at 1645, arrived at 1646.  Treatment: Juice was provided and consumed, assessment by RNs and EMTs, assisted to lay on cot. EMS obtained VS (1646: BP 92/60 laying, HR 61, SPO2 98% RA. 1655: BP 112/60 sitting, HR 64). PT educated by EMTs on vasovagal responses, s/s to watch for and to seek urgent care if s/s return. PT verbalized understanding.  Outcome: PT reported feeling better after juice, resumed affable affect. PT standing and walking without difficulty, returned to baseline aside from 'mild headache'. PT was medically cleared to drive home by EMTs at 1703.
Breakout of hives down both her legs, thighs.; Rash on her mid back.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Breakout of hives down both her legs, thighs.) and RASH (Rash on her mid back.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Hives in September 2020.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced URTICARIA (Breakout of hives down both her legs, thighs.) and RASH (Rash on her mid back.). At the time of the report, URTICARIA (Breakout of hives down both her legs, thighs.) and RASH (Rash on her mid back.) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication included diphenhydramine topical cream.
large red hive.  warm and itches  about an inch below injection site. not decreasing
The non-serious initial spontaneous case was received on 11-Oct-2017, concerning a female patient of an unspecified age. On an unspecified date, the patient was vaccinated with AFLURIA (TIV) (dose: 0.5 ml, route of administration, anatomical location, batch number expiry date: not reported). On an unspecified date, after vaccination, the patient experienced rash at injection site. The outcome of the event was not reported. The reporter assessed this case as non-serious.
two blood clots in his right calf; It is painful; This is a spontaneous report from a contactable nurse. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in arm left at 10 am on 16Mar2021 (Batch/Lot number was not reported) as 1st dose, single; dose 2 via an unspecified route of administration, administered in arm left at 10 am on 08Apr2021 (Batch/Lot number was not reported) as 2nd dose, single, both for covid-19 immunisation. Medical history included ongoing varicose vein (for years, barely noticeable). No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations received within 4 weeks. The patient's concomitant medications were not reported. The patient experienced two blood clots in his right calf on 27Apr2021, it is painful. The event 'two blood clots in his right calf' was reported as serious and seriousness criteria were medically significant and disability. He said it is better today once he started apixaban (ELIQUIS). He did not know if that was physical or mental. The adverse event required a visit to physician office. The patient underwent lab tests and procedures which included sonogram on leg: unknown results. The outcome of events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Headache, pain and pressure behind eyes - blood shot eyes, nausea, fatigue for first few days after vaccine. Then, had headache, nausea and fatigue for several days. On 8/21/2021 had sweating, headache, congestion, body aches, nausea, fatigue which then progressed to low grade fever, difficulty breathing and coughing. Had telehealth visit with Dr.  on 8/23/21 who prescribed medrol dose pack and Covid test. Tested positive for Covid on 8/24/2021. Symptoms progressed with difficulty breathing, coughing and decrease pulse oxygen level to 94%. also loss of taste and smell for 4 days. Doctor began Dulera inhaler and Z-pack. Have gradually improved since.
Started like a big whelp, and the skin  come off; A scab nasty; Two inch by two inch  were  originally burn the skin off/like a severe severe burn/major layers of his skins were burn off; Whole shoulder was red; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Started like a big whelp, and the skin  come off), SCAB (A scab nasty), VACCINATION SITE PAIN (Two inch by two inch  were  originally burn the skin off/like a severe severe burn/major layers of his skins were burn off) and VACCINATION SITE ERYTHEMA (Whole shoulder was red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN EXFOLIATION (Started like a big whelp, and the skin  come off), SCAB (A scab nasty), VACCINATION SITE PAIN (Two inch by two inch  were  originally burn the skin off/like a severe severe burn/major layers of his skins were burn off) and VACCINATION SITE ERYTHEMA (Whole shoulder was red). At the time of the report, SKIN EXFOLIATION (Started like a big whelp, and the skin  come off), SCAB (A scab nasty), VACCINATION SITE PAIN (Two inch by two inch  were  originally burn the skin off/like a severe severe burn/major layers of his skins were burn off) and VACCINATION SITE ERYTHEMA (Whole shoulder was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient report a severe reaction with the Moderna  shot .The place where he got it (the vaccine) was shock.  No concomitant medication was reported. No treatment medication was reported.
Fever of 102.1, Crabby and crying baby (unusual for this infant).
Less than 5 minutes after receiving vaccine he became drowsy and less responsive. Extremely pale face/lips were grey and complained of excruciating stomach pain and nausea. Couldn?t/wouldn?t stand or walk. He was able to be helped to the bathroom where he could not vomit but was able to have a bowel movement. Approximately 30 minutes later he started to feel some better and get color back. Approx an hour later he complained of stomach pain/nausea ongoing but not worsening.  He was ?normal? a few hours post vaccine.
I became seriously ill; bizarre nerve vibrations in my head, neck, body; sensitivity to light and sound; sensitivity to light and sound; devier exercise intolerance; muscle spasms; severe insomnia; debilitating headaches; chronic fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I became seriously ill), NEURALGIA (bizarre nerve vibrations in my head, neck, body), PHOTOPHOBIA (sensitivity to light and sound), HYPERACUSIS (sensitivity to light and sound) and EXERCISE TOLERANCE DECREASED (devier exercise intolerance) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I became seriously ill), NEURALGIA (bizarre nerve vibrations in my head, neck, body), PHOTOPHOBIA (sensitivity to light and sound), HYPERACUSIS (sensitivity to light and sound), EXERCISE TOLERANCE DECREASED (devier exercise intolerance), MUSCLE SPASMS (muscle spasms), INSOMNIA (severe insomnia), HEADACHE (debilitating headaches) and FATIGUE (chronic fatigue). At the time of the report, ILLNESS (I became seriously ill), NEURALGIA (bizarre nerve vibrations in my head, neck, body), PHOTOPHOBIA (sensitivity to light and sound), HYPERACUSIS (sensitivity to light and sound), EXERCISE TOLERANCE DECREASED (devier exercise intolerance), MUSCLE SPASMS (muscle spasms), INSOMNIA (severe insomnia), HEADACHE (debilitating headaches) and FATIGUE (chronic fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the reporter did not remember much in January and February of this year. No treatment medication was reported.   This case was linked to MOD-2022-592428 (Patient Link).