chrisvoncsefalvay/vaers-outcomes huggingface dataset:
like someone beat me up; 101.3 F; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (like someone beat me up), PYREXIA (101.3 F), CHILLS (chills) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 017B21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Depression, Headache and Blood cholesterol abnormal. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety depression, ATORVASTATIN CALCIUM (LIPITOR) for Blood cholesterol abnormal, VITAMINS NOS for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced FEELING ABNORMAL (like someone beat me up), CHILLS (chills) and MYALGIA (body aches). 12-Nov-2021, the patient experienced PYREXIA (101.3 F). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (like someone beat me up), PYREXIA (101.3 F), CHILLS (chills) and MYALGIA (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, Body temperature: 101.3 (High) 101.3 F.         Concomitant medication also includes unspecified headache medication.
single varicella-like rash @ inj site;4 other blisters scattered-chest arm & leg;
Vaccine given 9/29/06 and nurse noted almost immediate induration on the left leg. Pt returned following day with temp 100.2, 102 at daycare. Left leg was erythematous with two nodules at each site. Pharynx was erythematous. Nodules were quite tender. Pt otherwise normal. AUGMENTIN started. Following day, decreased erythema, induration , tenderness. Throat still erythematous. Fever gone. Called 10/5/06 pd did develop slight cough, rhinorrhea, leg completely normal.
Patient was anxious about getting IM injection. She received injection by holding her mom's hand which made her more comfortable. She stated she got all worked out about nothing. When she got up to walk out to check out of clinic with her mother she passed out. When patient came to asked her if she drank and ate anything today. She stated she had nothing to eat. She was picked up at school before lunch. When she asked about fluids she said she had several caffeinated beverages and one bottle of water. Gave patient bottle of gatorade to drink.
Pt experienced flu-like symptoms for aprox 24 hours. Included headache, feeling shaky, tender skin (whole body), joint aches, especially the neck. Redness and swelling at Tdap injection site (limited to injection site only). Pt reports steady improvement 24 hours later.
Chills, fever(highest 102), headache, nausea,diarrhea.  Tylenol used.
My spouse first saw strange lesions on his face. A couple weeks later I also saw these on my face. I went to a dermatologist for biopsy which was negative except for a staph infection from scraping the lesions. I took KEFLEX which cured the staph but the lesions increased. The dermatologist had never seen anything like this. I saw family doctor and he cultured a lesion and it was negative. We both are using Tretinoin with no improvement. We think this is Molluscum Contagiosum contracted from my spouse's Shingles vaccine. He was very sick from the 2 shots and this skin issue began about two weeks after the first shot.
Received flu shot in the morning approx. 1-1 1/2 hour later stated to feel numbness and tingling in whole body and had dizziness. No fever and no vomiting. symptoms lasted all day then gradually disappeared over 2 hours. Was fine the next day since then.
Within hours of receiving vaccine patients left upper arm was red and swollen from shoulder to elbow. Patient was treated with prednisone.
I have had 4 terrible days after the vaccine that I had to spend in bed. I had horrific severe headaches at the front of my head and at the back starting in less than 24 hours after the vaccine. On the next day I had a fever added to these headaches. I couldn't open eyes and light hurt my eyes. I had a loss of appetite and huge weakeness. I couldn't walk and had literally to crawl to the bathroom. When I stood up from my bed I almost fainted.  After 96 hours after vaccine I still have nausea and headaches that diminished a bit. Fever disappeared only after 96 hours. Still I'm very weak, have nausea and can't really do anything except being in bed.  I have never had anything like that in my life after a vaccine. and I'm in perfect health and don't smoke, don't drink any alcohol, doing regular gym and my BMI is normal
some hives, racing hr, anxious, tingling  self treated with benadryl and hydration, symptoms improved
PATIENT RECEIVED A PNEUMONIA VACCINE LESS THAN 2 WEEKS FROM THE MODERNA VACCINE
Covid 19 treatment; Covid 19 treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown, single (batch/lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "penicillin allergies" (unspecified if ongoing); "acacia allergies" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: 20 years breast cancer survivor. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Sep2023 to 21Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
headache; big hard lump for a full week; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headache) and SWELLING (big hard lump for a full week) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0112A01) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and SWELLING (big hard lump for a full week). At the time of the report, HEADACHE (headache) and SWELLING (big hard lump for a full week) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications reported.   Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-067558 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067558:crosslinked with dose 2
sick; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ILLNESS (sick) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   In September 2020, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Information was received from a pharmacist who heard second-hand that a female patient (demographics unknown), was vaccinated with PNEUMOVAX23 (date of vaccination, dosage and route of administration not provided). She received concomitantly an unspecified influenza virus vaccine (manufacturer unknown). It was reported that the patient was "sick for a week." Additional information has been requested.
he  felt "fluttering in his leg, behind the knee cap and the calf; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, a little over a day after vaccination, the patient reported he felt "fluttering in his leg, behind the knee cap and the calf". He specified that it was not painful but almost like a twitching feeling. The patient mentioned that he was scheduled for their second dose in two weeks. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Patient has never had love disease. Patient was given acyclovir 200mg/5ml 1 1/2 tsp. for 5 days. Dx'd with shingles on 6 March 2015.
Shingles diagnosed today by doctor 5/13/21.  Valtrex started 5/13/21
discomfort in their chest; had no energy; felt they could not work out as usual; at night felt like their heart skip a beat; shortness of breath; very fatigue; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (discomfort in their chest), ASTHENIA (had no energy), FEELING ABNORMAL (felt they could not work out as usual), EXTRASYSTOLES (at night felt like their heart skip a beat) and DYSPNOEA (shortness of breath) in a 59-year-old female patient 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 Egg allergy. Concomitant products included LOSARTAN for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced MYALGIA (arm was a little sore). On an unknown date, the patient experienced CHEST DISCOMFORT (discomfort in their chest), ASTHENIA (had no energy), FEELING ABNORMAL (felt they could not work out as usual), EXTRASYSTOLES (at night felt like their heart skip a beat), DYSPNOEA (shortness of breath) and FATIGUE (very fatigue). On 25-Jul-2021, MYALGIA (arm was a little sore) had resolved. At the time of the report, CHEST DISCOMFORT (discomfort in their chest), ASTHENIA (had no energy), FEELING ABNORMAL (felt they could not work out as usual), EXTRASYSTOLES (at night felt like their heart skip a beat), DYSPNOEA (shortness of breath) and FATIGUE (very fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reported that all the symptoms lasted a couple of weeks.  No treatment information was provided by the reporter.
Chills, temperature 99.4, lethargic, dull, depressed.
Brain bleed; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Brain bleed) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-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 an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion medically significant). At the time of the report, CEREBRAL HAEMORRHAGE (Brain bleed) was resolving.            Patient had two shots of the Moderna COVID-19 vaccine and they were going to go for the booster dose,  had brain bleed after the moderna shots, reporter does not have the dates and the patient goes to his doctor on the 30Nov2021.  Patient was getting over brain bleed and has been cleared for the seizure medication.  Concomitant product use was not provided by the reporter.   Treatment medication included seizure medication.  Company comment: This is a spontaneous case concerning a 90-year-old male patient with no relevant medical history reported, who experienced serious, unexpected event of Cerebral haemorrhage. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. It was reported that patient experienced brain bleed after the Moderna shots, he's just getting over and has been cleared for the seizure medication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 90-year-old male patient with no relevant medical history reported, who experienced serious, unexpected event of Cerebral haemorrhage. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. It was reported that patient experienced brain bleed after the Moderna shots, he's just getting over and has been cleared for the seizure medication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pre-syncope, lightheaded, diaphoretic, pallor, spots before eyes.  "I think I'm going to pass out." Symptoms lasted approximately 30 minutes. Symptoms resolved with lying supine.
This spontaneous report as received from   a licensed practical nurse to a 1 year old male patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 28-APR-2003, the patient ws vaccinated with a dose of VARIVAX (Merck) lot # reported as 643082/0593M expiration date 21-JUN-2004 (dose and route were not provided). There was no concomitant medications. On 09-MAY-2003, 12 days after onset of therapy. The patient experienced chickenpox after receiving VARIVAX (Merck). The patient's mother called the doctor's office. BENADRYL and CALADRYL were given as treatment. There were not laboratory diagnostics studies performed. The outcome of chickenpox was reported as recovered/resolved. Additional information has been requested.
Pt given Rotavirus vaccine, was not age appropriate.  No adverse reation noted prior to or after immunization.
Patient diagnosed with shingles after receiving Shingrix.  Had pain with dermatomal distribution unilateral from back to breast.  Treated with Acyclovir and Prednisone.
Pt recvd 1st dose of Hep B vax 10SEP91 & 45 minutes following vax  devel tightening of throat, swelling of tongue, slurred speech & generalized weakness; tx w/DPH & was hospitalized; pt recovered & was discharged next day;
fever; extreme stomach pain; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (extreme stomach pain), DIARRHOEA (diarrhea) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (extreme stomach pain) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, ABDOMINAL PAIN UPPER (extreme stomach pain), DIARRHOEA (diarrhea) and PYREXIA (fever) outcome was unknown.            No concomitant medication reported  No treatment information was provided   Reporter did not allow further contact
After a couple of weeks one or 2, I went to the gym in the morning and my vision seemed blurry, so I closed my eye  and now the vision of my left eye was worse and the shark shape or fish shape that I started seeing before (the branch retinal occlusion), was now a big blob and it was in my opinion about 1/3 on the bottom of my left eye. I was seen by Dr. who checked it and said it was bigger than last time and closer to the central retinal artery.
headache weakness no energy confusion very sore arm where shot was given Lasted 1 1/2 days
Topical BENADRYL per mother. Informed patient to give antihistamine, MOTRIN, cold compresses on 10-17-14. Came into office 4-18-14 per Dr. Start ORAPRED solution 15 mg/5ml 5.5 ml 1 time a day for 3 days continue with BENADRYL and MOTRIN.
Nausea, vomiting, light-headedness, chills, sweating.  Lasting about 30mins overnight/early morning hour at about 3am.  Came on abruptly, and ended quickly.
lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications.  On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills.  As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Acid reflux very bad after injections; Sore throats; Stomach pain in the pit of the stomach; Stomach cramping; Achy bones; Runny nose; Loose bowels; Having pain and redness in right arm; Having pain and redness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux very bad after injections), OROPHARYNGEAL PAIN (Sore throats), ABDOMINAL PAIN UPPER (Stomach pain in the pit of the stomach), MUSCLE SPASMS (Stomach cramping) and BONE PAIN (Achy bones) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux very bad after injections), OROPHARYNGEAL PAIN (Sore throats), ABDOMINAL PAIN UPPER (Stomach pain in the pit of the stomach), MUSCLE SPASMS (Stomach cramping), BONE PAIN (Achy bones), RHINORRHOEA (Runny nose), DIARRHOEA (Loose bowels), PAIN (Having pain and redness in right arm) and ERYTHEMA (Having pain and redness in right arm). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux very bad after injections), OROPHARYNGEAL PAIN (Sore throats), ABDOMINAL PAIN UPPER (Stomach pain in the pit of the stomach), MUSCLE SPASMS (Stomach cramping), BONE PAIN (Achy bones), RHINORRHOEA (Runny nose), DIARRHOEA (Loose bowels), PAIN (Having pain and redness in right arm) and ERYTHEMA (Having pain and redness in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR was received Contains no new information.
swollen left arm 3-4 inches around the injection site. hives rash from neck to waist started one and half days after administration lasted about 4-5 days. woke up one day and was gone. took benadryl second day but did not help resolve rash or anything. no fever chills.
Lyme disease; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4501159-00. A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYME DISEASE (medically significant) with onset Aug2022, outcome "unknown". The action taken for adalimumab was unknown. Solicited report from the USA by a consumer of a 59-year-old male with events of non-serious Lyme disease and diagnosed with COVID again with Humira (Adalimumab). In Jul2022, the patient experienced diagnosed with COVID again. In Aug2022, the patient experienced Lyme disease. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Lyme disease and diagnosed with COVID again was not provided. Suspect drug: Humira (Solution for injection in pre-filled pen) (Adalimumab), Unknown. Causality: Lyme disease (Lyme disease). Causality as per reporter (drug/vaccine) was not reported. Dechallenge: N/A. Suspect drug: Pfizer BioNTech COVID-19 vaccine (Tozinameran) (Tozinameran). Causality: Lyme disease (Lyme disease), Causality as per reporter (drug/vaccine): Possible, Dechallenge: N/A. Did event abate after stopping drug: NA.  The reporter considered "lyme disease" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and event LYME DISEASE cannot be completely excluded. 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.
pt recv vax 15SEP96 & lab eval indicated a failure to seroconvert;
When reconstituting the Pfizer vaccine, 0.8ml of sterile saline was used instead of 1.8 of sterile saline. Pt was given 0.3 ml of reconstituted vaccine as above.