chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delayed response of  mild backache in upper and lower back that began one week after first dose of vaccine.  Initial response of  fatigue resolved in 12 hours and arm soreness and general muscle/joint aches resolved in 48 hours.  Back ache became noticeable on day 8.   Pain does not interfere with daily function, but pain has persisted 4 days from onset and is has not resolved at day 12 from injection.  No injection site erythema or edema beyond initial two days.
Patient deceased in hospice due to metastatic urothelial carcinoma. This event was within 6 weeks of receiving COVID vaccine.
At 1035 reported nauseated; escorted to B2 with older sister, vomited in toilet, - sister stated OK. Left in care of sister at approximately 1039 - returned to lobby - seated in chair with 3 siblings. Left on own at approximately 1048. At 1050 called to parking lot to assist - c/o lightheaded - seated in chair - head down on lap - threw up x 3 more times - took few sips of water, cool cloth to lips - at 1059 - stated feeling better 'stomach hurts' - seated 5 more mins - escorted back to lobby at 1110. Mother called at 1110 with assist of interpreter to make aware of reaction to #3 HPV - informed she became nauseated et threw up in BR toilet also c/o lightheaded. Recovered quickly after head lower to lap/(in chair) - mom stated had same reaction after 1 & 2 HPV but was fine - no long term issues - mom stated the HPV was the only immunization she has ever had reactions too. Encouraged to seek medical care for further questions or concerns. Verbalized understanding. Mom given nurse's name and number encouraged to called if any questions or concerns. Stated she would. Pt. sat in lobby till 1130. When pt stated she was OK. Left ambulatory with 3 sibling. "I'm OK". Encouraged to take a easy today drink fluids, call doctor prn.
First shot gave me a sore arm and fatigue; First shot gave me a sore arm and fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 (Lot number: EW0153) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Penicillin-Allergy" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; LEXAPRO; FENOFIBRATE. Past drug history included: Augmentin for Product used for unknown indication, reaction(s): "Drug allergy", notes: Augmentin. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset May2021, outcome "unknown" and all described as "First shot gave me a sore arm and fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  No follow-up attempts are possible. No further information is expected.
Pt reported chest tightness after getting her flu shot. She denied any shortness of air nor any airway tightening. She states that typically gets chest tightness after vaccinations (eg. flu, pneumonia).
tolerated first dose of Moderna vaccine done on 03/01/2021.  No adverse reactions.  After the second dose on 04/02/2021, started with itching rash on legs and progressed upwards, sparing the proximal thigh areas and GU areas, but arising on abdomen and chest, and back, along with arms.  Sparing the neck and face / head.  Seen by dermatologist, and a biopsy was taken, demonstrating what appears to be an allergic reaction / Id reaction.  Has been using topical steroids Triamcinolone cream and oral Prednisone.  The rash is less intense but not gone,  The itchiness is not present anymore.  During the height of the rash he had weeping rash.  The rahsed are not weeping anymore.  No fevers came about.  No new muscle aches nor other constitutional symptoms.  No vision chagnes, no changes in urination.
Pericarditis, Chest Pain. 2 trips to emergency room. Treatment ongoing/ anti inflammatory
That evening after immunization experienced redness, swelling, tenderness, heat at site of injection on L arm. Had 1st dose of varicella on 10/23/03 with no local reactions and concerned about getting a local reaction after this 2nd dose. Advised anti-inflammatory meds, ice on heat for comfort.
Got 1st dose Covid vaccine 3/10/21 from Walgreens. Symptoms of Head ache, fever- highest 103 (on 3/19/21- am), chills, body ache started on 3/17/21.
I got the shot at noon on Friday, February 12th.  Felt pretty well with arm pain at injection site and flush face the rest of the date.  On Saturday, the 13th, I was fatigued, extreme arm pain at injection site, flush face, and cold all day.  Sunday, the 14th, much the same as Saturday until evening when extreme dizziness and diarrhea set in.  Woke up in the night with extreme dizziness and nausea.  All day Monday, 2/15, I had lethargy, lightheadedness, dizziness, flush face, body aches and chills.  Tuesday, 2/16, same exact symptoms as Monday.  Wednesday, 2/17 was still mild body aches and flush face.  Thursday, lesser body aches but still flush face.  Today, 2/19, I still have flush face and fatigue.
delayed reaction arm redness; delayed reaction arm swelling; delayed reaction arm itching; A spontaneous report was received from a consumer concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events delayed reaction arm redness, delayed reaction arm swelling, delayed reaction arm itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 020M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) delayed reaction arm redness, delayed reaction arm swelling, delayed reaction arm itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), delayed reaction arm redness, delayed reaction arm swelling, delayed reaction arm itching was unknown.
I had Spikevax. I had a really painful left arm that is swollen and red and puffy. I have been puffy on my legs, arms, and face. My ears feel like they are "gone", like when you're under water and your ears are plugged up. It feels like being waterlogged in your ears. Even at this moment. It has pressure to it, like when you pinch your nose to blow the pressure out. It makes things sound muffled and a vibrating sensation especially when I talk. I had ringing in my ears at the beginning after the vaccine. It was in both ears but now its in my right ear. It has lasted 1 week and 2 days. I also have extreme brain fog and confusion.
Swelling, warm to the touch. Pt received TDaP 8/28/18 as part of wellness visit. Called 8/30/18 to report vaccine site warm and swollen. She did not see need for visit at that time. Assume resoled.
High fever (104.5), temporary paralysis in the left arm (unable to move or lift arm for 8 hours), foggy memory (had to look up my birthday)
Tiredness, starting 3-4 hours after injection and lasting several hours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Mar2021 10:00 (Lot number: EP6955) at the age of 50 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION; TRI-SPRINTEC; ZOLOFT. The following information was reported: FATIGUE (non-serious) with onset 16Mar2021, outcome "recovered" (Mar2021), described as "Tiredness, starting 3-4 hours after injection and lasting several hours.". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. The patient had no known allergies. The patient did not receive other vaccine in four weeks. The vaccine was given in a workplace clinic.  No follow-up attempts are possible. No further information is expected.
sudden intense pain in both calves lasting approximately 30 minutes.  Then I experienced and odd taste in my mouth and my lips, the inside of mouth, tongue (to a lesser degree) and left side of face and left earlobe were numb and tingling.  The closest comparison would be the feeling after having shots of Novocain as they are wearing off. In addition, my lips were swollen on the inside of my mouth--outwardly they did not appear swollen but rubbing my tongue along the inside of my lips, they were swollen--feeling like having a "fat lip". The odd taste lasted approximately 20 minutes but the numbness and swelling lasted for over 24 hours before the swelling began to subside and the numbness of my tongue began to improve; however, the numbness of the inside of my mouth, lips, face and earlobe were still present.  Another 12 hours passed before the facial numbness almost completely disappeared.  Another 24 hour and most of the numbness was gone and the swelling was almost completely gone but there is still an odd feeling in my lips.
Information has been received from a consumer concerning her husband who on 12/18/03 was vaccinated with a dose of pneumococcal 23v polysacchardie vaccine (lot # 645853/0256N). On 12/22/03 the patient began breaking out in a rash and experienced facial swelling. At first, he thought his teeth were bothering him and he went to a dentist. The dentist took x-rays and examined him and said that his teeth were fine and perhaps it was a medical problem. The patient then went to his family doctor and by then he had a visible rash and facial swelling. The doctor gave him a methylprednisolone dose pack and hydroxyzine hydrochloride. The rash basically affected his arms and legs but it really was not around the site of injection. As of 2/5/04, the swelling went away and there is only a trace of the rash left, but most of January he felt poorly. The patient had no prior history of any allergies. There was no product quality complaint involved. Upon internal review, the patient's facial swelling was considered to be other important medical event (OMIC). Additional information has been requested. On 30AUG2004 the physician reproted six months post vaccination the patient has had recurring hives and a rash. The patient has complained several times and has been treated for hives/ rash on his ankles and elbows. Treatment included steroid cream and methylprednisolone (MEDROL) dose pack. Subsequently, the patient recovers. However, the hives/ rash outbreaks are monthly now and the patient insist "the rash is from the pneumococcal 23v polysaccharide vaccine".
Information has been received from a business manager for a physician concerning a 12 year old female who on an unknown date was vaccinated with her first dose of Gardasil.  It was reported that the patient received four injections (therapy unspecified) at that time.  Subsequently on an unknown date the patient experienced syncope, hit her head and cerebral bleeding and was hospitalized.  It was reported that subsequently, on an unknown date, the patient had full recovery.  This is one of several reports received from the same source.  No further information is expected.
Information has been received from a registered nurse concerning a female who, "a number of years ago," was vaccinated with MMRII. Subsequently, the patient was diagnosed with autism. Upon internal review, the patient's diagnosis of autism was determined to be an other medical event. Additional information has been requested. Follow-up info was received from the same RN which indicated the pt's mother reported that the child had a 15 month visit that was reported to be WNL. On 3/30/95, at 16 months of age, the child received MMRII (lot 0604A) in the left thigh. On a visit of 5/15/95, it was documented that the child frequently does not respond to loud noise and only has a vocabulary of 1 or 2 words. On 2/15/96, a visit was documented that stated the child was continuing to have developmental delays and language delays. The child was not engaging in social interactions and did not play at this time. On 5/9/96, the physician's office saw the child for her 2 year old well visit and the child was dx'd with a developmental delay, autism. The child was enrolled in a Developmental Program in school. The reporter noted that the mother requested her 2nd child receive MMR as single doses because she saw a piece on a "20/20 television program" and thought that single dose administration could "avoid autism". As of 4/24/01, the mother reported that the autistic child was doing "as well as can be expected". Additional information has been requested.
Aching at injection site 1 hour after shot given-continued for 3 days, then stopped Headache for 29 hours straight since 7:00am on 4/15/21 Nausea and chills for about 1 hour at 10:45am-11:45am on 4/15/21 One minimal bump and slight itchiness (like mosquito bite) at injection site noticed at 7pm on 4/15/21 4 mosquito-sized bumps and slight itchiness (like mosquito at injection site noticed at 7am on 4/16/21
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Ectopic pregnancy on date and Alcohol use. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-May-2020 and the estimated date of delivery was date. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       ON an unknown date, post vaccination. the patient reported that she experienced symptoms of exposure during pregnancy.   No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: Internal review on 24-Jun-21 resulted in updates to pregnancy details.
Fluttering of the heart/ it became a little more frequent/ It is on and off and goes away on its own; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Fluttering of the heart/ it became a little more frequent/ It is on and off and goes away on its own) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     The patient's past medical history included Heart fluttering (Had even before she got the Pfizer vaccines whenever she was anxious). Previously administered products included for Product used for unknown indication: Pfizer (1st dose - EW0164) on 22-Apr-2021 and Pfizer (2nd dose - EW0173) on 13-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 09-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced CARDIAC FLUTTER (Fluttering of the heart/ it became a little more frequent/ It is on and off and goes away on its own) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (Fluttering of the heart/ it became a little more frequent/ It is on and off and goes away on its own) had not resolved.            No concomitant medications were provided. The patient said that she was nervous about getting the vaccine that was probably why she was experiencing it more often than her usual. No treatment medications were reported.  Company Comment - This regulatory authority case concerns a 43 year old female patient with medical history of cardiac flutter, who experienced the serious (medically significant) unexpected event of cardiac flutter. The event occurred 2 days after the third dose of mRNA-1273 vaccine. Patient's medical history of cardiac flutter remains a confounder. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 43 year old female patient with medical history of cardiac flutter, who experienced the serious (medically significant) unexpected event of cardiac flutter. The event occurred 2 days after the third dose of mRNA-1273 vaccine. Patient's medical history of cardiac flutter remains a confounder. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
FELT LIKE SINUS PROBLEM; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported), (dose number series 1) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-DEC-2021, the patient experienced cough and felt lethargic. On an unspecified date, the patient felt like he had sinus problem. On 24-DEC-2021, the patient had, at home covid-19 test done which showed positive results twice (suspected clinical vaccination failure, and suspected covid-19 infection) (dose number series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and felt like sinus problem was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211265893. This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220131710-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates, these patients received doses of improperly stored VARIVAX (Merck). No adverse effect was reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to VARIVAX (Merck). Additional information has been requested.
2 1/2 hours post vaccination, swelling of eyes and Left hive rash (urticaria).
Pt recvd vax & exp bilateral bursitis; lab eval on 16APR92 revealed anti-Hbs of 3.9; Anti-HBc IGG pos;
Started with constipation after exercising on May 25, took MagOx and Miralax. Went to ER in Aug 1 after feeling very uncomfortable with constipation and fast heart beat, shaky and sweating. Did X-ray and ultrasound, said I was obviously constipated and also showed pelvic congestion syndrome. Went home took miralax, was no longer constipated a week later but went to ER again after fast heart rate, they said I was having a panic attack. I also get dizzy, shaky and pin pokes over skin. Still feel pinches or shock like feeling in skin. I also lost 5 lbs in a week after not being able to eat
Felt fine after vaccine - no effects at all. Then a week and a day later, my arm was swollen and red and itchy. It lasted for 2 days.
Swollen from shoulder to elbow for several days. Warm to touch. No other symptoms.
Pt. at ER with lethargic behavior, and was febrile. Treated for pneumonia.
patient received an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix) (batch number NC7GR, expiry date 17-JUL-2023) for prophylaxis.   On 03-JUL-2023, the patient received Havrix. On 03-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Havrix). 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: 03-JUL-2023 The reporter consented to follow up by email. The reporter reported that a patient received an expired dose of Havrix, which led to expired vaccine used.
Pt recv vax on 6/26/98;on 7/6/98 pt exp flu sx-achey &tired, headache
Upon arising between 8:30 and 9:00am while using the restroom he passed out hitting the floor.  He came to and tried to exit the restroom and passed out again.  He is now running a low grade fever.  He has eaten and taken Tylenol and is feeling some better.  He states he did not sleep well last night.