chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I awoke the day after the 2nd Moderna shot with swelling and pain in my tongue and lips.  It resolved on its own mostly by the end of the day and completely by the next day.
Shot administered on Friday, 5/11/01. Pt ran a fever of 102F from 5/12/01 to 5/14/01.
The wart over his eye on his eyelid, which had started to impede vision, started to slough off; Wart over his eye on his eyelid; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (The wart over his eye on his eyelid, which had started to impede vision, started to slough off) and SKIN PAPILLOMA (Wart over his eye on his eyelid) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Wart (Large wart on his wrist/upper hand which had been present for years).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced VISUAL IMPAIRMENT (The wart over his eye on his eyelid, which had started to impede vision, started to slough off) and SKIN PAPILLOMA (Wart over his eye on his eyelid). At the time of the report, VISUAL IMPAIRMENT (The wart over his eye on his eyelid, which had started to impede vision, started to slough off) and SKIN PAPILLOMA (Wart over his eye on his eyelid) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The patient also had a large wart on his wrist/upper hand which had been present for years that at this point has almost disappeared.
two sores on both knees; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, two weeks before the time of report as dose number unknown, single for COVID-19 immunisation; dupilumab (DUPIXENT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed two sores on both knees. The patient was not sure whether it was from the vaccine or the DUPIXENT. The patient was unable to speak to RPH as she was at work. The action taken in response to the event and for dupilumab was unknown. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.
Injection area hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection area hurting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and INSULIN GLARGINE (TOUJEO MAX SOLOSTAR) for Diabetes, LOSARTAN, MELOXICAM, GABAPENTIN, CLONIDINE, METOPROLOL, OXYBUTYNIN, TRAZODONE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection area hurting). At the time of the report, VACCINATION SITE PAIN (Injection area hurting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also include Victo. No treatment information was provided.   This case was linked to MOD-2021-116637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up information was received and contain no new information.
Patient was called to see how  he was doing after receiving the COVID- 19 vaccine Moderna Spikevax 23-24 since we had an error administration, vaccine was given before thaw time. We have been unable to contact to see if he had any side effects after the vaccine was given. We keep trying to contact patient.
low grade fever; rigors; myalgias; headache; skin hurt; unable to stand without feeling like passing out; This is a spontaneous report from a contactable other hcp. A 46-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 11Jan2021 17:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included lichen sclerosus from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), caffeine, paracetamol (EXCEDRIN [CAFFEINE;PARACETAMOL]). The patient previously had the first dose of BNT162B2 on 21Dec2020. The patient experienced low grade fever, rigors, myalgias, headache, skin hurt, unable to stand without feeling like passing out on 11Jan2021 18:00. The patient underwent lab tests and procedures which included body temperature: low grade on 11Jan2021. No treatment were received for the events. The outcome of events was recovering.  Information of lot/batch number has been requested.
random green yellow bruising all over body, nausea, return of migraines that had been in remission for more than two years
Pain, swelling, unable to move arm due to muscle spasm. Fever, Chills
flu clinic given at senior assisted living and care facility advisor instructed all patients over 65 and patient verbal confirmation when applicable but patient was actually 61 years old and was given HD FLUZONE
Patient received shot on Thursday. On Saturday, noticed on underside of arm the look of broken veins. Sunday swelling noted to elbow and also on underside of arm all the way to armpit. Today no as swollen but does have a swollen knot that patient states it is moving down his arm. Also Saturday noticed pain on underside of arm in between the muscles, about as wide as a finger, all the way down arm to the end of thumb. This was the patient's seventh Anthrax shot. Patient is station at Eglin.
This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6198), at the vaccination age of 79, via an unspecified route of administration, on Mar 8, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient has an allergy to penicillin. On an unspecified date, patient experienced severe itching all over; burning in the palms of her hands/it felt like burning and she felt slightly nauseous. The outcome of severe itching all over recovered on an unspecified date; and of others: unknown. No follow-up attempts possible. No further information expected.
Rash at inoculation site, also maculopapular eruption w/ one urticarial area.
Woke up and felt very naseaus; vomited; fatigued; chills; body aches for the rest of the day; felt very weak; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 12Apr2021 at 09:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included depression. Patient had no known allergies to food, medications and other products. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and cannabis sativa (CANNABIS) both for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 06:45 when the patient woke up, she felt very nauseous. After an hour, vomited and felt very weak, fatigued, and had chills and body aches for the rest of the day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches for the rest of the day, felt very weak, very nauseous, vomited, fatigued and chills were recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
A 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 9/28/02 and 171 days later died on 3/18/03 of respiratory failure secondary to COPD. Death certificate states immediate cause was respiratory failure due to or a consequence of chronic obstructive lung disease due to or as a consequence of tobacco. The investigator assessed the events as unrelated to study products. On 10/17/02 the pt had been hospitalized with pneumonia, treated with Biaxin 10/29/02 to 11/2/02, Suprex 10/29/02 to 11/2/02 and Medrol Dose Pack 10/29/02. The pt recovered 10/29/02 (the date of discharge). The investigator assessed the events as unrelated to the study products. On 12/2/02 the pt was hospitalized for signs and symptoms of CHF and COPD. The pt was discharged on 12/5/02 and the condition was on going. On 12/9/02 the pt was hospitalized for COPD/AECB/bilateral pedal edema and CHF. A chest x-ray was done which showed pulmonary edema. The pt was discharged on 12/11/02 and the condition was on going. Follow-up info received 3/25/03. Discharge summary received for 12/2/02 to 12/5/02. Admission diagnosis date: chronic obstructive pulmonary disease, emphysema exacerbation, congestive heart failure. Discharge diagnosis date 12/5/02: 1. Chronic obstructive pulmonary disease exacerbation, emphysema. 2. Congestive heart failure with hypersensitive episodes. 3. Intermittent claudication. Diagnostic studies: Chest x-ray which shows marking consistent with chronic obstructive pulmonary disease and mild cardiomegaly. White blood count elevated throughout hospital stay secondary to high dose steroid use. This is a 79 year old female with long standing chronic obstructive pulmonary disease that has been having shortness of breath for a couple of days. She has a history of pacemaker and congestive heart failure. The pt was started on high dose Solu-Medrol and also Lasix diuresis and given Rocephin and Azithromycin in the hospital stay. The pt's symptoms improved each day with her breathing better and her pitting edema subsequently also diminished. Condition on discharge: The pt is stable and breathing much improved with no more chest tightness. The pt is stable for discharge. Discharge medications: Azithromycin 250mg po qd x 5 days and tapering Prednisone 20mg bid x 3 days and then qd x 3 days. The pt is to continue home medicines. The pt is to follow up with doctor in 5 to 7 days and encourage to ambulate at home and also use her incentive spirometry. Manufacturer number 2003-00031 was previously reported as number 2003-03-1109. Additional info received 7/8/03. Correction on administration date of vaccine to 9/28/02 for cases crossed referenced with this SAE, Linked cases for this pt-SAE 2002-10-10793, 2002-12-0874, 2002-12-0875
The parent reports the pt did not have any problems after his shots. He had an upper respiratory infection about 2-3 weeks ago and completed antibiotics about 1 week ago. He was seen in ER. The ER dx'd URI with nasal congestion. He had green matter in both eyes and that was dx'd as conjunctivitis and treated with Polysporin optical ointment. The child was fed a bottle of Enfamil with Iron about 10:00 and was found unresponsive and pronounced DOA at 11:41 at the hospital. The hospital will fax Health Dept report. The baby was found by coroner with a bottle propped in the crib with a pillow and stuffed animals. COD as per autopsy report -- undetermined. Per F/U 4/13/02: Pleural surfaces have focal petechiae and are atelectatic. Lungs show edema and congestion, the liver shows congestion and the kidneys show a focal area of chronic inflammation.
Myocarditis; Inappropriate dose of drug administered; Injection site bleeding; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4216278-00.  A 27 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of drug administered "; INJECTION SITE HAEMORRHAGE (non-serious), outcome "recovered", described as "Injection site bleeding". The action taken for adalimumab was unknown. 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 blood at injection site/most of the medication ran out and lost unknown onset, blood at injection site/most of the medication ran out and lost unknown onset and covid vaccine developed myocarditis was not provided. Causality for Pfizer biontech covid-19 vaccine (tozinameran) The reporter's causality for the event(s) of blood at injection site/most of the medication ran out and lost unknown onset, blood at injection site/most of the medication ran out and lost unknown onset  was not provided and the reporter causality for the event Covid vaccine developed Myocarditis was possible. 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 in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.
Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Lymph Node Swelling-Medium
he experienced a stroke shortly after receiving his second covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4390777-00-2.  A 62-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Alcohol use/six glasses of beer per day", start date: 2015, stop date: 2022; "Buerger's disease" (unspecified if ongoing); "Tobacco use/six packs of cigarettes per day" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM taken for supplementation therapy; ATORVASTATIN CALCIUM taken for blood cholesterol abnormal; CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM] taken for supplementation therapy; VITAMIN D [ERGOCALCIFEROL] taken for nutritional supplementation. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 2021, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (caused and prolonged hospitalization, medically significant), outcome "recovered", described as "he experienced a stroke shortly after receiving his second covid vaccine".  Clinical course: The patient held his Humira injections for 18 months due to concerns regarding the covid pandemic. He resumed Humira when his psoriasis symptoms came back. He experienced a stroke shortly after receiving his second covid vaccine.   The reporter's causality for the event(s) of Stroke with Pfizer BioNTech COVID-19 vaccine (BNT162B2) was reasonable possibility. Pfizer BioNTech COVID-19 vaccine - Stroke, Non-Health Care Professional,  Possible. Pfizer BioNTech COVID-19 vaccine - Stroke.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Flu vaccine given to 2 month old no adverse event patient is not having symptoms or other reaction.
Rash all over left arm > 72 hours, HA, myalgia x3 days.  Rash went away x7 days post vaccine.
OUT OF SORTS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced out of sorts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of sorts was not reported. This report was non-serious. This case, from the same reporter is linked to 20210520625 and 20210520722.
Two days after injection, 11/2/18, woke up with a mild, itchy rash starting on her hands and feet. By late morning rash encompassed her lower extremities to her buttocks and across her hands with diffuse scattering onto the forearms. At the time of exam, 11/5/18 the rash had not spread and seemed to be improving. Treated with Benadryl at bedtime and Claritin during the day with no topicals. Continue conservative care and consider topical if unchanged. Follow up with provider on 11/9/18.
Approximately 10hrs after receiving the 2nd dose of the Moderna vaccine, I was experiencing fever- up to 102?F resolving with Tylenol and chills, respiratory- cough sinus congestion, GI- diarrhea, joints- severe body aches and pain, also brain fog with severe fatigue. On Wednesday the fever resolved, hives developed on my left arm, then left side of my torso, and resolved with PO Benadryl.  Thursday I developed a lump on my left shoulder approximately the size of a quarter that is hard to touch and pain with range of motion.
pt to hospital on 10/10/21 with respiratory failure related to COVID pneumonia; pt had a positive COVID test on 10/7/21; O2 supplementation; O2 needs continued to increase; transferred to ICU where he was intubated; vasopressors, dexamethasone, and ABX given; pt's condition worsened and he was hypoxic despite maximum therapy; family decided on comfort care for the pt and he expired in the hospital
Initial report received on 07 December 2007 from a nurse.  A seven-month-old infant male, who is a twin, and who was born premature weighing three pounds and eight ounces at birth, and who had no concurrent illnesses, had received on 06 November 2007, a dose of DAPTACEL (lot number C2607AA); a dose of IPOL (lot number A0170); a dose of PREVNAR (manufacturer Wyeth, lot number B08702D); and a dose of ROTATEQ (manufacturer Merck, lot number 1152U).  The routes and sites of administration were not reported.  Twenty eight days later, on 04 December 2007 at 10:00 a.m., the patient received a first, intramuscular, right thigh dose of Fluzone SV 2007-2008 (lot number U2528AA); and a second, intramuscular, left thigh dose of a medication called Synagis (manufacturer Melimmune, lot number 06E628/06H631).  The Synagis was being given against RSV infection since the patient had been born prematurely.  It was not reported when the first dose of Synagis was given.  On the evening of 04 December 2007, following the Fluzone and Synagis injections, the patient developed a "red face, like a wind burn."  The red face received within 48 hours (approximately 06 December 2007) without medical intervention.
Mother put child in crib for a nap around 3 pm; went in to get her up around 5 pm and found child not breathing. 4/20/06 Received autopsy report which stated COD as undetermined after complete exam/ss
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 12:00 as dose 1, single (Lot number: ER8727), in right arm and on 13Apr2021 at 12:00 as dose 2, single (Lot number: EW0161) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Oct2021 at 14:30 as dose 3 (booster), single (Lot number: 011F21A), in right arm and on 29Apr2022 at 14:30 as dose 4 (booster), single (Lot number: 049L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "allergies to ambient and food" (unspecified if ongoing). Concomitant medication(s) included: ENTECAVIR (Pharmaceutical Pharmadax), start date: 08Jun2016, stop date: 08Jul2022. Past drug history included: Toradol, reaction(s): "Known allergies: Toradol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 03Jul2022 to 07Jul2022.
Red band type area about 2 inches below injection site. Warm to touch and swollen.
Client states next day after receiving shot, she developed a lump at injection site which became fist size. Also had swelling in axilla and discomfort of entire arm, later had pain in all joints. No fever, as of 4-23-03 states she is back to normal
Mom states- last night subject was shaking turned blue, alert oriented, vomited and felt better, no fever-  Had flu shot rashes in the day? if it was from the shot.
My 2.5 WEEK old daughter was accidentally administered the Dtap instead of HepB vaccine. I do not know which manufacturer or other specifics at this time, only that it was the Dtap and it was not something I requested or that her pediatrician had intended for her to be vaccinated with.
Dizziness and blurred vision reported 2-3 minutes after vaccine. Patient reports a history of anxiety and reports this feels like anxiety. Symptoms completely resolved within 5-10 minutes of observation/assessment by medical team.
HCP administered the vaccine to a patient under the age of 18; A spontaneous report from USA was received from reporter concerning a under 18 year old female who received Moderna's COVID-19 vaccine (mRNA-1273) by a Health Care Profession.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 28 January 2021, prior to the onset of the events, the patient received their first  dose of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the  unknown anatomical location for prophylaxis of COVID-19 infection. There are no recorded events of symptoms experienced by the patient.  Laboratory details are unknown.  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the given event is unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (under 18 year old female) for mRNA-1273 (lot number 013L20A) with no associated AEs reported.
per patient she experienced and increased heartrate of 90-100 for 8-9 hours only relieved by laying down which decreased her heart rate to 80-90bpm