chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 10 yr old male with no reported history and no allergies who was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair). On 03Dec05 the pt experienced a breakthrough case of chickenpox. He had a fever, stomach ache and a rash that developed into lesions. No lab tests were done. At the time of this report the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Large red area, with itchiness. Started with red spot then swelling to a large area. Has pain at the side.
Sever brain fog for almost 4 weeks. Feeling unlike myself. Moments of confusion, and loss of thoughts. I have been forgetting a lot of things I don?t normally forget. The feelings are starting to make me feel depressed.  I had a couple of good days that made me feel like I was coming out of it. Then the next day would have me back to square one.  I feel like I?m constantly high from marajuana.  I find myself just staring at a wall and completely forgetting what just happened. Everything?s seems unreal.  I had dizzy spells that have subsided since the beginning.
Pt received vaccines at noon on 2/4/19. Mom reports seizure activity started at 3pm that same day and continued for less than 2 minutes and described as "jerky movements to arms and legs, eyes glazed and rolled back in head." Denies blue-tint to skin or around mouth. Pt immediately fell asleep after event. Pt returned to clinic at 4:30pm for exam....had just awakened and was neuro intact, afebrile, and with normal exam. EEG ordered.
Agency nursing staff called to report client had uncontrollable vomiting about 2 hours after the injection was given. Another individual had the same reaction, so probably gastroenteritis, but reporting it just in case.
01/26/11 - 0.1 cc tetanus toxoid administered (L) Volar forearm intradermally instead of PPD 01/28/11 - 15 mm area of erythema with smaller central area of induration 01/31/11 - Erythema & induration markedly reduced.
not feeling well; This is a spontaneous report from a contactable consumer (daughter of the patient) received via Medical information Team and via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced not feeling well on 30Mar2021. The patient was due to get the second dose on 30Mar2021 but she was not feeling well that day and was not able to get the second dose. The consumer was asking if someone can come to their home to administer the vaccine to the patient. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
itching all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PRURITUS (itching all over body). At the time of the report, PRURITUS (itching all over body) had not resolved.            Concomitant product use was not provided by the reporter. The treatment information included Benadryl.
Received varicella vaccine on Friday, 11/16/18. Adverse symptoms presented on Saturday evening, 11/17/18 and continued to worsen. Right arm where it was administered was red, hot, swollen, itchy, and tender to touch. Went to ER on 11/18/18 and received a prescription for Naproxen and was evaluated and released.
pt recv vax 16FEB97 & 31MAR97 pt exp welts on the arm of inj;
an allergic reaction to the Pfizer; face swelling/She says she was like a actor doing the clump. She says her lip and jaw looked just like that; She says she was like a actor doing the clump. She says her lip and jaw looked just like that.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 11:00 (at the age of 50-year-old) as 1st dose, single for covid-19 immunisation.  Medical history included ongoing high blood pressure, blood clot on her right kidney from 2016, high cholesterol from 2016. Concomitant medications included warfarin; cholesterol. The patient was calling about the Pfizer COVID-19 vaccine. She says she had both of them. She says she had an allergic reaction to the Pfizer; she is assuming it was the Pfizer. She says the 15th through the 19th she was like a actor doing the clump. She says her lip and jaw looked just like that. She says it was at a the pharmacy. She says she went to Urgent Care, they gave her Benadryl, and admitted her to the hospital because they thought her throat was going to close(it started 20Apr2021 or 21Apr2021 and ended on 21Apr2021). The patient stated she was started on a high blood pressure medication after the first time of being in the hospital with face swelling. Prior Vaccinations (within 4 weeks) there is no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There is no AE following prior vaccinations. The patient says she has no allergies and was not sick at the time of either vaccination. There is no Family Medical History Relevant to AE. The outcome of the events was unknown.
extremly cranky, fussy; fever 104; diffuse maculo papular rash; nl exam other than rash 23JUN93;
Information has been received from a RN concerning a 53 year old female who on 05/04/04 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). Subsequently, the pt developed swelling, warmth and pain at injection site with a low grade fever. Medical treatment was sought.  Treatment included over the counter medication only. No product quality complaint involved. Additional information has been requested.
Breakthrough case admission after 2 vaccines; Pfizer x2; Pfizer 5/5/21 Lot# Ew0179; Pfizer 5/26/21 Lot# EW0183.
I am 27 weeks pregnant, due on July 24th.  I have injection site pain in my arm.  I have body aches and a slight headache, nothing debilitating.
pt became nauseated, flushed, clammy, dizzy, visual changes-blurred vision; also became pale; lasted for a few minutes then would ease up then sx would reappear lasted for 1/2 hrs to 1 hr;
pt diagnosed by PCP for being positive for COVID 4 days before admission to hosp; presents to ED with c/o worsening SOB x 2dys; non-productive cough, headache, fever, diarrhea, body aches, O2 sats 52% in ED on RA; placed on BiPAP; COVID pneumonia; pt experienced severe drop in O2 sats with sinus bradycardia; continued to struggle with oxygenation and ventilation; became hypotensive, bradycardic, and hyposic; pt transitioned to comfort care; pt died in the hosp
1PM tonic seizure-stiffening of extremities, duration of 30-60 seconds; 8PM same as above;
Pt received vaccine and felt light headed and nauseated.  He vomited and felt warm. BP 108/68, hr 98. pulse ox 96-99% Placed cool rags at neck and head, and given water,  within minutes pt felt better. Was accompanied by mother.
Hard knot at injection site; whole personality changed day after shot; fever spiked and stayed up for several days (102.7 degrees) took 2 weeks + to return to normal.
Complained of shortness of breath & racing heart. Nurse auscultated lungs & heard expiratory wheezes. Complained of itching, swelling eyes. Treated with Benadryl, IM shot.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). An 83-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medication included Tylenol. The patient experienced arthropathy (affected forearm), with outcome of unknown. Additional information: After taking the first shot of the vaccine, patient experienced forearm problems/arthropathy. She mentioned she took Tylenol half an hour after getting the vaccine. No follow-up attempts possible.  Information about batch/lot number cannot be obtained. No further information expected.
Information has been received from a registered nurse referring to a patient of unknown age and gender. No patient's concurrent conditions or medical history were provided. On 15-MAR-2016, the patient was vaccinated with a dose of improperly stored (temperature: 12 degree Celsius, time frame: 8.5 hours) MMR II (lot# L012482, expiry date: 10-APR-2017, dose, route and site of administration were unspecified). There was no temperature excursion issues previously. Concomitant medication was not reported. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a nurse refers to a 13 year old female patient. The patient pertinent medical history included pregnant. Last Menstrual Period (LMP) was around 29-JUL-2014 and estimated delivery date (EDD) would be 05-MAY-2015. On approximately 05-AUG-2014, (reported as "about two weeks ago"), the patient was vaccinated with first dose of GARDASIL injection (dose, frequency, route and lot# unknown). The patient sought medical attention at physician practice to receive a blood pregnancy test on 17-AUG-2014 to determine pregnancy. The outcome of the event was unknown. Additional information has been requested.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            No concomitant provided. Patient treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR Received: and contains no new information
The pediatric Pfizer 5-11yo 0.2mL vaccine was administered to the patient on Saturday morning, after which he left the pharmacy premises with his brother (who got same vaccine) and father. About 45 minutes to an hour later, it was realized that he received an undiluted dose. The parents were immediately notified. The only report of side effects came during my follow-up call at 5:30pm that same day. The father reported that one of his sons (did not specify) was feeling sleepy. The parent was told to contact the pharmacy if any concerns were to arise. As of the time of this report, we have not been contacted.
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 2-week-old female patient who received ENGERIX B pediatric. Co-suspect products included ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B adult (batch number K35HY, expiry date 14th April 2018). On 16th November 1998, the patient received the 1st dose of ENGERIX B pediatric. On 14th December 1998, the patient received the 2nd dose of ENGERIX B pediatric. On 14th September 1999, the patient received the 3rd dose of ENGERIX B pediatric. On an unknown date, the patient received the 4th dose of ENGERIX B adult. On 14th September 1999, not applicable after receiving ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B adult, an unknown time after receiving ENGERIX B pediatric and not applicable after receiving ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B adult, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder, accidental overdose and adult product administered to child. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long, accidental overdose and adult product administered to child were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B pediatric. Additional details were provided as follows: This case was reported by a vaccine coordinator. The patient received 3rd dose of ENGERIX B pediatric longer than the recommended schedule, which led to the lengthening of the vaccination schedule. The staff member of the reporter inadvertently administered an adult dose of ENGERIX B to the patient at an age of 17 years. This led to an accidental overdose and an adult product administered to child. The patient received 4th dose of ENGERIX B due to being a therapy non-responder. The reported lot number (K35H8Y) for 4th dose of ENGERIX B adult did not exist and was updated to K35HY as per the sales database. There was discrepancy in vaccination date of 4th dose and clarification was requested for the same.
felt like my whole body was on fire inside; My eyes hurt; headache; The burning pain lasted for almost 24 hours.; This is a spontaneous report from contactable consumer reported for herself. A 41-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EN6206), via an unspecified route in the left arm on 09Mar2021 at 09:15 (age at vaccination: 41-year-old), as a single dose for covid-19 immunization. Medical history included pituitary tumor and known allergies with Tylenol, many foods and environmental allergies. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL), ibuprofen, vitamin B complex and vitamin D. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 09Mar2021 at 18:30, 9 hours after getting first vaccine shot, patient had just come back from taking a walk and suddenly felt like her whole body was on fire inside. Her eyes hurt, had a headache, but no fever. The burning pain lasted for almost 24 hours. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Immediate soreness "couldn't move my arm", soreness improved slightly but persists 13 days later.
On day 5 after vaccination noted a marked decrease in exercise tolerance, need for frequent stops to catch breath, and sudden decrease in VO2max as estimated by Apple watch. Marked decrease in embouchure muscle stamina playing the flute (a daily activity as a professional).  These have persisted and worsened since onset three days ago.  As after the first two Moderna shots, I had a mild headache for 3-5 days, about 2 on scale of 10. Minimal soreness in right deltoid for 4 days as expected (and much less than after the second injection).  Note: The nurse did NOT aspirate before injecting.
Information has been received from a nurse referring to a female patient of unknown age. The patient's medical history and drug reactions were not reported. "30 years ago" (approximately in 1985) when the patient was in her childhood, the patient was vaccinated with only one dose in the series of MMR II injection (therapy type: HSA, dose, route, lot number and expire date not reported) and the patient had severe anaphylactic reactions with clindamycin, penicillin (unspecified) (unknown formulation), "the sulfas", erythromycin, and KEFLEX (anaphylactic reaction to drug). A recent (approximately in 2015) unspecified titer level was low. The outcome of anaphylactic reaction to drugs and viral titer decreased was not reported. Additional information has been requested.
Received phone call from mother ~32hrs after flu shot.  Patient had been fussy all day, and arm and shoulder had become bright red and "hard", temps 100 to 100.1, got Tylenol all day. No streaking.  Had mother mark edge of erythema.  Following day, patient was much more comfortable, erythema had regressed overnight.
Brachial neuropathy [not shown to dr. But patient thinks it is brachial neuropathy].
Patient stated feeling like her throat was closing and some dizziness No shortness of breath and patient was able to talk in clear sentences Patient provided with water and symptoms improved Patient seen by medical team, refused medical transport and signed AMA form
died from clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "died from clots". The patient date of death was unknown. Reported cause of death: "died from clots". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112856 same reporter, drug and event, different patient;US-PFIZER INC-202300112854 same reporter, drug and event, different patient;; Reported Cause(s) of Death: died from clots
had a big filling that fell out; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INJURY (had a big filling that fell out) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O21A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced TOOTH INJURY (had a big filling that fell out). At the time of the report, TOOTH INJURY (had a big filling that fell out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.
Patient reported redness in her right eye the day after immunization was administered. Patient experienced headache for about 24 hours. Per patient, she felt little tired for one day. No other symptoms were reported.
on 20-APR-2021 the patient came for her 3rd dose of GARDASIL 9; the first and second dose were administered back in 2016; no additional adverse events reported; This spontaneous report was received from a nurse and refers to a 23-year-old female patient. There was no information regarding her medical history, current conditions nor concomitant therapies provided.  On unspecified dates in 2016, the patient received the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact doses, route of administration, anatomical location, lot # and expiration dates were not provided) for prophylaxis. Then, she skipped coming back for the third scheduled dose of the series. On 20-APR-2021 (described also as today), she came into the nurse's office for her third dose of the vaccine (outside of prescribed recommendation of scheduling), however it was unknown whether the dose was administered to her. No adverse events were reported.
Information has been received from a pharmacy student concerning a 10 year old female who on an unspecified date was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck) intramuscularly. Subsequently the patient developed soreness and redness at the injection site. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information is not available.
a little swelling in throat; Rapid heart rate; Peripheral muscle pain/burning; A spontaneous report was received from a Health Care Professional concerning a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Sore throat , Rapid heart rate, Peripheral muscle pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 11 Jan 2021 Monday, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021 Monday , the patient experienced Ongoing Sore throat, Rapid Heart rate, Peripheral muscle pain . No Treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events, Sore throat, Rapid Heart rate, Peripheral Muscle pain, were considered not resolved on 11 Jan 2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After receiving vaccine fast heart beat; High blood pressure; Extreme body itching; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 10:00, as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient's concomitant medications included losartan 50mg, and atorvastatin 20mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021 10:00, the patient experienced after receiving vaccine fast heart beat, high blood pressure, and extreme body itching. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome for all the events was not recovered.  Information on lot/batch number has been requested.