chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 15 minutes of my first vaccine, I experienced hives in my right arm and left arm. The  hives also radiated to my back, face and chest. I felt my chest and throat closing up on me. Every once in awhile I get an itchy spot where the first dose vaccine was injected. I did not get my 2nd dose vaccine due to my first dose symptoms.
Miscarriage. Treatment: Rhogam shot 11/09/2009. Blood work, ultrasound on 11/10/2009.
Patient was given vaccine that was involved in excursion and so deemed not viable. Letter has been sent out to Patient's Parents to get her rescheduled for vaccination.
Indurated warm area on the right anterior thigh. Skin over central area had small blistering lesions. No fevers or signs of generalized infection.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Laboratory test: (Jun2022) unknown results, notes: Laboratory test, consumer stated, "It happened while back it didn't happened recent, it happen in June. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that she wanted to report about bad side effect but she wanted to continue what else has happened this was like in June of last this past year, prior august, September. The patient reported that she was not 75 years old at the time she was 74 years old. Now she was 75 years. About product details she replied she threw it away. She did not have it. It would be on the insert that was in it or it would be on the outside of the package. She probably had the insert but she threw the package. The patient received unspecified concomitant medication which she was taking over the counter. Regarding laboratory test he patient stated It happened while back it did not happened recent, it happen in June. Not in two past week, no. The patient received Paxlovid treatment and she went to physical therapist three different times.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Given MMRV on 4/6/16. On 4/7/16 started with a small area of surrounding redness and induration to the left arm @ site of injection. Increased size of redness and induration on 4/8/16.
fatigue; came down with a cold; little cough/bad cough/cough drops; sick/ffeling sick; lost voice; sinus draining; headache; Platelets dropped; throat hurt; This case was reported by a consumer via patient support programs and described the occurrence of fatigue in a 48-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included niraparib (Zejula) capsule for malignant neoplasm of ovary.   On 11th November 2022, the patient received Flu vaccine and Zejula 100 mg 300 mg once daily (300 mg daily). In November 2022, less than 2 weeks after receiving Flu vaccine and Zejula, the patient experienced fatigue, cold, cough, sickness, loss of voice, sinus disorder, headache, platelets decreased and throat pain. The action taken with Zejula was unknown. On an unknown date, the outcome of the fatigue, sickness, loss of voice, sinus disorder, headache, platelets decreased and throat pain were unknown and the outcome of the cold was recovered/resolved and the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the fatigue, cold, cough, sickness, loss of voice, sinus disorder, headache, platelets decreased and throat pain to be related to Flu vaccine and Zejula.     Additional Information: GSK Receipt Date: 23-NOV-2022. Reporter's Comments: This case was reported by Patient via Program. Patient reported adverse events of fatigue and came down with a cold when she first started Zejula. Patient reported the cold has resolved except for a little cough.   Follow up information received on 01-Dec-2022 Reporter's Comment:  The adverse Events of cold and missed doses the duration was ongoing.  The patient was sick and flu shot same weekend started it (Zejula began therapy 11/11).  The patient experienced cold, bad cough, throat hurt, cough drops, lost voice, sinus draining, feeling sick, headache.  The patient platelets was dropped told me to stop taking it 29 November, start it up two weeks to a month depending on my labs. Summary of changes: Updated product tab, event tab, narrative.
Fever, large red rash on arm where vaccine was placed, difficulty breathing, light headiness/dizziness.
Covid arm centered on the vaccination site which she described as reddening, the size of a grapefruit; she described as reddening; the size of a grapefruit; a large rash about the size of grapefruit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm centered on the vaccination site which she described as reddening, the size of a grapefruit), ERYTHEMA (she described as reddening), SWELLING (the size of a grapefruit) and RASH (a large rash about the size of grapefruit) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient reported that animal dander causes asthma.), Hay fever (Patient reported that dust causes hay fever.) and Allergy to animal dander.    On 09-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In 2021, the patient experienced VACCINATION SITE REACTION (Covid arm centered on the vaccination site which she described as reddening, the size of a grapefruit). On an unknown date, the patient experienced ERYTHEMA (she described as reddening), SWELLING (the size of a grapefruit) and RASH (a large rash about the size of grapefruit). At the time of the report, VACCINATION SITE REACTION (Covid arm centered on the vaccination site which she described as reddening, the size of a grapefruit) outcome was unknown and ERYTHEMA (she described as reddening), SWELLING (the size of a grapefruit) and RASH (a large rash about the size of grapefruit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-270465.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received on 5-Aug-2021. Updated patient demographics, medical history, product start time, patient route of administration. Added new event rash.
Large red localized wheal that was very hot and hard. Progressively got > hot, red, painful (kept me awake x 48 hrs. hurt so bad, even w/TYLENOL and hydrocodone for pain). No better w/ice, finally, oral and topical antihistamine decreased reaction. Wheal = 3 1/2 inches x 3 1/2 inches x 3-5 days. Didn't respond to TYLENOL and topical ice and steroids. The tissue was beginning to look necrotic b/4 I put BENADRYL cream on it. I am on BNIBSN x 38 yrs.
Patient reported headache, itchy, watery eyes, swollen lips approximately 4 hrs after receiving vaccination. Recovered the next day.
RASH SHOWD UP 3/28/2021 STARTING ON MY LOWER STOMACH AND HAS SINCE SPREAD FROM GROIN AREA TO SHOULDERS BOTH FRONT AND BACK.  SOME ON PALM OF HANDS AND IN SIDE ARMS AT ELBOW BEND. 4/5/2021 WENT TO DOCTOR AND SHE PUT ME ON PREDNISONE FOR 2 WEEKS.  SHE IS NOT SURE OF CAUSE.
Sore arm at injection site; This is a spontaneous report from two contactable consumer (one of them is parent). A 23-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at age of 23-year-old at arm on 03Apr2021 12:30 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient hadn't allergies to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient experienced sore arm at injection site in Apr2021. No treatment received for event. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No reaction until day 8.  Developed itchy, swollen spot on right arm, approximately 1 inch from where vaccine was given. extremely sleepy and a little light-headed.  balance was off a little.
Adverse event happened multiple weeks after booster on 9/21/22 at 11:45pm.  Was told I still need to report this illness as an adverse event.  Woke up shaking and ended up in urgent care with a fever of 101.2 and had an elevated heart rate.  Given Tylenol and 1 Bag of Saline fluid via IV.  Was checked on a little while later and fever went up to 101.6.  Was then given IV Toradol and another bag of saline fluid via IV. Fever went away and was told to rest and take Ibuprofen every 6 hours as symptoms persist.  Symptoms were alleviated in a couple days and I stopped taking Ibuprofen on Sunday 9/25/22.
This spontaneous report was received from a 26 year old licensed practical nurse (LPN) via field employee reporting on herself. On an unknown date in April 2015 the patient was vaccinated with GARDASIL (dosing regimen unspecified), intramuscular. After receiving her first injection in early April 2015, the LPN stated that she started to experience "muscle twitching" (unspecified location) around the end of April 2015. She continued the remaining 2 injections, but was also seeing a specialist for the ""muscle twitching". The LPN was 26 years of age when she began the series, and completed the series at the age of 27 years. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the event was recovered/resolved. The causality assessment was not provided. No further information provided. Additional information is not expected as the reporter did not wish any further contact.
11-1-22 symptoms initially noted in left calf suspicious for DVT.  11-4-22 visit to primary care provider due to no improvement and continued suspicion of DVT.  Same day referral for ultrasound diagnosed 2 clots in lower left leg.  Immediately went to ER for consultation and was started on Eliquis 10mg 2xday for 1 week with reduction to 5 mg 2xday after the first week and discharged with instructions to follow up with primary care doctor and referral to cardiovascular specialist and to discontinue birth control pills.  Cardiovascular specialist indicates need for lifelong blood thinner medication due to hx of previous DVT 22 years ago.
On the morning of 10/7/19 you noticed a red rash on left arm where injection was and it was warm to the touch. Patient's arm is still sore.
A dose of Pfizer bivalent was given for a 2nd dose of the primary series instead of a dose of Pfizer monovalent.
Moderna COVID?19 Vaccine EUA Also had similar adverse reaction to first shot. second shot reaction 4/15 insomnia due to pain in arm and overall body pain, fatigue, chills, malaise, headache On 4/16 during the daylight hours -awake 5 hours sleep 1 hour on and off, chills, low normal blood pressure, high normal heart rate, freezing, dizzy, loss appetite, headache, sinus pain, small amount of blood from nose, food smelled terrible, sweating, malaise body pain, muscle pain overall pain and in arms and joints pain. 4/17 slept 6 hours awoke with headache, left knee muscles did not want to work (painful would not take weight, food smells bad, shortness of breath. still small amount of blood from nose, arm pain greatly reduced
Patient received Moderna vaccine under the age of 18 years old. Patient states he had no adverse reactions.
After a flu shot, started with the shivers, then feeling faint, slight headache, thirsty, achy, weak.  It's as if I have the flu!  I haven't had a flu shot in 15+ years; perhaps, this is how my body is reacting to the shot.  Also was given a pneumonia shot which I don't think I've ever had as a condition although bad bouts of asthma is a little scary with heavy breathing.
he's been having psychotic effects, nightmares/ bad dreams; he's been having psychotic effects, nightmares/ bad dreams; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 06Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NIGHTMARE (non-serious), MENTAL DISORDER (non-serious) all with onset 2021, outcome "unknown" and all described as "he's been having psychotic effects, nightmares/ bad dreams". Additional information: It was reported that the patient who was currently taking Keppra, received both doses of the Pfizer BioNTech Covid 19 vaccine, the first dose on 16Mar2021, and the second was on 06Apr2021. Since the first dose he had been having psychotic effects, nightmares/ bad dreams.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heavy, painful period lasting approximately 2 weeks.  Prior to second dose, I had not experienced any periods for the past 1.5 years due to birth control.
Soreness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes medications for cholesterol and blood pressure. No Treatment Medication Was Provided.
pain on the right side of her chest; This is a spontaneous report from a contactable consumer (patient).   A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that she received the first dose of the Pfizer-BioNTech COVID-19 vaccine on a day before reporting, and around 7-8 she experienced pain on the right side of her chest in Apr2021. She had specified the pain was not sharp. She asked if she should consult a doctor. The outcome of event was unknown  No follow-up attempts were needed, information about lot/batch number could not be obtained
Local injection-site reaction at left arm. Patient communicated she developed a rash, pruritis, and hard "knot" after vaccination. Patient has not symptoms outside of injection site. 3 days after injection patient described symptoms as improving.
onset of h/a p/inject, worsened by bedtime when pt moved head; felt fine on arising following AM, but soon felt was spinning w/head movements; sensed ambulation deviated to rt; 4MAY93 felt eyes were moving rapidly to & from w/rapid heart be
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jan2023 as dose 4 (booster), single (Lot number: GL0447) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: 32030BD), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Chronic Back Pain" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "known allergies: Percocet"; Vicodin, reaction(s): "known allergies: Vicodin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 16Aug2023 to 20Aug2023.
lethargy; sleeping all the day; hoarseness; Constant headache; fatigue; This is a spontaneous report received from a contactable consumer, the patient. A non-pregnant female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on the left arm on 01Mar2021 at 01:30pm as single dose for COVID-19 immunisation. Medical history included degenerative arthritis/joint disease, chronic pain and allergies to penicillin, aspirin, NSAIDs.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient received unspecified medication within 2 weeks of vaccination stating that too many to fit here. Past drug history included penicillin and aspirin for unknown indication. On 01Mar2021 at 08:00pm, the patient experienced constant headache, fatigue, lethargy, sleeping all the day and hoarseness. No therapeutic measures were taken for the events. The clinical outcome of the events constant headache, fatigue, lethargy, sleeping all the day and hoarseness was not resolved.  No follow-up attempts are possible; information about lot number cannot be obtained.
Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms. No additional AE. Time frame:65.2F for 9 hrs 45 mins,32.4F for 42 hrs 45 mins; This non-serious spontaneous safety report, with reference number, was received by a partner on 19-JUL-2023 and forwarded to agency on the same day and significant additional information was received by a partner on 19-JUL-2023 and forwarded to agency on 20-JUL-2023, from a HCP  The causal relationship between Vaxelis and the reported event "Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms. No additional AE. Time frame:65.2F for 9 hrs 45 mins,32.4F for 42 hrs 45 mins." was assessed as not applicable due to the nature of the event.  Further information is expected.
wheal devel above MMR site a/leaving bldg; tc to primary care provider MD advised mom to watch for any rash or diff breathing; report to ER or call MD-mom to make appt
vomiting, chest tigthness and shortness of breath, tongue swelling and difficulty swallowing
my mom died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient 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: DEATH (death), outcome "fatal", described as "my mom died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Reporter was inmate at (institute name withheld). Reporter found out what you put in the vaccines and other pharmecuticals, how you were involved in the Covid 19 scandal and corrupt scientists. Reporter knew all about your nanotechnology trash used to control people. Reporter's mom died because of your secret.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: my mom died
delayed rash at injection site about a week later (non painful but growing in size); migraine/tiredness/arm soreness day after vaccine
Red, itchy circle around the injection site that measured 3 inches x 2 inches.  Slightly swollen.  Not painful.  Lasted 5 days.  No other symptoms, I felt totally fine.  Currently arm that area will still itch, but is no longer red or any visible rash.
Chilled; headache; blurred vision; This is a spontaneous report from a contactable Other Health Professional (patient). A 64-year-old female patient receivef bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the right arm, first dose on 18Dec2020 10:15 at a single dose for immunisation. Medical history included cervical dystonia wherein she takes botox treatments quarterly for this. Concomitant medications included estradiol, rosuvastatin calcium (CRESTOR), gabapentin and montelukast sodium (SINGULAIR). The patient was not pregnant. The patient was not diagnosed with covid 19 prior to vaccination nor been tested since vaccination. The patient experienced chilled, headache, and blurred vision on 18Dec2020 at 12:00 PM with outcome of recovered on an unknown date in Dec2020. The patient did not receive any treatment for the events. The events are considered non-serious by the reporter.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 22-JUL-2015 the patient was vaccinated with expired dose of M-M-R II, Lot # J006955, expiration date- 07-JUN-2015. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.