chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning a male with no medical history or allergies who in 1995 at the age of 2.5 to 3 year old was vaccinated with a dose of MMR II. There was no concomitant medication at the time of vaccination. Subsequently the pt was diagnosed as having highly functioning autism. Medical attention was sought and the pt was placed on therapy with Ritalin to treat the autism. The pt's highly functioning autism persisted. The reporter did not have any further information. Upon internal review, highly functioning autism was determined to be an other important medical event (OMIC). Additional info has been requested.
sore arm; aches; chills; overall tiredness; This is a spontaneous report from a contactable consumer. Follow-up (20Apr2021) was received from same reporter and processed together with initial information.  An adult female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown) via an unspecified route of administration on unspecified date in Mar2021 as single dose for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It is unknown whether the patient is pregnant at time of vaccination. On Mar2021, the patient experienced sore arm, aches, chills, overall tiredness. It was unknown if the patient received treatment to the events. It was unknown if the patient has been tested for COVID-19 since the vaccination. Outcome of the events was recovered on unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PAIN IN ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210430209.
Headache, NauseaVomiting, head pressure, arm sore, scratchy throat and left ear hurts Narrative:
When the pt came to store. She  was total health but After She got Covid 19 vaccine she had dizzness and get a fever.
Flu like symptoms, fever, chills, then a rash broke out all over his body.  It didn't itch, it hurt when something was dragged over it, like a finger or clothing.  It was deep, deep red and some parts of his body there was no regular skin showing.  Took him to ER, where tests were run, showing his liver counts were way off.  Biopsy was taken of the rash.  It was determined that the rash was similar to Stevens-Johnson and he was admitted for 2.5 days.  They put him on large doses of steroids, which helped the rash.  All labs were headed in the right direction except his liver panel.  He was sent home and returned to doctor in 3 days to run panels again.  All were headed in right direction, even the liver.  He will see his cardiologist to be put back on his heart medicines.
pt recvd vax & had a syncopal or vasovagal episode; pt recovered w/o any residual effects; No further details were provided; MD reported 20 pts;
1/28/22 pt seen in ED at the hospital and had a positive COVID test; bilateral pneumonia; given steroids and IV Rocephin in ED; dc'd to home; on 2L O2 via NC at home due to CHF; 2/2/22 pt presented to ED at the Medical Center in with c/o worsening SOB; requiring 6L O2 via NC in ED; febrile, diarrhea and weak; poor oral intake; decompensated quickly requiring 15L O2 via NC; severe metabolic acidosis requiring intubation; despite 4 vasopressors and Bicarbonate supplement pt's condition deteriorated; pt transitioned to comfort care and passed away in the hospital
This spontaneous report as received from the Mother of the Patient refers to her approximately 20 month old daughter with Ear infection. On 26-AUG-2013 the patient was vaccinated with M-M-R II (lot # H01582, expiration 24-AUG-2014), (dose unspecified), injection. Other suspect therapies included VARIVAX (Merck) and HIB vaccine (unspecified carrier) (manufacturer unknown). Concomitant therapies included amoxicillin. The Mother reported that since received the vaccine, the daughter's behavior had changed. In August 2013 she expressed that the child seemed "intoxicated", scratched her head, walked on her toes and occasionally stumbled. When slept, the child seemed to be perspiring but was cool to the touch with chills. The reporter specified that there were two vaccination sites, one in the arm and one in the leg, however, she was uncertain as to which site received which vaccine. The child had been seen by an unspecified Urgent Care facility as well as by her regular doctor. No treatment was given. At the time of report, the events outcomes were unknown. Additional information has been requested.
Severe pain in left arm, radiating to left side of chest; Extreme swelling in upper left arm; Inability to lift left arm; Extreme warmth in Left arm.
vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Nov2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold induced asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received treatment from 14Jun2022 to 18Jun2022 for COVID 19 Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient fainted about 2 minutes after receiving vaccine. Pt immediately regained consciousness (in about 1 min) - 911 was called. Pt was not taken to the hospital. Pt was able to walk out of clinic.
Redness at injection site; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for ACE inhibitor fetopathy.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided
No adverse reaction. Patient is 16 years old. Was given FLULAVAL which is for 18 year olds and older.
Hard itchy bumps on back with no concurrent redness. Started 5-7 days after vaccination and lasted over 30 days.
Developed new onset atrial fibrillation, bradycardia and SOB.  Work-up EKG, ECHO. On 2/12/2021 had placement of permanent pacemaker.  Continued to complain of some fatigue with no energy. On 3/8/2021 felt winded and fatigued. SOB progressed and on 3/17/2021 was diagnosed with bilateral PEs. Admitted to hospital. Discharged on Eliquis anticoagulant,
Eight weeks after my second dose my daughter noticed that my left leg was a little swollen. I started to have some pain in my left leg behind my knee. I called my doctor and a Deep Vein Thrombosis  was found on Ultrasound when they came out to my house. I also had a DVT in my groin on the right side when I went to the Emergency Room. I was hospital for five days. I am now taking Eliquis and I am due to get more blood Work.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: complained of heart burn and blood pressure rose
Headache; vaccine was expired by one day; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Deltoid Left on 13Aug2021 (Lot Number: EW0196; Expiration Date: 12Aug2021) (at age of 37-year-old )as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took amoxicillin and Aspirin and experienced drug allergies.  The patient experienced vaccine was expired by one day and headache on 13Aug2021. reporter stated that she considered this Medically Significant because even though she gave the expired vaccine, she had the patient stay for 15-20 minutes and the patient still had a headache. Treatment: There was No further treatment needed. The outcome of the event  headache was not resolved. Causality: Yes related, the patient was not having any headache before the vaccine.  Information on the Batch/Lot number has been requested.  Follow-up (16Aug2021): New information reported from a contactable pharmacist includes: reporter updated,patient age, gender, suspect drugs details and event 'headache' added. case was upgrade as serious now.; Sender's Comments: Based on the available information and the close drug event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event headache cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
My right thigh was itching and l  gave it a medium scratch.  My skin began to peel off leaving a 1 inch section of white exposed area.  This has never happened before.  I applied a triple antibiotic ointment to the area and immediately began to try to contact someone about this.  Could this occur in other areas on my body?
No adverse event reported.   Administration error: Patient was given 1 ml of Moderna vaccine instead of 0.5 ml
Swollen/hard at the injection site fever x 1 week. Her fever started one week after the vaccine and lasted for one week. Patient experienced sores across her abdomen. Upon reporting the adverse reaction to the pharmacist, she was referred to see her PCP.
Initial report was received on 31 March 2010 from a healthcare professional, who also provided follow-up information on 06 May 2010. After the receipt of information on 06 May 2010, it was determined a case narrative was required; therefore the following narrative has captured all case information received to date. A 4 year old male patient received on 29 March 2010 a right thigh injection of TRIPEDIA (lot number U3009AA) and a left thigh injection of IPOL (lot number D04132 reported on 06 May 2010, lot number B0480-1 reported on 31 March 2010; neither a valid sanofi pasteur lot number). On 30 March 2010 the patient experienced a right thigh erythema, swelling and 10 cm wheal with a hive like thickness which was itchy. Medical history and concomitant medications were unknown. The patient had no illness at the time of vaccination and no event following prior vaccinations. As of this report the events had not resolved. Follow-up information received from a health care professional on 24 May 2010 reported that the patient received the TRIPEDIA intramuscularly. The lot number of the intramuscular injection of IPOL was confirmed to be lot number D04132. The localized reaction covered the entire anterior thigh and took 5-7 days to resolve. The patient was treated with BENADRYL only and no testing was performed. Documents held by sender: None.
approx 1mo p/vax 3rd vax exp a strnage sensation from hand up to shoulder for 30-40seconds;this has happened about 3 times since the shot
where patient experienced chills; skin sensitivity; joint pain in upper/lower back and fingers; sensitive/painful lymph nodes; and ran a 102.3 fever for several hours/Patient broke fever on 13Jan2021; body aches; headache; This is a spontaneous report from a non-contactable other HCP.   A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 12Jan2021 at 07:30 intramuscular at single dose for COVID-19 immunization. Relevant medical history included asthma and allergy to ibuprofen. The patient received first dose of vaccine on 24Dec2020 at 05:00 intramuscular on left arm. Concomitant medications were not reported. On 12Jan2020 at 19:30, the patient experienced chills, skin sensitivity, joint pain in upper/lower back and fingers, sensitive/painful lymph nodes in armpits/groin/neck, and fever (ran a 102.3) for several hours. Patient recovered from fever on 13Jan2021 and was recovering from other reported events.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Intussusception - preceded by fever and gastroenteritis with vomiting and diarrhea.  ROTATEQ #3 on 6/6/08.  10/17/08 Reviewed hospital medical records of 7/13-7/14/2008. FINAL DX: intussusception, barium enema reduced Records reveal patient experienced vomiting, diarrhea & viral like symptoms.  Admitted for overnight observation s/p IS reduction.
came down with COVID; came down with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2022, outcome "recovered" (Sep2022) and all described as "came down with COVID". The patient had Covid from 01Sep up until the end of Sep. He was ill for one month; by the end of Sep, he was both over it. He wanted to know if they should wait longer before they get their second booster which was scheduled on 27Oct2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256200 same reporter/products/AEs, different patient;
Vertigo; Crazy dizziness; Some arm pain; Big toe swole up; she can't shut her eyes because the dizziness is so bad; 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 40 year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset Apr2021, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Crazy dizziness"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Some arm pain"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Big toe swole up"; EYELID FUNCTION DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "she can't shut her eyes because the dizziness is so bad".  Additional information: Patient received the second dose of the Pfizer COVID vaccine seven days ago and she is still having vertigo and crazy dizziness. It has been constant but comes and goes away since receiving the vaccine. It was reported that the vertigo started between 7-10 hours after receiving the second dose of the vaccine. patient cannot shut her eyes because the dizziness is so bad. She never had dizziness or vertigo before receiving the vaccine. Caller states this has been known as COVID toe and she called (pharmacy name withheld) and they told her that was a normal side effect. Patient wanted to know if dizziness and vertigo has been reported as a side effect, if side effects usually last two to three days and what she should do about her side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Irregular menstrual cycle - incredibly light for two months (April and May) and now late/missed entirely in third month (June).
Patient's description is when he got home he had loss of control of bladder and bowel and then was "unconscious" for a "couple hours". They did not call 911 or seek emergency care. He then slept the next day. He called today so that it could be put in his records.
started her period again, but it was bright pink and red; intense abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (intense abdominal cramping) and MENSTRUAL DISORDER (started her period again, but it was bright pink and red) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included Opiates (On opiates for 14 years). Concomitant products included CANNABIDIOL and MARIJUANA for an unknown indication.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced ABDOMINAL PAIN (intense abdominal cramping). On 12-Jun-2021, the patient experienced MENSTRUAL DISORDER (started her period again, but it was bright pink and red). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 11-Jun-2021, ABDOMINAL PAIN (intense abdominal cramping) had resolved. At the time of the report, MENSTRUAL DISORDER (started her period again, but it was bright pink and red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-229893 (Patient Link).
Left foot numbness developing gradually over the course of about 1-1.5 weeks after vaccine.  Right leg pain starting about 1.5 weeks after vaccine from foot up. As the time is progressing the pain moved from foot to behind the knee traveling up to base of buttock.  Left facial numbness/tingling/unusual sensation developed around 10/7/2021
7/13/15-patient reported red, hot, rash. Called pharmacy to report. RPh referred pt to doctor. Pt went to urgent care within 2 hrs of reporting. Rx-clindamycin 300mg three times a day for 10 days. 7/28/15 patient fully recovered.
Redness, swelling, pain, and itching at the injection site Headache Muscle and joint pain Congestion Fatigue
Pressure in my head behind my ears. Clear drainage from my nose. Feeling shaky has been going on for past 15 days. Due for second dose afraid to take it.
Pt received COVID Pfizer vaccine on 4/3/21. Pt tested positive for COVID on 4/14/21. Pt hospitalized on 4/14/21 for weakness d/t COVID
LEG FATIGUE/FATIGUE ELSEWHERE; This spontaneous report received from a patient concerned a 55 year old male. 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-APR-2021, the subject experienced leg fatigue/fatigue elsewhere. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg fatigue/fatigue elsewhere. This report was non-serious.
Red itchy rash approximately 3" x 3" around site of injection appeared 7 days after vaccine.  Arm is also swollen at site of rash.
Cold sweats by 10 pm on 04/02 Fever 3 am Vomit 3 am Muscle aches 04/03
After a week after my vaccination, 02/12/2021, I noticed I was wheezing. It had been about 10 to 15 years were I had an episode of asthma. This was going  on for like a month. I was trying to treat myself, I took some steroids myself. What caught my attention, it was winter of all the season of the year, it's the time of season I feel my best. and I was thinking why am I wheezing in the winter. I went to see my allergist about a month later, on 02/27/2021. The doctor did not think the asthma was related to the vaccine. The doctor put me on a different asthma inhaler and a nasal inhaler. The nasal wasn't bothering me as much as the wheezing . It seemed to have resolved with the 2 inhalers he gave. I did a short course of oral steroid, Prednisone. I am a doctor and I have been double masking since May 2020, and this started like in February, and I wasn't sure if it was the mask, but I really don't think it had anything to do with it, neither did the doctor. My perception is I felt like I am reacting to everything, like the vaccine set off my immune system. All of my allergies just seem to have come back, since 15 years ago. My allergies were just reacting  especially during a season, winter,  they normally don't react.
Eye rolling-unresponsiveness-prolonged crying. Follow up on 06/04/2004: States pt recovered from adverse events. "Normal development at 10 monts visit 02/2004.