chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said one side of face felt numb as if she was having dental work done.  She took Benadryl, and said she would contact her physician if didn't feel better. I followed up with patient next day and she said she was feeling fine.
pt seen @ hosp for fussiness & vomiting;found to have intussusception that was reduced w/an air contrast enema;monitored x 23hr-home;
Discomfort started a few weeks after first vaccine in my right big toe.  Felt as if needed to "pop" but never could.  Saw my family physician, thinking it might be gout, however after exam he diagnosed arthritis and prescribed a topical cream. I received the booster on 10/26/21 of the J&J.  Within 4 days of receiving the booster I began a more severe discomfort in my right ankle- almost as if I had rolled/sprained my ankle.  I tried home remedies- wrapping, ice, elevation, ibuprofen but there was no relief and shooting pain when going down steps.  This time I went to an orthopedic specialist- who confirmed the original diagnosis and added the arthritis diagnosis for the ankle as well. I received two cortisone shots one in the joint of my big toe and another in the ankle.  This relieved the pain from the arthritis.  The doctor said I could get these shots every three months....  It is currently the end of March and the pain is starting to resurface now that the cortisone shot is coming to a conclusion. Because there is no other place to list it- I received the booster at  on 10/26/2021 at 10:00am lot number is above.
That evening I noticed a round bruised-looking circle above the area on the left shoulder where the shot was given.  The next day I noticed these same circles on the inside of my left arm, 3 of which felt like a pinpoint knot where they were (attaching pictures).  I can still feel the knot.  After a day or two I found 2 more on my right leg (one on the thigh and one down on the leg.)  I don't recall any little knots on these two.  I do not feel all of these areas spots are bothersome or worrisome but I was told by my daughter to notify the County about them.  I do take Plavix every day and have since 2003 which I feel may have caused this reaction.
This spontaneous report was received from a certificated medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 26-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L038503, expiration date 18-DEC-2017 (dose, frequency, route of administration were not reported). The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Suspected vaccination failure; Shingles on left hand; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2022, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot two years ago.  Last week, the patient got shingles on left hand and was very painful. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was linked with the case US2022AMR180047 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR180047:Same reporter
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe
Rash/ hives  on entire body from the neck down.  Concentrating especially on the back and stomach completely encompassed in splotches and running down both legs.  Swollen hands and sanative to the touch.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I was forced to have 4 anthrax vaccinations without informed consent and even lied to by the med tech who gave them. He said there have been no deaths caused by this vaccine. There have been no illness caused by this vaccine, other than maybe a rash at injection area. I myself have fatigue and muscle twitches since being inoculated.
Pallor and seizure like activity less than 2 min after shot was given recovery in about 1-2 min but lethargy for about 5 min plus.
COVID 19 Treatment; COVID 19 Treatment; Wrong vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 12:30 as dose 1, single (Lot number: GJ6665) at the age of 66 years, in left arm for covid-19 immunisation. The patient didn't receive bnt162b2 (BNT162B2). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 25Oct2022 at 12:30, outcome "unknown", described as "Wrong vaccine administered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures as Paxlovid were taken as a result of drug ineffective, covid-19 from 19Sep2023 to 23Sep2023.  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-202300315083 same patient, different drug and different AE.;
makes me sick; Initial information received on 20-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who developed makes me sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious event "makes me sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE for Flu and prophylactic vaccination.  It was reported "I end up in bed for several days sick are the years that I got the flu shot and every year that I didn't get the flu shot I didn't get sick at all".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (makes me sick).  At time of reporting, the outcome was Unknown for the event makes me sick.
Moderate Facial Swelling. Started on 3/31/21 and continued until 4/4/21. Joint pain. Started on 3/31 and has continued. All other symptoms were reported to be normal. Fever, headache, fatigue, loss of appetite, dizziness, and left arm swelling, pain and redness. I had a telehealth virtual doctor appointment on 4/2/21. A course of steroids was recommended. After inquiring if the steroids would lessen the effectiveness of the vaccine, and being told yes, I declined the steroids.
Body started feeling uncomfortable, woke with a headache at 5 am by 7 am had a migraine and could barely walk up stairs so exhausted...headache lasted half the day slept on and off uncomfortable, rapid hert beat through out much of the first 24 hrs, no fever, felt dizzy, felt horrible and am worried about the second shot being worse!
Felt sick 3 hours post shot. Swelling around injection site 3 hrs post shot. Slept for 4 hours woke shakes from chills, low grade fever, vomiting arm (shoulder to elbow) was red & swollen. Condition improved but still has some redness on 10/7/10.
HEADACHE; FEVER; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included yeast infection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered to the left arm, on 01-APR-2021 10:40 for prophylactic vaccination. The  batch number was reported and has been requested. Concomitant medications included fluconazole for yeast infection. On MAR-2021, Laboratory data included: Yeast infection (NR: not provided) Positive. On 01-APR-2021 17:00, the subject experienced headache. On 01-APR-2021 17:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on APR-2021. This report was non-serious.
the patient was diagnosed with "an active rotavirus infection 2 weeks ago"; This spontaneous report was received from a nurse prescriber referring to a 6 month old female patient. The patient did not had any pertinent medical history, concomitant therapy or allergies. On 15-JUL-2019, the patient received first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (of lot # R034103, expiration date not reported, but upon internal validation established as 26-JUN-2020) and on 16-SEP-2019, the patient received second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # R030924, expiration date not reported, but upon internal validation established as 10-JUL-2020) via oral route (strength, dose, frequency unknown) for prophylaxis. On an unknown date in 2019, the patient experienced active rotavirus infection. On approximately 04-NOV-2019 (reported as "2 weeks ago"), the above infection was diagnosed by polymerase chain reaction (PCR) test. The patient sought medical attention and seen at physician's office. The patient did not received any treatment for the event. No significant disability, incapacity, seriousness or overdose was reported. On 15-NOV-2019, the event was resolved. Causality assessment was not reported by the reporter. Furthermore, no product quality complaint involved.
Spontaneously developed rash on medial side of right arm, appearing as raised annular ulcers resembling blisters. This occurred the morning of 12/30/20. Rash began as one ulcer and began clustering, accompanied by erythema to surrounding skin along with pruritus.  Self-treated with hydrocortisone 2% topical cream once to affected area and rash resolved in about 4 hours.  Checked temperature orally when rash occurred and was afebrile, 97.8 F, but felt feverish.   Morning of 12/31/20, rash appeared again with same appearance this time on the lateral side of right arm and pruritic. Again, treated with hydrocortisone 2% topical cream with resolution of rash in approx 4 hours.   Unsure if side effect of vaccine, planning to contact PCP when office is open after holidays.
no additional AE details available; PROQUAD (4 doses) that have been stored outside of recommended range have been administered to patients; This spontaneous report was received from an office manager and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. The concomitant therapies included sterile diluent used for vaccine reconstitution.  On an unknown date in 2022, also reported as between 28-JUN-2022 and 1-JUL-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot #W006585, expiration date: 23-AUG-2023 (dose, vaccination schedule, site and route of administration were not provided) for prophylaxis (product storage error). Temperature excursion occurred on 28-JUN-2022 in temperature ranges: 6 Fahrenheit degrees (F) up to 14F for 50 minutes; 14F up to 46F (15F) for 30 minutes. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000563: US-009507513-2207USA000544: US-009507513-2207USA000470: US-009507513-2207USA000552: US-009507513-2207USA000561: US-009507513-2207USA000765: US-009507513-2207USA000771: US-009507513-2207USA000775:
tested positive for covid after 1st dose received on 03Jan2021; tested positive for covid after 1st dose received on 03Jan2021; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported similar events for 15 patients. This is 8th of 15 reports. A patient of an unspecified gender and age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. As per caller 15 residents tested positive for covid after 1st dose received on 03Jan2021. Would like to know if and when they should receive the second dose i.e. wait 10-14 days without symptoms.The second dose was scheduled for 24Jan2021. The outcome of events was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for covid after 1st dose".,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Bells Palsey - complete paralyzation of the right side of my face - unable to move face, unable to close eye, unable to sniff, eat or drink out of ride side of mouth.
High Dose influenza was given to patient aged 64 years, 11 months, and 5 days. No adverse events reported
This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 58-year-old male patient who received SHINGRIX (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced generalized rash and generalized pruritus. The patient was treated with prednisone. On an unknown date, the outcome of the generalized rash and generalized pruritus were not reported. It was unknown if the reporter considered the generalized rash and generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient reacted to SHINGRIX, 10 days after, with rash on body and itching. The physician prescribed Prednisone due to reactions. The reporter gathered patient's information.
pt was underage (17) at the time of the first vaccination, at the presentation for the second vaccination. Written informed consent was obtained from the parents and they elected to have her be given the second Moderna dose.  First dose was on 3/31/2021 Second Dose was 4/27/2021
pt called the office on 9/25/13 at 11:46pm and stated she had localized swelling at the site without signs of infection.  She may have had fever at the time but denied SOB, neuro changes, headache, etc.  Pt offerred an appt and declined.  Pt instructed to use ice compresses, antihistamines, and nsaids.  And to follow up if needed.  Pt seen in the office 9/26/2013 at 11:40am.  Site noted to be red, hard, swollen and tender.  Site approx. 6-7" in diameter.  Ice pack offered to pt but pt declined.  Pt stated site slightly better today.  Pt to continue to monitor, apply ice, NSAIDS, etc., and let us know if symptoms worsen or as needed.
After the first shot I just had a sore arm and nauseous for 4 days.  After the second shot I had a sore arm (significantly more than after the 1st), had a massive headache for about 24 hours, but woke up this morning (2nd day after the shot) with swollen nymph nodes under my left arm along with pain and tenderness.  It hurts to lift my arm or have anything putting any form of pressure on it.
She states she is very upset and very furious with this product; pain; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date, NDC and UPC number: unknown), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated on an unspecified date she was very upset and very furious with this product, because if she knew it was not fully approved, she would not have gotten it and would never allowed her 12-year-old to get it. The patient recently had, when she had first got it, the patient was experiencing the pain on an unknown date. So then when the patient got the second shot the patient was having the same pain. The report was non-serious. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Dizziness after flu shot. Pt denied SOB/hard time breathing/chest pain.
COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. #21K-163-4074567-00). A contactable consumer (patient) reported for herself. Solicited report by a consumer of a 39 year old female with an event of non-serious COVID-19 Positive with Skyrizi (Risankizumab). There was no reported medical history. On 01Sep2021, the patient experienced COVID-19 Positive. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 08Aug2021 (at age of 39-year-old), she received 1st dose COVID-19 Vaccine manufactured Pfizer BioNTech via intramuscular at single dose for COVID-19 immunization. The action taken in response to the events for Risankizumab was unknown. The outcome of event was recovering.  The reporter's causality for the event(s) of COVID-19 POSITIVE with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Symptom onset was 8-30-2021. Symptoms were not reported; family member explained that it was difficult to differentiate between Covid-19 symptoms and those due to Parkinson's disease. Case tested positive for Covid-19 on 09-02-2021. She was hospitalized at  from 09-02-2021 through 09-07-2021. The case had received three Covid-19 (Pfizer) vaccines, on 02/12/2021, 03/05/2021 and 08/30/2021.
I had my previous two COVID19 Pfizer shots on 4/2/2021 and 4/26/2021. This booster was Moderna. Almost 24 hours to the minute, I started getting a bad headache. Which then progressed to my left under armpit lymph node becoming extremely sore (i never felt a bump there) but it hurt greatly. Then I started to feel "out of my head." My head was fuzzy and it was an extremely uncomrotable almost "out of body" experience and getting light headed and off balance when I would walk. I was like this for 4-5 days, drinking lots of water (never lost my appetite), and resting as much as I could. I never did develop a fever. I did not go to the doctor- I waited it out and rested as much as I could. It was a little over a week before I started to feel normal again.
Sore Right Upper Arm; Bilateral breast tenderness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7534) via an unspecified route of administration in the right arm on 20Mar2021 at 12:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included idiopathic hypersomnia, obsessive compulsive disorder, bells palsy, obesity, postural orthostatic tachycardia syndrome, Ehlers Danlos syndrome, mast cell activation disorder. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lactobacillus nos (CULTURELLE); both from unknown date for unspecified indication. The patient previously received fluticasone propionate; salmeterol (ADVAIR DISKUS), cephalexin (MANUFACTURER UNKNOWN), armodafinil (NUVIGIL) and ferric carboxymaltose (INJECTAFER IRON INFUSION); all from unknown date for unspecified indication and experienced drug allergy and IV CT Contrast from unknown date for unspecified indication and experienced contrast dye allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 14:00, the patient experienced sore right upper arm and long lasting moderate bilateral breast tenderness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events sore arm and breast tenderness was not recovered. No follow-up attempts are needed. No further information is expected.
I had a fever 101 and chills; I had a day of a bad headache. I vomited once but was nauseous for a long time - a couple of days. I had a rash on left arm - on my bicep - all across it (big) It was a blotch and it was strange.  I called my doctor and told him about reaction. That was there for four or five days. I had a severe reaction to Piqray (Pickray gene)- Chemo pill - it's a hormone a blocker. March 7th,  I went to ER after speaking with my doctor and I was admitted to  hospital. I had a Very bad rash all over my body and it started to attack my liver and kidneys - DRESS was name of reaction. I had been on the medicine 12 days and then had the reaction. It's a very rare reaction. Treatment: High dose prednisone for 10 weeks. That helped to resolved the DRESS. I can't take that medicine anymore. I had to change my medicine - I went back on Chemo for awhile. I am taking a chemo pill  Xeloda  now - more of a chemo pill than a hormone blocker. Rash is gone now.