chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; little pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (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 (First dose), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "little pain at the injection site"; DIARRHOEA (non-serious) with onset 04Mar2021, outcome "recovered" (04Mar2021), described as "diarrhea".  Additional information: The patient was querying if these were typical side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately one week post vax the pt experienced a varicella like rash with 7-10 lesions.
Information has been received from a physician concerning a 4 year old female patient with no pre-existing conditions who on 19-OCT-2010 was vaccinated with MMR II (lot number 664455/0588Z). Concomitant therapy included VARIVAX (lot number 667759/0779Z), KINRIX and MOTRIN. On an unspecified date the patient experienced erythema and induration at the injection site. The MMR II injection was given in the right upper thigh. The reporter stated that there was no adverse event related to the other vaccination products. On an unknown date the patient recovered from erythema and induration at the injection site. No lab diagnostics studies were performed. The patient sought unspecified medical attention. No further information is available.
Swollen lymph nodes  Migraine headaches Burning in back of left thigh continuously  Numbness in left foot
Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.  Reporter stated 56 doses were given after the 30-day use by date limit but the total amount of doses that were given was currently unknown to the HCP. On 06-Dec-2021, the vial was initially stored in the refrigerator. Everyday,that lot number was distributed numerous times. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-449565, MOD-2022-449456, MOD-2022-449634, MOD-2022-449491, MOD-2022-449651, MOD-2022-449729, MOD-2022-449588, MOD-2022-449524, MOD-2022-449610, MOD-2022-449544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Follow up received contains significant information, case became valid, patient demographics added, drug start date, dose details, event start and stop date were updated.
Bleeding occurred at injection site at time of injection, but stopped in timely manner. Around 3 pm on 8/12, pt found inj site to be warm, itchy and red. By 8/13 had spread to area of about 3- inches in diameter. By 8/14 had subsided and was returning to normal.
Passing out; Could not feel arms and legs- Had numbness immediately along with weakness; Could not feel arms and legs- Had numbness immediately along with weakness; Distorted face; Dizziness; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm on Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (age at vaccination was 59-year-old).  Medical history included a lot of allergies. The patient's concomitant medications were not reported. Historical vaccine included flu shot for immunization and patient experienced allergies to the flu shot. The patient experienced a distorted face, passed out, dizziness and could not feel arms and legs on the day of vaccination. Clinical course was reported as distorted face- started immediately. She was passing out and they had to lay her down, put her feet up, and she told them she was going out. They laid her down and told them her face felt numb then it was noted her face was all distorted. This lasted four hours. Passing out-Occurred same day had the vaccine, immediately after the vaccine. This would have been really life threatening if she went out and hit her head, but she got down and was able to put feet up. Dizziness: this happened immediately after getting the vaccine. It lasted on and off for days. She had to miss a couple of days of work. Could not feel arms and legs- had numbness immediately along with weakness. This lasted 3-4 days. Passing out and could not feel arms and legs- Had numbness immediately along with weakness were reported as life-threatening by reporter. Distorted face and dizziness were reported as disability by reporter. Outcome of passing out was unknown. Outcome of distorted face was resolved in Jan2021. Outcome of other events was resolved in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events loss of consciousness, hypoaesthesia, muscular weakness, muscle twitching and dizziness cannot be totally 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.
Dose 3 was given on date listed above, 12/17/2021.  I didn't know how to delete the others once I added.   I am a 57 yr old female with no previous related medical problems. No hypertension, normal lipids, normal BMI, 0-2 alcohol drinks per month, do not drink caffeine, exercise regularly, never smoked, etc. On March 7th 2022  at 9 pm I had rapid heart rate with Afib. Went to ER. Dx Afib with RVR. Sedated and cardioversion attempted 4 x, unsuccessful. They then admitted me and converted to sinus rhythm with IV medication. Took a few hours. I was discharged at 1 pm on March 8th. Sent home on a medication I never took as they told me take next dose at 6 am.  At 4 am on March 9th I woke up with it happening again. Back to ER. Same Dx. They admitted me a second time. They changed and increased medications, changed first drug and added a second. Discharged on March 10 at 10:30 am. I went home, showered, took a nap and at 4 pm the same day it started again! Back to ER, they converted me in the ER with medications, increased meds again and I went home that day without being admitted.  I was then on Diltiazem 30 mg/2x day and propafenone/Rythmol 300 mg/2x day.  This maintained everything but negatively affected my exercise ability.   On July 29th, 2022 I had an ablation done and have since weaned off all heart related medication. So far everything is good and no sign of Afib or rapid heart rate. My ablation was another matter. The doctor said the number of ?active? places on my heart during the procedure was ?definitely higher than average? at 5. Cardiologist did my ablation. I do not know the ER Dr names. I also saw a doctor who then transferred to another area.  You may not care but stating it here anyway. I believe I have a family hx with my Dad having Afib in his 70?s and living to age 86. I believe the vaccine affected my heart and caused this to happen many years earlier than it may have otherwise, and maybe it never would have as I am careful with diet and lifestyle.   I had never had COVID infection before any of this took place.  Can the Dr say 100% this was caused by vaccine, no. But I believe if studied there will be more cases like mine.     There are errors in my ER records such as I did not have a kidney stone that same month. It was exactly a year before during the same month.  Thats another report, any connection of kidney stones with vaccine?
Vomiting for 6 hours, severe nausea, high fever (103 first time, 102.6 second time) ringing in ears, tunnel vision.
Patient says that he has dermatitis; Rash; This is a spontaneous report from a contactable pharmacist and physician (patient himself). An 81-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: EL9261, exp date: May2021), via an unspecified route of administration on the left arm on 22Jan2021 15:30 at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications reported as none.  The pharmacist was calling to report that her father who had the Pfizer COVID-19 vaccine has a rash, a lot of a rash, after his first dose on 22Jan2021. No treatment was done for the rash. The pharmacist stated that her father though that the rash was a virus reaction.  Patient (father) abruptly takes over the phone call and confirmed that he was the patient. Patient stated that he has dermatitis (this was a virus reaction) on upper and lower limbs for two days after the injection of vaccine (at night for 3 hours every night). The patient stated it was a virus reaction and he was dermatologist, a dermatology specialist, he has been for 50 yearrs experience. Patient stated it was a slight reaction, 2-3 hours of rash and physical reaction. Outcome of the events were unknown.
lump on wrist; extreme fatigue; hives; flushing of face from neck up from Pfizer COVID vaccine; This is a spontaneous report received from a contactable consumer. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 14:15 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. Medical history included ongoing psoriasis, diagnosed 5 or more years ago, patient stated she has never been checked for psoriatic arthritis, but she has joint pain, ongoing gastrooesophageal reflux disease, ongoing epstein barr virus positive mucocutaneous ulcer, Severe allergies, atrial fibrillation, cerebrovascular accident. Concomitant medications included apremilast (OTEZLA) taken for psoriasis, start and stop date were not reported; lansoprazole (PREVACID) taken for an unspecified indication, start and stop date were not reported.  The patient previously took flu vaccine VII, got really sick, never took it again got all the flu symptoms. Caller reports she had flushing and then hives that night and then extreme fatigue. Caller reports noticing a lump on left wrist on 25Mar2021. Lump was red and purplish, caller reports rubbing the lump and the lump ended up moving. Caller reports it was painful. Caller went to the doctor 07Apr2021 and diagnosed with thrombosis of left ulnar artery. Caller states that she knows there not a lot of data out of there. Caller mentioned she has psoriasis and takes Otezla. Therefore, she is autoimmune compromised. Caller went today 08Apr2021 for follow up appointment and the doctor said to report her symptoms to Pfizer because she is immunocompromised and immunocompromised people were not part of the original clinical trials. The extreme fatigue reminded her of Epstein- Barr. Otezla-stopped the day of the first shot. She started it back up a week and half later. Flushing started 4 or 5 hours after dose around 6:15 or 7:15 PM on the top of face from neck up. Caller reports that she had the same thing from a cortisone shot. Hives started 8 hours after first shot around 10:15 PM hives developed on the bottom of both arms from the elbow down on both arms. Caller states that it was very strange.  Caller states that she woke up in the night with the itching. Caller states that the hives were gone in the morning. Caller states that extreme fatigue occurred 23Mar2021 and it was hard to even open her eyes. Patient went to emergency room for ultrasound only. Patient visited physician office for event lump wrist. Outcome of event lump on wrist was not recovered, of others was unknown.   No follow-up attempts are needed. No further information is expected
swollen and tender lymph nodes in throat, difficulty swallowing, predominantly on left side causing impaired breathing especially early morning after sleeping.  lasting 5 days approximately and now intermittently continues to flare up with less intensity as the onset side effects. Also accompanied by extreme fatigue. Have an appointment to follow up with doctor to see if any treatment is possible.
I had abdominal pain and mucus in my stool. I went to the doctor on April 1st; I thought I had a UTI, and they took a urine sample and prescribed antibiotics. They sent me to have a CT of my abdomen on April 5th, which showed a bowel infection and advised me to get another CT in 3-4 months. I had another bout of abdominal pain on July 12th and was told I had to wait for another 3 months for another CT scan. I had the CT scan on Sept. 9th and waiting for results.
pt recv vax & started jerking movements involving head & extremities;crying during this time;taken to PMD;MD told nurse pt had a nervous rxn;
Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lot # L024993, expiration date 17-OCT-2017, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The medical assistant reported that the vaccine was exposed to a temperature of 51F for 1 hour and 30 minutes and then was also exposed to a temperature of 48F during an hour and that this information was obtained with a digital data logger. Finally, no product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for follow up was given.
Chest tightness for 1 hour , difficulty breathing for 2 hours, sweats for 5 minutes, rash ongoing x 24 hours
This case was reported by a physician and described the occurrence of low blood pressure in a female patient who received DTP (A or W not known). On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTP vaccine, the patient experienced low blood pressure. On an unknown date, the outcome of the low blood pressure was unknown. It was unknown if the reporter considered the low blood pressure to be related to DTP vaccine. Additional information received: Pharmacist reported that a patient developed a severe reaction such as her blood pressure "bottoming out" after receiving a DTP vaccine and was sent to an emergency room. No further information was provided.
Rapid heart beat; A general feeling of not feeling well; Anxiety; Body aches; chills; Feels feverish but doesn't have a fever; Felt terrible after the injection and stated, "it feels like a truck ran over her".; Lower back pain (last night); Headache (last night); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), VACCINATION COMPLICATION (A general feeling of not feeling well), ANXIETY (Anxiety), DISCOMFORT (Felt terrible after the injection and stated, "it feels like a truck ran over her".) and BACK PAIN (Lower back pain (last night)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM and DULOXETINE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DISCOMFORT (Felt terrible after the injection and stated, "it feels like a truck ran over her".), BACK PAIN (Lower back pain (last night)) and HEADACHE (Headache (last night)). On 12-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), VACCINATION COMPLICATION (A general feeling of not feeling well), ANXIETY (Anxiety), MYALGIA (Body aches), CHILLS (chills) and PYREXIA (Feels feverish but doesn't have a fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, q6h. At the time of the report, HEART RATE INCREASED (Rapid heart beat), VACCINATION COMPLICATION (A general feeling of not feeling well), ANXIETY (Anxiety), DISCOMFORT (Felt terrible after the injection and stated, "it feels like a truck ran over her".), BACK PAIN (Lower back pain (last night)), HEADACHE (Headache (last night)), MYALGIA (Body aches), CHILLS (chills) and PYREXIA (Feels feverish but doesn't have a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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. Further information has been requested
fainting spells; Metallic taste in the mouth; weakness; nausea; vomiting; This is a spontaneous report from a contactable consumer.   A 20-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, as single dose in in left arm on 08Mar2021 12:30 AM for COVID-19 immunisation, administered at drive thru site.   Medical history included hypertension, COVID-19 prior vaccination, no known allergies. Concomitant medications in two weeks included lisinopril (manufacturer unknown); methylphenidate (manufacturer unknown), both taken for an unspecified indication, start and stop date were not reported.  No other vaccine in four weeks. On 08Mar2021 13:00 the patient experienced fainting spells, metallic taste in the mouth, weakness, nausea, vomiting. No treatment received. COVID-19 was not tested post vaccination. The outcome of events was unknown.    Information about lot/batch number has been requested.
pt had fever the night after taking the vax.  The next day she when she woke up her entire right side of the body was sore and had diarhea.  She had fatigue and developed a rash on her left arm.  Three days later she still has a rash, sore arm, slight fever and diarhea.  Pt will be going to urgent care today for treatment.
Case number PHEH2044US003858, is a spontaneous initial report from a pharmacist received on 21 FEB 2014 with a follow up received on 21 MAR 2014. This report refers to a 15-year-old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) which was well tolerated. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 004011A) at a dose of 0.5 ml intramuscularly into the left arm on 02 JAN 2014 at 14:40 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).    Follow up received from pharmacist on 21 MAR 2014. Updated vaccination history, vaccination time and site of vaccination of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
I selected "Influenza Seasonal" for vaccine, but I have no idea what type of vaccine it was...I only know that it was flu vaccine. The day after vaccine I couldn't sleep and was puking all night long. By the morning, diarrhea kicked in. By 3PM I had fever over 100 degrees and started getting extremely bad backache. The fever subsided, but the back pain keeps intensifying and I'm not sure what to do now.
Chronic arm pain. Numbness in hand. Limited use of arm/hand. Interferes with daily activities and sleep.
pt began to feel tightness in her throat. md was called, epi and solumedrol given. 911 called.
got sick after getting the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  A male 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: ILLNESS (non-serious), outcome "unknown", described as "got sick after getting the Pfizer Covid 19 vaccine".  Additional Information: She was calling on behalf of her children who got sick after getting the Pfizer Covid 19 vaccine. And also her uncle and her girlfriend that got sick after getting the vaccine. Asking if there are some vitamins or medications that can boost their immune systems. Caller stated that she has 2 young adult children that got sick after getting the Pfizer Covid 19 Vaccine, and also her Uncle and her brother. She was only looking to find a medication or product so they can get immediate relief, but she was not finding any products that can help them. Her friend (Name withheld) that she works with, has had diarrhea for almost a year and was told that she has long covid. Her other friend (Name withheld) that lives in (state withheld) had a heart attack and appendicitis in the same day. Attempted to verify the caller's name and phone number that was provided by the transferring agent, but caller stated that she doesn't want to be on the radar. She just wants to know if there was a product that can alleviate the symptoms, or was it just pushing the vaccine. This report was for the caller's Uncle.   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) : PFIZER INC-202300056731 same reporter, product and event, different patient (report 2 of 5);
Hot flashes started again within 4 hours of the vaccination, have been happening about 2-4 times a day since the vaccination, despite good adherence to previously effective estrogen/progesterone regimen.  (Previously hot flashes had begun in 10/2022, became severe, but had completely resolved by March 2023 after initiation of HRT in January.  Had zero hot flashes for 6 months prior to vaccination while continuing estrogen/progesterone HRT.   In retrospect, the hot flashes had started shortly after the previous Covid vaccine in 10/2022, but I did not make a connection , until the hot flashes started again within hours of the booster).
Patient's arm started to get a red rash with tingling down her arm almost immediately after vaccination. Did not spread past the right arm. Patient took a Benadryl and stayed for 30 minutes for observation. The rash did not progress any further and patient went home after 30 minutes. Spoke to patient 7/10/21 (next day) and she is doing fine, rash and tingling resolved.