chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches all over; Body aches all over. Arms, lower back, breasts; Body aches all over. Arms, lower back, breasts; Body aches all over. Arms, lower back, breasts; Fever up to 103.1/ Fever for over 24 hours.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 21:00, the patient experienced body aches all over in arms, lower back and breasts and fever for up to 103.1 (unknown units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches all over in arms, lower back and breasts and fever were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
I positive for COVID-19 on 20MAR2023, I was crummy, headache, stuffy head and congested but no fever. I didn't seek treatment just took Tylenol, I am feeling better but not a hundred percent but much better than last week.
not able to get out of bed or have lights on; Unbareable Headache; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Continues eye twitching; Exteremly tired; 102.5 fever; Body Aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient).  A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose BNT162B for COVID-19 immunization and experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on. she had a hard time walk due to the body aches.  After second shot, she also experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on, she had a hard time walk due to the body aches, and 102.5 fever that didn't want to come down. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Considering a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The case will be reevaluated should additional information become available. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Hives on trunk and extremities; tightness of chest and SOB within 10 minuts of vaccination.  Febrile with within 24 hrs.
Patient had a headache, pains, some issues eating food, and ache at the injection site.  She claimed that it resembled the symptoms that she had when having the shingles 20 years ago.  She is using ice, otc pain med and benadryl to treat the reaction and it seems to be working.   She only needed to call the Pharmacist and the doctors office for guidance, no visit or ER needed.
Unknown kidney issues.  Thought it was kidney stones or kidney infection based on prior experiences. Went to ER, and they could find  neither. Sent me home with pain meds, said it was probably muscle spasms, but they weren't sure... Do not believe it was just muscle spasms.
s to get a 2nd dose and is already late with that dose / they are in quarantine right now for COVID; This case was reported by a nurse and described the occurrence of social problem in a 31-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On an unknown date, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On an unknown date, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device and an unknown time after receiving RabAvert, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received Rabavert vaccination for pre exposure prophylaxis. The nurse stated that the patient who was to get a 2nd dose of Rabavert was already late with that dose, as the patient was in quarantine right now for COVID. The patient's 2nd dose was due on the day of reporting. The nurse wanted to know that so with their schedule now was the patient able to get her 2nd dose next week or does she need to wait due to COVID, as she should be out of quarantine next Tuesday and so the patient should be able to come in then or should they wait on the physician. The reporter consent to follow up.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 23-JUL-2014 the patient was vaccinated with (oka/merck) VARIVAX (lot # J014229, EXP 08-NOV-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Pt vaccinated with DTP/OPV experienced prolonged sleep for about 18 hrs.
2/21/2022: COVID  booster, patient left arm felt like it was burning from the inside at the time of the injection for about 30 minutes and then became sore in the left shoulder (deltoid) muscle. 2/22/2022: Left shoulder muscle remained sore.  In addition, patient experienced a persistent headache throughout the day, bouts of aches along the spine at the base of the neck, continuous back aches in the kidney region, bouts of nausea. 2/23/2022: Left shoulder muscle soreness reduced.  Continued persistent headache throughout the day, bouts of aches along the spine at the base of the neck, continuous back aches in the kidney region, bouts of nausea. 2/24/2022: Left shoulder soreness completely gone.   Continued persistent headache throughout the day, bouts of aches along the spine at the base of the neck, continuous back aches in the kidney region, bouts of nausea. 2/25/2022: Continued persistent headache throughout the day, bouts of aches along the spine at the base of the neck, continuous back aches in the kidney region, stronger bouts of nausea.
I am reporting on dose #2 however for dose #1 I had a red circle the size of a 50 cent coin around the injection with no other issues. For dose #2 my left upper arm turned major red the next day and grew in size over progressive days to a minimum size like a pizza slice and bigger and was HOT to the touch and felt itchy.  The reaction was my main concern I monitored. Meanwhile, I dealt with traditional flu side effects with major tiredness on the 3rd day, major night sweating, blah feelings, and by Thurs. shaky and light-headedness. I also experienced muscle pain in my underarm and breast area on the left arm where the dose was given.  Treatments included sleep when I could get it, started a Tylenol and Ibuprofen on Tues-9/13/21 with a benedryl also started afterwards per Pharmacist with follow up to Doctor at 4:30p per direction which occurred on Thurs, 9/16/21 where I was prescribed Azithromyci 250mg 6-pak and Pendnisone 20mg (up to 5 tablets as needed) to address the allergic reaction and bacterial infection.   I have been informed I am not a candidate for the booster and will be collecting acknowledgement from my pharmacist.
very heavy menstruation; worsening arthritis pain; fatigue; chills; low grade fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable 41-year-old consumer reported on herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunization. Patient's relevant medical history included immunocompromised with pre lupus, obesity, arthritis and shingles outbreak. The patient's concomitant medications were not reported. It was reported that some of the side effects after first dose included very heavy menstruation, worsening arthritis pain, fatigue, chills and low grade fever on an unspecified date. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt received first dose of Pfizer COVID vaccine. 2-3 minutes after the shot was completed, I was alerted that someone has "passed out" in the designated waiting area. upon arriving  at the scene, I saw his mother holding him and helping him to the floor. she states he had fainted---she states he did not lose consciousness, did not fall, and did not hit his head. I called 911 and stayed with him the whole time until the rescue squad arrived. parent states pt has never had a reaction to a vaccine previously, has no health conditions, no allergies to food or drugs. upon arrival, rescue squad gathered information. a mutual decision was made between parent and rescue squad not to take patient to hospital; they walked him to the vehicle
less than 5 minutes after the shot, patient had a vasovagal response that included his eyes rolling back like a seizure and sliding down a chair.  The event was over in 10-15 seconds but paramedics were already called.  he did not go to hospital and called back to the pharmacy an hour later saying he was fine and that the same reaction occurred when he was  a teen after the Tdap shot and again when he got eye drops.
MOM REPORTING HAD SMALL AMOUNT OF BLOOD MIXED WITH STOOL, RED STOOLS AFTER 2ND DAY OF DIARRHEA EPISODES SUSPECTED DUE TO ROTA VACCINE.  SHE IS NOT SURE IF THIS EPISODES WAS TRUE BLOODY DIARRHEA DUE TO ROTA.
Approximately one week and a half after 2nd dose of COVID 19 Pfizer vaccine, I developed fevers (101) and extreme fatique daily.  This continued for two weeks (fevers every evening) until I went to the clinic.  I was told my resting heart rate was around 100bpm and I lost around 7 pounds. PCR test was negative for COVID and I was diagnosed with hyperthyroidism. I was told it was the result of infection - thyroiditis, but I had not had cold symptoms prior to the fevers starting and was active (running 20 miles per week) as usual.  I started on medication and after two weeks I went hypo and was switched to generic levothyroxine and was told I will be on this for the rest of my life.
HIVES CHEST, FACE, ARMS.  tREATMENT  prednisone, antihistamines oral, H2 blockers
ON FRIDAY, 30 APRIL 2021, ABOUT TWO WEEKS AFTER GETTING THE FIRST COVID VACCINATION, I NOTICED A NUMBER OF SMALL PATCHES OF ECZEMA FLARING UP ON MY ANKLES, ELBOWS, AND HANDS. ON MONDAY, 3 MAY 2021, I VISITED MY GENERAL PRACTITIONER ABOUT THE ISSUES WITH MY SKIN AND HE WONDERED IF I HAD STEPPED IN POISON IVY OR POISON OAK. I EXPLAINED TO HIM THAT I HAD NOT BEEN HIKING AND THAT WE DO NOT HAVE POISON IVY OR POISON OAK IN OUR YARD. HE PRESCRIBED A .5 PERCENT CLOBETASOL STEROID CREAM. THE VISIT TOOK TWENTY MINUTES AND I WAS CHARGED $98.95. ON FRIDAY, 14 MAY 2021, AT 3:00 PM, I RECEIVED THE SECOND COVID VACCINATION. BY 9:00 PM, I NOTICED TINGLING AND NERVE PAIN ON MY HANDS...
Saturday she felt like she had the flu all day and her arm was red and swollen and hurting.
Dust allergy; Grass allergy; This spontaneous case was reported by a consumer and describes the occurrence of DUST ALLERGY (Dust allergy) and SEASONAL ALLERGY (Grass allergy) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced DUST ALLERGY (Dust allergy) and SEASONAL ALLERGY (Grass allergy). At the time of the report, DUST ALLERGY (Dust allergy) and SEASONAL ALLERGY (Grass allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient had reaction from shoulder to elbow of swelling, heat, itching, and pain. patient went to their doctor and was treated 48 hours after administration with an antibiotic. patient is still being monitored
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with ZOSTAVAX (Merck).  Per physician, the patient received ZOSTAVAX (Merck) and later developed a bad case of shingles.  Per physician, "this is the worst case of shingles he has ever seen".  Lot # was not available.  It is unknown whether the patient had history of shingles prior to receiving ZOSTAVAX (Merck).  The patient's bad case of shingles persisted.  Additional information has been requested.
Information has been received from a physician concerning a patient who was vaccinated with a 4 doses of Varivax over 18 months and has failed to seroconvert. Unspecified medical attention was sought. Additional information has been requested.
Red raised rash on hands, chin 6/12 taken to Medical Center Rx for Prednisone 20 mg Qd II tabs 6/15 spoke with mother, patient is doing well today.
Left deltoid with 4" x 5" red, warm, swollen area, distal to injection site. Symptoms started 1 day post injection worsened overnight into day 2 post injection. Some tingling in fingers with certain positions. Recommended ice, evaluation, ibuprofen, and BENADRYL
Pt is a 32 y/o female who is an employee of who got her covid vaccine earlier today and reports to the ED for headache and tingling to the left side of the body and feet.  PT says she felt ok right after the shot and then started with a headache and weakness and tingling.   PT denies any CP, SOB, difficulty swallowing, dizziness or any other concerning signs/symptoms.  Encounter Diagnoses 1. Acute nonintractable headache, unspecified headache type    2. Paresthesias
Stroke that lead to loss of speech and use of right arm and leg.  Patient currently in rehab facility.
I received COVID-19 booster dose (Pfizer vaccine) and several days later noticed axillary lymph node swelling in my left armpit. It was painful. It took 5 days to resolve. I did not have this reaction to the first or second doses in the series.
After the first injection arm was sore for three days. Second shot started with fever of 102.7.  Extremely cold with chills.  Headache.  Muscle and joint pain.  Very tired.  Second day fever went down to 101 with Advil.  Day 3 developed hives in my mouth and my throat started to feel as it was closing up.  The throat was better the second day but the mouth hives stayed until about day 6 or 7.   Last night my arm was still sore to sleep on at the injection site. Today it is still tender but better.
patient developed fever the night of receiving vaccination as well as red macular rash on face and ears.  Rash was nonpruritic and nonpainful.  mother gave Motrin and Benadryl which did not help improve symptoms. Resolved after 24 hours.  Subsequently developed swelling, firmness and redness with tenderness to left deltoid area for 3 days afterwards.
ASYMPTOMATIC COVID-19; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's weight was not reported and height was 149.86 centimeters. The patient's concurrent conditions included: down syndrome, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced asymptomatic covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
severe headache, pressure in chest and abnormal thumping of my heart. I was wide awake for 36 hours, and I normally sleep without issues. I went to urgent care four days after experiencing heart issues. They detected an irregularity and sent me to the emergency room. This was on 11/20. I was released but still feeling strange with heart palpitations. I will see the doctor on Monday, 11/29
Per mother's report, client had injection site pain x 2 days following vaccination, followed by 2 days pain free. 5 days following vaccination, client began to have arm pain. By day 8 following vaccination, client's arm was red, swollen and warm to the touch from collarbone to wrist and into her fingers. On day 9 following vaccination, client was seen by physician on call for Dr' (other Dr. is her PCP) and was diagnosed with cellulitis. She was prescribed Bactrim x 10 days at that time. She has had some decrease in symptoms since starting antibiotics.
On Saturday after getting her2nd  vaccine on Friday, patient slept most of the day. Not requesting food or needing to go to the toilet. After 5pm when offered dinner, it was noticed she wasn't quite appropriate mentally. Making disjointed sentences and thought patterns. I spoke with patient on the phone and could tell she was confused, and agitated at all our questioning and our insistence on getting her up because she had wet on herself. She has been confused twice before, once in 2012 at the hospital after being moved during the night, the other time in 2017 when she had the flu and her O2 was diminished. She had no signs of CVA. Because of the time of night, I thought it was "sundowners" AND related to the vaccine. She began to clear a little in around 3 hrs but wasn't completely herself till the next morning.
PROQUAD ADMINISTERED EXPIRED ON 9/25/23.  PT DISPLAYED NO SIGNS OR SYMPTOMS OF DISTRESS.  REPEAT DOSE IN 28 DAYS PER GUIDELINES.
Received flu vaccine 10/3/2018 in left arm. 10/9/2018 laid down in bed and had tingling in bilateral feet and buttocks. 10/10/2018 awoke with numbness and tingling bilaterally from toes to waist including perineum. Saw PCP on 10/12/2018 and was prescribed a prednisone taper over 12 days (60, 40, 20). No improvement of symptoms. Continued numbness and tingling bilaterally and in pelvic area. New loss of balance and pain when walking on flat surfaces and especially walking down stairs. On 10/15/2018 saw chiropractor and he states exam showed increased dullness and decrease in strength on right side lower extremity. On 10/19/2018, had an MRI of lumbar spine. 10/24/2018, saw neurologist. He states exam abnormal.
Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, diarrhea, rash, sore throat, headache
Whole body pain, headache, sore throat that all started when I woke up the day after the second dose.
Started with aches, pain at injection site, and fatigue.   2nd day fatigue, diarrhea, stomach pain and noticeable swelling at injection site, third day fever and slight headache.
HORRIBLE stomach pain, had to go to the hospital twice for blood work and an ultrasound on my Gastro organs.
Patient got Moderna booster and 15 minutes later she started reporting itching and difficulty in breathing. She was responsive and comunicating well. I called 911. The paramedics came in and gave her a shot of benadryl and then transported her to the hospital. Today she is doing fine
Unable to receive second dose within the extended dosing window of 42 days; A spontaneous report was received from a consumer concerning a female patient, of unknown age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and the patient would be unable to receive second dose within the extended dosing window of forty-two days/ inappropriate schedule of product administration.  The patient's medical history included a broken hip. No relevant concomitant medications were reported.  On 04 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   The patient was originally scheduled for her second Moderna COVID-19 vaccine on 02 FEB 2021. The patient was hospitalized due to a broken hip that occurred prior to receiving her first dose of the vaccine and has not been released to receive her second dose. The patient was kept at the hospital for a scheduled hip replacement on 16 FEB 2021 and will not be released to receive the second vaccine. The hospital would not allow a vaccination provider to administer at the hospital where she was staying and therefore would be unable to receive her second dose within the extended dosing window of forty-two days. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.  The outcome of event, would be unable to receive second dose within the extended dosing window of forty-two days was considered as resolved.; Reporter's Comments: This case concerns a female patient of unknown age who would be unable to receive second dose within the extended dosing window of forty-two days(inappropriate schedule of product administration )for mRNA-1273 vaccine. ( Lot # not available as vaccine is yet to be administered) .
HIVE AROUND INJECTION SITE APPROXIMATELY 4CM X 4 CM LESS THAN 20 MINUTES AFTER IMMUNIZATION ADMINISTERED.  HIVES CONTINUED APPEARING OVER FACE, ARMS AND UPPER BACK. PHYSICIAN WAS PRESENT, BENADRYL WAS ADMINISTERED AND CHILD WAS SENT TO THE ER.
p/vax pt had runny nose late afternoon;child wheezing & difficult breathing;pt could not drink water;T101;