chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got just a really bad migraine; really bad pain; really bad nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Lot number: EW0171) at the age of 64 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "had the migraine symptom before" (unspecified if ongoing), notes: I may be had the migraine symptom before but 7-10 years before the vaccine. Concomitant medication(s) included: WARFARIN taken for atrial fibrillation. Vaccination history included: BNT162b2 (LOT# (first shot): ER8737, Date of first shot: 01Apr 2021), administration date: 01Apr2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "recovering", described as "I got just a really bad migraine"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "really bad nausea"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "really bad pain ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, pain, nausea. Additional information: The patient wanted to report her reaction to Pfizer COVID-19 vaccine. She had her first dose on 01Apr2021 then the second dose on 22Apr2021. She got just a really bad migraine with full on really bad pain and really bad nausea. And then she was on that for a year and would say it was still there, gradually getting better but it was something that she did not suffer before. She did not have before the vaccine. She maybe had the migraine symptom before but 7-10 years before the vaccine. Treatment included gabapentin for a little while, which kind of made her mind foggy, it's a brain fog so she didn't like it and went off of it.
This spontaneous report as received from a medical assistant refers to a currently 30 year old male IV drug user patient who on 03-AUG-1992 was vaccinated with the first dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (dose and route were not reported). On 08-SEP-1992, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose and route were not reported). On 30-MAR-1993, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose and route were not reported). The medical assistant reported that a patient had a negative anti-HBs titer (less than 5) after receiving the primary three dose series of Hepatitis B vaccine (manufacturer unknown). The primary vaccination series was administered at another unspecified clinicians office. No adverse event reported other than the negative anti-HBs titer. On 01-DEC-2012, an unspecified titer test was performed (results not provided). Also it was reported that the patient was administered a dose of RECOMBIVAX HB on 02-APR-2013. The patient sought unspecified medical attention by an office visit. At the time of the report, the patient's outcome was not provided. Additional information is not expected.
After I vaccinated the patient, she bruised instantley and her arms swelled where the injection was given. A hard knot formed underneath her skin where the bruise was. The patient, however, felt fine.
45 TOTAL VIALS INVOLVED IN TEMPERATURE EXCURSION; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: 11/APR/2022) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-NOV-2021, the patient experienced administration of expired vaccine. On an unspecified date, the patient experienced 45 total vials involved in temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and 45 total vials involved in temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20211143090 and 20211139494.
I had a very heavy postmenopausal period - the heaviest menstrual bleeding of my life.
minor arm pain after shot.  woke up at 11 pm (12 hours after shot) with fever (100 degrees) and chills, muscle, head and stomach aches.  Took aspirin...   fever, chills and aches lasted for about 18 hours....    thought I was finished with symptoms but some 36 hours after symptoms started I got an extreme case of nausea and diarrea.  Then I was finished.
Short term effects- Headache, muscle/body aches, sore arm, chest pain. Long term- I've had the iUD for 5 years with occasional cramping and no spotting. Now I experience spotting and more severe cramps.
Patient began to feel faint and nauseous immediately following vaccine. Monitored patient for 30 min. including BP and Glucose. Patients daughter came and picked her up.
rash on lt arm, indurated area approx 4" circumference c/o numbness, pruritus;
Hives all over torso, developed neurological symptoms as though my nervous system was hyper on all over my body, tingling and numbness, heavy metal toxicity, blurred vision, swollen glands and lymph nodes, twitching, mental fog, clumsiness, tripping, joint pain.
Based upon a report received from a health care professional, a patient was inadvertently given Flushield vaccine with a TB syringe and subsequently developed a red mark the size of a coffee cup at the injection site.
Pt received 2nd dose of Pfizer vaccine on 08/05/21. came to pharmacy on 08/12/2021 to report that she developed rash all over her body couple days after receiving the vaccine and her doctor prescribed OTC Benadryl.
This spontaneous report was received from the registered nurse regarding a 14 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 05-SEP-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Information has been received from a registered nurse concerning a 20 year old female with no drug reactions/allergies who on 03-DEC-2007 was vaccinated IM in the left arm with the first dose of Gardasil (lot # not reported).  There was no concomitant medication.  On 04-DEC-2007 the patient experienced itching in her right leg and rash on her stomach and all extremities.  The patient's itching in her right leg and rash on stomach and extremities persisted.  No laboratory diagnostic tests were performed.  Additional information has been requested.
Information has been received from an office manager at a physician's office concerning a 31 year old male with no known allergies and a non-remarkable past medical history who on 11/12/2001 was vaccinated with varicella vaccine. There were no concomitant medications. Subsequently, the pt developed a rash over his entire body and experienced great deal of itching. Unspecified medical attention was sought. Additional info has been requested.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 18-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Chills within 90 minutes of vaccine; 4 hours later, severe muscle & body aches, chills; no elevated temp; headache; nausea; no appetite; significant pain/discomfort at vaccination site.   Symptoms were severe, lasted 72 hours during which I was bedridden.  Arm (vaccine site) lasted 5 days.  Self treatment :  ibuprofen; Tylenol; fluids; lots of sleep; anti-nausea prescription which I had on hand.
Patient reports that the pain after vaccination didn't go away fully, his shoulder became more painful while lifting his arm and stiff as well.
Unexplained itching around the neck, redness from scratching overnight. Pustules noticed last night (2/25/2021). Adverse reaction did occur from February 23rd through 26.
The patient stated that he did not have any prior COVID vaccinations but when he was looked up in the Database he had previously received the Janssen vaccination. This information was not seen until after the Moderna vaccine was given.
Site reaction - blisters formed Sunday. Bumped arm Friday-hurting. Saturday-arm uncomfortable.
This spontaneous report as received from a nurse refers to a 5 year old child of unknown gender. Medical history, current conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with PROQUAD (lot # M006103, expiry date 01-AUG-2017) as prophylaxis. No adverse effect was reported. No temperature excursion reported. No product quality complaint. The outcome of expired product administered and no adverse event was unknown.
Expired dose given on accident. Vial expired on 04/04/2022 but given on 04/15/2022.  No adverse reaction, just expired dose given. All expired vials had been wasted,but one was left in the fridge corner and new hire did not realize it was expired. She has been spoken to and trained on how to prevent this occurring again.
This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L032402, expiry date: 26-NOV-2016). Temperature excursion details of the vaccine included: temperature 29 degree F, time frame 7 hours 15 minutes, which came back in range. No adverse effects were reported. Additional information has been requested.
At approx 6pm on 10/23/09 my eyes started to burn ferociously. It hurt to open them for about 24 hours. Both eyes watered and were blood shot.
My period was supposed to start 12/1/2021. It was delayed by two weeks, starting 12/15/2021. Cycle returned to normal the next month, starting 1/15/2022.
About 8 hours after receiving my second dose of the Pfizer Covid 19 vaccine my left shoulder at the injection site was very sore. I also had a low grade fever of 99.8 degrees and a dull headache.  I took two capsules of Aleve Liquid Gels (naproxen sodium capsules, 220 mg each and went to bed for the night. I woke up the next morning at 7:00am with no headache or fever and the soreness in my left shoulder was much better!
I was driving and had loss of vision in my right eye, it was like my peripheral  vision was gone for about 5 to 10 mins, Then my speech was jumbled. Also had bad headaches.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2017 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot # was administered) (dose, route of administration and location were not reported). This is one of the several reports received from the same reporter. Additional information has been requested.
On April 21, 2000, she developed an injection site reaction characterized by redness and swelling. The swelling extended to involve her entire thigh. This is 1 of 3 patients from this facility who developed an injection site reaction.
Redness, 2 circles around injection site (1 inch & 3 inch in diameter), sore & warmth.
PT CALLED ON WEDNESDAY MARCH 10TH WITH A LOT OF SORENESS IN HER ARM AND THE PHARMACIST TOLD HER TO TAKE TYLENOL OR IBUPROFEN TO HELP WITH THE PAIN. SHE CAME TO THE PHARMACY TODAY MARCH 15TH WITH THE SAME COMPLAINT AND SAID IT HAS GOTTEN WORSE. I TOLD HER TO GO TO URGENT CARE IF IT REMAINS THESAME OR GETS WORSE.
Ringing very loud day after injection, then dropped to moderately loud, continuous, persisting into at least 3rd week post vax.
Swollen lymph node along my right clavicle of my arm that was injected/swollen on right side of her neck; Body aches; Extremely high temperature, a fever over 102; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), PYREXIA (Extremely high temperature, a fever over 102) and LYMPHADENOPATHY (Swollen lymph node along my right clavicle of my arm that was injected/swollen on right side of her neck) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (Extremely high temperature, a fever over 102). On 12-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node along my right clavicle of my arm that was injected/swollen on right side of her neck). At the time of the report, MYALGIA (Body aches), PYREXIA (Extremely high temperature, a fever over 102) and LYMPHADENOPATHY (Swollen lymph node along my right clavicle of my arm that was injected/swollen on right side of her neck) outcome was unknown.            no concomitant medication provided. no treatment taken
Nausea, chills and hot flashes, Extremely Dizzy, needed help to use restroom. Fatigue lasting for 2 days or more. Slight pain at injection site.
Repetitive behavior, zoning out-as if deaf, sensory integration problems, motor apraxia, oral tactile defensiveness, loss of acquired speech, pica, nutritional deficiency (malabsorbtion), loose stools, immune dysfunction, heavy metal toxicity.
Extreme aches in all joints Swelling at injection site that continues to swell more even three days after injection  High fever lasting three or more days Cough starting at day three after injection  Repeated nosebleeds for first two days after injection Tightness in chest with difficulty breathing
Self-limiting Pain at injection site (lasted 3 days) Self limiting Tingling in left arm (pins and  needles feeling) starting morning after the vaccine and lasting for 3 days and mild hand tingling (lasting 4 days).
Within in minutes of receiving vaccine patient developed rash and itching from head to toe.  Due to patient's history of anaphylaxis, EMS was called. Patient was transported by EMS to Medical Center
2 days after vaccination all body skin rush and itching. Over time got less and less but still coming in patches on knee arm hand and feet.; 2 days after vaccination all body skin rush and itching. Over time got less and less but still coming in patches on knee arm hand and feet; 2 days after vaccination all body skin rush and itching. Over time got less and less but still coming in patches on knee arm hand and feet; Dose 1 administration date: 28Jan2021 + Dose 2 administration date: 28Jan2021; This is a spontaneous report from a contactable consumer. This 73-Year-old female consumer (Patient) reported. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL 8982), via an unspecified route of administration, administered in Left arm on 28Jan2021 14:00 (70-year-old at the time of vaccination) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN 6201), via an unspecified route of administration, administered in Left arm on 28Jan2021 as dose 2, single for covid-19 immunisation. The patient medical history included elevated blood pressure from an unknown date and unknown if ongoing. The patient concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported. There was no vaccine administered in four weeks. There was no COVID prior the vaccination. The patient had no known allergies. The covid was tested post vaccination. On 20Feb2021 22:00, 2 days after vaccination all body skin rush and itching (over time got less and less but still coming in patches on knee arm hand and feet). The patient received treatment Antihistamine / Allergy Relief. The patient underwent lab tests and procedures which included sars-cov-2 test (Covid test name post vaccination=PCR) which was negative, on 09Aug2021. The outcome of events body skin rush and itching (over time got less and less but still coming in patches on knee arm hand and feet) were resolving.  Follow-up attempts are completed. No further information is expected.
Vaccinee a non responder following a series of 3 Engerix-B vaccinations (deltoid).
Received the vaccine on the 3rd and 31st of March. Got my period on the 2nd of April and now I am having it again on the 24th. Unsure if related by I have had Normal periods for 20 years and the only thing changed is getting the vaccine.
Daycare and mom noticed a firm lump at the left thigh injection site on 3/13/19 that has persisted over the two days since noting.
Received DPaT in right upper thigh on 11/09/2005, had fever first night (Tactile), Resolved. Today has warm swollen local reaction 5 x 5 cm. NO fever, eating well. No systemic SXS, no red streaks.
Some mild pain; This case was reported by a pharmacist via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine and had some mild pain which got resolved within a week. The reporter consented to follow-up. For tolerance to the 2nd dose of Shingrix, refer case US2020215518.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020215518:Same suspect, same reporter, same patient, different dose (1st dose)
Severe dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Severe dizziness) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Severe dizziness). At the time of the report, DIZZINESS (Severe dizziness) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug was reported. No treatment drug was reported. Caller said that they had a friend whose niece had severe dizziness after getting the Covid-19 shot and stayed in bed for one week.
after 30 minutes was very light headed and mild headache started.  This has continued for 3 days now and now experiencing muscles fatigue with dizziness and headache.
Stated that  morning OP 06/07/08, noticed a large nodule at the injection site with a large red raised area roughly 4-5" in diameter around the injection site. Red area is warm to touch, and raised' Red as of 06/11/08. Also reports having migraine headaches since 6/6/08. No sent to clinic for evaluation at 6/11/08
Information has been received from a licensed practical nurse (LPN) concerning a 6 month-old patient with gastrooesophageal reflux who on 08-JAN-2008 received their first 2.0 ml oral dose of Rotateq. The nurse is planning on giving the patient a second dose in the next 4 to 8 weeks. No adverse experience (AE) reported. A product quality complaint was not involved. Additional information has been requested.
The day after I got the flu shot I started having this feeling of rocking, swaying, floating and it was constant, all throughout the day. I didn't find anything that was making it better or worse. I went to the urgent care clinic a week after I got the flu shot and the doctor prescribed meclizine and it didn't help at all. I saw my primary care doctor multiple times who order multiple blood work and everything was normal. For the first two months, I was having this feeling of imbalance continuously. I had to skip school and come back home. I only went back to take my finals. When it got worse, I went to the urgent care clinic and the PA prescribed VALIUM which helped for few hours. I have seen multiple neurologists in the past month and am doing physical therapy. I have terrible ear pain, ear popping and ringing. The dizziness hasn't gotten any better. I am taking a semester off from school because I can't concentrate/focus or do anything by myself. I have tried prednisone and valacyclovir and they haven't helped at all. One of the neurologist thinks its labyrinthitis. I am unable to walk by myself or shower by myself because I am so dizzy. Right now, it is not constant all day but it is still most times of the day. I am not sure if flu shot caused it but I know it started the day after I got the flu shot and before that I was completely healthy.
This spontaneous report was received from a medical assistant regarding a 12 month old patient. On 25-AUG-2016, the patient was vaccinated with fourth dose of ROTATEQ (lot # M025565, expiry: 06-NOV-2017) 2 ml, oral after 32 weeks. No adverse effects were reported. Additional information has been requested.