chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles twice.).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and upset stomach. On an unknown date, the outcome of the pain in arm and upset stomach were recovered/resolved.   It was unknown if the reporter considered the pain in arm and upset stomach to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comment: This case was received from Consumer via interactive digital media. The patient had shingles twice and it was no joke.  The first time was awful and the second not as bad and the patient was much younger. The older now and did not want it again so the patient just had the fist of two shots and had a sore arm and upset stomach for a couple of days but still better then shingles. The follow-up would not possible as no contact details were available.
24 hours after the left forearm intradermal injection, he had swollen, itching, painful, burning, hot to touch (no drainage) areas around the injection site that is "spiraling up to my shoulder". It is only affecting his left side.  Advised treatment: cool compresses, Ibuprofen 400-600mg with food every 6-8 hours, can take Zyrtec or Benadryl as directed for swelling and itching, follow up with PCP or urgent care if continues to worsen. 6/23/23 spoke to patient today and symptoms have resolved. There is a little scar where the injection itself entered his skin on forearm.
My arm of injection is very sore; my arm pit is visibly swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 15:30 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing), notes: sulfa drugs. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 11Aug2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 19Jul2021, when the patient was 45 years old, for COVID-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Feb2022 19:00, outcome "not recovered", described as "My arm of injection is very sore"; SWELLING (non-serious) with onset 15Feb2022 19:00, outcome "not recovered", described as "my arm pit is visibly swollen". It was unknown if therapeutic measures were taken as a result of vaccination site pain, swelling.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. No Hospitalization Prolongation. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Immediately after receiving H1N1 vaccine (IM) client became light headed and stated she had an alcohol/metal taste in mouth.  Had to lay down for 20 min. and sat in chair for another 20 min. before leaving the clinic.  Also given juice to drink.  Never had this reaction when receiving vaccines, in the past.
Four days after the date of vaccination, the patient developed a mild itchy rash with pustules that evolved to violet spotty patches, approximately 2 cm in diameter. The patient's current condition is hyperpigmented spotty lesion. The rash occurred all over the patient's body. Patient was seen by the health care provider on 01/06/13. Patient has not received any treatment for the adverse reactions. The patient's physician will order that the patient stop taking Hydrochlorothiazide and will re-evaluate his condition. Patient recovered by 01/14/13.
Inconsolable screaming that began 1 hour post DTaP and lasted 8 hours.
I started Anthrax 1, 2 and 3 in the states and I noticed that I gained 4 pounds. Out of the states, I had the 4th and 5th Anthrax. With the 5th shot, I had a cellulite and keep gaining weight. In 3/00, I had the 6th Anthrax and still gaining weight. I gained a total of 27 pounds since 9/98 to 4/00. Until today, I still work out, everyday to loose that weight. It's been hard.
During the night after receiving my second dose of the vaccine I woke up to an incredibly high fever of 103.6 and cold sweats. IN the morning I had severe aches and pains throughout my entire body to the point that I was barely able to stand or walk. I was so weak that I was unable to open or close the blinds or even open water bottles. My fever stayed for about 36 hours even with the use of Tylenol and Advil. The aching was accompanied by sharp pains in my back that would cause numbness in other areas of my body. By around noon the day following my vaccine I was having difficulty breathing, it felt like there was a weight on my chest and I could breathe shallow inhales. Today is the second day following the vaccination and the aching and pains have diminished to the point where I am able to walk, but I have been unable to work or complete my normal daily tasks without frequent rest breaks. I have also developed indigestion, heartburn, and diarrhea today. Additionally, I have had a migraine for 2 days nonstop.  I am incredibly frustrated by the adverse side effects of the vaccine because I am a very healthy individual who is very active and does not have any pre-existing health conditions. I also tested positive for COVID-19 in November of 2020 and recovered quickly with little to no side effects at all.
After several days, I developed strong and frequent heart palpitations, shortness of breath, chest pain, and lightheaded feeling. Shortness of breath and lightheaded feeling dissipated after about a week. Heart palpitations and chest pain decreased over time in terms of frequency and intensity. Ten weeks later, I still have heart palpitations mostly at night while lying in bed. The heart palpitations are less frequent and less intense.
Pt presented to  ED on 3/9 with R eye pain and blurred vision, plus R-sided facial dropping which started that morning. Physical exam positive for facial asymmetry. Per ED provider note: "Pt now with clear R-sided 7th nerve palsy compared to arrival when lower portion was more pronounced.... Labs largely unremarkable.... Overall, exam at this point most consistent with Bell's palsy. Will start on prednisone, acyclovir, eye patch, and artificial tears."
Patient received COVID 19 vaccine through work at the company in the location on 05/05/2021.  14:45.  Said he didn't feel "right" immediately.  Waited the 15 minutes without sxs of allergic reaction and went home.  On arrival home felt dizzy and laid down.  Had initial ED visit that night and again on morning of 05/09/2021.  Full body hives, itching, facial swelling, throat swelling.
COVID19 infection well after successful vaccination; COVID19 infection well after successful vaccination; This is a spontaneous report from a contactable other health professional. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EJ1685), dose 1 via an unspecified route of administration, administered in Arm Left on 18Dec2020 as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number:EJ1686) as single dose for COVID-19 immunization. On an unspecified date the patients medical history included drug hypersensitivity(Penicillin, Rocephin). On an unspecified date concomitant medications included sertraline hydrochloride (ZOLOFT), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), amlodipine (AMLODIPINE) taken for an unspecified indication. The patient previously took rocephin [ceftriaxone sodium] and experienced drug hypersensitivity. On 19Mar2021 the patient experienced covid19 infection well after successful vaccination, covid19 infection well after successful vaccination. The outcome of the events recovering.; Sender's Comments: The event COVID19 is most likely an intercurrent condition. Based on temporal relation, the association between onset of event COVID19 and vaccination cannot be ruled out.
20 minutes after vaccine administration, client reported swollen lips and facial flushing. Client seen and cleared by EMS
Body Aches/Joint Aches/ Freezing for 6 - 8 hours. Hot/Cold/Hot. Continued till 09/23/2010 PM, then developed diarrhea for 2 days.  Just hurt so bad could not move. Also had redness and swelling at injection site.
flu shot given on 18OCT93 approx 415PM; around MN pt awoke w/fever fo 106; ran fever next day up to 104 & day p/of 100; h/a, nausea, lethargy;
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
pain under her armpit; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she felt pain under her armpit. She wants to know if this is a known side effect of the vaccine, how long it will last, and what she can do to minimize the pain. Outcome of the event was unknown.  Follow up attempts are needed. Further information has been requested.
Dizziness, Myalgia, Fever, FATIGUE, "TINGLING ALONG BASE OF SPINE, STIFFNESS IN NECK, Narrative:
Patient received vaccine at 3:17pm, following which they were instructed to have a seat in the waiting area. At 3:21pm, mother reports patient stating they were not feeling well, head tilted to the left and they slipped out from chair onto the floor, resulting in minor trauma to the mouth area. Pharmacy staff responded quickly, calling EMS, instructing patient to stay on floor in recovery position while help arrived. Patient was responsive and alert to questions during this time, mother was blotting mouth area with gauze and water. Patient quickly stabilized after. EMS arrived at 3:37pm and performed follow up tests including HR and blood glucose in EMS vehicle to which mother states results were normal, but patient was again light headed due to sight of blood. Mother and patient declined ride to additional medical facility.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic inflammatory demyelinating polyradiculoneuropathy" (unspecified if ongoing), notes: CIDP. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (booster); Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (booster); Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 5 (booster); Manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 12Oct2023 to 16Oct2023. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336370 same patient, different drug and event;
Subsequently the pt experienced swelling redness at the site of injection down the arm and to the elbow. Additionally it was noted that 3 pts experienced similar reactions.
Biopsy on 11/3/2023 confirms condition of IgA nephropathy; he gets sick for 3 days after each COVID shot; This spontaneous case was reported by a consumer and describes the occurrence of IGA NEPHROPATHY (Biopsy on 11/3/2023 confirms condition of IgA nephropathy) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 039B21A and 001B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 03-Nov-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IGA NEPHROPATHY (Biopsy on 11/3/2023 confirms condition of IgA nephropathy) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (he gets sick for 3 days after each COVID shot). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, IGA NEPHROPATHY (Biopsy on 11/3/2023 confirms condition of IgA nephropathy) had not resolved and ILLNESS (he gets sick for 3 days after each COVID shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Urine analysis: urine was brown/red. On 03-Nov-2023, Biopsy: confirms condition of IgA nephropathy in previously healthy patient. On an unknown date, Blood test: Blood work every 6 months since then has shown RBC and blood in the urine, though not visible to naked eye now.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Following 3rd dose on 02-Dec-2021, patient's urine was brown/red. They immediately went to the pediatrician at the time for blood work and the pediatrician sent them to the Nephrologist. Patient will be on lifelong medication to manage. It was unknown if the patient experienced any additional symptoms/events. At the time of each of 3-day sickness, only acetaminophen to manage fever, was needed.  Company Comment This spontaneous case concerns a 19-year-old male patient with no medical history reported who experienced the unexpected medically significant seriousness criteria event of IgA nephropathy; the unexpected event of illness in the context of 3rd. dose of mRNA-1273 vaccine. The patient felt sick for 3 days after each COVID shot; 11 months after the 3rd. dose, a biopsy confirms condition of IgA nephropathy in previously healthy patient. At the time of the report, this condition had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt recvd vax;itching starting w/ elbows & knees;took dph; next day swelling of lip;seen in er & given a "shot" & script for medrol dose pack;resolved in 3 days;
Information has been received from a 63 year old female consumer with sulfonamide allergy (chodroitin sulfate) and drug hypersensitivity (novacine, xylocaine, and cetirizine) who on 29-NOV-2007 was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included irbesartan (AVAPRO), levothyroxine Na, estrogens, conjugated (CENESTIN), "Promethium" (therapy unspecified), fenofibrate (TRICOR) and fexofenadine hydrochloride.  The patient developed fatigue and malaise followed by an injection site reaction following the vaccination with ZOSTAVAX on 29-Nov-2007.  The caller reported that the fatigue and general malaise started on 30-Nov-2007 and that the injection site was red, swollen, warm, and itchy which started on 02-Dec-2007.  The injection site reaction was still present on 13-Dec-2007 and described as itchy, red, "2 C2BD" inch oval area at the injection site.  The swelling and warmth are no longer present as of 13-Dec-2007.  The patient received the vaccination at the pharmacy.  Unspecified medical attention was sought.  No product quality complaint.  Follow-up information received from the physician indicating that she is not aware of any adverse events or the patient.  No further information is expected.
Day of injection had right arm pain. Next day had swelling, increased pain, and redness from shoulder to elbow. 3rd day having decreased redness and swelling continues with pain. Will continue to monitor for possible infection.
Red rash on face that comes on after washing face and stays for about 30 mins. Blotchy spots when face is touched
Not feeling good 4 days after shot; Dry mouth on and off since shot.; This is a spontaneous report from a contactable patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH mRNA COVID-19 vaccine; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 17:30 hours (at the age of 60-year-old) for COVID-19 immunisation. Medical history was not reported. Concomitant medications reported as clonazepam (MANUFACTURER UNKNOWN) taken within prior two weeks of vaccination. The patient was reported to be allergic to codeine and dilladid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 15Mar2021 at 18:00 hours, the patient experienced dry mouth on and off and on 19Mar2021, the patient was feeling unwell. No therapeutic measures were taken by the patient for the events. The clinical outcome of event dry mouth was not recovered, while the outcome of feeling unwell was unknown at the time of report. No follow-up attempts are possible; information about lot number cannot be obtained.
Swelling of the lymph node in left supraclavicular area Hives around neck area
Diagnosed with Guillain-Barre syndrome on 11/29/2017-Bilateral lower extremity numbness below knee and bilateral upper extremity numbness below elbow. Home Health Care with OCC. therapy and Physical Therapy ordered.
Fainted approx. 2-5 minutes after the injection. Patient was sitting on a chair and the nurse caught him before he fell off. Patient came to quickly and was then nauseous and vomited stomach bile a few times. Patient exhibited cold sweats, dizziness, shakiness, and was faint and pale for approx. 15 minutes. Nurses gave him juice and observed until he could speak and stand up for five minutes. Mother took patient home, where he drank water and ate some toast and crackers. He still felt nauseous and unwell, and fell asleep about two hours after the injection.
my heart rate went from the 70s to about 150; As soon as I got the shot I got a strong smell of metal in my nose; dizziness; my nose wouldnt stop running; shaking with jumping nerves and tremors; intense burning, on fire sensation in my chest, underarms, and head; trouble walking on my own; balance being off; my tonsils were swelling; weak leg; feeling notably hot; I was switching between very hot and very cold; I felt very flushed and sick; nausea; I felt very flushed and sick; weak; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 09Aug2021 13:00 (at 40 years old, not pregnant) (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia from an unknown date (resolved). Concomitant medications included diphenhydramine hydrochloride (BENADRYL); ibuprofen; vitamin d; ascorbic acid, calcium pantothenate, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN). On 09Aug2021 13:00, patient got a strong smell of metal in my nose, she felt very flushed and sick, and her heart rate went from the 70s to about 150. She had nausea, dizziness, my nose wouldnt stop running, she was switching between very hot and very cold, was shaking with jumping nerves and tremors, and she had a very intense burning, on fire sensation in my chest, underarms, and head. She was observed and sent home to take Benadryl. She had trouble walking on my own because of the dizziness and balance being off. At home her heart rate kept spiking, her tonsils were swelling, and she had trouble drinking water so she went to the ER. The Benadryl did help quickly,  but she could not leave the ER because of her dizziness and balance. The burning sensation has continued to come and go the last four days. She woke up in the middle of the night shaking very badly, with very weak legs, feeling notably hot, and the burning sensation in my chest. She was still weak and have the burning sensation. All events started on 09Aug2021 13:00. The outcome of the events was unknown. All events was given treatment. The adverse events resulted in visit to Doctor or other healthcare professional office and Emergency room/department or urgent care. Treatment was given, Benedryl, ER gave me Dexamethasone. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 12Aug2021.  No follow-up attempts are needed. No further information is expected.
mom states pt began to devel raised, reddened ares (hives) w/in 1hr p/vax;areas first appeared just below inj site & then on lt side of neck & lt cheek;rx w/DPH & spoke w/child's MD;pt improved later that evening (6PM);
2 days post vax, pt devel swelling of left leg w/ moderate edema. Left thigh non-tender with mild erythema. Event considered OMIC by reporting physician. Pt recovered 4 days later.