chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three days after my second Moderna jab on Sunday, March 7, 2021, I developed fever blisters across my lower lip. I rarely get fever blisters. I had received my second jab the morning of March 7, and 11 hours later I had a fever (3 degrees), chills, and fatigue. The next morning I still had some fever but felt okay and took it easy that day and the next day, i.e., Monday and Tuesday. On Wednesday morning I started getting the fever blister symptoms and they became full-blown over the following days.
painful tongue and mouth sores/They started to subside but then increased again after the second dose; herpes zoster (shingles); This is a spontaneous report from a contactable physician. A 70-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 29Jan2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have Covid-19 prior to vaccination and did not test for covid post vaccination. There were no known allergies. The patient had received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jan2021 at 12:30 PM as single dose for covid-19 immunization. After 4 day of being vaccination, on 12Jan2021 at 08:00 am patient developed painful tongue and mouth sores starting which have persisted over a month. They started to subside but then increased again after the second dose (condition aggravated). The patient had never suffered from any tongue or mouth sores before and was told the sore on tongue was herpes zoster (shingles) and I took Valtrex with gradual improvement. But the other sores in mouth have not responded. Therapeutic measures were taken for events. The patient was recovering from shingles and not yet recovered from other event.  Information on the lot/batch number has been requested.
pt recv vax in 1971 & exp t105, staring, sore throat, coma;also exp crossed eyes, fussy, jerking congested, tongue hurt, would not drink or eat, could not breathe, stare mode, lifeless, eyes rolled back in head, limp comprehension bad;
COVID-19 Vaccine EUA. I have had a swollen, sore lymph node in my left armpit since Tuesday. I understand this is one of the possible side effects so I have not yet sought out medical treatment. If it is still swollen and sore in a few days, I will check up on it.
I fainted/passed out while driving directly after my first vaccine shot. I waited 20 minutes at the location I received my  vaccine. One or two minutes later, I passed out suddenly behind the wheel. Thankfully, no one was hurt during the incident. I was passed out for 6 blocks in a very busy road in the city.
Patient began to develop purpura on shins w/o antecedent trauma. Bruising progressed over the next two days to include purpura on arms and back, as well as petechiae on chest, face, ears, mouth and back. Was seen in the pediatricin's office on 10/19, where platelet's were noted to be 4000. Pt was admitted to the hospital for further workup. Provisional diagnosis of immune thrombocytopenia (ITP) was made in the hospital. A single dose of intravenous immunoglobulin was administered. Platelet count began to increase 12hrs after IVIG infusion. Patient was discharged to home 48hours after admission.
Following SPIKEVAX booster: nausea, dry heaves, fatigue, chills, aches, headache, loss of appetite the morning after the vaccine was administered
PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On 26th October 2018, the patient received Flu vaccine (intramuscular). On 26th October 2018, less than a day after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the patient experienced swelling and rash. On an unknown date, the outcome of the pain in arm was resolved with sequelae and the outcome of the swelling and rash were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling and rash to be related to Flu vaccine. Additional details were provided as follows: The patient reported that she received flu shot in the morning at her physician's office and experienced sore left arm for five days. The soreness started within 12 hours of vaccination. Less than a week after receiving Flu vaccine, the patient also experienced a little swelling and a bump which resolved after three days. The patient refused to provide any name or demographic information and wished to remain anonymous.
MENACTRA administered 8/10/15 in (L) deltoid started with numbness/weakness in (L) arm 8/12/15. Treatment: Ibuprofen and referral to pediatric neurology for follow up.
PATIENT RECEIVED INITIAL COVID VACCINATION (PFIZER) 4/5/2023. SECOND COVID VACCINATION (BIVALENT MODERNA) WAS ADMINISTERED TODAY 5/1/2023, WHICH WAS GIVEN BEFORE THE MINIMUM 2 MONTH INTERVAL. CDC HOTLINE WAS CONTACTED AND RN WAS INFORMED THAT THE DOSE WOULD NEED TO BE REPEATED WITH A 2 MONTH INTERVAL STARTING TODAY WHEN THE INCORRECT DOSE WAS GIVEN. PATIENT WAS INFORMED AND AGREED TO COME IN FOR REPEAT DOSE 2 MONTHS FROM NOW.
This spontaneous report received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-MAY-2017, the patient received an improperly stored dose of PROQUAD (dose, frequency not reported) (Lot: M043306, expiry date: 24-APR-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA000302: US-009507513-1706USA000301: US-009507513-1706USA000300: US-009507513-1705USA000847.
Pfizer-BioNTech COVID-19 Vaccine EUA  - all started within 30 minutes to 1 hour after injection: headache, tingling scalp, menstrual cycle started immediately and wasn't due. Had more than usual cramping. Light spotting at first but became full flow by end of day.  First full cycle over a few days in years. Flow would lessen then cramping would start again and flow would worsen - to passing small to rather large (hand-sized clotting) being passed. Flooding pads within a hour at times. I'm on week 3 now of same flow of slow to over flow at times. Was nearing full menopause when this occurred after receiving the first shot. Headaches and tiredness continue to be more prominent than prior to receiving injection. A bit of brain-fog at times has also presented itself.
SYRINGE DEFECTIVE, LEAKED OUT OF SYRINGE INSTEAD OF GOING THROUGH NEEDLE
Information has been received from a nurse practitioner concerning a 52 year old female who received a complete series of RECOMBIVAX HB. The vaccination dates were November 2006, December 2006 and July 2007. On 28-APR-2010, the patient had a negative hepatitis B titer. The patient's negative hepatitis B titer persisted. Additional information has been requested.
After 1st shot on 1/17/21, noticed swollen lump over R collarbone, also aching in R neck on 1/26/21. Condition is still present and unchanged now on 3/21/21 at the time of this report. After 2nd shot,large  red and tender area developed distal and medial to injection site  and lasted several days. before resolving.
h/a; crying, irritability onset day of vax; treated for poss stuffy nose
AFTER PT HAD 3 VACCINES TYPHIM HAVRIX AND ADACEL PT FAINTED  BP AND HR TAKEN AMBULANCE CAME AND TOOK TO HOSPITAL FOR OBSERVATION.
My underarm swelled and remained swollen for about 6 days. It was hot and sore. I took the vaccine in the right arm and that's the arm that swell up.
Fatigue, aching, headache, viral infection, elevated enzyme in liver, nausea (Patient just started feeling a little better today - 6-25-12). Patient said 1 Dr said she may have lyme's disease if its not from.
Rash consistent with erythema multiforme.  Started 10 days after vaccines.
Burning chest pain/sharp chest pain; Sharp back pain; Body pain; Headache; Body pain; Fatigue/tiredness; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Burning chest pain/sharp chest pain), BACK PAIN (Sharp back pain), PAIN (Body pain), HEADACHE (Headache) and MYALGIA (Body pain) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Colitis. Concomitant products included MESALAZINE (LIALDA) for Colitis, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), PROBIOTICS NOS, FISH OIL, INFLIXIMAB (REMICADE) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced CHEST PAIN (Burning chest pain/sharp chest pain), BACK PAIN (Sharp back pain), PAIN (Body pain), HEADACHE (Headache), MYALGIA (Body pain) and FATIGUE (Fatigue/tiredness). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, CHEST PAIN (Burning chest pain/sharp chest pain), BACK PAIN (Sharp back pain), PAIN (Body pain), HEADACHE (Headache), MYALGIA (Body pain) and FATIGUE (Fatigue/tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-significant follow-up information received on 23-JUN-2021 and contact information updated.
Within 1 hr of vaccines infant started fever (99 degrees), diarrhea, vomiting & a pink rash on arms legs, stomach, face started next day. Every day he got worse - by Fri 4/12/13 fever was 102, diarrhea q 15-20 min - projectile, watery, foul-smelling & vomiting. Severe diaper rash - Taken to ER 4/12 - Dx dehydration, rotavirus. Dr. stated he got rotavirus from the shot and may also be having allergic reaction to shot(s). Infant given IV's & foster mom gives PEDIALYTE. Infant continues to have fever, vomiting & severe diarrhea. Two antibiotic ointments for diaper rash.
Information has been received from a healthcare worker referring to unknown number of patients (unknown age and gender). The patients were vaccinated with improperly stored ROTATEQ (oral route, dose, dose # and lot # were not reported), since 01-OCT-2015. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from an other health professional refers to a 9 year old female patient. On 30-APR-2013 the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly. On 12-JUL-2013, 73 days after vaccination the second dose of GARDASIL, the patient experienced pain on swallowing and fever. The outcome of pain on swallowing and fever is unknown. Action taken with GARDASIL due to pain on swallowing and fever was not provided. Additional information has been requested.
Lump left leg. Immunization 10/4/02. Mom states cranky on Sunday, fight sleep, crying after bottle.
After Tdap developed four red hives - 3 were 1" length - 1 was 2 1/2" length along the side of injection.  Took 3 days to go away.  Rash itched a little bit as well.
w/in 10 min p/HIBTITER/DTP/OPV, pt was lethargic & had hypotensive episode based on perfusion appearance & very brief; Pt was never seen in office p/immun; However, father is pediatrician;
Bad bilateral ringing in both ears starting at the same time as other symptoms (headache, fatigue, etc.) in the evening of the same day as the shot.  The other symptoms subsided, but the ear ringing has been 24/7 in the 10 days since then and is driving me mad
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EP7534) at the age of 76 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Apr2021, outcome "recovered" (09Apr2021), described as "Slight Headache after second vaccine/Severe Headache"; MYALGIA (non-serious) with onset 08Apr2021, outcome "recovered" (09Apr2021), described as "Muscle Aches just like with the first shot"; PAIN (non-serious) with onset 2021, outcome "recovered" (09Apr2021), described as "pains"; HEADACHE (non-serious) with onset 16Mar2021, outcome "recovered" (17Mar2021), described as "Slight Headache after second vaccine". Additional information: Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 78 year old Caller states she received 1st dose of the Pfizer Covid vaccine 22Feb2021 and second dose 16Mar2021. Why was the patient taking Covid 19 Vaccine. (Verbatim): Has pre-existing conditions and wanted to get the vaccine to not get Covid-19. Other Products: No. Patient History: No. Investigation Assessment: No. She got her second vaccination on 16Mar2021. She had a slight headache that same day and the next day it was gone. Then on 08Apr2021; 23 days after the second vaccine, she had severe headache and muscle aches like the ones she had from the first shot. States they lasted one day. The pains eased off that evening and were gone on 09Apr2021. She originally stated her first vaccine was on 22Apr2021 and her second on 16Apr2021. Weight: Reports as 179-180 pounds. Indication Continued: While discussing indication for Covid Vaccine caller states that she had some kind of episode 2 years ago in December before Covid-19 came out. She said she was very, very sick. Stated that the February after that was when Covid-19 came out. She said during her illness in that December she had every symptoms like Covid-19. Her doctor told her it probably wasn't Covid-19 and there was another flu that had come around. Stated the illness she experienced was severe enough that she went and set up her living trust. Stated she does not want Covid-19 if it was anything like that was. Concomitant Products, Medical Conditions, Investigations: Caller denies any medical conditions, medications, labs, testing, or treatments relevant to this report. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Physician Office: No. Patient's Medical History (Including any illness at time of vaccination): None. Family Medical History Relevant to AE(s): None. No follow-up attempts are possible. No further information is expected.
A few hours after vaccine - developed tightness in throat, raspy hoarse voice, shortness of breath. Solumedrol IV (pt pregnant)
Patient received his first dose of Pfizer COVID-19 vaccine on 3/15/21, administered by store. He had the following reaction within minutes of receiving the vaccine. States he was still under the watch of the clinical team who administered it:  Turned red, and got really hot. He tried to stand up, he felt fine but was sweating terribly. He developed a rash on the middle of his back 6-7 inches red rash, it did not itch. Reactions resolved within that same day. However, had a severe headache for about 24 hours.
Post vax the patient developed itching with skin eruptions, hives, congestion, a temp of 100.1, swelling lips and swelling eyes. The patient was treated with Vistaril, SoluMedrol, Atarax, and Prednisone.
Varicella Information has been received from a physician concerning patient (between elementary school age and high school age) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In approximately November 2005, "between November and December 2005" the patient experienced breakthrough chickenpox. There were 20 lesions or less. Unspecified medical attention was sought. Subsequently, the patient was fine and recovered from chicken pox. No product quality complaint was involved. Additional information has been requested.
Possibly cellulitis, was given cephalexin by urgent care provider.   On Sept 27th, pt stated symptoms improving
COVID-19 SHOTS CAUSED BREAKOUT ON NECK FOR BOTH SHOTS; This spontaneous case was reported by a consumer and describes the occurrence of RASH (COVID-19 SHOTS CAUSED BREAKOUT ON NECK FOR BOTH SHOTS) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced RASH (COVID-19 SHOTS CAUSED BREAKOUT ON NECK FOR BOTH SHOTS). At the time of the report, RASH (COVID-19 SHOTS CAUSED BREAKOUT ON NECK FOR BOTH SHOTS) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) and mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the event of COVID-19 SHOT CAUSED BREAKOUT ON NECK FOR BOTH SHOTS was not provided.
This spontaneous report was received from a registered nurse via a company representative and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot #, dose, and route were not provided). On unknown dates, the patients passed out after administration of GARDASIL 9. The outcome of the event was unknown. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of "passing out" was considered to be medically significant. Additional information has been requested.
first dose / on October2020 / second dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The pharmacist reported that , till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details for 1st dose were reported. The reporter consented to follow up.
Patient got her 1st dose on 2019 and is just now requesting her second vaccine; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-JUN-2022 Reporter's comment:The case was received from the other healthcare professional via interactive digital media. The reporter enquired that he/she had a patient who got her first Shingrix vaccine in 2019 and was just now requesting her second vaccine.  The reporter asked did patient need to restart the series or just get her second shot. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow-up could not be possible as no contact details were available.
one day after, got extreme itching on right lower back then pain in same area (last for 3 months) then now have rash at wrists, elbows underarms, behind knees, at back of thighs; one day after, got extreme itching on right lower back then pain in same area (last for 3 months) then now have rash at wrists, elbows underarms, behind knees, at back of thighs; one day after, got extreme itching on right lower back then pain in same area (last for 3 months) then now have rash at wrists, elbows underarms, behind knees, at back of thighs; This is a spontaneous report from a contactable other HCP (patient).   A 65-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=EN5318, via unspecified route of administration at the left arm for COVID-19 immunization on 28Jan2021. Medical history included autoimmune thyroiditis and hypersensitivity. The patient was not pregnant. There were no concomitant medications. The patient experienced one day after, got extreme itching on right lower back then pain in same area (last for 3 months) then now have rash at wrists, elbows underarms, behind knees, at back of thighs. The events were assessed as non-serious. The outcome of the events was reported as not recovered. The patient did not receive treatment for the events.    Follow-up attempts are completed. No further information is expected.
Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was a resident at an assisted living facility and by 3/11/21 he had several falls within the last week, one of which he hit his head and need to be evaluated by the ER due to him being on warfarin. Patient had dementia and psychosis and told wife he was falling intentionally. He deceased at the rehab facility on 3/30/21 after requiring hospitalization 4 times over the last for not getting blood flow to his brain per wife.
Patient given vaccine 5/27/08 - returned to clinic 5/29/08 - had no complaints. Over weekend developed itchy red raised "hive" appearance rash. Seen by MD 6/2/08 - Benadryl ordered and cold compresses
Pt recvd 3 doses of Engerix-B 4NOV90, 1DEC90 & 29APR91 & 8SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
I was being monitored for 15 mins since I was allergic to tree nuts stayed 20 mins. I started feeling dizzy and exp nausea lasted 20 sec. After about 12 hrs later I woke up had difficult swallowing felt like something in my throat. I went to ER received a dose pack, Benadryl and steroid injection.