chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a  patient of an unknown age and gender 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,  after starting mRNA-1273 (Spikevax), the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient had a stroke 2 days after taking the Moderna vaccine. No treatment medications were reported.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected serious (medically significant) AESI of Cerebrovascular accident which occurred 2 days after a dose of mRNA-1273 Vaccine in COVID 19 vaccination series. Details regarding medical history, treatment, clinical course, outcome are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event serious assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected serious (medically significant) AESI of Cerebrovascular accident which occurred 2 days after a dose of mRNA-1273 Vaccine in COVID 19 vaccination series. Details regarding medical history, treatment, clinical course, outcome are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event serious assessed as per medical judgement.
The next morning when I woke up I started feeling short or breath like my asthma was exacerbating and used my inhaler. 3- 4 hours later I had to use my inhaler again. And it started happening more often than every 4 hours. So that is when I reached out to my PCP and he prescribed me a nebulizer solution and prednisone.
24 hours from injection she developed an 'apple' sized swelling of her left axillary lymph nodes which is painful and visible. No fever, redness or red streaking
Stomach pain  Diarrhea (first day after injection only) Lack of energy (3 days in) Slight headache
The shot was in my upped left arm, possibly muscular? Severe swelling at the site of the shot and surrounding area, went down gradually over about 5-7 days. Itchiness of the same area on and off while it was swollen, cortisone cream relieved the itchiness for a while. Pain when sleeping on that side for about 4 or 5 days.
Localized edema and erythema 10x13cm - Surrounding injection site - meningococcal (MENACTRA) - two days following immunization.
Narrative: Patient received the vaccination from outside site on 4/9/2021 and was diagnosed with transverse myelitis at an outside clinic 4/21/2021. Patient is being treated with oral antibiotics and steroids for this new condition. Patient was evaluated for other sources of infection, but none could be noted. This was deemed to be associated with the vaccine.
Redness, swelling, induration of the injection site. Started 2 days following injection and reaction worsened from 8/7-8/11. Site is improved today. At its worse the area of redness/swelling/induration was approximately 3 in x 3 in in size. Only minimally painful to palpation. No systemic symptoms.
dizzy after vaccine, increased heart rate, itchy skin , temperature , swelling in lymph nodes under left arm and left breast, stiff neck , rib cage pain on left side, weakness, fatigue, nausea ,
I did an at home COVID-19 test on 5/22/2022 that was negative. I started getting symptoms late at night with coughing that did not stop. On 5/23/2022 and 5/24/2022, I had sore throat, coughing, body aches, runny nose, headache, chills, possible fever, brain fog, nausea, and fatigue. I did an at home COVID-19 test on 5/23/2022 that was positive. I contacted my doctor on 5/24/2022 because my symptoms progressed so strong, I was scared due to being out of state. I did a virtual visit and was prescribed PAXLOVID. I never did take PAXLOVID due to bad side effects and wanted to wait and see how my symptoms went. On 5/25/2022 most all of the symptoms were gone except for runny nose and cough which is mild.
Patient complained of pain in injection site and when examined in the office her left upper arm had approximately a 10cm x12cm red circular area with tenderness with palpitation and warn to touch. Tx was BENADRYL, ibuprofen, prednisone 20mg BID x 2 days, and ice.
pt recv vax & 10 days post vax pt devel a rash;pt exp a local rxn @ the inj site, nausea & blister type sores over body;
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unspecified dates since 11-MAR-2015, an unspecified number of patients were vaccinated with doses of VARIVAX (Merck) 1350 U, (dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored exposing to temperatures outside of the recommended range. No adverse effects were reported or observed and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 92-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 26th June 2018 16:00, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than 3 months after receiving SHINGRIX, the patient experienced tiredness and injection site pain. On an unknown date, the outcome of the tiredness and injection site pain were recovered/resolved. It was unknown if the reporter considered the tiredness and injection site pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's daughter. The reporter reported that the patient received SHINGRIX on the left deltoid. The contact details of the physician were provided. For tolerance to next dose, refer case US2018GSK171940. This case is linked to the case US2018166441, reported by the same reporter (the daughter's case).
administration of IV Boostrix; administration of IV Boostrix, another dose IM on the same day; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In May 2022, the patient received Boostrix, Boostrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device. In May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device and not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route and overdose. On an unknown date, the outcome of the intramuscular formulation administered by other route and overdose were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment: The pharmacist reported that administration of intravenous Boostrix to a patient in early May 2022. The patient received another Boostrix dose intramuscular on the same day. The reporter did not have any patient demographics or specific details about the adverse event at the time of the call. The reporter was consented to follow up. Additional Supportive Information: The patient received Boostrix by intravenous route of administration and received another Boostrix dose intramuscular on the same day, which led to Intramuscular formulation administered by other route and overdose.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history was not reported. Concomitant medication(s) included: CETIRIZINE, start date: 13May2022; FLONASE [FLUTICASONE PROPIONATE], start date: 13May2022. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin"; Cipro, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) positive, notes: 11 days after initial positive test; (27May2022) positive, notes: Rebound Covid infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
having tingling and numbing on the whole left side of my body and my right arm; The first one it was just a little bit on my foot; having tingling and numbing on the whole left side of my body and my right arm; The first one it was just a little bit on my foot; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number was not reported) and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number was not reported) both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having tingling and numbing on the whole left side of body and right arm; the first one it was just a little bit on foot. Patient started experiencing like numbness in the left side about a week after the 1st dose. The reporter stated that the first one, it was just a little bit on foot (Confirmed experienced after first shot) and the second one was whole left side (Confirmed experienced after second shot). Outcome of the events was unknown.  Information about lot/batch number has been requested.
Fever (over 101), headache, muscle aches, nausea, diarrhea, extreme fatigue. Fever and muscle aches lasted for around 32 hours. Nausea and diarrhea is still ongoing. Headache comes and goes, but is still ongoing.
Patient presented today requesting COVID-19 booster dose. The immunization screening questions were reviewed. Booster dose given in accordance with Health Officer guidance at 8:28am. Patient requested flu vaccine. Administered at 8:27am.    Shortly after at about 8:29am patient stood up still in nurse vaccine station and stated he felt dizzy, and he needed to lie down. PHN gently helped guide patient to the floor, into the supine position. Patient went unconscious immediately and PHN began to hear a gurgling noise, PHN took off his face mask, checked his airway nothing was found, rolled him onto his right side, PHN helped and lifted his legs. Patient was out for about 15 seconds. PHN then placed him back onto his back and he began to talk. He then went out again and made the gurgling noise, his face turned red. PHN assessed airway, nothing found rolled patient onto his right side. PHN continued to hold his legs up, he was out for approximately 15 seconds again. Patient returned to conscious level and was placed back onto his back, he began talking to the nurses and stated he has a history of vasovagal episodes, patient was encouraged to take a few deep breaths. PHN asked if he had eaten before coming in today, he stated he had not. He was given a cookie and a juice, he had two sips of the juice. The ambulance was called at 8:30am by site lead. PHN notified patient that the ambulance was on the way, vital signs were taken B/P 120/70, P86, O2 Sat 99% RA, he remained lying on the floor until the ambulance arrived at 8:50m. He continued to have trouble with orthostatic hypotension, the ambulance crew took him to the hospital.
Symptoms: Loss of Short Term Memory for 7 hours Event: Ischemic stroke on right parietal superior cortex 1.2cm Treatment: aspirin 325 mg 1 daily; atorvastatin 40 mg 1 daily Outcome: hospital stay, 2 days. Sent home for recovery. Follow up with Primary Care Physician in 1 week
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. From an unspecified date, unspecified patients were vaccinated with 8 doses of improperly stored ROTATEQ (dose and frequency were not reported) (lot # J01234 and expiry date: or J011334) since the excursion. The reporter was unsure about the lot number (J01234 or J011334). No adverse effects reported. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1501USA005041 and 1501USA008491 (same reporter link). Additional information has been requested.
Breakthrough case after 2 vaccines Pfizer 2/22/21 Lot# EL9267;  Pfizer 3/15/21 Lot# EN6199
The shot site was extremely sore but not red. Towards evening became extremely exhausted and ached all over!  At approximately 9:15 I got the chills and became light headed. Throughout night I got the sweats!  When woke 9/24/2015 was dizzy, chills, and had diarrhea and had no energy. I had a Low grade fever of 100.
Expired Menactra vaccine was given to a patient. Expiration read 25 May 20, which was interpreted as May 20, 2025 when it was actually May 25, 2020. Patient has to have titers one month post immunization.
Severe headache, body aches, chills. Onset within 2-3 hours after shot. Resolved 24 to 30 hours after.
Within 1 hour of vax, with numbness to left chin/neck and ear region. Neg PMH.  Stable. Directed to f/u with occupational health services.
With my first vaccine the only adverse reaction was insomnia. I could not sleep at all the first night. I even had trouble sleeping the 2nd night after the shot.; I could not sleep at all the first night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 16:30 (Lot number: ER8732) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PAXIL [PIROXICAM]; TOPAMAX. The following information was reported: INSOMNIA (non-serious) with onset 01Apr2021, outcome "recovered" (Apr2021), described as "With my first vaccine the only adverse reaction was insomnia. I could not sleep at all the first night. I even had trouble sleeping the 2nd night after the shot."; INSOMNIA (non-serious) with onset 01Apr2021, outcome "recovered" (Apr2021), described as "I could not sleep at all the first night". Therapeutic measures were not taken as a result of insomnia, insomnia.  Additional Information: With patient's first vaccine the only adverse reaction was insomnia. she could not sleep at all the first night. She even had trouble sleeping the 2nd night after the shot. she had no other ill effects. The 2nd shot though was much different. She actually blacked out. She got up at 4am running a fever. She took tylenol. She threw up the tylenol a short time later. She then don't remember anything. The next thing She remember was her dog waking him up by licking his face about 20 mins later. She was laying face down in the hallway between the bathroom and the bedroom. Other than some scratches, She didn't get hurt. She also could not form coherent sentences while trying to call her husband to tell him to come home from work. She don't remember much from Friday morning at all. It was all a fog. But the blackout was scary. She was fevered and sick feeling for 24 hours and then was fine again. The Patient reported that she did not affected with Covid 19 prior to vaccination and post vaccination. Patient was not having with any known allergies.  No follow-up attempts are possible. No further information is expected.
patient became light headed, dizzy, and nauseous, 10-15 minutes after dose was administered
This is a spontaneous report from a contactable physician. A patient of unspecified age ethnicity and gender received third dose of PREVNAR 13 via intramuscular route of administration, in left thigh, at single dose, on unknown date. No illness was present at time of vaccination. The patient medical history was not reported. Concomitant medications were none. On an unspecified date, the patient experienced excessive sleeping/sleeping from 7 o'clock in evening to 7 o'clock in morning (but easily awakened), excessive cranky/very very fussy and screaming 3 hours after vaccination. The outcome of the events was unknown. Follow-up (18Feb2015): New information from a contactable physician includes: vaccine lot number, route of administration, anatomical location of vaccination, dose number, events details. Follow-up attempts completed. No further information expected.
None Phenyl & Pt sister PKU + mom strong on mercury free.  Physician ordered wrong in Epic
Arm still has a little itching; This case was reported by a consumer and described the occurrence of itchy upper limbs in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced itchy upper limbs. On an unknown date, the outcome of the itchy upper limbs was unknown.   It was unknown if the reporter considered the itchy upper limbs to be related to Shingrix.  Additional case details were reported as follows: At the time of this report, the patient continued to have a little itching after shingles shot. The reporter consent to follow up.
pain/ burning; Body aches; Chills; Headaches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 08th December 2021, for tolerance to 1st dose, refer case US2022AMR040148).   On 25th February 2022, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, general body pain, chills and headache. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the general body pain, chills and headache were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, chills and headache to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR040148  Additional details were provided as follows: The patient self-reported this case. The patient received her second dose of Shingrix into the muscle of her left arm, she took Tylenol and iced her arm after the injection. The patient still experienced the pain and burning with the injection. The patient also developed body aches and chills with the second dose. The reporter did not consent to follow-up. The reporter did not give consent to contact her health care professional.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR040148:Same patient, 1st dose
Patient developed generalized itching, and flushed face after receiving second dose of COVID-19 vaccine. Patient received a  25 mg dose of diphenhydramine resulting in improved symptoms within 30 minutes. BP,P,RR : 115/68, 72, 20 @ 0732                                        118/72, 76, 18 @ 0750
next AM lt arm was kind of red;by evening (about 36hr p/vax) pt devel a deep red,  splotchy 2 1/2" red area extending from the inj site toward the shoulder, & the lt arm was hot as was forehead but mom believes no fever;would not move arm
Information has been received from a physician concerning a 12 year old female with a history of delayed mixed immunodeficiency who on 24-AUG-2008 was vaccinated with the first dose of GARDASIL (lot # unspecified).  Concomitant therapy included TDP.  On 24-AUG-2008, after she received her first dose of GARDASIL the patient experienced nausea, body ache, headache and low grade fever for two days.  There was no lab diagnostics studies performed for the patient.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from nausea, body ache, headache and low grade fever and recovered date was unspecified.  Additional information has been requested.
This spontaneous report was received from a pharmacist via company representative referring to a 74 years old female patient. The patient's concurrent conditions, allergies, medical history and concomitant therapies were unknown. On 07-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (site, lot number and expiration date were not provided) for prevention from shingles. On 10-JUN-2017, the patient called the pharmacist to report a knot at injection site where the ZOSTAVAX had been administered. It was reported that the patient did not seek for medical attention and that no treatment was given for this adverse event. No intervention to prevent serious criteria was made. No death, disability, hospitalization, overdose nor life threatening were reported. The outcome of the event was unknown by the time of reporting. The pharmacist did not supply the demographics for the patient or the patient's physician. The causal relationship of the knot at injection site with the ZOSTAVAX was not provided.
Fever of 103.1F so far for an hour not reducing after Ibprofen. Shivering and chills.  Random talking about fears and just nonsense.
Information has been received from a healthcare worker referring to a 21 month old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 15-JUN-2015 the patient was vaccinated with 0.5ml dose of (Oka/Merck) VARIVAX (lot # K016132, expiration date 24-SEP-2016) which had been exposed to temperatures outside of the recommended range, subcutaneously. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.