chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received a sunburn on the left side of my chest. It was bright red. Very unusual for my skin. Its 2 weeks later and the redness hasnt went away and it is dry and peeling.; Received a sunburn on the left side of my chest. It was bright red. Very unusual for my skin. Its 2 weeks later and the redness hasnt went away and it is dry and peeling.; Received a sunburn on the left side of my chest. It was bright red. Very unusual for my skin. Its 2 weeks later and the redness hasnt went away and it is dry and peeling. Received a sunburn on the left side of my chest. It was bright red. Very unusual for my skin. Its 2 weeks later and the redness hasnt went away and it is dry and peeling.; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302) dose 2 via an unspecified route of administration, administered in Arm Right on 04Feb2021 07:00 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 48 years). The patient medical history was not reported. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]); macrogol 3350 (MIRALAX) taken for an unspecified indication, start and stop date were not reported received these other medications in two weeks. Historical vaccine included bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302) dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 07:30AM as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient did not received other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced on 04Jul2021 she was on vacation. Patient was swimming in a pool and received a sunburn on the left side of her chest. It was bright red. Very unusual for her skin. Its 2 weeks later and the redness hasn't went away and it is dry and peeling. Her sister experienced the same thing. We are from 2 different states and can only see that that we both received the Pfizer shot and have that in common. Normally a sunburn turns into a tan after a few days. It's been 2 weeks and 3 weeks for her sister and not much color change. The patient did not received any treatment for the events. The clinical outcome of all the events were recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hard/thick skin, warm to the touch, itchy - about 2 inches in diameter at site of vaccine
Monday-soreness, put on ice pack, achiness on arm, weakened. Tuesday, wiped out chest aching, nausea, loss of appetite.
Vaccine Administered at Inappropriate Site; Warmth; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received Shingrix. In October 2019, less than a month after receiving Shingrix, the patient experienced injection site warmth and injection site erythema. On 19th October 2019, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site warmth, injection site erythema and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The pharmacist states that a patient received Shingrix on Saturday and thought that it was administered at an area lower than the deltoid on left arm, which led to vaccine administered at inappropriate site.  She was inquiring if there was any efficacy results if Shingrix was administered at a site other than the deltoid.  Caller also mentioned that the arm was warm and there was redness around the injected area. The reporter consented to follow up.
Fever, nausea, diarrhea & head/right sharp pains, body aches by following day, subsequent pain thoracic & left shoulder & arm, with possible dx brachial neuritis. Tx with IM DECADRON/KENALOG & Phys. Therapy.
Initial unsolicited report received from a nurse on 11-Oct-2017. This case is linked to case 2017SA201143 (same reporter and same vaccine). This case involves a 42-year-old male patient who was vaccinated with 0.1 ml single intradermal dose of FLUZONE QIV (Batch number: UT5903AA, expiration date, dose in series were not reported) in the right deltoid on 04-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, after the vaccination, the patient developed a very large area of redness, swelling and hardness with possible cellulitis with no confirmed culture. It was reported that the diagnosis was based on overt symptoms. Reporter stated she was referring the person to an urgent care center called City MD for antibiotics. Laboratory investigations and other corrective treatment were not reported. The outcome of all the events was reported as unknown. Upon internal review, the company decided to consider the case as serious due to important medical event: possible cellulitis with no confirmed culture. List of documents held by sender: none; Sender's Comments: The patient experienced very large area of redness, swelling and hardness with possible cellulitis with no confirmed culture post vaccination with FLUZONE QIV ID. Time to onset was not reported. No information regarding patients medical history or ongoing medical condition or tolerance to previous vaccinations was reported. There could be an underlying etiology or the evnts could be related to improper aseptic technique followed by the administrator that led to ingress of surface pathogens into deeper layers of skin. Based upon reported information the role of the vaccine can not be assessed.
3/15/21 @ 10:30 AM, TOP LIP SWOLLEN  3/16/21 RASHES APPEAR ON LEFT Arm. Every day, more itchy rashes appears and spread to other areas.  3/19/21 FACE STARTS SWELLING AND FEELS HOT AND ITCHY.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19; This spontaneous report received from a consumer concerned a male of unspecified age. Initial information was processed along with the additional information received on 16-JUL-2021. 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: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date the patient (reporter's sister-in-law's husband ) got COVID-19 after getting vaccinated (suspected clinical vaccination failure).  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the COVID-19 and suspected vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000186312.; Sender's Comments: V0: 20210732319-COVID-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Burst blood vessel hemorrhage and is small; eyelids were a little bit swollen; Right eye is red; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (Burst blood vessel hemorrhage and is small) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 04-May-2021, the patient experienced EYE HAEMORRHAGE (Burst blood vessel hemorrhage and is small) (seriousness criterion medically significant), SWELLING OF EYELID (eyelids were a little bit swollen) and OCULAR HYPERAEMIA (Right eye is red). At the time of the report, EYE HAEMORRHAGE (Burst blood vessel hemorrhage and is small), SWELLING OF EYELID (eyelids were a little bit swollen) and OCULAR HYPERAEMIA (Right eye is red) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-109540, MOD-2021-109560 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-109540: MOD-2021-109560:
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects).   At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant products were reported by reporter. No treatment medication provided by the reporter.
A vaccine was given that experienced a temperature excursion. The affected vial was in the freezer past the 2 weeks of stability from info provided by the CDC.
Experienced sore arm for a couple of days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Experienced sore arm for a couple of days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 007B21A, 013M20A and 013M20A) for COVID-19 vaccination.     Patient had no allergies reported. Patient had never tested COVID-19 Positive. No other vaccine was given within 1 month prior to Moderna COVID-19 Vaccine.  Concurrent medical conditions included Diabetes (Started 27 years ago), Kidney failure (Started 27 years ago) and Blood pressure high (Started 27 years ago). Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMAN INSULINK) for Diabetes, AMLODIPINE, CLONIDINE, GUANFACINE, PRAVASTATIN, CALCITRIOL, LOSARTAN and SODIUM BICARBONATE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Experienced sore arm for a couple of days). At the time of the report, PAIN IN EXTREMITY (Experienced sore arm for a couple of days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient only had Sore arm for a couple of days after first four shots.  No treatment details were reported.   This case was linked to MODERNATX, INC.-MOD-2022-652241 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-652241:Bivalent booster dose case
Macular papular rash on face neck, back with superficial edema and erythema site of injection. Occurred 36 hrs post Prevnar vaccine.
Fever; pain; This case was reported by a nurse via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number NP33H, expiry date 8th April 2022) for prophylaxis.   Previously administered products included ZOSTAVAX (received in the past.).   On 22nd July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever was unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows:  After receiving  1st dose of Shingrix, the patient experienced fever and pain for 33 hours. The nurse was looking for more medical information about side effects after Shingrix. The patient was worried about having second dose and feeling worst. The reporter consent to follow up.
STROKE; This spontaneous report received from a consumer via a company representative via social media concerned a 50 year old male of unspecified race and ethnic origin. 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: unknown and expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On DEC-2021 (3 weeks ago), the reporter stated that, the patient experienced stroke and now he was disabled. (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Disability Or Permanent Damage). This case, from the same reporter is linked to 20211254092, 20211253879, 20211254072 and 20211247927.; Sender's Comments: V0: 20211254110- COVID-19 VACCINE AD26.COV2.S- Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
per patient report: broke out with generalized rash with itching 4 hours following initial vaccine, took diphenhydramine and issue was resolved, rash lasted x3 days
Patient was given expired vaccine. Vaccine vial expired on 12/10/2021 1640. Vaccine given 12/13/2021 1140.
I was diagnosed with POTS about 3 weeks after the second injection. I started developing episodes of tachycardia, hypotension, and near syncopal episodes.
First thing was I noticed that this shot was more painful than the first two vaccinations, then within two hours the vaccination site began to swell about the size of a tennis ball and it began to raise up off my skink and became hot to the touch, and it was very red, that lasted for about 5 days. I also had wheezing and had to use my inhaler for my asthma and had to take Benadryl. Also had a breakthrough case of COVID on May 28th, my symptoms scratchy throat, fever, slight cough, progressed to tightening of the chest and went to urgent care for treatment.
Change in menstrual cycle schedule (still experience mild symptoms during original schedule time), menstrual cycle increased from 1 week to 2 weeks, pain with menstrual cycle decreased, blood during menstrual cycle also appeared different (looked really dark and old). Now (September/October) cycle is returning to normal across all levels, extreme levels of pain are also returning.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (single dose, intramuscularly; lot # M044032, expiration date: 03-JUL-2017). The doses of the vaccine experienced temperature excursion of 13 degrees Celsius for 1 hour and 58 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the nurse. Sender's Comments: US-009507513-1707USA001296.
pt recv vax;pt failed to seroconvert p/ 2 doses;serology test revealed a neg titer;
Rash Rash on face and facial swelling  Narrative:  Developed a rash the day of the vaccine and then woke up with eye and facial swelling the following day. States he took Benadryl which helped the rash go away, but some of the swelling remains today. States it was difficult to open his eye lids first thing in the morning.
Slightly sore arm initially.  3 days postinjection noticed redness near the injection site. Warm to touch and burning. Redness disappeared within a couple of days; however, burning persisted for several days. May have been aggravated by physical workouts.
Sudden onset of severe headache, chest pain, difficulty breathing, fatigue and nausea, ~72 hours post vaccination.  After 16 hours of bad symptoms that got worse, I took my husband to the ER, as he was having difficulty breathing and moving.  (He is normally very fit, active and healthy). In hospital, they ran a battery of tests and found signs of inflammation in chest and lymph nodes.  They gave him fluids, and intravenous pain meds (acetaminophen, Toradol), which helped slightly.  Symptoms diminished slowly over next 24 hours, and he was feeling 90% better by Saturday afternoon.
LOW GRADE HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with phenytoin for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced low grade headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade headache on 16-AUG-2021. This report was non-serious.
Shortly after administration, the patient reported feeling dizzy and lightheaded, then passed out and lost consciousness for about 10-15 seconds. 911 was called and EMT arrived. Before they arrived, he had come to. I provided a damp cloth and some water. Once they arrived, they checked his vitals. While checking his blood sugar, he passed out again. Based on the 2 episodes and his vitals, he was transported by EMS to the ER for further testing.
covid test result: Positive / covid test date: 03Feb2022; covid test result: Positive / covid test date: 03Feb2022; Sore Throat; Cough; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 (Lot number: FF8839) at the age of 52 years as dose 3 (booster), single, administration date 05Feb2021 (Lot number: EL3247) as dose 2, single and administration date 14Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP, gout; "gout" (unspecified if ongoing), notes: Other medical history: HBP, gout. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Feb2022, outcome "unknown" and all described as "covid test result: Positive / covid test date: 03Feb2022"; OROPHARYNGEAL PAIN (non-serious) with onset 03Feb2022, outcome "recovering", described as "Sore Throat"; COUGH (non-serious) with onset 03Feb2022, outcome "recovering", described as "Cough"; INSOMNIA (non-serious) with onset 03Feb2022, outcome "recovering", described as "insomnia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of oropharyngeal pain, cough, insomnia. Clinical course: The facility where the COVID-19 vaccine was administered is Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts possible. No further information expected.
Past few days started with upper respiratory symptoms. Two days ago a rash started on the back of neck spreading down upper back and on abdomen, macular papular rash.
After patient received the Moderna (Spikevax) vaccine, about 1 minute later, patient turned red and couldn't breath. Inject  Epipen right away. Patient  fell a little better and gave second epipen  about 8 minutes later. Pt rested and checked blood pressure. Pt's blood pressure was 143/82 pulse 102.
Case number PHEH2012US005066, is an initial spontaneous report received from nurse on 27 Feb 2012: This case refers to multiple patients. These patients may have received MENVEO vaccine (batch number: M10031), at dose of 0.5 ml intramuscularly on unspecified date. MENVEO vaccine exposed to temperature between 32 and 34 F over two-month period and vaccine did not freeze. No adverse events were reported.
PATIENT HAS EXPERIENCED MUSCLE PAIN FROM THE SHOULDER TO THE TOE OF THE LEFT SIDE OF HIS BODY FROM 06/04/2021 UNTIL NOW . THE PAIN HAS PERSISTED AND NOT GOTTEN ANY BETTER.  HE WENT TO MASSAGE PARLOR ON JUNE 7,2021 FOR MASSAGE , THE PAIN WAS GETTING WORSE AFTER MASSAGE.
vomiting several times since 8:00, it's now 11:16 headache sore arm fatigue NO DR VISIT YET
Case number PHEH2015US010838 is an initial spontaneous report received from a medical assistant on 29 May 2015, and with a follow-up report received from medical assistant on 30 Jul 2015. This report refers to a 16 year old male patient. Past medical history and concomitant medications were not reported. The medical assistant reported that the refrigerator reached 14 degree Celsius in the month of Jan 2015 and the patient was vaccinated with FLUVIRIN (batch number: 1412201) multi dose vial (MDV) intramuscularly on 03 Feb 2015 which underwent one temperature excursion. No adverse events were reported following the maladministration. Follow-up report received from medical assistant on 30 Jul 2015. Updated patient weight.