chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 15 July 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 17 November 2013 and estimated date of delivery was on 10 September 2014. The subject was exposed to the vaccines during the last trimester. The conception was a normal one (no in-vitro fertilization used). No adverse event were reported. At the time of reporting the pregnancy was ongoing.
Patient registered for a first dose of Moderna. Pharmacist prepared a booster dose. Vaccinator administered a booster dose. Lead nurse caught the error and brought patient back into the clinic. The patient was administered the rest of the full dose.
she felt sick for 48 hours; she experienced a severe reaction during 1 week; her left arm was swollen from the shoulder to the elbow; her left arm was hot from the shoulder to the elbow; her left arm was red from the shoulder to the elbow; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she felt sick for 48 hours), IMMUNISATION REACTION (she experienced a severe reaction during 1 week), PERIPHERAL SWELLING (her left arm was swollen from the shoulder to the elbow), FEELING HOT (her left arm was hot from the shoulder to the elbow) and ERYTHEMA (her left arm was red from the shoulder to the elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 prophylaxis.     Concurrent condition included high cholesterol.  Concurrent medical conditions included Blood pressure high (Started 10 years ago), Egg allergy, Environmental allergy, Allergy to antibiotic (Tetracycline,), Allergy to antibiotic (Erythromycin), Sulfonamide allergy (Sulfa), Penicillin allergy and Rheumatoid arthritis (started 3 years ago). Concomitant products included TELMISARTAN (MICARDIS) for Blood pressure high, ROSUVASTATIN and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced ILLNESS (she felt sick for 48 hours), IMMUNISATION REACTION (she experienced a severe reaction during 1 week), PERIPHERAL SWELLING (her left arm was swollen from the shoulder to the elbow), FEELING HOT (her left arm was hot from the shoulder to the elbow) and ERYTHEMA (her left arm was red from the shoulder to the elbow). On 01-Sep-2021, ILLNESS (she felt sick for 48 hours) had resolved. On 06-Sep-2021, IMMUNISATION REACTION (she experienced a severe reaction during 1 week), PERIPHERAL SWELLING (her left arm was swollen from the shoulder to the elbow), FEELING HOT (her left arm was hot from the shoulder to the elbow) and ERYTHEMA (her left arm was red from the shoulder to the elbow) had resolved.            No treatment drug details was reported.   This case was linked to MOD-2022-608551 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 12Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history, no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Sep2022) Positive; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid to treat COVID 19, treatment start date: 01Sep2022, treatment stop date: 06Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mild fussiness. Small amt mucous in stools. Temp 100.8. Mom reported has mucous last time too no other sx.
Patient experienced a seizure within 2 minutes of receiving vaccine. seizure lasted approximately 30 seconds. patient recovered and then experienced another brief seizure approximately 5 minutes later. This lasted about another 30 seconds.  Seizures displayed muscle rigidity, slight shaking, and dilated pupils. patient became pale and unconscious during these seizures.
Physician diagnosed Guillain Barre Syndrome. Onset 12/27/09 with weakness, tingling and numbness in fingers and toes-progressively worse extending up arms and legs that day. Take by squad to ER 12/28/09 in a.m. Progressively worse. Developed dyspnea-transferred to med central hosp 12/30/09-on ventilator. Also received seasonal flu vaccine on 12/23 at hospital while hospitalized for Diverticulitis.
Bad headache; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8920, expiry date unknown), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization.  Medical history included COVID from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated that she had a very slight case of COVID in Nov2020 and her family doctor told her about three weeks ago that she needed to get the vaccine. However, he did not tell the patient that she needed to wait 90 days from when she had COVID (as reported). So, she got the Pfizer vaccine about two months and a week after she had COVID itself. Ever since about five days after she had the vaccine, on an unspecified date in Jan2021, she came down with a bad headache and have had a headache since that day. She is on day nine of a headache and this is the headache that require medication. It is not the headache that you think is going way because it has not. She wanted to know if she got the headache because she got the vaccine too soon after having COVID. The patient got medicine for the headache because she had to go to the emergency room for the event. She had blood work done on an unspecified date but had unknown results. The outcome of the event was unknown.
Stated that it showed that she had sinus rhythm with arrhythmia.; stated that her chest got tight; shortness of breath; limb weakness for both arms/limb weakness for both legs; had palpitations; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (Pfizer Covid 19), intramuscular in the left deltoid on 08Jul2021 (Lot Number: EW0172) dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The events were described as follows: she had the Pfizer vaccine on 08Jul2021 had some sort of reaction from it. Stated that 12 minutes after, her chest got tight and lasted for two days. On 08Jul2021, she had shortness of breath, limb weakness for both arms and legs, palpitations and tachycardia. The patient asked if she should get the second vaccination. Stated that she had lasting effects of shortness of breath from her chest tightness. She visited with the doctor she worked with and had an electrocardiogram (EKG) on 09Jul2021. It showed that she had sinus rhythm with arrhythmia. The doctor told her that it was due to her breathing and he thought it was completely normal. Outcome of event arrhythmia was unknown, shortness of breath recovered on 12Jul2021, limb weakness for both arms/limb weakness for both legs recovered on 09Jul2021, chest got tight, palpitations and tachycardia recovered on 10Jul2021. Events assessed by reporter as serious. The reporter assessed the events as related to vaccine.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events shortness of breath, limb weakness, palpitations, tachycardia, chest tightness, and arrhythmia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Pt very lethargic p/shot; would not nurse became very pale, grunting a lot; t103 during the night; lt thigh became reddened & was purplish by next day; had high pitched cry 1st day into the night;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "migraine" (unspecified if ongoing); "rosacea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Omeprazole, reaction(s): "Known allergies: Omeprazole", notes: Known allergies: Omeprazole; Amoxycillin, reaction(s): "Known allergies: Amoxycillin", notes: Known allergies: Amoxycillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical details: It was reported, COVID 19 Treatment, Paxlovid from 06Sep2022 to 08Sep2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
After receiving vaccine patient had shaking at night for 1 night. She was tired for 2-3 days after. Couldn't lift her arm for about 1 week.
This spontaneous report as received from a register nurse, refers to a currently 39 year old female patient, with asthma and latex allergy. The patient was also not immune to measles. On an unknown date approximately in 1990, when the patient was 15 year old, was vaccinated with MERUVAX II, (strength, dosage, route and lot# were not reported). Concomitant therapy was not reported. The register nurse informed that in approximately 1990 (also reported as "when the patient was 15 years"), the patient experienced peripheral swelling, reported as "her arm swelled up", and she was sent home from school, the peripheral swelling went down. The register nurse also stated "this Fall (2014)" the patient received FLUMIST on an unspecified date and went on an unspecified steroids (after a phone call to an unspecified allergist) because of her asthma. Also stated that the patient recovered in a couple of weeks. The patient sought medical attention calling an unspecified allergist. The outcome of peripheral swelling was reported as recovered/resolved. The reporter considered the event peripheral swelling to be life threatening. Additional information has been requested.
Two patients received Moderna vaccines 15 days after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna vaccines 15 days after expiration date) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2022 at 11:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna vaccines 15 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna vaccines 15 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter called to report that two patients received Moderna vaccines 15 days after expiration date. The expiration date was 04-Jan-2022. The date the vial initially stored in the refrigerator was unknown. It was reported that the vial didn't undergo any temperature excursions.  Reportedly, the patient did not experience any physical adverse reaction and was notified regarding the expired vaccine and would come to clinic to get a repeat booster. The patient received the booster as 0.25 of unknown unit. It was also reported that the patient had no known allergies.  No treatment information was provided.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Rash was hot to touch at injection site), DIZZINESS (Dizziness), PAIN (Body aches), VACCINATION SITE PRURITUS (Itching at the site) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .  Concomitant products included IBUPROFEN (ADVIL 12 HOUR).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Had a headache). On 10-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (high fever). On 11-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Rash was hot to touch at injection site), VACCINATION SITE RASH (rash where the shot) and VACCINATION SITE ERYTHEMA (Rash was hot to touch and very red near the injection site). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Rash was hot to touch at injection site), DIZZINESS (Dizziness), PAIN (Body aches), VACCINATION SITE PRURITUS (Itching at the site), CHILLS (Chills), PYREXIA (high fever), HEADACHE (Had a headache), VACCINATION SITE RASH (rash where the shot) and VACCINATION SITE ERYTHEMA (Rash was hot to touch and very red near the injection site) outcome was unknown.            No Concomitant medications were provided
urticaria rxn 58 hrs p/vax tx w/DPH by parents w/dec sx; afeb
realized after the fact it was a little past 24 hours sitting out/Dose administered after exposure to room temperature more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (realized after the fact it was a little past 24 hours sitting out/Dose administered after exposure to room temperature more than 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (realized after the fact it was a little past 24 hours sitting out/Dose administered after exposure to room temperature more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (realized after the fact it was a little past 24 hours sitting out/Dose administered after exposure to room temperature more than 24 hours) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient accidently got a Moderna booster vaccine on 21-Jul-2022. On 16-JUL-2022,the vial was initially stored in the refrigerator. The vial doesn't undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius = 46 degree to 77 degree Fahrenheit) 25 or 26 hours. Treatment information was not provided.
Approximately 5-10 after Moderna Covid vaccine was given, patient became dizzy and started vomiting food previously eaten. Patient refused pharmacy to call 911. After patient sat in waiting area for 30 minutes, claimed she was feeling better, was rechecked by pharmacist and left.
I was positive for COVID-19 on 05JAN2023, I had cold like symptoms. Headache, body aches and congestion but I did not have a fever. I did not receive any treatment, I started feeling better within 10 days.
weakness; feeling lousy; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number B37G7, expiry date 23rd May 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th June 2019, 1 days after receiving Shingrix, the patient experienced weakness and feeling bad. On an unknown date, the outcome of the weakness and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the weakness and feeling bad to be related to Shingrix.  Additional details were provided as follows: Batch number of Shingrix was reported as B3767, which was corrected to B37G7 as per sales data sheet. The patient experienced weakness and was feeling lousy after receiving Shingrix vaccine. This case is linked to the case US2019109683, reported by same reporter.
Sore & red at injection site by 10 PM after given vaccine (7 hours later) with area covering 3x2 inches. Area was tender to touch and very painful and hot and hard. Pain was gone by 3/5 while some discoloration remained. Patient took ADVIL Friday evening.
Febrile seizures; This is a spontaneous report from a contactable physician received via a sales representative. A 12-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported) and flu vaccine, both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered flu and pneumococcal 13-val conj vac (dipht crm197 protein) in the same visit and experienced febrile seizure. The outcome of the event was unknown.  The information on the batch/lot number and expiration date has been requested.; Sender's Comments: Based on the information currently available, a contributory role of both suspected vaccines towards the occurrence of event febrile seizure cannot be fully excluded.
This spontaneous report received from a registered nurse refers to unspecified number of patients with unknown demographics. No medical history was reported. It was reported that since 09-DEC-2015, unspecified number of patients had been vaccinated with improperly stored VAQTA (dose, route, frequency: unknown, lot number: L015460, expiry date: JULY 2017). No adverse effects was reported. The excursion temperature was reported as 29.8 degrees Fahrenheit (F) for 24 hours. Outcome of excursion was reported as "not supported" and it was also reported that there was no previous temperature excursion. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
after about 7 mins after vaccine, felt a weird sensation - describes leg tingling + fogginess tingling in lips + arms. He was brought back to observation area. Vital signs were taken BP 157/109. Heart strip done - sinus rhythm 95. glucose initialy was 57. EMS administered glucagon + pt given gatorade @ 18:50 glucose rechecked - it was 91.
I had a bad headache and was not feeling well at all. It lasted maybe three or four days and was prescribed antibiotics.
could get a blood clot that could go to your brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood clot" (unspecified if ongoing), notes: Caller said that one clot was previous to the vaccine. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "could get a blood clot that could go to your brain". Therapeutic measures were taken as a result of thrombosis.  Clinical information: Caller was a consumer that was calling about the COVID-19 vaccine booster dose. She had the booster shot before and now they are saying that there is a problem that they said you could get a blood clot that could go to your brain. Caller said that with her previous booster they never told her that. She has had several clots and is wondering if she would be more prone to get a blood clot in her brain and said that one clot was previous to the vaccine and one was after surgery and she already had the shot then.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had shortness of breath, heavy chest, dry cough approx. 20 minutes after being vaccinated. She independently ambulated to assessment area. Vitals @ 1044 BP 162/90, P 104, R 22, 02 SAT 98%.  vital signs at 1055 160/90 HR 61 RR 20 O2 sat 98% on room air.  EMS called at 1045 and arrived at 1052 to facility. Patient stated her breathing did not feel any worse and declined epi pen. Per EMS, epi pen not recommended at this time. Patient monitored one to one till 1135 with no worsening symptoms. Patient called family and left under supervision of family member. Patient advised to follow-up with PCP.