chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CLOT BLOOD; ACUTE ISCHEMIC STROKE IN LEFT FRONTAL LOBE; PARTIAL LOSS OF USE IN RIGHT LEG; MUSCLE WEAKNESS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included amoxicillin and flexeril allergy, and migraine. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:30 on left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, ergocalciferol, iron, and withania somnifera.  Approximately three days after the vaccine, on 11-APR-2021 08:20, the patient experienced clot blood. Which caused an acute ischemic stroke in left frontal lobe resulting in partial loss of use in right leg and muscle weakness. The patient had a blood test, CT scan, Carotid artery ultrasound, diagnostic ultrasound, electrocardiogram (EKG) and an MRI, results are unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clot blood, acute ischemic stroke in left frontal lobe, muscle weakness, and partial loss of use in right leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 46 year old, female patient  who experienced a blood clot that caused an acute ischemic stroke in the left fontal lobe 3 days after receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Patient has migraine and allergies to amoxicillin, flexeril and cyclobenzapine hydrochloride. Concomitant medications included ascorbic acid, ascorbic acid/ ergocalciferol/folic acid/ nicotinamide/ panthenol/retinol/ riboflavin/ thiamine hydrochloride, ergocalciferol, iron, and withania somnifera.   Smoking history, drug abuse and alcohol intake were not reported. Three (3) days after receiving the vaccine, patient was noted to have a blood clot (unspecified area) that caused an acute ischemic stroke in the left frontal lobe, resulting in muscle weakness and partial loss of use of the right leg. Patient had blood tests done as well as CT Scan, carotid artery ultrasound, electrocardiogram and MRI but the results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.
per pt, day after the injection, developed a rash in the middle of the chest and bilateral arms. which dissipated on its own the following day.  Stated that this is not the 1st time that this has happened and has been happening each time that she has received the covid vaccine
Fever 104.8, restlessness, chicken pox rash, very irritable, jerking/seizure, bad cough, loss of appetitie, uncontrolled screaming/pain
Patient started having severe bifrontal headache, bilateral leg muscle pain, sore throat, and localized redness and pain at the site of injection about two hours after the shot.  Symptoms became progressively worse over the next seven days, especially in the past two days, when she felt her throat was swelling up and had difficulty  in swallowing.  The pain in her thigh muscles was so severe that she almost couldn't walk.  She took Advil 200 mg every 6 hours a couple of times a day with minimal relief.
Extreme nausea, dizzy can't eat throat and lungs sound horrible can't lay down feel no air
Almost 3 weeks after vaccine, experienced heavier and more painful than normal menstrual cycle. Suddenly developed a server UTI with high fever (102.8 highest), body/back aches and pains, extreme fatigue and nausea.
Sore throat; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 16:45 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included CVID (common variable immunodeficiency), WM and allergy to peanuts and quinolones. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) , simvastatin (MANUFACTURER UNKNOWN) and losartan potassium (LOSARTIN) for unknown indication and from unknown dates within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 16:45  (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 09Apr2021 at 06:00, the patient experienced sore throat and sore arm. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the event sore throat and sore arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a medical assistant concerning a 74 year old female with a history of urticarle and with a codeine allergy who on 26-JAN- 1999 was vaccinated in the left deltoid with PNEUMOVAX 23. Concomitant therapy included alendronate sodium, (duration, dose and indication unknown). Other concomitant therapy included calcium supplement, vitamins, ECOTRIN, and VOLTAREN. Concomitant vaccines included ACELLULAR vaccine. On 27-JAN-1999 the patient experienced a large indurated area at the injection site that "looked like a hugh hive" with blanching in the center. The area was pinkish and slightly warm. When the area was checked again, it was "classic wheal and flare looking (histamine like)". The patient also experienced a fever of 100 degress F. That day, the swelling extended down the arm from the top of the shoulder to the elbow. The patient was administered acetaminophe n. cold compreseese, and CLARITIN. Follow-up was received froma physician which indicated the patient also experienced discomfort. No further information is available.
On 9OCT2003 at 12:00 the vaccinee developed erythema at the injection site after receiving Fluvirin in her left deltoid muscle on 8OCT2003. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 10NOV2003: Further information received from a health care professional on 10NOV2003 indicated that the vaccinee received Fluvirin on 9OCT2003. The vaccinee experienced erythema at the injection site on 10OCT2003 and recovered three days later. No follow up pending. Cross reference with : PJP200300792, PJP200300793, PJP200301113
Rash, pruritus and moderate swelling to injection site, and burning sensation. Tx: Anhistamine, Corticosteroid - topical.
No adverse effects; Expired Proquad was Inadvertently administered; This spontaneous report was received from a health professional (Medical assistant) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 06-AUG-2019, the patient was inadvertently administered one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Therapy type: rHA, lot # R002936, Expiry date: 29-JUL-2019) for prophylaxis (expired product administered). No adverse effect was reported. No PQC was involved. The outcome of expired product administered and no adverse event was unknown.
Vaccine placed in refrigerator on 22 Sep 2021,expired on 09 Oct 2021 and was administered on 18 Oct 2021; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 22 Sep 2021,expired on 09 Oct 2021 and was administered on 18 Oct 2021) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 22 Sep 2021,expired on 09 Oct 2021 and was administered on 18 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 22 Sep 2021,expired on 09 Oct 2021 and was administered on 18 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response code was scanned. Date vaccine was placed in refrigerator was on 22 Sep 2021. Vaccine had not undergone any temperature excursion and patient had not experienced any adverse event. No treatment medications were reported.
Mother noticed left calf of leg swelling on 08/22/2005.  On fever.  Patient has atopic Dermatitis.
Right arm and leg pruritus; he was feeling hot; throat pain; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 9- year-old male patient received Bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Nov2021 14:29 (Lot number: FK5127) at the age of 9 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "known allergies: peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: pruritus (medically significant) with onset 17Nov2021 14:45, outcome "unknown", described as "Right arm and leg pruritus"; feeling hot (medically significant) with onset 17Nov2021 14:45, outcome "unknown", described as "he was feeling hot"; oropharyngeal pain (medically significant) with onset 17Nov2021 14:45, outcome "unknown", described as "throat pain"; dizziness (medically significant) with onset 17Nov2021 14:45, outcome "unknown", described as "dizziness". The events "right arm and leg pruritus", "he was feeling hot", "throat pain" and "dizziness" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pruritus, feeling hot, oropharyngeal pain, dizziness. Events details was reported as follow: The patient was vaccinated Pfizer-BionTech COVID-19 Vaccine at 14:29 17Nov2021. Around 14:40 the observation nurse noted that the patient was fanning himself. The patient complained that he was feeling hot, Right arm and leg pruritus, new "throat pain" and dizziness. The observation nurse and POD lead then called 9-1-1 at 14:45 and initiated the anaphylaxis protocol. An epipen JR was administered (Lot #LFN341) IM to right thigh at 14:51 and at 14:57 0.4ml of Diphenhydramine (lot # 080008) was administered IM to R Deltoid by Nurse withheld. EMS arrived at 14:58 and hand off occurred to the EMS crew at 14:59. Transport to the ER occured at 15:05.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As per available information, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. 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.
According to the mother, she saw redness around the injection site about 24 hours after the Flu shot was given. On Thursday 11/1 the girl complain of her arm hurting. A baseball size area of redness was noted and it was warm to touch.
3 days after my 1st vaccine I started to have heart palpitations that have yet to resolve after 7 days; started my period the same day as my 1st moderne vaccine was administered  It stopped completely 8 hours later; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (3 days after my 1st vaccine I started to have heart palpitations that have yet to resolve after 7 days) and POLYMENORRHOEA (started my period the same day as my 1st moderne vaccine was administered  It stopped completely 8 hours later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PALPITATIONS (3 days after my 1st vaccine I started to have heart palpitations that have yet to resolve after 7 days) and POLYMENORRHOEA (started my period the same day as my 1st moderne vaccine was administered  It stopped completely 8 hours later). At the time of the report, PALPITATIONS (3 days after my 1st vaccine I started to have heart palpitations that have yet to resolve after 7 days) had not resolved and POLYMENORRHOEA (started my period the same day as my 1st moderne vaccine was administered  It stopped completely 8 hours later) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Left leg red, not warm no fever - noted this am. Was fussy after imms yesterday and wakeful during the night.
"Patient was due for 3 vaccines and needed the first dose of COVID Vaccine. The patient was due for the Monovalent COVID-19 vaccine and was mistakenly given the Bivalent dose.
The employee had his flu vaccine given on 10/21/2002. On 10/22/2002, he returned complainy of his arm being reddened, warm to touch, and swollen at injection site.
Extra large area on L upper arm was hot to be touch and hard and painful for a solid week after the vaccination. Area almost four in diameter.
Blood pressure was low 98/62; Checked oxygen levels and it was at 84; Heart was racing; Pulse was irregular; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure was low 98/62), OXYGEN SATURATION DECREASED (Checked oxygen levels and it was at 84), PALPITATIONS (Heart was racing) and HEART RATE IRREGULAR (Pulse was irregular) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESTRADIOL (IMVEXXY), LEVOTHYROXINE, MONTELUKAST, METOPROLOL and ATORVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced HYPOTENSION (Blood pressure was low 98/62), OXYGEN SATURATION DECREASED (Checked oxygen levels and it was at 84), PALPITATIONS (Heart was racing) and HEART RATE IRREGULAR (Pulse was irregular). On 24-Feb-2021, HYPOTENSION (Blood pressure was low 98/62), OXYGEN SATURATION DECREASED (Checked oxygen levels and it was at 84) and HEART RATE IRREGULAR (Pulse was irregular) had resolved. At the time of the report, PALPITATIONS (Heart was racing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Blood pressure measurement: 98/62 mmHg Low. On 24-Feb-2021, Heart rate: 85. On 24-Feb-2021, Oxygen saturation: 84 After an hour it increased to 94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Initial muscle soreness within 3 hours that progressed to sharp, tendinitis-like pain and decreased strength and mobility in left arm over the course of 6 hrs after receiving vaccination. Muscle soreness in the deltoid is relatively mild, but sharp pain and decreased use persists in the anterior portion of my shoulder - has not improved in the 48 hrs post-vaccination.
made my son sick; regress in language; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced sickness and language disorder. On an unknown date, the outcome of the sickness and language disorder were unknown.   It was unknown if the reporter considered the sickness and language disorder to be related to Meningococcal B vaccine.  Additional information was provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The reporter stated that this vaccine made patient sick and regress in language for months, definitely not good for the brain.
had Covid-19 the week of May 9, 2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (had Covid-19 the week of May 9, 2023) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A T) for COVID-19 prophylaxis.     Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 30-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (had Covid-19 the week of May 9, 2023). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (had Covid-19 the week of May 9, 2023) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that patient wife had mild case of Covid-19 vaccine. Like having the flu for a couple of days and then started to get better. The patient and his wife were prescribed Paxlovid and felt worse after day 1 of the Paxlovid regimen They felt so bad from the Paxlovid worse from Paxlovid than from the Covid-19 infection. Patient and his wife stopped the Paxlovid after 1 day.   This case was linked to MOD-2023-727718 (Patient Link).
Took the 1st dose of Pfizer at 10:45am on 3/1. Began projectile vomiting ahoetly after at 12:00pm. Vomiting & diarrhea continued through the fay until 10:00pm. Lost 5 lbs in 9 hours.
Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3545AA received on 01 December 2009, lot number C3579AA received on 01 March 2010 and lot number C3573AB received on 03 May 2010 (routes and sites of administration not reported). On 06 May 2012, the subject developed a cough, approximately two years after the last dose. On 13 May 2012, the subject developed paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 19 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 22 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Has numbness; back problems; gotten a blister on buttocks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 73 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9269), administration date: 09Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "1st blister", "numbness", "back problems"; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6198), administration date: 02Mar2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF8839), administration date: 27Sep2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: FM7553), administration date: 17May2022, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: BLISTER (non-serious) with onset 27Oct2022, outcome "unknown", described as "gotten a blister on buttocks"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Has numbness"; BACK DISORDER (non-serious), outcome "unknown", described as "back problems". Therapeutic measures were taken as a result of blister.  Additional Information: This is not 1st time but this is the 2nd time that caller has gotten a blister on buttocks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282459 same patient and event, different dose/drug;