chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the Pfizer BionTech covid-19 vaccine with liquid coming out during administration (potential leakage); the Pfizer BionTech covid-19 vaccine with liquid coming out during administration (potential leakage); Think a vein was nicked in the arm; Bruise on the arm; It look like when took the nedle out the arm there was bleeding; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 12:30 as dose number unknown, single (Lot number: GJ6665) at the age of 71 years, in left deltoid for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation. The following information was reported: CONTUSION (non-serious) with onset 24Oct2022, outcome "unknown", described as "Bruise on the arm"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 24Oct2022, outcome "unknown", described as "It look like when took the nedle out the arm there was bleeding"; VACCINATION SITE INJURY (non-serious) with onset 24Oct2022, outcome "unknown", described as "Think a vein was nicked in the arm"; PRODUCT LEAKAGE (non-serious), UNDERDOSE (non-serious) all with onset 24Oct2022, outcome "unknown" and all described as "the Pfizer BionTech covid-19 vaccine with liquid coming out during administration (potential leakage)".  Additional information: There was an issue yesterday. Someone received the vaccine yesterday. Reporter is not exactly sure what happened. The patient received the vaccine and think a vein was nicked in the arm and it caused a bruise on the arm. It looked like when took the needle out the arm there was bleeding and clear liquid came out. Wondering if the the vaccine leaked out. He is calling to see if the patient needs to be re-vaccinated. Reporter reporting on Bivalent Covid Vaccine. The manufacturer date is Jul2022 and thinks the expiration date is 12 months after the manufacturer date. On the bottle and box, it only has the manufacturer date. He did not see an expiration.
Pt states that her heart rate and blood pressure have gone up since she received the Moderna Vaccine on 3/24/21.  Until the vaccination, pt states that her HR was in the 50-54 range.  Now she states that it is around 90.  Pt states BP went from 170/94 to 259/110.  Pt states that the increases began on 3/25/21 the day after the vaccine was given.  States that she has had BP issues for 30 years.  She is very concerned about the HR.  She went to the ER on 3/29.  Amlodipine 10mg QD was added to her regimen.  States that she went to her PCP on 4/1 or 4/2 - BP regimen was not changed by PCP.  I checked her BP it was 215/128, HR 90.  Pt reiterated to me that she is primarily concerned about the change in HR not her BP.  States that she has an appointment with her PCP in 2-3 weeks.
Dizziness; Diagnosed with Encephalitis; This is a spontaneous report received from a 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 mRNA VACCINE), administered in arm left, administration date 30Nov2021 16:30 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); " Irritable bowel syndrome (IBS)" (unspecified if ongoing). Concomitant medications included: GABAPENTIN; lamotrigine (LAMICTAL); levetiracetam (KEPPRA); TRAZODONE; OMEPRAZOLE. Past drug history included: carbamazepine (TEGRETOL), reaction: "Allergy"; venlafaxine hydrochloride (EFFEXOR), reaction: "Allergy". Vaccination history included: Bnt162b2 (lot unknown; dose administration time=12:00; dose number=2; location=Left arm), administration date: 26Apr2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (dose administration time=12:00; dose number=1; vaccine location=Left arm; lot unknown), administration date: 05Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: ENCEPHALITIS (medically significant) with onset 30Nov2021 21:00, outcome "not recovered", described as "Diagnosed with Encephalitis"; DIZZINESS (medically significant) with onset Dec2021, outcome "not recovered", described as "Dizziness". The events "diagnosed with encephalitis" and "dizziness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of encephalitis which included prednisone. Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was diagnosed with encephalitis. The patient was getting migraines four to five times a day for eight days. The patient had to go to the emergency room (ER) and was then put on new medications. The patient now had cluster headaches. At the time of the report, it had been almost three weeks and the patient had terrible head pain and dizziness. The patient went to see five specialists. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
second dose was given at 3 weeks; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given at 3 weeks) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given at 3 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given at 3 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-326623 (Patient Link).
Headache; Back aches-lower back; Back aches-lower back and shoulders/neck; Back aches-lower back and shoulders/neck; Chills; night sweats; Slight throat discomfort; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL9261; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on 03Feb2021 01:15 PM (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation at a Hospital. The patient's medical history was not reported. Concomitant medications included biotin, bifidobacterium lactis (PROBIOTIC), vitamin b and an unspecified oral contraceptive; all taken for an unknown indication, stop and start dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL3249; Expiration date was not reported), administered in the left arm on 13Jan2021 10:30 AM (at the age of 42-years-old) as dose 1, single for COVID-19 immunisation. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient experienced headache, back aches-lower back and shoulders/neck, chills, night sweats and slight throat discomfort on 05Feb2021 01:00 PM. No treatment was taken for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
doses administered past 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient received second booster dose on May 2022.  They stated that they were calling back to provide more information to receive an assessment on invalid dose administration to 16 patients. They were busy when they had called earlier and could not provide any information to the agent at that time. The 16 patients were administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period. Treatment medications were not reported.
Nausea and body aches for 24 house. Took Naprosyn and avoided food.. better today, just left foot/ankle/ leg pain.
Pt recvd vax & exp arthritic sx in jaw, neck, hands, hip, foot & shoulder; @ time of report, joint pain persisted; No further details were provided;
felt hot; flush; light headed; heart rate elevated; fever; This is a spontaneous report from a contactable consumer (patient). This 37-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EH9899) via an unspecified route of administration at right arm on 06Jan2020 12:15 PM at single dose for COVID-19 immunisation. Medical history included known allergies to Penicillin and Hashimoto's thyroiditis. Concomitant medications included atorvastatin and clarithromycin (CLARITIN). The patient previous took Amoxicillin and Azithromycin, both experiencing allergies; the 1st dose of flu shot on 21Dec2020 at arm left. Within 5 minutes of injection, the patient felt hot, flush, light-headed and heart rate elevated from 06Jan2021 at 12:30 PM. The patient was under observation and the nurse laid him down in a room. The patient was monitored vitals with a doctor. Symptoms subsided and stopped by 30 minutes post injection. The patient felt normal and fine after fever. The patient did not have any symptoms himself. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of all events was recovered.
Pain in trachea w/pain radiating up to right ear.  Pain increased momentarily w/each inhaled breath.  Felt like someone kicked me in the wind pipe from the inside.  Sides of throat sensitive to touch.  No sore throat or impairment to swallowing.  No relief from Motrin taken at 15:15 or 19:30 or 23:00.  Pain continued thru 15:00 next day.  Of note, I rec'd 2 injections in face during dermatology skin biopsies, ICD10 D48.5 AT 1400 TO 1430.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's medical history included chickenpox. On 10-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot# were not reported). Concomitant therapy was not reported. Within one day, approximately in 11-NOV-2014, the patient developed itchy generalized rash. That was progressed to over 300 spots all over her body. On an unknown date approximately in November 2014, the patient was seen by the physician who diagnosed her with chicken pox. The patient had been quarantined for the next week. Patient sought medical attention by visiting physician. No Product Quality Complaint (PQC) was involved. The outcome of chicken pox was reported as not recovered/not resolved. Causality assessment was not provided by the reporter. This is one of the two reports from the same reporter. This case was linked to MARRS # 1411USA007397 (patient husband case). Additional information has been requested.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 19-year-old patient who received Hepatitis A vaccine (batch number 95DB2) for prophylaxis.   On 28-FEB-2023, the patient received Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Eye irritation; Eye pruritus; Lip swelling; Paraesthesia oral; Pruritus; Swelling of eyelid; Urticaria; This case was received via United States FDA VAERS (Reference number: 0917887) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of EYE IRRITATION (Eye irritation), EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PARAESTHESIA ORAL (Paraesthesia oral) and PRURITUS (Pruritus) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Jan-2021, the patient experienced EYE IRRITATION (Eye irritation), EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PARAESTHESIA ORAL (Paraesthesia oral), PRURITUS (Pruritus), SWELLING OF EYELID (Swelling of eyelid) and URTICARIA (Urticaria). At the time of the report, EYE IRRITATION (Eye irritation) and PARAESTHESIA ORAL (Paraesthesia oral) had resolved and EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PRURITUS (Pruritus), SWELLING OF EYELID (Swelling of eyelid) and URTICARIA (Urticaria) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Chest pain, tightness, left arm pain, neck/ back pain, tingling, anxiety, feeling unwell, confusion.
Don't have much energy; Pain in the injection site; Muscle pains on their back; Muscle pains on their legs; Muscle pains on their arms; Headaches; They're tired; Have fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms) and HEADACHE (Headaches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms), HEADACHE (Headaches), FATIGUE (They're tired), PYREXIA (Have fever) and ASTHENIA (Don't have much energy). At the time of the report, INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms), HEADACHE (Headaches), FATIGUE (They're tired), PYREXIA (Have fever) and ASTHENIA (Don't have much energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of a 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 6 of 7 (see case IDs A0885121A, A0885268A - A0885271A, A0885273A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information was received on 26 October 2010. It was reported that the subject was 54 years old at the time of events. No additional information was provided.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of an unknown age and gender. Medical history and drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information  has been requested.
The patient was administered a second dose of MMR II. After administration, the MMR II dose expired 3/20/19. I contacted patient who denied any adverse reactions. The manufacture Merck advised  the company has data to support the potency of the dose administered after the expiration date  of 03/20/2019.
Narrative: 76 yo with unknown past medical history reported having headache with some sinus congestion the day his covid-19 pfizer vaccine on 2/8/2021. He said he also felt a "little confused" but the headache and confusion resolved the following day. Patient reported this ADR when he came back for his second dose on 3/1/2021, both vaccines were administered without complication.
No additional AE/PQC.; Caller reported inadvertent administration of MMR-II 6 days post-expiry; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 09-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliters (ml) and sterile diluent (dose number, frequency, vaccination scheme, route of administration, anatomical location, lot number, and expiration date were not provided) 6 days post-expiry (expired product administered) with no known temperature excursion (TE). No reported symptoms at time of call. No additional adverse event (AE).
Nausea 10/24, vomiting 10/27, diarrea 10/27. Drinking lots of water
Severe Body ache Mild headache  Low grade fever 100.5ish Tired
The patient and his wife got their 2nd Shingrix vaccine on Thursday morning.  Starting Friday morning, the patient started having chest pain which led to breathing problems. His wife called a triage nurse and was instructed to call EMS. The patient is currently in the hospital getting stabilized. Currently the patient is stable, but still in the hospital.
administered Kinrix / was the patient's 3rd DTaP and 3rd IPV dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was 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 was provided as follows: The nurse practioner reported that a 4 year old patient was administered kinrix last wednesday. It was the patient's 3rd DTaP and 3rd IPV dose, which led to inappropriate schedule of vaccine administered. The reporter consented to follow up.
Fully immunized person developed symptoms of COVID-19 on 3/8 and tested positive by antigen test on 3/9.  He had been exposed to his son, who was also ill.  Both appear to be recovering.
feeling a metallic taste in her mouth; This is a spontaneous report from a non-contactable consumer report for daughter. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced feeling a metallic taste in her mouth. Event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe headache, unilateral localized in the left eye mostly. This headache is so severe it wakes me up after I go to sleep. It last for 30 minutes- i take OTC for it immediately
STROKE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke, and was hospitalized (date unspecified). The patient was treated at hospital. The number of days hospitalized was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230120898 and 20230120818.; Sender's Comments: V0: 20230120832-Stroke. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.