chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral treatment for COVID-19 with paxlovid from 19Sep2022 to 23Sep2022. No known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A nurse who was visiting this memory care inadvertently gave the second dose of Pfizer-BioNTech COVID-19 Vaccine 14 days after the first dose. The first dose was given on 1/28/2021. The second dose was given on 2/11/2021.  The memory care facility coordinator did not provide the patient's vaccine record card upon screening, nor the nurse or a pharmacy technician who was helping the vaccine clinic, checked the previous vaccine dose dates. The second dose was given on 2/11/2021 before noon. There was no signs or symptoms of abnormal reaction or behavior occurred to the patient. The patient seemed normal and stable; no medical attention was necessary.
This spontaneous report as received from medical assistant refers to a 58 year old female patient. The patient's medical history includes hypertension, skin cancer, seasonal rhinitis, migraines. The patient has a history of a drug reaction to PERCOCET (unspecified manufacturer) of nausea and vomiting and a history of a drug reaction to Sulfa (unspecified manufacturer) described as Idiopathic thrombocytopenic purpura (ITP). On 06-DEc-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, lot# J008432 expires on 11-OCT-2014, subcutaneous. Over the weekend on 07-DEC-2013 or 08-DEC-2013, the patient stated over the phone to physician that she experienced a large bump at the injection site which was located at the back of her left upper arm and was described as red, itchy and swollen. The patient sought medical attention at an unspecified clinic on 09-DEC-2013 where the patient was diagnosed with cellulitis at the injection site and prescribed KEFLEX 500 mg twice per day. The outcomes of the reported events were reported as recovering/resolving. Additional information has been requested.
hospitalized, 18 days p/MMR vax acute fever, progressive nausea, anorexia, vomiting & diarrhea; acute tenosynovitis of ankles & feet w/edema & toxic chemical; t100-104; dehydration, erythema;
Arthritis had gone away; This is a spontaneous report from a contactable consumer (patient's neighbor). A 7-decade-old (patient is in her sixties) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Medical history included arthritis. The patient's concomitant medications were not reported. The reporter while providing a positive effect for himself and the Pfizer COVID 19 shot stated that he heard from another person who was in her sixties that a similar thing had happened to her. It was not as fast but similar. Her kids thought it was from the Pfizer shot. She felt great. He had spoken to the son of the neighbor next door, at his cottage. It was reported that patient's arthritis had gone away. The clinical outcome of the event was unknown.   Follow-up attempts are needed. Information about lot/batch number requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021667417 Same reporter/drug/AE and different patients.;US-PFIZER INC-2021582573 Same reporter/drug/AE and different patients.
Patient reported feeling nauseated, lightheaded, dry heaving, near syncopal episode Patient provided with food and water and seen by medical team Patient stated symptoms improved and refused medical transport and signed AMA form Patient will be driven home by mother
Patient reported difficulty breathing and itching a few hours after vaccine was administered. On 10/2/2017 she went to Clinic for itching and was prescribed hydroxyzine HCL.
given Bexsero to a 3 month old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The health care professional given Bexsero to a 3 month old by mistake , which led to inappropriate age at vaccine administration. The patient was fine, had no adverse reaction. The reporter consented to follow up.
Suspected vaccination failure; almost continuous shingles on head; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles vaccine and had almost continuous shingles on his/her head ever since. The patient stated it was awful and that he/she would not take the Covid vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 7 (booster) single (Batch/Lot number: unknown) at the age of 76 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number:1), for COVID-19 immunization; Moderna (Dose Number:2), for COVID-19 immunization; Moderna (Dose Number:3), for COVID-19 immunization; Moderna (Dose Number:4), for COVID-19 immunization; Moderna (Dose Number:5), for COVID-19 immunization; Moderna (Dose Number:6), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "Fever". Additional information:  She reported experiencing fever on and off couple of times this week.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: scalp pain-Mild
I noticed my arm was red in an oval area about 4:30 PM after a shower 1-30-2021.  The redness continued to get more pronounced and was tender and mildly itchy.  I saw my primary doctor 2-1-2021 who determined this was a reaction to the vaccine.
on administration of improperly stored vaccines; This spontaneous report as received from a certified medical assistant refers to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent.  On 31-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: recombinant human albumin (rHA); dose and route of administration were not reported, lot # S021326, expiration date 05-JAN-2021) for prophylaxis. Previously, the vaccine had experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. The current temperature excursion was from 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Digital data logger was used.  This is one of the multiple reports received the same reporter.; Sender's Comments:  US-009507513-2009USA000931:
On 07/30/02, it was reported that a 4 year old male patient received Daptacel (lot # C0725AA, administered in right deltoid), IPOl (lot 3u0823, administered in right deltoid), and Hepatitis A (lot # 0409M, administered in left deltoid) on 07/25/2002. On 07/26/02 at 7;50 pm, the patient experienced an allergic reaction versus cellulitis of the right deltoid, area measured 16 x 12cm of erythema and induration, no tenderness to palpation. Patient did have a fever but is on antibiotics for Strep throat. The patient was seen by by doctor. His recovery status is unknown. Linked cases u2002-00597, U2002-00599 & U2002-00600.
My lungs begin to get congested over a couple months. I had to used inhaler and other medicine. I was not able to breathe and not able to take a deep breath.
warm; Rash at the injection site; Itching at the injection site; a little bit swollen; Redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE WARMTH (warm), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE SWELLING (a little bit swollen) and INJECTION SITE ERYTHEMA (Redness at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM, CALCIUM and CLONAZEPAM (CLONAPAM) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE SWELLING (a little bit swollen) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (warm), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE SWELLING (a little bit swollen) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.
but I think the girl gave it in the wrong place in my arm; With the second shot I still have a bump on my arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient still have a bump on his arm but he think the girl gave it in the wrong place in his arm. Outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
enlarged lymph node on the left side of my neck; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 27Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "never used illegal recreational drugs" (unspecified if ongoing), notes: never used illegal recreational drugs; "obesity" (unspecified if ongoing); "never smoked" (unspecified if ongoing); "have not drunk alcohol", stop date: 1975, notes: I have never smoked, have not drunk alcohol since 1975. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Product name/manufacturer Lot number: Pfizer EK9231 MRNA, Date: 13Jan2021), administration date: 13Jan2021, when the patient was 66-year-old, for enlarged lymph node on the left side of my neck; BNT162b2 (DOSE 1, SINGLE, Product name/manufacturer Lot number: Pfizer EL1284 MRNA, Date: 23Dec2020), administration date: 23Dec2020, when the patient was 66-year-old, for enlarged lymph node on the left side of my neck. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "enlarged lymph node on the left side of my neck".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101142 Same patient and similar event, different vaccine doses.;
Pain left arm.  Redness and warmth that spread down the posterior triceps area on posterior arm.  Size was about 5 inches by 4 inches.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-SEP-2014, the patient was administered with an expired dose of PROQUAD (expiration date: 12-SEP-2014) (dose, route of administration, lot # were not reported). No adverse effect was reported. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted briefly during the observation period after recieving the shot
sore arm pit in lymph nodes; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 10:00 (Lot number: EW0164) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine Name: Covid-19 , Manufacturer: Pfizer , Lot Number: ER8730, Anatomical Location: left arm , Date: 26Mar2021), administration date: 26Mar2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Her arm was sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Apr2021, outcome "not recovered", described as "arm soreness"; AXILLARY PAIN (non-serious) with onset 18Apr2021, outcome "not recovered", described as "sore arm pit in lymph nodes".  Additional information: After getting the second dose her arm has stayed sore longer. Her arm pit has been really sore in the lymph nodes. The soreness in her left arm started in the afternoon after she received the second dose. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
On 2/2/00, pt had episode where eyes rolled back into her head, loss of consciousness, clonic/tonic movements & c/o stomach pain & headache. Pt was seen by MD on 2/3, Dx: undertermined. No further sx's. Seizure 5 yrs ago/Hypoglycemia.
Information has been received from a nurse, referring to a patient (gender and age unknown). Information about medical history, concurrent condition and concomitant therapy was unknown. On 14-AUG-2018, the patient was vaccinated with M-M-R II injection (dose, route, strength and frequency unknown; lot # M035935, expiration date: 09-AUG-2018, therapy type: recombinant Human albumin (rHA)) for prophylaxis (expired product administered). The M-M-R II did not have any previous temperature excursions prior to administration. No adverse symptoms reported.
patient's spouse reported to the pharmacy that patient had aches, pain and fever.  He stated that she took a shower the day after the vaccine and passed out after her shower.  She fell and hit her head on the toilet when she passed out and believes that she was unconscious for about 10 minutes.
passed out in the car; tingling in my hand; pain above my ear followed by a warm sensation from the spot over my ear and into my jaw which became numb just in front of my ear; pain above my ear followed by a warm sensation from the spot over my ear and into my jaw which became numb just in front of my ear; Numbness in jaw persisted for two days; Dizziness; nauseous; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was 8R8731 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm on 12Jul2021 08:30 (at the age of 47-years-old) at dose 1, single for covid-19 immunization. Medical history included known allergies to Penicillin, sulfa, lots of food and chemicals. Concomitant medications included ethinylestradiol, norethisterone acetate (MICROGESTIN); calcium; magnesium; acetylcysteine (NAC); vitamin d nos; vitamin c [ascorbic acid]. Patient was not pregnant. The patient previously took e-mycin [erythromycin], c-flox [ciprofloxacin hydrochloride] and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination and patient was not tested post vaccination. The patient had most recent COVID-19 vaccine at Public Health Clinic/Veterans Administration facility. It was reported that fewminutes after injection patient felt a tingling in hand then a sharp pain above ear followed by a warm sensation from  the spot over her ear and into her jawwhich became numb just in front of her ear. After 35 minutes of waiting, patient left and was dizzy walking out. She became nauseous and passed out in the car. Numbness in jawpersisted for two days. Dizziness came and went for two weeks. The events occurred on 12Jul2021 at 08:30am. The events were resulted in Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Client jerked arm away during injection of 3rd dose, only received partial dose, though only small amt lost (appears to have rec'd half or more of 0.5 ml dose).
Painful swelling of the lymph node in the right armpit. Difficulty driving. Difficulty sleeping.  Extremely painful.  The pain subsided after five days but the swelling is still present.
CHILD'S AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN SYSTEM WITH DIFFERENT DATE OF BIRTH. CHILD TOO YOUNG FOR VACCINE ON 6/9/2021. SEE VAERS #744948 FOR FIRST DOSE.
Bad chills/shaking for 2 hours.   Headache (took tylenol several times, gone by noon next day) Tired and general achiness through the next day (gone by 3-13-21) Light red rash under arms and across rib cage area (gone by 3-14-21)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), in Oct2020 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Oct2017, stop date: 07Aug2022; LEVOTHYROXINE, start date: 03Nov2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
died from the flu shot; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case from a non-health care professional via social media.  This case is linked to case 2020SA289370 (same reporter).  This case involves a female patient of unknown age who died (death), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done and the cause of death was not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns a female patient of unknown age who died, after vaccination with INFLUENZA VACCINE (produced by unknown manufacture). The time to onset is unknown. Also, further information regarding patient's concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations and autopsy result are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death nos