chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THREE BLOOD CLOTS IN BRAIN; STROKE; This spontaneous report received from a consumer via a company representative via agency concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. 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 three blood clots in brain, and stroke. The reporter reported that "It's a freak thing. It's not like she's old and just a slob that doesn't take care of herself. She's only 44 and is one of those diehard people of taking care of themselves. So for her to have three blood clots in her brain and have a stroke is very suspicious of the cause. They also have her on blood thinners because there was smaller clots forming that they said they couldn't get too". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the three blood clots in brain and stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220161645.; Sender's Comments: V0: 20220216426 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Three blood clots in brain, Stroke. This event(s) is considered unassessable. The event(s) 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(s).
itchiness at the shot site; This is a spontaneous report from a contactable consumer (patient reported for himself). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, strength 0.3ml (reported as 30mcg/0.3 ml), Lot Number: EL9262, expiry date not reported), via an unspecified route of administration on 05Feb2021 (at the age of 76 years old) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported.  There were no concomitant medications.  Patient had no problems with the first shot, she had the first shot 05Feb2021 and she had no problems other than the band aid left some glue behind, she left it on for 10 minutes then she yanked it off, that was because she had a coat on and could not get to it but the glue on the band aid was enough that she had itchiness at the shot site (05Feb2021) but that was not because of the shot other than that she had no problem with the first shot. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and reporter assessment, there is no possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Vaccination site pruritus which cannot be fully assessed/excluded. The case will be reassessed if 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.
her symptoms worsened; This is a spontaneous report from a contactable physician from a 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. Medical history included strong traumatic disorder (PTSD) (is take SSR medications). The patient's concomitant medications included SSR medications for PTSD. On an unspecified date, the patient's symptoms worsened. The physician wanted to know if that side effect was associated with the vaccine and the potential side effects of the second dose. The reporting physician assessed the event as non-serious. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Woke  up with red, swollen, golf ball size mass ( hematoma) at the injection site. It was also. Hot to touch.  I worked at an facility today and had a nurse look at it. She felt that it would go away in time.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). There were no concomitant medications (No other medication in 2 weeks). Past drug history included: Meloxicam, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible. No further information is expected.
headaches, fatigue, blood pressure elevated, low temp, heart palpitations, nausea and diarrhea
pain around the injection site/soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain around the injection site/soreness around the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain around the injection site/soreness around the injection site). At the time of the report, VACCINATION SITE PAIN (pain around the injection site/soreness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information  provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report has been received from a pharmacist refers to a 68 years old female patient with no Pertinent Medical History or drug allergy. The patient was vaccinated with a dose of ZOSTAVAX on 15-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-JUL-2012 the patient developed shingles with blisters and "whelps". The patient sought medical attention by seeing physician and ZOVIRAX was given to patient for the AE treatment. The outcome of shingles with blisters and "whelps" was reported as not recovered/not resolved. Additional information has been requested.
BODY ACHES, COLD CHILLS, STOMACH PAIN,  BAD FATIGUE
After administration of Prevnar 20 and Twinrix into right deltoid patient reported feeling dizzy. Patient looked pale and after about 1 minute patient fainted. Patient was unresponsive for about 2-3 minutes. Patient says she had very little to eat all day, only a bowl of cereal since 9:00 AM.  Patient remained seated in the vaccination chair until paramedics arrived.
Time Course:  1) Flu Shot - 11 am  2) Reaction/Hives - Noon (same day as the flu injection)  3) Reported to Health Clinic 2pm 4) Left Health Clinic 3pm   Signs:  1) Notice of Hives  2) Warmness  3) Tightness and Soreness in Arm Received Injection   Symptoms:  1) Severe Hives Both Front and Back of Arms Spread of Hives From Shoulders to Wrists  2) Area of Injection Swollen - Left Arm  3) Area Below Injection - Location of Start of Hives - Severe Redness and Warm - Left Arm  4) No Hives in Area of Injection  5) Hives On Leg Shins - After Returning From Health Clinic   Outcomes: 1) Recommended From Health Clinic Doctor - Report to Emergency Room to Receive Injection, etc. - Did Not Report to Emergency Room  2) Health Clinic Doctor - Provided a Benadryl for the Second Option - Oral Pill  3) Health Clinic Doctor - Provided Ice Pack for Swelling  4) Took 25 MG Benadryl with Water Departing From Clinic  5) Returned Directly Back to Work  6) Returned Home After Work  7) Reaction Gone Down Since Taking Medication 8) Tiredness - Bed Early From Benadryl
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-MAY-2014 the patient was vaccinated with VARIVAX (lot# and expiration date not provided) of dose 0.5 ml (milliliters) subcutaneously. It was reported that VARIVAX was exposed to an improper temperature for the third time on 29-MAY-2014 in which it reached a high temperature of 25 Farenheit (F) for 20.5 hours. No adverse effect was reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA015420, MARRS#1405USA015421, MARRS#1405USA015422, MARRS#1405USA015423, MARRS#1406USA005107, MARRS#1406USA005109, MARRS#1405USA014687). Additional information has been requested.
ER visit; patient left after triage. This visit was within 6 weeks of receiving the COVID vaccine.
Received PCV13 vaccine left thigh 8/4/10. Pt developed large local reaction seen 8/6/10 - 8.5/5 cm induration: warm, tender. Seen 8/7/10. Worsening swelling: Dx: cellulitis started on abx course.
Patient states he felt dizzy and had a light headache after administration of vaccine. Patient was monitored for 30 minutes and discharged from clinic.
pt recv vax & exp pain, redness & swelling @ inj site; The pain radiated up the arm; subsequently, pt recovered;
temp increase of 3 degrees, chills and generalized body aches.  Feels like shortened mild case of the flu
sore arm; This is a spontaneous report from a contactable consumer, the patient. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: not reported), via an unspecified route of administration on 25Feb2021 as a single dose for COVID-19 immunization; and apixaban (ELIQUIS), at an unspecified dose, frequency, route of administration and dates of use for blood thinner. Medical history included blood thinner therapy from an unknown date and unknown if ongoing; the patient had no allergies. Concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced a sore arm. The patient stated that he noted that the paperwork stated to tell the nurse if you were taking a blood thinner, he took apixaban, but no one asked him about that. The patient wondered if there was known information about apixaban with the vaccination. The action taken in response to the event for apixaban was unknown. The clinical outcome of sore arm was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (26Feb2021): This is a follow-up report based on information received by Pfizer from [manufacturer control number [COMPANY--2021-021398], license party for apixaban (ELIQUIS) and includes: License Partner Assessment.  Assessment: For Eliquis (Unknown), the reporter did not provide any causality assessments. Further company follow-up with the Consumer is not possible. Sore Arm was non-serious and related to apixaban
ITP- treated with Decadron and 2 doses of IVIG. Patient admitted with platelet count of 3.
severe myalgia; severe and arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe myalgia) and ARTHRALGIA (severe and arthralgia) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 07-Jan-2021.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MYALGIA (severe myalgia) and ARTHRALGIA (severe and arthralgia). At the time of the report, MYALGIA (severe myalgia) and ARTHRALGIA (severe and arthralgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
September 15, 2021:  Received Johnson and Johnson COVID vaccine in left arm.  Within 5ish minutes felt a "warm rush", blurred vision, racing heart, shortness of breath.  Nurse took blood pressure and told me it was elevated but my oxygen was 100%.  Nurse stayed with me until felt well enough to go home.  At home I began to feel pins and needles in my left hand.  September 16, 2021:  Experienced extreme fatigue and exhaustion.  Had low grade fever of 101 F.  Felt achy and developed cramping in left calf which traveled to my left clavicle.  Went to ER.  Exam and EKG was normal.  Declined additional testing that that time.   September 20, 2021:  Experienced sensation of throat closing as well as tingling of hands, feet and lips.  Led to 2nd visit to ER.  Normal exam, Blood work included a normal CK, CBC, CMP, thyroid function, and troponin level.  D-dimer was normal as well.  Declined CT and was recommended to see Neurologist.  September 21, 2021:  While driving experienced tingling in hands and feet.  Unable to open or close hand.  Pulled over at gas station and asked worker for ER medical assistance.  Once again, vitals came back normal.  Declined trip to ER and had husband drive me home.  September 27, 2021:  Still has significant fatigue.  Intermittently experiences paresthesia of hands and feet.  Cramping in both calves.  Feels swollen in face and hands.  Caffeine triggers a panic attack sensation.  Sleeping excessively despite continuing to use Armodafinil.  Had MRI and blood work for ANA and sedimentation rate.  Additional tests have been scheduled for EMG, blood work for B12 and copper level.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Jul2023 as dose 5 (booster), single (Lot number: Gj3682) at the age of 82 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Reactive airway" (unspecified if ongoing); "Known allergies: Opiates" (unspecified if ongoing); "Known allergies: tegretol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Sep2023 to 01Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320803 same patient, different drug/event;
has been having excruciating pain in her arm; none help alleviate it; This spontaneous report was received from a 42 years old female patient referring to herself. The patient's pertinent medical history included unspecified thyroid problem and concomitant medication included unspecified thyroid medication. The patient had none drug reactions or allergies.  On 25-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot# and expiration date were unknown) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) tetanus vaccine toxoid (ADACEL) (strength, dose, route, lot# and expiration date were unknown) in right arm for immigration purposes (prophylaxis).  On 25-SEP-2021 (also reported as since then), the patient has been having excruciating pain in her arm. Both vaccines were administered in her right arm, which was her dominant arm. The patient was unsure which vaccines was causing her the pain. In approximately 2021, the patient has tried paracetamol (ACETAMINOPHEN), ibuprofen and naproxen for pain as well as ice packs and none help alleviate it (Drug ineffective). The patient was administered the vaccine at a local pharmacy and not at her physician's office. The pharmacy staff recommended the patient contact the manufacturer of the vaccine. Referred the patient to her healthcare provider for recommendations. Agreed to schedule an appointment soon. The patient had already received all of the required vaccines at a young age, but she does not have her childhood immunization record and therefore, immigration was requiring she be re-vaccinated. No medical attention was sought. Action taken with paracetamol (ACETAMINOPHEN), ibuprofen and naproxen was not reported. The outcome of pain in arm was not recovered. The outcome of drug ineffective was not reported. The causality assessment was not provided.
Narrative: Patient admitted -- however, found to have prosthetic joint infection. Reaction not suspected to be related to COVID vaccine
Light headedness, wooziness, headache, chills, sweating with difficulty sleeping for 2.5 days, soreness, redness and swelling at injection site and below  injection site (7cm diameter).
29yo man who is an active swimmer presenting with persistent significant left shoulder pain, worse with activity. Coincides with getting his first covid vaccine 5-7 days earlier. Occurred the evening after his first swim after the covid vaccine. Exam notable for significant pain and shoulder instability. Worse pain was with external rotation. No evidence of impingement.  test positive. Empty can test somewhat positive. Concern for labral vs rotator cuff issues. Referred to Ortho for second opinion. x-ray ordered and will follow up with MRI.
Report 2001019244-1 describes edema in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). Medical History included allergy to diphenhydramine (Benadryl). Concurrent medications include bupropion HC1 (Zyban), which was initiated by the pt's primary care physician on approx 2/6/01. the pt rec'd her first injection of Engerix-B on 1/19/01. she had no adverse experience following receipt of this injection. She rec'd her second injection of Engerix-B on 2/20/01, within 24 hrs of receiving the second injection, she developed edema all over. She went to the local ER on 2/21/01 and was treated with unspecified steroids. The vaccine provider reported that the pt's primary care physician considered the edema to be a possible adverse event to either Engerix vaccine or Zyban. Therefore, the primary care physician discontinued Zyban therapy on 2/21/01. The edema resolved after an unspecified period of time.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 12/30/2020, 1/20/2021, and 9/23/2021. Patient with PMHx of lympblastic lymphoma, CHF, Afib on Eloquis, recent UTI on abx presented to ED w/AMS. Admitted for acute hypoxic respiratory failure, Covid-19 pneumonia and CHF. Tx'd w/remdiseivir x5days, dexamethasone D#8/10, completed rocephin and Zithromax x5days for elevated procal. Oxygen demands continued to worsen and continued to deteriorate despite doubling steroids and adding cefepime. Expired on 11/30/21.
Swelling of lips within hours of vaccine and  mild to moderate swollen eyes and face within 12 hours of vaccine.
Information has been received from a Nurse Practitioner concerning a female who was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced pain in her abdomen and turned yellow for two weeks. The patient's outcome was not reported. No further information is available.
Urticaria Pruritus. Diphenhydramine 25 mg QID.
Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 60 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Mar2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (03May2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid from 26Apr2023 to 30Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183026 same reporter/patient, different drug/AE;
Information has been received from a Nurse Practitioner (N.P) concerning a 24 year old female patient who on 11-MAY-2009 was vaccinated with the first dose of GARDASIL intramuscularly into the left deltoid. It was reported that the patient had been experiencing intermittent arm pain since receiving her initial dose of GARDASIL. The pain came and went with no pattern. The pain was described as muscle pain and felt like the day she initially received the vaccine. It was reported that the patient had arm pain when given the GARDASIL on 11-MAY-2009. The last time the patient had pain in that arm was two weeks ago. It was reported that the patient said it could be weeks between episodes of pain. The outcome of the patient was not reported. Additional information has been requested.
27M presented to clinic w 8d hx bilateral upper and lower extremity petechial rash 3 days after receiving 1st pfizer covid vax (vax 16th, petechiae 19th-present).