chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse, subject) and described the occurrence of reaction to influenza vaccine in a female subject of unspecified age who was vaccinated with influenza vaccine (unspecified), GlaxoSmithKline. On an unspecified date the subject received unspecified dose of influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with influenza vaccine (unspecified), the subject experienced reaction to influenza vaccine. No specific details were provided. The subject questioned the latex content of flu vaccine produced by GlaxoSmithKline. Per the nurse (subject), "the infection control nurse at the hospital told her mom the flu vaccine given to her was from a single dose vial" and that "the flu vaccine had 'GlaxoSmith' on it." The reporter refused to "give any information yet because she first need to find out which flu vaccine she was given." Per the reporter, "this is one of the worst things that has happened to her." At the time of reporting the outcome of the event was unspecified.
Received the vaccine at 10am on Friday, started itching all over my body 24 hours later. Developed a measles-like type of rash that spreads all over my body. It is very itchy and is not going away. Today is the 5th day of the rash. Have taken Benadryl in pills and topical Cortizone.
Patient stated that an hour after she received the vaccination she felt a pain in her lungs. She had a hard time breathing for about 6 hours. She received a bad headache. Her vision started to go in and out of vision. She is tired all the time. She is sleeping  for 3 or 4 hours in the day time. She said her body hurts to walk. Her arms are sore and she is very irritated.
tested positive for covid virus after first dose vaccine; tested positive for covid virus after first dose vaccine; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A patient of unspecified age and gender received 1st dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for covid virus after first dose vaccine. The patient underwent lab tests and procedures which included covid virus test: positive on an unspecified date. The outcome of event was unknown.  Information about lot/batch number has been requested.
This spontaneous report was received from an approximately 81 year old male patient, reporting on himself. The patient's pertinent medical history included blood pressure issues (unspecified). He was allergic to SULFA. The patient did not have any concomitant therapies. In October 2015 (reported as 1 year and 6 months ago), the patient was vaccinated with a dose of ZOSTAVAX 1 time vaccine for shingles prophylaxis (lot #, expiration date, site, dose and route of administration were not reported). In January 2016 (reported as 3 months after getting the vaccine), the patient got shingles in his left eye. On unknown dates, the patient experienced high blood pressure of 200/200 (unit not provided), low blood pressure below the 30s (unit not provided), he was losing sight in his left eye and did go to the hospital for an unspecified reason. The patient sought medical attention, spoke with his physician and an unspecified treatment was given for the events. No lab diagnostic studies were performed. At the time of report, the patient was concerned the shingles was spreading to his right eye and that he would start to lose sight in that eye as well as his left eye. The only relief he had was from cold compresses. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not assessed. Upon internal review, the events of ophthalmic herpes zoster and high blood pressure of 200/200 (unit not provided) were determined to be medically significant. Additional information has been requested.
the vaccine the patient received went without being refrigerated; chickenpox; This spontaneous report was received from a nurse refers to a 5 year old male patient. The patient's historical conditions, past drugs, drug allergies and concomitant therapies were not provided. Concurrent conditions included asthma and seasonal allergy. On an unspecified date in October 1998, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, lot# and expiration date was not provided) for prophylaxis. On an unspecified date in October 1998, patient developed chickenpox (varicella) within a couple weeks of receiving the vaccine. Nurse reported patient took an unspecified dose of benadryl (manufacturer, dose, lot and expiry unknown by reporter) on unspecified dates for treatment of itching associated with chickenpox. On an unspecified date after patient received the vaccine stating the refrigerator was unplugged and the vaccine the patient received went without being refrigerated for an unspecified period of time prior to the patient receiving the vaccine (product storage error). Product quality complaint and overdose was not involved in the case. The event chickenpox (varicella) was not related to cancer. Outcome of the event chickenpox (varicella) was reported as recovered/resolved. Causality of the event chickenpox (varicella) was not provided.
She had a fever, fatigue, cough, congestion, and vomiting for some time. We called and got advice from her pediatrician, but she was not seen. We took her to get a PCR COVID-19 on 09/25/2022 which came back negative, but when her symptoms worsened, we took her to get retested on 09/27/2022 which eventually came back positive. The pediatrician recommended TYLENOL and MOTRIN to help subside her symptoms for recovery. Currently, she's doing fine and not having the lingering cough like her brother.
She was given a total of fours shots in one day: polio, hep A/B in the right arm, she thinks she got tetanus and meningococcus in the left. Within five minutes she "did not feel right," throat closed up, her tongue swelled up and she could not breathe, her chest and right arm got broke out with a bumpy red rash (does not recall if it was pruritic). An ambulance crew gave her BENADRYL and took her to the hospital where she got an EPIPEN. She was not admitted overnight; took BENADRYL for a couple of days. She has never had a reaction like that to anything. She has subsequently received the hep A/B shot without problems and also FLUMIST.
Little bit diarrhea; Lot of pain at site of injection; Heavy joint pain; Little nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Little bit diarrhea), VACCINATION SITE PAIN (Lot of pain at site of injection), ARTHRALGIA (Heavy joint pain) and NAUSEA (Little nausea) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Little bit diarrhea), VACCINATION SITE PAIN (Lot of pain at site of injection), ARTHRALGIA (Heavy joint pain) and NAUSEA (Little nausea). At the time of the report, DIARRHOEA (Little bit diarrhea), VACCINATION SITE PAIN (Lot of pain at site of injection), ARTHRALGIA (Heavy joint pain) and NAUSEA (Little nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was 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.
I don't know if it's related, but a friend reminded me I should report it on my V-safe, and then they called me and told me to fill this out.  On 6/3/2021 I found a lump in my left breast (same side as the vaccine) and it has been confirmed today (6/10/2021) to be Intraductal Carcinoma. It has already spread to a lymph node.
woke up with swelling at the vaccine site and itching; woke up with swelling at the vaccine site and itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (woke up with swelling at the vaccine site and itching) and VACCINATION SITE SWELLING (woke up with swelling at the vaccine site and itching) 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 VACCINATION SITE PRURITUS (woke up with swelling at the vaccine site and itching) and VACCINATION SITE SWELLING (woke up with swelling at the vaccine site and itching). At the time of the report, VACCINATION SITE PRURITUS (woke up with swelling at the vaccine site and itching) and VACCINATION SITE SWELLING (woke up with swelling at the vaccine site and itching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No significant information was received.
This case was reported by a consumer and described the occurrence of brachial neuritis in a adult male patient who received TWINRIX adult (batch number B457F, expiry date unknown). On 27th September 2013, the patient received TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced brachial neuritis (serious criteria disability) and injury to shoulder nos. On an unknown date, the outcome of the brachial neuritis and injury to shoulder nos were unknown. It was unknown if the reporter considered the brachial neuritis and injury to shoulder nos to be related to TWINRIX adult. Additional details were provided as follows: The age at vaccination was not reported. The patient's right arm was injured due to vaccination with TWINRIX adult. The patient experienced shoulder injury related to vaccine administration (SIRVA) and brachial neuritis. The patient was possibly permanently disabled.
pt recvd vax 15mins later onset of feeling spaced out, diaphoretic, shaking, dizzy; chest pain; blurred vision; called 911; paramedics eval -pt stable; pt refused transport; girlfriend took pt home; no problems
flu like symptoms; severe headache; chills; aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache), CHILLS (chills) and MYALGIA (aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 029L20A and 040C21A) for COVID-19 vaccination.     Medical history was not provided.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). 20-Feb-2021, the patient experienced HEADACHE (severe headache), CHILLS (chills) and MYALGIA (aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache), CHILLS (chills) and MYALGIA (aches) outcome was unknown.            This case was linked to MOD-2021-295649, MOD-2021-295635 (Patient Link).
One day post vax pt was taken to the ER and diagnosed with cellulitis in right thigh.
This is a spontaneous report from a contactable consumer (patient). A 55-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6207), at the age of 55,  via an unspecified route of administration, in the right arm, on Mar 12, 2021, at 12:30, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to vaccination. On Mar 12, 2021 at 12:30, patient experienced ringing in ears, dizziness and fatigue. The events resulted in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures taken as a result of the reported events. Since the vaccination, patient has not tested for COVID-19. The outcome of ringing in ears and fatigue recovered on an unknown date in 2021; while that of dizziness recovered on an unknown date in Mar 2021. No follow-up attempts needed. No further information expected.
Miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration in the left arm on 28Jan2021 08:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 07Jan2021 at 09:00 AM for COVID-19 immunization. Patient was pregnant. Patient has no other vaccines in four weeks and no other medications in two weeks. Patient has no COVID prior vaccination and no known allergies. On 05Feb2021 at 06:00 PM, patient experienced miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant. No treatment received for the event miscarriage. The event resulted in doctor's office/clinic visit. The patient was not tested for COVID post vaccination. The outcome of the event miscarriage was recovering.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of the vaccination with BNT162B2 in triggering the onset of miscarriage in this patient at 6 weeks pregnant cannot be excluded. Additional information regarding relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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.
Inbound call from HCP stating that 6 month old was inadvertently administered a dose of GARDASIL 9. No symptomatic side effects reported at time of call. No additional AE details or PQC.; No symptomatic side effects reported at time of call. No additional AE details; This spontaneous report was received from a pharmacist and refers to a 6-month-old patient of unspecified gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, vaccination schedule, lot #, expiry date, and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). No symptomatic side effects and no additional adverse event details were reported (No adverse event).
Headache, myalgia, skin rash and chills, sweats, redness.
Child given DTAP in left deltoid. Almost immediately, redness developed on left arm. By the next day, arm was swollen and minimally tender.
arm was numb from shoulder to elbow; warm to touch; golf ball size inflammation; searing pain; nauseated; disoriented; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated), DISORIENTATION (disoriented), HYPOAESTHESIA (arm was numb from shoulder to elbow), INJECTION SITE WARMTH (warm to touch) and INJECTION SITE INFLAMMATION (golf ball size inflammation) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced NAUSEA (nauseated) and DISORIENTATION (disoriented). On 28-Jan-2021, the patient experienced HYPOAESTHESIA (arm was numb from shoulder to elbow), INJECTION SITE WARMTH (warm to touch) and INJECTION SITE INFLAMMATION (golf ball size inflammation). 28-Jan-2021, the patient experienced INJECTION SITE PAIN (searing pain). At the time of the report, NAUSEA (nauseated), DISORIENTATION (disoriented), HYPOAESTHESIA (arm was numb from shoulder to elbow), INJECTION SITE WARMTH (warm to touch), INJECTION SITE INFLAMMATION (golf ball size inflammation) and INJECTION SITE PAIN (searing pain) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
Nurse Administered the FLUMIST as directed to each nostril. Immediately the patient became pale he complained of nausea, light headed and he began to sweat. Nurse took his blood pressure and it was 80/60. We then made him comfortable and watched him for about 10 minutes and then called 911. An ambulance arrived and took him to the hospital.
Patient is a 65 y.o. female with a PMHx of Asthma, Chronic respiratory failure, HLD, HTN, DMII, CHF, RA, anemia who presents with shortness of breath and found to have acute resp failure with hypoxia. presented with 2-3 days of worsening SOB. Pt states having sob at rest and with exertion. Husband is sick at home. Pt is on 3L O2 at home chronically. Pt tested + on 2/12 for covid. Clinical respiratory status worsened and was brought to the ICU on HHF. Due to patient's history of kidney transplant and current immunosuppression from post-transplant medications, it would be in the patients best interest to be transferred for further management and care.    Assessment and Plan:   Acute respiratory failure with hypoxia Covid-19 infection Respiratory acidosis MRSA Bacteremia Sepsis Requiring HHF D-Dimer elevated to 11 Heparin gtt started by ED, continued Bed rest orders: Purewick ordered Unable to order CTA due to renal function, VQ scan contraindicated due to Restarted home inhalers Coughing up frothy red sputum Procal mildly elevated in the setting of CKD Blood cultures 2/15 grew 1 of 2 MRSA    - Continue Vancomycin - HHF during day, BiPAP at night - Will hold remdesevir per ID - Decadron 6mg every day  - ID consult for Covid-19 - Ur pna ags pending - Sputum culture, repeat cultures pending   Presumed Pulmonary embolism Hypotension Elevated troponins Noted on admission, bp was 80/40s fluid responsive Requiring repeat bolus after admission Unable to confirm PE via imaging: CTPA contraindicated due to renal function, VQ scan contraindicated due to covid New Frothy red sputum production, BNP 31k, D-dimer of 11, Trop 85->73 EKG with no signs of acute ischemia does have right axis and chronic T wave inversions in inferolateral leads Echo 2/15 shows EF 55%, severely enlarged RV with severely reducede function. Severe tricuspid regurgitation, s/p mitral valve repair. Mild MV regurg   -
pt recv 1st & 2nd vax,exp generalized muscles aches;to MD,anti HBs neg;3rd dose given,anti HBs less than 10;was vax w/ booster dose 11mar94;Pt thinks sx related to vax but MD disagree;pt recovered from aches & pains;
sore arm at injection site; headache; got the second vaccine 9 weeks later; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (got the second vaccine 9 weeks later), VACCINATION SITE PAIN (sore arm at injection site) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028A21A) for an unknown indication.     Concurrent medical conditions included COVID-19 on 30-Jan-2021.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced OFF LABEL USE (got the second vaccine 9 weeks later). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm at injection site) and HEADACHE (headache). At the time of the report, OFF LABEL USE (got the second vaccine 9 weeks later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, COVID-19 (positive-positive positive): positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO CONCOMITANT AND MEDICATION DRUGS WERE USED   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Sore arm, HA post second dose
Erythema and swelling noted to Right Upper Arm.  Hardened area noted underneath the injection site.  Lymph nodes to right axillary enlarged and tender to touch.  Patient complains of pain in right arm.  Pt called clinic on 10/2/2/2007 stating symptoms had become worse.  Pt was referred to her pcp for follow-up and treatment.
Chills; muscle aches; joint aches; vomiting; headache; fatigue; brain fog; This is a spontaneous report from a contactable consumer(patient).  A 25-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0176) via an unspecified route of administration, administered in Arm Left on 28Apr2021 (at the age of 25-year-old) as single for covid-19 immunisation. The patient medical history was not reported. The patient received Birth control pill within 2 weeks of vaccination. The Patient did not receive any other vaccines within 4 weeks Prior to vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On 21May2021 at 23:00 the patient experienced chills, muscle aches, joint aches, vomiting, headache, fatigue and brain fog. The patient did not receive any treatment for the events. On an unspecified date, the outcome of the events was resolving.