chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever Chills Nausea Headache  Body aches Sore arm at injection site Began approx 11hours after injection.  By 3pm on 12/21/2022 all symptoms had subsided other than some minor body aches.
Narrative: Patient received one and first dose of COVID (Moderna) vaccine and later reports needed to be hospitalized for 2 days after having vaccine administered d/t having COVID symptoms
edema; redness to her midface; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): GL-081222-20072.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; hyaluronic acid (RESTYLANE), on 01Apr2022 as dose 1, single (Lot number: 19423, Expiration Date: 31Mar2024) and on 01Apr2022 as dose 2, single (Lot number: 19921, Expiration Date: 31Aug2024). The patient's relevant medical history included: "Last dental procedure 1.5 yrs ago" (unspecified if ongoing), notes: Last dental procedure 1.5 yrs ago; "Allergic to PCN" (unspecified if ongoing); "dental procedure" (unspecified if ongoing), notes: Last dental procedure 1.5 yrs ago. The patient's concomitant medications were not reported. Past drug history included: Simvastatin for increased cholesterol. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, She had Pfizer Covid-19 vaccines on: 08Mar2021), administration date: 08Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, She had Pfizer Covid-19 vaccines on: 29Mar2021), administration date: 29Mar2021, for COVID-19 immunization.  The following information was reported: OEDEMA (non-serious) with onset 01Jul2022, outcome "unknown", described as "edema"; ERYTHEMA (non-serious) with onset 01Jul2022, outcome "unknown", described as "redness to her midface". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oedema, erythema.  Clinical course: On 01Apr2022, the consumer was injected with 2 vials of Restylane Lyft-1 vial on each side of the midface for midface volume loss. The lot number and expiration were Lot 19921, Exp 31Aug2024 given to the right side & Lot 19423 Exp 31Mar2024 given to the left side. The consumer experienced late onset edema and redness to her midface bilaterally and intermittently beginning on 01Jul2022. She was treated by HCP with Hylenex 300u to affected areas on 11Aug2022 as a filler reversal. Medical history includes Fitzpatrick 3, Healthy, Simvastatin for increased cholesterol. Allergic to PCN, Last dental procedure 1.5 yrs ago. She had Pfizer Covid-19 vaccines on:08Mar2021; 29Mar2021 and Pfizer booster on 08Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He began getting petechiae and abdominal pain. Had a biopsy  and was diagnosed with HSP,  (Henoch-Schonlein Purpura) full body inflammatory response, swelling in joints, abdominal pain,  Petechiae is on abdomen, back, legs, groin, both arms, feet, butt, these are broken capillaries leaking blood under the skin.  He is getting progressively worse.  Been to the doctors three times and dermatologists twice.  Has an appointment with a Nephrologist because this causes kidney involvement.  Was on a five day course of prednisone.
Vitals T-99.1; P-80; R-16; B/P-136/82.  Non toxic appearing A&O, Patient shows significant amount of erythematous pustular papules over upper torso, neck, extremities, with few similar lesions over lower extremities. + TTP; left axillary region with + lymphadenopathy. + adenopathy, supraclavicular nodes on left side. Inoculation site approx 1.5 cm pustular lesion with erythematous circle approx 6 cm in diameter. Flushed skin. Diagnosed with disseminated [generalized] vaccinia with viral syndrome s/s.  This is patient's primary vaccination.
Hypertensive emergency; Newly diagnosed uncontrolled hypertension; Elevated troponin; pulmonary hypertension
ADMINISTERING THE JANSSEN COVID 19 VACCINE TO PATIENTS MORE THAN 6 HOURS AFTER THE FIRST VIAL PUNCTURE (VIALS STORED IN THE FRIDGE AFTER PUNCTURE) (OUT OF SPECIFICATION PRODUCT USE); INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. 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: 207A21A, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administering the Janssen covid 19 vaccine to subjects more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use), and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administering the Janssen covid 19 vaccine to patients more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220527916, 20220528196, 20220528223 and 20220528115.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Fever-Severe
Considerable pain at the injection site. Did not respond to acetaminophen or ibuprofen. Often too painful to even concentrate.
Rash 2 days after 2 dose, developed into painful raised rash with intense itching over the course of the weekend. Saw Doctor on Monday, March 1 and was diagnosed with Shingles. Since it was 72 hours since onset of symptoms, was told only recourse was to wait out the course of the outbreak.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer (patient's wife) concerned a 43-year-old male. The patient's height, and weight were not reported. The patient did not have any underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-MAR-2021 for prophylactic vaccination on right arm.  No concomitant medications were reported.  On 20-MAR-2021, 8 hours after the shot, the patient experienced flu-like symptoms. On 30-JUL-2021, the patient had Antibody test which showed Immunoglobulin G (IgG) was negative and immunological vaccine failure was confirmed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 21-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210760356. This report was associated with product quality complaint: 90000188476.; Sender's Comments: V0: 20210802749- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
major breathing issues tight chest right arm numbness pain shooting down right arm right arm pit pain neck/shoulder and back pain
A physician reported the occurrence of cartilage degeneration in a 65 year old male who was vaccinated with Lyme disease vaccine recombinant LYMErix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On unspecified dates "at least two years" ago, the subject received three LYMErix injections. Starting in approximately October 2002, the subject began to experience "rapid" cartilago dengeration with knee pain and the inability to walk. The subject was evaluated by a rheumatologist and an orthopedist. No cause for these events was found. The subject did not respond to physical therapy, non-steroidalanti-nflammatory drugs NSAIDS or corticosteroids. MRI performed at an unspecified time in the past was "completely normal." The "most current" MRI showed "degradation of the cartilage." The cartilage degeneration in this report is considered medically serious (OMIC) because the subject "cannot walk."
Patient received the 2nd dose of the Moderna Vaccine on the 21st day on 5/10/21 as opposed to the 28th day, Pt received the first dose on 4/19/21
COVID +; COVID +; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 49 years 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: FLUCELVAX QUADRIVALENT taken for immunisation, on 28Sep2022 as dose 4, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2023, outcome "not recovered" and all described as "COVID +". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Prior to vaccination, the patient was not diagnosed as COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine (as reported). List of any other medications the patient received within 2 weeks of vaccination was reported as unknown. On 02Jan2023, the patient began to have mild symptoms.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
prod cough; SEVERE body aches; shortness of breath on exertion; inj site pain; exhaustion; headache; fever; patient received IMURAN concomitantly; patient received IMURAN concomitantly; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL 0142) via an unspecified route of administration in left arm on 21Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included Crohn's disease, migraine. Concomitant medication included azathioprine (IMURAN), propranolol, sertraline hydrochloride (ZOLOFT). The patient previously took infliximab (REMICADE) and morphine, both experienced drug allergy; received the first dose of bnt162b2 (Lot number: EL1284) in left arm for COVID-19 immunization and experienced severe body aches, headache, heavy feeling injection arm unable to lift it, cough and exhaustion. The patient experienced prod cough, severe body aches, shortness of breath on exertion, inj site pain, exhaustion, headache, fever, all on 22Jan2021 05:00. No treatment received for the adverse events. Reporter considered the events as non-serious. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Swelling at injection side; Fever; Chills; Muscle Pain; Really Tired; Headache; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), VACCINATION SITE SWELLING (Swelling at injection side), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cholesterol.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced TENDERNESS (Tenderness). On 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection side), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle Pain), FATIGUE (Really Tired) and HEADACHE (Headache). At the time of the report, TENDERNESS (Tenderness), VACCINATION SITE SWELLING (Swelling at injection side), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle Pain), FATIGUE (Really Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were reported as high blood pressure and cholesterol medication.
Patient was in for immunization on 01/25/08. One hour after receiving shots, child had inconsolable screaming for 9 hours. Child called PCP at 3am in morning; Dr said child had a reaction to shots, and to tell Health Dept when she brought infant book for next shots. Child was also seen in Dr's office morning after shots. Reported to health Dept 4/7/08
NOTE: no prior TIA or stroke  #1 Suspected TIA (chest pain, dizziness, confusion, thick tongue, search for words, weakness left arm and leg, high blood pressure) - transported by ambulance to hospital, hospitalized for 24 hours - put in low dose aspirin regimen and tests ongoing  #2 suspected TIA 3 weeks later - same symptoms except no chest pain - exchanged Plavix for aspirin - tests ongoing
pt recvd 3 doses of Engerix-B & the next day exp a rash on face & arms; Event resolved w/o treatment; 1 of 2 pts who exp a rash @ facility;
"Covid-Arm" present 9 days after the initial injection and first dose -redness raised bump started 8 days after with pain at the injection site and slight itch
Bell's Palsy; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm at the age of 34-year-old on 04Apr2021 15:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. Medical history included asthma, pernicious anaemia, Polycystic ovarian syndrome, Hashimots thyroiditis, Atopic dermatitis. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34-year-old on 07Mar2021 15:00 at left arm for COVID-19 Immunization. The most recent COVID-19 vaccine was administered at Hospital. No other vaccines within 4 weeks prior to the COVID vaccine received by patient, other medications the patient received within 2 weeks of vaccination confirmed yes but not specified and stated more than there was room for here. The patient experienced bell's palsy on 04May2021 12:00. The event resulted in Emergency room/department or urgent and Doctor or other healthcare professional office/clinic visit, no treatment received. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.  No follow-up attempts are possible. Information about batch/lot number can not be requested.
The day after getting the Covid vaccine, I had a bad headache or migraine, along with muscle aches all over my body and especially in my right shoulder and neck. I also had a severe fever that lasted into the second day. The symptoms did lighten on the 2nd day.
Every time I get up. I feel so fatigue. I get a sharp pain in my back and shoulders for about 2 weeks. At one time I could not even talk. I had a headaches as well for a few weeks. The tiredness last before about a month and half. I went to my doctor about this. They did a physical exam. They blood work, normal results.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9702), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: tested negative during treatment with Paxlovid; (17Jan2023) Positive, notes: positive antigen test 2 days after last dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Rebound/recurrence of Covid symptoms and positive antigen test 2 days after last dose of Paxlovid. Had been asymptomatic and tested negative during treatment with Paxlovid
the night of the vaccine patient had some flushing and subjective fevers however felt okay.  Following day in evening he developed   Burning pain in his right shoulder that "felt like even his hair was on fire".  The following morning he developed a rash which I diagnosed as shingles.
Over 24 hours of dizziness, headache, burning spine, muscle and joint pain, nausea, couldn't move arm, unable to sleep the night of injection, non functional the day after
patient was administered an expired dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th May 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: GSK Receipt Date: 11-MAY-2022 Reporters comment: Nurse reported that, the patient was administered an expired dose of Kinrix.  The reporter consented to follow up via email.  The Vaccine Administration Facility is the same as Primary Reporter. Additional supportive information: The patient was administered an expired dose of Kinrix, which led to expired vaccine used.
Mom noted red, swollen, hard lump the size of a golf ball at the injection site. At 10 pm it was hot, red, hard lump the size of a baseball, and tender to the touch. Went to ER and started on Augmentin to rule out cellulitis.
Significant pain and swelling of arm of injection site.  Skin became warm to the touch, and a significant area of spreading redness developed.  This occurred over the course of 48 hours immediately after the vaccine was administered and lasted 96 hours. This was dose #2 of the vaccine.  The reaction subsided after 96 hours. The patient had no similar reaction to the first dose administered in April 2023.  Only reaction to first dose was normal level of tenderness at the injection site.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 83-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in 2015). On 14th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 16th December 2018, the patient experienced pain, feeling unwell, headache and neck pain. On 19th December 2018, the patient experienced diarrhea. On an unknown date, the outcome of the pain, feeling unwell, headache, neck pain, diarrhea and injection site pain were unknown. It was unknown if the reporter considered the pain, feeling unwell, headache, neck pain, diarrhea and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter's father-in-law. The patient received SHINGRIX on an unknown arm. After vaccination, the patient felt achy. the patient had his ears cleaned at a recent doctor appointment because the patient had lots of wax. The physician did not know the origin of the neck pain. The reported information regarding the onset date of injection site pain was discrepant with the vaccination date, so the partial onset date for injection site pain was captured. This case has been linked with case US2018230551, reported by the same reporter.
pt recv vax & 7MAY97 devel 15-20 chickenpox, a sl fever & redness pt recovered;
Pt. described "whole upper arm redness and swelling, painful to move arm, all per pt.'s report" On ~2/12/21, pt. communicated to clinic that he received antibiotic from an urgi care provider for site infection. On 2/14/22, myself and Dr. examined arm: all reported side effects completely resolved, in terms of observation.
mild erythema and induration/ left thigh cellulitis-oro more likely a mosquito bite (per Dr.). Septra Pediatric susp.
The pt developed a macular-papular rash over his head and body beginning 1 day post vax. The pt was prescribed calamine lotion and Atarax. No hx of fever or URI. Symptoms point to rash development.
Second dose administered past 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered past 36 days) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered past 36 days). On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered past 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs, Lab data, Treatment information, if any, not provided.   This case was linked to MOD-2021-269938 (Patient Link).
This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with the first dose of ROTATEQ (orally, lot # L035510 and expiration date 13-MAY-2017, dose was not reported) at the age of 4 months old. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pre syncopal , dizzy, flushing, diaphoretic. Evaluated by EMS-Cleared