chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 65-year-old male patient received BNT162b2 (BNT162B2, Vaccine brand: Pfizer / BioNTech, Vaccine brand unknown, Vaccine lot unknown and Vaccine dose number unknown: False), on 03Apr2022 at 19:00 as dose 3 (booster), single (Lot number: FM0698) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Vaccine brand unknown, Vaccine lot unknown and Vaccine dose number unknown: False), on 27Oct2021 at 13:00 as dose 2, single (Lot number: 058E21A), in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE, Vaccine brand unknown, Vaccine lot unknown and Vaccine dose number unknown: False), on 01Apr2021 at 10:00 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "known allergies: Naproxen", notes: known allergies: Naproxen. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Jun2022 at 07:00, outcome "unknown", COVID-19 (medically significant) with onset 29Jun2022 at 07:00, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: COVID 19 Treatment; (29Jun2022) Positive, notes: positive antigen test within 5 days of completing Paxlovid medication. Anti viral details: Product: COVID 19 Treatment. Brand: Paxlovid, Treatment start date: 18Jun2022, Treatment stop date: 23Jun2022. Adverse event: COVID rebound (positive antigen test within 5 days of completing Paxlovid medication). Report about covid treatment: Yes. If vaccine received: Yes. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Mar2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID infection". Therapeutic measures were taken as a result of covid-19.  Clinical information: Caller is a pharmacist asking on behalf of one her patient who just finished a 5 day treatment of Antiviral after getting COVID infection on Mar2022. and the patient would like to know how long after the Antiviral treatment they would be able to receive the third booster dose of Pfizer covid vaccine. Pharmacist is unsure if the Antiviral taken by patient is Paxlovid or molnupiravir. Call was not transferred as he AE was recognized after the call had ended. Spoke from the attached document. Use in COVID-19 Vaccinated Patients and informed caller The study excluded individuals with a history of prior COVID-19 infection or vaccination: as part of the protocol the study did not include participants if they had received or were expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit. Informed pharmacist to recommend the patient to consult his HCP.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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) cannot be ruled out.
pt recv vax 16JUL96 & 30 to 60 min p/vax pt exp a hypotonic episode;pt reportedly recovered;past medical hx showed that the pt was a 30 wk gestational baby @ birth;
12/3-skin red, sore slight swelling lt. upper arm. 12/4-red area increased eventually to 3" x 5" area, w/more swelling. 12/7-more swelling, hot to touch, pain. 12/10-area finally reduced to normal.
This spontaneous report was received from a pharmacist refers to a 11 years old concerns to her daughter with no known allergies. On 17-JAN-2013, the patient was vaccinated with GARDASIL intramuscular, left deltoid (dose and lot not reported). No other co-suspects were reported. No concomitant medications were reported. On 17-JAN-2013, within a few hours after vaccination, the patient's left hand and wrist developed hives. That morning, the patient's hand was swollen and looked as if it had a "prickly heat" rash, in addition to the right hand appearing red around the wrist as well. On 17-JAN-2013, the pharmacist called an unspecified physician to determine how to treat the hives. The patient was treated with ibuprofen and ALLEGRA. At the time of the report, the outcome of the patient's left hand and wrist developed hives was unknown. The relatedness for the patient's left hand and wrist developed hives was unknown for GARDASIL. Additional information is not expected.
Itching. Rash on feet, legs, arms. Swollen tongue approx 1 week later. Went to dermo and got cream. OK - now.
Episodes of tachycardia and shortness of breath occurring when at rest. First week occurring regularly out to 2 years.
No Adverse event; Patient received 1st booster dose instead of 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received 1st booster dose instead of 3rd dose) and NO ADVERSE EVENT (No Adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 52C21A, 032L20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received 1st booster dose instead of 3rd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received 1st booster dose instead of 3rd dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received 1st booster dose instead of 3rd dose).    No concomitant information provided Patient was immunocompromised, & patient took 5 different immunosuppressants.  Patient received 1st dose: 24Jan2021 with Lot: 027L20A Patient received  2nd dose: 24Feb2021 with Lot: 032L20A Patient received  1st booster dose: 21Aug2021 with Lot: "52C21A" No treatment information provided   This case was linked to MOD-2022-661304 (Patient Link).
Had first COVID vaccine 12/28/21. Had shivering the next day then felt fine. Received second dose 1/25/21. Woke up at 3:30am with vomiting then began to shiver, was flushed, developed body aches, and discomfort to lower extremities. Called off work. Symptoms remained the same all day. Slept 15 hours then woke up in am 1/27/21 and was hallucinating. Saw huge spiders on her wall. She had nightmares the previous night also. Hallucinations stopped when she got up. Other symptoms continued through the rest of the day. Also had pain in arm so she couldn't lift above shoulder level. Went to bed and had nightmares that night. Woke up and had trouble walking without stumbling. All symptoms began resolving around 2pm. Went to bed the night of 1/27/21 and still had some nightmares then woke up and returned to work. Today she is having indigestion and diarrhea. No hx COVID disease.
This spontaneous report as received from a pharmacist refers to approximately 60 year old female patient. The patient medical history included high blood pressure, drug reaction/allergies to penicillin and novocaine. Concomitant therapies included aspirin. On 28-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J013135 expiration date 17-JAN-2015, route subcutaneous to prevent shingles. On 30-APR-2014, 3 days after onset of therapy the patient developed red baseball-sized knot surrounded by halo at the site of ZOSTAVAX injection. The outcome of red baseball-sized knot surrounded by halo at the site of ZOSTAVAX injection is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Normal Labor and delivery on 10/1 /2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
Redness at injection site; Swelling at injection site; Dose-1 on 28-AUG-2021 Dose-2 on 13-SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 on 28-AUG-2021 Dose-2 on 13-SEP-2021), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 13-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 on 28-AUG-2021 Dose-2 on 13-SEP-2021). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 on 28-AUG-2021 Dose-2 on 13-SEP-2021) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved with sequelae.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
turned out to be Covid; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program .   A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in right arm on 28Jan2021 at 15:00 (at the age of 70-years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included unspecified blood pressure medications. There was no history of previous immunization with the Pfizer vaccine that was considered suspect. The patient did not take any other vaccine four weeks prior Covid-19 vaccination. On an unspecified date (3-4 days of vaccination), patient had sore throat and fever which he thought was strep and needed to visit physician office. Patient stated that they were sent to the hospital for treatment. The patient received treatment that included infusion with monoclonal antibody. On 02Feb2021 at 11:00, doctor checked and found out that patient was COVID Positive. Patient and his wife both were tested Positive. The patient underwent lab test which included SARS-CoV-2 test: Positive on 02Feb2021. They were informed to wait to get his 2nd dose. Stated that they were fine and relieved. Nurse informed that they shall not have shot until about 90 days. Patient wants to know when he should get the second dose. The patient stated that he was taking vaccine because government scared him and told him he would get sick and die without it. The symptom sore throat was resolved in 3-4 days. The outcome of the COVID-19 was unknown.
severe itching on thighs and lower back; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Mar2021 15:00 at the age of 71-year-old (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization in the public Health Clinic/Veterans. The patient was not pregnant at time of vaccination. Medical history included macular degeneration, abdominal hernia, hypertension and e-cadherin and p120 breast tumor recently diagnosed; all from an unknown date. The patient previously took aspirin and vancomycin and experienced allergy. The patient previously had BNT162B2 on 08-FEB-2021 16:00 dose 1, single in the left arm for COVID-19 immunization. The patient experienced severe itching on thighs and lower back on 01Mar2021 20:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was taking goli - apple cider vinegar gummies concmitantly. No treatment given for the event.The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination The outcome of events was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  .
Varicella - Information has been received from a nurse practitioner concerning a 6 year old caucasian male patient with a history of right otitis media who on 19 Nov 1987 was vaccinated with a first dose of varicella virus vaccine live in the left arm.  On 05 apr 2000, the patient was diagnosed with varicella.   It was indicated that on 19 Nov 1997 the patient was prescibed mulfamethoxazole (+) trimethoprim.  Bactrim 200 mg bid for 10 days for right otitis media
This child died in her sleep on 9/13/05. Pronounced dead at hospital. Autopsy report rec'd 10/19/2005, COD was SIDS.
Flapping of hands, intermittent through until 5 AM 04/23/2010. Uncontrollable crying all day of 04/22/2010. Sudden loss of coordination, twice. Falling over, uncharacteristic of this patient, once from seated, once from standing.
Fever, tired, arm pain, chill. All these symptoms started from the second day i took the vaccine, and lasted for one day long.
CLONIC EPILEPSY 4/26/2022,  7/25/2022,  8/19/2022,  12/8/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Felt better but still felt dragged out, just didn't feel right; Felt nauseas, wrenching, and threw up; Spiked a temperature of 101 and felt nauseas and threw up some yellow stuff; She had a bad sinus headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (She had a bad sinus headache), FEELING ABNORMAL (Felt better but still felt dragged out, just didn't feel right), VOMITING (Felt nauseas, wrenching, and threw up) and PYREXIA (Spiked a temperature of 101 and felt nauseas and threw up some yellow stuff) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced SINUS HEADACHE (She had a bad sinus headache) and PYREXIA (Spiked a temperature of 101 and felt nauseas and threw up some yellow stuff). On 12-Mar-2021, the patient experienced VOMITING (Felt nauseas, wrenching, and threw up). On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Felt better but still felt dragged out, just didn't feel right). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE (She had a bad sinus headache), FEELING ABNORMAL (Felt better but still felt dragged out, just didn't feel right), VOMITING (Felt nauseas, wrenching, and threw up) and PYREXIA (Spiked a temperature of 101 and felt nauseas and threw up some yellow stuff) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 101 (High) high.         Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-045997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021 contains non-significant information.
pt recv vax; post vax the same day, pt exp a fever of 110.8 degrees (axillary) and a 5-6 cm area around the inject site which was firm & tender.
nausea migraine- alternated ibeuprophen and tylenol arm pain- took tylenol  kidney stone- nausea medication along with oxycodon
After my first dose, I started having spasms in my calves. Doctor decided that it was some kind of inflammatory response. It was never diagnosed as to why. After this dose, was hoping that it would subside but didn't, and had a fever for 36 hours. Calf spasms finally subsided about 6 months later.
1hr p/vax pt exp itching, swelling, burning @ inj site became progressively worse size 100mm x 100mm 24hr later then devel periorbital edema lt eye, lower lip edema & patches of lesions;
Developed 3 in wheal on left arm and 6cm wheal on right arm, erythematous and warm, mild induration <24 hours after application. Treated with warm compresses. Had used Permetrim for scabbies the night after application.
Vaccine given (R) deltoid 2/27/2020 9 am (approximately) within 24 hrs arm felt heavy she couldn't life (R) arm + sensitivity/painful arm to touch, esp @ injection site. Pt 2/29/19 AM vomited upon waking + fever > 102.5; she slept entire day - managed fever. 2/29/20 evening red circle around injection site appeared with density underneath. Developed extreme fatigue/HA. Symptoms lessen in intensity but not resolving. Neg flu test 3/6/2020.
Pt developed a rash on forehead after 15min getting a covid vaccine. Rash - 10cmx4cmx0cm redness on forehead.
A week after vaccination two quarter size rashes appeared on injection side. The rashes were with pruritus.
PATIENT STATED THAT HER HEART IS RACING AND SHE IS SHAHY, V/S CHECHED, HR 104, BP 153/96, 02sat of 98, patient has anxiety problem, educate patient to calm down, take a deep breath, breath slowly and relax, educate patient on the important not to reflect on the negative taught about vaccine. patient was observed, v/s 134/87, HR 88, patient states that she feel better and was send home.
This spontaneous report as received from a physician via company representative concerning a 16 year old male patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details, lot#, expiry date were unknown) dose 2 at 2 month interval via intramuscular route for prophylaxis. On an unknown date, the patient experienced rash at injection site. The patient visited the doctor's office. No treatment was given for the event. No lab tests were performed. The patient did not visit the hospital. Therapy with GARDASIL 9 was continued. The outcome of injection site rash was reported as recovered/resolved on an unknown date. The reporter did not provide the causality between rash at injection site and GARDASIL 9. There were no product quality complaints (PQC) involved.
Initial report received from a health care professional on 22 October 2010. An unidentified patient had received an intramuscular injection of FLUZONE HIGH-DOSE (lot number not reported) on an unspecified date after vaccination the patient experienced weakness, shortness of breath (SOB) and fatigue. Medical history was not reported. Per the reporter, the recovery status is unknown. The reporter for this case is the same as for cases 2010-06115 and 2010-06116. Documents held by sender: None.
had it when he was 35 years old.\ had the breakout for months \ suspected vaccination failure; had it when he was 35 years old.\ had the breakout for months; blisters; numbness; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 35-year-old male 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 vaccination failure (serious criteria GSK medically significant), shingles, blister and numbness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the blister was recovered/resolved and the outcome of the numbness was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and numbness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported for reporter's son. The age at vaccination was not reported. The reporter stated he had Shingles vaccine and set him on his behind.  The reporter stated even after the blisters cleared up, he still experienced numbness where he had the breakout for months. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
c/o feeling hot, temp not ck'd devel rash, arms, abdo, back & lower extremities rash-whelps; c/o itching & wheezing; 24 hrs was given Advil & DPH; pt stated feet & legs were swollen & hard to walk;
Patient received 1st of dose Pfizer from nurse on duty. Within five minutes patient become dizzy and nauseated. She was barely coherent and blood pressure was low at 66/45. She was laid on the floor to help and paramedics were called. paramedics took her to hospital. she was more coherent and bp improved but still having side effects.