chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got both of the Pfizer shots and he was sick as hell with COVID; got both of the Pfizer shots and he was sick as hell with COVID; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via the program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date unknown) as dose 2, single and; the first dose via an unspecified route of administration on an unspecified date (lot number and expiry date unknown) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The report the patient got both of the Pfizer shots and he was sick with COVID right now. The patient stated that the vaccines didn't take, and his antibodies were very low after the shots. The patient stated, So much for being protected. The outcome of the event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
A lot of blood in my urine (like a period).  This happened in the middle of the night after the onset of the normal reactions, fever, chills, aching muscles.  I took a Tylenol at 4:30 went back to bed and back to sleep.  When I got up my symptoms were much better except I had another major bleeding event.  The third bleed was much less but contained large clots.  After that there was only a incident with brown urine.  By early afternoon the urine returned to very light yellow and has remained that way.  There was never any pain, a mild cramping at the time of the colors mainly.  Bowel movements were  not affected.
Pt indicated that she broke out in hives the next day after receiving 3rd COVID19 Pfizer booster. No reactions with prior 2 doses.  Body aches and chills were also identified but expected.
Patient was mistakenly given  Moderna Covid Vaccine. It was noticed by staff when patient was called for scheduling of second dose. Mom informed of med error and stated that patient developed the following symptoms after having received the first dose of the vaccine: fever (102 F), chills, headache, cough, runny nose for a couple of days after administration.
pt recv vax 28MAR98 & about 5-10min p/vax c/o itching on tongue & throat;itching around neck;Epi given;needs to go to ER dept;
A report has been received from a Health Professional concerning a 3 year old female patient. The relevant history and concomitant disease of the patient were not reported. Concomitant medications included AGRIFLU. Patient has been receiving Nasal FLUMIST started on an unknown date for unknown indication. It was reported that patient had a blood clot with nasal mucous coming from nose (preferred term: epistaxis). The patient recovered from the event of blood clot with nasal mucous coming from nose on an unspecified date. The report was considered to be non-serious by reporter.
The left side of her face went completely numb and she couldn't move it. Her face was tingly and in the morning there was a significant droop. she couldn't eat or swollow.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old patient who received SHINGRIX for prophylaxis. On 14th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm and axillary pain. The patient was treated with non-drug therapy (Heat Therapy). On an unknown date, the outcome of the pain in arm and axillary pain were unknown. It was unknown if the reporter considered the pain in arm and axillary pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in arm that slided down into the armpit. The patient wondered if that was normal and can just keep moving it and putting heat on it like before. The patient's doctor did not have any doses to administer and did not found anyone else in trouble.
Information has been received from a physician concerning a female who on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23. The physician reported that the patient was only showing positive antibody to 14 different types of PNEUMOVAX 23. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-NOV-2015 19:19, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date; 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 7.5 and 2.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pericarditis. On 11/8 -chest pain - felt like heart attack - admitted to hospital- documented as STEMI pre cath - normal coronaries in cath. On 11/9 started on COLCHICINE. On 11/10 started on IBUPROFEN.
Starting to feel ill, no current fever, right shoulder (injection site) is tender and starting to swell
Pregnant; A spontaneous report was received from consumer who is a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was pregnant when vaccinated.   The patient's medical and pregnancy history was not provided. Concomitant medications not provided.  On an unknown date, the patient received the first dose of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.   The date of the patient's positive pregnancy test and first day of the last menstrual period were not reported. The estimated date of conception and due date were not reported.  The patient received Moderna vaccine and was pregnant, also stated that she received the Tdap vaccine 19 days ago as well.  Action taken with mRNA-1273 was not reported.  The outcome for the event exposure during pregnancy is resolved/recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Mild headache a day after receiving the Pfizer-BioNTech covid vaccine 2nd dose; nausea a day after receiving the Pfizer-BioNTech covid vaccine 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headache a day after receiving the Pfizer-BioNTech covid vaccine 2nd dose"; NAUSEA (non-serious), outcome "unknown", described as "nausea a day after receiving the Pfizer-BioNTech covid vaccine 2nd dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had the Pfizer as their first two doses; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had the Pfizer as their first two doses) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included VALSARTAN, METFORMIN and OXYBUTYNIN for an unknown indication.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had the Pfizer as their first two doses). On an unknown date, the patient experienced CHILLS (Chills). On 11-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had the Pfizer as their first two doses) had resolved. At the time of the report, CHILLS (Chills) had resolved.            The patient only experienced chills for one day.  No treatment information was provided.   This case was linked to MOD-2021-425605 (Patient Link).
62F with stage 2 mycoises fungoides, peripheral neuropathy, HTN, HLD, admitted from hepatology clinic on 3/25/21 for worsening liver injury and URI symptoms, found to be COVID positive. Liver biopsy with evidence of severe hepatitis with bridging necrosis. Course complicated by increase encephalopathy 3/31/21 concerning for acute liver failure, requiring stay in COVID ICU, transferred to hepatology service on 4/2/21. DDx remains viral hepatitis, autoimmune hepatitis, and drug-induced liver injury now on steroid therapy as of 3/31/21 and NAC. Pt. had worsening ALF and encephalopathy, transitioned to comfort care.  Pt died early morning of 4/4/21
Left arm red and swollen. Sore to touch and scratchy. Red from armpit to wrist. Ice on it made itching go away. Received Anthrax #6 8Feb04.
Approximately six hours after receiving the shot he developed a runny nose and congestion.  18-hours after the shot he developed a cough.  36-hours after the shot he began vomiting.  48-hours after the shot he developed a 103 degree temp.  He was given Robitussin for the cough, tylenol for the fever, Benadryl for the sinus and crackers, soup and liquids for the vomiting.
Small bowel obstruction. No history of prior abdominal surgery.  Occurred approximately 10 days after first dose. Spent 3 days in hospital.
severe refractory immune thrombocytopenia; This literature-non-study case was reported and describes the occurrence of IMMUNE THROMBOCYTOPENIA (severe refractory immune thrombocytopenia) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Rapid response to mycophenolate mofetil in combination with romiplostim in a case of severe refractory immune thrombocytopenia post COVID-19 vaccination.    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (severe refractory immune thrombocytopenia) (seriousness criterion medically significant). The patient was treated with ROMIPLOSTIM for Immune thrombocytopenia, at an unspecified dose and frequency and MYCOPHENOLATE MOFETIL for Immune thrombocytopenia, at an unspecified dose and frequency. At the time of the report, IMMUNE THROMBOCYTOPENIA (severe refractory immune thrombocytopenia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (severe refractory immune thrombocytopenia) to be related.    No concomitant information were reported.  Patient developed severe refractory ITP with multiple bleeding sites post second dose of COVID-19 vaccination.  Treatment resulted in rapid platelet count recovery.  Company comment: This literature-non-study case concerns a 25-year-old female patient with no medical history reported, who experienced unexpected event of  immune thrombocytopenia. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient developed severe refractory ITP with multiple bleeding sites, she was treated with ROMIPLOSTIM  and MYCOPHENOLATE MOFETIL at an unspecified dose and frequency. Treatment resulted in rapid platelet count recovery. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 25-year-old female patient with no medical history reported, who experienced unexpected event of  immune thrombocytopenia. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient developed severe refractory ITP with multiple bleeding sites, she was treated with ROMIPLOSTIM  and MYCOPHENOLATE MOFETIL at an unspecified dose and frequency. Treatment resulted in rapid platelet count recovery. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
36-48 hours after injection, mother called & reported large indurated, reddened area at injection site. (4in x 3in). Fever reported high of 103.2.
Child received the vaccines listed below. Within about 5 min, he developed periorbital edema and parents brought him back to the office for eval (from parking lot). He developed wheezing but no swallowing difficulty. He received DECADRON, BENADRYL, and Albuterol jet neb with good results. We watched him for 2 hrs. He developed facial hives but no reoccurrence of wheezing or cough. Sent home on Prednisolone, BENADRYL and instructions to use jet neb if needed.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 02-JUN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Vaccine at 3:10 pm March 18, arm pain and nausea began about 7:00 am on March 19. Nausea lasted about 18 hours. Sore arm was significantly less the morning of March 20th.
Developed H/A 30 minutes after Vaccine. Took tylenol  and felt better in 30 minutes.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ATORVASTATIN for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 03-Feb-2021, PAIN IN EXTREMITY (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 contains non significant information.
Patient scheduled to receive the second dose of the vaccine is being administered 90 days after first dose; This spontaneous case was reported by a physician and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient scheduled to receive the second dose of the vaccine is being administered 90 days after first dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient scheduled to receive the second dose of the vaccine is being administered 90 days after first dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Patient scheduled to receive the second dose of the vaccine is being administered 90 days after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications reported.
pt recvd 4th dose of vax & was found to be pos for Anti-HBs;
Post vax, the pt experienced swelling and redness at the site of injection down the arm and to the elbow.
sickness for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "sickness for 3 days". Additional information: Reporter stated that, patient had first dose two week ago but doesn't want to give an exact date. Experienced sickness for 3 days after the first dose, was asking if can refuse to take the second dose. While connecting the call to DSU, the caller hangs up. Provided the PMI phone number and hours of operation. Created an AE Form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 69 years old female patient with medical history of mastectomy in right side and unspecified cardiac history who on 15-OCT-2012, was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot number reported as: 1420AA, expiration date: 11-APR-2013) intramuscularly and a dose of FLUZONE both in her left arm. Concomitant medications included carvedilol, furosemide, imipramine hydrochloride, diazepam, ramipril, potassium chloride, pantoprazole and estrogens (unspecified). The pharmacist reported that he believed that the patient had received a dose of PNEUMOVAX 23 in the past at an unspecified date. The pharmacist also reported that the patient called the pharmacy on 16-OCT-2012 and reported that she was getting redness around the injection site and swelling around her elbow on the injection arm. The pharmacist reported that he instructed to the patient to follow up with primary physician, but he did not know if she ever contacted her physician or if the injection site worsened or had presently improved. At the time of the report, the patient's outcome for the adverse events was unknown. The relatedness for the adverse events was unknown for PNEUMOVAX 23. Additional information has been requested.
She explained a raised area (like a knot) on her arm at injection site occurred a couple days after vaccine. It went down after a few days and then reoccurred on day 9 and got bigger through day 10. She indicated it was about twice the size of the 1st time. Complained of tenderness, irritation, feeling nauseated and having headache. I called her on day 11 and she said she felt it was starting to subside and she felt a little better.
This case was reported by a physician (an allergist and not the physician responsible for vaccination) and described the occurrence of swelling in a 4-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received 3rd dose of INFANRIX at 0.5 ml in the right hip. An unspecified amount of time later, on the same day that the 3rd dose of INFANRIX was administered, the subject developed swelling. The event resolved within a couple of days. In the reporter's opinion, the events were probably related to treatment with INFANRIX. The physician also stated that according to the subject's mother, the subject experienced swelling, was out of sorts and mumbling following previous DTAP (manufacturer unknown) vaccinations. The outcome of these events was not reported.
who received "expired" vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.   This case was linked to MOD-2021-278394 (Patient Link).
He had his first Pfizer shot and recently got Covid; He had his first Pfizer shot and recently got Covid; breathing getting bad and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 30Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis", start date: 1989 (ongoing), notes: Sarcoidosis has created other conditions. No further details provided.; "Autoimmune disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DYSPNOEA (medically significant) with onset Nov2022, outcome "unknown", described as "breathing getting bad and pain"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2022, outcome "unknown" and all described as "He had his first Pfizer shot and recently got Covid". The events "he had his first pfizer shot and recently got covid" required physician office visit. The events "breathing getting bad and pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive, notes: confirmed he had Covid. Those test were done on the 23Nov2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Flu vaccine reaction. Vaccine administered to left deltoid on 10/23/06. Left arm pain and swelling fine 10/23/06 - got worse on 10/27. Went to ER. Treated with Benadryl 25 mg PO every 4-6 hrs prn and Predisone 40 mg PO daily x 4 days.
No additional AE; HBP reporting that VARIVAX was administered after it experienced a supported temperature excursion.; This spontaneous report as received from an administrator and refers to a patient of unknown age and gender. No information on patient's medical history and current conditions was provided. Concomitant therapies included sterile diluent.      On 12-JUL-2023 the patient was vaccinated with first dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # W025277 and expiration date 10-AUG-2024, 0.5 milliliter for prophylaxis (route and site of administration were not provided) (product storage error and no adverse event).  The temperature excursion was -8.6 degrees Celsius and lasted for 51 minutes. There was previous excursion that lasted 1 hour, 16 minutes, 0 seconds and the temperature was -11 degrees Celsius.