chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid; covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Jan2023 as dose 5 (booster), single (Lot number: GJ6742) at the age of 61 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN6203), in arm, on 24Mar2021 as dose 2, single (Lot number: ER8733), in arm, on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm and on 17Jun2022 as dose 4 (booster), single (Lot number: FJ4991), in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2008 (ongoing), notes: Diagnosed in 2008 after hysterectomy; "hysterectomy" (unspecified if ongoing), notes: Diagnosed in 2008 after hysterectomy. Concomitant medication(s) included: INSULIN taken for type 2 diabetes mellitus (ongoing). She rarely takes medication, but does take Insulin 70/30 everyday. They put her on a keto diet recently. she has been on insulin a long time. The patient called because she wanted to report after getting the five Covid vaccines from Pfizer she got Covid this week. The first vaccine was in Feb2021 and then the last was on 14Jan2023. She never had Covid before. Her first Covid vaccine was in Feb2021, the second in Mar2021, the third was in Nov2021, the fourth was in Jun2022, and the last one was Jan of this year (2023). She took two different home test that said, she was positive. She went to a local walk in and thought about checking in to get the medication to shorten it. Her husband got sick first, but he only had four Covid shots. She thinks her husband brought Covid to her after a trip to. Her husband got "pissy," and wouldn't wait at the clinic, so they didn't get Paxlovid. She doesn't feel that sick. Feels like a bad cold. She coughs a lot. If she lays down, she coughs more. She is taking Alka-Seltzer Plus Cold during the day and Nyquil at night. She has also taken Sudafed once a day for the past two days. She is not falling down dead, but doesn't feel particular great. She clarified that her symptoms started Tuesday, 28Feb2023, but she tested positive for Covid on 02Mar2023. She weighs 170-175 pounds right now (2023). The patient had not recovered from COVID at the time of report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300094238 similar report from same reporter;
Patient contacted the office 3/31/21 with complaints of arm/shoulder/axillary pains since receiving the vaccines, treated in office 4/5/21 for lump at injection site and continued axillary pain, treated 5/25/21 for shingles outbreak on chest, contacted office again 5/28/21 with elevated bp, heart rate and confusion- possible med reaction, contacted office 6/9/2021 with low blood pressure, dizziness, confusion, increased edema, treated 6/15/21 for urinary tract infection. Treated with oncology - notes from 4/13/21 notes patient is doing well, but with 'knot' on arm and axillary tenderness following COVID vaccine, then notes from oncology 6/24/21 notes patient found to have new retroperitoneal and pelvic lyphadenopathy, along with new splenic lesions with sudden rapid change in mental status and new diagnosed pulmonary hypertension. Patient placed on hospice and deceased as of 7/7/2021
Vaccine was given IM not SubQ. Patient was observed for 30 minutes following administration of vaccine. No adverse effects noted.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-SEP-2014, the patient was vaccinated with ZOSTAVAX (LOT # unknown, expiry date unknown) that were exposed to a supported temperature excursion. Concomitant medication was not reported. There was no product quality complaint. No adverse experience has been observed. Outcome of the event was unknown. This case linked to other case 1409USA002420 and 149USA002419 (Same reporter link). Additional information is not expected.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-OCT-2018, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # M039904, expiration date 26-SEP-2018, subcutaneously, (dose and frequency were not reported) for prophylaxis. The vaccine was administered along with a sterlie diluent, Lot # N008379, expiration date 14-NOV-2019. No adverse effects were reported. No product quality complaint (PQC) was involved.
pt recv vax 24MAR98 & reportedly the next day pt exp a rash on lt thigh that spread to generalized rash;pt was reportedly seen by MD;
Has 13 cm area that is swollen, hard and warm to touch. More pain than she's had in the past with flu shots.
Patient states he noted swelling to both wrists, knees, and ankles 1.5 hours after receiving both seasonal and H1N1.
Chronic migraine headaches for at least 2-3 hours per day since 2 days after the second dose of the vaccine. I have never had a migraine in my life previously.
Vertigo; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 30Mar2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient does not have any allergies to medications, food, or other product. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) since an unknown date and for an unknown indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021, the patient experienced vertigo and dizziness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events vertigo and dizziness was not resolved at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Within 2 minutes had pharyngeal tightness, sligh difficulty breathing, facial flushing and acute low back pain. Did not use Epipen, sx began to resolve in a few minutes. Took Zantac. All sx resolved when patient came to Occ health.
Nausea vomiting every morning after taking my normal medications. For 4 days after. Then it went away.
Tinnitus; Sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and PAIN IN EXTREMITY (Sore arm for a few days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     The patient's past medical history included Epstein-Barr virus infection (Got infected in her early 20's.).   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus) and PAIN IN EXTREMITY (Sore arm for a few days). At the time of the report, TINNITUS (Tinnitus) outcome was unknown and PAIN IN EXTREMITY (Sore arm for a few days) had resolved.            Concomitant products were not provided. Treatment medication were not reported. Patient had experienced tinnitus ever since the second dose of the Moderna vaccine, she has visited multiple doctors and has no reason for the tinnitus.
No adverse event; received expired doses of the Moderna COVID19 vaccine bivalent from the same vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about 2nd patient out of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-735211 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735211:Master case Patient 1
The patient came for an outpatient visit. About 1 minute after receiving immunization, pt c/o difficulty breathing. Dr. evaluated the patient - the following were her findings:  The patient was noted to be breathing fast with oxygen on her face. Patient reported itchy burning skin with "some" difficulty breathing. Denied tongue or lip swelling. Saturation was 96-100%. On auscultation patient had clear sounds, with good air movement, and no wheeze. Notable splotchy erythematous rash on forearms and neck, with no wheals to suggest hives. No facial or oral edema. Pt was given O2 and benadryl.  The patient was discharged to home.
Takotsubo Syndrome - chest pain, nausea and weakness. ER for Tx.
Rash on body for 1 day. Pediaprednisone and Benadryl.
On 26AUG92 5PM, t100; APAP rash very light, noted around site & above & below diaper line; bath given; itching devel & powder applied; 27AUG92 t101; rash was sl more prominent;
Patient seen back in office 2 hours after shots given in office. Patient returned with whelps and itching all over. Seen by Dr. and given dose of BENADRYL.
Site: Pain at Injection Site-Medium, Additional Details: Patient's symptoms resolved within about 40 minutes after vaccination given. EMS was called. Patient stabilized and refused ER visit/
14 year old male patient was given FLUBLOK instead of Flulaval, no AE; 14 year old male patient was given FLUBLOK , no AE; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 year old male patient who inadvertently administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA VACCINE INACT SPLIT 3V [FLULAVAL] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation.  On 21-Dec-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Shot prompted a Lupus flare of inflammation of  right side of my face.  Nose pain, eye pain, temple pain and ear fulness and pain.  Lighted headed.  Happened right after both shots.
headache; nausea; left the vaccine out for longer than 6 hours after the vial was punctured; A spontaneous report  was received from a consumer who was a 53-year-old, female patient, who was administered Moderna's COVID-19 vaccine and the patient received first dose more than six hours after vial was punctured/expired product administered, and had headache and nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 FEB 2021, the patient received her second dose of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.   The patient's doctor told her that she received a non-effective first dose of the vaccine because the doctor left the vaccine out for longer than the six hours after the vial was punctured which was on 14 JAN 2021. The patient returned to the healthcare professional for second dose and she was informed her first dose might had been invalid/ineffective. On 11 FEB 2021, the patient experienced headache and nausea. The treatment included ondansetron as an indication for nausea on 12 FEB 2021 in the morning (am).  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable.  The outcome of event, received first dose more than six hours after vial was punctured was considered as resolved on 14 JAN 2021. The outcome of the events, headache and nausea were considered as unknown.; Reporter's Comments: This case concerns a 53-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Expired product administered. Additionally, the patient experienced headache and nausea after receiving their second of two planned doses of mRNA-1273 (Lot number: 029L20A). Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
got Covid even after completing the shots; got Covid even after completing the shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid even after completing the shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got Covid.  Clinical course: Caller needed an explanation why he got Covid even after completing the shots, he had the 2 primary doses and about to get the 2nd booster dose, he even wore a mask and kept on washing his hands many times. There were some medical questions addressed by this program forwarded/referred to Medical Information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
None, The abberation that occurred is the patient was given Menactra by nurse, but the Dr did not order it. Per the HCP follow up report-There was no adverse event. The wrong vaccine was given (Menactra) on 9/22/05, but there was no adverse reaction to the vaccine. The vaccine was given at approx 2pm that day. Unfortunately, the nurse did not document the lot # for the MMR vaccine.
Information has been received from a 24 year old female patient (also a registered nurse) with no pertinent medical history and with azithromycin allergy reporting on herself who on 13-JUL-2011 was vaccinated intramuscularly with a dose of GARDASIL (dose and lot # not reported). There was no concomitant medication. On 13-JUL-2011, the same day about 4 hours after receiving the shot the patient broke out in hives. The hives started on her legs and spread to the rest of her body. One of the patient's eyelids almost swelled shut. The patient also had difficulty breathing. The patient took at CLARITIN and the events resolved. On 15-JUL-2011 the patient developed pain in her left arm pits and her lymph node felt swollen. The patient developed pain in her right knee and hip. On 16-JUL-2011 the patient began taking aspirin and then on 18-JUL-2011 began ibuprofen. On 19-JUL-2011 the patient's arm pit pain resolved. On 25-JUL-2011 the patient had bleeding from two of her fingers. She had blood came out from under nail bed. And the patient had about 15 "petechiae" on her body. On 27-JUL-2011 returned from a trip and went to the emergency room. Blood tests were performed but all her levels were normal. The patient was still having joint pain had had not resolved. The joint pain had now spread to other parts of her body, including her wrists. At the time of reporting, the outcome of blood came out from under nail bed and the patient's 15 "petechiae" on her body and her lymph node felt swollen were unknown. Follow up information had been received from a licensed practical nurse who reported that the first dose of GARDASIL was given on 13-JUL-2011 (lot # 669285/0691AA). No concomitant vaccines were given. Many tests were performed including Lyme, rheumatoid factor (RF) test and C-reactive protein (CRP) test; all were normal. The physician suggested to the patient that she waited about six weeks for symptoms to subside before consulting a rheumatologist; in the meantime, the patient prescribed ALEVE and told to exercise to keep limber. Follow up information has been received from the physician who reported that the patient with a history of rash after azithromycin and no illness at the time of vaccination was vaccinated with a first dose of GARDASIL in the afternoon. It was reported that on 13-JUL-2011, the patient experienced severe joint pain eventually, started as hives and muscle twitches 4 hours post vaccine and lasted 12 hours. On 16-JUL-2011, 3 days after vaccination, joint and axillary pain begun. Labs performed were all normal, the patient had been referred to rheumatologist. It was reported that the events required an emergency room/doctor visit. At the time of reporting the patient had not recovered from axillary pain and severe joint pain. Severe joint pain, hives, muscle twitches and axillary pain were considered to be disabling by the reporter. Additional information has been requested.
Spontaneous bleeding and bruising of individual fingers and toes.  Bruising would appear on a single digit and remain for 24-72 hours.  Not related to any injury or known reason to cause bruise to occur.  The frequecy of bruising increased post vaccine injection.  From 4/9/21 to the present there have been 12 episodes of spontaneous bruising.  Patient did seek medical advice from a hematologist in August 2021. Laboratory testing was done including complete cbc, PT & PTT, ESR, von Willibrand factor screen, serum Cryoglobulin, serum Complement C4, serum Complement C3, Fibrinogen Antigen and ANA Direct.  All test results with the exception of ANA were WNL. The ANA was positive and abnormal.
No adverse event; 6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration) and NO ADVERSE EVENT (No adverse event) in a 32-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.
24-30 hours after receiving vaccine pt complains of sore leg. Redness of distal 1/2 to 1/3 of left thigh. No obvious tenderness left inguinal node. Referred to doctor (on call) ? Allergic reaction to DTaP. Advised to pt to follow-up if fever tenderness.