chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site rash; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date, Rash and Hives. Concomitant products included POTASSIUM for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were reported  as unknown medication for high blood pressure with diuretic.   The treatment information was not  reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date, Rash and Hives. Concomitant products included POTASSIUM for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were reported  as unknown medication for high blood pressure with diuretic.   The treatment information was not  reported.
Small, itchy bumps on my body - especially on my arms, legs, and torso. The itchiness woke me up on the night I got the vaccine. The rash is subsiding but not gone yet. I have been taking Benadryl at night to help with the symptoms
Mother reported today at visit that about 3 hours after receiving DTap at the 2 month visit, patient became very fussy and cried inconsolably for approximately 12 hours. He also had fever, and his right thigh was red and swollen. She administered TYLENOL, and the symptoms gradually subsided.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates in 2004 and 2013, the patient was vaccinated with the first and second doses of VARIVAX injection (dose, frequency, route, lot # and expiration date were not reported), respectively, for prophylaxis. On 10-MAR-2017, the patient was inadvertently vaccinated with a third dose of VARIVAX injection (dose, frequency, route and lot # were not reported) with expiration date of 23-NOV-2017, for prophylaxis. The medical assistant did not know the lot number of any of the diluents (manufacturer unknown) that were used to prepare the doses of VARIVAX. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
WRONG VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced wrong vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wrong vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210603388.
This spontaneous report was received from a physician assistant via a company representative referring to a 70 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date, reported as 1 year after the patient was administered ZOSTAVAX vaccine, the patient experienced the shingles virus. It was unknown whether the patient sought medical attention, a treatment was given for the adverse event or lab diagnostics studies were performed; it was unknown if the patient was hospitalized or experienced significant disability, incapacity, life threatening, cancer or an overdose. The patient did not die. At the time of the report, the patient was recovered from herpes zoster. The causal relationship between herpes zoster and ZOSTAVAX was not reported. Additional information has been requested.
Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Mar2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Mar2021 (also reported as at 15:45), the patient experienced metal taste in mouth. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metal taste in mouth was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt received vaccine on 6/17, arm was sore until today when he developed a 2 1/2" very itchy red circular spot around the injection site,   he took several doses of advil per recommendation of pharmacist and is now feeling much better
Around 10 that night I felt chills, lethargy, and fever. Next morning a headache. Still have a headache.
1 week after vaccine, the site where I received the shot became a hive and my throat started to itch and become tight. I took 2 Benadryl that didn?t seem to calm the reactions. I went to the ER and received Famotidine and dexamethasone.
SYMPTOMS OF COVID; This spontaneous report received from a patient concerned a 21 year old male. 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: 211A21A and expiry: 14-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced symptoms of covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms of covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220150408 and 20220151154.
Client called afterhours on 3/14/2008 to report "hivelike rash on arm where shot was" Started >24 hours after immunization.  Denies fever.  Taking OTC Benadryl for itch.  "Not bad enough to go to the Dr."  Client was contacted a.m. 3/17/2008 and sxs were resolving but client wanted RN to see it.  Client is a night shift worker and was going to do a walkin clinic and see nurse.  Client contacted 3/18/2008.  Symptoms almost totally resolved.
No discomfort in arm for 2 weeks after vaccination. Full pain in most of left arm
Pneumonia and mrsa got worse and was hospitalized. Stopped breathing  was on leave from January to April. St experiencing issues with lungs and mrsa infections.
pt recv vax; hypotonic & hyporesponsive; adm to hosp;
allergic reaction; hives; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and URTICARIA (hives) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 093D21A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient mention had hives before but is spiraling now like crazy.  The patient's past medical history included Hives.    On 20-Jul-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 HYPERSENSITIVITY (allergic reaction) and URTICARIA (hives). At the time of the report, HYPERSENSITIVITY (allergic reaction) and URTICARIA (hives) outcome was unknown.        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.   Concomitant medication and treatment were not reported.  She stated her allergic reaction are going crazy. She gets hives every single day. The hives started 2 weeks after the first shot. She wanted to know if there is anything that can be done to stop the allergic reaction from going crazy.
Site: Redness at Injection Site-Mild, Systemic: numb over entire body, could not move, after 7days still numb-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: she also has cystic fibrosis. after initial 7days, she still is numb from knees down to toes, arms to fingertips. she is going to the er for evaluation
pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after; arthritis; joint pain; This is a spontaneous report received from contactable reporter(s) (Physician).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: PANCREATIC CARCINOMA STAGE IV (death, medically significant), outcome "fatal", described as "pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after"; ARTHRITIS (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain". The events "pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after" required emergency room visit. It was unknown if therapeutic measures were taken as a result of pancreatic carcinoma stage iv. The patient date of death was unknown. Reported cause of death: "pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after". It was not reported if an autopsy was performed.  Clinical course: Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. It was unknown if COVID Prior vaccination and if COVID tested post vaccination. Patient in remission from pancreatic cancer. Decided to get Pfizer Bio-N-Tech Covid-19 vaccine series. Immediately after second dose, she experienced arthritis and severe joint pain. 4 months after getting second dose, she was diagnosed with stage 4 cancer and passed away shortly after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pancreatic carcinoma stage  IV  and the suspect product BNT162B2cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after
Increased lymph node swelling and tenderness in left axillary and supraclavicular nodes, general malaise, chills, body aches that developed 1 week post vaccination. Symptoms in arm improved over the next 48 hrs but patient still does have Increased swelling in supraclavicular lymph nodes.
Pt was given 2nd dose of Moderna one week earlier than recommended schedule (1st dose on 8/7/21, 2nd dose on 8/28/21), vaccine error was discovered today on 9/24/21. Called patient to follow up, he stated he felt okay, no adverse reaction noted.
fever/chills started 8am on 2/5 lasted all day Pt. took 1 Tylenol 650mg. On 2/6 red bump slightly raised size of quarter appeared upon waking located 5 in below injection. Only hurts on touch but radiates heat Today (2/7) spot is pinkish color about same size but a little spread out.
8/27/2000 felt warm 8/28/2000 99.9 axillary 06:30 am @ 2:00 pm had almost 103 temperature.  Broke out in rash resembling measles or rubella. 8/31/00 checked with mom child continued to run fever to 103 fever, rash still present but improve won't eat
Warm around shot site after 2nd dose; Red area around shot site after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm around shot site after 2nd dose) and VACCINATION SITE ERYTHEMA (Red area around shot site after 2nd dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 VACCINATION SITE WARMTH (Warm around shot site after 2nd dose) and VACCINATION SITE ERYTHEMA (Red area around shot site after 2nd dose). At the time of the report, VACCINATION SITE WARMTH (Warm around shot site after 2nd dose) and VACCINATION SITE ERYTHEMA (Red area around shot site after 2nd dose) outcome was unknown.            Other relevant medication history included thyroid medication. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
moderate soreness at injection site 12 hours after; mild achy joints (knees, hips) 24 hours after; redness/tenderness/heat at injection site 48 hours after; redness/tenderness/heat at injection site 48 hours after; redness/tenderness/heat at injection site 48 hours after; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 30-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Lot number: ER8732), via an unknown route of administration in left arm on 26Mar2021 at 11:00 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. She had no known allergies. Concomitant medication included escitalopram (ESCITALOPRAM) for an unknown indication from an unknown date. No other vaccine in four weeks. Other medications in two weeks were birth control, escitalopram and multivitamin. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Lot number: EN6199), via an unknown route of administration in left arm on 05Mar2021 at 13:00 as historical vaccine (at the age of 30-years-old) as dose 1, single for COVID-19 immunization and experienced very mild soreness at injection site. On 27Mar2021 at 04:00, the patient experienced moderate soreness at injection site 12 hours after, mild achy joints (knees, hips) 24 hours after and redness/tenderness/heat at injection site 48 hours after. No COVID prior vaccination. No COVID tested post vaccination. No treatment for events. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
pt was crying when recvd vax; held breath X 5 sec & turned dusky on the face; pt started to turn pink & breathing after 10 secs;
her left arm hurt; warm to the touch for about a week; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 65-year-old female patient received bnt162b2 (BNT162B2, formulation; Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9264) as DOSE 1, SINGLE (at the age of 65-year-old) for covid-19 immunisation. Medical history included ongoing cancer and metastatic thyroid cancer (had metastatic thyroid cancer in her lungs rare and it is working on her slowly from an unknown date and unknown if ongoing. Family Medical History Relevant to AE was none. Concomitant medication included lenvatinib mesilate (LENVIMA) taken for cancer from Jul2020 to an unspecified stop date. On an unspecified date, the patient stated with her first Covid shot, her left arm hurt and was warm to the touch for about a week. It was the only reaction she had from it. The patient underwent lab tests and procedures which included covid 19 test was positive on Nov2020 She had Covid, it she did not have a fever but had extraordinary fatigue and stated that she has that now too. She said that she walked to her car and back and she is fatigued. The outcome of the event left arm hurt was reported as not recovered and for the event warm to the touch was unknown.  No follow-up attempts are possible. No further information is expected.
Headache, shoulder pain worsening over several weeks, arm and hand weakness and numbness.  Prescription for prednisone after 3 weeks, relieved symptoms somewhat. Problems continued, recovery lasted another 8 weeks before getting back to normal.
Narrative:  73yo patient died on 10/21/21 after had self-presented to community emergency facility on 10/9/21. Pt was consult to cardiology and kidney on 10/20/21. No other info provided given about pt's death. Pt had received covid vaccines on 2/1/21 & 3/4/21. Likely vaccines not related to pt's death given pt's age and length of time between date of vaccines given & date of pt's death.
Patient developed fever and febrile seizure approximately 10 days after varicella immunization. 1-2 days after seizure, child developed exanthem consistent with varicella.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, received third 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) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient experienced COVID.  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  Company comment: This spontaneous case concerns a 66-years-old female patient, with medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine. SARS-CoV-2 test was Positive as on unspecified date. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was resolving. Non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis could be the risk factor for the event. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 66-years-old female patient, with medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine. SARS-CoV-2 test was Positive as on unspecified date. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was resolving. Non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis could be the risk factor for the event. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Pateint received 1st Moderna COVID 19 vaccine on 03/18 she was given a card and appointment for her next vaccine 28 days later. She came in. She did not fill out paperwork and told person giving vaccines she needed her second. She received her second shot. When she came to desk for second dose she told a volunteer she had just recevied her second shot. Volunteer then reported to Nurse.  Event was documented on 4/2/2021. Nurse to follow up with patient of any adverse reactions. None at time of report.
Bruising, very swollen, red, hard as a rock and soar. Expected to be mildly soar and a bruise but the swelling is the diameter of a baseball, hard and very soar. Have had a headache everyday since receiving shot and have had to take more pain relievers in the last few days then over the last 10 years. Site is very soar, red and swollen, not what I would consider a "mild" reaction. Received a tetanus with whooping cough vaccine, not sure what it was called or who manufactured it.