chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/16 pt. presented with inflammation from mid upper arm to mid lower arm on inside of arm. Stated that injection site had been warm and swollen and spreading down arm. Injection site clear but itchy as it continued to move down arm warm and bright red. At this point recommended Diphenhydramine oral. That evening swelling going down but redness continues to move down arm. 10/17 pt arrived around 10AM. Lower arm swollen, red and slightly warm. No pain, still just itching. 10/18 noon, less swollen and improving from previous day. 10/20 1000 AM. Can see an outline of areas that have been affected. Pt's only complaint of internal itching at site.
Reports onset of extreme fatigue, generalized body aches and generalized joint pain began 24 hours following vaccination. Reports induration size of fist at injection site on right deltoid.
Pain at the left side of the heart coinciding with each heartbeat, then heartbeats accelerated to a very rapid beat lasting about 15 seconds the returning back to normal within milliseconds. Never experienced this my entire life, even after running 10 miles, 4 times weekly. Usual minor flu-like symptoms were also felt like dizziness, and then tiredness. Slept a lot on the day my heart rate went up.
3/12/21 I began to experience soreness in both my legs.  3/13/21 I began to experience swelling in both my knees, but primarily in my left knee and leg.  3/14/21 I could barely bend my left knee, but there were no issues with my right knee.  By 3/16/21 some of the swelling had gone down on my left knee.  As of today 3/17/21 I still have some swelling in my left knee and lower leg.
Growing pain -- unable to reach pants pocket by 5:00 PM, 100.0F that night (normally 97.7). Severe pain overnight, pain all next day, still sore late Saturday (injection was Thursday).
Death; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. The reporter informed there were 2 deaths of those who had received their second dose of Moderna vaccine, same day, same location who died 2 hours after vaccine administration. Treatment information was not provided.  This is a patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unk) and died after he received the second dose of vaccine. No Medical History information was reported. Concomitant product use was not provided by the reporter Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is a patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unk) and died after he received the second dose of vaccine. No Medical History information was reported. Concomitant product use was not provided by the reporter Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Unknown cause of death
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 14:30 as dose 1, single (Lot number: ER8735), in left arm and on 05May2021 at 13:30 as dose 2, single (Lot number: EWD175) at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 024021A), in left arm and on 18May2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACICLOVIR, start date: Dec2010, stop date: 12Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Sep2022) Negative; (20Sep2022) Negative; (21Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Adverse event: Anti-viral details: product COVID 19 Treatment, Paxlovid, Treatment start date 13Sep2022, Treatment stop date 18Sep2022, Indication Treatment of COVID-19. Rebound: After feeling better (only fatigue remained and that was improving) and testing negative with rapid antigen tests on 18Sep and 20, I started to have sinus/throat symptoms and congestion, and extreme fatigue again on 21Sep afternoon, and tested positive on rapid antigen test again on 21Sep at 7:30 pm.
Patient with itching about 6 hrs after vaccine, followed by swelling, warmth, erythema. Allergic reaction cellulitis.
About 1 1/2 hours after vaccination, they were in Target.  Patient began breathing heavy, head and arms felt heavy, eyes fluttering and looked like she wanted to sleep.  Was seen at the Urgent Care where breathing returned to normal and medical provider felt she may have had panic attack or hyperventilated.
VARIVAX given 8/5/09 - 48hrs later, seen in office with 3-4cm circular cellulitic rash at injection site.
Limited movement of left arm; Muscle pain; Pain in her arm; This is a spontaneous case reported by a pharmacist to agency (reference number: SEQ20-00421) and initially received on 28-Jan-2020, concerning an 80-year-old, female patient   The patient's medical history included thyroid issue.  The patient did not take any concomitant medications.  On 11-Dec-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 262311 and expiration date: 30-Jun-2020] for influenza prophylaxis.  On 12-Dec-2019, the day after receiving the vaccine, the patient developed pain in her arm. The patient called her health care provider (HCP) and he advised her to wait to see if the pain resolved.  On an unknown date, reported as after injection, the patient complained about muscle pain and the muscle pain that had not gone away. It was reported that the patient had limited movement of left arm.  On 15-Jan-2020, four days after vaccination, the patient was seen by her HCP for muscle pain and limited movement of left arm. It was reported that the magnetic resonance imaging (MRI) had been scheduled and that tretament measures associated with the events included medication no name known by reporter.  At the time of the report, the patient had not recovered from the events of muscle pain and mobility decreased, while the outcome of the event pain in arm was not reported.  The case seriousness and causality assessment were not provided.  Company comment: The patient experienced mobility decreased, pain in extremity and myalgia after vaccination with the suspect product, Fluad (TIV). Medical history of thyroid issue may have contributed to development of the events. No concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced mobility decreased, pain in extremity and myalgia after vaccination with the suspect product, Fluad (TIV). Medical history of thyroid issue may have contributed to development of the events. No concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Felt like I had the flu; Pressure In Head; Sore arm; Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like I had the flu), HEAD DISCOMFORT (Pressure In Head), PAIN IN EXTREMITY (Sore arm) and PAIN (Aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included AMLODIPINE for an unknown indication.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like I had the flu), HEAD DISCOMFORT (Pressure In Head), PAIN IN EXTREMITY (Sore arm) and PAIN (Aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Flu-like symptoms, at an unspecified dose and frequency. In February 2021, INFLUENZA LIKE ILLNESS (Felt like I had the flu), HEAD DISCOMFORT (Pressure In Head), PAIN IN EXTREMITY (Sore arm) and PAIN (Aches) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Red lump 2 inches below the location of the shot It's hot to the touch and sore It matched what the CDC's site said about side-effects, except for being 2 inches away from the location of the shot
Information has been received from a registered nurse concerning a 25 year old female with allergies to penicillin and sulfa antibiotics, who on 27-NOV-2007 was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly (lot# 658560/1062U).  There was no concomitant medication.  The nurse reported that on 15-JAN-2008, the patient received the second dose of GARDASIL 0.5 ml intramuscularly (lot# 658560/1062U).  The nurse noted that in March 2008, the patient developed red flushing on her cheeks, nose and forehead and experienced hot flashes.  The patient sought unspecified medical attention.  The nurse reported that the patient recovered (date unspecified).  No other information was available.  Additional information has been requested.
Pt vax 3 doses in 1982.  Given 2 booster doses on 08May & 20Dec, 1990.  Found to be non responder.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-APR-2015, the patient was vaccinated with dose of RECOMIVAX HB (reported batch#J010201, lot# 0589AE, exp date: 27-MAR-2015) (strength and route not reported) which was expired. No adverse effcts were reported. The outcome of the patient's events was not reported. Additional information has been requested.
Lack of appetite; Mild chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lack of appetite), CHILLS (Mild chills) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Lack of appetite), CHILLS (Mild chills) and FATIGUE (Fatigue). At the time of the report, DECREASED APPETITE (Lack of appetite), CHILLS (Mild chills) and FATIGUE (Fatigue) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-027237 (Patient Link).
headache; COVID-19; chills; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), HEADACHE (headache) and COVID-19 (COVID-19) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced CHILLS (chills) and COVID-19 (COVID-19). On 14-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, CHILLS (chills), HEADACHE (headache) and COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (COVID-19) to be not related. No further causality assessments were provided for CHILLS (chills) and HEADACHE (headache).    No relevant concomitant medications were provided. He received a monoclonal antibody treatment on 14 Jan 2021 at his physician's recommendation. No treatment information was provided for headache.
Swelling , pain and redness at injection site, breathing difficulty, rapid heart beat, hard to swallow, fever, chills, sweats, headache, muscle and bone pain, nightmares, nausea, diarrhea, tiredness
Patient started with pain in arms. Couldn't lift both arms up to head. Then develop mucous in chest and cough. Then arms swells and are red. Cough and mucous got really loud 2 weeks later. Patient had to go to ER. Patient got Azithromycin 250mg two day 1, one x4d. Patient still has redness on face under eyes and has not gone away until now.
Migraines; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines) and HEADACHE (Headaches) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraines) and HEADACHE (Headaches). At the time of the report, MIGRAINE (Migraines) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Red bump with red and white circular areas surrounding. Started on 6/4, symptoms worsened on 6/5. Pt sought care on this day, was diagnosed with cellulitis and given Clindamycin.
CONGESTIVE HEART FAILURE; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race, and ethnic origin. 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 (series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, with frequency time 1 total for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter reported that, "one person went into congestive heart failure." The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of congestive heart failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211205693 and 20211210341.; Sender's Comments: V0: 20211210328-covid-19 vaccine ad26.cov2.s-congestive heart  failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Initially admitted to ER for symptoms of stroke. Later admitted to ICU and put on ventilator due to vomiting and inhaling it, which cause respiratory distress, then suspected of having an infection. He was taken off the ventilator after almost 2 days and moved to a regular room. He was discharged 6 days later.
Instant onset Sharp headache, spiked fever, cramping, nausea, with all adverse events intensifying over a 30 minute period
In November 2022, I began to experience a different type of tinnitus than I'm used to. It's audible. The sound is coming from the inside of my body, but it's actually audible to other people. I even made a recording of it. This has only happened three or four times and does not occur regularly. I've had other types of tinnitus for a long time now, but this is a new form. My doctor had me undergo an MRI, which did not detect anything discernable that would have caused it.  I've also had vertigo for years, but it's gotten worse recently. My doctor thinks it may be related to my migraines, but we're not entirely sure. I should add that on 2/15/2023, I went to an audiologist to undergo a hearing test. An odd pattern of hearing loss was detected in the left ear.
There were no adverse reactions, however pt was 17 years old at time of administration.  When the vaccine was given the computer system was not working and the pt was was given his dose via a paper form. After the second dose was administered on 1/28/2021 Moderna Lot #029L20A Left Arm, into a computer chart our IIS rejected administration due to age. Pt was called to verify age, pt confirmed he was 17 at time of administration but did not report any adverse reactions to vaccine.
TINNITUS; EAR DISCOMFORT, EAR PRESSURE, EAR FULLNESS; This spontaneous report received from a patient via a company representative 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced tinnitus, and ear discomfort, ear pressure, ear fullness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tinnitus and ear discomfort, ear pressure, ear fullness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210758691 and 20210758713.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
CLINICAL IMPRESSION 1. Hypoxia  2. Wheezing  3. Pulmonary infiltrate  4. Shortness of breath  5. Thoracic aortic aneurysm without rupture
Pt awoke the following day with weakness, presented to the emergency room for evaluation.  Admitted to hospital on 2-19-21. Required 2L of oxygen by nasal cannula on 2-21-21. Discharged on 2-22-21 to home with home health to cont. and PT and OT.
Pt fainted after administration of vaccine. 12-7-09 - 1325 - spoke with mother, she stated "fine" "no problem" encouraged to call RN for questions
Patient reported during immunization screening on Sept 22 when in clinic to receive Varicella vaccine that he was worried he had myocarditis from Covid19 vaccination received 9/10/21 and wanted to know if he should get dose 2.  He stated he had an elevated heart rate of 80-100 bpm and had called an ask a nurse line at the clinic after the vaccination.  He received the Varicella vaccine without inicdence.  Upon checking records, doctor from facility had tried to call patient back on 9/11/21 but patient didn't have voicemail and didn't return call to clinic.  Patient called clinic on 9/24/21 and had experienced chest pain again and asked to see a provider.  He was examined by NP that day.
EXHAUSTED; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 18-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ulcerative colitis, and crohn's disease. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 19-APR-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from exhausted on 19-APR-2021. This report was non-serious.
I had no side effects after my first two shots, except soreness at injection site. The booster resulted in a 100ºF fever, body aches, chills, sweat, fatigue and nausea/loss of appetite. I got my shot around 9:30 am, the side effects began around 9:30 pm that day (12/17/2021) and lasted 24 hours.
Client became very dizzy, rash with welts at 6pm on 02/026/2021 Client went to hospital ED that same day and received Benadryl and other medications that she could not remember   Then on 03/01/2021 visited Dr who prescribed prednisone for her rash which she began the next day on Tuesday and completed the course of treatment  The rash was resolved on 03/02/2021 Then she was prescribed prednisone for 03/24/2021 to take the day before the 2nd dose which was on 03/25/2021
Headache, shivers, temperature, sleepiness. Took TYLENOL every 8 hours. Felt better by 06/23/2018.
Arm turned red and warm with lump  almost immediately after vaccine. Continues to become larger and still a lump at Day 10.
pt recv vax & noted weakness of feet-over next 24hr worsens to include knees & hands;pt adm to hosp EMG showed conduction abn of legs & hands;dx GBS;pt able to walk small distances & fine motor of hands improving;
Patient reports that after receiving her 2nd Shingrix on 1/11/23 that her arm became infected. She reports redness, pain, warmth and swelling at the injection site and fever.  She was seen by her provider on 1/14/23 and was given Bactrim DS 1 tablet BID for 5 days for cellulitis to her left upper extremity.  Patient states her arm is improving and is now only a little red.