chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2022 as dose 4 (booster), single (Lot number: Gh9694) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Positive, notes: Test-positive minimally symptomatic rebound following completion of five-day. PAXLOVID course. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2, BNT162B2 OMI BA.4-5 cannot be excluded. The case will be reassessed once new information is available.
Fever, chills, nausea, shakes, headache, tiredness - still ongoing. Arm soreness of site injection.  Confined to bed. Tylenol every 6 hrs
This spontaneous report was received from a 79 year old female patient regarding herself. The patient had no pertinent medical history or drug allergies. On an unknown date in 2011, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported) in the arm. Concomitant therapies included (reported a atnolol) atenolol for mitral valve prolapse(reported as mitro valve) and LEVOXYL (reported as lavoxil) as thyroid medication. On an unknown date in DEC-2012, the patient stated that marks start out as red and as the months go by the patches that are 2 to 3 inches in diameter turn brown. Treatment rendered for the event was unknown. There was no laboratory tests performed. The outcome of the event was reported as unknown. The patient did not see medical attention. Additional information is not expected.
Myalgia, Fever, Chills, Stomach pain, & arm pain Narrative:
No adverse events were reported.  The patient received a second dose of the same vaccine on 12/9/2021.  On investigation, it was found that the date of birth furnished at the time of vaccination was one year less than the date of birth recorded in Immunization Registry making the child reported age 5y6m and 5y 8m respectively.
Pt recv'd 5th dose of Anthrax on 3/23/99;pt states he was dxed w/ Bell's Palsy in late May.Tx w/ prednisone. Patient states to still have Bell's Palsy symptom to date.  Patient states that he went to the Anthrax briefing at theater on 2/2/00 given by the allergist who mentioned that he was seeing a patient with Bell's Palsy which the patient thought was Anthrax related.  Patient states that  after asking the doctor "How was these adverse reactions tracked? The doctor answered through pilling out a VAERS form patient states that at that point he decided to report related incident by filling a VAERS form at Public Health the following day. Per follow-up: Approx 6 mos after shot #6 (24Sep99) a raised rash formed on L upper ulnar side of arm. Rash was itching. Pt also states same type of rash on R arm, same spot. Rash on R arm resolved, L did not. Pt saw provider on 24 May and was given a hydrocortisone type cream to apply, shortly after, a second rash appeared in close proximity to L axilla area - this rash was on the front part of top of arm. Pt has refilled cream x 1 and rash is still present, however rash does not alway itch. Pt also states possible spread to inner thigh area, but not as severe.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild
Experienced the expected soreness / heaviness of arm, but also had a sizable red mark on my arm about an inch below the injection site. The injection site never really felt sore or showed redness. The mark was probably 4 inches long, 1-2 inches wide and was fairly red for about two days. There was pain exactly where the mark was when pressed on.
Soreness in her arm; Warm to touch; Injection site was hard; Injection site was red; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 045A214) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown. Not Provided          Concomitant medicine and Medical history were not reported. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received on 04-Aug-2021 included no new information
This was a medication administration error attributed to parental (parents are separated/divorced) miscommunication and a medical records issue. There were no adverse events noted, and patient was observed for 30 minutes instead of 15 after shot administration and discovery of error.  Patient arrived at clinic with his mother as guardian. Patient and mother verbally verified more than once that this was the patient's first dose of the Pfizer vaccine. Patient's paperwork from registration process confirmed the first dose. Patient did not have a CDC vaccination record with him.  Once shot was administered and record was being entered into the database, the patient's medical record number indicated that this was, in fact, his second shot.  Database indicated that first shot was administered on 01/22/2022 (Pfizer lot #FK9729, mfg exp 05/2022). Second dose was administered today, 02/01/2022 (actual second dose given on FEBRUARY 1...but it is January 31 in the contiguous (Pfizer lot #FK9729, mfg exp 05/2022).
Lt thigh swollen, hard, red w/warmth, child will not bear wt. Course of 4-41/2 hrs
I got diagnosis for cancer, had cancer surgery and treatment from that. I still have radiation to do.
Achy Muscles and it hurts at night to sleep and it hurts to move her arm.  Patient also states the pain goes into her breast.
Pregnant at time of both vaccines, due date 4/30/2021 Several hours after receiving second dose of vaccine started sweating a lot. A few hours later was running fever, body aches, and exhaustion. Symptoms heavily mimic a severe  flu. Throughout the evening could not sleep for more than a hour or two at a time  due to feeling so ill. Woke up at 4:30am with entire body shivering/shaking.  Roughly two hours later woke back up and had sweat through all my clothes. Flu like symptoms continued till around 10am and by 5pm (day after shot) i felt fine. Was on Tylenol entire time and still felt extremely ill.
On 8/21/2012 at 3:05 PM pt received influenza vaccine Fluzone and PPD/TB skin test few minutes apart, same day. Well tolerated at the clinic. When she gets home she developed SOB, chest tightness, wheezing, and wet cough. Treated at home by parents who are nurses with steroids and albuterol orally. Shortly after symptoms resolved. Pt returned to HC on 8/24/2012 at 12:15 PM for PPD/TB skin test results and reported the event at that time. Now pt is doing well, no complains at this moment.
Patient was in exam room with older brother. She received the immunization first. Brother received his after.  The Medical Assistant subsequently left the room and not more than 1 minute later, brother called for assistance. Pt was found unresponsive on the ground with rigid body, arched back and eyes rolled. She had urinated. She did hit her head; some symptoms might be related to that. Provider rubbed pt's sternum for 15-20 seconds until patient regained consciousness. Pt complained that she could not see or breathe. 2 liters of O2 was administered and 911 contacted. Pt was brought to the ED.
The morning of the 25th, I was peeing more. I was very thirsty. On Tuesday, I called the doctor. On Thursday, I went to the doctor. They did a blood work, normal result. They did a urine sample, that showed high osmolality and increased output. They did a kidney ultrasound, normal result. They order another urine sample; the osmolality had come down.  I was referred to a specialist. They did another 24-hour urine sample, that has a high sodium level. They had not diagnosis me with anything. Somedays the symptoms are okay and others day they are not fine.
Heart palpitations for 16 days,  escalating at day 10 which resulted in ER visit.
Sick; Fever; influenza A; Sore throat; Could not talk; Dry cough; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (influenza A), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), APHASIA (Could not talk) and ILLNESS (Sick) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-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) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced COUGH (Dry cough). On 09-Apr-2021, the patient experienced INFLUENZA (influenza A), OROPHARYNGEAL PAIN (Sore throat), APHASIA (Could not talk) and PYREXIA (Fever). On an unknown date, the patient experienced ILLNESS (Sick). On 14-Apr-2021, INFLUENZA (influenza A), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) had resolved. At the time of the report, APHASIA (Could not talk) had resolved and ILLNESS (Sick) outcome was unknown.            No concomitants medications was reported.  No treatments medications was reported. Patient stated that he had his second shot of Moderna vaccine and did not have any adverse reaction.   This case was linked to US-MODERNATX, INC.-MOD-2021-077839 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received on 04 Aug 2021 contains information for 2nd dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077839:wife's case crosslinked
Nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleed) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (Nose bleed). At the time of the report, EPISTAXIS (Nose bleed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided. Treatment information were not provided.   Reporter did not allow further contact
aches; adverse reactions; Chills; muscle soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (aches), VACCINATION COMPLICATION (adverse reactions), CHILLS (Chills) and MYALGIA (muscle soreness) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), VACCINATION COMPLICATION (adverse reactions), CHILLS (Chills) and MYALGIA (muscle soreness). At the time of the report, PAIN (aches), VACCINATION COMPLICATION (adverse reactions), CHILLS (Chills) and MYALGIA (muscle soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Approximately 12 hours after receiving the vaccine, I woke up around 2:00 a.m. or so with extreme body aches, fatigue, headache, nausea, dizziness, and slight fever. Around 9:00 a.m. or so that same morning, I went to  Emergency room because I was so sick I didn't know what to do. They said I was just having a reaction to the vaccine, and it should go away in a day or so. They gave me Ibuprofen and Tylenol and a shot of toradol. I was then discharged and went back to my living quarters. I had covid already back on January 20th 2021. But the vaccine was five times worse than the virus.
Patient received 2 doses of the Pfizer Bivalent vaccine (one in left arm and one in right arm).  Pt indicated they will stay to be monitored for 15 minutes.  No reported side effects at time of reporting.
Rash around the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Rash around the injection site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included SERTRALINE and BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 07-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site). On 31-Dec-2020, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE RASH (Rash around the injection site) 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.   Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Rash at the injection site is consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Rash at the injection site is consistent with the known safety profile of the vaccine.
White blood cell count increased; Rash all over her legs / lesions on her legs that were diagnosed as Henoch-Schonlein purpura (HSP) / ongoing and worsening purpura / patient had blood draws which showed trace blood in the urine - "5-10 RBC"; An ultrasound was performed on the patient's left calf due to pain / "pain around her great toe" - physician feels this is due to the vasculitis associated with the HSP.; This spontaneous report was received from a physician referring to a 18 year old non-pregnant female patient. The patient had no any concurrent condition, medical history, previously drug reactions or allergies and had no concomitant medications.  On 24-JAN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided) as vaccination (prophylaxis) without incident.   On 28-MAR-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on left deltoid intramuscularly, lot number N017686 with expiration date on 02-FEB-2020 (strength and dose were not provided) as vaccination (prophylaxis).  On 01-APR-2019 (also reported as: within a few days), the patient experienced a rash all over her legs. She went to the emergency care and they were unable to diagnose her. Then, the patient contacted the physician who recommended again a emergency room visit. On 03-APR-2019, the patient was seen at emergency room and there the lesions on her legs were diagnosed as Henoch-Schonlein Purpura (HSP).On the same date, at the emergency department, she also had blood draws which showed an elevated white blood cell count (WBC) (white blood cell count increased), trace blood in the urine 5  10 red blood cells (RBC) (units not provided) and her blood pressure was within normal limits.   On an unspecified date in April 2019, an ultrasound was performed on the patient's left calf due to pain and ruled out a deep vein thrombosis (DVT). The prothrombin time (PT) and partial thromboplastin time (PTT) was drawn without results provided. On 05-APR-2019, the patient was seen again by the physician because she had pain around her great toe (pain in extremity), and physician felt this was due to the vasculitis associated with the HSP.  At the time of the report, the patient had ongoing and worsening HSP which had been treating with prednisolone for 2 weeks; and the patient had neither recovered from the other adverse events. The physician stated that patient would need to have several repeat uroanalysis.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) was not reported.
Patient stated had some fever and other expected side effects after second shot.  3 days after shot started to have some eye itching and irritation.  Was seen 5 days after the eye symptoms started and noted to have corneal dendrites right eye, herpes keratitis.  No known previous episodes.  Started treatment and will follow up.
Sore arm; fever; chills; headache; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-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. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous) had not resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant and treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
abdominal, stomach pain. pain located in umbilical region/ diagnosed with acid reflux; pain in her back; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (abdominal, stomach pain. pain located in umbilical region/ diagnosed with acid reflux) and BACK PAIN (pain in her back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 GASTROOESOPHAGEAL REFLUX DISEASE (abdominal, stomach pain. pain located in umbilical region/ diagnosed with acid reflux) and BACK PAIN (pain in her back).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Red rash all over body; red rash which is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash all over body) and PRURITUS (red rash which is itchy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced RASH ERYTHEMATOUS (Red rash all over body) and PRURITUS (red rash which is itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash all over body) and PRURITUS (red rash which is itchy) outcome was unknown.            Concomitant product information as not provided by the reporter. Action taken with MRNA-1273 in response to the events was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: NNI.
I received the 1 dose on Feb 2nd at 10:30pm.  I came home and went to bed.  I slept in but when I woke up I had a small red bump on the outside of my left breast.  That bump continued to grow larger.  I went in to my Radiologist a week later and was put on antibiotics.  I saw my doctor, my breast surgeon (Lumpectomy  Mar 3, 2020).  I had the Bracey Therapy for my Radiation.  The diagnosis is that I have MRSA in my left breast.  I am on a coctail of non-penicilin antibiotics.  My Dr said I was ok to get the second dose so I had that on Feb 23, 2020.  I didn't think this was related but I'm not sure.  I think I would have noticed if I had it prior to the shot.
Patient reported left chest pain since 8:30AM 5/31, onset while driving, worse with movement such as moving his arms or neck.  Later around noon he began having numbness in his left pinky and hand, thus presented to the UC. Diagnosed wtih costochondritis and discharged but high-sensitivity troponin came back elevated at 94 and was asked to present to hospital. Repeat trending down. Cardiology consulted, diagnosed with pericarditis.
Approximately 12 hours after shot, lasting about 1 week - large local reaction - red, swollen, spread onto chest wall & breast. Painful to lift arm. All localized. No respiratory, gastrointestinal, cardiovascular symptoms but did feel malaise & lightheaded. No treatment.
rt leg red & swollen (size of nickel), limping (mom thought HIB leg) seen by MD tx for poss cellulitis;
T104, swelling, redness @ site, crying; Shot was @ 130, 4PM began crying; Fever dec p/approx 36hrs; Pt was irritable;