chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; minor headache; tiredness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 08Jan2021 at 17:00 at single dose on left arm for COVID-19 immunisation. Medical history included penicillin allergy, histoplasmosis and degenerative disk disease.  Historical vaccine included 1st dose of BNT162B2 (Lot number=EK5730) administrated on 18Dec2020 at 7:00 am on left arm for COVID-19 immunisation at age of 50-year-old. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), diclofenac sodium (DICLOFENAC NA), atorvastatin (LIPITOR [ATORVASTATIN]) and methocarbamol, all from unknown date for unknown indication.  The patient experienced chills, minor headache, tiredness, all on 09Jan2021 at 04:00 with outcome of recovering.  No treatment was received.
Patient developed bruising and had excoriated skin at the injection site.  She had gone to see her allergist for an unrelated matter. The allergist covered with dry sterile gauze and told her to keep the area covered until healed.
diarrhea; body and muscle aches; a sudden feeling of hotness; lightheadedness; rash from the injection site that was red, hot, and swollen; rash from the injection site but closer to the elbow; rash from the injection site that was red, hot, and swollen; rash from the injection site that was red, hot, and swollen; chills; body and muscle aches; throwing up; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness) and INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Right arm surgery). Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) for Thyroid disorder.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness), INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen), VACCINATION SITE RASH (rash from the injection site but closer to the elbow), INJECTION SITE ERYTHEMA (rash from the injection site that was red, hot, and swollen), INJECTION SITE SWELLING (rash from the injection site that was red, hot, and swollen), CHILLS (chills), MYALGIA (body and muscle aches), VOMITING (throwing up) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness), INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen), VACCINATION SITE RASH (rash from the injection site but closer to the elbow), INJECTION SITE ERYTHEMA (rash from the injection site that was red, hot, and swollen), INJECTION SITE SWELLING (rash from the injection site that was red, hot, and swollen), CHILLS (chills), MYALGIA (body and muscle aches), VOMITING (throwing up) and HEADACHE (headache) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   This case was linked to MOD-2021-049558 (Patient Link).
I am 3 weeks late on my menstrual cycle. No cramps or period related side effects. I was suppose to start on May 17. Not pregnant.
flu shot rxn 8x5cm red, hot raised area;no pain;MD saw pt & advised to apply ice & ASA;
Myalgia SOFT TISSUE SWELLING RIGHT AXILLA, SWOLLEN UPPER ARM; Narrative:
pt recvd vax & exp pain in back & lt arm has been considerable; became inflamed immed that day & have been taking anti-inflamatorys & muscle relaxants ever since; I also have been to physical therapy;
This  83 year old female received the Covid shot on   1/19  and went to the ED on 2/3/21    and was admitted  on 2/3/21  with  the diagnoses listed below.  I63.9 - Cerebral infarction, unspecified G50.0 - Trigeminal neuralgia J12.82 - Pneumonia due to Coronavirus disease 2019
Within 20 minutes of leaving pharmacy I had a BAD burning sensation in my stomach and the whole 25 minutes driving home, I began to ache, hurt all over, my arm hurt ALOT and this was the way I felt for the next 6 day,s then it left my body. This is why I have not taken the second Shingle shot.
Dizziness Lips tingling, tongue feels thick, and throat feels like it has a glob of snot in it. Narrative:
Patient reports chills, headache, and polyuria after receiving Prevnar 13 vaccine. Reports that theses issues had stopped by 3/11/16.
4 days after first shot, she called me complaining of bad back pain. She was going to her family doctor the next day for her 21 yr old well visit and was going to get it checked out then. She had a complete physical and was cleared even her lungs were clear and she was good. Tuesday night April 13th at  10pm, she told me she had "air bubbles" in her chest. I said you mean indigestion, take tums I said. She said not mom, actual air bubbles and they are popping in my chest. I said you just got your physical, you are fine. They Thursday night April 15th she started having difficulty breathing and was out of breath. She went to urgent care on April 16th because she felt awful and they saw in an X-ray that she had a "cyst" in her upper right part of her lung and her lung was about to collapse. Sent her home on bed rest with a stereos and 2 inhalers. We got her Friday night from college because the pain in her back and now her chest was worse. Took her to ER and she had a collared lung and pneuomothroax. She was admitted to the hospital and they tried to see if the lung would heal itself.  It did not. They had to do surgery to repair the hole. When they were in there they saw a cobblestone texture where the hole was an they removed that texture and repaired the hole. She has never had a lung issue. Ever. She is also the 3rd person in my family to have had an adverse reaction to the shot. 6 of us vaccinated and 3 with injuries.
Pt was dosed with Pediarix combo vaccine (IPV+HepB+dTAP) + HepB single dose INSTEAD of Pediarix + Hib. Therefore, pt received an extra dose of HepB and no Hib. Pt tolerated vaccines well and continues to be asymptomatic per mother.
patient received 2nd dose of twinrix late; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received HAB (Twinrix) (batch number 3y7nl, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 20th September 2020).   On 30th June 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by a registered pharmacist. The patient received 2nd dose of Twinrix later then the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Information has been received from a license practical nurse concerning a 12 year old female who on 08-SEP-2008 received the second dose of VARIVAX (Merck) (Lot#661562/0996X) SQ in left arm and  the first dose of MENACTRA (Lot#U2726AA) IM in right arm. On 09-SEP-2008 the patient experienced redness and swelling at injection site of VARIVAX (Merck). At the time of report on 13-OCT-2008, the patient had recovered. Additional information has been requested.
Information has been received from a physician concerning a 1 year old patient who on 24-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # 663197/1418X) by mistake, the vaccine that the patient should have received was VARIVAX (Oka/Merck) (MSD). there was no localized symptoms, no swelling and the patient was fine. No further information is available.
5 days after Moderna Covid Vaccine, patient developed swelling, redness and tenderness over hands/wrists/knees/ankles and feet.
a warm sensation down his left arm then the rest of his body; uncomfortable after the injection/felt disgusting/He stated he felt bad; became extremely sick/vaccine made him so sick; stayed in bed for 3 days with fever; no energy; sweating; got depressed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (a warm sensation down his left arm then the rest of his body), DISCOMFORT (uncomfortable after the injection/felt disgusting/He stated he felt bad), VACCINATION COMPLICATION (became extremely sick/vaccine made him so sick), PYREXIA (stayed in bed for 3 days with fever) and ASTHENIA (no energy) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OLANZAPINE, HYDROXYZINE, MELATONIN and PRAZOSIN for an unknown indication.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced FEELING HOT (a warm sensation down his left arm then the rest of his body), DISCOMFORT (uncomfortable after the injection/felt disgusting/He stated he felt bad), VACCINATION COMPLICATION (became extremely sick/vaccine made him so sick), PYREXIA (stayed in bed for 3 days with fever), ASTHENIA (no energy), HYPERHIDROSIS (sweating) and DEPRESSED MOOD (got depressed). The patient was treated with IBUPROFEN for Fever, at a dose of 600 milligram. On 28-Jun-2021, PYREXIA (stayed in bed for 3 days with fever) had resolved. At the time of the report, FEELING HOT (a warm sensation down his left arm then the rest of his body), DISCOMFORT (uncomfortable after the injection/felt disgusting/He stated he felt bad), VACCINATION COMPLICATION (became extremely sick/vaccine made him so sick), ASTHENIA (no energy), HYPERHIDROSIS (sweating) and DEPRESSED MOOD (got depressed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Tinnitus. Constant electrical-like buzz/humming, and a Morse code-like high pitched, fluctuating tone can be heard at all times. Have not sought treatment as of yet.
Facial swelling; mottled red skin on body; difficulty breathing. Tx - BENADRYL and steroids.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EJ1685), in left arm, on 16Feb2021 as dose 2, single (Lot number: EL9261), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FF2087), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Occasional asthma" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 14Jun2022 to 18Jun2022. No other medication in 2 weeks with treatment of Paxlovid.
Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and HEADACHE (Headaches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 27-Jan-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) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced PAIN (Body aches) and HEADACHE (Headaches). At the time of the report, PAIN (Body aches) and HEADACHE (Headaches) was resolving.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. The patient stated that she hasn't taken any medications for the events but her vaccination provider told her to take aspirin-acetaminophen-caffeine and Excedrin if the symptoms continue.
Hospitalized 11/24/2021-still admitted currently; COVID-19 positive 11/23/2021; fully vaccinated  ASSESSMENT/PLAN:   The patient is a 69 year old male who resides at an AFC home with PMHx of Parkinson disease, dementia, A-fib on eliquis, chronic diastolic CHF, CKD3 who presented with fatigue, weakness and cough secondary to COVID pneumonia. The patient was admitted for acute hypoxic respiratory secondary to COVID pneumonia.  The patient's daughter is his guardian and DPOA.    Acute hypoxic respiratory failure COVID-19 Pneumonia Vaccination status: Vaccinated Moderna x2 (last dose 1/27/2021) Symptom onset: 11/23/21  COVID positive PCR: 11/23/21 CXR findings compatible with acute pneumonitis.  Plan: - O2 status: On 4L nasal cannula - Dexamethasone (Start 11/24) - Remdesivir declined. The patient is within the window to be a candidate for Remdesivir. The patient's guardian is concerned about the risks. Will consider and discuss with day team recommendations tomorrow. - VTE ppx: Lovenox - Inhalers: Albuterol PRN - Trend CMP, CBC, D-dimer, CRP - Prone as tolerated 12/1/2021 notes: Acute hypoxic respiratory failure COVID-19 Pneumonia Aspiration pneumonia  Vaccination status: Vaccinated Moderna x2 (last dose 1/27/2021) Symptom onset: 11/23/21  COVID positive PCR: 11/23/21 CXR worsening right sided infiltrates .  Plan: - O2 status: 6L NC - Dexamethasone (Start 11/24) end12/3 - Remdesivir declined.  - Continue IV Unasyn - VTE ppx: Lovenox - Inhalers: Albuterol PRN - Trend CMP, CBC, D-dimer, CRP - Prone as tolerated - additional one time dose of IV lasix today
UNEXPLAINED HIVES/RASHES THROUGHOUT BACK AREA,  ELBOWS AREA, AND WRISTS.  RED, RAISED, WARM TO TOUCH, ITCHY, IRREGULAR SHAPE, AND CLUSTERS.  OBSERVES TO OCCUR AFTER NAPS OR SLEEP  NO PROFESSIONAL ATTENTION.  HOME REGIME OF ZYRTEC ONCE DAILY.
On May 21, patient presented fever and headache; he took 2 Advil to alleviate his symptoms. During the following four days, he felt well. However, on May, 26 patient complaints of chest pain, coccyx/back pain and was unable to speak to his parents. At 7:30am he went to the Emergency Room. A head CT and blood test (ABGS,CMP, CBC, COVID-19) were performed. Then he was transferred to another Hospital and admitted to the Intensive Care Unit. Patient continue hospitalized and under the care of a neurologist, hematologist and cardiologist. Prognosis is reserved. Today he patient received  5U PRBC's.
Chest pains, trouble breathing . Diagnosis: Non ST segment elevation myocardial infarction
Trouble breathing, feeling of throat swelling, dizziness.  Took Benadryl three times that night and missed work the next day due to dizziness, shortness of breath.  Hands and feet were swollen.  Continued to take allergy medicine and Motrin for pain.  Swelling progressed through whole body along with muscle spasms, soreness and fatigue.  It has been nine months now since the vaccine and I still have these symptoms.  I have been to internists & cardiologists all who can find nothing in the tests that lead to a diagnosis.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 044B21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included Hematuria, Obstructive sleep apnea syndrome, Barrett's esophagus, Hearing loss (Right ear) and Pain in toe. Concurrent medical conditions included Varicose veins (Right ear), Cervical disc disease, Allergy NOS and GERD. Concomitant products included CETIRIZINE HCL for Allergy NOS, ACETYLSALICYLIC ACID (ASPIRIN 81), PANTOPRAZOLE SODIUM, CYANOCOBALAMIN (VITAMIN B-12), ZINC GLUCONATE (ZINC (GLUCONATE)), VITAMIN C [ASCORBIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), FISH OIL, ROSUVASTATIN CALCIUM (CRESTOR) and UBIDECARENONE (COQ 10) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported and results not reported (Inconclusive) Results not reported. On an unknown date, Laboratory test: results not reported (Inconclusive) Results not reported. On an unknown date, Physical examination: results not reported (Inconclusive) Results not reported. On an unknown date, Urogram: gross painless hematuria (abnormal) Gross Painless Hematuriaa. On an unknown date, Urological examination: gross painless hematuriaa (abnormal) Gross Painless Hematuriaa.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab test included CAD, non obstructive 76 score in the LAD   No treatment medication were provided.  On 11-Nov-2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  Patient had physical therapy evaluation and treated for neck pain due to DJD (Degenerative joint disease). Patient was due for TD booster, hemoccult or sigmoid.  The reporter wanted to know if the 2069 expiration date on the packing slip was a valid expiration date.
Pt reported marked upper arm (R) to elbow swelling, redness, pain. Temp 102 degrees, diarrhea, vomiting, nausea and headache. All began same evening shot administered. Lasted several days.
The patient was given 3 doses of Imovax after 2 months, no AE; Initial information was received on 05-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a male patient (age unspecified) who was given three doses of RABIES (HDC) VACCINE [IMOVAX RABIES] after 2 months (Inappropriate schedule of product administration)  Medical history included animal bite (unknown date in June). Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (IMOGAM) for post exposure immunisation.  On 03-Aug-2020, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot 120D1H20KFMG76, expiry: 30-Apr-2021) via unknown route in unknown administration site for post exposure immunisation.  On an unknown date, the patient received two doses (second and third) of suspect RABIES (HDC) VACCINE (lot number: not reported) via unknown route in unknown administration site for post exposure immunisation.  This was a case of an actual medication error due to drug dose administration interval too long.  The laboratory test (unspecified) was inconclusive.  No adverse event was reported at the time of reporting.  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
The parent falsified the date of birth of the patient. On the vaccine consent form she stated the date of birth was 0/1/13/2003 making her 18 y.o. at the time of vaccination. I was told her real birthday is 01/13/2005
Unexpected brain aneurysm (subarachnoid hemorrhage) with no warning signs and no family history that nearly resulted in death and resulted in 71 day hospitalization; Permanent cognitive disability and unable to work
Rash developed behind patient's neck within 24 hours of vaccination. It's possible that something else caused the reaction. Rash was red and bumpy and covered an area approximately 1 inch by 1 inch.
12 hours after vaccine, I had severe chills. severe headache, and fever of 101. Chills lasted four hours. Headache lasted 24 hours. Fever of 99 remained for three days. Diarrhea started after 36 hours and lasted three days. 72 hours after vaccine, I had a migraine headache.
Blisters on left leg starting just above knee and processing down the leg. The area was about three inches wide and 9-10 inches long. Saw PCM: M.D. at Clinic - Doctor prescribed Triamcinolone Acetonide cream USP 0.1%. The blisters eventually scabbed over and has started to heal but are still red like chicken pox. Dr said it looked like shingles as did the Pharmacist who gave me the shot.
Pain, redness and swelling of injection site.  Muscle aches, feeling tired and weak with a mild headache with shivering.
The same day of vaccinations the pt developed a temperature of 101F and a hard bump at the site of the injection.
Site: Pain at Injection Site-Mild, Systemic: Swollen feet-Medium, Additional Details: Pt reports swelling on both foot occurring about a week after second shot and lasted for about 3 weeks after.
Patient received dose of Pediatric Pfizer instead of Adult Pfizer COVID vaccine. Mom was notified of this and per CDC guidelines, redose is not needed.
Headache, nausea, severe diarrhea. Headache starting approx 2 hours after injection. Nausea and diarrhea starting approx 14 hours after injection.
Mom reports child vomited on Thursday pm. Friday developed red, raised rash on buttocks which spread to entire body by Sunday, MD appointment 6/1/09; MD reports possible viral infection; question mild disease related to vaccination, HIB?