chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WATERY DIARRHEA; VOMITING; MUSCLE ACHES ALL OVER; FEVER 99.7 DEGREES FAHRENHEIT; NAUSEA; TIREDNESS; FELT LIKE BLOOD SUGAR DROPPED; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 110 pounds, and height was 70 inches. The patient's concurrent conditions included: diet controlled diabetic, pancreatitis issues, anemia, and allergic to contrast ct dye, and other pre-existing medical conditions included: Patient had no daily medications. The patient experienced drug allergy when treated with morphine, and ondansetron.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced felt like blood sugar dropped. On 25-AUG-2021, the patient experienced tiredness. Laboratory data included: Blood glucose (NR: not provided) dropped. On 26-AUG-2021, the patient experienced watery diarrhea. On 26-AUG-2021, the patient experienced vomiting. On 26-AUG-2021, the patient experienced muscle aches all over. On 26-AUG-2021, the patient experienced fever 99.7 degrees fahrenheit. On 26-AUG-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99.7 F. Treatment medications (dates unspecified) included: tizanidine hydrochloride, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from felt like blood sugar dropped on 25-AUG-2021, and fever 99.7 degrees fahrenheit, was recovering from watery diarrhea, had not recovered from tiredness, muscle aches all over, and nausea, and the outcome of vomiting was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04May2023 as dose 6 (booster), single (Batch/Lot number: unknown), 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Meniere's Disease" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04May2023, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the Paxlovid treatment from 23Aug2023 to 28Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events Interchange of vaccine products, Drug ineffective, COVID-19 and suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300291342 same patient/reporter; different drug/AE;
On 6-27-2022, I started having body aches and a headache. The following day, I started having head congestion, a cough and sore throat. On 6-29, I had a low grade fever of 98.2 which is high for me. I took a Covid19 home test with positive results. On 6-30, I had a virtual telehealth visit with my PCP and he ordered the Monoclonal antibodies. I was taking mucinex and stopped taking ibuprofen and switched to tylenol. . I went to Hospital on 7-1 and had the antibodies. Four days after the antibodies, I started feeling alot better. I am reporting a breakthru case of Covid.
My arm felt sore for about a day and a half after receiving the vaccine. It was most comparable to the dull pain that I felt 1-2 weeks after breaking my arm. I had limited mobility due to the pain and the area around the vaccine hurt to touch. The pain gradually faded away after the first day and was completely gone by the end of the second day.
Rash on injection arm, getting worse, red, itchy and raised. Larger pattern.
C/o of left arm being red and swollen, warm to touch. Denies fever. Told to use ice to arm and take Tylenol.
Patient developed a 3x2 1/2 inch erythematous, warm, papular rash on left thigh around the site of injection with no induration. Rash is also itchy per patient.
Flushot was administered (Fluzone quad) for patient 10 years of age, approximately 5 minutes after administration patient began to vomit. She had 2 episodes and was pale, patient sat down and took deep breaths. Oddly, patient's brother also began vomitting 5 minutes after vaccine administration of fluzone quad as well.  After about 15 minutes patient was able to leave with family.  I called patients mother 3 hours later to check in and patient was doing 100% better, appetite was back and she had eaten dinner. No other concerns at this time.
Sweating, fainted, lethargic, pale and "could not see" for several minutes. EMS called. Vitals taken. Given water and monitored for 30 minutes.
Case number PHEH2014US016760 is an initial spontaneous report received from a pharmacist on 20 Aug 2014. This report refers to a male patient of an unspecified age. His past medical history and concomitant medications were not reported. Two weeks prior to this report, he was vaccinated with MENVEO (batch number: not reported) intramuscularly. Approximately one week after the vaccination, he began to experience fatigue. The patient was taken to a personal physician. The outcome of fatigue was not reported. The seriousness and causality of the event were not reported.
Patient received Moderna vaccine first dose on 4/23/21 and received Pfizer vaccine in error on 6/12/21.
Patient came into a vaccine clinic for his Moderna COVID 19 booster dose. Dose administered should have been 0.25ml and 0.5ml was administered to patient.  After administration it was found out that Moderna vial was expired.
possibility that my heart problems started/heart caught the virus; they hit the blood vessel instead of muscle; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (possibility that my heart problems started/heart caught the virus) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (they hit the blood vessel instead of muscle) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (possibility that my heart problems started/heart caught the virus) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (they hit the blood vessel instead of muscle). At the time of the report, CARDIAC DISORDER (possibility that my heart problems started/heart caught the virus) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (they hit the blood vessel instead of muscle) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient stated that there was a possibility that heart problems started when patient got second vaccine for COVID, they hit the blood vessel instead of muscle and heart caught the virus.  Treatment information was not provided.
I began my period suddenly and very painfully to the point blood was running down my leg. it stopped7 days later and then began the following day for another 5 days and then stopped for a day and then started for another 3 days. I finally Stopped having these symptoms but they were all accompanied by increased bleeding compared to normal and they were more painful.
died two days after receiving the vaccine; Fever; This is a spontaneous report from a contactable consumer (patient's stepchild). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 07Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included an unspecified statin. The patient experienced fever on 08Jan2021. The patient died two days after receiving the vaccine on 09Jan2021, which was reported as fatal. The clinical course was reported as follows: The patient had a fever the day after getting the vaccine and then he just died in the middle of night. It was reported that it was not clear what exactly happened, but they are looking into this. The clinical outcome of fever was unknown and of died two days after receiving the vaccine was fatal. The patient died on 09Jan2021. The cause of death was not reported.  An autopsy was not performed (was reported to be taking place soon).  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: died two days after receiving the vaccine
No adverse event directly related to the vaccine was noted. It was discovered that the vaccine that was administered on 7/18/22 had a refrigeration expiration of 7/15/22 at 9:30am.
5 minutes after receiving the vaccine I developed shortness of breath, wheezing, tachycardia, GI symptoms, and later followed by generalized hives.
feeling extremly over tired; muscles ache; This is a spontaneous report from a contactable consumer, the patient. A 61-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 an unspecified date at 15:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had received other unspecified medications in two weeks of vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021 at 15:00, the patient reported that for the last 2 days feeling extremely over tired and muscles ache. The patient reported that doesn't know if the problem was a result of the vaccine but wanted to check if it could be. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extremely fatigue and muscle ache was unknown at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
blistering; swelling; weeping; inflammation; loss of some muscle function in joint areas; weakness; redness; pins and needle feeling; LEFT arm, torso, leg unknown rash; Full Body joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in the left arm on 10Sep2021 at 08:30 in a hospital (Batch/Lot Number: EW0164) at the age of 41-years-old, single, for COVID-19 immunization. Medical history included hypertension and known allergies to sulfa & e-mycins. The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ), and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XL), taken for unspecified indications, start and stop dates were not reported (both medications reported as medications the patient received within 2 weeks of vaccination). On 12Sep2021 at 06:00 PM, the patient experienced left arm, torso, leg unknown rash with blistering, redness, swelling, weeping and inflammation, full body joint pain and inflammation with weakness, pins and needle feeling, and loss of some muscle function in joint areas. The adverse events resulted in an Emergency Room/Department or urgent care visit and a doctor or other healthcare professional office/clinic visit. Treatment for the events included steroids (oral & topical) and antihistamines (IV & oral). Outcome of the events was recovered with sequelae (recovered with lasting effects) in Sep2021. The case was reported as non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events blister, swelling, crying, inflammation, muscle disorder, asthenia, erythema, paraesthesia, rash and arthralgia is assessed to be related. Standard Statement For All Other Sources: BR statement  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Patient noted that his left arm was "very sore and achy" the day after receiving the shot.  He came to the office today and stated he's experienced a rash all over his body and extreme itchiness the day after the shot was administered.  He has a few itchy lesions left 3 days after administration.
First broke out in hives in folds of arms and on neck, some wheezing and shortness of breath.  Later hands and feet swollen and muscles and joints ached for weeks.
** Tested COVID positive 1/3/22. Fully recovered. Due to mandate for healthcare workers and no printed CDC literature, was presented with Booster dose as requirement and condition of employment. After seeking advice from Employer, was told booster was "safe", irrespective of recent infection. Approximately one month after covid booster, started experiencing numbness and tingling in feet with weakness and inability to walk up steps without fatigue and weakness of thigh muscles and lower extremities. Weakness persisted for 6 months with no improvement and underwent 3 months of physical therapy with slight improvement. Currently still not at full strength or able to resume former exercise/ activities due to impairment.
Pt recvd 3 doses of Hep B vax 22FEB91, 25MAR91, 26AUG91 & 23OCT91 it was determined that titer was neg; Booster dose was given 1NOV91 outcome of booster is pending as of 3JAN92;
slight rash at injection site noticed 24 hours after injection. Slight rash covering most of my torso noticed 30 hours after injection. No itchiness or discomfort.
COVID-19; Shingles; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and HERPES ZOSTER (Shingles) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and HERPES ZOSTER (Shingles). At the time of the report, COVID-19 (COVID-19) was resolving and HERPES ZOSTER (Shingles) had resolved.            No concomitant product was reported. Patient stated that when she started Rinvoq she got the shingles, she thought COVID caused more fatigue even after recovery. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. 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.
He has a bumpy rash (tiny bumps) covering his entire chest and upper back. I first noticed the rash on Aug 31, but according to him, it had been there a couple days. It was a little itchy on Aug 31. He had a couple scratch marks on his upper back. My wife and I decided to wait and see if it would clear up on its own. We checked a few times and there was no change. It has not been very itchy since Aug 31. He does not currently have any scratch marks. We took him to his pediatrician Sept 6. After the examination and describing the symptoms, the doctor believes the rash is likely pityriasis rosea. After the appointment, we searched online to learn more about pityriasis rosea. We saw articles listing it as a rare side effect of the COVID-19 vaccine.
After taking Tizanadine around 11:00 PM I noticed a rash on my left leg above my knee about 4x4 inches big along with an itching feeling. Also had a stomachache and I throw up The stomachache lasted all day
shortness of breath; body ache; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (shortness of breath) and MYALGIA (body ache) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Previously administered products included for Drug use for unknown indication: Johnson and johnson. Past adverse reactions to the above products included No adverse event with Johnson and johnson. Concurrent medical conditions included Diabetes.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DYSPNOEA (shortness of breath) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath) and MYALGIA (body ache) outcome was unknown.            No Concomitant Drug details were reported.
died of heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (died of heart attack) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (died of heart attack) (seriousness criteria death and medically significant). The reported cause of death was died of heart attack. It is unknown if an autopsy was performed.            No concomitant medications were reported. No treatment medications were reported. Reported that patient had the vaccine and died of heart attack. Also mentioned people having heart problem after getting the vaccine.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the fatal event of MYOCARDIAL INFARCTION. Vaccination date and onset date of the event were not reported; hence, latency cannot be assessed. Very limited information was provided for medical reviewing and no consent for follow-up was obtained. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-460399 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the fatal event of MYOCARDIAL INFARCTION. Vaccination date and onset date of the event were not reported; hence, latency cannot be assessed. Very limited information was provided for medical reviewing and no consent for follow-up was obtained. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: died of heart attack
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 6, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage, Abortion (2 Terminated), Pregnancy (2 Full term pregnancies.) and Nicotine addiction (pack/day) in March 2019. Concomitant products included ventyl for gall bladder attacks, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE].    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Sep-2020 and the estimated date of delivery was 01-Jul-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound antenatal screen normal: (normal) 2* ultrasound.     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.   Additional laboratory data include genetic testing and results were normal. Patient had 1 miscarriage, 2 terminated and 2 full term pregnancies.
Fever of 99.5. Fatigue. Soreness/Achiness in limbs and lower back.