chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stomach problems-upset with gas and more; felt flush- almost like a menopausal flush; terrible sweats; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach problems-upset with gas and more), FLUSHING (felt flush- almost like a menopausal flush) and HYPERHIDROSIS (terrible sweats) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. LOT 001A21A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, RAMIPRIL, HYDROXYUREA and LEVOTHYROXINE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach problems-upset with gas and more), FLUSHING (felt flush- almost like a menopausal flush) and HYPERHIDROSIS (terrible sweats). At the time of the report, ABDOMINAL DISCOMFORT (stomach problems-upset with gas and more), FLUSHING (felt flush- almost like a menopausal flush) and HYPERHIDROSIS (terrible sweats) outcome was unknown. Not Provided          No Treatment information provided
headache; Chills; soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 14:30 as dose 5 (booster), single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, on 21Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose number: 01, Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number: 02, Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number: 03, Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number: 04, Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 02Oct2023 at 23:30, outcome "recovering"; HEADACHE (non-serious) with onset 02Oct2023 at 23:30, outcome "recovering"; PAIN (non-serious) with onset 02Oct2023 at 23:30, outcome "recovering", described as "soreness". Therapeutic measures were not taken as a result of headache, chills, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine and about 3-4 hours later began having severe pain in the injected arm. Over the next 2 hours pain worsened and patient became lightheaded, which made her decide to go to the ER. In the ER patient reports experience "non-anaphylactic" shock and became unconscious. Treatment not noted, but patient was evaluated for heart attack due to pain in arm and lightheadedness. Patient regained consciousness in ER and was discharged once stable later the same evening. Patient followed up with on 1/14/19 and reports no systemic effects, but still has mild pain in injected arm. Has a follow-up scheduled with PCP for 1/16/2019.
7/9/10 started with bruises/vesicles on abd chest thighs itchy only a couple each site per patient.
The patient developed a flat, erythematous, confluent rash on the chest and upper back about 5 minutes after the vaccine was given. She appeared flushed. She did not have any hives, shortness of breath, dysphagia, itching of her lips, trouble swallowing or wheezing. She was given 50 mg of BENADRYL and monitored for 35 minutes afterwards. The redness and rash improved. She did not develop any other symptoms. She was advised to take another dose of BENADRYL in 4 hours. She is to go to the ER if she develops any further hives, SOB, wheezing, trouble swallowing. Her mother drove her home.
Partial small bowel obstruction -  Patient symptoms rapidly resolved with NG tube.  Her bowel function was restored.  She is tolerating p.o. and she is having bowel movements.  She will be discharged in stable condition. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
metallic taste; fever; achy; This is a spontaneous report from a contactable pharmacist. A 45-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.The patient took previously BNT162B2 dose 1 for Covid-19 immunization. The patient experienced metallic taste, fever, achy on an unspecified date. The 45-year-old man, about 6 ft 3 in. Vaccinated with Pfizer COVID Vaccine. He reported metallic taste in his mouth after Vaccination. This was his second dose - had fever and achy a few hours later. The outcome of the events was recovered/ Resolved the next day on unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ (date, dose and route not reported). The patient received concomitant vaccines (not known which vaccines were administered). The physician reported that the patient developed a rash after administration of ROTATEQ. The patient sought medical attention at an office visit. The course of treatment and outcome were not reported. A product quality complaint was not involved. Additional information has been requested.
Pt complained of light headedness, poor balance, diffuse and pain and clay colored stools.
Vaccine administered 3/1/16. Persistent tenderness of upper arm. 3/8/16 patient noticed redness and induration medial and lateral to injection site. No redness or induration at injection site.
Fever Chills Muscle and joint aches All moderate and lasting approx 6 hrs with no treatment
diagnosed with afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (diagnosed with afib) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ATRIAL FIBRILLATION (diagnosed with afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (diagnosed with afib) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   No Lab data was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
7 days later, redness/swelling/tenderness at injection site x ~48 hours
partial hysterotomy from tumor growth; Migraine; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4454423-00.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 11Mar2021 (ongoing) (Batch/Lot number: unknown), subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of Administration: Intramuscular.), administration date: 04Mar2021, when the patient was 47-year-old, for COVID-19 Immunization. The following information was reported: MIGRAINE (medically significant) with onset 2021, outcome "not recovered"; PNEUMONIA (medically significant) with onset 2021, outcome "recovered" (2022); UTERINE NEOPLASM (hospitalization, medically significant) with onset 2021, outcome "recovered" (2022), described as "partial hysterotomy from tumor growth". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "pneumonia", "partial hysterotomy from tumor growth" and "migraine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of partial hysterotomy from tumor growth was not provided. The reporter's causality for the event(s) of pneumonia after second dose of Pfizer vaccine and migraines with Humira (Adalimumab) was no reasonable possibility. Opinion was that the event of partial hysterotomy from tumor growth was not assessable. Opinion was that there was a reasonable possibility that the events of pneumonia after second dose of Pfizer vaccine and migraines are related to Humira (Adalimumab).  Causality for Pfizer BioNTech COVID-19 Vaccine: The reporter's causality for the event(s) of Uterine neoplasm, Pneumonia & migraine was not reported.  Clinical Information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events "pneumonia", "partial hysterotomy from tumor growth" and "migraine" and the suspect drug BNT162b2.
On 5/15/2022  tested positive for Covid - I took Paxlovid and had a mild case
rt arm where recvd  vax welt 4" by 1" red, denies warmth exp flu like sx since 24JUL; denies itching, SOB, anxiety;
Got shingles after the shot/Suspected vaccination failure; Shingles/ got shingles after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Feb-2023 Reporter's Comments: The case was received from the consumer via interactive digital media. The reporter reported that his/her brother had the patient (neighbor) got the shot and got shingles after the shot. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding primary schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available. This 1 of 4 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR028532:Same reporter US-GSK-US2023AMR028533:Same reporter US-GSK-US2023AMR028534:Same reporter
After H1N1 complained of lightheadedness, headache & vomiting (48 hour) lasted for 3 days.
symptomatic COVID and under quarantine; symptomatic COVID and under quarantine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PAXLOVID. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "symptomatic COVID and under quarantine".  Clinical Course: It was reported that patient was nterested in taking Paxlovid personally. Patient was a fully vaxx veterans administration surgeon. Patient recently become symptomatic COVID and under quarantine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a consumer referring to his daughter, a 5 months old premature female patient. The patient had no drug reactions/allergies or concomitant medications. In April 2013, the patient was vaccinated with one shot of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), injection, for prophylaxis (strength, dosage schedule, lot number and expiration date were not reported). The patient developed a high fever on the date of administration after having received the vaccine. As a result of the fever, the patient was taken to the emergency room for medical attention, but she was not admitted to the hospital. The patient was treated during the emergency room visit with intravenous fluids and tylenol. No studies or diagnostic laboratories were carried out. The outcome of pyrexia was reported as recovered on an unspecified date. Causality assessment was not provided. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1809USA000752 :
Localized redness and swelling (right leg), Pyrexia (transient) to 104 48 hrs. Nausea with mild anorexia x 48hrs. (resolved upon presentation to urgent care)
I have been wants about my heart, taken left and right and middle and bottom and top and right and bottom and I never had chest pain before that.; I felt like the  sharp pain go up my arm across my shoulder and went to my heart and I was since then, I have been getting like these sharp pain in my heart constant.; I am not feeling well; I feel extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Lot number: Unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (medically significant), outcome "unknown", described as "I have been wants about my heart, taken left and right and middle and bottom and top and right and bottom and I never had chest pain before that."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I felt like the  sharp pain go up my arm across my shoulder and went to my heart and I was since then, I have been getting like these sharp pain in my heart constant."; MALAISE (non-serious), outcome "unknown", described as "I am not feeling well"; FATIGUE (non-serious), outcome "unknown", described as "I feel extremely tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 10/30/14 patient received two vaccinations: one was for the flu (Rx # 0504505 FLUZONE QUAD); and the other was for pneumonia (Rx # 0504506 PNEUMOVAX 23 vial). Early on 10/31/14 a red welt-like patch appeared at the site of the pneumonia injection. It got much worse, accompanied by fever. Went to the ER at Hospital and was admitted.
FAINTING, DIZZYNESS HEADACHE , STARTED THESE FAINTING SPELLS AFTER THE 2ND SHOT  THAT WAS IN 6/09 HAS FAINTED 6 TIMES. PUT ON BETA BLOCKER AND FLORINEF BY DOCTOR,BEEN TO TWO SPECIALIST FOR HEART, MAY WANT TO PUT IN PACE MAKER. WAS DIAGNOSED WITH NEUROCARDIOGENIC SYNCOPE. WE ARE VERY INTERESTED TO FIND ABOUT HOW TO BE DETOXED FROM THESE SHOTS 12/31/09 Medical records received for date 6/11/09. Pt had OV for vax. No other info provided.
Patient started with symptoms (lesions) a couple days after vaccine. Patient was seen by PCP and an ophthalmologist. He has lesions on face and eye involvement. He is taking valacyclovir 1 GM TID and using trifluridine eye drops 9x a day. Also Ibuprofen.
About a week after receiving vaccination pt experienced joint pain in hands, feet and neck. Felt like getting arthritis. Waited a week and contacted doctor. MD wanted to see her. Symptoms started to go away after about 2 months. Symptoms started off worse in the beginning and slowly got better.  Had 2 joints (right index finger and left right toe) became swollen. Still has swelling in right finger.
This case was reported by a healthcare professional and described the occurrence of nodule injection site in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 8 December 2009 the subject received unspecified dose of ENGERIX B (.1 ml, subcutaneous, right arm). On 8 December 2009, at the time of vaccination with vaccination with ENGERIX B, the subject experienced wrong vaccine administered. Less than one month after vaccination with ENGERIX B, the subject experienced nodule injection site. This is the third case of three in which a nurse reported the subjects inadvertently received ENGERIX B instead of PPD. ENEGERIX B was administered subcutaneously on 08 December 2009. Two subjects returned on 24 December 2009 and one subject returned on 28 December 2009 reporting a reaction of "knots at the site". At the time of reporting the outcome of the injection site nodule was unspecified. Please see cases A0836972A and A0836975A for the additional two reports with ENGERIX B.
Red, warm, sore to touch arm below the injection site in muscle area and then red also today a little above elbow
Patient had a positive COVID-19 PCR on 10/05/2021 after receiving two doses of Moderna vaccine
pt recv vax & devel circumoral cyanosis & generalized pallor; MD felt it was a hypotensive episode although no BP was taken @ the time of the event; No further details were provided;
Hole in her back was cauterized and it became infected; procedure on her back and it left a hole and it was not completely healed/still had a hole in her back; This is a spontaneous report from a contactable consumer (patient reported for herself) via a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated she had a procedure on her back and it left a hole and it was not completely healed (2021). Caller asking if she got the vaccine, would it cause any adverse reactions or stop the process of healing. Caller stated it had been 42 days since she had the first injection and was wondering if she may have to restart the series or if she would just get her second dose. The reporter asked if the Pfizer-BioNTech COVID-19 vaccine can shed the virus. It was answered that: No, the Pfizer-BioNTech COVID-19 vaccine cannot shed the SARS-Cov-2 virus. Caller asking if there were any antibodies with the first or second shot of the Pfizer COVID vaccine. Caller stated she had a procedure on her back and it left a hole and it was not completely healed. The procedure was done after she had received the first dose of the Pfizer COVID vaccine, in which she had missed her second dose. Caller stated it had been 42 days since she's had her first dose of Pfizer's COVID vaccine. Caller asking with the new variants that are coming around, if there would be booster doses. The patient wanted to know if there were any antibodies in the first vaccine or were they all in the second dose. Caller had a procedure done after receiving the first dose, where a hole in her back was cauterized and it became infected (2021), so she was placed on an antibiotic, but she still had a hole in her back. Caller wanted to know if it was safe to get the second vaccine now, or should she wait until the back was completely healed, which would be about 2 months from now. Faxing AE of needing to have a hole in her back cauterized after receiving the first Covax vaccine and developing an infection after receiving the Pfizer vaccine. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
redness around the given area, swollen & painful;fever x 2 days;tx Zithromax & motrin;
patient disclosed that she was afraid of needles.  the pharmacist on staff gave her the shot, she appeared to be well. walked out of room with her mom and passed out a few moments later.   a paramedic came and evaluated her, she signed a form saying she didn't want to go to the hospital and she left with her family after her 30 min wait time post vaccine
vasovagal syncopal episode after receiving his first COVID vaccine.  Patient became nauseous and began to perspire.  He was able to respond to verbal commands, and never had complete LOC.  We were able to provide oral hydration and cold compresses.  After 15 mins I was able to have him sit in a chair, where he stated he was feeling much better.  After a total of 45 mins, he was able to walk out of clinic independently
Dizziness since receiving the vaccine; This is a spontaneous report from a contactable nurse (patient).  A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: ELO140), via an unspecified route of administration on the right arm on 26Dec2020 17:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included reported as none and the patient had no known allergies.  The patient's concomitant medications were not reported. It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 27Dec2020 05:00, the patient experienced dizziness since receiving the vaccine. The patient did not receive any treatment for the adverse event. Outcome of the event was recovering.
Information has been received from a consumer concerning her 16 year old daughter who on 11-JUN-2008 was vaccinated with the first dose of GARDISIL and VARIVAX. At the time of vaccination, the patient was probably 6 weeks pregnant (LMP approx. 30-APR-2008, EDD 4 FEB-2009). In approximately July 2008, the patient had x-ray done at the dentist's office. Also, about a week ago, the patient had "two boils". The patient did not seek medical attention. Additional information has been requested.
chills and sweating at night; swollen lymph nodes; chills and sweating at night; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (chills and sweating at night), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills and sweating at night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CHILLS (chills and sweating at night). On an unknown date, the patient experienced NIGHT SWEATS (chills and sweating at night) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, NIGHT SWEATS (chills and sweating at night), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills and sweating at night) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided