chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt experienced full vaso vagal reaction post COVID vaccine.  Cold packs were administered to back of neck and forehead.  Pt sweating resolved and color came back.  Aided pt to stand until feeling came back in legs/feet.  Called Dad into room.  He stated he was a nurse and understood the situation.    Everyone was calm.  Had pt stay for additional time and offered snack once feeling better. Pt was not thirsty so allowed sip on water and gave reese cup.  Dad walked around store for a bit before getting into the car.
Subsequent to receiving the first dose of Havrix, the pt experienced a rash. As of 01/23/2001, the outcome of the event is unknown.
feeling bad; taste is gone; can't eat; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad), AGEUSIA (taste is gone), DECREASED APPETITE (can't eat) and DIARRHOEA (diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included PANTOPRAZOLE, SERTRALINE, ESTRADIOL (ESTROGEN), GABAPENTIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D3, FOLIC ACID, ATORVASTATIN, DONEPEZIL, FESOTERODINE FUMARATE (TOVIAZ), QUETIAPINE FUMARATE, METFORMIN, ISOSORBIDE, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), SPIRONOLACTONE and MODAFINIL for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (feeling bad), AGEUSIA (taste is gone), DECREASED APPETITE (can't eat) and DIARRHOEA (diarrhea). At the time of the report, FEELING ABNORMAL (feeling bad), AGEUSIA (taste is gone), DECREASED APPETITE (can't eat) and DIARRHOEA (diarrhea) had not resolved. Not Provided      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.   No treatment medications 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.
Hives presented at home after the 15 minute evaluation period. They have been subsiding...patient is well enough to have walked in the pharmacy though. Patient also reported itching, headache, chills & muscle aches/pains. These all resolved on their own.
This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date was not reported) via an unspecified route of administration on 17Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date of 2021 patient reported that she has been feeling extremely tired after vaccination. Patient added that the main thing was nausea, 2 days later she still has nausea. The patient specified she had to sleep for 11.5 hours. She asked if her experience included in the reported side effects of the COVID-19 vaccine. The outcome for the event extremely tired was unknown, and for the event nausea was not recovered. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Doubled over in pain in my stomach. Lasted for 5 hours add an excruciating level. Continued on for 24 to 48 hours at some degree. Still having some weird effects after reading at this point.
Headache and nausea started day of vaccine.  Improved, then on 11/30/11 started with rash seen today, which was thought was shingles.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 21-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J003808, expiry date 03-JUL-2014, 0.65 ml/once) subcutaneously. No adverse effect was reported. Additional information has been requested.
24 hrs after receiving DTaP #5 and IPV #4 in right deltoid, mom noticed swelling and redness at site. Came to Dr's office after 48 hours for IZ stated no change in arm since day before. Right deltoid noticeably swollen, 9" circumference compared to 7" circle on left deltoid. 4 1/2 x 3 1/2 erythematous induration. Tx'd with Keflex 250 mg PO QID for 10 days.
THE PATIENT RECEIVED THEIR SECOND DOSE OF MODERNA COVID-19 VACCINE 21 DAYS AFTER RECEIVING THEIR FIRST DOSE INSTEAD OF THE MINIMUM OF 24 DAYS AFTER RECEIVING THE FIRST DOSE. THERE ARE CURRENTLY NO KNOWN ADVERSE EVENTS ASSOCIATED WITH THIS PATIENT.
Fever (100.1); This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 6955), via an unspecified route of administration, in right arm on 10Apr2021 11:00 (at the age of 47-years-old) at single dose for COVID-19 immunization. Medical history included asthma and amoxicillin allergy. The patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced fever (100.1) on 18Apr2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of the event was resolved on an unspecified date.  No follow-up attempts are needed. No further information is expected.
w/in 6hr was quite lethargic-arousable but refused to eat 7 then would fall back to sleep;cont sx for approx 12+hours;also had mod erythema/swelling of lt thigh were IPV & HIB given;no tx;
This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On an unknown date, following administration of a dose of GARDASIL the patient vomited. At the time of the report the patient's outcome was unknown. This case is linked to MARRS 1307USA009233 and 1307USA010388. Additional information has been requested.
I have a complaint about a patient that came into our pharmacy to let us know that when she got her flu shot a month ago (09/16), she claimed that our pharmacy tech (licensed to vaccinate) gave the shot close to her shoulder and felt pain "right away" when she inserted the needle and injected the flu vaccine. She stated that she still felt weakness and could not raise her arm until this day. She claimed that she tried "everything" over the counter to relieve her pain, but to no avail. She took her flu shot every year at another pharmacy and didn't have any serious effects.
caught COVID from her; caught COVID from her; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caught COVID from her"; ILLNESS (non-serious), COUGH (non-serious), PYREXIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: now positive and are sick. caught COVID from her.  Clinical course- This reporter belongs to reporters aunt. Reporter said that was really strange was his family and sons and daughter all went to withheld for a wedding and he stayed there to take care of the dogs. They got back the first day they all were fine and the next day literally out of a group of 7 people 5 were now positive and were sick. His wife came back in the house and they were together and obliviously caught COVID from her and his symptoms and her mother and aunt and stuff were vaccinated and sick as a dog and coughing, hacking, fever, tired and his wife was at her mothers house and sick too trying to help each other. son had it and not as bad. Caller declined report on mother, aunt and others and said it would take all day. Reporter said at the end of the day does he need to contact his doctor and he said he obliviously should not take the pills. There is a product complaint to report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
large local rxn upper arm into bicep swollen, faint color rash, tender to touch w/sl itch;joints & shoulder blade area sore/aching;aches into hand;hurts to make a fist in lt hand;bump on inj site;
legs and feet swollen; breathing issues; Lethargic; les and feet swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (legs and feet swollen), RESPIRATION ABNORMAL (breathing issues), LETHARGY (Lethargic) and PERIPHERAL SWELLING (les and feet swollen) 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 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (legs and feet swollen), RESPIRATION ABNORMAL (breathing issues), LETHARGY (Lethargic) and PERIPHERAL SWELLING (les and feet swollen). At the time of the report, RESPIRATION ABNORMAL (breathing issues), LETHARGY (Lethargic) and PERIPHERAL SWELLING (les and feet swollen) 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.
Chest pains was experienced suddenly around 4:25 pm today while walking dog. This was accompanied by breathing problem and extreme lower back pain. This subsided after few minutes. Then nausea and headache came. Patient walked back to car with me and after 10 min, complained of chest spasms and an uncontrollable chill and shaking occurred for few minutes which led me to call his doctor's office where a nurse advised me to take him to ER.
After the 1st shot patient got a little red and warm her arm; After the 1st shot patient got a little red and warm her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (After the 1st shot patient got a little red and warm her arm) and VACCINATION SITE ERYTHEMA (After the 1st shot patient got a little red and warm her arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Patient did not have any allergies. Patient never had COVID-19 positive test or diagnosis.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (After the 1st shot patient got a little red and warm her arm) and VACCINATION SITE ERYTHEMA (After the 1st shot patient got a little red and warm her arm). The patient was treated with PREDNISONE at an unspecified dose and frequency and PREDNISOLONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (After the 1st shot patient got a little red and warm her arm) and VACCINATION SITE ERYTHEMA (After the 1st shot patient got a little red and warm her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2022-587868 (Patient Link).
No adverse event; a nurse gave a third dose of primary series of Moderna instead of the booster to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (a nurse gave a third dose of primary series of Moderna instead of the booster to a patient) and NO ADVERSE EVENT (No adverse event) in a 14-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient was not immunocompromised.    On 26-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2023, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (a nurse gave a third dose of primary series of Moderna instead of the booster to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a nurse gave a third dose of primary series of Moderna instead of the booster to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a nurse gave a third dose of primary series of Moderna instead of the booster to a patient).    Concomitant medication was not reported.  Treatment medication was not reported.
22APR96 mom reported pain rt deltoid inj site;23APR96 AM pt exp h/a & temp of 102.1;24APR96 AM pt exp h/a, temp of 101.8 & devel facial edema, eyes, nose, cheeks & lips;APAP recommended by MD for fever/h/a
15 year old received the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received the 1st dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received the 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received the 1st dose) 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.   Concomitant medication was not provided.  Treatment information was not provided.  Additional information included that the patient was about 16 years old at the time of 2nd dose.
Woke up with vertigo while lying in bed. Strong sensation of fast movement, I felt bed close to the bed. More vertigo when walking to bathroom, I felt myself go sideways a bit, as if I was bumped off track. Lots of nausea and dizziness during the following week. I now experience dizziness when looking up from a standing and sitting position. Very low energy. Dark circles under my eyes. Lump under  my L arm pit appeared the day after injection. Lack of energy tough. Sensitivity to noise,I continue to experience walking off track, I ljust go sideways sometimes, feels like I?m off balance suddenly. I basically felt as if I had experienced a concussion, aside from the vertigo, the morning after I received the covid booster. I did not have a concussion.
On my drive back to work after getting the vaccine the left lower part of my face when numb and tingly. Then it focused on my left nostril. The overall effect didn't last long but my nostril still doesn't feel right. Somewhat numb but not always. The left side of my face feels strange at times as well. Hard to explain.
fever to 105 R evening & noc p/vax;was less active than usual in following days;mom & sibling became ill w/in the week;
Guillain-Barre syndrome; neurological symptoms; Initial information received on 21-Dec-2022 by health care professional regarding an unsolicited valid serious literature case.  This case involves a 39-year-old female patient who experienced Guillain-Barre syndrome (GBS) while receiving vaccines BNT162B2 (The Pfizer BioNTech vaccine against COVID-19 (corona virus 2019)) and INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received the second dose of BNT162b2 and Fluzone® IIV4 INFLUENZA VACCINE (QUADRIVALENT) vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, and approximately 10 days later presented with neurological symptoms (neurological symptom) which required hospitalization for 21 days. Subsequently, the patient was discharged in stable and improved condition and met criteria for Brighton Level 2 diagnostic certainty for GBS.  Action taken: Not applicable Corrective treatment: unknown Outcome: Recovering / Resolving Seriousness criteria: Medically significant and hospitalization Reporter causality: Related; Sender's Comments: Sanofi company comment dated 27-DEC-2022: This case involves a 39-year-old female patient who experienced Guillain-Barre syndrome (GBS) while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT). Based upon the reported information, the role of a vaccine cannot be assessed due to compatible temporal relationship of ADR to the vaccine. However, lack of information regarding the past medications, family history and medical history details precludes a comprehensive assessment in this case.
The evening of the vaccine I was having a tingling sensation in my legs where I get Cellulitis. The next day my legs were painful and it got worse. I got Cellulitis in both legs and it normally only happens in one leg. I also had a rash on my right arm. It was a red swelled spot. By the time I was in the hospital the swelling was all the way above my knee. I was also wheezing but it was identified as long Covid-19 symptoms. I had Covid-19 in March of 2020. I was sent home after two days and prescribed Keflex. I was referred to a Pulmonologist.
Fever; Headache; Body aches; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) had not resolved. Not Provided      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.   Patient didn't clarify about the Concomitant drug.
Pt's wife contacted Health Department on 1/18/22 stating that her and her husband have been experiencing tachycardia and A-fib in the middle of the night and in the mornings off and on. Per patient's wife, the symptoms started about a month after recieving the second Moderna vaccine on 2/26/21. Pts wife stated that he wears a smart watch and that the watch was showing that pt was experiencing tachycardia and a-fib. During these symptoms, wife stated that pt wakes up in the middle of the night and can feel that his heart rate it high. Pts wife stated that his HR runs in the 50s usually and it was running <160 but higher than his normal.
migratory rash - very itchy. Rash would move around every 5 -15 minutes to new spots.  Prednisone helped immensely with itching.  Then when course was done had about another week of mild migratory, itchy rash.  Now no rash.
Administered vaccine in left arm at 11:46 AM . about 11:48 patient said he felt lightheaded. I got up to get patient a Gatorade and he began to snore. I realized he had passed out . I held his arm and said his name he immediately jerked awake and did not know where he was or what he was doing.  He drank some Gatorade and ate a couple of chocolate kisses.  He began to have cold sweats that lasted a few minutes.  I sat with him in counseling room for 15 minutes and then he sat in waiting room  until he felt better.  He did not feel that he needed further attention or medical assistance.
Devel high fever, shaking, chills, redness & swelling @ vax site; t105 resolved in 24 hrs;
received Moderna vaccine instead of Pfizer 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received Moderna vaccine instead of Pfizer 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE for COVID-19 vaccination.    No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and first dose of COVID-19 VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received Moderna vaccine instead of Pfizer 2nd dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received Moderna vaccine instead of Pfizer 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported    This case was linked to US-MODERNATX, INC.-MOD-2021-081486 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081486:Crosslinked
Bleeding/Spotting - eventual miscarriage of 6 week pregnancy 10/22/09 Medical records received for date 10/21/09. Pt. seen for c/o vaginal bleeding. Pt. states approx 5 weeks pregnant. Pt. received vax 10/19/09. Assessment: US performed which demonstrated normal endometrial stripe. No evidence of a gestational sac. No free fluid, no adnexal masses. DX:Early pregnancy, either a threatened miscarriage, continuing miscarriage, or ectopic pregnancy. Labs ordered. 11/30/2009 Dx early pregnancy
Temp - 100.5 F, chills, body aches, injection site sore & warm. Pt. called 3/7/13 to report symptoms. He continues on 3/7/13 with symptoms described.