chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaginal lesions developed, they were extremely painful; vaginal lesions developed, they were extremely painful; a high fever (102); body aches; chills; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER 8735) at the age of 33-years, via an unspecified route of administration, administered in left arm on 22Apr2021 at 10:00 at single dose for COVID-19 immunisation, at pharmacy or drug store. Medical history included IBS. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING). The patient previously took the first single dose of BNT162B2 (lot number: EW0150) at the age of 33-years, via an unspecified route of administration, administrated in left arm, on 01Apr2021 at 10:00 for COVID-19 immunisation. Vaginal lesions developed about 36 hours after vaccine. They were extremely painful and healed after a week. The event occurred on 23Apr2021 at 22:00. Also experienced body aches and chills about 8 hours after the vaccine (on 22Apr2021 at 18:00), and a high fever (102) beginning about 16 hours after vaccine (on 23Apr2021 02:00, lasting about 10 hours on and off). The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received lidocaine for pain as treatment. Outcome of fever was recovered/resolved on 23Apr2021 at 12:00; of vaginal lesions developed, they were extremely painful was recovered/resolved; while of remain was unknown. Since the vaccination, the patient has not been tested for COVID-19.
she tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's daughter).  A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via unspecified route of administration on 20Jan2021 (at the age of 80-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of the Pfizer COVID-19 vaccine on 20Jan2021 and was infected the same day. On 25Jan2021 Monday, the patient was tested positive. She started having symptoms on the 24Jan2021. Because of her age, she was taken to doctor and on 27Jan2021, she got antibody infusion for COVID. The patient was then told to wait 90 days because she had antibodies, and on 29Apr2021 she received her second COVID shot, it was Pfizer as well. The clinical outcome of the event was unknown.  Follow up (07May2021): This follow-up is being submitted to notify new information: Event onset date and lab data was added.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist, via company representative, refers to a patient of unknown age and gender. Patient's pertinent medical history and previous drug reactions and allergies were unspecified by the reporter. On an unknown date, in October 2014, approximately (six months ago), the patient was vaccinated with ZOSTAVAX. Concomitant medications were unspecified by the reporter. On an unknown date, the patient experienced impaired speaking ability. The patient sought medical attention. The outcome of impaired speaking ability was unknown. No product quality complaint was reported. Causality assessment was not provided. Additional information has been requested.
Flushing of cheek; Red cheek; Face swollen; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing of cheek), ERYTHEMA (Red cheek) and SWELLING FACE (Face swollen) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FLUSHING (Flushing of cheek), ERYTHEMA (Red cheek) and SWELLING FACE (Face swollen). At the time of the report, FLUSHING (Flushing of cheek), ERYTHEMA (Red cheek) and SWELLING FACE (Face swollen) outcome was unknown. Not Provided      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.   The patient was treated with Zyrtec
PATIENT PRESENTED TO PHARMACY DEPARTMENT WITH SWOLLEN LEFT BICEP THAT WAS WARM TO TOUCH. SHE INDICATED THAT THE SWELLING STARTED THE MIGHT OF THE VACCINE ADMINISTRATION.
Patient under-dosed for second vaccine shot. Called Pfizer for advice. They did not have official guidance on this specific scenario, but discussed bringing the patient who was under-dosed back to clinic to receive the balance of their full dose (full dose = 30mcg).  Patient brought back to clinic and received full dose.
He got his vaccine, didn't have any reaction until about 2 weeks later when he broke out with a blister on his right shin.  He went to his doctor for this, and the NP told him to keep it clean and bandage it up.  Every-time he took the bandages off it pulled the skin off about to the raw meat.  Then he went to Dermatologist Dr.  He did 3 skin grafts, had him on different medications, on Dapsone, Mycophenolate, Tramadol for pain, Cyclobenzaprine, Prednisone right now, Methotrexate 2 tablets on Friday's and 2 on Saturdays, and then he takes on the off days folic acid on Sunday-Thursday.  Starting tomorrow he will be on Smz-Tmp tablets.  He is also on vitamin D and iron tablets as well.  He had been going to Dr. at the hospital having infusions done, and then just yesterday he was started on a different type of infusion Rituximab which took 8 hours for the infusion. The other infusion he was on last month and the leg blistered up and broke out again and now he has a day nurse coming 3 x a week who is redressing it and taking care of it. Dr. is who is treating him with these medications Oncologist at and has a FU with her on 1/4/23.
pt states that she had the injection into the area around the rotator cuff on the right arm that caused her arm to go numb for an entire month.  She had to have physical therapy for 2 years after getting the vaccine due to the injection causing a small tear in the rotator cuff.  This happened 21 years ago and she continues to have problems to this day.  The area is still tender and feels like it is bruised at the injection site.
Cough  Shortness of Breath  Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Diarrhea
Per provider Pt developed a hard bump over 1 inch. Provider saw pt today stated no fear of infection. Provider prescribed anti- itch (Diphenhydramine) with Zinc 2%-0.1 topical cream.
Pt vaccinated with MMR/HIB developed welts on face & arms x 2 hrs, temp 99.6 (a), lungs clear. Hives on arms & face, none on trunk, legs, runny nose. Advised to take Benadryl Md did not think this was a reaction to vaccines.
RN gave vaccines meant for another patient to patient above. Patient got TDAP, Menveo and Gardasil. The vaccines ordered were DTAP and Hep A. As per provider, patient was cleared to get Hep A in which case patient received the Hep A today. Provider was informed. As per Dr., child will have no adverse reaction to the vaccines given and vaccines will not count towards vaccine schedule. Parent was informed during visit. No adverse reaction at this time.
Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction.  That was it until later that night I started getting a really bad headache/migraine.  I started taking Tylenol but that didn't help much.  I got chills and I'm sure a slight fever because I was sweating.   I started throwing up also..  After taking Tylenol every 4 hours my headache finally went away and I started to feel better.   This was around 2:30 pm the following day.  I would say my symptoms lasted for about 22 to 24 hours.
Pain onset 10/8/2019  in left posterior neck, running down his left scapula centered on his left shoulder. Pain extends down his left arm to his elbow and has pain, numbness, tingling to his left 4th and 5th fingers. Slowly improving.
Five minutes after injection, tingling tongue, severe dizziness, foggy brain, chest pressure, then coughing non stop
the day p/vax pt devel rash, pruritic one @ the inj site;this rash has progressed to incorporate much of face R&L, neck & a few isolated lesions on arms & chest;these are papular/vesicular lesions;no fever;also has lesions on TM's bilat;
dizziness, hives @ inj site w/edema, CP, leg shakiness, SOB;
On July 10, 2022, I tested positive for COVID-19. That Friday I tested myself because I was having COVID-19 like symptoms and it was negative but when I re-tested on July 10th, I tested positive. I contacted my doctor and she stated that I did not need Paxlovid because of my age and I wasn't high risk.
Fever 104.2 highest, diarrhea 5-6 episodes per day. Refuse to eat and lethargic, and crying.
Pediatric dose probably  given to adult; Pediatric dose probably  given to adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 44-year-old female patient who received HBV (Engerix B) (batch number L040458) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: Pediatric dose probably  given to adult) and adult use of a child product (Verbatim: Pediatric dose probably  given to adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 Nurse called to inform that around 2016, a dose of Engerix-B of unknown dosing (pediatric or adult) was administered to an adult patient.  HCP provided the lot number, but it wasn't found in system. However, HCP stated that it was from GlaxoSmithKline and that it was most likely for adult but was not completely sure. The reporter did not consent to follow up. The adult patient received dose of Engerix B, which led to underdose and adult use of child product. This case is linked with US2023046123 and US2023046121, reported by same reporter.; Sender's Comments:  US-GSK-US2023046121:Same reporter US-GSK-US2023046123:Same reporter
FACIAL SWELLING NEAR NOSE; LYMPH NODE SWELLING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced facial swelling near nose. On APR-2021, the subject experienced lymph node swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the facial swelling near nose and lymph node swelling was not reported. This report was non-serious.
10 doses administered past the 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 doses administered past the 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047821A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 doses administered past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 doses administered past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I feel I am dying; Headache/headache is killing her; I have been throwing up/vomiting; I can't keep down my stomach; some of my blood fall down in my cab. Keep freezing up; My legs keep locking up on me like hell.; pain; I can't keep down my stomach; My legs keep locking up on me like hell.; This is a spontaneous report received a contactable consumer, the patient. A female of unspecified age received a single dose (unspecified dose number) of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route on an unspecified date, for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The patient reported that ever since the shot she has been unable to keep her stomach normal and has a headache. The patient explained that she 'cannot keep down my stomach and some of my blood fall down in my cab, keep freezing up'. She is vomiting and has a headache that is killing her. The patient stated that her legs keep locking up on her like hell. The patient reported the she feels like she is dying. The patient inquired if the representative understood that she was in pain and asked if she should go to the hospital.  The outcome of the events unable to keep her stomach normal, cannot keep down my stomach and some of my blood fall down in my cab, keep freezing up, vomiting, headache, legs keep locking up on her, and she feels like she is dying was unknown.   Follow-up attempts to obtain Batch/Lot/Exp. information are ongoing
No adverse event; Mother thinks kids received Bivalent booster instead of Monovalent; Database shows received vaccine meant for 5M-11-year-old for booster dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Database shows received vaccine meant for 5M-11-year-old for booster dose) and NO ADVERSE EVENT (No adverse event) in a 12-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Database shows received vaccine meant for 5M-11-year-old for booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Database shows received vaccine meant for 5M-11-year-old for booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  The age of patient was reported as 12.5 year old. The patient's mother requested the Bivalent Booster for the patient. The patient's mother observed the HCP drawing the liquid out of the Moderna COVID-19 vaccine vial meant for 5M to 11 year old and administering it to the patient. Later the patient's mother found out that the Bivalent vaccine was not even approved to be used in patients younger than 18.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-647610, US-MODERNATX, INC.-MOD-2022-647605 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647605:Girl Child case US-MODERNATX, INC.-MOD-2022-647610:Mother case
Fluid on the ear; Bells palsy; Jaw pain; A spontaneous report was received from a consumer who was a 71-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced: Bells palsy(facial paralysis), jaw pain (pain in jaw), and fluid on ear (middle ear effusion).  The patient did not provide any relevant or specific medical history. Concomitant product use was not provided/unknown by the reporter   On 11 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number 013M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Feb 2021, the patient started to experience jawpain and went to see her doctor. The date of the doctor visit was not provided/unknown by the reporter. The patient was told by the doctor, "she had fluid on ear." Patient endorses, "she has had fluid on ear before and never had that type of pain."  Patient reports she returned for medical care on 06 Mar 2021 and was seen by a nurse practioner. The nurse practioner said she had Bells palsy. Patient indicated "she had all signs on(of) Bells palsy." The patient expressed concern regarding her eyesight as nurse practioner said "she could get dust in eye because of inability to close eye." Patient also wanted a call back on whether or not to take the second dose.   Treatment for the events included: "pregnisone" (presumed to be prednisone, reported as pregnisone 500mg/1000mg) and an anti-viral (reported as valacyclovir 1000mg) which was prescribed by the nurse practioner.   Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events of Bells palsy, jaw pain and fluid on ear was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
States that the booster dose really set it off and she got a rash.; States that now she has the little tiny red dots on her back, stomach, and top of her legs; Caller states that sometimes when they scratch it will bleed. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Lot number: FF8841) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot Number: Reported by the caller as being either EL9264 or FL9264.), administration date: 10Feb2021, when the patient was 65 years old, for Covid-19 immunization; Bnt162b2 (Second Dose, Lot Number: EN6203.), administration date: 03Mar2021, when the patient was 65 years old, for Covid-19 immunization, reaction(s): "itchy". The following information was reported: RASH (non-serious), outcome "unknown", described as "States that the booster dose really set it off and she got a rash."; RASH MACULAR (non-serious), outcome "unknown", described as "States that now she has the little tiny red dots on her back, stomach, and top of her legs"; SKIN HAEMORRHAGE (non-serious), outcome "unknown", described as "Caller states that sometimes when they scratch it will bleed.". Therapeutic measures were taken as a result of rash, rash macular, skin haemorrhage.  Additional information: Patient states that she has been to her doctor, dermatologist, allergist, and rheumatologist. States they have nothing besides the vaccine that is different. Patient asks is there any hope on the horizon? Will it go away?  Patient states that she looked it up and saw that it is an occurrence, chronic urticaria.  States that a man at her gym and a lady who just left her apartment have the same problem. Patient states that her primary doctor told her to take antihistamines, then the allergist put her on 5, then she had prednisone that knocked it out. Patient states that the man at her gym had the same thing. Patient says that she google searched it recently. Patient states that she was having side effects from the Prednisone. Patient states that on the Prednisone, at first she was all charged up, then retaining water. States she was on a massive dose at first after a while her doctor was hesitant. States she was then on a low dose. She was still kind of itchy, but it alleviated it. States she was on Prednisone from Christmas Eve until just a couple of weeks ago. Patient states that it lowers your immune system and can make you lose calcium. States that her doctor told her the Prednisone was really just a Band-Aid for her problem. States she has been running to doctors and giving blood like crazy.  Patient states that the lady is about the age of the patient and the patient states that she gave the lady some of her antihistamines she had left over. States that it helped a little bit. Patient states that the lady is suffering like the caller.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient had a "history of allergic reaction to Thimerosal". On an unknown date, reported as prior to 01-JAN-2007, the patient was vaccinated with PEDVAXHIB (dose, route of administartion, lot# and expiration were not reported) or RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced allergic reaction. The pharmacist could not provide specific details about the reaction. The outcome of allergic reation was unknown. The reporter considered allergic reaction to be related to PEDVAXHIB or RECOMBIVAX HB. Additional information is not expected because there was no consent to contact the reporter.
Patient reports he has had a sore arm starting 2 days after receiving 1st dose of covid vaccine. Patient describes it as soreness and the muscle being strained especially when moving the arm a certain direction. Patient still has a sore arm 28 days later when he came in for his second dose. Patient says he was gardening and using his arms heavily for gardening after receiving the first dose of the vaccine and soreness could be due to that.
A nurse reported the inability of a female in her 40's to respond to her 3rd injection of Hep B vaccine recombinant (Engerix-B). The subject had reportedly had an unspecified "immune disorder". However, the PT's physician indicated that this disorder "would not interfere with responding to the vaccine." Concurrent medications were unknown. The subject received Engerix-B in Sept. 01, Oct. 01, and Apr. 02. An unspecified titer measures 1 to 2 months after the 3rd injection listed a value "<10" (units and reference range unspecified). The subject received her4th injection of Engerix-B on 6/6/02 (lot ENG5270A4). An unspecified titer measured on 8/9/02, 64 days after the 4th injection, listed a value of "<10" (units and reference range unspecified). As of 8/21/02, the outcome of the event was unknown.
Left upper arm with increased redness and warmth at injection site which progressively got larger since time of injection. Seen in clinic on 11/12/2015 @3:45PM. Area measured 6.5cm x 7.5cm, was warm and red, slightly raised. MD prescribed Augmentin 875mg PO BID for 10 days.