chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Janssen COVID-19 Vaccine EUA Chills, muscle aches, left arm sore, fever 38.4 degrees Celsius.
Hx of metastatic rectal cancer, on chemo.  Admitted wit cough, dyspnea, found with COVID 19
Pt has history allergy to gentamicin & thimerosal, devel inject site rxn within 24 after vax. Redness, swelling resolved without tx after 1 day.
I felt achy and sick as if i were getting the flu.  It was difficult to walk up the stairs to go to bed, but i went to bed immediately.  I was asleep by 9 pm and didn't wake up until 7 a.m.  After being up for 30 minutes, i felt like myself ago and no additional effects.
Immunizations administered 17DEC90 on 21DEC90 pt developed lump & reddened area at injection site.
Patient notes that approximately two weeks after getting Pfizer #2 injection, she was diagnosed with Herpes Zoster along her right torso to back.  Was treatd with acyclovir for 7 days and versicular lesions resolved.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE 07/21/2021. PATIENT FULLY VACCINATED ON 05/28/2021.
Pt stated today (01/25/16 at 1430) that after his Tdap administration on 01/21/16 at 1500, he went home and at about 1900 that evening he started having cold sweats, body aches, pressure in his chest, and hallucinations. Pt didn't go to the ER, urgent care and came into the clinic this afternoon for blood draw and to report reaction. Pt also had rapid heart beat.
Under her right arm and side of breast is swollen. She stated that the pain is very intense and she has to take Motrin to relieve it some. She is having pressure in her chest, shoulder, back, and neck.
Information has been received concerning a male physician who experienced post vaccination a localized reaction that was 6 to 7 inches wide with swelling and tenderness that continued to spread until it was 210 degrees around circumference of the thigh. The site was warm to touch and he was unable to walk for 48 hours.
Strong heart palpitations for 2-3 hours starting about 8 hours after injection. As soon as the palpitations passed I got an onslaught of symptoms including fever, chills, sore muscles, weakness, headache, and light headed.
Experienced full and ?normal?menstrual period during menopause more than one year since last period.
1-2 mm hives starting about 12 hours after injection at same arm as injection. spread to entire body below neck. Very, Very itchy per pt
No adverse event; Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd dose); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd dose)) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 13-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd dose)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd dose)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd dose)).    Concomitant product use was not provided by the reporter.  Patient received Moderna Covid-19 vaccines for the 4 previous doses.  Patient received 2nd booster dose on 26-Apr-2022 and no other information were available at the time of the report.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2022: Follow-up information received included reporter email address was updated.
Patient was in distress and had a Stroke ( per his wife). Ambulance called and pt was admitted to hospital.
Patient stated that she felt dizzy and feeling faint after getting first Covid vaccine. Patient was taken back to recovery cot to lie down via wheelchair. She laid on the cot with an ice pack on the back of her neck for 35 minutes then stated that she felt much better. Patient slowly sat up, waited five minutes then stood and walked out to her car without incident.
Patient described swelling and bruising in arm and that the swelling continues still.  There were also flu-like symptoms, dry mouth and flaring on the left side of the face.  They were most concerned that the swelling continues.
Information has been received from a health professional concerning an 81 year old female with rheumatoid arthritis, allergic reaction to vancomycin, streptomycin, penicillin, codeine and tuberculin test reaction in the past but no diagnosis of tuberculosis who on 19-JAN-2009 was vaccinated I.M. with a 0.5ml dose of PNEUMOVAX vaccine (lot #: 663012/1163X) in the right arm. It was reported that the patient concomitant took "buckets full of med", but the caller would not specific medications. The patient was given PNEUMOVAX vaccine on in the past on 30-NOV-2001. On 21-JAN-2009, the patient came back to the office because of an injection site reaction. The exam revealed erythema of her right lateral arm without warmth. The patient had no fever. The physician determined that it was an allergic-type reaction with pruritus. The patient was prescribed clindamycin and was told to ice the area. The patient recovered on 29-JAN-2009. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. This is one of several reports received from the same source. Additional information has been requested.
This is my 4th Pfizer shot. Around 12:30 am, I woke up and became aware when the symptoms became unbearable, I felt my skin really hot all-over, while shivering. I couldn't sleep after, due to the shivers, I picked up a blanket to cover myself, even though my skin was boiling. I was extremely tired in the morning hours and started dozing off around 5:30 am, today, I have been feeling weak, achy, something is not right, but I manage. I am not the type to lay down during the day, but today I did 3 times. I had the same reaction when I got the 3rd shot, also at night. Worse shivering, I got up, drunk a cup of tea, and for some reason it calmed down the extreme shivering, teeth hitting each other badly, stopped shaking. So last night and today, I knew the possibility of having the same reaction was there.
She was sitting on the sofa at her grandmothers house playing her violin and she got an Instant pain in her buttocks and it went down her legs and her legs went dead. No bladder control. It happened instantly. But did have some leg numbness several times in between, but we thought it was from sitting on the floor. An ambulance was called and she was taken to the hospital
The moment the typhoon vaccine hit my skin. Immediately felt a wave of lightheaded ness and ?relaxation? across my body. It transitioned into a headache. Then spread from the left arm into my back around the shoulder blade in a tense manner feeling of pressure. That then moved into my left neck and into the left face as well as the arm. Arms started getting weird in middle and in hand. Dizziness continued for 40 mins. As dizziness faded chills started in my arm and then moved over my body.  Can feel into my legs
I felt hot/cold at 8:10pm so decided to go to bed.  By 8:30pm I was shaking uncontrollably, shivering, fever, nausea.  Assumed they were side affects and didn't want to go to ER.  Hot & a headache by 10pm.  Got a cold rag to put on my head and went to sleep.  Happy to wake up in the morning :)  Tired on Saturday so took a 5-hour nap, still a bit of nausea so didn't eat anything but soda crackers and drink water. Sunday I was back to normal.
Per chart review. Allergy assessment was entered by resident physician: NOV 07, 2019@11:48:35 by ORIGINATOR  Patient complained for SEVERE myalgia of bilateral lower legs, shortly after Prevnar 13 injection in the shoulder. Myalgia. CELECOXIB 200 MG EVERY DAY ,BACLOFEN 10 MG TID
whelp itchy; developed into a 3 inch whelp that is red; whelp that is  sore/whelp tender; little red mark at the injection site on the left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (whelp itchy), VACCINATION SITE URTICARIA (developed into a 3 inch whelp that is red), VACCINATION SITE ERYTHEMA (little red mark at the injection site on the left arm) and VACCINATION SITE PAIN (whelp that is  sore/whelp tender) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (little red mark at the injection site on the left arm). On 11-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (whelp itchy), VACCINATION SITE URTICARIA (developed into a 3 inch whelp that is red) and VACCINATION SITE PAIN (whelp that is  sore/whelp tender). At the time of the report, VACCINATION SITE PRURITUS (whelp itchy), VACCINATION SITE URTICARIA (developed into a 3 inch whelp that is red), VACCINATION SITE ERYTHEMA (little red mark at the injection site on the left arm) and VACCINATION SITE PAIN (whelp that is  sore/whelp tender) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patient had tried Advil, Tylenol, and cold compresses to try to help alleviate her symptoms, none has helped. Local pharmacist suggested she might try Lidocaine cream.
Moderate rush over the face and chest area. Mild rash over the abdominal and dorsal area.
Very lethargic for a few days, had some dizziness and then tinnitus settled in the left ear. Constant 24/7; have been to my personal doctor, had an audiology hearing assessment. I have an appt with an ENT and am pursuing acupuncture. Oddly enough, I now know 5 people who have had this same side affect.
Continuous crying, inconsolably for 4-6 hours then fevers the next day.
This spontaneous report was received from a mother's consumer refers to a 1 year old female patient. On 20-MAR-2013, the patient was vaccinated with VARIVAX (Merck) (manufacturer unknown) in the thigh as routine vaccination (lot number, dose not provided). On the same day, the patient received PROQUAD (Merck) (manufacturer unknown) (lot number, dose not reported) in thigh as routine vaccination. At that time, patient not showed any physical or emotional adverse reactions. Additional information has been requested.
PATIENT EXPERIENCED SYNCOPE EVENT AFTER ADMINSTERING COVID VACCINE. PATEINT BODY WAS COLD AFTER 1 MINUTE FROM THE ADMINISTRATION. I RAISED PATINT LEG  AND PATIENT WAS LAYING DOWN. LATER 1  MINUTE PATIETNT WAS NORMAL. WE STILL MONITOR THE PATIENT FOR 45 MINUTES UNTIL HE FEELS BETTER.
COVID positive. Symptoms include: muscle aches, cough, shortness of breath, nausea or vomiting, fatigue, and diarrhea.
miscarriage at 8 weeks; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in arm left on 21Jan2021 (age at vaccination 30 years) as dose 2, single; and first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in arm left on 31Dec2020 (age at vaccination 30 years) as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient medical history and concomitant medications were reported none. The patient had no past drug event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has been tested for COVID-19. On 11Sep2021, patient experienced miscarriage at 8 weeks. Seriousness of the event was medically significant. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Nasal Swab, SARS-CoV-2 test: negative on 03Nov2021. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded 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.
Immediately after administration, patient experienced a localized and minor itchiness. Patient continues to having minor itchiness and blisters locally for three weeks post injection.
hard tightness from the inner muscle of right shoulder all the way down to the palm; tightness in chest; face got little warm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (hard tightness from the inner muscle of right shoulder all the way down to the palm), CHEST DISCOMFORT (tightness in chest) and FLUSHING (face got little warm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN, LISINOPRIL and METOPROLOL for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (hard tightness from the inner muscle of right shoulder all the way down to the palm), CHEST DISCOMFORT (tightness in chest) and FLUSHING (face got little warm). On 14-Apr-2021, MUSCULOSKELETAL STIFFNESS (hard tightness from the inner muscle of right shoulder all the way down to the palm), CHEST DISCOMFORT (tightness in chest) and FLUSHING (face got little warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Diagnosed on 4/13/2012 with shingles/Herpes Zoster NOS in a varicella-vaccinated child; treatment acyclovia (Zovirax) 200mg/5ml oral suspension.
injection site turned red after couple of days; 2 inch wide and 4 to 5 inch in length patch from the top of the muscle down to the injection site; shot getting itchy; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (shot getting itchy), VACCINATION SITE ERYTHEMA (injection site turned red after couple of days) and SKIN DISCOLOURATION (2 inch wide and 4 to 5 inch in length patch from the top of the muscle down to the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZIA) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (shot getting itchy). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site turned red after couple of days) and SKIN DISCOLOURATION (2 inch wide and 4 to 5 inch in length patch from the top of the muscle down to the injection site). At the time of the report, VACCINATION SITE PRURITUS (shot getting itchy), VACCINATION SITE ERYTHEMA (injection site turned red after couple of days) and SKIN DISCOLOURATION (2 inch wide and 4 to 5 inch in length patch from the top of the muscle down to the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment medications were provided
Massive diarrhea and lethargy for 5 days and then diarrhea that lasted 2 months.  The diarrhea was liquid 4-6 times a day that caused a bleeding rash on his buttocks.
Health issues even before 1st dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Health issues even before 1st dose of moderna vaccine) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Health issues even before 1st dose of moderna vaccine). At the time of the report, ADVERSE EVENT (Health issues even before 1st dose of moderna vaccine) outcome was unknown.            No Treatment information was provided. No concomitant medication was provided.
Patient experienced double vision for 3 months; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Patient experienced double vision for 3 months) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In January 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 DIPLOPIA (Patient experienced double vision for 3 months). At the time of the report, DIPLOPIA (Patient experienced double vision for 3 months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
The day after the vaccine, I started feeling tired in the afternoon, and was bedridden for at least four hours with a fever less than 100 degrees. During this time, I had mild sharp pain in the heart twice, each lasting about 5-10 seconds. The fever was gone after I took Tylenol, but the heart pain is still quite stressful to think about even today.
sick with COVID; he was sick; short of breath; felt bad; breathing issues; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included transplant. Concurrent medical conditions included immunocompromised.   On 20th November 2020, the patient received the 1st dose of Shingrix. On 22nd November 2020, 2 days after receiving Shingrix, the patient experienced covid-19, sickness, shortness of breath, feeling bad and abnormal breathing. The patient was treated with oxygen. On an unknown date, the outcome of the covid-19, sickness, shortness of breath, feeling bad and abnormal breathing were recovered/resolved.   It was unknown if the reporter considered the covid-19, sickness, shortness of breath, feeling bad and abnormal breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had transplant in past and because of transplant patient was currently immunocompromised. The patient received the dose of Shingrix and 2 days after the vaccination patient was sick with COVID for 30 days The patient also experienced shortness of breath,felt bad and breathing issue. The patient did test for covid and result was neagative. The patient used oxygen for six days. The patient later visited pulmonologists through Jan and Feb 2021 for his breathing issues and by the 1st March 2021 patient felt better. The reporter did not consent to follow up. The patient refused to provide any demographic information or pharmacy information.
Injection site raised and pain upon touch - started 1/11 evening after vaccine dose 2. Then on 1/12 1600 noticed under arm swelling and discomfort - thinking it's lymphadenophathy just on left side. Took ibuprofen and no changed as of 1/13 am
Site of injection is noted red, swollen and painful for 4 daysl. Tx ice and Tylenol.
Migraines resistant to OTC NSAIDs. Pain phases lasting multiple days, with multiple nausea, aphasia, visual disturbance, and facial neuropathy phases. Pain phases will break after 3-4 days, followed by extreme tiredness, then onset of a new pain phase 1-2 days later.