chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine brand other=Moderna (Dose1,2,3)/Vaccine brand=Pfizer/BioNTech (Dose4, 5); COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Aug2023, outcome "recovered" (27Aug2023) and all described as "COVID-19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "Vaccine brand other=Moderna (Dose1,2,3)/Vaccine brand=Pfizer/BioNTech (Dose4, 5)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2023) Positive; (27Aug2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 18Aug2023 to 22Aug2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291415 same patient/reporter; different drug/event;
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a adult female patient who received Shingrix (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the chills to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 63 or 64 years. The healthcare professional (HCP) stated that the patient had grade 3 chills and shivering for 3 hours following  a dose of Shingrix. No further information was provided by HCP.
Sudden right hearing loss; Tinnitus of right ear; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (Sudden right hearing loss) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21H) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2022, the patient experienced DEAFNESS UNILATERAL (Sudden right hearing loss) (seriousness criterion medically significant) and TINNITUS (Tinnitus of right ear). At the time of the report, DEAFNESS UNILATERAL (Sudden right hearing loss) and TINNITUS (Tinnitus of right ear) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed no issues of concern.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   It was reported that after the booster patient had sudden right hearing loss and tinnitus of right ear.  Patient went to three doctor's and the expert ENT doctor, advised an MR Brain internal auditory canal temporal bond (MRI).  Treatment medication was not provided.  Company Comment: This spontaneous case concerns a 54-year old male patient with no medical history reported, who experienced the unexpected Serious (medically significant) event of deafness unilateral (sudden right hearing loss), around 25 days after receiving the booster dose of mRNA-1273 Vaccine. Patient also experienced tinnitus (non serious) in the same ear around the same time. Patient was advised an MR Brain Internal Auditory Canal Temporal Bond (MRI). The MRI showed no issues of concern. It is unknown if the patient experienced any additional symptoms/events. Events had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year old male patient with no medical history reported, who experienced the unexpected Serious (medically significant) event of deafness unilateral (sudden right hearing loss), around 25 days after receiving the booster dose of mRNA-1273 Vaccine. Patient also experienced tinnitus (non serious) in the same ear around the same time. Patient was advised an MR Brain  Internal Auditory Canal Temporal Bond (MRI). The MRI showed no issues of concern. It is unknown if the patient experienced any additional symptoms/events. Events had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Fever, headache, chills and difficult breathing since he got the JASSEN 2days ago.  Took ibuprofen 400mg @1300.
Breakthrough COVID-19 case after being fully vaccinated.  Symptom onset 07/28/2021: muscle aches, runny nose, fatigue, cough, congestion.
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications  were not reported. On 25-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I received the Vaccine on 2/18 .At 22:00 I had chills and low grade Fever. Middle of the night  I felt fatigue and body aches, dull Headache. In the morning I was nauseus. The symptoms   lasted for 24 hours.
shaking; chills; severe body aches; fatigue,; abdominal pain; This case was reported by a physician and described the occurrence of tremor in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. On 19th November 2022, less than a day after receiving Shingrix, the patient experienced tremor, chills, general body pain, fatigue and abdominal pain. On an unknown date, the outcome of the tremor, chills, general body pain, fatigue and abdominal pain were unknown.   It was unknown if the reporter considered the tremor, chills, general body pain, fatigue and abdominal pain to be related to Shingrix.     Additional Information: GSK receipt date: 21-NOV-2022 Reporters comment: The reporter stated on 19th Nov 2022 the patient had shaking chills, severe body aches, fatigue, abdominal pain occurred within 24 hours of injection. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive information: This case has been linked to the cases US2022AMR173954 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR173954:same reporter - husband case
ABOUT 15 MIN AFTER VACCINE I FELT A WEIRD SENSATION UNDER MY SCAPULA AND TINGLING DOWN THE LEFT SIDE OF MY BACK.   30 MIN AFTER I FELT TINGLING ON MY LIP AND LEFT CHEEK.   1 HOUR AFTER TINGLING SENSATIONS UP AND DOWN LEFT SIDE OF MY BODY EXCEPT MY FACE. I MESSAGED MY PCP AT THAT TIME. MY VITALS WERE NORMAL, I DID NOT HAVE ANY DIFFICULTY BREATHING, AND I JUST FINISHED WORKING NIGHT SHIFT SO I SLEPT 9 HOURS. WHEN I WOKE UP I HAD THE TINGLING/KIND OF ITCHING UNDER MY SKIN FEELING RANDOMLY ALL OVER MY BODY EXCEPT MY FACE. I WAS A LITTLE TACHYCARDIC BUT I WAS FEELING ANXIOUS ABOUT WHAT I WAS PHYSICALLY FEELING. ONCE I CALMED MYSELF DOWN MY HEART RATE WENT BACK DOWN TO MY BASELINE. STILL NO VISIBLE RASH OR DIFFICULTY BREATHING, AND FELT FINE OTHERWISE. HAD DINNER AND WENT BACK TO SLEEP ANOTHER 8 HOURS.   WOKE UP 7AM STILL WITH TINGLING SENSATIONS ALL OVER MY BODY BUT DIDN'T FEEL IT AS MUCH AS BEFORE. NOW IT IS ABOUT 33 HOURS AFTER THE VACCINE AND I STILL HAVE THE TINGLING/ITCHING RANDOMLY ALL OVER BUT TINGLING HAS BEEN CONSISTENT ON THE PALM OF MY HANDS. OTHERWISE I FEEL FINE.
Information has been received from a physician concerning a female who on 26-JUL-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included MENACTRA. On 05-SEP-2007 the patient developed paraparesis and urinary incontinence. The patient was examined in the physician office on 06-SEP-2007 and is scheduled for a consultation with a neurologist on 07-SEP-2007. The physician reported that the patient had a magnetic resonance imaging performed on 06-SEP-2007 but the physician was unable to provided the results. The physician was unable to provide the lot number of Gardasil. The patient's paraparesis and urinary incontinence persisted. Additional information is not expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Shortly after administration, patient got dizzy and fell to the ground. Was sweating profusely. Paramedics were called. Blood pressure and heart rate stable at time of their arrival. Brother of patient informed us after the event the patient smoked marijuana prior to coming in
Yellow fever and typhoid given left arm on 8/10/00. On Saturday 8/12/00, arm was red, slightly swollen and itches. Reddness on arm approximately size of golf ball. Spoke with her on 8/16/00, stated arm dosen't itch anymore; some pain when you touch it and pink-purple in color.
Trigger finger; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history was not reported, and concomitant medications were not reported. The patient previously took aspirin 81. On an unspecified date, the patient experienced trigger finger. The consumer wanted to know what the contraindication or effect of the vaccine would be from taking aspirin as he read information about "don't take an aspirin on non-steroidal medication before getting the vaccine" and reported that he stopped his 81 mg aspirin to take the first dose of the COVID vaccine for fear that it may have a negative impact on the vaccine. He asks for more information on this. He also wanted to know if getting a steroid injection in each hand would be a problem? Consumer further reported that he has "trigger finger" and was scheduled to receive steroid injections to each hand and he might have steroid injections to his hands for trigger finger since his first dose but reported that he would put that off if it was contraindicated. The patient also enquired about what is the efficacy after second dose. Response: Callback performed. Disclaimers provided. Spoke from attached documentation. Referred to HCP for further discussion and guidance. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd flu vax & devel herpes zoster; pt was treated w/Zovirax (5) time daily for 1 wk & sx abated; 1 other resident of the same facility had a similar react;
Pt had chills, fever, redness at site, painful nodule to area that started the next day. Redness lasted 5 days, all other complaints lasted 1 day.
THERE WERE NO ADVERSE EFFECTS BUT THE PATIENT WAS ON ENBREL AT THE TIME OF ADMINISTRATION. WANT TO CONTRIBUTE TO POST MARKETING SURVEILLANCE INFORMATION  REGARDING IMMUNOCOMPROMISED PATIENTS THAT MAY BE VALUABLE TO THE CDC.
Pt with rash on arms, upper chest & back.  Started 2 days ago, day after flu shot.  Started right arm first where flu shot given.  Rash itches.  Received PREDNISONE orapned 10 mg.  1 tab, by mouth every twice daily. BENADRYL and advised to use AVEENO bath when necessary to relieve itching.
Face Acne; Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Face Acne) and TACHYCARDIA (Rapid heart rate) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (Face Acne) and TACHYCARDIA (Rapid heart rate). At the time of the report, ACNE (Face Acne) and TACHYCARDIA (Rapid heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided By the reporter. No Treatment History was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received  contains non-significant information
real tired; legs felt heavy and aching; legs felt heavy and aching; I have a MTHFR mutation; This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date (at the age of 60-year-old, not pregnant), at single dose, for COVID-19 immunization; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198 and expiration date not provided), via an unspecified route of administration, in right arm, in Mar2021 15:45  (at the age of 60-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included MDD (major depressive disorder), allergies to IV contrast dye. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication included sertraline. The patient previously took oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET) and ketorolac tromethamine (TORADOL), both had allergies. The patient stated the first dose made her real tired, and after 2 weeks her legs felt heavy and aching (but no redness or swelling). Patient had a MTHFR mutation (Methylenetetrahydrofolate reductase gene mutation) so she was scared about clots. After the 2nd shot on 04Apr2021 patient feel better. Patient thought COVID is in our bodies already and the shot just stimulates antibodies which somehow create the clotting. No treatment received for events. No COVID tested post vaccination. The outcome of the events was recovered.   Information on the lot/batch number has been requested.
No adverse event; Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose; 1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 10-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023).    No concomitant medications were reported.  The patient received 1st dose on 02-Feb-2023 lot number 057A22A.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient did not reported symptoms.   No treatment medications were reported.
arm a little sore p/flu shot;Thursday AM fever & achy;Friday 27OCT96 2AM awoke w/lt arm throbbing, dark purple circle, arm swollen from shoulder to elbow;noted blister;MD ofc saw ulceration @ site;poss cellulitis, swollen ax;sores in mouth
No adverse event; PROQUAD was administered to a patient after a temperature excursion; This spontaneous report was received from a vaccine coordinator and referred to a patient of unknown age and gender. No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies and concomitant medications were provided.  On an unknown date the patient was vaccinated with the dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), subcutaneously 0.5 milliliter (ml), lot # U022728 has been verified to be a valid lot number, expiration date was reported and established as 16-JAN-2023, vaccination site was not provided) for prophylaxis.   On 29-DEC-2021, it was reported that measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), was administered to a patient after temperature excursion (product storage error). The vaccine was stored at a temperature of 8.1 Celsius (C) for a time frame of 2 hours and 58 minutes. No information was provided regarding previous temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
8/1/2021 Client admitted to Hospital with c/o fever, weakness, cough. No persistent hypoxia noted at the time. 8/9/2021 Client transferred to Hospital for Hospice and comfort due to declining condition. Notes on transfer indicating he had been admitted to ICU and intubated and had a CXR indicating pneumonia. Client died 8/10/2021. Death report: PNEUMONIA SECONDARY TO COVID-19. ACUTE HYPOXIC RESPIRATORY FAILURE. Submitter does not have access to any further medical records for this client. Please contact hospitals for any further information required:
Rash on back , buttocks, legs/Itchy and red rash; Itchy and red rash; Rash every 72 hours; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on back , buttocks, legs/Itchy and red rash), RASH ERYTHEMATOUS (Itchy and red rash) and RASH (Rash every 72 hours) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. In February 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 RASH PRURITIC (Rash on back , buttocks, legs/Itchy and red rash), RASH ERYTHEMATOUS (Itchy and red rash) and RASH (Rash every 72 hours). At the time of the report, RASH PRURITIC (Rash on back , buttocks, legs/Itchy and red rash), RASH ERYTHEMATOUS (Itchy and red rash) and RASH (Rash every 72 hours) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient's husband had called and reported this information to the pharmacist. The patient's concurrent conditions included sulfa and penicillin allergy. There was no information about the patient's concomitant therapies or medical history provided. On 13-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035694, expiration date 07-NOV-2017, in her upper arm (dose and route of administration were not reported). On 15-JAN-2017, the patient experienced injection site inflammation about the size of a baseball. The patient did not receive any treatment. There were no lab diagnostic studies performed. The outcome of injection site inflammation was unknown. The pharmacist stated that the patient never called back to report on her recovery. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Side effects have all been mild. Original vaccination was Pfizer (two injections) in April 2021. No symptoms for first injection, but second injection resulted in abnormal thirst and sleepiness (fatigue) for ~1 day. Six months later in late October2021 had positive test and symptomatic Covid.  On 20 December 2021 I chose to receive the Moderna booster. I do not know if it was full or half dose - I assume half dose. Five hours later, I was very thirsty just like the second original Pfizer vaccination. I slept soundly for 12 hours, was tired the rest of the day and slept soundly again the next night. I am fine now (42 hours post booster). All three times there was upper arm pain at injection site but was worst for second Pfizer vaccination, which was very painful during the injection with subsequent pain that lasted a week or more. I ascribe the pain of the second Pfizer injection to the technique of the technician who administered the injection and not to the vaccine itself.
pt states had flu vax & 26DEC96 devel GBS synd & was hosp for 45 days;
Patient was mistakenly given 0.1ml of the Moderna COVID-19 vaccine by a staff member.  The mistake was recognized on August 4, 2021 and all patients effected were informed.  Patient has since been revaccinated on 8/18/21 and 9/17/21.
pt says she developed tremors and difficulty with her balance.  She has exhaustion, brain fog and fatigue.  On 4/23/21 she went to her PCP.  Pt was referred to a Neurologist.  Pt has to scheduled this appt.
Redness, swelling, and itching at injection site. Patient was observed for 30+ minutes and no systemic reactions noted. Patient was recommended to follow-up for medical evaluation with her PCP.
30 min- shooting pains down injection site arm, extreme joint pain. very joint- clammy-felt like I had the flu, extreme fatigue. hard to breathe- (3 days of symptoms)