chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue, headaches, muscle aches with 12 hours. Low grade fever began 20 hours after vaccination. All symptoms subsided after 48 hours. Bruise-like tenderness at the injection site lasted >72 hours and burning sensation around the posterior of my left arm persisted for >72 hours.
Vaccination failure; COVID_test_result=Positive; Cold-like symptoms; clogged sinuses; fever (99.9 F); cough; chest congestion; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 24 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: PULMICORT; CLINDAMYCIN. Past drug history included: Amoxycillin, reaction(s): "Known allergies: amoxycillin", notes: Known allergies: amoxycillin. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 18Apr2022, outcome "recovering", described as "Cold-like symptoms"; PAIN (non-serious) with onset 18Apr2022, outcome "recovering", described as "body aches"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 18Apr2022, outcome "recovering", described as "chest congestion"; SINUS CONGESTION (non-serious) with onset 18Apr2022, outcome "recovering", described as "clogged sinuses"; COUGH (non-serious) with onset 18Apr2022, outcome "recovering"; PYREXIA (non-serious) with onset 18Apr2022, outcome "recovering", described as "fever (99.9 F)"; COVID-19 (medically significant) with onset 19Apr2022, outcome "recovering", described as "COVID_test_result=Positive"; VACCINATION FAILURE (medically significant) with onset 19Apr2022, outcome "unknown". The events "covid_test_result=positive", "cold-like symptoms", "clogged sinuses", "fever (99.9 f)", "cough", "chest congestion" and "body aches" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (18Apr2022) 99.9 Fahrenheit; SARS-CoV-2 test: (18Apr2022) Negative, notes: COVID test post vaccination: Nasal swab; (19Apr2022) Positive, notes: COVID test post vaccination: Nasal swab. Therapeutic measures were taken as a result of covid-19, nasopharyngitis, sinus congestion, pyrexia, cough, respiratory tract congestion, pain.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Pulmicort inhaler, Clindamycin, daily multi-vitamin, Fiber gummy within 2 weeks of the vaccination. Hospitalization was not prolonged. Treatment received for the adverse event were Zpak and OTC Muscinex, Advil, Robutussin cough gels. Prior to vaccination, patient was not diagnosed with covid-19. Since the vaccination, patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient noticed joint pain in all joints and weakness within 24 hours of second shot. The symptoms left for two weeks, then patient noticed pain in left leg and shortness of breath two weeks after second Moderna shot. Symptoms were mild at first, so patient monitored and didn't think they were related to vaccine. Persisted till 12/10/2021 with new symptom of swelling of left leg; follow-on Dr. appt. on 12/15. Test results showed blood clot in left leg (calf) with DVT and three blood clots in right lung (upper, middle, and lower lobe).
diarrhea; Nausea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea) and NAUSEA (Nausea) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 038B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concurrent medical conditions included Depression. Concomitant products included BUPROPION for Depression, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) and VITAMIN D NOS for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced DIARRHOEA (diarrhea) and NAUSEA (Nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (Nausea) outcome was unknown.            Concomitant Medication Generic Truvada was Indicated to use for Prevention of HIV
Low grade fever, malaise, diarrhea, flushing, headache lasting >5 days
This initial spontaneous report was received from a 54 year old female consumer reporting on herself, with allergy to seafood. There was no pertinent medical history described. On 05-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, frequency and lot# were not provided). Concomitant therapies included amoxicillin. The patient stated that on 06-OCT-2015 reported as "the next day", she experienced a fever to the touch of her arm (injection site warmth) and her arm developed a bruise (injection site bruising) and "fire engine red burn mark" around the ZOSTAVAX injection area (injection site erythema). She also stated that her arm appeared to be swollen (peripheral swelling). The patient did not sought medical attention and treatment was not given for the events. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of peripheral swelling, injection site erythema, pyrexia and injection site bruising was recovering. The relatedness between the events mentioned above to ZOSTAVAX was not provided. Additonal information has been requested.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). On 28-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Vaccine was frozen at the time of the excursion. The temperatures were reported as Maximum 30 Fahrenheit Degrees and Minimum -18.9 Fahrenheit Degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute Lot numbers were reported as 065K21A and 045L21A.   This case was linked to MOD-2022-591989 (Patient Link).
This is a spontaneous report from a contactable nurse. The nurse reported on a 3-year-old male patient received PREVNAR13 at 0.5 ml single on 21APR2011. Relevant medical history and concomitant medications were unknown. On 21APR2011 the patient was administered PREVNARA13 in the right thigh subcutaneously instead of intramuscularly and the patient experienced unknown discomfort. In addition the patient developed a small bubble on the skin at the spot where he was administered the PREVNAR13. The  relevant laboratory data was unknown. Therapeutic measures in response to discomfort and vaccination site bubble included application of pressure and use of ice pack. The patient was also prescribed ibuprofen at 8.9 ml every 6 hours as needed and TYLENOL at 8.3 ml up to four times a day as needed. The patient recovered from vaccination site bubble on 21APR2011. The clinical outcome of discomfort was unknown at the time of this report. Follow-up (03JUN2011): Follow-up attempts completed. No further information expected. Follow-up status: Follow-up attempts completed. No further information expected.
The pt experienced a choking episode, turned gray, stopped breathing (according to mother). Mother administered CPR and baby recovered quickly. Checked by our office 1/2 hour later. The infant was alert, active and back to normal. Took formula well post episode. Color was pink.
Left arm broke out in red, itchy marks; there are still large markings on my arm where the skin has a strange texture and white/pink color; This is a spontaneous report from a contactable consumer (patient).   A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7534) via intramuscular, administered in Arm Left on 16Mar2021 at 13:45 (at the age of 67-year-old) as dose 2, single for COVID-19 immunisation. Medical history included elevated cholesterol (none other than elevated cholesterol but treated with a mild statin). Concomitant medications included pravastatin and multi-vitamins 20mg. Patient had no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9809) via intramuscular, administered in Arm Left on 21Feb2021 at 14:00 (at the age of 66-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 at 16:00 the patient experienced left arm broke out in red, itchy marks, there are still large markings on my arm where the skin has a strange texture and white/pink colour. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient relevant tests reported as none. Patient received treatment for the events with triamcinolone Acetonide Cream USP- 0.1% on 29Apr2021. It was reported that purchased over the counter creams including cortizone 10 and Benadryl- applied topically. Outcome of the events was recovered with sequelae on 16Jul2021.  No follow-up attempts are needed. No further information is expected.
"Covid Arm" - red rash at site of injection, warm to the touch, swelling, lasted a week. Took benedryl and used a cool compress.
The day after the vaccine I felt painful cramping in the abdominal, it lasted 3 days. On the 5th day I began having issues urinating. I had a constant urge to urinate all the time.  Still having mild abdominal pain.  A bruise appeared on my right inner thigh.
DOUBLE VISION IN LEFT EYE; DARK SPOTS IN LEFT EYE; This spontaneous report received from a patient concerned a patient of unspecified age and sex with unspecified race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with non-company suspect vaccine included: MRNA 1273 ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. (Dose number in series 1)  On unspecified date, following vaccination with MRNA 1273, the patient had weird side effects. (Dose number in series 1)   The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on 19-NOV-2021 for prophylactic vaccination (booster dose). The batch number was not reported and has been requested. (Dose number in series 2) No concomitant medications were reported.   On an unspecified date, the patient experienced double vision and dark spots in left eye. And have optometrist appointment on 24-Nov-2021. The patient fear of blood clots or something worse. (Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the double vision and dark spots in left eye was not reported.  This report was non-serious.
No interest in food; Tiredness; Chills; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 14:30 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included lupus, thyroidectomy, atrial fibrillation (Afib), obese, high blood pressure (HBP) and arthritis. The patient previously received penicillin for an unknown indication on an unknown date and experienced allergy. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), apixaban (ELIQUIS), metoprolol (MANUFACTURER UNKNOWN), levothyroxine (L-THYROXINE) and omeprazole (MANUFACTURER UNKNOWN), all from an unknown date for unknown indication and unknown if ongoing. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 12Mar2021 at 15:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 07:00, the patient experienced tiredness, chills, nausea, headache and appetite lost. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events of fatigue, chills, nausea, headache and appetite lost was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
anaphalactic  shock reaction, epi injection by hospital emergency staff at vaccine site, emergency room admission . We were very lucky vaccine site was Hospital  was concerned that this might happen as patient had a previous anaphalactic shock by  antibiotic injection few years ago
Pt reported feeling dizziness 10 minutes after vaccination. Laying down his blood pressure was 110/70 P 74; sitting was 118/74 and standing 120/76. Patient was sent home he denied feeling any dizziness at time of discharge and reports that he was feeling well.
DAY ONE, Metallic taste in mouth, immediately after vaccine, over in minutes.     DAY ONE, Vagal body flush, sudden weakness, immediately after vaccine, over in minutes.  DAY TWO,   3:30 p.m., freezing chills.  Fever quickly rose to 104, took 2 Advil and 2 Tylenol, fever gone by 7:30 p.m.  Continued chills,  very weak and tired.  Developed COVID arm,  red, splotchy, warm to touch,  swollen, hard, very large area.    DAY THREE and  DAY FOUR, very weak, easily exhausted, no energy.  COVID arm.  DAY FIVE, much improved, still a little tired but able to drive and go to store. Still have COVID arm.
I received the booster shot in October and two months later I got a really bad UTI, PSC levels went up. I went to the emergency room and they gave me medication and I am currently taking the medication.
Patient claims pain in left arm (FLUZONE HD) after injection and days following injection (vaccine on 08/08/2019). Pain was not resolving. Patient had a follow up check up appointment with primary care doctor on 08/21/19 and arm was examined and was referred to ER. Patient went to Hospital ER same day where skin was diagnosed with infection and ulcer. Ulcer was cleaned out and packaged and is getting regularly cleaned by hospital. Patient's other injection (SHINGRIX) reports no adverse events.
Headache, Myalgia, Fever, arm soreness Narrative:  Headache, myalgia fever 99.6, arm  soreness; taking tylenol.
Received flu vacine 8A-215P developed numb lips, swollen lips and tough-scratchy throat-felt like it was closing. Rx ER steroids and antihistamines.
runny nose, , post nasal drainage, cough, headache. starting 1/22/22
mom noted maculopapular rash 1-2" in diameter on daughter's leg; where Hep vax was given; advised Cortoid; MD saw pt 2 wks thereafter cont on Cortoid; rash disappeared 1-1 1/2 mos p/inject;
I have since had a delayed sense of taste and smell I?ve been tested for Covid multiple times and tested negative.
Mild discomfort after number 2 and mild discomfort after 4 nothing lasting over a few hours.
At the end of April my left foot begun having arthrisit like pain. My foot was and still is tingly and I experience sharp shooting pains in my foot. After this began I was diagnosed with Bells Paulsy on May 3rd after I noticed on May 1st the left side of my face was weak and I could not blink my left eye.
NONE - REPORTING ERROR: PATIENT RECEIVED A 0.3ML DOSE OF PFIZER VACCINE THAT WAS MIXED WITH 0.8ML OF SALINE RATHER THAN 1.8ML OF SALINE, HUMAN ERROR ON PHARMACY PART OF PERSONNEL RECONSTITUTING VACCINE; PATIENT INFORMED ON 05/26/21 2:35PM OF VACCINE ERROR AND INSTRUCTED TO WATCH FOR ABNORMAL OR GREATER THAN NORMAL SIDE EFFECTS.
mom noticed rxn mid day 13MAY95; area red, hard, larger than now & warm; now area has erythema w/itching; somewhat warm to touch; pt denies pain;
Itching Local reaction pink 3-4 inches around warm and swollen at injection site Mild soreness
Restless legs; Reaction with her legs; Burning of my legs/my legs feels like they are hot; I am having a sort of numbness feeling in my legs/I am experiencing a sort of numbnessin my legs, in my legs in the muscles; hard of hearing; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: EL8982) both as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced restless, reaction with her legs, burning of legs/ legs feels like they are hot, sort of numbness feeling in legs/ legs in the muscles, hard of hearing. Therapeutic measures were taken because of restless legs which included over the counter drugs. Patient's lab data was not reported. Outcome of the events was not reported.   When requested for probing, Reporter stated, "No." Further probing could not be done as reporter don't want to share further information. Hence, limited information was available over the call.  Follow-up activities have been completed and no further information is expected.
Severe rash began on 1/25 ,  about 11 days after second dose of vaccine. Rash was erythematous, was not raised. Began on chest then spread all over body. Extreme pruritis, relieved for only 2 hrs after doses  of 50 mg Benadryl each time. Took Prednisone 20 mg on 1/27 then 40 mg on 1/28 with no relief. On 1/29 went to ER because of exhaustion due to not sleeping secondary to pruritis. In ER was treated with IV Decadron, IV Pepcid and IV Benadryl. CBC and BMP were normal. Dermatologist was contacted by ER  via phone . Felt reaction was due to the vaccine and to report it . I was prescribed Claritin 10 mg QID and Pepcid 40 mg daily. Rash resolved after 48 hrs. No SOB.
Secondary cellulitis; Onset tightness left forearm with swelling; Onset tightness left forearm with swelling/Left arm circumference 2.5 inch more than right; Shotty lymph nodes; mild left supraclavicular swelling/Axillary swelling/soft tissues swelling; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), intramuscular, administered in the left arm on 29Mar2021 as a single dose for COVID-19 immunization. Medical history included allergies to latex and pineapple, seasonal allergies, thrombocytopenia and chronic prostatitis (reported as chr prostatitis) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amitriptyline hydrochloride (ELAVIL); marijuana and meloxicam (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 on 08Mar2021 (lot number and expiry date unknown), intramuscular on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 19May2021, the patient experienced the onset of tightness left forearm with swelling. The left arm circumference was 2.5 inch more than right with mild left supraclavicular swelling. The patient went to the ER and had an ultrasound of left upper extremity including subclavian and cephalic veins which showed no DVT, MRA showed no arterial clots, CT with contrast showed axillary swelling, shotty lymph nodes, soft tissues swelling, no tumor nor clots. The patient was administered with cefadroxil as he may have secondary cellulitis. The patient had not recovered from the events.   Information on the lot/batch number has been requested.; Sender's Comments: The causal association between the event secondary cellulitis ad the suspect drug BNT162B2 cannot be totally excluded based on a temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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.
Headache Narrative:  Developed 2x migraines (has h/o migraines, no other noted triggers). One was that evening and another withing several days of being vaccinated. Described as typical migraine, was able to abort with acetaminophen (no need for triptan).
Patient rec'd 3 Moderna vaccines. He rec'd his first one on 2/17/21. He then rec'd a liver transplant on 3/21/21. His doctor told him to start the Moderna series over again. He rec'd a second vaccine on 4/29/21 and a third vaccine on 6/1/21.