chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/14/20 Went to Pharmacy Clinic to get Dtap, IPV, MMR and Varicella vaccines.   On 11/15/20, she had adverse reaction on the left deltoid, site was red, hot and swollen.  On 11/16/20-came into PCP office, left arm was still red, swollen and hot to the touch.-Cellulitis
Chest pain, wheezing, throat closing sensation, autoimmune flare up that lasted three weeks until the next shot.
Rash, large red itchy blotches on body, medium and smaller blotches on arms and legs.  They have started to subside, but still have numerous itchy red places on body and extremities.
BLOOD DID GO ALL OVER THE ROOM; This spontaneous report received from a patient concerned a female of unspecified age, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood did go all over the room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood did go all over the room was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211060556-Covid-19 vaccine ad26.cov2.s-Blood did go all over room. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Fever; Chills; soreness in her arm at the injection site; Tiredness; bit of a headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732; Expiration Date: 31Jul2021), via an unspecified route of administration in left arm on 26Mar2021 (at the age of 49-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included none. Patient has not had any other recent vaccinations or started any new medications. There were no concomitant medications. The patient experienced soreness in her arm at the injection site, tiredness, and bit of a headache on 26Mar2021 at night. Patient also experienced fever and chills on 27Mar2021. Patient said on Sunday she was a bit better and had slight fatigue and a little headache other than her arm being sore at the injection site. Patient said her work is now saying that she has experienced signs of COVID and have required a note saying that these things are expected when you have the shot before she can return to work. Patient took Advil three 200 mg by mouth every 4 hours or so on Saturday. Outcome of events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Tenderness, warmth, redness and swelling at injection site starting 24 hours post vaccine and self-resolved within 5 days post vaccine. Did NOT require treatment.
Information has been received from a pharmacist concerning a patient who on 21-JUL-2009 was inadvertently vaccinated with VARIVAX (Merck). It was reported that the patient was suppose to get ZOSTAVAX (Merck). No adverse effect was reported. Follow up information has been received from a physician's assistant concerning the 75 year old retired male who in the morning of 21-JUL-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot# 662470/0041Y, route not reported) into the left arm. There was no illness at time of vaccination. No relevant laboratory test was performed. No adverse reaction was reported. Additional information is not expected.
Erythema & edema w/tenderness, arm held in downward placement position (from shoulder) (1 day s/p vax); Rx Ceclor 375 q12 X 10d; Benadryl 1 PO q6 prn.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 08-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
My Left arm was red, hot, slight swelling and an itchy rash appeared on my arm.  Within a day or so the itchy small red bumps spread from my arm to my body.  The rash was mainly on the trunk of my body but did extend to my thighs and a little on my lower legs.
Case previously recorded as MA2009-3836. Case received on 06 NOV 2009 via MedCom from a healthcare professional the following information: A 3-year-old female patient was vaccinated i.m. with FLUVIRIN, batch no. 1007396P on 04 NOV 2009 into the deltoid. No adverse events were reported. MedCom no.: NA09-007726.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 12-DEC-2011, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
This spontaneous report was received from the patient's mother who is also a dentist, refers to a female patient of an unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient received complete series of RECOMBIVAX HB injection (strength, dosage route and lot# were not reported). Concomitant therapy was not reported. The patient's mother informed that on an unknown date the patient did not seroconvert. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Right arm where I got vaccinated was sore; Rash on the lower extremities of both arms; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. On 21Apr2021, on the 1st and 2nd day after receiving the vaccine, the patient experienced right arm where got vaccinated was sore and on the 3rd day had rash on the lower extremities of both arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcomes of the events right arm where got vaccinated was sore and rash on the lower extremities of both arms were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
blurred vision; This is a spontaneous report received from a contactable reporter (Physician) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received vaccine on 1/29/2021 and died on 2/13/2021.  Wife called agency and noted the pt received his 1st dose of vaccine and was having "side effects and began declining".    It is unknown what side effects he was having.
Cough  Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Sore throat  Congestion or running nose
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient had no known allergies. Other medications in 2 weeks was reported as no. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 20Jul2022 and stopped on 25Jul2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Erythema Multiform and Swelling. Diphenhydramine 0.5 ml once.
he was diagnosed with dissection of his internal carotid artery; Initial information received on 27-Jan-2020 regarding an unsolicited valid serious case received from a physician.  This case involves a male patient (of unknown age) who was diagnosed with dissection of his internal carotid artery (carotid artery dissection), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  On 06-Dec-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported, of unknown Expiration date) via unknown route at an unknown administration site for prophylactic vaccination.  On 13-DEC-2019, the patient underwent (serious) dissection of his internal carotid artery (carotid artery dissection) 7 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  Laboratory data was not provided.  Final diagnosis was carotid artery dissection.   It was not reported if the patient received any corrective treatment.  The patient outcome is reported as Unknown for dissection of his internal carotid artery.  Information on the batch number was requested.; Sender's Comments: This case concerns a male patient (of unknown age) who was diagnosed with carotid artery dissection after vaccination with FLUZONE HIGH DOSE. The time to onset is compatible. However, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Red lump at the injection site that is sore to the touch and is hot. Running fever off and on for a couple of days. Lump is about the size of a quarter.
Pt presented with a c/o dizziness and "feeling like she's about to pass out" as she stood up to leave after her 15 minutes of observation time was up. She was assisted to stretcher where she laid down, she was wheeled out into the hallway and vitals were assessed. Pt stated "I'm just having a panic attack, I have anxiety". Vitals were SPO2 100% HR57 BP 83/51  Pt denies any chance of pregnancy, no allergies, no past medical history. She states hypotension is normal for her especially after an anxiety attack. Pt monitored for an additional 15 minutes, vitals remained stable and chief complaint dissipated. Pt and her husband were accompanied to the exit.
Stroke 6/9/2021, after 11 months is hospital, craniotomy, dialysis, tracheotomy, feeding tube, several episodes of pneumonia, seizures,   Pt passed away 5/3/2022.
Approximately 8:00pm on 2/8/2022:  fatigue. Approximately 12:00am on 2/9/2022: high fever, chills, muscle aches all night (involuntary shivering). 2/9/2022:  low-grade fever, chills, mild muscle aches, fatigue
Myalgia and fever, chills plus pain/swelling around injection sites. Ibuprofen 600 mg once.
stroke; This case was reported by a consumer via media and described the occurrence of stroke in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. A patient got shingles shot and less than a week later she had a stroke.  The reporter showed her an article warning of risk of strokes. When the patient confronted, the physician admitted the risk which he had not mentioned to her. But he said there was no way to prove the stroke was from the shot.  The reporter said that the patient said could you blame for wondering. No contact details were available.
BLOOD CLOT IN LEG; This spontaneous report received from a consumer (Patient's wife) concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in leg and he prescribed with Xarelto and. Ultrasound test was scheduled to determine if the blood clot was dissolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of blood clot in leg was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220621170.; Sender's Comments: V0: 20221052932-blood clot in leg. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
vomited a lot; episode of fatigue for 3days; joint pain for 3days; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomited a lot), FATIGUE (episode of fatigue for 3days) and ARTHRALGIA (joint pain for 3days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pancreatic cancer in 2019, Immune disorder (NOS) and Psoriatic arthritis in 2011. Concurrent medical conditions included Allergy (General allergy). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and CLONAZEPAM for Anxiety, ACETYLSALICYLIC ACID, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (FIORINAL CODEINE) for Migraine, OXYCODONE, PROMETHAZINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PANCREATIN (CREON), METOPROLOL and OMEPRAZOLE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VOMITING (vomited a lot), FATIGUE (episode of fatigue for 3days) and ARTHRALGIA (joint pain for 3days). On 26-Mar-2021, FATIGUE (episode of fatigue for 3days) and ARTHRALGIA (joint pain for 3days) had resolved. At the time of the report, VOMITING (vomited a lot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-089285 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089285:
4 days of 103 to 104 fever, red eyes, Rash and on day 5 developed ear infection in both ears.
their son had gotten COVID-19 after being vaccinated with the Pfizer covid-19 vaccine; their son had gotten COVID-19 after being vaccinated with the Pfizer covid-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the parent.  A 15-year-old male patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "their son had gotten COVID-19 after being vaccinated with the Pfizer covid-19 vaccine". Reporter stated minor symptoms only.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Admitted for worsening SOB, tested positive in ER. Fully vaccinated. Treated with increased O2 (on 3L at home), steroids, remdesivir, zinc, singulair. Eventually improved, weaned O2 down and was discharged home.
Patient received two doses, one in each arm, of the Janssen COVID19 vaccine on 6/3/2021. Patient mistakenly believed he required two doses, one in each arm. Vaccinator administered the extra dose. He asked the patient if he had received the COVID19 shot before, but the patient misunderstood and said that he had not received the shot before that day. Patient reported lightheadedness and nausea approximately 24 hours after the vaccination. Approximately 72 hours after the vaccination, the patient reported no other side effects and said that he was in good condition.
Spot on forearm where vaccine dripped turned red; facility chose to administer another dose; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; (spot) blistered; A spontaneous report was received from a consumer concerning a 71-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  the syringe not tightly screwed on and the vaccine leaked down the patient's arm, received another dose of the vaccine, a red spot developed on her forearm where the vaccine dripped, and later blistered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05-Feb-2021, during vaccine administration the syringe was not tightly screwed on, and the vaccine leaked down the patient's arm. The facility chose to administer another dose and the patient received two doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID -19 infection.  On 07-Feb-2021, two days later, a spot developed on her forearm where the vaccine dripped, turned red, and later blistered.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The events, the syringe was not screwed tightly on and the vaccine leaked down her arm was considered resolved.  The events of a spot developed on her forearm where vaccine dripped, turned red, and later blistered were reported as unknown.; Reporter's Comments: This report refers to a case of syringe that was not tightly screwed on and the vaccine leaked down the patient's arm, and the facility chose to administer another dose for mRNA-1273, lot # unknown, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I?ve had extreme lethargy and most recently excruciating nerve pain for over two weeks.
Patient was mistakenly given a dose of expired Pfizer COVID19 vaccine as a booster dose. Patient was given a dose from a older vial that had thought to have been left out for 27 hours prior to administration. Patient was informed of the error the same day as the administration of the vaccine (03/07/22) and was informed that there would be follow pending from the Pharmacy clinical team/Pfizer manufacturer on the issue of the vaccination. Patient is currently still being monitored for ill effects and at time of reporting the incident in VARES and no adverse events have been reported or observed from the vaccine.
Two months after my second Moderna covid  19vaccine I experienced very dry chapped lips and numbness and tingling of lips. Also tiny cracks in corners of mouth (vitamin B levels were normal). Several years ago I had Volumina facial fillers around my lips and I truly believe I?m having a reaction to fillers. Today 5 months later my lips are still chapped, dry, numb and tingling. I?ve consulted my DDS and MD, neither know anything. Please share with me if others have experienced these symptoms after receiving Moderna covid 19 vaccine..
3 days after receiving the first shot, i developed what looked like rash systems around my legs, it got worse by Friday and Saturday. I went to Clinic and the PA said it didn't appear to be a rash but what she thought was Petechiae. She gave me a Z-pack steroid that I'm still taking however the systems are less today but I still made an appointment with my family care Physician to get checked out. My appointment is for 11:00 am this morning 4/12/2021.
Information has been received from a 22 year old female who in 1995 was vaccinated with the 1st and 2nd doses of varicella virus vaccine live. In 1995 and May, 1999, laboratory evaluation revealed a lack of response. No further information is available.