chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Bitter taste; Food tastes weird; Burning sensation in the front part of the tongue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the left arm on 19Dec2020 at 07:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 08Jan2021 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. The patient had no allergies to medications, food, or other products. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) and herbal glucosamine (MANUFACTURER UNKNOWN), both taken from an unknown date. 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 20Dec2020 at 13:00, the patient experienced severe bitter taste that had lingered on till the time of this report, sometimes mild and sometimes severe, most of all food tastes weird and burning sensation in the front part of the tongue, that comes and goes. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event severe bitter taste, food tastes weird and burning sensation in tongue were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
swollen leg first noticed 3/7/21, Saw my doctor on 3/11/21. Doctor sent me to get Ultrasound next day. After she got results by phone, she had me go directly to nearest ER that same day.
Patient presents at 4pm with hives. States noticed rash appear at around 11am. Flu vaccine most likely administered at 8:30 am today. Admits to pruritus. Denies OTC medications attempted. Denies SOB, wheezing, and retractions with breathing no other concerns.
The patient did okay on the day of the vaccine.  She began to develop worsening immune response symptoms over the afternoon of the day after through the next 3-4 days.  She woke up the morning listed with Bell's Palsy.  I evaluated her one week after her vaccination.
Bloody Stool; This is a spontaneous report from a contactable consumer. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, administered in the left arm on 25Mar2021 17:30 (batch/lot number: EP6955) at 31 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Workplace clinic. The patient's medical history included asthma, seasonal allergies, and tree nuts allergy; all from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL), salbutamol sulfate (PROAIR), and simeticone (GAS-X); therapy dates and indications for all were not reported. The patient received these medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 26Mar2021 07:30, the patient experienced bloody stool (haematochezia). It was unknown if patient received treatment. Outcome of the event was unknown.
fever 72 hrs p/vax given; pt refusing to ambulate; stiff rt leg; no swelling; pt was irritable x 24 hrs a/clinic visit on 23APR93; referred to hosp-ER adm; ?dx;
Pains; Muscle aches; Fever/elevated temperature; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Sensitivity to penicillin).  On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue). At the time of the report, PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated temperature (High) Elevated temperature.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  Concomitant product use was not provided by the reporter.  Patient had no COVID-19 in past or diagnosed with COVID-19.  Treatment information was not provided.   This case was linked to MOD-2022-580194, MOD-2022-580257, MOD-2022-580258 (Patient Link).
Fever, post-nasal drip, cough, burning throat, stuffy head, achiness, fatigued.  From Friday morning through Monday afternoon.   Starting Monday night the fatigue and fever seemed to go away and it was just the post-nasal drip, cough, and stuffy head through Tuesday.
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Parametics noted irregular rhythm of heart-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: EMS recommended him come into ER but patient refused stating he feels fine, will followup with md about event and recommendation for 2nd dose
Redness/rash around shot site with itching and soreness a week after I received the vaccine.  The redness/rash got about three inches wide.  I took antihistamines and applied over the counter anti-itch lotion.  The redness/rash faded, but spread to about five inches wide.  It was gone about a week after it started.
9YO received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 19th October 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Nov-2022 Reporter's comment: The health manager called to ask information on how to proceed after administration of Infanrix to two patients who were given their first dose at an inappropriate age. The vaccine administration facility was the same as primary reporter. The health care professional asked for follow-up from safety via email. The reporter consented to follow-up. This case was for 1 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received a dose of Infanrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022170379:Same reporter
Medication error was done by giving Moderna covid 19 booster as a transdermal injection; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Medication error was done by giving Moderna covid 19 booster as a transdermal injection) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transdermal) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Medication error was done by giving Moderna covid 19 booster as a transdermal injection). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Medication error was done by giving Moderna covid 19 booster as a transdermal injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Transdermal), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
Information has been received from a physician concerning an 8 year old patient who on 1/9/1998 was vaccinated with a dose of varicella virus vaccine live (lot 624724/1327B). On 6/10/2005 the patient developed a rash that was diagnosed by the LPN as breakthrough varicella with 250-500 lesions. The patient had a fever that lasted 1 day. There were no complications. The patients diagnosis was not lab confirmed. The patient had no history of chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
I had blood and urine workup done for yearly physical the day after my second vaccine. My EGFR came back  below 50 so my doctor had another series of blood and urine work done. My urine creatinine level was 15.7 and my protein/creatinine ratio was 828.  There was a sonogram done on my kidneys and all was fine. My EGFR had gone back up to 62 when I was tested in April.  Recently I read that kidney issues are presenting with the vaccine and since mine issues were so out of the blue I thought I should write this up.
approx 3-4mins p/vax pt body went limp in moms arms; MD was notified & promptly attended to pt who was placed supine on exam table; cold compress were applied to forehead, smelling salt given & 02 administered;
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with hypertension and hypothyroidism. The patient's medical history included morphine-derivatives: unknown reaction. On 21-OCT-2013 the patient was vaccinated SC with single dose of ZOSTAVAX (lot # J004600, Exp. 18-JUL-2014). Concomitant therapies included estrogens (unspecified) patch, thyroid supplement and ZIAC. On 22-OCT-2013, the patient developed redness and pain at the injection site. The patient called the pharmacy on 23-OCT-2013, to report the area of redness was the size of a softball and the pain was getting worse. No treatment was given for the events. No lab diagnostics studies were performed. The outcome of redness and pain at the injection site was reported as not recovered. Additional information has been requested.
after the first shot, it took a month for the side effects to start, but she had a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: States she already had high blood pressure. The patient's concomitant medications were not reported. Vaccination history included: Flu (she took the Flu and Shingles shots and she broke out with a rash under her breasts.), administration date: 2021, for immunization, reaction(s): "she broke out with a rash under her breasts"; Shingles (she took the Flu and Shingles shots and she broke out with a rash under her breasts.), administration date: 2021, for immunization, reaction(s): "she broke out with a rash under her breasts". The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "after the first shot, it took a month for the side effects to start, but she had a headache". Therapeutic measures were taken as a result of headache. Additional Information: Lot number was not provided as complainant does not have the product with them at the time of call. Expiry date of Covid 19 vaccine was unknown. Caller stated she took the first shot and she had no rash, she was just fine. Caller clarified , after the first shot, it took a month for the side effects to start, but she had a headache and she took pills for that aspirin.Caller stated she thought she would go ahead and take the second Pfizer shot because she did not break out with a rash with the first shot. Caller stated she does not like taking medication. Stated she stopped taking her blood pressure medication and her muscle relaxer before she started the Pfizer vaccines because she did not want to mix those up with the vaccines. Stated the blood pressure medication was not doing any good anyhow, her blood pressure kept going up and down and up and down. Treatment included Aspirin for High blood pressure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
allergic reaction after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction after the 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction after the vaccine). At the time of the report, HYPERSENSITIVITY (allergic reaction after the vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
t100.2 oral, sore, red swollen deltoid area; localized cutaneous react;
next morning after vaccinated -had fever-38.9,headache,muscle ache,pain on knees and ankle,chills,sorethroat,nausea ,pain on left arm
swelling rt arm started @ site on 22MAR93; today 26MAR93 t102.0 x 2 days; swelling from shoulder to elbow; no reddness; very tender to touch; dizziness;
My dad had a physical 9/30/2021 and received a clean bill of health complete with lab work. He then received his second covid vaccine. sunday 10/3/2021 my dad got up went to the store..called my mother around noon had lunch and went back to work. two hours later he had an event and DIED. he was In perfect tip top health. he was taken from us way to soon
TOOK FIRST DOSE OF VIVOTIF WITH FOOD; This spontaneous case report (PVX2019-2783) was received from a consumer on 11-Nov-2019. It described a female consumer who "first dose of Vivotif with food" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took her first dose of Vivotif with food on 09-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "first dose of Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "first dose of Vivotif with food" was considered as not applicable.
Patient did not have any adverse reaction we are aware of at the time of vaccination.  We have made efforts to contact mom to see how the child is feeling after the vaccination (left message).  We are reporting this because the child is under 18 but received a 3rd dose of Pfizer vaccine from us.  Mom reported that her son has a heart condition and is immunocompromised so needed to get an additional dose since his 2nd dose was on 4/15/21.
Pericarditis from the booster; Tightness in the chest; pain of three out of 10 pain increased to seven and became sharp pain in upper left chest; flu like symptoms; discomfort with deep breathing; aches; pain of three out of 10; discomfort in chest; fatigue; Low fever; This is a spontaneous report from a contactable consumer or other non hcp.  A 48-year-old male patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was FF2589, Expiration Date: Unknown) as dose 3, (BOOSTER) single via an unspecified route of administration, administered in Arm Right on 14Oct2021 10:00 (age at vaccination 48 years) for covid-19 immunisation. Historical vaccine received was (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EM9809, Expiration Date: Unknown) as dose 2, single via an unspecified route of administration, administered in Arm Right on 30Mar202110:00 for covid-19 immunisation and also received (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EM9809, Expiration Date: Unknown) as dose 1, single via an unspecified route of administration, administered in Arm Right on 03Mar2021 10:00 for covid-19 immunisation. Allergy were reported as reaction. Medical history included none-very healthy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 23Oct2021 12:00pm patient experience Tightness in the chest starting nine days after the booster, third shot. After 10 hours of chest tightness and pain of three out of 10, pain increased to seven and became sharp pain in upper left chest. Emergency room visit and subsequent appointments to cardiologist with labs revealed no cardiac abnormalities or blood clots. The primary theory is Pericarditis from the booster. Current symptoms are discomfort in chest and flu like symptoms. Low fever, aches, fatigue and discomfort with deep breathing. The patient underwent lab tests and procedures which included investigation: no cardiac abnormalities on labs revealed no cardiac abnormalities or blood clots , investigation: three out of 10 pain on , investigation: increased on pain of three out of 10 pain increased to seven and became sharp pain in upper left chest. Therapeutic measures were taken and currently patient on anti-inflammatories. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Shakiness, chills, felt fait, "fluttering heart," Abdominal pain.  0.3mg or epinephrine was administered.
I got the 2nd moderna vaccine on Wednesday, April 21st. With the shivers in the evening. Couldn?t sleep due to a fever. Had body aches the next day and felt light headed. Went bed that evening and slept a good 10 hours. So by Friday felt 90% still some stiffness, but felt good to go. Later in the afternoon and early evening I noticed a rash from the face down to the pelvic emerge. It is gone in the morning.  Hearing from a relative that got the Johnson and Johnson they also got the rash, but no other side effect.
Flu symptoms sudden, low grade fever, chills, aches in bones and muscles, fatigue, upset stomach(nausea, diarrhea), headaches so painful that could not sleep. This lasted approximately 24-48 hours - treatment with pepto, antacids, tylenol, and ibuprofen Swelling, redness, and itchiness at site.  -treatment with covering with a band aid to prevent itching and spread of virus.
1st dose COVID 19 - vaccine Pfizer - no AE 2nd dose COVID 19 - vaccine Pfizer - pt had body aches, shortness of breath, nausea,  sensitive back, weakness. + headaches for several days
Pt experienced headaches, body aches, and rash on back and chest for 3 days. Rash appeared as red and white blotches.
Began to experience intermittent tingling in arms and torso about 2 months post Covid, no medical explanation.
Moderna COVID- 19 Vaccine EUA was given on 12/29/20 and patient was hospitalized on 1/11/21 with COVID-19 and was released on 1/16/21 after receiving remdesivir and dexamethasone.
Can barely use left arm, can not put my clothes on can not pick up a cup of water hurt like hell can not sleep on my left side anymore hurts hurts 24 hours a day on a scale of 1 to 10 10 being the worst my pain is 9.5.
Severe headache, chest pain and SOB, scratchy eyes the afternoon and evening after receiving the vaccine at ~noon.
pt recv vax & w/in 20-30min p/vax felt weak & had pain in shoulder & neck area up to base of head;pt appeared pale;states felt clammy on exam;BP 100/64;mouth dry & weak;pt sleepy
Severe swelling in upper left inner thigh/both legs were swollen; retaining water; felt fatigued; legs felt uncomfortable; felt "bloated"; periods have been much heavier and more painful; periods have been much heavier and more painful; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. An 18-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 13:00 (Lot number: ewo186) at the age of 18 years as dose 2, single for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, brand=Pfizer, lot number: ewo161, administration date: 25Apr2021, administration time: 01:00 PM, dose number: 1, Vaccine location: Left arm), administration date: 25Apr2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 16May2021, outcome "unknown", described as "Severe swelling in upper left inner thigh/both legs were swollen"; FLUID RETENTION (non-serious) with onset 16May2021, outcome "unknown", described as "retaining water"; FATIGUE (non-serious) with onset 16May2021, outcome "unknown", described as "felt fatigued"; LIMB DISCOMFORT (non-serious) with onset 16May2021, outcome "unknown", described as "legs felt uncomfortable"; ABDOMINAL DISTENSION (non-serious) with onset 16May2021, outcome "unknown", described as "felt "bloated""; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 16May2021, outcome "unknown" and all described as "periods have been much heavier and more painful". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peripheral swelling, fluid retention, fatigue, limb discomfort, abdominal distension, heavy menstrual bleeding, dysmenorrhoea. Additional information: The patient did not receive other vaccines in four weeks. The patient had no other medication in two weeks. The patient reported that she experienced severe swelling in upper left inner thigh within 24 hours of receiving the shot. That swelling subsided overnight, but both legs were swollen and retaining water for approximately a month after receiving the shot. During this time, she felt fatigued and her legs felt uncomfortable. She also felt "bloated" in other parts of her body. In addition, since receiving the second shot, her periods have been much heavier and more painful than they were before she received the shot. The patient had no known allergies. The patient had no COVID-prior vaccination. The patient was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient was given SHINGRIX inj. at Pharmacy in the left deltoid on 9/4/18. Patient was seen by primary physician 9/7/18 due to the adverse reaction of redness, warmth and tenderness of the injection site. Denies fever, nausea, vomiting, diarrhea or any other concerns.
mom 1st noticed fine rash around neck, legs, buckled, rolled on the floor crying, then eyes rolled back & lips looked blue; adm to hosp & observed for 23 hrs;