chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was having a reaction to her Covid-19 vaccine; burning and tingling on my left side in my throat and in my mouth; Feels like the worst case of GERD I ever had in my life.; burning and tingling on my left side in my throat and in my mouth; burning and tingling on my left side in my throat and in my mouth; burning and tingling on my left side in my throat and in my mouth; This spontaneous case was reported by a patient and describes the occurrence of THROAT IRRITATION (burning and tingling on my left side in my throat and in my mouth), GASTROOESOPHAGEAL REFLUX DISEASE (Feels like the worst case of GERD I ever had in my life), PHARYNGEAL PARAESTHESIA (burning and tingling on my left side in my throat and in my mouth), ORAL DISCOMFORT (burning and tingling on my left side in my throat and in my mouth) and PARAESTHESIA ORAL (burning and tingling on my left side in my throat and in my mouth) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Primary series (Dose 1)), Pfizer (First Booster Dose) and Pfizer (Primary series (Dose 2)). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 18-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Oct-2022, the patient experienced THROAT IRRITATION (burning and tingling on my left side in my throat and in my mouth), GASTROOESOPHAGEAL REFLUX DISEASE (Feels like the worst case of GERD I ever had in my life.), PHARYNGEAL PARAESTHESIA (burning and tingling on my left side in my throat and in my mouth), ORAL DISCOMFORT (burning and tingling on my left side in my throat and in my mouth) and PARAESTHESIA ORAL (burning and tingling on my left side in my throat and in my mouth). On 07-Nov-2022, the patient experienced IMMUNISATION REACTION (she was having a reaction to her Covid-19 vaccine). At the time of the report, THROAT IRRITATION (burning and tingling on my left side in my throat and in my mouth), GASTROOESOPHAGEAL REFLUX DISEASE (Feels like the worst case of GERD I ever had in my life.), PHARYNGEAL PARAESTHESIA (burning and tingling on my left side in my throat and in my mouth), ORAL DISCOMFORT (burning and tingling on my left side in my throat and in my mouth), PARAESTHESIA ORAL (burning and tingling on my left side in my throat and in my mouth) and IMMUNISATION REACTION (she was having a reaction to her Covid-19 vaccine) outcome was unknown.            The patient received a second monovalent booster dose with lot number as 56M21A, expiry date as 02-Aug-2022 on the left arm. The patient had no adverse events. On 07-Nov-2022, the patient went to the physician and was informing about having reaction to COVID-19 vaccine.  No concomitant medication was reported.  No treatment medication was reported.
pt recv vax & devel flu-like sx (fever, cough & aching) on 21NOV96 p/vax on 29OCT96;pt was seen by MD 25NOV96 for these sx & was reported by RN;
Patient is fully vaccinated.  COVID + 1/8/2022 on admission to hospital.patient is a 48y.o. male with PMHx of morbid obesity, DM 2, CAD, HTN, and GERD presented with complaints of substernal chest pain ongoing since yesterday morning.  Patient describes the pain as squeezing and states that it is constant.  The pain radiates to his left shoulders.  He also has associated shortness of breath, diaphoresis, dry cough, runny nose, and some chills.  Patient presented with acute hypoxic respiratory failure from COVID-19 Pneumonia. Patient is short of breath, but is saturating at 96% on room air.   Chest x-ray shows mild CHF.  EKG shows nonspecific T wave changes, but no concern for acute STEMI. Troponin negative.  HE improved with systemic steroids, anticoagulation and antiviral therapy (remdesivir) and discharged home on room air once medically stable.
hepatocellular pattern of liver injury; This is a literature report for.  A 61-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; ibuprofen (IBUPROFEN) (Batch/Lot number: unknown) at unk (x 3 days). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered", described as "hepatocellular pattern of liver injury". Timing of presentation (days) Pattern of injury in relation to first dose of vaccine is 31 days. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 765 IU/l; biopsy: lymphocytes; none normal bile ducts; blood alkaline phosphatase: 230 IU/l; blood bilirubin: 2.6 mg/dl; inflammation scan: positive, notes: Portal and lobular No interface hepatitis; international normalised ratio: 1.2; laboratory test: negative; none; viral test: negative. The action taken for ibuprofen was unknown. Therapeutic measures were not taken as a result of liver injury. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also consider unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Liver injury. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Red raised rash on legs and back. Some purpuric lesions on the leg where the rash started returned to clinic on 11/12/04. Some fading mainly on thighs and lower abdomen a couple of non blanching erythema papules on upper trunk. Hive on trunk and leg.
Pain at injection site the next day. Headache, tired, feel like I'm getting the flu.
NOTE: Adverse event onset date has been since the date of administration per patient, but he bought this matter to our attention at the pharmacy on 09/23/2016. Patient states he cannot move his right hand above his shoulder level.
1 of 2 pts who recvd vax w/in 48 hrs devel fever 101, h/a & an inject site reaction (@ pnu-imune site); inject site reaction described as localized redness & soreness;
This spontaneous report was received from a medical assistant refers to a 11 year old child of unknown gender. Medical history was reported as none. No known drug allergy was reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) lot # J006732; expiry: 30-MAY-2015, dose: 0.5 ml (millilitres), subcutaneous in the right arm. Concomitant therapy was reported was none. On an unknown date the patient developed a rash at the injection site after administration of VARIVAX (Merck). The patients were evaluated in the office. No medical treatment was prescribed. The patient sought medical attention and had an office visit. The outcome of rash at the injection site was unknown. Causality assessment for the event was not provided. This case is linked to: 1402USA013049 (same reporter link). Additional information has been requested.
Pt developed 6cm-7cm area of erythema.  Pt states "felt itchy" immediately.
on the night of 1/5/2021, headache and right arm pain. starting in the pm on 1/16/21 vomiting started and lasted through Tuesday 1/19/21. As of today lasting symptom is fatigue.
Sick again from the second vaccine shot; missed a few days of work after the first dose; 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 ILLNESS (Sick again from the second vaccine shot) and JOB DISSATISFACTION (missed a few days of work after the first dose) in a female patient of an unknown age 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 ILLNESS (Sick again from the second vaccine shot) and JOB DISSATISFACTION (missed a few days of work after the first dose). At the time of the report, ILLNESS (Sick again from the second vaccine shot) and JOB DISSATISFACTION (missed a few days of work after the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided   This case was linked to MOD21-088258, MOD21-088310, MOD21-088311, US-MODERNATX, INC.-MOD-2021-114755, US-MODERNATX, INC.-MOD-2021-114654 (E2B Linked Report).; Sender's Comments:  MOD21-088258: MOD21-088310: MOD21-088311: US-MODERNATX, INC.-MOD-2021-114654: US-MODERNATX, INC.-MOD-2021-114755:
Confirmed breakthrough case   COVID-19 (Pfizer) 1  01/15/2021 local County Health Dept Pfizer EL3249   COVID-19 (Pfizer) 2  02/08/2021 local County Health Dept Pfizer EM9810   COVID-19 (Pfizer) 3  10/13/2021 vaccination center Pfizer ER2613
- Pain in the left armpit which extends through the left of my forearm to the big vein in the middle of the arm - Fatigue/Tiredness - Light chills, but no fever
I have had heavy vaginal bleeding for 8 days ,now spot bleeding... Also bad cramps in feet?s and pains in legs on and off,besides headaches.
There was no adverse event. The patient was under the age of 18 at the time of vaccination. Since she had already received one dose without incident (and her father was insistent that she be vaccinated), she was given her second dose of Moderna Covid-19 vaccine. She has had no adverse event after her second dose.
Narrative: COVID infection following COVID vaccine series 02/02, Moderna, dose #1 03/02, Moderna, dose #2 08/11 pt cc: diarrhea, headache, rhinorrhea, cough, fever, fatigue, sore throat exposure: unknown 08/12 -08/22 pt symptoms continue 08/12 COVID swab, result: detected 08/27 clinically resolved 09/08 COVID swab, result: not detected 09/21 COVID swab, result: detected
This spontaneous report was received from a 23-year-old female patient (medical assistant), who was reporting on herself via a company representative. The patient's concurrent conditions and medical history were not reported. Her concomitant therapy included an unspecified vaccine. On 29-AUG-2018, the patient was vaccinated with a single dose of GARDASIL 9, intramuscularly for prevention on Human papillomavirus (HPV) (lot # N03595; expiration date 09-OCT-2020). On 27-SEP-2018, the patient experienced the event of seizure, which lasted 5 minutes. It was reported that her eyes rolled back, her lips turned blue, she had trouble speaking, and she was shaking. The patient sought medical attention. She was taken to an unspecified emergency room but was not admitted to the hospital. An unspecified treatment was given to the patient. Computerized tomography (CT) scan, electrocardiography (EKG) and an unspecified blood work were done, however, the results were not provided. Outcome of the event was not reported. Causality between the event of seizure and GARDASIL 9 was not provided. The event of seizure was determined to be life threatening by the reporter due to its duration and, upon internal review, it was considered to be medically significant.
full body sweats; Fingers tingly; High heart rate; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (full body sweats), PARAESTHESIA (Fingers tingly) and HEART RATE INCREASED (High heart rate) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Sweating from 16-Jan-2021 to 17-Jan-2021, Paraesthesia from 16-Feb-2021 to 17-Feb-2021 and Heart rate increased from 16-Feb-2021 to 17-Feb-2021.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HYPERHIDROSIS (full body sweats), PARAESTHESIA (Fingers tingly) and HEART RATE INCREASED (High heart rate). On 17-Feb-2021, HYPERHIDROSIS (full body sweats), PARAESTHESIA (Fingers tingly) and HEART RATE INCREASED (High heart rate) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter  No treatment information was provided.
Patient (mother) was vaccinated at 13 and 16 weeks for dose 1 and 2 of the COVID-19 vaccine respectively. Soon after the second vaccination, the fetus' movement slowed and was barely detectible. no Illness or trauma occurred during this time. This concern continued throughout pregnancy and was raised with obstetrician. Pregnancy was otherwise unremarkable. Good maternal health. Delivery was uncomplicated and the baby was delivered full term. He weighed 8lb 7oz. Soon after birth, concerns were raised for neurological signs and symptoms. He was later diagnosed with an upper motor neuron disease. All diagnostic imaging, event history and extensive testing is unremarkable. Child is extremely delayed.
Patient possibly inadvertently received 1cc of Moderna COVID vaccine  instead of 0.5cc. Patient & State was notified
pt recvd flu vax & approx 3 hrs later devel fever & myalgia followed by night sweats, cough, h/a, nausea & chills; 1 wk later was given a dx of pneumonia; MD did not feel the pneumonia was related to flu shot;
Swelling and pain under the arm; Swelling and pain under the arm; Right breast swelling and heavy; Fluid type sack under arm and on side above ribs; Pain at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 13:30 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: Cats" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing); "Known Allergies: tree pollen" (unspecified if ongoing); "COVID" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Known Allergies: Codeine"; Demerol for Known Allergies:, reaction(s): "Known Allergies: Demerol"; Morphine, reaction(s): "Known Allergies: Morphine". Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer, Lot unknown=False,, Administration date=Mar2021,, Administration time=01:45 PM,, Vaccine location=Left arm,, Dose number=1), administration date: Mar2021, for COVID-19 immunization, reaction(s): "Breast swelling", "Bursitis", "Pain in arm", "Swelling arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Apr2021, outcome "recovered" (18Apr2021), described as "Pain at injection site"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Swelling and pain under the arm"; BREAST SWELLING (non-serious), outcome "unknown", described as "Right breast swelling and heavy"; BURSITIS (non-serious), outcome "unknown", described as "Fluid type sack under arm and on side above ribs".  Additional information: 1st shot, left arm 25Mar21. Next day pain and swelling under arm that went into left breast swelling, becoming very firm and tight. Could not wear a bra as it cut into the skin and left marks. Could not put the arm down completely at my side as the swelling under the arm prevented that. Fluid like sac under arm and downside of ribs. Lasted at least 7 days. Second shot, 15Apr21, right arm. Pain at injection site for 3 days and same symptoms as first shot. Swelling and pain under the arm (armpit). Right breast swelling and heavy. Fluid type sack under arm and on side above ribs. Could not wear bra as indentations and discomfort were the result. Ongoing, but after 6 days subsiding somewhat. AE was resulted in doctor or other healthcare professional office/clinic visit. Patient was recovered not recovered. No treatment for AE. There was covid prior vaccination. Not tested for covid post vaccination. Known allergies were cats, tree pollen, sulfa drugs, codeine, demerol, morphine. No other medical history. Lot was unknown because unable to locate or read the details. No other vaccine in four weeks. Other medications in two weeks were OTC multi vitamin flaxseed oil capsules.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills; body aches; A spontaneous report was received from a type concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, body aches.  The patient's medical history was not provided. Concomitant medications reported were Acetaminophen for drug use for unknown indication.  No relevant lab data was reported by the reporter.  On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient experienced chills, body aches.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, body aches was unknown.
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age who on 11-OCT-2011, was vaccinated with the first dose of GARDASIL and early on 08-NOV-2011, was vaccinated with the second dose of GARDASIL (doses, routes and lot numbers not reported). It was reported that the patient had not received the third dose of GARDASIL and was not experiencing any known symptoms. Additional information has been requested.
Flu like body aches and fever. Of note I tested positive for Covid on November 18, 2020.  Lasted 24 hours.
Tested positive for SARS-CoV-2; Tested positive for SARS-CoV-2; congestion; nausea; chills; headache; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 49-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular on 23Dec2020 as 1st dose, single dose for covid-19 immunisation. Medical history included hypertension, hypercholesterolaemia from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium, hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. On 14Feb2021 patient had congestion, nausea, chills, headache. On 16Feb2021 patient tested positive for sars-cov-2. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, sars-cov-2 test: positive on 16Feb2021, sars-cov-2 test: negative on 18Feb2021. The outcome of events was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Drug ineffective, COVID-19 and the suspect drug BNT162B2.
pt recvd 2nd dose of vax & w/in 24 hrs devel mild edema, swelling, erythema, tenderness & warmth @ the inject site; sx became more severe over the 2nd 24 hrs;
9 hours after receiving my third of of the Pfizer Covid booster at 10 am on December 30, 2021, I developed a high fever, headache, and nausea that lasted for 24 hours.  My heart palpitations began on January 1st, 2022, 2 days after receiving the vaccine.  After a week they still had not gone away, so I visited my family doctor on January 10, who referred me to a cardiologist whom I saw on January 14.  I wore a Holter monitor for 24 hours on January 24 and had an echocardiogram performed on February 1.  I met again with the cardiologist on February 16, where I was informed that there was fluid around my heart and that the palpitations were due to my third Covid vaccine.  At this time I am not on any medication as they have calmed slightly, but I am still experiencing palpitations   daily, multiple times throughout the day.
At my last doctor visit, I was advised that I was having premature ventricular contractions which I'd never had before.  When the symptoms were described, I remembered that I'd starting having a "fluttery" feeling in my chest as far back as January of 2021 when I had my first Covid-19 vaccine.  At this point, we're just monitoring.
Right hand swelling, with subsequent tenosynovitis occurred about three days after vaccine.  Took Medrol dose pack, but hand is still swollen and hard to use 2.5 weeks later.
DIZZINESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no.  On 12-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 12-MAR-2021. This report was non-serious.
6 hrs. after receiving BEXSERO vaccine (on 8/17/18) in left deltoid patient started having a lot of swelling and pain at the site. She could not hear from her left ear. The hearing loss dissipated overnight. On 8/18/18 she was seen at Hospital. Her swelling measured 5 cm x 6 cm and she was having left sided pain from her neck to her fingers. She could not move her arm at all. She was so dizzy she needed assistance with walking. She felt weak and heart rate at hospital was 130. On 8/27/18 patient was seen in our office. She had a raised lump at the injection site measuring 2.5 cm x 2.5 cm. There was no redness and area was semi-firm to touch. She had no pain with touch and she could move and use her arm normally. No signs of infection.
No treatment. Severe pain in left upper arm. Cannot lay on left side. Cannot lift left arm above 90 degrees without sharp pain. Pain is the same as the time of injection.