chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph node under the injection site on her arm pit/ lymph nodes were swollen under the injection site on her arm; tiredness; injection site pain; muscle ache; chills; swelling around the injection site; nausea; wasn't feeling well; Headache; Fever; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on unknown date for covid-19 immunisation. On an unknown date in Apr2021, the patient experienced injection site pain, tiredness, headache, muscle ache, chills, fever, swelling around the injection site, nausea, wasn't feeling well, and swollen lymph node under the injection site on her arm pit/ lymph nodes were swollen under the injection site on her arm which was still swollen today. The outcome of the event vaccination site lymphadenopathy was not recovered and other events was unknown.   No follow up attempts are needed. No further information is expected.
Sx onset 6/29/2021 (fever, chills, sore throat, muscle aches, and headache). Tested positive for COVID-19 via PCR on 6/30/2021.
Fever in excess of 103; Full body rash; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 05May2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, osteoarthritis, alopecia areata and known allergies to penicillin and iodine/iodine contrast fluid. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and diazepam (MANUFACTURER UNKNOWN); for unknown indication from unknown date and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 11:00 the patient experienced fever in excess of 103 degrees (unspecified units), full body rash and fatigue. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. On 05May2021, the patient had body temperature test and the result was 103 degrees (unspecified units). The clinical outcome of the event fever in excess of 103, full body rash and fatigue was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Mom called patient having respiratory difficulty. Went to ED by ambulance, questionable seizure activities, admitted to hospital for work up.
Right thigh red, swollen, itchy. Given prescription for Benadryl and advise cool compress to area. Return to clinic  if swelling doesn't get better.
Itching under the arm; Headache; Received both dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both dose of the vaccine), PRURITUS (Itching under the arm) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both dose of the vaccine). On 12-Mar-2021, the patient experienced PRURITUS (Itching under the arm) and HEADACHE (Headache). On 11-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both dose of the vaccine) had resolved. On 12-Mar-2021, PRURITUS (Itching under the arm) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # 036A21A. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Aug2023 at 12:00 as dose number unknown (booster), single (Lot number: Gl2042) at the age of 68 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rybelsus, stop date: 01Aug2023; Pantoprazole, stop date: 01Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Sep2023) Negative, notes: very faint line still negative; (08Sep2023) Positive, notes: positive again no symptom. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 31Aug2023 to 04Sep2023.
Fell out of bed; tonic clonic seizure; postictal (confusion); This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 22Feb2021 10:15 (lot number: EN6203) as single dose for COVID-19 immunisation. The patient's medical history included hypertension. The patient's concomitant medications included losartan and OTC vitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 03:45PM (lot number: EL9262) for COVID-19 immunisation. On 12Mar2021 06:30, the patient fell out of bed and wife witnessed tonic clonic seizure of 5+ minutes. And when EMS arrived on 12Mar2021 06:30, the patient was postictal (confusion). The events resulted to Emergency Room visit and patient was hospitalized for 3 days. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests and procedures and included blood test and scan, both with unknown results on an unspecified date and nasal swab/NAAT: negative on 12Mar2021. Therapeutic measures were taken as a result of the events and included numerous scans, blood tests and levetiracetam. The vaccination facility type was hospital. The outcome of the events were recovered with sequel.
Approx 3 hrs p/vax recvd pt exp palpitaitons, weakness & blurred vision; Also was hypotensive 50-60/40 requiring IV fluids & hospitalization;
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208.
Severe swelling in the right arm, numbness, rash that spread from arm all the way up to shoulder and chest, tightness in chest, difficulty breathing, feeling faint and this all happened within 5 hours of getting the shots. Had to go to the emergency room at 5:30 PM on 10/19/2017 where they diagnosed her with having a severe allergic reaction that resulted in her getting 3 shots to counteract the reaction. She is still not any better.
Initial misuse report received from a nurse on 16 November 2013. The patient had received FLUZONE. It was reported that vaccine administered to patient on same day in October 2013. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Pt recvd a series of 3 Engerix-B vax on 27APR90, 6JUN90 & 8NOV90 & subsequently tested for Hep B Antibodies & found not to have converted;
Puffy eyes; Throat swelling; Scaly skin; Itchy skin; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 12Jul2021 at 09:00(at the age of 46-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, it was unknown whether the patient was 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 medication within two weeks of vaccination. On an unknown date in Jul2021, the patient experienced puffy eyes, throat swelling, scaly skin and itchy skin. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event puffy eyes, throat swelling, scaly skin and itchy skin was recovered with sequelae on an unknown date in Jul2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
flu-like sxs w/hepatitis (inc LFTs, nl bili); arthralgias, myalgias, wt loss, fever, fatigue;
sore left arm shoulder deltoid muscle.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle.). At the time of the report, VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No Treatment information was reported.   This case was linked to MOD-2022-461876, MOD-2022-461877 (Patient Link).
Broke out in a red rash with raised white bumps/blotches on arms, under eyes, temples, and severe red blotchiness on chest and face.
1/6: diarrhea 1/6-1/10: fatigue 1/7-present (1/13): shingles (dx confirmed by MD 1/13)
Within 30 hours of shot, numbness and tingling from site of shot down through hand and up through shoulder to neck. Symptoms still present, but improving daily. Psoriasis flare within 8 days of shot. Also improving.
No additional AE reported; Caller reports that the PROQUAD and VAQTA was "assumed to be in normal storage range", but could not confirm if a temperature had occurred prior to the administration; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not reported.   On 10-OCT-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection, 0.5 milliliter, lot #W002894, expiration date: 06-MAR-2023, administered as prophylaxis (strength, and route of administration were not provided); and vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #W023869, expiration date: 24-JAN-2024, administered also as prophylaxis (strength, and route of administration were not provided). The nurse reported that her data logger died and did not record temperatures for about a week. She also reported that the vaccines were assumed to be in normal storage range. However, she could not confirm if a temperature excursion had occurred prior to the administration. The temperature, time frame, and previous temperature excursion were unknown by the reporter.   No additional adverse event (AE) reported.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: pt developed hives one week after TDAP and MMR vaccine
Booster given 3/23/2022, patient had a code blue in the facility on 6/4/2022 and expired
10/10 Extremly exhausted. 10/11 Headach started with the exhaustion. Nothing helped. Called PCP about getting something to help with the pain ordered a MRI Done 11/5/21 Second jab given 11/6/21 Increased Headache UC visit 11/8/21. Call 11/9/21 MRI showed a lesion in my Brain 11/9/21 was seen by MD. Ordered a CT of my Chest, Abdomen and Pelvic to rule out any primary tumor site. All negative. Will have a follow up MRI in 8 weeks. Pending a referral to a neurosurgeon. Started on a Medrol dose pack (steroids) to help decrease inflammation. Missed work 11/8-11/10/21 My Left eye for 24 hours. No pain, No discharge 10/13.
c/o subjective fever with dizziness and sweating.  Temperature, tmax 100.0F (A) at home.  Pt received 2nd dose of COVID Vaccine at 0930 02Feb2021.  Patient is a 21 year old male who presents to ED with subjective fever, dizziness, sweating and papitation 8 hours after receiving his second Moderna vaccine. He denies any chest pain, no shortness of breath. He doe shave some nausea, but it able to drink fluids well. No other significant PMH.
This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "CVD" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 25May2022, outcome "recovered" (2022); VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "recovered" (2022) and all described as "Patient tested positive for Covid on 25May2022"; NASAL CONGESTION (non-serious) with onset 25May2022, outcome "recovered" (2022), described as "congestion"; COUGH (non-serious) with onset 25May2022, outcome "recovered" (2022); AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 25May2022, outcome "recovered" (2022) and all described as "loss of taste and smell". The events "patient tested positive for Covid on 25May2022", "cough", "congestion", "loss of taste and smell" and "myalgia" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, Covid-19, cough, nasal congestion, ageusia, anosmia, myalgia. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feverish (chills and sweats) Body aches Fatigued Dizzy All started around 2AM the day after vaccine and ended the day following
no adverse reaction noted, student had already received the flu shot at the clinic; parent was present at time of flumist and signed the form,
Severe muscle and ligament pain. Upper and lower Back, and legs. Stomach/gut problems and depression.
pt had localized pain, erythema & edema which started a day or so afterward @ inj site;now has lesion approx 1.5cm rt upper arm;lesion now resemble tinea in appearance;rt upper arm cont to be intermittently painful but pt has full use;
Both of his ankles are swollen; Short of breath; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Both of his ankles are swollen) and DYSPNOEA (Short of breath) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS (Patient has stent implanted in his left heart and one in his right leg.). Concurrent medical conditions included Leukemia.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced JOINT SWELLING (Both of his ankles are swollen) and DYSPNOEA (Short of breath). At the time of the report, JOINT SWELLING (Both of his ankles are swollen) and DYSPNOEA (Short of breath) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.  Patient stated that he was sleep sitting up in a chair   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-Jun-2021 and does not contain any new information
This case was reported by a consumer and described the occurrence of pain in a patient who received SHINGRIX. On 3rd February 2018, the patient received SHINGRIX. On 4th February 2018, 1 days after receiving SHINGRIX, the patient experienced erythema. In February 2018, the patient experienced pain, swelling and feeling of warmth. On an unknown date, the outcome of the pain was recovering/resolving and the outcome of the swelling, erythema and feeling of warmth were unknown. It was unknown if the reporter considered the pain, swelling, erythema and feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Less than a week after receiving SHINGRIX, the patient experienced some pain, swelling and warm.
Patient states she has laryngitis, "whooping" cough, runny nose, and loss of appetite. Patient refused any treatment at this time.
About 2 minutes after the vaccine was administered, she began to experience a wash of pain all over from head to toe as she was walking. She did not have any other symptoms other than the pain (no fainting, no difficulty breathing, no vision changes, etc.). She was able to get to the walk-in urgent clinic in our store via a motorized shopping scooter to be examined by a provider and said the pain improved when she was able to hold still and not move. They prescribed her prednisone and diphenhydramine, but her symptoms had resolved by the time I followed up with her husband around 2:30 pm.
Patient experienced shaking, aching and terrible headache. Patient's wife expressed if the medication had mercury in it. The patient went to Doctor and Dr suggested patient to take Tylenol. I spoke to patient and he feels better now.
Mild fever and perhaps sleep disruption. Mild fever lasted 2 days. Very red, hot reaction over most of my upper arm, which is still present (although not as red) after five days. Mild itching remains.
Received Moderna on 09/23/21 at which time she experienced shortness of breath, chest tightness, palpitations and wheezing. Led to multiple medical visits.  Then received 2nd injection of Pfizer, at the instruction of allergy specialist. W/in 25 minutes of administration,  developed SOB, wheezing, chest tightness, hoarseness, difficulty swallowing and lymphadenopathy in the neck. This led to multiple medical visits including emergency room visit. Her symptoms  are managed only with high-dose steroids.
Very bitter taste in mouth, altered sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Very bitter taste in mouth, altered sense of taste) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy (sulfa drugs).   On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 19-May-2022, the patient experienced DYSGEUSIA (Very bitter taste in mouth, altered sense of taste). At the time of the report, DYSGEUSIA (Very bitter taste in mouth, altered sense of taste) had not resolved.            The was patient not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The concomitant medication was not reported. The treatment medication was reported.
Mild numbness in the left side of my face.  In 2013, while pregnant, I had a palsy event. Left side of face and body experienced numbness for weeks. CT scans and other tests were all normal then, no neurological issues either. It went away with acupuncture. Never really figured out what caused it, Dr. said it just happens sometimes with pregnancy.   Monitoring  myself. I don?t have easy access to health care so I?m not going in or calling anyone yet
I had the second dose on 04/05/2021 and on 06/28/2021 I had an ear infection and my ear started to swell and also my lymph node. The doctors prescribed me some oral antibiotics and some antibiotic ear drops. The problem has resolved.
Patient received Moderna (2nd dose) at 10:05. She began to vomit at 10:08. The patient stated that she had juice and a pie before the vaccine was given. The mother stated that the patient reacts with vomiting after every vaccine. The patient stated she was nervous.  BP 128/76 P:98 Spo2: 99%