chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Saturday patient started having twitching in eyes and lips and numbness in left leg.  Comes and goes intermittently since then.
Pain, tenderness, and swelling at injection site resulting in cellulitis starting at injection site and spreading down to elbow.
High fever (>101 F) for 24 hours; pain near site of injection at armpit; pain near site of injection at armpit; headache for first 24 hours; chills; Some skipped heartbeats were experienced; mild chest tightness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Oct2021 12:00 (Lot number: FF2589) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL2347, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 02Mar2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "High fever (>101 F) for 24 hours"; VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "pain near site of injection at armpit"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache for first 24 hours"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; EXTRASYSTOLES (non-serious) with onset 2021, outcome "not recovered", described as "Some skipped heartbeats were experienced"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "mild chest tightness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site pain, axillary pain, headache, chills, extrasystoles, chest discomfort.  Additional information: The patient had received no other vaccines within 4 weeks prior to COVID vaccine. The patient had not diagnosed with COVID prior vaccination and the patient had not tested to COVID post vaccination. Patient had high fever (>101 F) for 24 hours, pain near site of injection at armpit, headache for first 24 hours and chills. Continued into second day with mild fever (~100 F), no headache, continued pain in right arm and armpit. Some skipped heartbeats were experienced and mild chest tightness.  No follow-up attempts are possible. No further information is expected.
(L) arm itch, painful, swelling noticed and red in color. Advised BENADRYL, TYLENOL and to ice area.
We received a call from agent regarding this patient.  Patient stated they had not received a 2nd bivalent booster.  Patient in fact did receive the pfizer bivalent booster at a pharmacy and informed the staff here at pharmacy she did not.   She then asked for a Moderna Bivalent booster 2 days after her pfizer bivalent booster.   No signs and symptoms - just reporting that she received a 3rd bivalent booster when she should not have scheduled an appt for a 3rd.
pt experienced a fall from a horse, upon admission to the hospital she was tested for COVID and was positive
Spoke with client onsite. Immediately upon injection, client had swelling occur right at the injection site--her arm swelled up noticeably, about the size of a golf ball. The site was sore, the client describing it as "it feels like there is a lot of pressure where the vaccine went in".  No other symptoms occurred. After 30 minutes of observation there was some faint bruising at the bottom of the swelling.
Felt small circle on injection site; Pain on injection site; Skin was red; Arm was tender; 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 ERYTHEMA (Skin was red), TENDERNESS (Arm was tender), INJECTION SITE REACTION (Felt small circle on injection site) and INJECTION SITE PAIN (Pain on injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ERYTHEMA (Skin was red), TENDERNESS (Arm was tender) and INJECTION SITE PAIN (Pain on injection site). On 01-May-2021, the patient experienced INJECTION SITE REACTION (Felt small circle on injection site). The patient was treated with NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Skin was red), TENDERNESS (Arm was tender), INJECTION SITE REACTION (Felt small circle on injection site) and INJECTION SITE PAIN (Pain on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sore throat with raised bright yellow patches scattered on back of throat. This lasted until 11/03/2012 6:00 PM; 11/04/2012 body aches all day then at 3:27 AM of 11/05/2012 one of the worst headaches commenced. Vomited multiple times. Took an Imitrex 100 mg with a Zofran 4 mg to rule out migraine. 11/05/2012 by 9:30 AM left arm (shot arm) is very "heavy" and hurts to move fingers.
Information has been received from a physician, concerning a 7 year old male child, who on 2007 was vaccinated with the first dose of Pneumovax 23 (lot # not provided). Approximately 12 hours after the vaccination, the child developed swelling and warmth at the injection site. Two days later, he developed a fever of 104 F, with vomiting and a headache. He also had an increased white blood cell count (WBC) and increased c-reactive protein (CSF) (values not specified), and was hospitalized (date not specified). Treatment during hospitalization included antibiotics (not specified), and the physician indicated the child had a diagnosis of cellulitis. Cultures during the hospitalization were negative, and the child was discharged to home. On 19-SEP-2007, the child was seen in follow up at the Infectious Disease department and found to have an abscess at the injection site. a total of 3cc of pus was drained from the site, and a culture of the abscess was pending. At the time of this report, the outcome of the events was unknown. The reporting physician considered the events to be serious due to hospitalization and as an other important medical event. The physician also reported that since March 2007, an 18 year old male patient developed cellulitis after vaccination with Pneumovax 23 (lot # not provided (WAES #0707USA03967); and 3 other patients had serious injection site reactions following vaccination Pneunomax 23 (lot # not provided) (WAES #0707USA04149). Additional information has been requested.
Acute hypoxemic respiratory failure due to COVID-19; Hypokalemia; AKI (acute kidney injury); Elevated troponin
Pain in left arm post FLUVIRIN (9/15/10) and PNEUMOVAX (09/17/2010) vaccine; patient reported pain 10/22/10.
Pregnant and recieved vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and recieved vaccine) 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 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and recieved vaccine). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and recieved vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment information provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female of unknown age. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy .
Post vaccine COVID-19 infection. Experienced fever for 2 days, aches, headache, cough and fatigue.
No additional AE, no PQC reported; MMR II being administered to an 11 year old patient instead of a Meningococcal vaccine; This spontaneous report was received from an office manager, referring to a 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 29-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route, lot# and expiration date were not provided) for prophylaxis instead of a meningococcal vaccine (wrong product administered). No additional adverse events (AEs) or product quality complaint (PQC) reported.
Pfizer COVID Vaccine EUA  Pfizer Vaccine Dose 1 2/5/2021 (lot # not in state registry) Pfizer Vaccine Dose 2 3/6/2021 (lot # not in state registry) COVID Positive 3/27/2021 Hospitalized 3/27-4/2/21 Hospitalized 5/19-5/24/21  6/15/21: Presented to ED. This is a 77 years old gentleman with a history of COPD presents to the emergency department because of shortness of breath and chest pain.  Patient states that he was in his usual state of health and suddenly developed shortness of breath and chest tightness. By the time of my evaluation he no longer has chest tightness.  He was recently in the hospital and treated with antibiotics for Pseudomonas pneumonia.  He is reportedly compliant with his COPD medications at home.  He normally wears 2 L nasal cannula at home.  Currently he is on the BiPAP and reports feeling better after treatment in the emergency department.  He was given IV steroids, bronchodilator therapy.  He was also given IV antibiotics given recent history of Pseudomonas pneumonia.  Of note patient states that for the past week his bilateral ankle appears to be more swollen and he is on Lasix started by Dr. from pulmonology for this.  6/21/21: This patient with a history of COPD, atrial fibrillation on anticoagulation and chronic dementia, was again admitted 6/16 with increasing shortness of breath and chest pain.  It was noted that his COVID 19 test was positive.  He was started on IV Remdesivir, but since his COVID 19 test has been positive since March of this year was felt that he did not require additional treatment.  We are treating him for an exacerbation of COPD.  His chest x-ray was actually normal with COPD but no signs of infiltrate, heart failure or effusions.  He is on apixaban for atrial fibrillation and should not have a pulmonary emboli.  He was getting IV Lasix, but the BUN and creatinine were rising.  We have obtained an echocardiogram to see if there is a degree of systolic heart failure.  We will continue the IV antibiotics and steroid therapy.  The patient seems comfortable at rest but is on 5 L nasal cannula.  The patient reports that he is on 3 L of oxygen at home all the time.  I called to talk to the good friend who is listed as the 1st contact and reviewed the situation.  He does live by himself but has 24 hour a day care.  We discussed that our goal was to get him back down to 2-3 L of oxygen.  There seems to be some improvement but if still requires 5-6 L of oxygen, we will ask for a pulmonary consultation.  I have talked to the pulmonary team several times unofficially for advice and they seem to have nothing else to offer at this time.  Again today the patient seems comfortable and is warning why he can go home.Admitted and treated with bronchodilators, steroids, BiPAP and levaquin. Echocardiogram repeated. By the time of admission, chest pain resolved. Oxygen requirement stay high at 5 liters. Today improved to baseline 2 L. Discharged home.
pt recv vax OCT96 & 29DEC96 pt unable to eat for two days, was sweating, vomiting & had an asthma attack;31DEC96 dx w/kidney infect;tx w/ATB & has recovered;MD determined pt sx were r/t kidney infect & not flu vax;
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on an unknown date. It was reported that a temperature excursion of FLUMIST vaccine that had been given to 14 patients and patient number twelve received the FLUMIST vaccine, 0.2mol dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1ml was given in each nostril. FLUMIST Quadrivalent was continued. The outcome of the event of patient number twelve given FLUMIST vaccine that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril was unknown. The report was considered to be non-serious.
Very sore arm (7/10 scale) starting about 6 hours after the vaccine, and lasting up for 72 hours since the vaccine dose. Next day after vaccine had moderate chills and body aches that was present for one day. Tingling sensation on ulnar/pinky side of arm after waking up from first morning after vaccine. Worsened my cough from my cold.
red itchy rashes around  injection site. Seen March 4  in the pm, a little itchy. Next morning  March 5 , itchy , had to scratch.
I had COVID the first week of May2023; I had COVID the first week of May2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "I had COVID the first week of May2023".  Clinical course: The patient had COVID the first week of May2023 and the patient enquiring, how long do I wait before getting my next booster shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Extremely dizzy; Don't remember nothing; Felt like she was going to died; Felt so sick; Completely unconscious/passed out; High blood pressure 215 over 156; Vomiting for 1 hour constantly/threw up; Nauseate; Headache like someone is pressure her brain; Fast heartbeat; Weak; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced the following:  completely unconscious/passed out(loss of consciousness), dizziness, vomiting for 1 hour constantly/threw up (vomiting), don't remember nothing (amnesia), felt like she was going to died (feeling abnormal), high blood pressure 215 over 156 (hypertension), felt so sick (malaise), headache like someone is pressure her brain (headache), fast heartbeat (tachycardia), nauseate (nausea) and weak (asthenia).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin, bupropion hydrochloride, cetirizine hydrochloride, anxiety medicines, clonazepam, metformin,  metoprolol, and trazodone.  On 01 Mar 2021, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) and 45 minutes later was extremely dizzy. At home one hour later she started to vomit for one hour constantly, became completely unconscious, didn't remember anything, and was really scared. The last thing she remembered was telling her husband: you need to call somebody because she felt like she was going to die. The patient was taken by ambulance to the hospital and while in the ambulance, the patient was administered medicines for nausea and blood pressure. The blood pressure measurement taken in the ambulance was 215 over 156.  The patient didn't know her address or anything else.  She was released to go home after a few hours, but still felt so sick.  On Sunday night (07-Mar-2021), the patient threw up again.  On an unspecified date, she had a headache like someone was putting pressure on her brain; she also had a fast heartbeat.  Since the vaccine, the patient reported feeling really nauseous and remembering nothing about it.  She is still weak. Treatment information included ondansetron medicine for nausea.  Action taken with mRNA-1273 in response to the events was unknown.   At the time of reporting, the outcome of the event, weak, was considered not recovered/not resolved. The outcome of the events, completely unconscious/ passed out, dizziness, vomiting for 1 hour constantly/threw up, don't remember nothing, felt like she was going to died, high blood pressure 215 over 156 , felt so sick, headache like someone is pressure her brain, fast heartbeat, and nauseate were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Apr2022 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative following course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 12Jul2022 to 17Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 26Mar05 Pt noticed redness and swelling at the injection site of sm pox that extends to the shoulder. Pt had HA, fever 101.6 on 27Mar05. Pt took Excederin.
severe swelling and muscle ache in left deltoid; Rash on left deltoid; abscess formation; warm; painful; swollen; severe swelling and muscle ache in left deltoid; This is a spontaneous report from a contactable nurse (Patient). A 41-year-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 23Aug2021 16:00 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 23Aug2021 16: as dose 2, single for covid-19 immunisation. Medical history included penicillin allergy. Concomitant medication include Vitamin d3, folate, zinc, b12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination. The patient experienced rash on left deltoid, severe swelling and muscle ache in left deltoid, abscess formation, warm, painful, and swollen on 13Sep2021 15:00. The patient received treatment in response to the events. The patient underwent lab tests and procedures which included Covid antibody IgH/IgM test, Blood test was negative on 22Aug2021.  The outcome of the event as not recovered.
615pm went to sleep, 9pm woke up with headache that was moderate to severe, chills and racing heart later on my blood pressure went up to hypertension levels..my temp was 103.8, the back of my shot arm was ice cold, took 1 ibuprofen, 909pm 102.4 temp took 2nd ibuprofen, BP 155/82 @ 1059pm, 129/78@11pm. Racing heart between 121-111@1058pm. 99% oxygen. 1201pm 2 Tylenol rapid release, 101.2 temp heart racing 108-109, symptoms unchanged, 1232am 142/86, 100.8 temp 99% oxygen Symptoms mild. 122/83, 101-102 heart still racing melatonin taken..100.1 temp, 1:52 am 94-95 , 99.2 temp, 6:24 sleeping 70-71  heart rate 96.1 temp
Pt recv vax on 7/31/98; on 8/1/98 pt exp fever-101,diarrhea; on 8/2 pt exp bumps on trunk;8/3 exp red bumps all over body, dec appetite. Pt tx=Benadryl.
Patient's spouse reports he developed a rash a few hours after he received the 2nd COVID-19 booster. Spouse explains that rash began in left arm near injection site and has traveled to right arm and to the back.  Patient was seen by (mobile urgent care) which started patient on valacyclovir and prednisone. Rash has not resolved yet.
Employee complaining of redness, swelling, heat, and pain at injection site later that day. The following day had a "slight fever" and swelling was worse. Went to Urgent Care and was told she had cellulitis and was put on antibiotics.
Erythema of bilateral facial cheeks and right neck. Of note, patient had mild facial erythema after first vaccine dose. Received Benadryl 50 mg pO.
Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were administered with doses of improperly stored VARIVAX (Merck) (dose and route not reported, lot # L035124 and exp. date 14-SEP-2017). The vaccines were exposed to 1.6 degree centigrade for 5 hours and 51 minutes, and -8.6 degree centigrade for 4 hours and 46 minutes (two different days in February 2016). There was a previous temperature excursion with 4.1 degree centigrade and 20.1 degree centigrade for a total time frame out of range of 15 minutes in January 2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed chills and body ache approximately 13 hours after injection.  Symptoms persisted for 36 hours after injection.
Redness and warmth of the upper arm where the vaccine was given, measuring 2 inches by 2.25 inches.
Drooping of the left side of his mouth making it hard to eat and drink.  He also experienced eye irritation.  After examining him on 2/22/21 I felt like he probably had Bell's palsy, but did feel that stroke needed to be ruled out.
pt recvd vax;  8aug95 exp pain, soreness & swelling at inject site & stiffness;