chrisvoncsefalvay/vaers-outcomes huggingface dataset:
awoke, felt unwell, headache, nausea, "breathless." "couldn't open eyes." anxious. ate breakfast. back to bed. increasingly anxious with symptoms, called clinic visited in room, was able to open eyes. vss. sats 99%, lungs clear. brought to clinic. rested for 2 hours, resolved enough to go back to room of own accord.   Of note patient had received 2 doses of a non-approved vaccine while traveling abroad. Covaxin at 05/21/2021 and #2 06/18/2021. no reported adverse reaction after these doses
12 hours after vaccination, had a fever, chills, increased heart rate (roughly 50 bpm higher than normal), headache, pain in chest. This lasted roughly 12 hours through the night and into the morning
Shortly after my first dose of the vaccine (within a day) I started to notice a red, painful, swelling in the area where the shot was administered. It kept growing for about 3 days and then began to slowly go away. It then came back about 2 days after it had completely healed and was once again itchy, red, painful, and swollen but not as large. This lasted for about 2 days.
Injection site area Warm to the Touch; Injection site area started swelling, Little to itchy; Injection site area started swelling; Injection site area started swelling,kinda red,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site area Warm to the Touch), VACCINATION SITE PRURITUS (Injection site area started swelling, Little to itchy), VACCINATION SITE SWELLING (Injection site area started swelling) and VACCINATION SITE ERYTHEMA (Injection site area started swelling,kinda red,) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site area Warm to the Touch), VACCINATION SITE PRURITUS (Injection site area started swelling, Little to itchy), VACCINATION SITE SWELLING (Injection site area started swelling) and VACCINATION SITE ERYTHEMA (Injection site area started swelling,kinda red,). At the time of the report, VACCINATION SITE WARMTH (Injection site area Warm to the Touch), VACCINATION SITE PRURITUS (Injection site area started swelling, Little to itchy), VACCINATION SITE SWELLING (Injection site area started swelling) and VACCINATION SITE ERYTHEMA (Injection site area started swelling,kinda red,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Yesterday I received the second shot, and this time my sore throat started 12 hours after the shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 10:00 (Lot number: EN6208) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies; Yes" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE; PROPRANOLOL; PANTOPRAZOLE; FAMOTIDINE. Vaccination history included: Comirnaty (dose 1, lot number: EN6200, administration time: 12:00 PM, vaccine location: Right arm), administration date: 15Feb2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 08Mar2021 22:00, outcome "unknown", described as "Yesterday I received the second shot, and this time my sore throat started 12 hours after the shot.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain. Additional information: Patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was COVID tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021276546 Same patient/drug/event, different dose
This spontaneous report was received from a pharmacist via a company representative referring to a 70 year old female patient. Information about medical history and concurrent conditions was unknown.  On 10-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (expiration date 06-APR-2020, lot# R018741; dose detail and route were not reported) for prevention of pneumonia and concomitantly with HIGH DOSE of FLUZONE (high dose; route, lot # and expiration date were not reported) in the left arm for prophylaxis. On 12-OCT-2018, the patient experienced a rash, large grapefruit-sized red patch at injection site, high fever, heart palpitations, muscle aches, and weakness. No treatment given for the events and the patient did not seek medical attention. The causality assessments and the outcome of events were not reported.
Fever of 100.3 F; Headache; Felt achy; Fatigue; tested positive for COVID after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), SARS-COV-2 TEST POSITIVE (tested positive for COVID after first shot), FATIGUE (Fatigue), PYREXIA (Fever of 100.3 F) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN (Felt achy) and FATIGUE (Fatigue). On 23-Apr-2021, the patient experienced PYREXIA (Fever of 100.3 F) and HEADACHE (Headache). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID after first shot). At the time of the report, PAIN (Felt achy), SARS-COV-2 TEST POSITIVE (tested positive for COVID after first shot), FATIGUE (Fatigue), PYREXIA (Fever of 100.3 F) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: significant follow-up (New AE reported and initials confirmed)
she was diagnosed with COVID-19 following the first dose of the vaccine; COVID-19; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number and expiration date: not provided), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, following the first dose of the vaccine patient was diagnosed covid-19. Patient further enquired, if she should delay the second shot of the Pfizer COVID-19 vaccine as she was diagnosed with covid-19 following first. The patient underwent lab tests and procedures which included sars-cov-2 test which resulted positive for covid-19.. The outcome for the events was unknown.  Information on the lot/batch number has been requested.
noticed I was having DOE (dyspnea on exertion) sometime in December2021/January 2022.  also long time smoker so most likely not actually related to vaccine
Developed cough, headache, soreness/achy joints, extreme tiredness, loss of appetite, fever, chills, nasal/sinus congestion.
First injection on 3/14/21 Migraine Headache, dizziness and mild hives lasting  about 24 hours. These symptoms started about 30 minutes after injection. Injection site arm pain starting several hours later and lasting about 2 days. The second dose was given on 4/4/21. Hives starting about 2 hours after injection and more moderate than mild. They are larger. There are many more covering most of my body and they itch. I have had them for 7 days and am managing them with benedril. The second dose also caused mild arm pain at the injection site.
Information has been received from a medical assistant referring to a 23 year old female patient with none pertinent medical history and none drug reactions/allergies. On 02-SEP-2015 the patient was vaccinated with a dos of GARDASIL 9 (lot # L006547, expiration date: 04-MAR-2017, route and dose were unknown). Concomitant therapies included LO MINASTRIN FE, biotin and SOLODYN. On 11-SEP-2015, the patient started to have pain and difficulty ambulating with her right arm. Then the patient visited an urgent care center where x-rays were taken (results unknown) on an unknown date in September 2015. Two shots of an unspecified pain medication (dose and frequency unspecified) were administered, and an unspecified pain medication (unspecified dose and frequency) were prescribed. At the time of report, the outcome of the events was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Itching; abdomen is so swollen and distended; redness; Swelling face; tight throat; Sick; Diarrhea; vomiting; Fever; Headache; Muscle pain; Chills; used her inhaler 2 to 3 times; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), DIARRHOEA (Diarrhea), ERYTHEMA (redness), SWELLING FACE (Swelling face) and THROAT TIGHTNESS (tight throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included ONDANSETRON HYDROCHLORIDE (ZOFRAN) for Nausea, SALBUTAMOL (ALBUTEROL) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (Sick), DIARRHOEA (Diarrhea), SWELLING FACE (Swelling face), THROAT TIGHTNESS (tight throat), DYSPNOEA (used her inhaler 2 to 3 times), VOMITING (vomiting), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain) and CHILLS (Chills). On 27-Mar-2021, the patient experienced ERYTHEMA (redness). On 27-Apr-2021, the patient experienced ABDOMINAL DISTENSION (abdomen is so swollen and distended) and PRURITUS (Itching). On 26-Mar-2021, SWELLING FACE (Swelling face) and THROAT TIGHTNESS (tight throat) outcome was unknown. At the time of the report, ILLNESS (Sick), DIARRHOEA (Diarrhea), ERYTHEMA (redness), ABDOMINAL DISTENSION (abdomen is so swollen and distended), DYSPNOEA (used her inhaler 2 to 3 times), PRURITUS (Itching), VOMITING (vomiting), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment include Benadryl 50 mg every 4 hours,Tylenol as needed for fever   This case was linked to MOD-2021-091829, MOD-2021-091854 (Patient Link).
Beginning 10/21/20, patient had a slight fever, fatigue, and lack of hunger. Fever lasted 48 hours. On 10/24/20, patient woke up with chicken pox-like rash on face, chest, and back.
Patient reports that she received Moderna booster (01/20/22 @ 1400)l.  About 12 hours after the injection she woke up in the middle of the night with dizziness, weakness, feverish, chills, extreme headache, panic-like symptoms, and shortness of breath.  She is renting a room at a home .  She endorses Acetaminophen 500 mg ES x 2 at 0900 and experienced the "fever breaking."  She endorses feeling much better after acetaminophen, however, the dizziness remains.  The dizziness as well has improved since taking the acetaminophen, but has not dissipated.  She did fall back asleep after taking the acetaminophen.  She endorses drinking approximately 750 mL of fluid since this morning.
Patient received 2 days after its expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 2 days after its expiration date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received 2 days after its expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 2 days after its expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                             Treatment information was not provided by the reporter.
Since he's had troubles before, I gave him prophylactic Tylenol and Zofran at the time of the shot. at 9am on the 8th, he got a headache and nausea. I gave him Tylenol and Zofran. The headache lasted until 3:30pm on the 9th. The nausea lasted until 7pm on the 10th. at 7am on the 9th, he got a pain in his underarm. I gave him Tylenol and Zofran. The underarm pain lasted until 7pm on the 10th. at 4am on the 10th, the nausea was so bad that it woke him up. I gave him Zofran at 7am and noon on the 10th.
Patient reports she went into a.fib.  She also got a rash on extremities.  She also was vomiting and had diarrhea.  Shortness of breath was also reported.  Symptom onset was between 1-7 days.
constant involuntary jerking of lower part of rt arm (from elbow to hand), lasting for 1 wk; 2 days which were constant movement; the remainder of time the movement was intermittent; MD was called-no treatment given; MD recommended DT only;
None thus far.  The infant was inadvertently give a Fluvirin instead of a Fluzone.
Severe nosebleed, First Seizure 05/13/2016; 2nd Seizure 08/19/2016; 3rd Seizure 05/20/2016.
Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 12 years old patient of unknown gender who received QUADRACEL on 21-Aug-2018 instead of their fourth dose of ADACEL and third dose of IPOL. The patient's past vaccination(s) included IPOL POLIO VACCINE with 2 dose prior to 21-Aug-2018. And DTAP with three out of the four dose prior to 21-Aug-2018. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included MENACTRA for Immunization and also include Pediatric Hep. On an unknown date, the patient received a third dose of suspect IPV (VERO) lot number not reported via unknown route. On an unknown date, the patient received a Fourth dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. On 21-Aug-2018, the patient received a Fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA via unknown route in the left deltoid. It was a case of actual medication error due to Wrong vaccine administered and also for Inappropriate age at vaccine administration as patient received QUADRACEL at age of 12 years hence QUADRACEL was for the patient up to six years of age. It was not reported that any adverse reaction occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Administered COVID 19 Vaccine (Pfizer) to a 15 years and 7 months-old male. The HCP looked at the birth year and the handwritten age, determined it was a minor, verified that a parent/guardian signed the consent form, and administered the vaccine. The "5" in the "15" age section  resembled a "6" and the HCP mistakenly assumed it was a 16YOM based on the birth year. No adverse effects were noted during the Pt's 15 minute observation period.
Covid arm Sudden swelling, burning/itching, and  redness at injection site 10 days after vaccine administered. Used benadryl gel to stop the symtoms that lasted 5 days.
6/26/2012 Mother asked at pts six mo well child ck if any reactions to previous vaccines. Mom told Dr: Eve after shot -leg / warm thigh knee to hip swelled up with redness/warmth (Lt leg). T 102 degrees F; swell decreased after 2d.
Information has been received from a medical assistant concerning a female approximately 12 to 13 years of age, who at around 12 months of age, in approximately 1995, was vaccinated with varicella virus vaccine live (Oka/Merck). On 19 MAR 2007, the patient's mother reported that the patient was experiencing a breakthrough rash from the varicella virus vaccine live (Oka/Merck), that she had received at approximately 12 months of age. It was reported that the patient's entire body was covered, including her mouth and throat. The patient was treated with Viscous of Lidocaine. The patient is expected to return for for a follow up visit in a day or two. Unspecified medical attention was sought. There was no product quality complaint. No further information is available.
Induration at injection site starting on the 2nd day after receiving vaccine. As of June 30th, pt. still has inflammation and pain at injection site, but pain is subsiding. Pt taking ibuprofen.
Systemic: Other- tachycardia, elevated bp, radiating sensation, panic-Severe
POST VACCINE, PATIENT REPORTED DIZZINESS DUE TO ANXIETY, BROUGHT TO OBS VIA WC, FELT RELIEF AFTER LAYING ON STRETCHER FOR 20 MINS. VSS. ESCORTED TO EXIT WITH NO ISSUES AT 1701. 1655 INITIAL BP 107/71 HR 73 SATS 97% RA 1700 BP 115/80 HR 72 SATS 100% RA
This is a spontaneous report received from a contactable health care professional. A 26-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) as a single dose via an unspecified route of administration on 15Feb2021 (at the age of 26 years), for COVID-19 immunisation. No medical history was reported. Concomitant medication received within 2 weeks of vaccination included vit-D (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via intramuscular route of administration in her left arm on 25Jan2021 at 09:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 15Feb2021 at 12:00, the patient was fatigued and at 19:00, the patient was asleep and woke up at 11:00 with a fever of 103 and feeling freezing cold until about 12:00 following day fever persisted going up to 104, the patient had terrible chills and just overall felt like she was freezing cold. the fever finally broke the following day but still stayed higher than usual and she was fatigued for about 3 days following. She slept an abnormal amount. Patient received tylenol for chills, fever and feeling cold. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes for the events fatigue, insomnia, pyrexia, nasopharyngitis and chills was recovered at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
He felt tired and he said what he had taken; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient talked about his experience with the first and second doses, and how the second dose affected him a bit more. He did not have a temperature, but he felt tired and he said what he had taken. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Positive rapid COVID test; Nausea; Fever; Feeling COVID symptoms; Body aching; Slept all day; Food tasted terrible; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Feeling COVID symptoms), PAIN (Body aching), SOMNOLENCE (Slept all day), TASTE DISORDER (Food tasted terrible) and SARS-COV-2 TEST POSITIVE (Positive rapid COVID test) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Asthma (Patient is asthmatic and takes concomitant medication). Concomitant products included OXETORONE and DULOXETINE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced COVID-19 (Feeling COVID symptoms), PAIN (Body aching), SOMNOLENCE (Slept all day), TASTE DISORDER (Food tasted terrible), NAUSEA (Nausea) and PYREXIA (Fever). On 13-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive rapid COVID test). The patient was treated with ONDANSETRON ongoing since an unknown date at an unspecified dose and frequency and DOXYCYCLINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Feeling COVID symptoms), PAIN (Body aching), SOMNOLENCE (Slept all day), TASTE DISORDER (Food tasted terrible), SARS-COV-2 TEST POSITIVE (Positive rapid COVID test), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report as received from a physician refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587: