chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MEDICATION ERROR; PUNTURED VIAL USED AFTER 6 HOURS; This spontaneous report received from a health care professional concerned a 50-year-old female. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 01-APR-2021, the patient experienced medication error. On 01-APR-2021, the patient experienced punctured vial used after 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from medication error, and punctured vial used after 6 hours. This report was non-serious.
Approx 10-15 minutes after receiving the vaccine, client reports dizziness and lightheadedness. Vitals monitored. Client had removed her Clonidine patch the day before due to vaccine, and was instructed this was not necessary. Vitals stable, released to her son that was with her. Now c/o Headache and dizziness, but she thinks it may be related to her ear problems.
Redness at injection site on right deltoid that spread up over shoulder and down to mid-upper right arm. Also had swelling and a fever of 102F.
Achy, general malaise, headache, nausea and fever of 104.0 while taking 400 mg of Ibuprofen.
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable Pharmacist reported similar events for 2 patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller is a pharmacist asked if there is a contraindication for administering antibody therapy to a person after they have received the first dose of the covid vaccine. He reported that there are 2 patients that received the covid vaccine the week of 14Dec and subsequently tested positive for covid on the 23rd and 24th of December. He was trying to determine the safety of administering antibody therapy for those patients even though they already got the first vaccine dose. He reported this question has some urgency and needed the information within 48 hours. Attempted to warm transfer but caller reported that he does not have any patient specific information or identifiers at this time. Escalating Urgently for additional research. Outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the event "tested positive for COVID" and vaccination with BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2020516661 same reporter/ drug/ AE, different patient
I WOKE UP AT 3;30 AM ON WED 3/3/2021  WITH EXTREME DIZZINESS, GAGGING WITH THICK FLUID-SPITING IT OUT TO THE TRASH I CAN'T GET MY BALANCE GETTING OUT OF BED  BLOOD PRESSURE TO 163/92 PULSE OF 106- 3Kl lei & STILL EXPERIENCING LIGHT HEADEDNESS & WABBLE WALKING
tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine; "patient felt horrible"; Fever; Chills; Nausea; Diarrhea; tired; Rash; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine), FEELING ABNORMAL ("patient felt horrible"), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Hypertension.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine), FEELING ABNORMAL ("patient felt horrible"), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), FATIGUE (tired) and RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine), FEELING ABNORMAL ("patient felt horrible"), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), FATIGUE (tired) and RASH (Rash) outcome was unknown.        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.
legs pain; Ache in knee/joint pain; Muscle in legs not comfortable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs pain), ARTHRALGIA (Ache in knee/joint pain) and MYALGIA (Muscle in legs not comfortable) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL SUCCINATE and VALSARTAN for Hypertension.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs pain), ARTHRALGIA (Ache in knee/joint pain) and MYALGIA (Muscle in legs not comfortable). The patient was treated with ACETAMINOPHEN at a dose of 325 mg, 4-6 tablets in 24 hours. At the time of the report, PAIN IN EXTREMITY (legs pain), ARTHRALGIA (Ache in knee/joint pain) and MYALGIA (Muscle in legs not comfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure measurement: 200/100 mmhg (High) 200/100.         Additionally the patient received treatment with heating pads.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe aching), FEELING ABNORMAL (felt generally awful), MOBILITY DECREASED (strictly in bed all day), DIARRHEA (diarrea) and DECREASED APPETITE (no appetite) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced PAIN (severe aching), FEELING ABNORMAL (felt generally awful), CHILLS (chills) and PYREXIA (woke up with a temperature of 100.5). On 25-Aug-2021, the patient experienced MOBILITY DECREASED (strictly in bed all day). 25-Aug-2021, the patient experienced DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), FATIGUE (huge fatigue), HEADACHE (headache) and NAUSEA (nausea). On 31-Aug-2021, the patient experienced ASTHENIA (15 to 20 minutes of energy). On an unknown date, the patient experienced PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy) and DIZZINESS POSTURAL (worse with standing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 25-Aug-2021, MOBILITY DECREASED (strictly in bed all day) had resolved. On 26-Aug-2021, PYREXIA (woke up with a temperature of 100.5) had resolved. On 29-Aug-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN (severe aching), FEELING ABNORMAL (felt generally awful), DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy), DIZZINESS POSTURAL (worse with standing), ASTHENIA (15 to 20 minutes of energy), FATIGUE (huge fatigue), NAUSEA (nausea) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 24-Aug-2021, Body temperature: 100.5 (High) 100.5. No relevant concomitant product were reported
DIED; This spontaneous report received from a consumer via company representative via social media concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 total dose, therapy start date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died after one shot and it was reported by the consumer that "yeah my dad was one of em. And he died after one shot. So feel free to take as much as you want but I'm good. I don't need it". The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death); Sender's Comments: V0: 20211244541-Covid-19 vaccine ad26.cov2.s-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
mom called states pt had episode the day of vax of jittery & shaking for about 15mins 1 hr p/shots; sleeping now, not fussy;
Generalized aching , 102 degree fever, nausea and generalized weakness. Symptoms began 10 hours after vaccination and lasted about 30 hours. Treatment was  bed rest and naproxen sodium.
Pt recvd vax & 2JUL92 exp a 5-10 min ince in BP, nausea, dizziness, flushed feeling, SOB & h/a; treated w/DPH & referred to pvt MD;
Mom reported today (1/10/2022), when she came in for her own second shot, that she had to take her son to the doctor recently after getting his second shot because one part of his face was swollen and droopy, and that his mouth is bent when he tries to talk or smile. According to mom, his doctor says its Bell's palsy.
Pt. has a sharp pain at a right arm (upper arm above elbow). Pain goes away for couple days and then comes back since the pt. received vaccine. Pt. uses OTC topical muscle rub.
Sores mouth; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (Sores mouth) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced STOMATITIS (Sores mouth). At the time of the report, STOMATITIS (Sores mouth) had resolved.            No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporters causality for the events sores mouth with Humira (Adalimumab) was reported as not related. The reporter's causality for the event of sores mouth with Methotrexate was reported as probable.  No treatment medication information was provided.
rash is now starting to itch.; This case was reported by a consumer via patient support programs and described the occurrence of itchy rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 2nd dose of Shingrix .5 ml. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows:  The patient received Shingrix a couple of days before the date of reporting. The patient stated that had a rash since she received the 2nd dose of Shingrix. The patient stated it had gotten worse and that it was now starting to itch.  No further information was provided.
Received Heplisav-B and then Another Hepatitis B Vaccine; Initial Report Received on 25-Apr-2022  A registered nurse reported that a 23-year-old female patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and then another hepatitis B vaccine (RECOMBIVAX) as the second dose.  No medical history at the time of vaccination was reported.   No concomitant medications at the time of vaccination were reported.  On 22-Mar-2022, the patient received the first dose of HEPLISAV-B (Lot # 937231, expiration date 30 Jan 2023, NDC # 43528-003-05; serial number and route unknown) in the left deltoid.   On 22-Apr-2022, 32 days after having received the HEPLISAV-B vaccine, the patient received RECOMBIVAX (Lot #, expiration date, route, and injection site unknown) as the second dose. This was discovered on 25-Apr-2022, when the patient came into the facility for an immunization update and the vaccine registry was pulled up. The patient reported no adverse effects.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
I had a fever, felt nauseated and my body was temporarily immobilized, couldn't move for 2 hrs. Pt. had fever (101.7), chills, myalgia, malaise and a mild headache. Symptoms resolved in 48 hours.
Patient mentioned belief the vaccination was given too high  in the shoulder, not the deltoid muscle. Patient voiced,  "It hurt pretty bad the first two days. I could tell the puncture hole was more near the shoulder instead of the muscle... And, now I can barely move the [left arm] at the shoulder joint I made an appointment with my primary care for tomorrow." She states when not moving the shoulder joint the discomfort level is a "2-3" on a scale of 1 to 10, 10 being the most painful. However, with shoulder movement, the pain elevates to a "7 or something especially when I abduct my arm."
High fever; Chills; Achy all over; 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 received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: EN6198), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: Unknown, Anatomical location: Left arm), administration date: 06Mar2021, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "High fever", "Chills", "Achy all over"; BNT162b2 (DOSE 2, SINGLE; Lot number: EP7534, Anatomical location:  Left arm), administration date: 27Mar2021, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "High fever", "Chills", "Achy all over"; BNT162b2 (DOSE 3 (BOOSTER) SINGLE; Lot number: Unknown, Anatomical location: Left arm), administration date: 07Oct2021, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "High fever", "Chills", "Achy all over". The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Achy all over"; CHILLS (non-serious) with onset 2022, outcome "unknown"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "High fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, pain.  Additional information: It was reported that the patient did not had other conditions. No investigations were done. The reporter wanted to know some of the questions about the side effects of Pfizer vaccine for COVID and the Pfizer booster for COVID. The patient had a very high fever temperature after each one. The patient had high fever, chills, achy all over for approximately 24 hours on each of that 2 vaccines and the 2 boosters. When the patient got last booster, the CDC was monitoring me and sending a weekly, then monthly like how the patient was doing, has been been sick and got a questionnaire on Saturday and not heard anything. The patient wanted to make sure they may have happened maybe side effects. The patients age was 70 years (Not clarified as Age at time of Adverse Event hence not captured). The patient did not underwent any laboratory tests within 1 or 2 weeks. Therapeutic measures were taken as a result if the adverse events and included treatment with Tylenol 100 milligram. The patient received the first vaccine on 06Mar2021, the next one is 27Mar2021, the next one is 07Oct2021 and the last one is 21May2022. The reporter wanted to know some other side effects.
According to patient, she woke up at 2:00 a.m. to use the restroom and noticed she had a very dry mouth and was thirsty.  She passed out and when she came to she experienced decreased vision.  She was taken to the emergency room via ambulance for tests.  She was diagnosed with a blood clot to her lungs after CT scans.  She also had aditional scans and blood work and stayed at Hospital in town (I am having trouble adding this to the shaded area in question 21).
I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended up throwing up. I only got 4 hours of sleep.
Patient recieved her first dose of  Moderna vaccine today at 1033 am , Patient start coughing around 1048 am  after her fifteen minutes wait expired.  Daughter stated her mother do cough at times because of difficulty swallowing. Patient alert no other symptoms. nurse alert called at 1051 am. Nurse alert team arrived at 105 2am and assessed patient . Plan to monitor for an additional 15 minutes. Observed patient for an additional 15 minutes, no coughing her difficulty of breathing noted or any other reactions. Patient stable upon  leaving the department at 1105 am via wheelchair with her daughter.
Presented with GLF, noted to have hypoxia, elevated inflammatory markers; + covid with admit; Admit 9/25 to tele with hypoxia; tx: 9/25 maxipime, xarelto started   9/26 remdesivir, Vit D3, Vit B12, steroids, singulair, zinc started O2 requirements: 2 lpm throughout stay
patient has been having headaches followed by stomach pain since third day after vaccine was given on 01/18/2022 as reported by Mother.
2nd dose of Pfizer vaccine given too early on 3/24/2021. 1st dose was given on 3/8/2021
Information has been received from a physician concerning a 14 year old female who was vaccinated with Gardasil. After her second dose, the patient experienced nausea, diarrhea, vomiting and fever. The patient did not experience any symptoms after her first dose. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Initial and follow information has been received. Patient had no known allergies and no illness at the time of vaccination, who on 24-Apr-2007 was vaccinated IM in the right deltoid, with the second dose of GARDASIL (Lot # 655619/1427F). The following day, 25-Apr-2007, the patient experienced nausea, diarrhea, vomiting and fever, which lasted ofr 24 hours. The patient did not experience any symptoms after her first dose. The patient sought unspecified medical attention. No further information is expected.
Change in menstral cycle, weight gain, inflammation, intermittant heart racing, hypothyroidism, liver and gall bladder deficiency/ inflammation
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: thyroid removed" (unspecified if ongoing), notes: Other medical history: thyroid removed. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive, notes: First tested positive 28Jul2022; (04Aug2022) Negative, notes: tested negative 04Aug2022; (09Aug2022) Positive, notes: tested positive again on 09Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient reported that, First tested positive 28Jul2022, tested negative 04Aug2022, tested positive again on 09Aug2022 with paxlovid rebound (symptoms sore throat and runny nose) until 12Aug2022.
Tested positive (antigen test) on July 2. Completed a course of Paxlovid, tested negative for four days consecutive, and then on July 11 I tested positive again (likely rebound from the paxlovid).
Vomiting,Nausea,Dizziness,Swelling/Tingling in extremeties,Rash all started 7/16/22.