chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm was really sore at the site of injection; Developed body aches similar to the flu; Nauseous; Fatigued; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 12Jan2021 at a SINGLE DOSE (30mcg) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 23Dec2020. The patient stated, "I received my second vaccine shot on Tuesday, 12Jan2021. On Wednesday (13Jan2021), my arm was really sore at the site of injection and I developed body aches similar to the flu. I was also nauseous and fatigued (Jan2021). Thursday I started to feel better. I am 95% better today on Friday." The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
L arm became red, swollen (size of baseball) at site of Tdap and Menactra/ Pt also had a light Grand Mal seizure at school today (she gets them about once a month).
p/vax pt devel rash w/itching on trunk of body. benadryl given
In April had constipation that's new,  CT w/u showed liver abcess and perforated colon cancer,  required surgery; now after booster 9/18/2021, had new liver and mets,  patient is now dnr
Mild soreness left arm at injection site for 1 day, no redness or swelling; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old male patient received the first dose of bnt162b2 (Pfizer Biontech COVID 19 vaccine), Lot number: EH9899, intramuscular in the left arm on 18Dec2020 14:15 at a single dose for COVID-19 immunization. Medical history included Psoriatic Arthritis, HTN, HLD and known allergies: Sulfa. Concomitant medication included losartan and gabapentin. On 18Dec2020 14:15, the patient experienced mild soreness left arm at injection site for 1 day, no redness or swelling. The patient was not hospitalized for the event and did not receive any treatment for the event. The event was reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The event recovered on an unspecified date in Dec2020.
Patient is a 19-month-old who presents to clinic with mom and dad for concern of vomiting diarrhea and fatigue. Dad states that he has been sick over the past week. It all seemed to start after his well visit on 12/1 roughly 12 days ago. At that visit dad explains that he received an Infarix (DTaP) and Vaqta (HepA) vaccines as well as an additional adult Hep A vaccine in error. He seemed to develop symptoms shortly thereafter. He had diarrhea or has been having 3-4 stools per day. Family has not seen any blood or mucus in the stools. He is also had vomiting several times a day. He is not keeping food down well. His weight is down a little over 2 pounds. No fevers. He has had a slight runny nose.
Injection site redness; Injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itchy). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash-legs, abdomen, back, arms in initially-then palms and soles of feet with peeling skin.
Patient to PMD for physical. Was feeling well and received flu vaccine. Upon arriving home minutes later told wife "I don't feel well" and collapsed. Brought to ED in full cardiac arrest. Unable to resuscitate.  10/19/09 ER records received service date 10/2/09. Assessment: Cardiac Arrest. Patient arrived unresponsive, intubated with CPR in progress. Asystole on monitor with no spontaneous respirations. External trauma to eyes.  ICD-9 code 427.5 cardiac arrest.  12/16/09 Death Certificate received. DOD 10/02/09. Cause of Death - Hypertensive and arteriosclerotic heart disease.
Developed fever up to 101 on same day as vaccine administration. Maintained Fever For 5 days.
10 hours past 2nd  vaccination developed aches in joints and chills.  Aches lasted 12 hrs and chills lasted 2 hours.  No fever.
Day of the vaccine: fever, chills, body aches and headache Next Day: fever, body aches, lethargy and headache 4/12/21: headache started again at 1630; went to bed with headache 4/13/21: woke up with the headache
Case previously recorded as MA2009-3290. Initial case report received from a health care professional on 26 OCT 2009. Patient, age and gender unknown, was vaccinated i.m. with S-OIV FLUVIRIN (batch no. unknown) on 23 OCT 2009. The patient, under 4 years, was inadvertently given Novartis H1N1 vaccine. No adverse event was reported. Reference no.: NA09-007031.
approximately 10 minutes after vaccine administration patient experienced nausea and dizziness, followed by losing consciousness for a few seconds. She recovered quickly. 911 was called and medics arrived to take vitals (blood pressure, blood sugar, heart rate).
Headache, Arthralgia, Fever, NauseaVomiting, fatigue; Narrative:
Felt she was having a lupus flare up; Injection site swelling; arm hurt really bad; felt like arm was broken; body aches all over; felt cold; had chills; fever of 102.7; This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus syndrome aggravated in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On 17th May 2019, the patient received the 1st dose of Shingrix. In May 2019, 8 hrs after receiving Shingrix, the patient experienced systemic lupus erythematosus syndrome aggravated (serious criteria GSK medically significant), injection site swelling, pain in arm, arm discomfort, general body pain, feeling cold, chills and fever. On an unknown date, the outcome of the systemic lupus erythematosus syndrome aggravated, injection site swelling, pain in arm, arm discomfort, general body pain, feeling cold and chills were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the systemic lupus erythematosus syndrome aggravated, injection site swelling, pain in arm, arm discomfort, general body pain, feeling cold, chills and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 8 hours later she developed swelling at the injection site, her arm hurt really bad and felt like it was broken. She felt she was having a lupus flare up, had body aches all over, felt cold and had chills. The patient also developed a fever of 102.7 degree F after 12th hour that lasted for two days. The reporter consented for follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019AMR150026.
The patient presents to Urgent Care today with complaint of fever and dry cough x7 days. She had the J&J covid vaccine on 4/9 and began not feeling well on Saturday. She developed a fever and chills and tachycardic. She said every day since then her fever has been going up and down. She started to vomit on Sunday, last time she vomited was Monday night. She was having diarrhea as well. She denies rhinorrhea or congestion. She denies throat pain. She went to the ED on Tuesday and she was given fluids. She said she felt a lot better on Tuesday when she left the ED. She said now she feels bloated. She does have an appetite but because she feels full she isn't eating a lot but states she drinks 1 gallon of water a day, her water bottle is with her. She is having some sob. She denies chest pain. She has bilateral lower back pain when she is sleeping. She took anti nausea meds which did help. She has been taking ibuprofen.
2:46pm  patient reported mid-sternal chest pain. Checked vital B/P was 146/66 on left arm, HR 78 she was 98%o2. rapid response was called, they arrived at 2:33pm and patient was taken to the ER. Outcome unknown.
Syncope episode after vaccines. Patient seated in chair after vaccines. Became limp, fell to floor, hit head at (R) upper out orbital  rim. Briefly unresponsive, limp, tongue prominent. Awakened slowly placed in recumbent position. Given water, observed, ice applied to eyebrow, obs. 20 min, Ambulatory to leave
pt recvd vax & exp a sudden onset of nausea & accelarated pulse; a headache, & became extremely diaphoretic, clammy, pale & weak; pt devel also vomiting 30 min later;
20 cm x 40 in area of erythema/swelling at site of injection.
LEG SWELLING, 3 X 2 INCH AREA AND REDNESS, EXCESSIVE CRYING
Left arm pain, redness, swelling , warm to touch from left shoulder to elbow - more pronounced on inner aspect - started - 10-31/07 - 2000
FEVER; BODY PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced fever, and body pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body pain was not reported. This report was non-serious.
Little pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little pain at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 an unknown date, the patient experienced VACCINATION SITE PAIN (Little pain at injection site). At the time of the report, VACCINATION SITE PAIN (Little pain at injection site) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-068840 (Patient Link).
Narrative:  COVID infections following completion of COVID vaccine series 06/07/21 COVID vaccine dose #1 07/22/21 Pt reports cough, muscle pain, and rhinorrhea x2 days; exposed to positive COVID church member; swab performed - COVID POSITIVE 07/23/21 Pt reports loss of taste/smell, cough, muscle pain, runny nose; rx given for DM/guaifenesin 07/24/21 Pt reports dry cough, frontal headache, muscle pain, rhinorrhea 07/25/21 Pt reports mild cough, returning loss of taste/smell, muscle pain, runny nose 07/26/21 Pt reports fatigue 07/27/21 Pt reports mild productive cough 07/28/21 Pt reports cough improving 07/29/21 Pt reports SOB on exertion, improving cough 07/30/21 Pt reports continued loss of taste/smell; isolation end
Five minutes after receiving Pfizer Vaccine First dose, the patient complained of nausea and headache later on.  The patient was asked if she is diabetic and if she has eaten breakfast. Gatorade / water was given,  but she continuously felt nauseous and no relief. Vital signs were taken and looked stable as follows: BP 143/89, HR 101, O2 saturation 99%, Temp 98.  911 was called and EMS came to see the patient. Blood sugar was checked as well as Vital Signs by EMs. BG was 118.  The patient was still nauseous but refused to be brought to the hospital and signed the refusal form by EMS.   Advised the patient to have someone picked her up and not drive by herself and  be checked by her Primary Physician
Fever 99.8, Headache persistent, Fatigued, Some coughing, Sneezing, and runny nose.
Low-grade fever (101 F), chills starting approx. 5 hours post-vaccination and lasting approx. 10 hours
Developed skin reaction (hives).  Treated with 25 mg of Diphenhydramine orally and observed for additional 30 minutes.  Hives subsided and patient released.
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed is 12/31/2069.  To find the expiration date, ?look up expiration date? tool is to be used from Vial Expiration Date Lookup|Moderna COVID-19 Vaccine. Patient contacted on 12/4/2021 and no adverse effects reported.
This case was reported by a physician via a sales representative and described the occurrence of decreased therapeutic response [[name]] subject of unspecified age and gender who was vacc[[name]]ted with Twinrix for prophylaxis. Concurrent medical conditions included human immunodeficiency virus. On an unspecified date the subject received unspecified dose of Twinrix (unknown). At an unspecified time after vacc[[name]]tion with Twinrix, the subject experienced decreased therapeutic response. At the time of reporting the outcome of the event was unspecified.
Client c/o nausea and slight dizziness.  Client seen and assessed by EMT and vs are: BP 134/84, HR 90, O2 96.  Client denies any other symptom and verbalized that she no longer felt symptoms within 20 minutes of observation.  Client cleared to go home by EMT and advised to seek medical attention if symptoms reoccur.
Mom called on 7-23-03 (2 days after receiving vaccines).  Mom states first day after child vaccinated, she ran fever 103F.  Two days after vaccinations, mom states fever subsided but child felt dizzy, weak, appeared pale and lips were slightly blue in color.  Mom instructed to take child to office to see MD.
He had previously recieved Johnson and Johnson on 5/5/21, when he was in Rehab. He didn't realize that the series was complete with the J& J.  Today he received a dose of Moderna covid vaccine. I explained to him he does not need anymore vaccine.
CHEST PAIN WHEN LYING; SHORTNESS OF BREATH; ARM PAIN; NOT DOING WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced chest pain when lying. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced not doing well. Laboratory data included: Pain scale (NR: not provided) 4 and a half. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain when lying, arm pain, shortness of breath and not doing well was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Stiff neck , progressed to queasy stomach, slowly got weaker, went to bed feeling slightly nauseous.  During the night I woke up freezing and it hurt a lot to even move. I didn?t even go to the bathroom I felt so bad.  Severe chills, sweats to chills. It hurt to move everything. My entire body.
speaking was completely gargled and couldn't speak; arm soreness in her right arm; This spontaneous case was reported by a physician and describes the occurrence of SPEECH DISORDER (speaking was completely gargled and couldn't speak) and PAIN IN EXTREMITY (arm soreness in her right arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included Congenital heart disease NOS (surgery age 2) on 19-Mar-2001. Concurrent medical conditions included Drug allergy (Multiple sensitivities to meds and foods) since 19-Mar-2001, Allergy NOS (Lacks both of a a type of cyp enzymes) and Food allergy (Multiple sensitivities to meds and foods) since 19-Mar-2001. Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) from 03-Jan-2020 to an unknown date, VITAMIN D3 from 01-Jan-2006 to an unknown date, PROBIOTIC 10 from 01-Jan-2016 to an unknown date, SPIRONOLACTONE from 02-Jan-2020 to an unknown date and VALACICLOVIR HYDROCHLORIDE (VALTREX) from 01-Jan-2020 to an unknown date for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced SPEECH DISORDER (speaking was completely gargled and couldn't speak) and PAIN IN EXTREMITY (arm soreness in her right arm). On 31-Mar-2021, SPEECH DISORDER (speaking was completely gargled and couldn't speak) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness in her right arm) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received on 17-MAY-2021, patient demographic details and concomitant medication was added.
I was made aware today 04/27/21 at 4 pm that the patient has been  experiencing adverse reaction starting 9 days after her second dose. including pain and limited range of motion
He then said that his tongue has been white for a while now after receiving the vaccine.; He said it was a miracle that the vaccine helped clear up the awful fungus; This is a spontaneous report from a Pfizer sponsored program COVAX US support reported from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 11May2021 as second dose, single for COVID-19 immunization. Medical history included fungal infection from 2020 (from 1 year) and prescribed with creams but did not help at all. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient said it was a miracle that the vaccine helped to clear up the awful fungus in May2021. The patient also said that his tongue has been white for a while now after receiving the vaccine in May2021. The patient wanted to know about the ingredients of the vaccine which helped his fungus to clear up. The outcome of the event tongue has been white was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 19NOV97 & pt exp double vision in eyes & was irritable;pt also devel two pox which scabbed over;
The day after his vaccination (I think in the evening but I'm not certain) his wife noted that he was less interactive while watching TV together, and he had some trouble finding words. Of note, despite his age he still works as a judge. The next morning he was no better so he went to the emergency room where he was found to have an acute stroke.
Not sure what maker, received together Dtap and MCV4 (Meningococcal). One in each arm
BODY ACHE; VOMITING; NAUSEA; FEVER; This spontaneous report received from a parent concerned an 18 year old male. 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 (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced body ache. On 05-JUN-2021, the subject experienced vomiting. On 05-JUN-2021, the subject experienced nausea. On 05-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, vomiting, nausea, and fever on 06-JUN-2021. This report was non-serious.
Community member recieved 2nd dose within 17 days of first dose of Pfizer.
Pt had a high fever of 103F and vomiting at 21:00. Seen in ER and in the hospital from 9/18/00 until 9/21/00. Mom reported this to health dept on 1/8/01.
Initially, after my second vaccine shot on 2/18/2021 I felt exhausted for a few weeks.  But after that, I started getting red blotches on both arms that would last a few weeks, then go away, and come back a few weeks later.  I would not call the red areas a rash because they were not raised or itchy.  Typically the would appear on both arms and could be around 2"x3" in size.  Some time they appeared as a 2" or 4" long line of small red (1/4" to 1/8" in size) dots that would appear down my arms - then they would go away after a few weeks and then appear on one of my arms again.   This redness that occurred were not my initial reaction to vaccines.  After my second shot I was exhausted for about a month or so.
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a male patient who received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications not reported. On 26-Oct-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported in the left gluteus medius. It was a case of actual medication error due to Vaccine administered at inappropriate site. 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.
Patient was given first on 6/24. Second dose on 7/15. Second dose was 6 days to early.