chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a wave went over my chest, then I got chest pain; fatigue; arm was really sore (inj site); A spontaneous report was received from a consumer concerning a 87-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, arm was really sore (inj site)/vaccination site pain, a wave went over  chest, then got chest pain.  The patient's medical history included COPD, leaky heart valves. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) fatigue, arm was really sore (inj site), a wave went over  chest, then igot chest pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fatigue, arm was really sore (inj site), a wave went over  chest, then  got chest pain was unknown.
PATIENT RECEIVED VACCINE AND 2 MINUTES AFTER VACCINATION PATIENT STATED HE FELT DIZZY. LAID PATIENT ON EXAM TABLE. BP 114/61 AND FELT BETTER. LAID FOR 5 MINUTES. SAT UP BP 125/52. PATIENT STOOD UP 107/91 AND PATIENT STATED FELT BETTER. WALKED PATIENT TO CAR. INFORMED PATIENT IF FEELS DIZZY AGAIN LAY DOWN AND IF WORSENS GO TO ER.
Fever, chills, body aches, severe headache and nausea for 24 hours following administration of 2nd dose. After day 2, moderate to severe headache and nausea that has persisted for 10 straight days. Headache does respond to ibuprofen but keeps returning. Nausea is persistent. No vomiting.
/P vax pt has lipoatrophy of the buttocks.  His mother feels this is getting larger, size on 11Jun90 was 20 X 15mm.  Depression at injection site only.  No other symptoms.
(Took Pfizer for first two vaccines, then took Moderna for booster. ) Following the Moderna shot, I had a high fever, deep body aches, swollen lymph nodes, and slept all day. Symptoms dissipated after 36 hours but I continued to have extreme tightness around the injected arm and shoulder, including inflammation in my wrist, elbow, shoulder and the left side of my neck. I saw an acupuncture provider and got body work twice to alleviate these symptoms.
Fever, nausea, dizziness, body aches. Fever was from about 11:00 am till middle of the night. Nausea and dizziness was gone when I woke up the next day. Body aches i still have and tired today.
Patient had first dose of the vaccine on 09/03/2019. She said that her upper arm was sore after the vaccine and never returned to normal.  She had the 2nd dose on 10/02/2019 and said that her upper arm/shoulder area was sore again.  Over the last 7 months she said that she has had soreness and some pain.  She said that it hurts to lift her arm abover her head, for example taking off a shirt, or putting her arm behind her back, for example unhooking her bra.  She said that it won't hurt when she is doing nothing, but will always hurt on those situations.  She asked her doctor about it around December and the doctor said to keep an eye on it and let them know if there wasn't any improvement.  She has not been back due to the COVID 19 outbreak, but does intend to see the doctor again.
Syncopal,  did not fall, disoriented,  at shot table, got shot then passed out.  0riginal BP 63/34,  P 49  BP 96/53, P 65, nausea
Fever 102  and complaint of headache Fever about 104 at 11 pm and complaint of being very sleepy
I had wheezing, highness, wet cough that increased when walking. I had body aches. These lasted for a few days. I had a headache.
Missed Second Dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed Second Dose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed Second Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed Second Dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment medications were reported.  Reportedly, the patient was in his 20s and received the first dose in Jan-2021 and didn't receive the second dose. No other information was provided.
Cellulitis (redness, tenderness and swelling of thigh) from groin to knee-onset about 24 hr post injection.
50 kids broke out w/chickenpox this past month at the pt's school. Pt got Varivax on 5-9-02 and broke out with approximately 379 pox by 5-17-02.
I was injected with a booster of the Pfizer COVID-19 vaccine on Friday 1/28/2022 at 4:00 CST. The next morning I felt soreness and tenderness in my lymph nodes in my left arm pit. Pain has been mild to moderate depending on the activity I engage it. Today 1/30/2022 the swelling seems greater and still sore and tender.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 07-MAY-2014 the patient was vaccinated with (Merck) VARIVAX. Past medical history and concomitant medications were not reported. The physicians stated that an unspecified number of patients were vaccinated with a dose of improperly stored (Merck) VARIVAX, Lot #J005689 (expiration date: 07-MAY-2105). No adverse effects reported. No additional information to report. This is one of several reports received from the same reporter. This case is linked to 1411USA000763, 1411USA004435, 1411USA004436, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004694, 1411USA004695, 1411USA004696, 1411USA004698, 1411USA004700, 1411USA004701, and 1412USA006848. Additional information has been requested.
second dose of Moderna on day 19; A spontaneous report was received from a pharmacist concerning a patient of unknown age and gender, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) on day 19 from their first dose.  The patient's medical history and products known to have been used by the patient were not reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 28 Jan 2021, and after 19 days from the first dose on 16 Feb 2021 patient received their second of two planned doses of mRNA-1273 (Batch number: Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  No treatment information was provided.    No relevant laboratory details were included.  Action taken with the drug in response to the events was not applicaple.  The event was considered as recovered/resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their third dose of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.
36 years old received an engerix-B pediatric dose; 36 years old received an engerix-B pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 21st January 2024) for prophylaxis.   On 15th December 2021, the patient received Engerix B pediatric. On 15th December 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assiatant reported that, 36 years old patient received an engerix-B pediatric dose, which led to underdose and adult use of a child product. The reported consented to follow up.
This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated by the medical assistant that on unspecified dates since 02-JUN-2015, the patients were administered with an unspecified number of improperly stored (Oka/Merck) VARIVAX (lot #, expiration date and frequency were not reported), subcutaneous injection. No adverse effects were reported. Concomitant therapies were unknown. This is one of two reports from the same source. Additional information has been requested.
Starting about 20-30 minutes after receiving the vaccine I started getting a slight headache. Right before I left the pharmacy, I told them I had a metal taste in my mouth. This time the taste lasted in my mouth intermittently for about a day in a half. I felt a little tired and took a nap. The headache persisted so finally after almost a week I called my neurologist who called in a Medrol Dose Pack but that didn't help. I went in to see her and she said 2 other of her patients who have migraines had the same issue happen. I got my Botox injection and that helped. After a couple weeks passed, I felt the most relief. However, I still get them occasionally. 6 months after my 2nd dose, my hematologist has noticed some of my liver enzymes were elevated and has instructed me to hold off on any additional boosters. He wanted me to have an antibody test and liver enzymes test before having the booster dose. However, I ended up coming down with Covid. I had the monochromal antibodies and then when I saw him 2 days ago (03/30/2022) he saw my liver enzymes were elevated and said to hold off on boosters at this time.
Area of injection, left shoulder, became sore in the evening and even felt like it was shooting down my arm - my hand felt very tense or tight and I needed to flex & stretch it often.  The soreness got a little worse the next day and the first part of the 3rd day - was back to normal on the 4th day.  I also felt a bit more fatigued than normal
She got her vaccines, about 6 days after that she had hives on her left hip, and then it progressed to her belly, her back, her entire right side.  Within 12 hours it went down her legs, the length of her arms, all the way up her back, her neck.  She did not notice any on her palms or the bottoms of her feet, but nearly covered her arms, legs, back, could not sleep as they were so bad . She took a double dose of Benadryl every 6 hours for a day and a half and then it stopped.  The rashes did go away after that and has not returned.  It took 2-3 days for the rashes to go away.   She was fearful that her throat was closing and did feel a little irritation of her throat on the inside, but that went away with the use of the Benadryl.  Her daughter is a pediatrician and she recommended for her to take the Benadryl.
flu like symptoms which lasted for 16 hours; sore right arm which lasted for 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms which lasted for 16 hours) and PAIN IN EXTREMITY (sore right arm which lasted for 16 hours) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms which lasted for 16 hours) and PAIN IN EXTREMITY (sore right arm which lasted for 16 hours). In February 2021, INFLUENZA LIKE ILLNESS (flu like symptoms which lasted for 16 hours) and PAIN IN EXTREMITY (sore right arm which lasted for 16 hours) had resolved.            No concomitant medications were reported.  The patient reports no adverse reactions or side effects to the first vaccine.  No treatment medications were reported.   This case was linked to MOD-2022-521073 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow up received contains no new information to add.
tingling/numbness lip/face Narrative: Employee had taken benadryl prior to vaccine and developed tingling/numbness feeling of her lips/face after the vaccine and within a couple day had reoccurrence of this. Discussed with her allergist and did not feel she should get second vaccine due to concern for anaphylaxis risk with next dose.
MILD HEADACHE; MILD PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.  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 03-APR-2021 11:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced mild pain at injection site. On 03-APR-2021 19:30, the subject experienced mild headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache, and mild pain at injection site on 04-APR-2021. This report was non-serious.
Hoarseness, constricted throat, aches, headache, cough, irritated eyes, on verge of emergency room visit.
I feel that my Ulcerative colitis, which had been in remission for years has become active and I have been kicked back to 50 years; severe abdominal pain; This is a spontaneous report from a contactable consumer (patient) reported in response to consumer letter sent via follow-up letter. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EL9262) via unspecified route of administration on 10Feb2021, as SECOND DOSE, SINGLE for COVID-19 immunisation. The patient's medical history included ulcerative colitis and diabetes controlled by diet. Concomitant medications were not reported. Historical vaccination included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: OL1284) via unspecified route of administration on 20Jan2021, as FIRST DOSE, SINGLE for COVID-19 immunisation and experienced muscle ache and pain, vomiting, difficulty breathing, diarrhea, soreness of arm and severe fatigue, gastrointestinal upset and went on for a day, nausea and extreme tiredness. On an unknown date (reported as: one week following the second injection) the patient had constant severe abdominal pain for 7 days. The patient felt that her ulcerative colitis, which had been in remission for years has become active and she have been kicked back to 50 years. The patient experienced several narcolepsy events following the first injection where I lost up to 30 minutes of time. The outcome of the events was unknown.
Severe chills Body aches Severe muscle weakness Dizziness Fever 103 F.
Swollen left deltoid 8cm x 7cm each warm, noticed yesterday night, hard reddish, tenderness. No pain.
1.  Soreness in muscle/arm where shot administered - same day as vaccine - 3:00 pm on 1/18 through 1/19 2.  Fever of 100 degrees, body aches, fatigue, headache - day after vaccine - 1/19 - 8:00 am 3.  Rash on chest and neck (hives and welts) - day after vaccine - 1/19 - 11:00 am
Pfizer shot made her tired and she had a sore arm; Pfizer shot made her tired and she had a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high diagnosed most of her life; "High cholesterol" (unspecified if ongoing), notes: High cholesterol diagnosed most of her life. Her liver produces too much but it is pretty even; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension. Vaccination history included: BNT162b2 (DOSE 1, (SINGLE), Dose #1: Pfizer-MRN (lmp-s) PF.30mcg/0.3mL dose Date: 08Feb2021 Lot: unknown NDC: unknown Expiry: unknown Dose: 0.3mL), administration date: 08Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Pfizer shot made her tired and she had a sore arm", "Pfizer shot made her tired and she had a sore arm". The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Pfizer shot made her tired and she had a sore arm". Additional information:  Lisinopril HCTZ: 10mg/12.5mg tablets, she takes 2 now she used to only take 1 a day now she takes 2 a day.  The regular Pfizer shot made her tired and she had a sore arm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
HIGH FEVER (104F), EXTREME FATIGUE AND CHEST PAINS THAT LASTED LIKE 8 HOURS.
Based on additional information received on 02-Dec-2016, this case became medically confirmed. Initial unsolicited report received from other non-health care professional on 07 Nov 2016. This case involves two female patients (age not reported) who was vaccinated with a dose of FLUZONE ID (Batch number: UT5572AA, expiry date: 30 Jun 2017, dose, and site of administration was not reported) via intradermal on an unspecified date in Nov 2016. The patient illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks of vaccination was reported as not provided. The patient concomitant medications were not reported. It was reported as on an unspecified date in Nov 2016, following the vaccination, the patients reported an approximate 2 inch reddened area around the injection site which was tender, warm to touch and itchy. (Vaccination site inflammation and Vaccination site pruritus). The patients Laboratory investigations and corrective treatment were not reported. The outcome of the events were reported as recovered on an unknown date. Follow up information received from a physician on 02-Dec-2016: This case is linked to case number 2016SA227879 (same reporter). It was reported that a 32-year-old female patient was vaccinated with FLUZONE ID in the right arm on 03-Nov-2016 and MMR (batch number: M008588 expiry date 16-Feb-2018, dose details and route of administration not reported) in the left arm on 03-Nov-2016. On 04-Nov-2016, one day after the vaccination, it was reported that the patient discovered a lump on her right arm where she got a flu shot was very red. The patient received BENADRYL oral, cream as well as cold compress as corrective treatment. The outcome of the event vaccination site mass was unknown at the time of the report. List of documents held by sender: none.
This spontaneous report was received from a pharmacist refers to a 67 year old female patient. The patient had egg allergy. on 04-MAR-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J013345 (Expiry: 11-JAN-2015) 0.5 ml, intramuscular. Concomitant medications included SYNTHROID, ZOLOFT, MELOXICAM, DIAZEPAM and METFORMIN. On 04-MAR-2014, the patient remained in the pharmacy for 15 minutes after receiving PNEUMOVAX 23 and had no issues. On 04-MAR-2014, the patient experienced fever after returned home. The outcome of the event was reported as recovering (also reported as she is fine). The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
lethargy; sore arm/the same symptoms; headache/the same symptoms; stored in the refrigerator 4 days too long; Not immunocompromised; full dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not immunocompromised), ACCIDENTAL OVERDOSE (full dose), LETHARGY (lethargy), VACCINATION SITE PAIN (sore arm/the same symptoms) and HEADACHE (headache/the same symptoms) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09O21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Oct-2021, the patient experienced OFF LABEL USE (Not immunocompromised), ACCIDENTAL OVERDOSE (full dose) and PRODUCT STORAGE ERROR (stored in the refrigerator 4 days too long). On an unknown date, the patient experienced LETHARGY (lethargy), VACCINATION SITE PAIN (sore arm/the same symptoms) and HEADACHE (headache/the same symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Oct-2021, ACCIDENTAL OVERDOSE (full dose) and PRODUCT STORAGE ERROR (stored in the refrigerator 4 days too long) had resolved. At the time of the report, OFF LABEL USE (Not immunocompromised) had resolved and LETHARGY (lethargy), VACCINATION SITE PAIN (sore arm/the same symptoms) and HEADACHE (headache/the same symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
COVID vaccine 4-1-2022, and 24 hours later, f/c/dizziness.  T to 101 for 1 day. Had a BM (some straining); Got off commode and felt dizzy.  Got on all four;  Fell and hit face on hard wood floor (from crouching position).  Some bleeding from lips (no signs of concussion);  No headache, no focal w/n.
A day after the vaccine, I noticed a good size red, hard lump (about the size of a silver dollar and very painful to move my arm) Subsided after a few days. Then, about a week after I received the vaccine I developed a very large, red lump. (About 5 inches across and 3 or 4 inches top to bottom. Itchy off and on, swollen...but no pain.
Booster injection; Contracted COVID four weeks after having our booster injection; Contracted COVID four weeks after having our booster injection; This is a spontaneous report received from a contactable Consumer for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster injection"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID four weeks after having our booster injection". The patient thought the vaccine was effective, since he only had moderate symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101590502 same reporter and drug, different patient and event