chrisvoncsefalvay/vaers-outcomes huggingface dataset:
less than 24 hours I'm here in bed with a fever of 102.5; body aches; fatigue again; The left elbow is now worsening to the point there is not much strength in that arm any more; left elbow pain as severe; This is a spontaneous report from a contactable consumer(patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EWO153, Expiry date: Unknown) via an unspecified route of administration, administered in the left arm on 18Apr2021 at 15:15 (age at the time of vaccination was 44-year-old) as dose 2, single for COVID-19 immunization. Right knee injury, several bulged disk in back, chronic pain. Patient had one surgery about 15 years for acid reflux. No other chronic issues. Patient had covid prior to vaccination. Concomitant medications included loperamide hydrochloride (IMODIUM) and marijuana taken for an unspecified indication, start and stop date were not reported. Historical vaccine include dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW10201, Expiry date: Unknown) via an unspecified route of administration, administered in the left arm on 31Mar2021 at 03:30 PM as dose 1, single for COVID-19 immunization and the patient reported event described as 48 hours after first vaccine my left elbow seemed to lock up, joint was difficult to move and painful. On an unspecified date, the patient experienced a moderate fever, body aches and fatigue. Patient did not receive any other vaccines within 4 weeks prior and received other medications 2 weeks prior to the COVID vaccine. Patient allergies were none. Patient was not tested for covid post vaccination. It was reported that patient elbow never healed, and he never had any issues with either elbow until the vaccine. After second vaccine less than 24 hours he was in bed with a fever of 102.5, body aches and fatigue again. The left elbow is now worsening to the point there is not much strength in that arm anymore and the left elbow pain as severe on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 102.5 on an unspecified date. No treatment was taken for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
big red spot, (2 inches by 2 1/2 inches); little bit a sore arm; little red spot in the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit a sore arm), VACCINATION SITE ERYTHEMA (little red spot in the injection site.) and VACCINATION SITE RASH (big red spot, (2 inches by 2 1/2 inches)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high, High cholesterol, Hypothyroidism and Anxiety. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (little bit a sore arm) and VACCINATION SITE ERYTHEMA (little red spot in the injection site.). On 10-Mar-2021, the patient experienced VACCINATION SITE RASH (big red spot, (2 inches by 2 1/2 inches)). At the time of the report, PAIN IN EXTREMITY (little bit a sore arm), VACCINATION SITE ERYTHEMA (little red spot in the injection site.) and VACCINATION SITE RASH (big red spot, (2 inches by 2 1/2 inches)) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
This spontaneous report as received from a healthcare worker refers to a 21 years old female patient. The patient was vaccinated with first dose of GARDASIL on 10-NOV-2009, and second dose on 05-JAN-2012 (both lot# and route were unspecified). The reporter stated that the patient has not received the third dose of GARDASIL. No adverse effect was reported. The outcome of patient was unspecified. Additional information has been requested.
Patient felt dizzy and had to sit down after vaccinations. No LOL, no syncope. BP/Pulse monitored for 30 minutes after episode. Was normal and discharged.
10 mins p/vax pt c/o nausea 15 mins later pt c/o hot flashes, nausea inc, some SOB; pt transported to ER observed for 4 hrs sx ceased & pt released;
Patient developed Broncho and Laryngo spasm, hypertension, pulse 108 and difficulty breathing. .03 ephinephrine was administered after shot and resolved.
Symptoms 1. onset of frequent and severe migraines, include numbness on the left side of my face 2. chest pain in the left and center of my chest  Symptoms have not resolved in over 3 months and prevent me from regular exercise, daily 8 hours of work, and other parts of my general lifestyle. Treatments and investigation ongoing. Due to symptoms, I have not gotten the second dose of the vaccine yet.
Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Source document stated that patient had not experienced any symptoms.
This spontaneous report was received from a registered pharmacist concerning a female patient with fibromyalgia, depression and anxiety and no known drug allergies who on 01-SEP-2012 was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose not provided) (lot # 671779/0169AE, expiration date on 06-MAR-2013, sterile diluent lot # H012409 expiration date in June 2014). Concomitant therapy included acetaminophen, VICODIN, lorazepam, trazodone hydrochloride, gabapentin, ZOLOFT, PROAIR, LIPITOR, PRILOSEC and SKELAXIN. On 02-SEP-2012, the patient developed cellulitis after receiving the ZOSTAVAX. The injection site was swollen, red and hard with some "white colored" area near the site. The patient went to an emergency room (ER) to receive an intravenous antibiotic and the patient was released. The patient also was treated with KEFLEX. At the time of the report, the patient was recovering from the event. The relatedness for cellulitis was unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant referring a patient of unknown age and unknown gender. The patient's concurrent condition, historical drugs, medical history and concomitant therapy were not reported. On 09-JAN-2019, the patient was administered a dose of GARDASIL 9 (lot#: R008164, expiration date: 12-NOV-2020; strength, route and frequency were not reported; for prophylaxis) that may have been improperly stored. No adverse effects were reported.
Starting 1-2 days after vaccine, he developed profound fatigue and malaise, with a mild hypertensive response. Symptoms lasted 4-5 days
tested positive for Covid-19 after getting the vaccine; tested positive for Covid-19 after getting the vaccine; This is a spontaneous report from a contactable consumer via the Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date was not reported), via an unspecified route of administration on 11Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid-19 after getting the vaccine on 14Jan2021. The reporter and his wife both took a rapid test on 08Jan2021 and it was negative. On 11Jan2021, they both got their first dose of the vaccine. The patient had a swab test done on 14Jan2021; she is asymptomatic, but her test was also positive. They wanted to know if it's ok to get the 2nd dose of vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045686 Same reporter, drug, and event with different patients
Diarrhea, NauseaVomiting, HYPERtension, Tachycardia, tingling
This spontaneous report as received from a physician via a company representative refers to an unknown number of patients of unknown gender. On an unknown date the patients were vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patients were diagnosed with shingles. The outcome of shingles was unknown. The action taken with the therapy with ZOSTAVAX was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. It was reported that no VZV pack was offered to the physician since the physician stated that he did not want to be contacted regarding the adverse event. This case is related to case number 1403USA007399 via same reporter link. Additional information has been requested.
pt began to scream immed p/inject; pt skin began to flush; MD ordered pt to receive DPH inject;
pt recv vax & had a sz p/vax;@ the office visit pt reportedly had croop & bilat OM;pt did not have a fever & had two prev tripedia vax w/o incident;
Complained of muscle spasms from hand to neck and shoulder blades that started day after vaccine.  Arm swollen, warm to touch for 7 days.  No fever, no chills, still complaining of spasms.
Joint pain/swelling, mild fever, the inflammations last 2 days then move to another area. Blood work shows positive ANA, ESR elevated, CRP elevated. ED visit 10/21/16, PMD 10/28/16, PMD 11/1/16, ED visit 11/3/16, 11/1/16 Chiropractor, 12/6/16 Rheumatologist scheduled.
Rapidly progressive glomerulonephritis (RPGN) leading to hypertensive emergency. Treatment: Solu-medrol & prednisone, cyclophosphamide for RPGN.  Labetalol, nifedipine, Bumex for HTN.
PT EXPERIENCED SEVERE PAIN AT INJECTIONS SITE THAT SPREAD INTO BACK/SHOULDER, DELTOID, NECK, UPPER AND LOWER ARM, AND HAND. PT HAS HAD TO SEEK MEDICAL CARE AND CONTINUE TO USE OTC MEDS. PERSISTENT HEADACHE.
This spontaneous report as received from a from pharmacy technician concerning a currently 13 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 11-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
COVID rebound after taking Paxlovid; COVID rebound after taking Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: 027H21B) at the age of 47 years, in left arm 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: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID rebound after taking Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Paxlovid taken as COVID 19 Treatment from 18Jul2022 to 29Jul2022.
No real big effects just after the 2nd shot but 12 days after my second vaccination shot I experienced headache, bodyaches, fatigue, which lasted two days and then on the third day I experienced sore muscles. After the third day I was back to normal and the only thing that I can report now is occasionally I?ll get a sharp head pain, throughout the day but it doesn?t last all day long, it comes and goes.
I experienced ringing in my ears a few days after receiving the 2nd dose of the vaccine. It becomes extremely loud whenever I go to bed or performing normal activities and have to create white noise to manage it. I went to see my PCP on 05/19/2021 and she referred me to a hearing specialist who diagnosed me with Tinnitus.
pt had a high temp p/vax devel upper resp infect, became hypotonic, unattentive w/stiff neck & little movement in the limbs; stopped gaining weight & development delayed;
At the time of inserting the needle half of the medication was administered, bump was present and the needle retracted unexpectedly. The other half of the medication was wasted and a new dose of Jynneos vaccine of 0.1ml was administered on the opposite forearm.
I got my vaccine and shortly after walked to my car to wait the recommended 15 minutes. As I was walking to the car I immediately noticed a pain in my jaw, it wasn't bad but it was strange.  I got in the car and took my mask off and noticed that my eyes and entire face except my forehead was red and inflamed.  I thought it was the mask at first, but when I got home it was even worse. I had sent a message to my doctor that day, but didn't hear anything back so I went to the urgent care the very next day on 04/06/2021.  The doctor gave me an antihistamine and said that it was maybe a reaction due to the mask I was wearing, but I wear this brand all the time and I have never had this issue.  The redness lasted for a few days. After the redness went away I had these bags under my eyes, and then when the bags went away my skin under my eyes started to peel. I also noticed that my face started to peel as well.  For 10 days to 2 weeks, I had burning and itching on my wrists; my rt wrist was worse.  Since my Pfizer dose I now have eczema on my feet and ankles mostly, but I get it all over my body from time to time.  My toes remain an issue and on my hands too.  I also have rashes on my arms and back of knees. The doctor gave me a steroid cream that I use, but I can only use it for 2 weeks at a time and then I have to stop for a while.  Still today my eyes will sometimes feel dry around my eyelashes.  My right hand is the worst and the rash on my rt foot hasn't gone away at all.  This is the first time in my life I have ever had eczema.  I didn't get the Pfizer 2nd dose due to the nature of my reaction, my doctor confirmed that the reaction was sever.  I did however get the Janssen dose on 08/20/2021.
No additional AE; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-MAR-2021, the patient was vaccinated with doses of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039319, expiration date: 04-DEC-2021, 0.5 milliliter (formulation, strength and route of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot # T025945, expiration date: 30-JUL-2022, 0.5 milliliter (formulation, strength and route of administration were not reported), both for prophylaxis.  On an unknown date, the doses of the vaccines were exposed to temperature excursion at -1.6 Celsius degrees (C) for 1 hour and 36 minutes. There was no previous temperature reported. The call was due to digital data logger. No additional adverse event was reported.
Flu-like symptoms, hoarseness, cough, colored sputum, achy, tired.  Site of injection is hot, burning throat, fever.  Has been taking over the counter medication.  Today feels much better but still weak, and burning throat.
(1) Cellulitis Rt arm (2) Local Reaction Lt arm 11/13/07-records received for DOS 10/11/07-DX: Acute allergic reaction and cellulitis of right upper limb. Slight reaction to flu vaccine, more reaction to pneumonia vaccine. Gastric bezoar, having problems with eating. Developed swelling and tenderness and pain with painful movement of right shoulder. Swelling and pain right upper arm around injection site and extending to right axilla.
15.5 x 13 cm area of erythema at varicella site right upper arm.
Mild fever (101.0 F); This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, (Batch/Lot Number: EP6955),via an unspecified route of administration, administered in left arm on 13Apr2021 at 11:00 AM as SINGLE DOSE for covid-19 immunization. Patient was 62 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient received first dose of bnt162b2 via an unspecified route of administration, administered in left arm on 23Mar2021 at 12:00 PM (Batch/Lot Number: EP6955) as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination patient has not been tested for COVID-19. On 14Apr2021 at 19:00 PM, the patient experienced mild fever (101.0 F). In Apr2021, the event was recovered.  Followup#01(20Apr2021): No new information received.  No follow-up attempts are needed. No further information is expected.
(R) deltoid area with slightly raised 4 cm x 2.5 cm erythematous area no warmth.
improperly stored VARIVAX was administered to patient on 5/19/2020; No adverse affects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 19-MAY-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S012036, expiration date 17-APR-2021 (dose and route of administration were not provided) for prophylaxis.  The dose of the product administered to the patient was not stored properly for the time frame of 4 hours in the temperature of 48.2 degrees Fahrenheit on an unknown date. There was no previous temperature excursion. Digital Data Logger was involved. No adverse effects were reported.
Hepatitis B vaccine given 09/26/2001. Local reaction on injecton site, right deltoid from alcohol wipe. Taken to clinic same day, started on antibiotic for ear infection. Body hives developed on 10/03/2001. Has taken same antibiotic before.
09/09/22 presents to ED for "hypertension". PMHx of "hypertension, IDDM, CKD, CHF"
Have had shots, still get shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Have had shots, still get shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-MAR-2023 The case was received from the patient interactive digital media. The patient had Shingles shots and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
soreness right arm; right arm swelling; right arm hardness; right arm redness; right arm itchiness; hot to touch; right arm has pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness right arm), VACCINATION SITE SWELLING (right arm swelling), VACCINATION SITE INDURATION (right arm hardness), VACCINATION SITE ERYTHEMA (right arm redness) and VACCINATION SITE PRURITUS (right arm itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness right arm), VACCINATION SITE SWELLING (right arm swelling), VACCINATION SITE INDURATION (right arm hardness), VACCINATION SITE ERYTHEMA (right arm redness), VACCINATION SITE PRURITUS (right arm itchiness), FEELING HOT (hot to touch) and LIMB DISCOMFORT (right arm has pressure). At the time of the report, VACCINATION SITE PAIN (soreness right arm), VACCINATION SITE SWELLING (right arm swelling), VACCINATION SITE INDURATION (right arm hardness), VACCINATION SITE ERYTHEMA (right arm redness), VACCINATION SITE PRURITUS (right arm itchiness), FEELING HOT (hot to touch) and LIMB DISCOMFORT (right arm has pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were reported. no treatment details were reported.
Pt attested to NOT having had previous vaccines After receiving Moderna  1st dose, He was recognized by County worker as having previously gotten J&J upon looking him up in system, he had in fact, gotten Janson  4/12/2021, Dr  advised, no immediate adverse affect noted
Swollen around immun site/warm to touch 2 1/2x3cm. Cellulitis over area. Pt given Keflex250/5 1tsp PO BID.
ONSET OF SX 090506. HIGHEST TEMP 99.8. "MILD CASE OF CHICKEN POX" PER MD. RX. = BENADRYL. 20 "SCABS"  1 BLISTER. WILL RETURN TO SCHOOL 091106.
Sore throat, chills, fever, headache, cough, nausea. Next day - ache in calves of both legs.
Injection site became swollen and red. Area about 5 inches (circle). Patient complained about pain and inflammation.
14SEP92 & 15SEP92 t101; 16SEP92 ax temp 104, rectal temp 104.9; APAP given every 4-6 hrs;
pt recvd vax & c/o severe burning in leg 1/2 hr p/ vax;entire upper thigh,and genital area red & inflamed;tx w/ cold compress & dph;next day inflammed area severely bruised;remained that way for > 2 wks;very tender to touch;skin peeling