chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shoulder pain, bruising to bicep and tricep area down to elbow. Patient presented to pharmacy on 1/2/17 with complaint of pain/bruising. Patient followed up with his medical provider on 1/3/17. His provider notated bruising to bicep/tricep, hematoma to upper posterior arm. No imaging was performed, no coumadin level was checked.
LEFT DELTOID REDNESS, SWELLING AND WARMTH TO TOUCH. HIVES ON BILATERAL WRIST AND ONE ON LUQ.
Headache, Myalgia, Fever, FATIGUE, CHILLS, TIRED, ARM PAIN Narrative:  Other Relevant History:
Fever 101.7 Chills, Body Aches,  Generalized Weakness, Head Ache, Diarrhea
This spontaneous report was received from a 62 year old male patient referring to himself. The patient was a retired paramedic. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. The patient reported that on an unspecified date, a fewdays ago, he was vaccinated at the clinic with one dose of ZOSTAVAX, subcutaneously, for prophylaxis (strength, dose, lot number or expiration date were not reported). On an unknown date the patient developed localized swelling at the injection site with about 2.5 inches of diameter. The patient also reported that the affected area was warm to the touch. On an unspecified date, the patient also developed rash.  The patient did not seek medical attention and he had not taken any medication for the events at the time of this report. The outcome of injection site swelling, injection site warmth and rash was reported as not resolved. Causality assessment was not provided.
This spontaneous report as received from a nurse refers to a 12 month old patient of unknown age. On 27-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route and lot number were not reported) and (Oka-Merck) PROQUAD (dose, route and lot number were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain moved to all of their long bones and muscles), BACK PAIN (Back pain) and MYALGIA (Severe Myalgia) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included Cough (believes they had COVID-19 because they suffered having a bad cough back in 24Jan2020 through 15Feb2020) from 24-Jan-2020 to 15-Feb-2020. Concurrent medical conditions included Migraine. Concomitant products included FENTANYL, MORPHINE and TOPIRAMATE (TOPAMAX) for an unknown indication.On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Pain moved to all of their long bones and muscles), BACK PAIN (Back pain) and MYALGIA (Severe Myalgia). In March 2021, PAIN (Pain moved to all of their long bones and muscles), BACK PAIN (Back pain) and MYALGIA (Severe Myalgia) had resolved. Treatment information was not  provided. The patient explained these symptoms lasted through the first night, was gone the next day, then the pain came back the following day, and finally the next day it all went away.This case was linked to MOD-2021-294577, MOD-2021-294571 (Patient Link).
Subsequent to receiving a full series of varicella virus vaccine live the pt experienced a lack of response. The physician considered an IgG of 0.6 as a negative titer.
Rash on toes; Starred as swelling; Starred as swelling and blisters; Faded to blisters and discoloration; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 16:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 16:00, the patient experienced rash on toes. It started as swelling and blisters. It then faded to blisters and discoloration. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash on toes; started as swelling and blisters; faded to blisters and discoloration was resolved with sequelae on an unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Temperature 99.8, headache like my head is in a vice a little achy starting on second day of symptoms
Information has been received from a physician concerning a male patient in his 80's who on 02-AUG-2008 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) 0.65 ml SQ.  Subsequently the patient experienced a headache and a rash.  The patient's headache and rash persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
12-13-2017 @ 1137AM child received Flu vaccine. 12-15-2017 child was seen for allergic reaction redness, 7x8 cm, swelling, bruising. No fever. Treatment-Prednisolone x 3 days.
On the 8th I was tired and had a headache and not feeling great. On the 9th, my ear hurt, I had a headache and stuffy nose. I thought it was my allergies or a sinus infection. However, my ear was really bothering me with a stabbing pain. I went to the doctor for the ear ache and they tested me for Strep and Covid.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), ILLNESS (Major sick, just like covid), VACCINATION SITE MASS (Lump on left arm), CHILLS (Chills) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included OMEPRAZOLE for an unknown indication. On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headedness), ILLNESS (Major sick, just like covid), VACCINATION SITE MASS (Lump on left arm), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Red circle on left arm). At the time of the report, DIZZINESS (Light headedness), ILLNESS (Major sick, just like covid), VACCINATION SITE MASS (Lump on left arm), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Red circle on left arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Antibody test: high (High) High. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Two weeks prior to vaccination, patient had COVID infection and had recovered from COVID. Concomitant included thyroid medication. No treatment medication was provided.
Hypertension; Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID) and HYPERTENSION (Hypertension) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2021, the patient experienced COVID-19 (Contracted COVID). On an unknown date, the patient experienced HYPERTENSION (Hypertension). At the time of the report, COVID-19 (Contracted COVID) had resolved with sequelae and HYPERTENSION (Hypertension) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Blood pressure measurement: High.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. The primary reporter did not have the lot number information, because the packaging was discarded.  No treatment medication was reported.  The reporters causality for the events of contracted COVID and hypertension was not provided for co-suspect Humira.
Small, red, slightly raised and splotchy rash at injection site. Started about 8 hours after second dose. No rash at first dose. Has since spread down to forearm: red, slightly raised in spots, splotchy and very itchy. No pain, only faintly hot. No hives. Day 5 since injection and it's still there.
The next day and for a week I experienced a large 5? area of swelling, a lump, redness , itchiness and moderate pain at the injection site. I thought it was normal but read an article that said it?s really not. I felt slightly dizzy right after the shot and developed a fever of 102 lasting for about 6 hours beginning about a day and a half after the shot. I?m back to normal and get # 2 on 2/9.
the patient had an acute Myocardial infarction within 48 hours of modern vaccination no prior history of coronary artery disease
Joint pain; Eyelid twitching; Fever; Headache; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Lot number: 33130BA) at the age of 29 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: none; Known allergies: none. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8732; Anatomical location: left arm), administration date: 27Mar2021, when the patient was 29 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EU0161; Anatomical location: left arm), administration date: 17Apr2021, when the patient was 29 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Dose number 3"; ARTHRALGIA (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Joint pain"; BLEPHAROSPASM (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Eyelid twitching"; PYREXIA (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Fever"; HEADACHE (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Headache". Therapeutic measures were not taken as a result of arthralgia, blepharospasm, pyrexia and headache.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
I had the shot now I hav the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient had the shot and had shingles, the patient hope the shot helped but doubted it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Patient reported lightheadedness after receiving flu shot and fell forward from her chair. Did not hit her head or have any other allergic reactions. No other symptoms and recovered after resting and drinking water. Patient has history of fainting and lightheadedness with shots/blood draws before due to fear of needles.
Received Hep A VAQTA in left deltoid at 945 AM 3/15/16. Developed hives (all over body) 3/16/16 at 7 PM. No SOB, diff. breathing, cough or fevers. No new exposures. Rec. 50mg BENADRYL, ZANTAC x1 - hives improved but reoccurring - BENADRYL Q6 hours - seen 3/17/16 10 AM - hives (erythema multiforme) on left wrist, (R) shoulder, left deltoid and back on BENADRYL Q6 hours.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 18-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Information has been received from a physician assistant concerning a female who on 01-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (lot # 664502/0687Y).  Subsequently the patient developed a blistery rash at the injection site.  The patient has sought medical attention via office visit..   Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of arthralgia in a elderly female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 24th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced arthralgia, fever, myalgia and injection site swelling. On an unknown date, the outcome of the arthralgia, fever, myalgia and injection site swelling were unknown. It was unknown if the reporter considered the arthralgia, fever, myalgia and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient had a severe fever, arthralgia, myalgia and severe swelling at the injection site. The reporter agreed to be contacted for follow up.
woke up next day feeling very congested, & achy;as day progressed, felt worse/more achy, sore neck & sore rt arm;rt hand sl swollen, hot, diaphoretic, fever 100.4;inc aches, wheezy chest;
Started with pain and inflammation of the left deltoid muscle, soreness of muscle and a feeling of nausea and lightheadedness at noon on 7/26/12.  Symptoms of nausea and lightheadedness continued all day 7/26 and until ~ 1 PM on 7/27.  Swelling did not resolve until 8/30/12.  Pain and inflammation was relieved by ibuprofen 200mg every 6-8 hours as needed.
About 5 minutes post vaccination, the patient's girlfriend stated that he slouched over dropping his phone with his eyes closed. He came to it right away, but seemed confused.  Patient stated that he had breakfast & drake coffee, but no other beverages. He stated he felt dizzy and was was given a bottle of water to sip on. He progressively become more pale in the face and lips.  EMT was altered and his BG and BP were taken. His BG, BP and HR were all reported low. The EMT gave him M&M's and chocolate milk to help elevate his BG. The patient declined ER visit, but was advised by EMT to follow up with PCP.
2/16/22 pt presents to hosp with lethargy and poor appetite; hx of positive COVID test on 1/22/22; admitted with encephalopathy metabolic secondary cellulitis vs in-patient delerium; probable cellulitis RUE vs septic joint; IV ABX; AKI; pt made DNR/DNI, no feeding tubes or artificial nutrition; transitioned to comfort care/hospice; pt passed away in the hospital
No additional AE/PQC reported; HCP called to report that the patient was given PROQUAD instead of MMR II; The PROQUAD also suffered from a non supported temperature excursion; This spontaneous report was received from Pharmacist and refers to a patient of unknown gender or age. Information regarding the patient medical history, historical drug, current conditions or concomitant therapies was not provided.  On 05-MAY-2023, the patient was vaccinated by mistake (wrong product administered) with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W029552 rHA, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) patient should received instead measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II.)  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 8 degree celscius for 1032 hours on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 17-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016 (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Within 24 hours after injection, a welt the size of 7.5cm x 4/5 cm on my left deltoid appeared with pain, swelling and redness. I went to employee health to be checked out and was told to come back if it gets worse. I applied ice all morning to the site. Went back to employee health later in the day because I now had left arm and left neck pain on top of the redness and welt. It took approx. 3 days for the redness and swelling to disappear but I still have soreness at the injection site. I never had a reaction to any flu vaccines before.
The site of my joint replacement on my left hand/arm became quite weak, painful, and went backwards in strength and healing.  Was coming back to where it had been when I received my 2nd vaccine on 4/23/21.  Same weakness and pain occurred and am working to strengthen and aleve pain to where it was in March.
Headache; Diarrhea; Nausea; Vomiting; Chills; Fever; Shortness of breath; Racing heart; Pain swelling and redness in arm of injection; Pain swelling and redness in arm of injection; Pain swelling and redness in arm of injection; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Sep2021 at 12:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, overactive bladder (OAB) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included erenumab aooe (AIMOVIG) and mirabegron (MYRBETRIQ); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jul2021 at 09:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 02Sep2021 at 02:00, the patient experienced headache, diarrhea, nausea, vomiting, chills, fever, shortness of breath, racing heart, pain, swelling and redness in arm of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with acetaminophen (TYLENOL), ranitidine (ZANTAC), sumatriptan (IMITREX) and diphenhydramine (BENADRYL). The clinical outcome of the events headache, diarrhea, nausea, vomiting, chills, fever, shortness of breath, racing heart, pain, swelling and redness in arm of injection were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 19-SEP-2016, the patient received improperly stored doses of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
Sore throat, muscle sore and very tired for 3 days. My temp is 99 when I first get up when very warm in blankets, then goes down when up for a period.
Sore arms and achy all over.  Right upper arm (75 x 55 mm) very erythematous, warm and tender with pneumovax left upper arm (25 x 18 mm) mildly red and tender with flu vaccine.