chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said the day after the Flu shot, her arm was sore, but she said she thought it was normal soreness after a shot, but it continued to hurt. After 4 to 5 days she called her physician who gave her a steroid shot and said she thought it was tendonitis. The shot helped for a couple of days, but came back, not as severe. She called the MD again, who prescribed Diclofenac. She can still feel some discomfort in the shoulder.
CHILLS; FEVER; WEAKNESS; MUSCLE PAIN; INCREASED PULSE RATE BY 10 BEATS; This spontaneous report received from a patient concerned a 34 year old of unspecified 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, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 15:00 for prophylactic vaccination. he batch number was not reported and has been requested No concomitant medications were reported.  On MAR-2021, the subject experienced increased pulse rate by 10 beats. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills on 08-MAR-2021, and had not recovered from weakness, muscle pain, and increased pulse rate by 10 beats. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Dime size fluid filled blister at injection site, patient staes it itches, no other complaints.
Patient reports "extreme soreness" even at rest, swelling, pain with movement, & decreased range of motion which started immediately after receiving the vaccine. Sx going on now x 4 wks. She reports having throbbing pain immediately after flu shot was given.  She says she has had flu shots in the last 2 yrs and never had any adverse symptoms like this.  Pain rated 9/10 and it keeps her awake at night.  Tylenol/Ibuprofen helps only a little.  She reports that it is just as painful now 4 wks later.  I advised her to see a doctor because she has not yet been seen by a physician to evaluate this.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: sulfa drugs" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing); "Allergies: corn, eggs" (unspecified if ongoing); "Allergies: dairy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 12Oct2023 to 15Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335938 same patient, different drug/event;
had a swollen lymph node under clavicle for a month; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient (currently 25-years-old) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (at the age of 24-years-old) on 06Jan2021 12:45 at 0.3 mL, single in right deltoid for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: 31Mar2021), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient had a swollen lymph node under clavicle for a month on 09Jan2021 13:00 with outcome of not recovered. She reported, "I've had both doses of the vaccine. The last one was on 06Jan2021. I have had a swollen lymph node under clavicle for a month." She says she got the second dose 06Jan2021 and on 09Jan2021 she was at the doctor's office and he felt what he thought is a swollen lymph node like under her clavicle, it is the size of a golf ball now, it is not going away. She says the swollen lymph node is under the clavicle on her left side. The doctor didn't seem too concerned about it but it has been almost a month and it is still there she doesn't know what it is but it is still there. She confirms the second dose was 06Jan2021 and on 09Jan2021 her doctor noticed it was swollen, she didn't even notice it before he did. She thinks it has gotten worse but she also might be freaking out for no reason but she thinks it has gotten bigger. She says she has the information for the first dose but the second dose is on another card because she forgot the card when she went back for the second dose. The information for the second dose is at home and she is not at home right now. She does not see an NDC Number. She says the lot number information could be available later if needed for follow up because the card is at home. Dose: It is not on the card but she thinks it is 0.3 ml, she doesn't remember for sure. At the time she got the dose she was being treated for ring worm. Her doctor did draw a Calcium and a PTH and they were both normal. She says the doctor was not too concerned about but it has been almost a month and it still has not gone down (as reported). She has asthma which she has been dealing with kind of on and off because this winter has been so cold but other than that nothing else has happened, her vitals are normal she did not even have any temperature or anything after the vaccine. The event was assessed as non-serious. Vaccination Facility Type was hospital. The adverse event did not require a visit to the Emergency Room or Physician Office. It was noted while she was in the doctors office but she has not had to go back for it. No prior vaccinations within 4 weeks.  Information on the lot/batch number has been requested.
has a bull's eye at the site of injection; warm; has a darker red circle to the border; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (has a bull's eye at the site of injection), VACCINATION SITE WARMTH (warm), PAIN (soreness) and VACCINATION SITE ERYTHEMA (has a darker red circle to the border) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN (soreness). On 23-Mar-2021, the patient experienced VACCINATION SITE VESICLES (has a bull's eye at the site of injection), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (has a darker red circle to the border). On 15-Mar-2021, PAIN (soreness) had resolved. At the time of the report, VACCINATION SITE VESICLES (has a bull's eye at the site of injection), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (has a darker red circle to the border) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use were reported as Birth control pills. No treatment information was reported.
I got the flu shot twice, and caught the flu twice, both times was extremely sick for over 2 weeks, then mildly sick for another week; I got the flu shot twice, and caught the flu twice, both times was extremely sick for over 2 weeks, then mildly sick for another week; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown demographics who caught the flu twice (influenza), both times was extremely sick (illness) for over 2 weeks, then mildly sick for another week after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient caught by flu twice (influenza), both times was extremely sick (illness) for over 2 weeks, then mildly sick for another week (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the events.  There will be no information on the batch number for this case.
INJECTION SITE RED /SWOLLEN/ITCHY /SMALL RASH GROWING INCH BY INCH; This spontaneous report received from a patient concerned a 40 year old female. 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site red /swollen/itchy /small rash/. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site red /swollen/itchy /small rash. This report was non-serious.
Reported Symptoms:  10028813:NAUSEA; 10037087:PRURITUS; 10047700:VOMITING;   Narrative:  Other Relevant HX: Patient called nurse 8/2/23 reporting: Pt is calling to report that since receiving the shingle vaccine on Friday he has had a stiff neck, muscle pain, vomiting and calmly skin. Pt states he is unable to hold down food or fluids  He did has toast today and has kept it in but unable to keep in fluids still. Pt states neck is stiff and locking up. Pt used ginger candy for nausea but it was not effective. Pt was advised to go to ER for eval and TX of s/s and to check for dehydration. Pt v/u. Pt did not say which ER would go to, he states the both are not good and the wait time will be 12 hours. Pt was given the ER notification number.   Patient went to outside facility ER. 8/3/23 the report sent over stated patient seen with: Rash and other Nonspecific Skin Eruption Nothing else follows. Other: NAUSEA AND VOMITING; PRURITUS
Patients mother called 2 days after vaccine was given....said patient had redness and swelling at injection site and also had a fever........told patient's mother to be seen by provider which she agreed.
8cm (W) x11cm (L) left upper arm with local erythema, tender to the touch with swelling.
Pt. received PNEUMOVAX 11/26/13 at around 10 AM. She notes that on same day in the PM the arm started to swell, get red and painful. Seen in the office at 10AM 11/27/13; findings are confirmed = adverse Rx to shot with cellulitis 20 cm x 17 cm.
B/P bottomed,  nausea,  vomiting,  extreme weakness,  loss of consciousness
Aug 5th 20 sec episode of stiffening/ eye rolling, consistent with seizure. Aug 12th 20 sec similar episode consistent with seizure.
Patient complained of sore swollen arm that began in the evening after he had the shot, ran a fever during the night and had chills. Does not know what his temperature was because he did not take it. The arm was still slightly red and swollen when he came in 9/27/2010. The swelling was where I gave the Pneumovax 23.
Muscle ache; Chills; Headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work; Left arm is too sore way it was administered; This is a spontaneous report from a contactable consumer who reported for himself. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as none. Concomitant medications were reported as none. On an unspecified date ("roughly" 6 hours after the vaccine was administered) the patient experienced "muscle ache", "chills", "headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work" and "left arm is too sore way it was administered". The patient reported that he called "because he took the COVID-19 vaccine last night and he had been having reactions from last time till this time" (as reported). The patient stated that there was no doctor that prescribed the medication, it was administered to him because he was a healthcare worker (certified nursing assistant). He stated that he had been having "muscle ache, chills and severe headache, the headache is so severe, the most disturbing one." He reported that one of the Tylenol doses was administered to him by the nurse that administered the vaccine. He reported that he took some Tylenol and ibuprofen but this time it was not helping. He stated that he received the vaccine about 24 hours ago and started to experience muscle ache, chills and severe headache roughly about 6 hours after the administration. He reported that "I could hang in, but it was getting too bad, my head wanted to fall off, so I am driving home now so I could not work." When the patient was asked about the vaccine dose and route he stated "I believe normal dose I believe, I cannot remember I cannot recap anything, but I know it was administered in my left arm, my left arm is too sore the way it was administered." He stated that he received the vaccination for prevention and to be on the safe side. The patient stated that he did lab work with his doctor a few months ago, probably around 6 or 7 months ago. The clinical outcome of the events "muscle ache", "chills", "headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work" were all not recovered/not resolved, while the clinical outcome of the event "left arm is too sore way it was administered" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Has not received 2nd dose, 68 days since first dose 7May2021; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Has not received 2nd dose, 68 days since first dose 7May2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Has not received 2nd dose, 68 days since first dose 7May2021). On 07-May-2021, INTENTIONAL PRODUCT USE ISSUE (Has not received 2nd dose, 68 days since first dose 7May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient stated not receiving the second dose due to personal reasons as he had to fly out of the country for 3 months.
Symptoms of narcolepsy diagnosed and treated over the next year. Stimulants prescribed (and eventually sedatives). Subsequently learned a Study abroad linked that year's vaccine to narcolepsy.
High level of fatigue.  Fatigue and extreme tiredness seems to have triggered PVCs.
12 hours after Td immunization. Broke out with red maculopapular around eyes and slight swelling of eyelids. Red splotches on cheeks. No muscle weakness. No paresthesia. No facial weakness. No dysphagia. Afebrile. Same reaction noted with amoxicillin
tested positive for covid on 12Jan, is asymptomatic, and tested negative after two days; tested positive for covid on 12Jan, is asymptomatic, and tested negative after two days; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first dose of the COVID vaccine on 30Dec2020 and was supposed to take the next dose on 20Jan2021. However he tested positive for COVID on 12Jan2021 and was asymptomatic, and tested negative after two days on 14Jan2021. He wanted to know if he can take the second dose even if he tested positive. The outcome of the event was recovered on 14Jan2021.   Information on the lot/ batch number has been requested.
The area on the arm around where the immunization was administered is red and looks swollen.  No infection seen.
Developed mild ringing in both ears and my hearing seems muffled.  Hoping it clears up.  Not sure if it is a reaction to the vaccine but the timing seems like it is.  I also had the regular low grade fever and lethargy that I generally get with these shots.  That went away after a day
have asthma; high B/P; This is a spontaneous report from a contactable other HCP (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced high B/P and had asthma on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. The outcome of all the events was unknown.  No follow up attempts are possible. Information about lot or batch number cannot be obtained.
This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. The patient was vaccinated with a dose of GARDASIL (lot # 672652/0022AE; expiry date 28-SEP-2014) on 15-OCT-2012. Route was unknown. No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient received GARDASIL that was improperly stored at 28 F for 8.5 hours. No adverse effect was reported. This is 1 of 2 cases from the same source (other case number 1210USA008284). Additional information has been requested.
At injection sites both times two different had large baseball size hard lump with bright red burning and some itching. One month after 2nd shot, was hiking a usual hike for me and had extreme shortness of breath. Took hours to get back to trail head. One month after that I was just going to sleep and had extreme jaw and chest pain with profuse sweating and nausea. Went to doc next day. Ekg was normal. Exactly one month after that while out of town, I woke up at 5:30 am with 4 different episodes of that same pain. Went to ER had complete work up except angiogram. All normal. Followed up with primary doc out of town. He and ER doc determined it was Prinzmetal Angina which will present as normal on tests. Still have not been able to get in to see a cardiologist due to a shortage of docs. Have had 3 more episodes with clusters of same symptoms in the middle of the night or very early morning with arrhythmia and jaw pain during the day. Have been to ER 3 times. Primary doc put me on Ranolazine 2x a day. Heading back home and will see my cardiologist Dr. then.
COVID infection (omicron) after the booster; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID infection (omicron) after the booster) in a patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID infection (omicron) after the booster). At the time of the report, COVID-19 (COVID infection (omicron) after the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter Company comment: This is a spontaneous case concerning unknown age and gender patient with no medical history reported, who experienced the non- serious unexpected, according, AESI of COVID-19. The event occurred after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning unknown age and gender patient with no medical history reported, who experienced the non- serious unexpected, according, AESI of COVID-19. The event occurred after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from an office manager via a company representative referring to 7 patients of unknown age and gender. No concurrent or historical conditions were provided. They were not pregnant. On unknown dates, the patients were vaccinated with ZOSTAVAX, dose was reported as "recommended dose", subcutaneously for prevention of shingles (lot# was L006382 and expiration date 25-MAY-2016, strength unknown). There was no concomitant medication reported. On unknown dates, the patients experienced swollen lump and redness at the injection site after receiving ZOSTAVAX. The patient sought medical attention via phone calls. The outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
PAIN IN MY RIGHT SHOULDER AFTER 2HRS. AND FEVER THE NEXT MORNING( 100.6)
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment for the event was not provided.