chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe allergic reaction; has a drop foot that felt rubbery; Dizziness; Dry mouth; This is a spontaneous report received from two contactable consumers (once is patient himself). A 79-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection and Lot Number: EN6208), via an unspecified route of administration in the left arm on 15MAR2021 15:15 (at the age of 79-years-old) at a single dose for COVID-19 immunization. Patient medical history included Diabetes ongoing, patient has had three heart attacks. The first was over 20 years ago. He is waiting to have a stress test prior to having an angioplasty and Heart condition ongoing. Concomitant medications were reported as none. Lab data includes patient had all kinds of testing at the emergency room, test results that he had at the emergency room were all negative. They checked his heart and did a CT scan on 15Mar2021. Patient received the first dose of the COVID-19 vaccine on 15Mar2021. He received the vaccine at 3:15 pm. Within a minute after getting the vaccine he was getting dizzy. He was monitored for 15 minutes. He thought the dizziness went along with it. On the way home the dizziness was really hard to explain. He has never gotten this dizzy. It took his whole head over. It wasn't a spinning dizziness. He is 79 years old and has a lot of physical problems. He has a drop foot on his good leg. When he got home his drop foot felt rubbery. It is not usually like this. He also had a dry mouth. The papers said this is under the severe allergic reaction. Patient's daughter called the doctor and was told to go to the emergency room. He had all kinds of testing at the emergency room. 3-4 hours later the dizziness dry mouth went away. His foot was back to normal. He is wondering about the second dose. He is asking if the second dose will be stronger than the first. Patient received first dose of vaccine on 15Mar2021 and experienced dizziness, he believes it was a severe allergic reaction. His symptoms subsided a few hours later. He has a history of diabetes and heart issues. Event has already been reported to Pfizer. Patient has a Nuclear cardiac stress test on 01Apr2021. His second dose is schedule for 06Ap2021. He would like to know is it safe to get second dose considering his side effects. Outcome of event (severe allergic reaction) was unknown and recovered on 15Mar2021.   No follow-up attempts are possible and no further information was provided
I had a loss of smell starting on 10/09/2022, my wife had me take a home COVID-19 test that came back positive. Until the test came back positive, I was unaware that I had COVID-19 as I was not feeling under the weather. Once I tested positive, it was the weekend my PCP office was not open, I went to the local urgent care. I was prescribed PAXLOVID that I started taking that evening and finished in the five days. I did get rebound COVID-19 on 10/24/2022.
CONTRACTED COVID DESPITE BEING FULLY VACCINATED AT TIME OF EXPOSURE AND PCR + TEST.  CURRENTLY ASYMPTOMATIC.  POSITIVE PCR TEST 8/12/21
Patient had immediate swelling/redness at injection site. By evening, she had redness down to elbow and intense itchiness. After taking BENADRYL every 4-6 hours, it is now only red/swollen at injection site and itching has resolved.
Site on left arm had redness, was tender and had hard knot underneath with heat associated with it.
With the first vaccine I had a strong hypoglycemic episode 30 hours after the injection.  The next day, about 24 hrs. later I became very dizzy but didn't develop shaking, diaphoresis, or black spots in my vision.  (I've had hypoglycemic episodes rarely, maybe every several years, but I know well what they feel like.  No further episodes since then.  I wasn't prepared for the episode and didn't have candy or orange juice handy.  It required I lay down for 10 minutes while I was very shaky and cold, clammy diaphoresis.  Pita Chips helped---I presume.    Yesterday I received the second dose and 29 hours later I started getting hypoglycemic again but quickly drank some concentrated sugary lime juice.  I remained slightly shaken but never developed black spots or diaphoresis.  I still felt too light and shaky so I had another half glass of juice and feel normal after about 10 minutes.   When I reported this, my daughter, who is an ER doctor, was doubtful the first time it was vaccine related because of the 30 hour gap.  Before receiving the second dose, the doctor there also didn't believe it was related for the same reason.  But I find it very odd now that after both vaccines, at around the 30 hour mark, I had the same effects.  Except for a slight migraine- like headache, no other real symptoms----maybe some lethargy.  I'm not diabetic, so I'm not on insulin or diabetic pills.  I take a lower dose of blood pressure meds and have well-controlled hypertension.  I can't even remember the last time (in years) I had hypoglycemia, but I've never had it as bad as I did the first time.  Since I caught it this time with the juice and stopped the symptoms, I don't know if it would have reached the level of the first dose of vaccine.
Patient presented in clinic today and started with fevers x 3 days. Because vaccine were given recently can be a concern for it to be related to vaccines.
First sign was throat swelling up. Went to drink water and wouldn't go down as normal. Backed up in throat and drained ever so slowly down my throat. Then fever hit hard at 104 degrees for 2 days, 103 for 2 days, 101 for 1 day........though fever would break a little and then go back up. Along with it....severe body aches especially along lower back, super parched mouth....so thirsty. Shivering. Nausea. Massive headache. Sweating through sheets for 5 days, dizziness. This is day 10 and only just starting to feel better though still a little difficult to swallow.
Information has been received from a third party claims administrator on behalf of a pharmacy, concerning a male customer (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date the patient was vaccinated with PNEUMOVAX 23 (total dosage, lot#, and route were unknown), (NOC #00006-4837-03). The third party claims administrator reported that the patient suffered an adverse reaction (NOS) to PNEUMOVAX 23 and was hospitalized for 36 days (onset date not provided). Treatment and outcome of the adverse reaction were not reported. Additional information has been requested.
Oval rash at vaccination site which appeared about nine days after the vaccination. Not painful, just red and slightly swollen.
Seven days after injection of first dose, had itchiness and white spots around the injection site.  The next day, the white dots had become scabs (I did NOT scratch then to make cuts; happened on its own, almost like poison ivy can). Scabs remained for about a week. No other adverse events or symptoms that I know of.
About 10 days after vaccination with VARIVAX she developed a generalized rash that developed into small blisters and than scabbed - 50-60 lesions.  No systemic symptoms.
I started with headache then got nausea and started running fever. Over 24 hr period I was constantly vomiting. I went to the hospital on Sunday stayed for 5 days.
day following vax pt woke up c/o sore rt arm, h/a, nausea, spiked temp to 103, vomiting p/Mylantin progresively got better;
pt started fever 3PM 16MAR95; had febrile sz 9PM 16MAR95; was hospitalized overnight & found to have ear infect; took amoxicillin from 16MAR95 to 26MAR95; 26MAR95 had rash & itching for approx 5 days; no signs of illness w/rash;
Severe reflux starting the day following the injection; continues to persist for several days requiring H2 blockers
Purple top COVID vaccine lot FD0809 was set to expire on Oct2021 on original labeling and then with extended expiration date Jan2022; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FD0809, Expiration Date: Oct2021) 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: PRODUCT EXPIRATION DATE ISSUE (non-serious), outcome "unknown", described as "Purple top COVID vaccine lot FD0809 was set to expire on Oct2021 on original labeling and then with extended expiration date Jan2022". Additional information; vaccine being given after expiration date. Purple top COVID vaccine lot FD0809 was set to expire on Oct2021 on original labeling and then with extended expiration date Jan2022. It was held at ultra-cold temperature, then taken out and refrigerated one week. The vaccines were given Apr1-5. Could you please tell us if there is any additional stability testing done to extend the expiration date of the product Outbound call back at 2:31 PM  The patient stated this was reported to her from another pharmacist and that 50 people total were administered the vaccines. She does not have any further details regarding patient information/demographics. Agent e-transmitting as AE, patient declined warm transfer to agent stating she didn't have any additional information. can you give us any guidance on re-vaccination for the patients who received the expired vaccine. Response: This is to confirm receipt of inquiry. Please note this case as INT-00620080. Agent will follow-up with the customer. Kind Regards,  No follow-up attempts are possible, No further information is expected.
SHOTS WERE GIVEN AT SCHOOL. SYNCOPAL EPISODE OBSERVED 30 MINUTES BY SCHOOL NURSE. MOM TOOK TO ER.
I experienced sudden heart palpitations.  I was at work and had not been doing any sort of strenuous exercises.  My watch recorded a heart rate of 210 bpm.  After about 20 minutes, heart rate did not decrease and my co-workers called 911.  Once the paramedics arrived and I was in the ambulance I was given 6 mg of Adenosine intravenously, which did not bring my heart rate down.  After a second administration  of 12 mg adenosine, heart rate decreased to about 130 bpm.  I was hospitalized that evening.
Cold chills; Body ache especially button; Lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old 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 21Apr2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Mar2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not receive other vaccine within four weeks prior to the vaccination. On 22Apr2021 at 00:00 the patient experienced cold chills, body ache especially button and lower back pain. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold chills, body ache especially button and lower back pain was unknown at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
lost the appetite; the arm was hurting at the vaccination site; shivers; Back ache; head aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost the appetite), VACCINATION SITE PAIN (the arm was hurting at the vaccination site), CHILLS (shivers) and HEADACHE (head aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterol.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DECREASED APPETITE (lost the appetite), VACCINATION SITE PAIN (the arm was hurting at the vaccination site), CHILLS (shivers) and HEADACHE (head aches). At the time of the report, DECREASED APPETITE (lost the appetite), VACCINATION SITE PAIN (the arm was hurting at the vaccination site), CHILLS (shivers) and HEADACHE (head aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were reported included medications for diabetes and cholesterol   No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up was received Reporter mentioned patient is fine now, outcome updated. No further FU required.
Headache, myalgias, fever, chills for 24 hours, starting 18 hours after vaccination
I had a flu vaccine 9/8/20 at 3pm at the Center RX Alfuria Quad 2020-2021 vial 33332-0420-10 Sequirus, Inc. Qty.5 I went into afib 9/8/20 at 10pm which didn't stop until I took flecainide and diltiazem at 2am. I was diagnose with sleep apnea which caused afib for the first time last October 30, 2019. Since diagnosed and on a CPAP haven't had an afib episode since January 2020.
Patient had usual post vaccination myalgias and lethargy for a few days after injection.  These resolved spontaneously.  However, about a week after vaccination he developed recurrent fevers 102°F.  He also had complaints of body aches and bilateral jaw pain.  He had extensive evaluation including laboratory testing for infectious etiologies of his fever and none was identified.  He was noted to have very high sed rate and CRP.  When no specific etiology for his fevers could be identified we decided to proceed with a short course of prednisone which did seem to help his fever and jaw pain.  After prednisone was stopped he had recurrence of fever and developed worse jaw pain and pain at the base of his neck. I examined him in clinic and found that he had a tender swollen thyroid.  I directed him to the emergency department where CT scanning of his neck confirmed evidence of thyroiditis.  TSH was undetectable and free T4 was about 2 times higher than normal.  He was diagnosed with subacute thyroiditis.  However, his symptomatology seemed quite dramatic for subacute thyroiditis, and the timing in relation to his vaccination is concerning for possible adverse vaccine reaction.
Patient received Moderna initial vaccine instead of the expected Moderna Bivalent booster shot. No adverse reaction reported.
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 05-JUN-2015, the female patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 24-JAN-2017, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
WEIRD HEADACHES/COMPLICATED MENSTRUAL HEADACHE/HEADACHE BEHIND EYES; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included complicated menstrual migraine, and knee surgery, and other pre-existing medical conditions included no blood thinners, no clotting issues, been pregnant 13 times.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included ketorolac tromethamine for weird headaches/complicated menstrual headache/headache behind eyes, and naproxen for weird headaches/complicated menstrual headache/headache behind eyes. On 28-DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE (units unspecified). On 15-APR-2021, the subject experienced weird headaches/complicated menstrual headache/headache behind eyes. On 16-APR-2021, Laboratory data included: CT scan (NR: not provided) Normal, no blood clots or tumors., Complete blood count (NR: not provided) platelets were normal. (units unspecified), and Scan with contrast (NR: not provided) Normal, no blood clots or tumors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weird headaches/complicated menstrual headache/headache behind eyes. This report was non-serious.; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s ,complicated menstrual headache, Medical assessment comment not required as per standard procedure as case assessed as non serious .
Severe swelling (5 inches diameter) around injection site. Getting bigger over last two days. Patient going to walk in clinic 11/9/13.
Pt rcvd a 0.2 mL volume injection of Moderna vaccine (blue cap for 6 months-5years) when it should have been 0.25 mL. Clinic noticed error, notified parents of patients, advised of current CDC recommendation for this error, and changed clinic practice to prevent future errors.
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
I woke up to pee after sleeping fir several hours and felt dizzy. I went to get a sip of water and fainted en route. I came to and remained dizzy for a bit (10-15 min) and eventually fell asleep again. I probably had a mild fever and also aches and headache. I felt significantly better by 4/24 at 10 (though I did take Tylenol at this time).
Runny nose; Cough; Fever; This is a spontaneous report from a contactable consumer or other non-health professional. A 63-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EW0185)), dose 1 via an unspecified route of administration on 12Jul2021 (age at the time of vaccination was 63-year-old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, on the fifth day patient started having runny nose, fever and cough. Patient was trying to report a side effect and was not sure it was side effect or something else, but patient have runny nose, and cough and it has been 2 weeks since patient got the first dose of Pfizer. 26Jul2021 (Today), so it was 7 days. The patient informed about the role of Pfizer drug safety department and confirmed it was the Pfizer Covid19 vaccine. The patient was informed that Pfizer has a legal and ethical responsibility to report every problem to . Also, we maintain accurate safety profile of the drug which ultimately helps others using this product. When informed about Pfizer medical information department for the concern, consumer stated, "I should call them because it was impossible to talk. You are breaking up a lot. The fever went away in 3 days and runny nose and coughing was continues. Patient asked whether it was normal or should go and test for COVID-19. Maybe patient was not affected and if it was so where will they go, should go to any clinic or pharmacy or what was the procedure. The outcome of the event fever was recovered on an unspecified date in 2021, while all other events were not recovered.  Follow-up attempts completed. No further information expected.
Information has been received from a pharmacy student concerning a patient who was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient developed fevers. At the time of the report the patient outcome was unknown. Additional information has been requested.
Video showing individual in mid-twenties over holiday getting handed presents outside from balcony since they have Covid.Do not know vaccine status of individual - reporting out of caution. Sourc; Video showing individual in mid-twenties over holiday getting handed presents outside from balcony since they have Covid.Do not know vaccine status of individual - reporting out of caution. Sourc; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown; Solution for injection) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Video showing individual in mid-twenties over holiday getting handed presents outside from balcony since they have Covid.Do not know vaccine status of individual - reporting out of caution. Sourc".  No follow-up attempts are possible, No further information is expected.
01/14/22 presents to ED for "dyspnea". PMHx of "DM II, HTN, ESRD s/p renal transplant 2018"
My arm was sore for 2 days after I received the shot, then it got completely better. However, 9 days after receiving my shot, my arm got sore again in the exact same place I'd had the injection. I had not done any lifting or exercise in the few days preceding the second onset of injection site soreness. It's been sore for 2 days again so far.