chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted (vasovagal syncope) after receiving the Covid 19 vaccine.  Store leadership stated patient hit his head when he fainted and therefore 911 was called.  Patient was unconscious for about 30 seconds, but quickly became conscious again.  He was given water and propped up.  Paramedics came and took his vitals and determined he was ok.  Patient stayed at pharmacy for 30 minutes following vaccination.  Patient then left with his mother.  Pharmacist in charge called patient the following day to make sure patient was doing ok and mother stated he is completely fine.
This spontaneous prospective pregnancy report as received from a patient's father refers to a 14 year old female patient with allergy to amoxicillin and with no pertinent medical history. On 17-MAR-2015 the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Other suspect therapies given on the same day included VARIVAX (Merck) (dose, route and lot number were not reported), hepatitis A virus vaccine (manufacturer unknown) (dose, route and lot number were not reported) and meningococcal vaccine (dose, route and lot number were not reported). During those vaccinations the patient was pregnant. The LMP and EDD is not known. The pregnancy outcome was pending. The patient's father stated that the patient's pregnancy was confirmed on 08-APR-2015 (office visit). Lab diagnostic studies included pregnancy test (urine and blood) and sonogram. The patient's father reported that the patient would not receive the two subsequent doses of GARDASIL. Additional information has been requested.
Red rash changing to blisters w/i 24 hour of vaccine administration started on back of neck, (L) side of neck, then (B) arms below elbows only. Takes a couple of weeks to resolve, (+) itching. Occured after 1st & 2nd doses of TWINRIX, but didn't report it. Increased rxn after each shot. Has used hydrocortisone prior. Prednisone 5d now.
10 days after injection red area 3"/2" appeared near area of injection, itchy ,, slightly swollen, sore to touch .. enlarged area over next 2 days and currently active.  topical hydrocortisone, oral cephaphlexin started on day 1, Benadryl gel cap taken first day with no improvement. rash less defined after 2 days but still spreading slowly.
Pt called pharmacy on phone 2/15/21 @ 1215pm 1) Rec'd vaccine 2/12/21 @ 145pm 2) Started feeling bilateral "stiff, achy legs"        on SAT 2/13/21 continuing until        today 2/15/21 (had to call out from work) 3) Advised APAP/call MD for direction
ran a slight fever; Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (ran a slight fever) and EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     The patient had no known allergies. The patient had no acute illnesses at the time of vaccination and upto one month before and no chronic or long standing health conditions. The patient had never been tested positive or been diagnosed with COVID-19. It was reported that the patient received other vaccines 4 weeks prior to Moderna Covid-19 vaccine.  Previously administered products included for Product used for unknown indication: Tdap and Hepatitis B (booster). Past adverse reactions to the above products included No adverse event with Hepatitis B and Tdap.    On 19-May-2023 at 2:30 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023). On 20-May-2023, the patient experienced PYREXIA (ran a slight fever). On 20-May-2023, PYREXIA (ran a slight fever) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   On 19-May-2023 at 2:30 PM, the patient received booster dose of Moderna Covid-19 vaccine.  In the left deltoid, the patient had no soreness.  Concomitant medication information was not provided.  It was reported that the dose was given to the patient after the published expiration date.  The published expiration date of the vaccine was 16-May-2023. No adverse effects were felt by the patient except the fact that the patient felt slight fever in A.M hours of 20-May-2023. The patient felt fine later on that day.  No additional doses, medications, or treatments were provided to the patient.   This case was linked to MOD-2023-725968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2023: Follow-up received include Patient details (Ethnic, race, height, weight) added, suspect Product (Spikevax Bivalent) dose details updated, event Pyrexia added.
Hives; itchy rash on her upper arm of the injection site; rash across her shoulder and both her chest and back and bottom of neck/it spread across her shoulder to right side of her chest, neck and upper right part of her back.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, exp date not reported), via an unspecified route of administration (anatomical location: arm right) on 21Jan2021 10:45 given to protect against the virus (COVID-19 immunisation). Vaccination Facility Type: Hospital. Vaccine was not administered at military facility. Medical history included immediate, severe allergic reaction penicillin when she was a kid and she hadn't had it since. The patient had no other medical history and family medical history relevant to adverse event. The patient's concomitant medications were not reported. Patient had no other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The patient was looking for guidance about getting the second dose of the Pfizer Covid vaccine. Had the first dose on 21Jan2021 (Thursday) and had no reaction until 24Jan2021, 3 days later (Sunday). That night she developed what she believed waas hives, an itchy rash on her upper arm of the injection site that spread across her shoulder and both her chest and back and there was also a rash at the bottom of her neck. The hives were still there the day of reporting and been there since.  Patient heard that when you have a severe allergic reaction to medicines in past it could be an indication. States she was not seen at the emergency room or at the doctor's office, she only called the doctor's office. They recommended her not to get the second dose, but she wanted to be sure and wanted more information. Relevant tests were not done. Patient would like to know if she should get the second dose of the covid vaccine after the reaction she experienced post 1st dose. The outcome of events was not recovered (ongoing).
1st COVID Vaccine given on 2/13/2021 and 30 minutes after receiving burning , tingling, and then numbness in left side of face and lips. As of 2/20/2021 I still have numbness in the left cheek. I spoke to a doctor and they had no advice to give me because she said that the drug is new.
Pt was given shot by immunizing technician.  And then sat down by her parent in the waiting area.  Immunizing tech came and got me since parent was worried.  Pt briefly passed out. By the time I got out into the waiting area pt had already woken up.  Pt felt hot got her water and checked blood pressure and pule all within normal range.  Stayed with pt who after a few minutes said was feeling better. Did not call 911 due to quick recovery.  Pt was kept for observation for an additional 20 minutes.  Saw further improvement and pt continued to say she feels a lot better.  Told pt and mother (mother did not speak English) that they should contact primary care provider about the event and further discuss if she should receive second dose or not.  Due to quick recovery, believe patient most likely was nervous and worked herself up before getting the vaccination causing her to pass out.
Vaccine Thursday. Reaction noted Fri PM - erythema, edema, induration. Mom an LVN, gave MOTRIN & TYLENOL as syx persisted thru Sunday. Today no pain - mild erythema diffuse with .5cm induration.
Hard at injection site; Swollen at injection site; Red at injection site; Rash at injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE SWELLING (Swollen at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE RASH (Rash at injection site) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE SWELLING (Swollen at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE RASH (Rash at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE SWELLING (Swollen at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were provided as High blood pressure; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
BROKE OUT IN HIVES; This spontaneous report received from a parent concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 01-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 01-APR-2021, the subject experienced broke out in hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from broke out in hives on 01-APR-2021. This report was non-serious.
Abd pain off and on since 3 21 17, HA frontal fever-warm to touch, sore tht, reg strep culture, Dx. Sinusitis 3-27-17.
Drug Interaction; tested positive for Covid-19/Received 1st adult Pfizer Covid-19 Vaccine on 19Nov2021 and tested positive to Covid two days later; jitters in the body/Experiencing like severe jatter in whole body; rapid heart rate/I am not cold and I have no fever, not cold with rapid heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: EW0191) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 22Nov2021, outcome "unknown", described as "tested positive for Covid-19/Received 1st adult Pfizer Covid-19 Vaccine on 19Nov2021 and tested positive to Covid two days later"; DRUG INTERACTION (non-serious), outcome "unknown", described as "Drug Interaction"; FEELING JITTERY (non-serious) with onset Nov2021, outcome "unknown", described as "jitters in the body/Experiencing like severe jatter in whole body"; HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "rapid heart rate/I am not cold and I have no fever, not cold with rapid heart rate". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) rapid heart rate; (Nov2021) increased; sars-cov-2 test: (22Nov2021) positive, notes: she tested positive to Covid on 22Nov2021. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient took her first dose of the Pfizer BioNTech Covid-19 vaccine and two days later patient tested positive for Covid-19. Patient states on 24Nov2021 she received an infusion of two products being bamlanivimab and etesevimab for treatment. After the infusion, patient experience severe jitters in the whole body and a rapid heart rate. Patient stated that she was not cold and she had no fever, not cold with rapid heart rate. Patient also takes cholesterol medication (atorvastatin) and D-tab blocker (lisinopril). Patient would like to know if the jitter in her body and the rapid heart rate were caused by the infusion or the Covid-19 vaccine she received and if there is any drug interaction with atorvastatin, lisinopril and the Covid-19 vaccine. She also wanted to know if there be any chance that might be causing her jatter because it seems like every time, she took that and she got jatter, or possible the Infusion as well. Patient states that due to the infusion she received on 24Nov2021, she was advised to wait 90 days to receive her second dose.   No follow-up attempts are possible. No further information is expected.
at immediate time of vaccine felt a tingling down left arm where he got the vaccine.  then it stopped--has not had any further tingling on arm.  since then, he states has felt tingling on the left ankle 2-3x per hour.  As of 3-30-21 states the tingling has moved to his Left calf. same frequency of sensation. also generally states he feels a bit weird.  these symptoms started since the vaccine and have not hindered his normal activities.
After the second vaccine my arm swelled up, turned red and became hot to the touch. I took some allergy medicine to help out, helped some but not much. A couple days later a rash appeared near the injection site, very red, itchy, hot to the touch, was also very sore. This reaction lasted for about 3 days before it went away
5 days after administration of Varivax, pt developed urticaria (diffuse, without associated respiratory symptoms). Treated with diptenhydramine.
23 minutes after administration of flu vaccine, patient had an anaphylaxis reaction. Airward closed up and patient couldn't breathe. Administered one 0.3mg EpiPen which seemed to help, but then 3 minutes later airway started to close. Administered another 0.3mg EpiPen and that opened up her airways again. Had patient using ice packs as she stated she felt hot. Pt was alert. Vitals were taken periodically throughout. Pt stated her throat was feeling itchy again. Provider ordered 1ml of 50mg/ml Benadryl to be given IM. Administered it and continued to monitor patient. After 30 minutes patients stated that she was feeling better. Vitals were in normal range, just an elevated pulse. Had patient sit up for 10 minutes and then tried to stand her up to sit in a reclining chair. 5 minutes later airways began to close and another Epi pen 0.3mg had to be administered. Airways opened. Provider then inserted an IV it left arm and started a NS drip. In the IV they administered long dose steroid and another 25mg of Benadryl as patient started to report feeling itchy after steroid was given.   Provider also ended up administering lorazepam 2mg/ml via IV. Throughout this, patient refused to be taken to ER. She was monitored for 4 hours prior to being sent home with brother with strict instructions from provider on when/if to go to the hospital. Patient was sent home with Epi pens and oxygen just in case.
Information has been received from a registered nurse concerning a female patient, and employee, who was vaccinated on unspecified dates, with two doses of varicella virus vaccine live and did not seroconvert. There was no product quality complaint reported. The sought unspecified medical attention. Additional information has been requested.
rash and swollen left armpit. Armpit slightly painful. Injection site sore, chills and fever for one night.
day after vax pt exp papular rash on la, one on her neck and one under chest. looked like chickenpox rash. m.d. thought it might be a zoster rash
The patient was waiting the regular 15 min after vaccination and with 10-12 minutes I heard a big sound . I ran and out site the Pharmacy Department and the patient was just getting up from the floor after a fainting  episode.      The patient was sweating perfusely and he was very pale and very warm to the touch.
Fatigue resolved by rest lasted about 24 hours Tenderness at site of injection resolved in about 48 hours
rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200023743 same drug /event, different patient.;
PT C/O MALAISE SWELLING AND RASH OF LEFT ARM AND FEVER AFTER RECEIVING THE VACCINES ON 2/8/07. WHEN SHE CAME INTO THE OFFICE THE DOCTOR DID NOT OBSERVE SWELLING AND RASH OF LEFT ARM. PT REPORTS MALISE AND SOB
Patient at the time of the event was 12 years of age. Patient received the pediatric dose of Pfizer which was 0.2 ml. Patient should have received the 12 year and older dose of Pfizer which is 0.3 ml. No adverse events, treatment and or outcome noted at the time of event and or after. No signs or symptoms noted at the time of event and or after. No further instructions and or orders noted per facility.
Received a single dose in February 2020. Does the patient need to restart the series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not received second dose of Shingrix which led to incomplete course of vaccination. The reporter asked if the patient need to restart the series. No further details provided via web form. The reporter consented to follow up.
First 24 hours were ok - some fatigue and sore arm.  Around 5 pm on 4/3/21 started intense body aches, chills, fever (101 F), nausea, vomiting. Afternoon of 4/4/21 continued with low grade fever (98-99 F) and mild.  6 am on 4/5/21 had allergic reaction on the left cheek. Hot red, swollen, itchy, and hives. Left ear swollen as well. Not hives or reaction anywhere else on the body. Began Benadryl, Zyrtec, and Methylprednisolone steroid pack with doctor's guidance. Swelling resolved by day 5 (4/9). On 4/8 woke up hot, tingly, hot feeling in ears and back of throat. Some numbness in limbs later. Attributing this to a panic attack.
Hearing is distorted after getting vaccinated/having trouble hearing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Hearing is distorted after getting vaccinated/having trouble hearing) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced HYPOACUSIS (Hearing is distorted after getting vaccinated/having trouble hearing). At the time of the report, HYPOACUSIS (Hearing is distorted after getting vaccinated/having trouble hearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Concomitant product use was not provided.
A spontaneous report has been received from a health professional concerned a female patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. The patient had been receiving FLUMIST Quadrivalent (intranasal) started on an unknown date. Doctor explained she thought the first dose was expired, then later found it was not expired after administering the second dose. The action taken of the FLUMIST Quadrivalent was unknown. The outcome of the event of overdose was unknown. The company physician assessed the event of thrush to be non-serious.
At injection site, patient bled more than she says is usual for her.   Pressure was applied for approximately one minute and bleeding from site stopped before patient left the chair.
Case PHEH2016US023441 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 35 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN, batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
fever, I was shaking like I was freezing, I took aspirin and covered up with a heavy blanket. I fell asleep and woke up every few hours. I took aspirin at 8 am, I felt like I needed to pee, when I tried it, it hurt too much so I tried not to. I drank glasses of water, but I was still not able to pee more than a little.
After receiving immunizations, family had left and headed to their car - child then complained of breathing problems and itching.  Child also complained of his feet burning.  Mom brought them back to clinic.
pt recv vax 18DEC95 & 19DEC95 exp redness & swelling of lt hand & tingling sensation of lt fingers;20DEC95 exp numbness of   lt fingers;beginning FEB96 exp swelling of hands & atrophy of space between thumb & index finger;to ER;face swell;
Son called reporting patients are was warm, red and swollen around injection site and down arm. No fever reported.