chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Head was spinning light headed within one hour; Head was spinning light headed within one hour; Then as I drove home altitude 5300 foot elevation I was drunk without the alcohole; stumbling; coordination was way off, impaired; I had brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 15:15 as dose 4 (booster), single (Lot number: GJ3275) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart deviated septum," (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 Immunization; Bnt162b2 (DOSE 3, SINGLE; Lot number: Fh8028; Anatomical location: left arm), for Covid-19 Immunization. The following information was reported: VERTIGO (non-serious), DIZZINESS (non-serious) all with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022) and all described as "Head was spinning light headed within one hour"; FEELING ABNORMAL (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "I had brain fog"; FEELING DRUNK (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "Then as I drove home altitude 5300 foot elevation I was drunk without the alcohole"; COORDINATION ABNORMAL (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "coordination was way off, impaired"; GAIT DISTURBANCE (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "stumbling". Therapeutic measures were not taken as a result of vertigo, dizziness, feeling drunk, gait disturbance, coordination abnormal, feeling abnormal.  Additional information: Head was spinning light headed within one hour. Then as he drove home altitude 5300 foot elevation he was drunk without the alcohol stumbling coordination was way off, impaired and he had brain fog. Nothing made sense of his symptoms from the vaccine. No made sense of his symptoms from the vaccine. No other symptoms, lasted 24 hours. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medications within 2 weeks. The patient's known allergies were reported as none. AEs did not result in physician office visit or emergency room visit.
pt recv vax & 11JUN96 pt exp swelling of the throat, swelling of the mouth, hives/itching;pt taken to ER;
Malaise, fatigue, injection site pain, intestinal distress in the form of constantly feeling like I need to have a bowel movement or am having gas but not really needing necessarily to do either.
Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
MY APPT FOR MY VACCINE WAS 2:15PM BUT IT WAS LATER THAN THAT WHEN THE LADY ATTEMPTED TO GIVE ME THE INJECTION.  SHE TOOK THE NEEDLE AND PRICKED MY ARM DOWN BELOW THE MUSCLE AND  THREW THE NEEDLE AWAY.  I COULD SEE THE LIQUID COMING FROM THE NEEDLE ABOUT TO DROP TO THE FLOOR.  SHE NEVER STUCK THE NEEDLE INTO MY ARM NOR MY MUSCLE, THEREFORE THERE WAS NO INJECTION.  I DID NOT GET VACCINE BUT IT DOCCUMENTED THAT I DID.
no adverse event; an expired, administered vaccine; This spontaneous report was received from a nurse referring to a 19 months old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 14-DEC-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (0.5 milliliter, once, lot # S032055 with expiration date 09-NOV-2020; route was not reported) for prophylaxis (expired product administered). The dose was supported by post-expiry memo and had not undergone a temperature excursion. No additional adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
patient received DAPTACEL instead of ADACEL/no adverse event; DAPTACEL was given to 70 years elderly male patient/no adverse event; Initial information was received on 16-Sep-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via Medical Information (Reference number- 00773106).  This case is linked to case 2021SA309592(CLUSTER).  This case involves a 70 years old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.    On 10-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5687AA and expiry date: 09-DEC-2021) via an intramuscular route in the deltoid nos for prophylactic vaccination.  It was of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day)  At the time of reporting, no adverse event reported.  It was reported "caller asks if the patient's should be injected with Adacel now, or if the Daptacel was sufficient."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Right deltoid area swelling, redness, warmth, tenderness, site of vaccination having purulent drainage per mothers report.  Patient sent to ER/Urgent Care.
After the two weeks of getting the second dose of Pfizer vaccine, heart palpitation has been irregular. It's continuously  pounding and does not stay at a normal heart rate; rapid heartbeat. The highest heart rate I tracked was 180 bpm. It's difficult to breathe because of tightness in chest and pain when inhaling or exhaling. When I lay down there is more pressure in the heart an chest. I feel fatigue, body ache in joints and muscles. I feel dizzy and lightheaded throughout the day. There is also numbness and tingling sensation in my right foot which reaches to my leg.  Numbness in my right hand which goes up to my arm as well.
generalized muscle pain; tenderness at injection site; fever; Pain at injection site; headache; Generalized join pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (generalized muscle pain), INJECTION SITE PAIN (tenderness at injection site), PYREXIA (fever), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoma. Concomitant products included APOAEQUORIN, COLECALCIFEROL (PREVAGEN [APOAEQUORIN;COLECALCIFEROL]), PHENYTOIN SODIUM (DILANTIN D.A.), LISINOPRIL, MELOXICAM, OMEPRAZOLE, AMLODIPINE, PRAVASTATIN, APREMILAST (OTEZLA), ONDANSETRON, CALCIPOTRIENE, MECLIZINE HCL and CITALOPRAM.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Apr-2021, the patient experienced MYALGIA (generalized muscle pain), INJECTION SITE PAIN (tenderness at injection site), PYREXIA (fever), INJECTION SITE PAIN (Pain at injection site), HEADACHE (headache) and ARTHRALGIA (Generalized join pain). At the time of the report, MYALGIA (generalized muscle pain), INJECTION SITE PAIN (tenderness at injection site), PYREXIA (fever), INJECTION SITE PAIN (Pain at injection site), HEADACHE (headache) and ARTHRALGIA (Generalized join pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient continues to have pain and difficulty in motion of arm. Range of motion is effected. Having pain at night and intermittently on motion.
The patient passed out (Syncope) for less than 5 minutes after administration of the shot.
This case was reported by a other health professional and described the occurrence of swollen arm at the injection site in a 44-year-old male patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. Concurrent medical conditions included allergy (to mushrooms). On 27th October 2014, the patient received the 1st dose of FLULAVAL (intramuscular). In October 2014, less than a week after receiving FLULAVAL, the patient experienced swollen arm at the injection site and warm arm at the injection site. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the swollen arm at the injection site and warm arm at the injection site were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the swollen arm at the injection site and warm arm at the injection site to be probably related to FLULAVAL. It was unknown if the reporter considered the pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November 2014: This is one of the 5 cases reported by the same reporter for the same vaccine (with the same lot number).
Received a dose on day 30 after the expiration time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) 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.   No concomitant and treatment information was reported.
got the shot to protect myself from Shingles and landed up with them within 7 days; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingles vaccine and landed with Shingles within 7 days.
I got a second Covid shot Pfizer this morning; I just had a nose bleed out of nowhere; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received  second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown [LOT#: Consumer stated, "ER873 I think it's a 5 or an S, it might be an S (Further not clarified)] via an unspecified route of administration on 27Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that patient got a second Covid shot Pfizer this morning on 27Apr2021, and patient just had a nosebleed out of nowhere since about 2 or 3 hours ago they got the shot on 27Apr2021, patient just was wondering if that has anything to do with shot, they just want to get some information. Seriousness of the event was non serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore Arm; This is a spontaneous report from a contactable consumer (patient's husband). A 65-years-old female patient (reporter's wife) received first dose of BNT162B2 (COMIRNATY VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Batch/Lot Number: EN5318) as dose 1, single and received second dose of BNT162B2 (COMIRNATY VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EN6203) as dose 2, single for covid-19 immunization (at the age of 65-years-old). Medical history included ongoing rheumatoid arthritis (diagnosed about 26 years ago). Concomitant medication(s) included adalimumab (HUMIRA) taken for rheumatoid arthritis from 2004 and ongoing. Reporter called on behalf of his wife and stated that after receiving the first dose of vaccine on 04Feb2021 the patient experienced sore arm and stated that she experienced the same after receiving second dose of vaccine as well which received on 26Feb2021. The patient had no reactions to the vaccine except soreness in the arm that started the same day and was gone by the next day. The patient did not receive any treatment for the event. The outcome of the events was recovered initially on 05Feb2021 and later on 27Feb2021.  No follow-up attempts are needed. No further information is expected.
Passed out twice on the 2nd day after vaccination; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 14-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Jun2021 (at the age of 14-year-old) as an unknown, single dose for COVID-19 immunisation. The patient's medical history was reported as none. No known allergies were reported. There were no concomitant medications or other medication within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 since the vaccination. It was reported that, on 08Jun2021, the patient passed out twice on the 2nd day after vaccination. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the event. The outcome of the event was reported as resolved on an unspecified date in Jun2021.  Information on the lot/ batch number has been requested.
She was waiting the advised 15 minutes and passed out. Rapid heart rate with fluttering eyes - unsure if it was seizure. after about 5 minutes she came to and started complaining of being cold with chills .
One dose (0.5ml) of Janssen COVID-19 vaccine lot #203A21A  with expiry date of 09/21/21 was administered to the patient on 09/22/21.
The next day after receiving the vaccine, I started having joint and muscle pain in my arms and legs. They lasted about three or four weeks. I took ibuprofen to help with the pain.
Erythema of the L/arm & hives on his feet & face. Admin Benadryl 12.5 mg. & kept pt for 1 1/2 hrs & discharged. Pt was fine.
Administration of expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) 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 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Information has been received from a physician concerning a female who was vaccinated on an unspecified date with Gardasil (lot# not reported). Subsequently the patient experienced a panic attack after receiving the vaccine. The patient sought unspecified medical attention and her outcome was not provided. Additional information has been requested.
Pt started the Vivotif 1 capsule po every other day x 4 doses regimen on 2/1/2016.  On 2/4/2016 he noticed that he had a headache, at that time he did not attribute it to the Vivotif.  The following day, on 2/5/2016 he took the third dose.  On 2/6/2016 he noticed a rash on hands and feet with pruritis.  Rash spread centrifigully but only with itching on palms and soles of feet.  Also had an episode of diarrhea overnight with brown stool and became lightheaded.  Endorses some neck stiffness which began 2 days on 2/4/2016, in addition to the headache as previously mentioned.  Endorses chills without fever.  He has hx of urinary urgency over last 3-4 months, but 24 hours prior to admission became more urgent.  Upon presentation to the emergency room patient was hypotensive 77/54 mmHg, HR 74, RR 16, Temp 36.4C. SpO2 98% on room air.  Rash described by MD as involving his hands and feet, both palms and soles, face, trunk and extremities, erythematous, not urticarial and does blanch.  Anaphylaxis vs septic shock.  Given IV fluid bolus 30 ml/kg and blood pressure improved.  Given methylprednisolone as pt complained of throat tightening. Also give IM epinephrine which helped with throat tightening. Rash defervesced.
sore arm; feeling sicker; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Arexvy and MODERNA COVID VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm) and feeling unwell (Verbatim: feeling sicker). The outcome of the pain in arm and feeling unwell were resolving.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Arexvy.     It was unknown if the company considered the pain in arm and feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-NOV-2023 The pharmacist reported that when Arexvy was co-administered with Moderna Covid vaccine, patients were reporting sore arm and feeling sicker.  This was occurring with the patients that reported not usually having any reactions with vaccines.  However, patients usually felt better after a few days. It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Moderna covid vaccine. The reporter did not consent to follow up.
woke the AM p/vax given w/rash on trunk & inner aspects of knees & elbows;rash appeared symmetric;small vesicles, single on trunk & clustered on knees, elbows;looks like heat rash;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 22Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RITALIN [METHYLPHENIDATE HYDROCHLORIDE]. Past drug history included: Azithromycin, reaction(s): "Allergy", notes: known allergies: Azithromycin and Claritin; Claritin, reaction(s): "Allergy", notes: known allergies: Azithromycin and Claritin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19 which included Paxlovid.
COVID breakthrough. Patient presented to the emergency dept on 9/25 after feeling dizzy and falling. He has been feeling dizzy for a couple days. COVID+ on 9/25/22.
Patient received vaccine booster on 11/11/21 then next day developed left lower extremity swelling and pain which has increased and then progressed to dyspnea on exertion and intermittent chest pain. Patient symptoms were so severe than he had to be admitted to the hospital on 11/14/21, was started on heparin infusion and then transitioned over to Eliquis. At time of discharge on 11/16/21 but continued to have persistent lower extremity swelling, pain and intermittent chest pain.
Fever up to 100.5F, strong chills, muscle and joint aches in the arms, sensitive skin for two days. Starting the third day after vaccination: redness and warm feeling at injection site that extended for 3x5in for 8 days, tired and sleepy. These symptoms lasted for another 8 days.
After the first dose,  about 36 hours later I had severe vomiting followed by intense chest pains. About three months later it was determined by cardiologists that I had suffered an SMI at that time and hadn't realized it. It was also determined that I was 80 - 90% blocked in the main artery which likely was  the culprit and two stents were implanted. I have no idea (nor do the doctors) if the vaccination was in any way related to the cardiac event, but I felt completed to report it due to the closeness in timing. I am currently on different medications and cardiac rehab therapy.
CLINICAL IMPRESSION 1. COVID-19 virus infection  2. Acute kidney injury  3. Hyperkalemia  4. Non-intractable vomiting with nausea, unspecified vomiting type  5. Dehydration  6. Hyponatremia
High pitch cry x 45 minutes unable to soothe child. TYLENOL (little fevers) given by mom, cool soaks to injection sites.