chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle soreness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle soreness). At the time of the report, MYALGIA (muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Vomiting and diarrhea. Emesis x 4 (projectile) with hypoactive bowel sounds for 1 - 2 days then diarrhea.
Left thigh with 4 cm redness and warmth.  No fever. Rx: BENADRYL x 1 dose.
A report has been received from a Pharmacist concerning a 65 year old, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The reporter mentioned that he inadvertently administered FLUMIST to 65 year old. The outcome of the event of inadvertent administration to 65 yr old is unknown. The report was considered to be non-serious.
Information has been received from a registered nurse (R.N.) concerning a patient who on 28-OCT-2008 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). No symptoms reported. Additional information has been requested.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles when he/she was 10 years old).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2023 This case was reported by a patient via interactive digital media. The patient had his/her shingles booster shot and developed shingles the next day. The doctor confirmed it.
I had a fever, cough, headache, body aches, fatigue & congestion. My lungs were clear & I did not have any shortness of breath.
I am not diabetic but I do get hypoglycemic at times. A little bit after I got the first dose; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN6199, Expiry date: Unknown) via an unspecified route of administration on 06Mar2021 (age at vaccination: 55 years) as dose 1, single for COVID-19 immunisation. Medical history included menopause from an unknown date and unknown if ongoing, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included fluoxetine (FLUOXETINE) 16mg total, a 10mg capsule and 6 mg liquid of the Fluoxetine taken for an unspecified indication, start and stop date were not reported; thyroid (ARMOUR THYROID) about 5mcg a day taken for thyroid disorder, start and stop date were not reported. On an unspecified date, the patient experienced, that she was not diabetic but she do get hypoglycemic at times, a little bit after she got the first dose.  The outcome of events was Unknown.  Follow-up attempts are needed. Further information is expected.
Acute medullary stroke. Patient admitted to the hospital for initiation of aspirin and stroke work-up.
event occurred around 11:30 when mom noticed pt stiffened, drooling, staring straight ahead unresponsive;mom picked up & patted back because pt was holding breath & gurgling;entire episode lasted 30sec;
Chills, fever, whole left arm aches, bump and red at shot site - for four days.  Whole Left arm aches still and it?s been 7 days now.
Pt deltoid developed area of induration, redness and pruritis 12x13cm with warmth.
Henoch Schonlein purpura starting 1 day after influenza vaccine given.
The pt developed two wheals near the injection site. None noted elsewhere on body. Child is not in distress. The wheals diminished in size within 30 minutes with no intervention.
four days after vaccine low grade fever, chills, cough; extreme exhaustion. five days after vaccine had diarrhea and tested COVID negative; symptoms continued until Oct. 12.
Headache, Arthralgia, Fever, fatigue, injection site arm pain, lymphaenopathy Narrative:
having covid; having covid; Pregnancy Due Date 31Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 34-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0164), in left arm and on 09May2021 as dose 2, single (Lot number: EW0167) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 17Jan2022. The patient is expected to deliver a baby(s) on 31Oct2022. Concomitant medication(s) included: ENOXAPARIN [ENOXAPARIN SODIUM]; L-METHYLFOLATE; B-12; D3; PRENATAL + DHA; MULTI COMPLETE PRENATAL VITAMINS; ASPIRIN BAYER.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "having covid"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "Pregnancy Due Date 31Oct2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details includes: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 17Jun2022, Treatment stop date: 22Jun2022, Lot number: GC4027, Indication: Treatment of COVID-19. After having covid and starting to feel better, I became sick again with the following symptoms: Congestion (26Jun2022 - present), Runny Nose (27Jun2022 - 3Jul2022), Tiredness (27Jun2022 - present), low fever (99.7) (28Jun2022 - 29Jun2022), Cough (28Jun2022 - present), Headache (29Jun2022 - 1Jul2022).
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 09-JAN-2017 at 14:47, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000403:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000473:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000411:  US-009507513-1704USA000412:  US-009507513-1704USA000413:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000416:  US-009507513-1704USA000417:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000422:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426:  US-009507513-1704USA000427:  US-009507513-1704USA000428:  US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000437:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704U
pt recvd vax 19APR93 & began having local reaction of redness & swelling 21APR93; seen by MD; fever 99;
t102.7- 2 febrile seizures; taken to hosp & seen in the ER-not admitted;
Extreme itching began at 1:00 AM, following day progressed to hives on hands, burning sensation.
ended up getting coronavirus; ended up getting coronavirus; This is a spontaneous report from the Pfizer marketing program. Information received from a contactable consumer reporting for the mother.  A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date  at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.   It was reported that the patient took the first dose of the vaccine but ended up getting Coronavirus a week after her first dose.  Information about lot/batch number has been requested.
Heavy period and clumps the next day which was my second day of my periods. Usually the first two days are heavy but I had never seen as much flow as I saw after the vaccine. I literally I had to change every couple of hours and wear double pads.
LARYNGEAL EDEMA/SPASM, HIVES, PRURITTS, WHEELS, SWEATING 1/2 HOUR POST ANTHRAX SHOT
experienced deliria; left arm swelled up; experienced a fever; This spontaneous report was received from a 63-year-old female patient regarding herself. The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided. The patient's concurrent condition included immune system disorder and asthma.  On 28-SEP-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter in left arm (lot#, expiry date, strength, frequency were not reported) for prophylaxis. On an unknown date, the patient started therapy with mometasone furoate (ASMANEX TWISTHALER) (lot#, expiry date, strength, frequency and indication were not reported). On 28-SEP-2017 (also reported as later that evening), the patient's left arm swelled up (peripheral swelling), she experienced deliria (delirium) and fever (pyrexia). On an unknown date in 2017, symptoms caused the patient to get hospitalized for the 10 days. The patient felt like she was out of it. The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not available for retrieval. It was unable to arrange retrieval of mometasone furoate (ASMANEX TWISTHALER). Action taken with respect to mometasone furoate (ASMANEX TWISTHALER) was unknown. The outcome of peripheral swelling, delirium and pyrexia was reported as recovered. Causality assessment was not reported.  Upon internal review, the event of delirium was determined to be medically significant. combinationproductreport: Yes; brandname: ASMANEX TWISTHALER INHALER (DEVICE); commondevicename: mometasone furoate; productcode: KCO; devicetype: NASAL SPRAY, ENT DELIVERY (KCO); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
fever of 101F; severe pain at injection site after 1 hr; fatigue after 24 hours/fatigue after 36 hours; extreme nausea; This is a spontaneous report from a non-contactable consumer (patient herself). A 20-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9264; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 10Feb2021 18:30 (at age of 20-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as none. Concomitant medication included cefdinir (CEFDINIR) taken for an unspecified indication. Patient had not any known allergies. Patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1283; Expiration date: unknown) via an unspecified route of administration, administered in Arm left on 20Jan2021 18:15 (at age of 20-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 19:30 after 1 hour of vaccination patient experienced severe pain at injection site, fever of 101F on 11Feb2021 18:30 after 24 hours of vaccination. Fatigue after 24 hours/fatigue after 36 hours and extreme nausea on 2021. Patient did not receive any treatment for adverse events. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on an unspecified date in 2021; fever of 101F. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Received first dose of Moderna on 1/20/21 and second dose on 2/17/21. Became symptomatic on 7/26/21 with Influenza Symptoms - cough, fatigue, body aches. Notified Doctor via phone - prescribed antibiotic and steroid. Tested negative via rapid on 8/2/21. Tested positive on 8/3/21 after presenting to emergency room.
Later the evening of the injection, I started feeling weak and sluggish. Otherwise felt ok.  The next day (Thurs 04/08) I still had a sluggish feeling, and my limbs felt weak, and I also started having a little trouble breathing- just like I was "winded", or couldn't quite catch my breath.  It got worse that night, I couldn't take full breaths and when I did breath in I had a pain across my mid / upper back.  I also experienced chills off and on.  I took my temperature several times, which was normal.  Today (Fri 04/09)  I feel better, but still have a leftover sluggish feeling, and any kind of activity makes me short of breath and my limbs are weak and shaking.   I have reported this to my primary doctor.
Left arm hard, swollen, pain of "10", ice applied, Tylenol given, pharm and MD informed.
Dizziness; for 2 days had some stomach issue that was like upset unable able to digest a piece of toast; Tired; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (for 2 days had some stomach issue that was like upset unable able to digest a piece of toast), FATIGUE (Tired) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.  No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (for 2 days had some stomach issue that was like upset unable able to digest a piece of toast), FATIGUE (Tired) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (for 2 days had some stomach issue that was like upset unable able to digest a piece of toast), FATIGUE (Tired) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants were not reported. Treatment was not reported.
SHE WAS EXPERIENCING PRESSURE IN HER CHEST AND LIGHTHEADEDNESS APPROXIMATLEY  10 MINUTES AFTER RECIEVING VACCINE. ONSITE EMS WAS REQUESTED. VITALS WER BP 190/116 HR 90 AND EKG SHOWED NORAL SINUS RHYTHM. PATIENT HAS NEVER EXPERIENCE REACTION TO VACCINE BUT SHE HAS NOT HAD ANY VACCINE SINCE SHE WAS A KID. SHE STATED SHE WAS NERVOUS ABOUR RECEIVING THE VACCINE PHYSICIAL ON SCENE RECOMMNED THA TH PATIENT TO TO THE ER DUE TO HYPERTENSION. RATIENT REFUSE SAYS SHE WILL GO HOME AND TAKE HER LOSARTAN.
Right arm very sore and both shoulders became very stiff with headache, low grade fever. Pt seen by Dr.
Low titers; adult dose given to pediatric patient; adult dose given to pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 25-MAY-2023, the patient received Engerix B adult. On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On 25-MAY-2023, an unknown time after receiving Engerix B adult and not applicable after receiving Engerix B, Engerix B and Engerix B, the patient experienced adult product administered to child (Verbatim: adult dose given to pediatric patient) and overdose (Verbatim: adult dose given to pediatric patient). On an unknown date, the patient experienced therapeutic response decreased (Verbatim: Low titers). The outcome of the therapeutic response decreased, adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was an Office staff member. The patient completed the series as a child, but her titers came back low, so the physician wrote to restart the series and the adult dose given on 25 May 2023 was dose one of the repeat series.  The reporter did not consent to follow up. 18-year-old patient received Engerix B adult which led to adult product administered to child and overdose.
Information has been received from a registered nurse concerning a male with no drug reactions/allergies who on 07-NOV-2002 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). ON 03-OCT-2007, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot 658403/1121U). There was no concomitant medication. On 05-OCT-2007, the patient experienced red, irritated, tennis ball size reaction at the site of the injection and chickenpox rashes down the entire left arm. Subsequently, it was reported that the patient recovered from red, irritated, tennis ball size reaction at the site of the injection and chickenpox rashes down the entire left arm. The office assumed the patient had recovered because the patient hasn't followed up with office. No laboratory diagnostic studies were performed. Additional information has been requested.
Fever, Lightheadedness, Shortness of breath  15 minutes post vaccination felt very dizzy with SOB.  Had similar symptoms 2 days ago.  Found to have temp 101.5  Sent via butler to ED for further evaluation
pt was extremely cranky /win 2 hrs of vax.  Mother noticed localized erythema & edema of lt thigh (covered entire thigh) 3 doses of Tylenol given 12 hr period & pt slept /s probs. Symptoms resolved /win 24 hrs
Patient exhibited vasal vasal reaction soon after Vaccine administration. Alert and oriented during 30 minute observation. Mild throat scratchiness and chest tightness reported. Requested hydration. Vitals: RR: 18 HR: 58 BP: 108/76. Diphenhydramine administered 50 mg orally by mouth. Denied dizziness. RN present providing supportive care. Discharged from care with instructions to seek medical attention should throat symptoms or chest tightness worsen.
About 8hr after injection, body aches, fatigue, headache. At midnight had severe chills and body aches.  Took 1000mg APAP at 1am. Improvement around 2am and could sleep again. All day on 1/23/21, extreme fatigue.  By 1/24/21 mostly back to normal.
Pt. reported red swollen (L) upper arm to nurses on 3/16/11 at 8:30A no other acute distress. Appt. arranged with Dr. at 9:30-10:00. Examined at 10AM. Bruising at antecubital, red, swollen tender to touch L. upper arm since last evening. On 3/14/11 had CT scan dye (L) AC site, BENADRYL 50 mg IM and PNEUMOVAX 23 IM (L) delt. No dyspnea, fever, chills or other systemic symptoms. Temp 98.5 110/66, 88 reg. 18 resp. Advised ice pack to site at intervals - watch for elevated temp. and chills.
Warm; Swollen arm; rash on her arm/the size of the rash was about the size of a tennis ball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE RASH (rash on her arm/the size of the rash was about the size of a tennis ball) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE RASH (rash on her arm/the size of the rash was about the size of a tennis ball). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (oral) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE RASH (rash on her arm/the size of the rash was about the size of a tennis ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment includes ice on and off.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: follow up received from 11-JUN-2021 :Patient said she is doing fine and declined for further follow-up
Patient reported pinpoint pain to chest at 1538. VS at 1540 BP 143/81 pulse 79 pulse 98%. Patient denied any symptoms of shortness of breath, jaw pain, and throat tightness. At 1540 patient signed
Client is a 61 yo F, presented to the vaccination site requesting a 2nd dose of Janssen J&J COVID vaccine per her NP's recommendation. Client stated she received a 1st dose Moderna COVID vaccine (LOT # 025J20-2A) on 01/09/2021 in the left deltoid and reported having a "severe cellulitis" reaction following the Moderna COVID vaccine dose. She stated she required 2.5 weeks of steroids in order to resolve the cellulitis. Client denied any other anaphylactic like symptoms including shortness of breath, tingling of lips, throat or mouth, chest pain or headache. Lead RN consulted with the medical team regarding approval of a 2nd dose J&J. MD approved administration of Janssen COVID vaccine as a second dose. At 1429, RN administered Janssen J&J COVID Vaccine (LOT # 1822809) into the client's left deltoid. The client stayed for a 30 minute observation period without incidence. She left the vaccination site at approximately 1500 on her own accord and with a steady gait.