chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep for three days), LIMB DISCOMFORT (light discomfort in the arm) and INSOMNIA (could not sleep in the whole night) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced INSOMNIA (could not sleep for three days). On 10-Feb-2021, the patient experienced LIMB DISCOMFORT (light discomfort in the arm) and INSOMNIA (could not sleep in the whole night). On 14-Jan-2021, INSOMNIA (could not sleep for three days) outcome was unknown. At the time of the report, LIMB DISCOMFORT (light discomfort in the arm) and INSOMNIA (could not sleep in the whole night) outcome was unknown. Not Provided. Concomitant medications reported were blood thinners, medication for hernia cancer. No treatment information was provided.
Rash to right arm, elbow and RT cheek. Rash appeared on 9-19-09 and was treated with steroids and PREDNISONE. Same rash reappeared on 9-26-09 with treatment in emergency room due to rash/hives on face arms. 9/28/09 still has rash.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions were reported for the patient. The reporter stated that the patient was vaccinated with first dose of GARDASIL on an unspecified date in 2013 and the 2nd dose of GARDASIL also on an unspecified date in 2013. The reporter stated that the patient was present in the unspecified physician's office on 24-MAR-2015, to receive the third dose of GARDASIL (Dose strength, route of all the doses vaccinated were unspecified) (inappropriate schedule of drug administration). No adverse effects reported. The outcome of events reported was unknown. No product quality complaint was involved. Additional information has been requested.
Immediately after GARDASIL injection in RD, pt. c/o pain in arm, felt lightheaded. Recovered within 3-4 minutes, so flu vaccine administered. Became hypotensive c/o lump in throat. Recovered in 15 min.
patient reports swollen right hand and swollen right foot that resolved after a few days.  He also reports his IBS acting up, and and unsteady gait and felt weak walking for a few days after receiving vaccines
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Two days, post vax, pt developed a fever of > 101F, erythema, induration and pain at injection site. Went to ER and treated with heat, Vicodin, Keflex and Atarax.
No adverse event; Medical Assistant reported that an expired dose of MMR-II was administered to a patient; This spontaneous report was received from a medical assistant referring to a 13-month-old male patient. The patient's medical history, concurrent conditions and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 15-AUG-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5ml subcutaneously, 1 dose, lot #T029549, expiration date: 10-SEP-2022 (expiration date reported as 30-JUL-2022) for prophylaxis (expired product administered). It was unable to provide sterile diluent information stating they do not have a way to document the lot and expiration for the diluent. There were no side effects reported (no adverse event). The vaccine has not had any temperature excursions.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2209USA002318: US-009507513-2209USA002251:
Throwing up (24 hours after for 6 hours, 20 times) Diarrhea (2 hours after for over 24 hours) Severe shaking (10 hours after, 4 hours, woke up shaking)  102 fever Headaches (right after for 5 days) Fatigue (right after for 5 days) Very weak (24 hours after)
Saturday (day after) started with fever (102AX) body aches and tiredness. Parent states fever lasted 6 days. Some lightheadedness, diarrhea, dizziness. Generalized rash that was not really itchy or raised.  Lips no rash. Seen in office on 8/10 and physician suspected enterovirus infection.  Low WBC. Spleen tip palpable.
Td receiv'd for clean nail stepped on Jan '01. W/in 24 hrs, temp 101,cough,emesis;Erythromycin started. Next 3wks experienced pain in chest, rapid pulse, pronounced muscle weakness. Mar 14th boil on(R)hip. Mar 22nd to ER for tremors, nausea. Currently(L)side weak,drops items occasionally.
Awoke with entire body itching, did not take medicine due to early hour but could not fall back asleep, took shower at 6:20 notice raash on palms. After shower applied OTC hydrocortisone cream to arms. Took benadryl at approximately 6:45. Reported to school, itching had resolved but fellow employees noticed rash on face and I then noticed my forearms had broken out with hives. Nurse took temperature and pulse ox--both normal, but also noticed rash on shoulder blades. Went to Urgent care vitals were normal with BP 130/84 which is only slightly high for me. By the time I saw doctor it seemed hives were less severe. He advised continuing OTC meds and following up with family physician in five days. Today all has resolved except palms are still splotchy red to pink rash occasional mild itching. NO new or strange foods or meds were ingested and he thought the vaccine was the most likely cause.   I had COVID diagnosed on Jan 1, 2021 which was mild and resolved within six days, but has a few lingering effects (Brain fog and loss of taste) now resolved.  I was hospitalized in late  June with Sepsititis secondary to cellulitis.  I am currently over weight 266 lbs down from 306 lbs in June. Weight loss is intentional and physician monitored.
Per pt. 4 days post injection, pt. presented to the ED with severe epistaxis x 5 hours.  ED refereed pt. to ENT.  There is no documentation in the medical record of these events.
Lump on arm; Erythema on arm; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a adult 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 local swelling and erythema of extremities. On an unknown date, the outcome of the local swelling and erythema of extremities were unknown.   It was unknown if the reporter considered the local swelling and erythema of extremities to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported by the patient that after receiving shingrix patient experienced that arm developed a dark red lump with size of tennis ball. The reporter did not consent to follow up.
Test positive for covid; Test positive for covid; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer covid vaccine first dose on 07Jan2021, then she tested positive for covid on 18Jan2021. The patient was scheduled for second vaccine on 28Jan2021. The patient asked if still get 2nd dose on 28Jan or start series again at later date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Fever 101, myalgia, chest pain. Next day pleuritic chest pain, shortness of breath; cardiac enzymes elevated, ECG normal. Diagnosis: myocarditis. MUGA normal ejection fraction. Returned to duty with followup ECG scheduled.
No adverse reaction. Patient marked on consent form stating never received any COVID vaccine, but when pharmacy bill the insurance with a rejection "additional dose not allowed." When pharmacy called insurance, insurance said patient had one Janssen vaccine in 6/30/2021. When we called patient to confirmed, patient stated he admitted he received one dose already and he didn't mark correctly on the consent form because he was worried pharmacy would not do it for him. He stated he has immunocompromised condition (didn't mark on the consent form) and worried about the delta variant. Pharmacy staff explained that second dose is not currently approved by CDC.
chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EL3247), via an unspecified route of administration, administered at Arm Left on 09Feb2021 at 11:45 AM (age at vaccination was 32 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history was not reported. No known allergies reported. The concomitant medication escitalopram from on an unspecified date as other medication given in two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3247), via an unspecified route of administration on left arm on 19Jan2021 at 11:45 AM (age at vaccination was 32 years) as DOSE 1, SINGLE for covid-19 immunisation at facility type vaccine: Workplace clinic. The patient was not received other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Feb2021 at 07:00 AM, the patient experienced chills and fatigue. The patient did not receive any treatment for events. Outcome of the event was recovering. Upon follow-up received on 11May2021, it was reported that follow-up attempts completed. No further information expected.
Information has been received from a consumer concerning her 24 month old granddaughter, who on "about a week and a half ago" was vaccinated with a dose of VARIVAX (Merck). Then a few days later she go an infection at the injection site and then broke out with chickenpox all over the body. The consumer reported that the patient saw her physician who stated that she had developed a mutation of the chickenpox. The consumer reported that at the time of reporting on 30-JUL-2009 the patient was recovering. No further information is expected.
Sore Arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th April 2021, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had Shingles vaccine on friday before date of reporting and got sore arm but not bad.
No additional AE reported.; the vaccine expired on 15-APR-2021 and was administered to a patient on 21-MAY-2021; the vaccine had a temperature excursion on 07-APR2021 and was administered to a patient on 21-MAY-2021; This spontaneous report was received from a consumer referring to themselves, a patient of unknown age and gender.  No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided.  On 21-MAY-2021, the patient was vaccinated with  hepatitis a vaccine, inactivated(VAQTA) lot # T014590, which has been verified to be a valid lot number, expiration date reported as 15-APR-2021 and upon internal validation established as the same (expired product administered) (dosage schedule, route and anatomical location were not reported) for prophylaxis. It was also reported that the vaccine had a temperature excursion on 07-APR-2021 (product storage error). There was no adverse effect reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
No adverse reaction.  Patient given Pfizer dose by another provider on 02/16/21.
No adverse event; GARDASIL 9 were administered to patient after temperature excursion; This spontaneous report was received by customer refers to a 13-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with one dose of improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1775827, expiration date: 27-JUN-2024, or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U032681, expiration date: 26-OCT-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1780876, expiration date:09-NOV-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1775811, expiration date: 07-DEC-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot# W009829, expiration date: 19-OCT-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions. Total time 25 minutes (09-SEP-2022 for 8 minutes, 16-SEP-2022 for 5 minutes and 03-JAN-2023 for 12 minutes (product storage error). No additional adverse event (no adverse event).
Information was received from an office manager concerning an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route not reported, lot number reported as K011526 which was non valid for quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine, expiration date: 08-APR-2017). The vaccines were stored in 33 Fahrenheit degrees for 5 hours. They were back in range. There was no previous temperature excursion. The report was made because of digital data logger. There were no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
HEADACHE WITH A PAIN SCALE OF 5/10; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A,  expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-AUG-2021, the patient experienced headache with a pain scale of 5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache with a pain scale of 5/10. This report was non-serious.
My mom & I both had our vaccinations given at the same time & both have same symptoms/ is it bad batch?  Extremely sore arm, very painful, big knot at injection site, red, hot (did not happen with 1st 2 doses)
Guest arrived for the first dose of Moderna vaccine and in the post-vaccination observation space with concerns of localized itching at the injection site (left deltoid). No other signs/symptoms of concern. Benadryl was offered but refused by client. Patient stated, "I feel fine and the itchiness is going away". Patient was given some water and she was able to leave the clinic of own volition. Client was advised to call 911 if any emergency symptoms arise or seek care if needed for further non-emergency symptoms.
5:56pm - Resident brought back from dining room with arms jerking spasmodically. Initially though it was a seizure but her eyes were tracking and she moved head from side to side when spoken to. Incident times. Jerking stopped at 5:38 (lasted for 5 minutes). A few more arm jerks seen, then stopped. No nonverbal s/s of pain/distress, though she groaned during the incident. Res grip WNL, wanted to hold hands.  6:56pm - VS:100.5-122-16-142/96. 02 sats 94% RM. Given scheduled Tylenol for fever and Oxycodone for pain. Patient teary eyed and having left hand/arm fine small jerks: seizure activity noted. 7:26pm - on-call provider ordered for resident to go to ER for monitoring r/t continued intermittent seizure activity.
how to proceed with 2nd dose, 1st dose given October 11, 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 11th October 2019).   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 reported as follows: The age at vaccination was not applicable for this report. The patient had received first dose of Shingrix and never received second dose, which led to incomplete course of vaccination. The patient consented to follow up via email.
Patient immediately got a bad hot flash. Drank some water and a few minutes later was fine.
Pt states he exeperienced a rash on foot after receiving the anthrax vaccination.  This complaint is from an injection patient received a year ago. Patient was due for an anthrax booster 8 june 2008 and that is when he brought up concerns from prior injection.
Moderna COVID-19 Vaccine EUA: patient seen in emergency department two hours and seven days after vaccination for tachycardia and chest pain.  First visit pulse 125 beats per minute, bloodp ressure 186/108 mmHg, rest of vitals within normal ranges. Patient administered intravenous fluids, Maalox + lidocaine, NSAID, and discharged to home stable when symptoms resolved and vitals improved. Second visit pulse 103 beat per minute, blood pressure 170/101 mmHg, rest of vitals within normal ranges. No medications administered and patient discharged to home stable when symptoms resolved and vitals improved with prescription for antihypertnsive medication.
I awoke at 3:30 AM unable to move my neck side to side or up and down. I was in extreme pain in my neck and shoulders extending into my arms.
I had a fever of 101, body aches, fatigue, nausea, dizziness.  Did not see a doctor.  I am feeling better now.
Very slight muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198 and Expiration Date not reported) via an unspecified route of administration, in Arm Left on 05Mar2021 07:00 PM (Age at vaccination: 73 years) as single dose COVID-19 immunization. The patient's medical history included coronary artery disease. The patient concomitant medications included metoprolol, chlorthalidone, simvastatin and clopidogr; all taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID-19 prior vaccination and not tested for COVID-19 post vaccination. On 06Mar2021 06:30 AM, the patient experienced very slight muscle soreness. The patient did not receive any treatment for event. On the same day, the event was resolved.  Follow-up activities closed. No further information is expected.
"I got my vaccine earlier and my arm has not stopped shaking.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 19Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 19Apr2021, outcome "unknown", described as ""I got my vaccine earlier and my arm has not stopped shaking.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On 07-MAY-2019, the patient was vaccinated with improperly stored hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose, frequency, route of administration and anatomical location were unknown) (lot # R034340 and expiry date 23-NOV-2019) for prophylaxis (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 35.72 Fahrenheit (F) for a time frame of 5 hours and 5 minutes on 06-MAY-2019. There was previous temperature excursion reported as 31.28 Fahrenheit (F) for a time frame of 5 hours and 7 minutes on 03-MAY-2019, 32.68 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019, 31.26 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the four reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004979: US-009507513-1905USA005069: US-009507513-1905USA005070:
Patient was administered an expired vaccine on 10-8-22. Lot FL 2757 expired ion 9/30/22