chrisvoncsefalvay/vaers-outcomes huggingface dataset:
crying greater than 3hr then had fever treated w/motrin;then was afeb;another fever 20JAN98 & dx w/UTI;
Shoulder soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder soreness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ARTHRALGIA (Shoulder soreness). On 15-Apr-2021, ARTHRALGIA (Shoulder soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that after first dose he experienced shoulder soreness the day after the injection.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-132260 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: NNI, reporter confirms that information was already given via phone call
5 days, post vax, had a fever of 101.6F and diffuse urticaria. Treated with Benadryl. On day 6 and 7, fever was 101.6F with urticaria. Went to ER and was treated with Prelone and Atarax.
From shot 1-3 of ANTHRAX I felt hands burning and unable to write.  From shot 4-6 felt burning at both hands, arms, chest, face & back of head.
I was traveling and had the Shingles, They gave me antiviral medicine and pain medicine. When I got home a doctor prescribed me Lyrica and I had an allergic reaction to that and then I was on gabapentin and I was losing my memory.
Developed sore throat and cough. became positive for Covid - 19 after Johnson and Johnson Vaccine was received-
The day of the vaccine, I had fever dreams. About 6-7 days after the vaccine, I noticed sediment in my urine. I made an appt with my doctor 6/15/2021. I got a urine dipstick test which showed positive for proteins. I came in the blood test the next day-which came back normal. The blood test for lipase came back elevated possible pancreatic. I am waiting CT scan results. I was prescribed a non fat diet and low carb diet to avoid inflaming the pancreas.
Fever of 102 degrees, backache so severe it brought her to tears, woke up at 3 in the morning, General malaise, pain at injection site
itchy skin on her neck, both arms and chest / itchy skin on her neck, both arms and chest; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy skin on her neck, both arms and chest / itchy skin on her neck, both arms and chest) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Diabetes.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PRURITUS (itchy skin on her neck, both arms and chest / itchy skin on her neck, both arms and chest). At the time of the report, PRURITUS (itchy skin on her neck, both arms and chest / itchy skin on her neck, both arms and chest) had not resolved.            Other concomitant medications included diabetes, cholesterol and heart medicines. No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-218368 (Patient Link).
Urgent Care facility mistakenly administered Tdap vaccine .5ml subcutaneously in left forearm instead of TB test Tuberculin. Within a few hours injection site started expanding in redness and has been increasing in size with pain, swelling, hot to touch. Center has turned hard and hurts to touch and measures 3/4". Redness area has been increasing and at 48 hours is at 3.25" x 2.5". Doctor prescribed 500mg Keflex 2x/day for 1 week. Will need to check tomorrow at 72 hours if it is still increasing in size.
Patient's mother reports 4 year WCC 12/10/15. 12/11/15 Rash at injection site. 12/12/15 Fever, vomiting, diarrhea. 12/13/15 (L) facial swelling, continued fever. 12/14/15 Office visit (L) facial swelling TTP c/w mumps or parotitis OTW well. Advised home care. No school x 5 days and when swelling resolved.
TINGLING SENSATION IN BOTH ARMS UP TO SHOULDERS, TINGLING SENSATION IN NASAL SINUSES, LABORED BREATHING. HOSPITAL VISIT  REQUIRED; LITER OF FLUID, 2 EKGS, BLOODWORK, CT SCAN.    5 HOURS VISIT AT HOSPITAL
No Adverse event; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received  on 16-JUN-2022 from an administrator regarding a patient of unknown age or gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unspecified date, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U022321, expiration date: 15-JUL-2023) was stored at an inappropriate temperature of 6F for a time frame of 30 minutes. The was no previous  temperature excursion.   On 09-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot #U022321, expiration date: 15-JUL-2023) administered subcutaneously for prophylaxis (strength was not provided). No adverse events were reported.
Patient was vaccinated at 11am and was found at the facility in his room deceased at approximately 3:00pm. Nurse did not have cause of death
got COVID positive; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (got COVID positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (got COVID positive). At the time of the report, SARS-COV-2 TEST POSITIVE (got COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive Positive.     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 medications reported. No treatment reported.
Caller tested positive for covid Thursday and its more sinus symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caller tested positive for covid Thursday and its more sinus symptoms) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller tested positive for covid Thursday and its more sinus symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of 3 pills at atime. At the time of the report, COVID-19 (Caller tested positive for covid Thursday and its more sinus symptoms) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       The patient was prescribed Paxlovid 3 pills at a time. Patient told that it was very large pills, and simply cannot swallow them. Patient was asking that paxlvoid could be made smaller so that  she could take 6 pills. Patient was told that cannot crush or cut the Paxlovid. The patient could not get them down, they were not going anywhere. The patient had talked to one other person at the doctor office and had the same problem, had a horrible time with Paxlovid. Patient was told  to take 3 pills each dose and they were all about the same size except the white is bigger not everyone had the problem with big pills, but certain people do and would like to take it to be on safe side. The patient was vaccinated and double boosted all Moderna Covid vaccines.  At her age patient would be nice to had something. Concomitant medications were not reported.
Patient reported to me that he developed small painful rashes around elbows about 1 week after the vaccine, that lasted for about 24 hours. Uncertain if related to vaccine or if another condition, patient was not seen in clinic for this rash. Patient was advised to contact PCP to see if second dose would be needed due to this possible reaction.
Child noted pale at sx monitoring station, escorted to health room 8:50. Had ch lay - legs elevated. Wet cool compresses to forehead. V/S/ taken. Parent notified 9:10. Reassessed 9:15. Child recovered. Returned to class after 1 hr.
Initial report received from a healthcare professional on 31 October 2013. A pregnant female patient whose age, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number: C4426AA) on right deltoid via intramuscular route on 29 October 2013. List of documents held by sender: none.
Merck Vaccine Representative called on behalf of Nurse Practitioner. Merck Vaccine Representative stated that the Nurse Practitioner mentioned that they know someone who had warts on his hands, not on his genitals, who received GARDASIL 9 and some ti; This spontaneous report was received from a Nurse and refers to a male patient of unknown age. The patient's concurrent conditions included wart on hands (not genital). His medical history, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, strength, dose, route of administration, anatomical location not provided) as prophylaxis.   On an unknown date, after vaccination, the warts that the patient had on his hands were gone (therapeutic response unexpected). Outcome of the event was unknown.   Causality assessment between the therapeutic response unexpected and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was considered as related.
Headache; feeling Achy; Fever of 100.4; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received Shingrix (intramuscular). On 10th September 2020, 1 days after receiving Shingrix, the patient experienced headache, pain and fever. On an unknown date, the outcome of the headache, pain and fever were unknown.   It was unknown if the reporter considered the headache, pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix on next morning after vaccination patient experinced fever of 100.4 degree F, feeling achy and a headache. The reporter was patients spouse. The reporter consented to follow up.
EE reports facial swelling with pressure and HA at 3:00 pm went to the ER at 6:00 pm
Vaccination site pain; This is spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced vaccination site pain. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.
This report described the occurrence of flu-like symptoms in a 37 year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. The patient received an injection of Lymerix on 4/13/01 and a second at a later time according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered flu-like symptoms, fatigue, vision problems, and memory loss. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. Medical history included fatigue, insomnia, sore throat, dyspnea, asthmatic bronchitis, anxiety, depression, use of clenbutrol and ephedrine to build muscle, and cough. Between 1994 and 1995, the patient experienced chronic episodes of extreme fatigue and sluggishness. Medical records confirmed that the patient received Lymerix vaccine (lot number LY144B9) on 5/16/00. Approximately two and half months later, on 8/29/00, the patient complained of loss of muscle strength. At that time, the patient reported that he had been performing squats with 400 pounds and was running one mile three times weekly, but had to decrease his squat weight to 225 pounds which he performed with difficulty. On 2/13/01, the patient was examined for complaints including fatigue, nausea, and weight loss. Following the reported onset of flu-like symptoms, the patient experienced a left breast lump (suggestive of gynecomastia), gastritis, possible allergies characterized by cough, groin strain, elevated creatine kinase, and chest pain. The patient was evaluated to have a high cardiovascular risk, based upon cardio C-reactive protein values as well as an ongoing history of hypercholesterolemia and hypertriglyceridemia. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 12/8/03 did not provide outcome to reported events.
Swelling, redness, heat from above elbow to above shoulder. Fever developed. Sent from urgent care to hospital. Admitted and treated with Ancef for 2 days. Discharged on Augmentin. Discharge diagnosis: vaccination reaction with possible.
The brand was what I got the pfizer dose. 45 minutes after having the vaccine I had very bad blurred vision in my right eye only while driving which lasted 3 hours and only subsided once I put my eye drops in .I  saw Dr.  today and he advised me not to have the second vaccine on March 15th. It left no damage to the eye thank God.
Feel numbness to the arm/her left arm went numb for about 15 to 20 minutes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Mar2021 (Lot number: ER8730) at the age of 39 years as dose 1 , single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 26Mar2021, outcome "recovering", described as "Feel numbness to the arm/her left arm went numb for about 15 to 20 minutes". The event "feel numbness to the arm/her left arm went numb for about 15 to 20 minutes" was evaluated at the physician office visit.  Additional information: Time of the vaccination was reported as 13:00 or 14:00. After receiving the shot the left arm she began to feel numbness to the arm about 15 to 20 minutes. Immediately afterwards her left arm went numb for about 15 to 20 minutes. The caller's arm was extended out of the vehicle when they gave it to her. The nurse directed the caller to the observation area. Not even a minute after receiving the vaccine the caller's arm was going numb, completely numb. The caller waved down the staff and she went to the nursing station. The caller was kept in observation for 20-25 minutes and the caller couldn't feel anything in her left arm. Caller wanted to know is this a normal side effect. The caller didn't get the second shot because she was extremely scared. Caller would like to know if this a reported side effect of the Pfizer COVID vaccine and wants to know if she should proceed in receiving the second dose. This report is not related to study or program. No investigation assessment was reported. Vaccine was not administered at Military facility. No emergency room visited. The caller also said that she went to the doctor and he suggested for her to call Pfizer. The patient had no family history. The patient did not receive any other products. No previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The caller saw her Primary care provider a few weeks after this event to let them know that this event happened.  No follow-up attempts are possible. No further information is expected.
pt recvd vax; ha, redness, pain, swelling, itching at site p/ dose 2; pre tx w/ dph dose 3;
no other AE information given at this time; incorrect product storage; Recalled product administered; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 08-OCT-2020, the patient was vaccinated with an improperly stored (clarified internally) and recalled pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # S036495, expiration date on 13-SEP-2021, for prophylaxis (strength, route of administration and anatomical location were unknown). No other adverse event information was given at the reporting time. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-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 meet the criteria for Reportability
07/22/2015 Moderate Other Patient has no known drug allergies. Patient was sent home. When arriving home she started to have a seizure. Patient was sent to emergency department.
Rash started on face first within 6 hours of vaccine, then the next day appeared all over body with macular appearance.  Rash lasted 30-36 hours.
On 25APR93 rt upper arm was hot/red, swollen; 26APR93 rt upper arm hot & swollen tight w/swelling extending to half of forearm; pt was seen by MD on 26APR who prescribed Antihistamines & APAP;
There was no adverse event. Patient received sub-optimal dosing in error (less than 0.5ml). This occurred due to leftover fluid in a needle tip that was changed out for a new needle tip without pharmacist aware of loss of fluid. Patient to be re-vaccinated with correct dosage.
have not had a normal menstrual  cycle since the second injection, starting in February. I have not had a period currently since late April and am not pregnant, not a chance to be pregnant, no change in stress, diet, weight etc.
My husband went into the doctor, he has a good chance of having bronchitis, but was COVID-19 positive. I felt like a horrible case of sinus in my throat and through my head. It was not in my chest, just head and my throat. I did have a cough. I was COVID-19 positive. At my husband's doctor's visit, they gave me a Z-PAK and a steroid and continue my allergy medicine when I called for myself the next day. I did not feel the greatest for about a week.
pt was fussy p/shot; mom arrived home between 11AM-12noon placed pt in crib then head went back w/eyes rolling to back of head & arms & legs began to twitch; pt was unresponsive; t101.9 ax;
administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported as unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The follow up information received includes non-significant information -updated reporter address.