chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called and spoke with the pharmacist about redness on and around the arm where the vaccine was given.
Vasovagal reaction after HPV injection. Seconds of loss of consciousness. All vitals stable.
Pain, Redness, Swelling, Fatigue, Headache, Fever, Nausea, Fever Blister. Patient had for 10 days.
Pain in the back of my neck; chills; Pain in the arm; Headache; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (Pain in the arm) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 046B21A and D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NECK PAIN (Pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (Pain in the arm) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (Pain in the arm) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant products included diabetes medication, asthma medication,cholesterol medication,blood pressure medication   This case was linked to MOD-2021-379422, MOD-2021-379421 (Patient Link).
Swollen left shoulder, with growing rash.  Only soreness during first shot. Second shot is where the swelling and rash appeared
Light-headed, blurry vision, heart rate dropped from 80 to 50. Walked around to raise heart rate.
Shot given 4-16-12. 2 days later had pain below right ear behind jaw. Went away after about 3 days. Lump started developing behind right ear about 4-24. Didn't hurt. 4-30-12 woke up in severe pain with right arm. Couldn't raise up arm more than 6". Red spots around shot area about 2-3 in area (not raised rash) swelling, hot to touch. Lump behind ear about size of nickel. (Lymph node). No fever. Pain severe in arm. At ER, given script for 1, 500 mg of Penicillin a day for 10 days. Pain med - tramadol HCL 50 mg (every 6 hours). Which didn't alleviate pain hot pad didn't help either.
stroking; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW01B1/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 (at the age of 67 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension (HTN) and COVID-19 on an unspecified date. The patient had known allergies to ciprofloxacin (CIPRO), latex and iodine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021 at 12:00AM, the patient reported that after having her first vaccine on 19Apr2021, the next morning her blood pressure went up to 210/110 and HR 130 with a pounding headache and reported "thought I was stroking". The patient received treatment for these events which included extra medicine: an extra dose of losartan, clonopin and two acetaminophen (TYLENOL) and slept 24 hours. The outcome of the events blood pressure went up, heart rate increased, headache and "thought I was stroking" was recovering. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient had immediate swelling and redness on her arm. Patient also had fatigue, fever, chills, myalgia on 03/27/18. Patient experienced right axillary lymph node which was swollen, tender with palpation.
bell's palsy; herpes simplex; This spontaneous report was received from a consumer referring to herself, a 60-year-old female patient. The patient's medical history included peripheral swelling and swelling after received two unspecified tetanus vaccines. The patient's concurrent conditions and concomitant medications were not provided.  On 05-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route, vaccination schedule, anatomical site, lot# and expiration date were not provided).  On 07-JAN-2015, the patient experienced bell's palsy and was hospitalized on an unknown date due to this event; during hospitalization the patient was diagnosed with herpes simplex. The patient went out from hospital after one and a half days.  The outcome of bell's palsy and herpes simplex was not provided.  The causality assessment between the occurrence of the events and the suspect vaccine administration was not provided.  Upon internal review, the event of bell's palsy was considered to be medically significant.
11/01/2022: 4 Years old Male accompanied by mother with fever that occurred this morning. Symptoms viewed as moderate by parents. Better with nothing, worse with nothing.  No history of other contacts with same symptoms. No travel overseas.  Patient's mother stated that he went to visit his primary care provider where he got his vaccines and a flu shot.  After that he started to develop a fever of 103.  She gave him Tylenol which has not been helping with his fever. Patient has exam that is consistent with a post-vaccination fever that does not require antibiotics.  Patient has currently been stabilized in the emergency department and is safe for discharge. Patient is non-toxic appearing, well hydrated, and playful. Patient?s symptoms not typical for other emergent causes of URI such as pneumonia requiring inpatient observation, sepsis etc. Patient will be discharged with strict return precautions and follow up with primary MD within 24 hours for further evaluation.
This study report as received from a consumer, as part of a marketing research study, refers to a female patient of unknown age enrolled in an market research. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with M-M-R II, subcutaneous. On an unknown date, she had a reaction to MMR vaccine when she was small. She just passed out. At the time of this report, outcome of event loss of consciousness was unknown. The reporter did not assess causality of event loss of consciousness with MMR. Upon internal review, event loss of consciousness was determined to be medically significant. Additional information has been requested.
Chills, fever, some nausea, tiredness, headache, didn't want anything to eat
Patient started experiencing headache, nausea, body aches, exhaustion, unclear thinking, strange behaviors per patient's son on April 4, 2021. These symptoms didn't get any better the day after. Patient lost appetite, and no energy and started shortness of breath started April 5, 2021.  On April 6, breathing problems got worse, and too tired to work. Patient woke up with nausea, headache, no energy, shortness of breath and on going problems until April 12 when patient came to the ER due to irregular heart beat and Atrial fibrillation, and patient can't function.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
No additional AE details or PQC.; 2 doses of PNEUVMOAX 23 were administered after a supported temp excursion occurred.; 2 doses of PNEUVMOAX 23 were administered after a supported temp excursion occurred.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drugs reactions/allergies were not reported.  On 09-AUG-2022, 2 doses of Pneumococcal vaccine, polyvalent (23-valent) (PNEUVMOAX 23) injection (lot number: U026796, expiration date: 28-JAN-2023; strength, dose and route of administration were not provided) were administered for prophylaxis after a supported temperature excursion occurred (product storage error; overdose). The temperature excursion was of 9.2 Celsius degrees for 48 minutes. It was reported that there was no previous temperature exclusion. No additional adverse event (AE) details were reported.  This is one of the three reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA005566: US-009507513-2208USA005835:
Day 7/8 post first dose of vaccine developed redness, itching, swelling in left upper arm. Pain and tenderness in arm and lymph nodes in underarm
Tingling hands and feet, numbness in hands and feet, weakness in body, face partially paralyzed. Unable to walk for almost a month.
Small rash on the arm he received the shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Small rash on the arm he received the shot".  Additional information: Caller received 1st Pfizer vaccine and had a small rash on the arm he received the shot. Received the 2nd vaccine and broke out into a rash all over his body. Caller stated he was speaking with a woman who said she will call him back, he attempted to get his information to transfer him to speak with a medical professional he said he will wait for the call back because he had a lot on his calendar. Caller disconnected. This Medical information team reported that this is to confirm that we are unable to proceed with the inquiry. There are no contact details nor medical information question to be addressed. Follow up (10May2021): This is a follow up spontaneous from a Pfizer sponsored program. A non-contactable male consumer (patient) reported for himself that: No clinical information received. Follow up (11May2021): This is a follow up spontaneous report from a medical information team. This Medical information team reported No clinical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
peripheral neuropathy; type two diabetes; hardly walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "peripheral neuropathy"; TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "type two diabetes"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "hardly walk".  Clinical course: After patient took the Covid shot when it came out patient almost gave up for being so patient will but kept on but patients medical condition was still bad patient have a real bad case of peripheral neuropathy where cannot hardly walk and patient have a type two diabetes.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Child told mother he felt weird and had itchy tongue.  Shortly thereafter he broke out in hives.
Left deltoid noted to be warm to touch, red, swollen.  Erythema extended to inner aspect of the bicep 3-4cm diameter from the injection site. Pt stated she took ibuprofen and diphenhydramine. Instructed to watch closely. 10/19/16: erythema significantly increased to >10 cm extending from deltoid covering entirety of the inner aspect of left bicep. Patient reported fever PM of 10/18/16. discomfort is significant. Advised to see PCP as soon as possible for assessment.
The pt received a shot on 7/31/00 and felt fine. Two days later the pt felt lethargic and went to bed early. The next morning had a headache and felt nauseated. Threw up and slept the entire day. Got up briefly toward evening.
Increased heart rate and throat felt swollen or constricted, heart rate went up and down for about an hour, throat felt swollen or constricted for a few hours.
I felt about 20 minutes later the back of my neck swelling and 48hrs I began to have dizziness and headaches.  It feels like my temples have pressure.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-JUN-2014, the patient was vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneously. Lot number reported as J004155, expiration date 05-APR-2015. On 06-JUN-2014, the patient received improperly stored VARIVAX (Merck) exposed to 15F for 86 hours. No adverse event were reported. This is one of several reports from the same source. Additional information has been requested.
anticipated fever; flu like symptoms; pain in elbow joint/occasionally he feels elbow pain; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient received first dose on unspecified date for COVID-19 immunization no adverse effect after first dose. Medical history and concomitant medications were not reported. The patient mentioned that post the second PfiZer COVID vaccine along with the anticipated fever and flu like symptoms the patient experienced pain in elbow joint on unspecified date that lasted for 3 days and a month later occasionally he feels elbow pain. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
BODY ACHES; JOINT PAIN; NUMBNESS LIPS; CHILLS; FEVER; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced joint pain. On 01-APR-2021, the subject experienced numbness lips. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness lips, and had not recovered from fever, body aches, chills, and joint pain. This report was non-serious.
I started to receive severe back pain. Developed a fever over 102.5 while taking ibuprofen. Severe sweats. The pain worsened til chest became tight. Breathing was labored. Shivers from fever. After 24hrs fever broken and paid became minimal
Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Headache nearly 24 hours; 102.7 fever; swollen, red, hot large circle around injection site with itching at site.
Pain to injection site, tenderness and pain, swelling to Rt. Axillary nodes. mild fever, discomfort.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 33130ba) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Mar2021 as dose 2, single (Lot number: 022m20A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown results. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Conclusion of Previously Completed Investigation : The complaint for a lack of effect in a vial of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled, and packaged by Pfizer. The final scope was determined to be lot 33130BA. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or SQRTs/AQRTs were held because of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met all release specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior to any lot being released to the market.  Follow-up (16Jun2022): This is a spontaneous follow-up report from product quality group providing investigation results. This report included that:  Updated Information included: Batch and lot tested and found within specifications in Product tab per verbatim (The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met all release specifications); Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Approximately 20 minutes after second vaccine, became orthostatic, flushed, and pre-syncopal.  Given intravenous diphenhydramine, and sent home ~60 minutes later.  Patient did take off work the next day, experiencing aches, malaise, and diarrhea.
Patient received her first dose of the SHINGRIX vaccination on 4-10-18 and she stated that when she woke up on 4-11-18 her arm was stinging and burning around the injection site. She stated that it continued to get worse and it started stinging under her arm as well. She did end up going to the doctor because she states that she can not move her arm anymore. Patient is currently going to physical therapy for her arm.
Swelling underneath my left arm pit which may be a possible blood clot; Swelling underneath my left arm pit which may be a possible blood clot; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 08Apr2021 (16:15) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (05:45), the patient had swelling underneath my left armpit which may be a possible blood clot. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered. The patient did not have COVID-19 prior to vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
FELT DIZZY; COLD; MILD FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced felt dizzy, cold, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizzy, cold, and mild fever. This report was non-serious.
Itchiness on arms, feet and thighs which progresses to hives. Occasional lip swelling.
w/in 48 hrs, devel t101, rhinitis, pharyngitis, stiff rt arm, & upper resp infection;
Big rash on the arm by the area where the vaccine was administered. Burn, itching , and big rash.