chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My father's indolent follicular lymphoma transformed into a highly aggressive double hit B cell lymphoma, noticeably after he received the COVID bivalent booster on November 10, 2022.  My father's follicular lymphoma was routinely monitored by his oncologist Dr. at the Clinic since he was first diagnosed with follicular lymphoma two years ago.  My father's last visit with Dr. in late August 2022 showed no progression of the follicular lymphoma.  The transformation of my father's follicular lymphoma into a highly aggressive double hit B cell lymphoma was accidentally discovered on a CT scan performed on December 31, 2022 (seven weeks after the bivalent booster) and confirmed with a biopsy that was done on January 16, 2023.  My father died from this aggressive B cell lymphoma on January 27, 2023.  Transformation from indolent follicular lymphoma into an aggressive lymphoma is normally very rare, occurring in only about 3% of the cases.
peripheral neuropathy; This is a spontaneous report from a contactable other HCP. A 75-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. Medical history included herpes 10 years ago. The patient's concomitant medications were not reported. The caller stated she received the second dose PFIZER-BIONTECH COVID-19 VACCINE in March 2021 and developed peripheral neuropathy 1-2 weeks after vaccination. She referred to her feet as the affected region. She explained she had shingles 10 years ago, but it affected different body parts. She specified "now 2 months" later, her symptoms were "finally dissipating". She explained she didn't take the "pharmaceutical route" as a treatment option and specified "didn't choose gabapentin". She mentioned she went for a "topical" treatment. She said she read in a study from Israel that some people had developed shingles from COVID-19 itself or the COVID-19 vaccines. She mentioned two of her friends developed reactions from the PFIZER-BIONTECH COVID-19 VACCINE. She specified her 75-years old female friend had a "cold sore, a type of herpes virus", while her 65-year-old male friend had "shingles". She further said her female friend's pharmacist said she encountered 2 additional people who had cold sores after getting the COVID-19 vaccine. She asked if peripheral neuropathy was reported as a side effect from the vaccine. She asked if cold sores or shingles were reported as a side effect from the vaccine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2 ,a temporal association between the event peripheral neuropathy and administration of BNT162B2 cannot be excluded. Due to limited information, a  complete medical assessment cannot be made. 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.,Linked Report(s) : US-PFIZER INC-2021545288 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021545286 Same reporter/ drug, different patients/ events
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FM9992) at the age of 79 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Dilantin, reaction(s): "known allergies: Dilantin", notes: known allergies: Dilantin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (15May2022) Positive, notes: Positive test at 10 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Mother reports that child had swollen, red area at injection site, temp 99, erythema and edema at injection site lasted two days.
Client verbalized feeling anxious and nervous. Client was evaluated by Fire Rescue and released to go home 3:21 pm accompanied by spouse.
Information has been received from a registered nurse who is the mother of a 5 year old female who at 12 months old, was vaccinated with a dose of varicella virus vaccine live. Subsequently, at 5 years old, the patient developed a breakthrough. On 9/16/03, it was reported that now at 8 years old, the patient just had shingles. Additional information has been requested.
Experienced numbness on the left side of the face and toes. Face swelled, redness and hives on the face. Tingling on the left side of face and wheezing. Swelling , numbness , tingling lasted for 3 1/2 weeks. I still have tingling on the left side of my face.
Patient passed out about 5 minutes after receiving both Gardisil #3 and Hep B #2 immunizations. Came to rather quickly after cold compresses were applied to forehead and neck, and was able to walk out of clinic with mother in about 15 minutes after event.
administration of Kinrix to a 51 y/o patient instead of Boostrix; administration of Kinrix to a 51 y/o patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 51-year-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 24-AUG-2023, the patient received Kinrix. On 24-AUG-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: administration of Kinrix to a 51 y/o patient instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 51 y/o patient).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-Sept-2023  The case was received from the medical assistant. The patient received a dose of Kinrix instead of Boostrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
I feel wered; Chill achace; Chill achace; 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 MALAISE (I feel wered), PAIN (Chill achace) and CHILLS (Chill achace) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (I feel wered), PAIN (Chill achace) and CHILLS (Chill achace). At the time of the report, MALAISE (I feel wered), PAIN (Chill achace) and CHILLS (Chill achace) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment drug information was not given. The patient also enquired about how long they should wait to see a doctor.
Headache started 5:00 PM then felt like passing out at 5:30 PM then nausea, diarrhea at 6:00 PM then terrible leg aching all night.
Patient is a 71 y.o. female admitted on 5/1/2021 due to falls.  Please refer to the History and Physical report for information on presentation   Patient was admitted to the hospital due to recent multiple falls and hitting her head.  Patient family brought her in, reported that she has been very drowsy lately, she barely comes down to eat dinner.  She sleeps most of the time.  She has been compliant with all her medications.  All imaging studies showed no acute findings.  Including CAT scan head which showed chronic white matter changes, but no acute finding.  Neurology evaluated patient, they have done extensive work-up in the past to rule out falls including lumbar puncture, MRI,eeg However all the testing has been negative.  Patient's vitals remained stable.  Patient states she just feels her legs gives up.  PT eval the patient, recommended rehab.  Patient will be discharged to rehab.  Patient's medications were also titrated down to decrease drowsiness.  Patient remained AAO x3 during hospital stay.
Severe pain in upper arm and shoulder and restricted range of motion.  Difficulty lifting arm or moving arm behind back.  Difficulty dressing and completing other physical tasks.  Treatment has included Motrin, ice, and physical therapy.
Swollen tongue for 4 hours after  injection.  It started 1 hour after.
The evening of the vaccine patient, after the late afternoon nap (~4:30 PM), he had a fever, was very lethargic, and showed discomfort. I gave him Tylenol. He slept normally that night, but still had a fever in the morning. Administered Tylenol during the day, and he was active, though not quite at normal levels for him. After a late afternoon nap he showed signs of greater discomfort, and his fever seemed to be on the rise. I gave more Tylenol at about 5 pm. The fever continued to climb. At 6 pm I took his temp again and it had not decreased, and I was shocked to see it had spiked up to 103. He was on my lap, and was obviously not comfortable. I was considering going to the ER, when he had two very short (< 1 sec) spasms which after the fact I realized were a precursor to a Febrile seizure. I was about the pick up the phone to inquire of my friend about what ER she would recommend when he had what later turned out to be a Febrile seizure. It lasted about 30 seconds, and he essentially began to shake and went limp and unresponsive. I immediately dialed 911 and an ambulance took us to the Medical Center, where the condition was diagnosed, and treated with Tylenol and Ibuprofen. We left the ER about 3 hours later and patient went to sleep normally. During the next day his fever gradually returned to normal. No other symptoms of illness were present before, during, or after. (ie no coughing, runny nose, etc). His twin brother also had the vaccine at the same time, and showed no fever or other symptoms.
extremely high heart rate/ pulse for approximately 72 hours, between 120 to 140 beats per minutes at times
The Pfizer 5-11 bivalent and the Pfizer 12 and up bivalent were in the same container. Internal Medicine staff were not aware that these boosters were kept together in the same container. There is a label on the container indicating that the Pfizer 5-11 bivalent has a pink package label and that the Pfizer 12 and up bivalent has a blue package label. Inside the container, there are 2 clear ziplocks, each housing the vials, separately. Staff member (On soft independence orientation with a phone RN backing up clinic) mistakenly grabbed the Pfizer 5-11 bivalent and drew up 0.3 ml which was administered to the patient. The medication was not diluted as it normally would have been if prepared by a pediatric RN. Undiluted, at this dose, the patient received 42.857 mcg rather than the typical 30 mcg dose. The patient was notified that she received her vaccine from the incorrect vial. Pharmacy was notified and they communicated with the state. They recommended monitoring the patient for 30 minutes post vaccine administration as opposed to the normal 15 minute monitoring period. They also recommended not repeating any doses and watching for local and systemic adverse events such as hypersensitivity, increased fatigue/drowsiness, chills, nausea, vomiting, diarrhea, headache, myalgia, and fever. Patient was contacted and notified of dose received as it was in excess of recommended 30 mcg dose. Immediately notified the clinic staff via high priority email and phone call that the container houses both the 12 and up and 5-11 pfizer bivalent doses and to pay careful attention when giving this medication. Spoke with Director of Primary Care who has already sent out communication that we are working on getting a separate, pink container for the 5-11 pfizer bivalent doses. Spoke with clinic staff RN regarding the importance of checking the five rights of medication administration prior to giving medication(s). The RN was receptive and acknowledged his error. He will use this as a learning opportunity.  I spoke to patient on 10/28/22 at 12:38p. She reports having a headache that she cannot seem to get rid of. The headache was better on 10/28/22 than it was when she woke up on 10/27/22. The patient took tylenol twice on 10/27/22 and once on 10/28/22. She reported some itching at the injection site that had resolved by the time of the call on 10/28/22 at 12:38p. Reviewed maximum tylenol and ibuprofen dosing with patient (Tylenol 1000 mg PO Q6H if no hx of liver impairment or contraindications, Ibuprofen 800 mg PO TID if no hx of kidney impairment or contraindications). If itching returns, pt. will apply OTC hydrocortisone cream and/or consider taking an OTC antihistamine according to package directions. I asked the patient to notify our office if questions or concerns arise or if she failed to improve. Patient verbalized understanding.
Left upper arm soreness, limited ROM s/p 3 weeks after vaccine administration, feels pain is not improving, reports throbbing pain.
Profound tachycardia and hypertension 7 minutes after the injection. BPM 160, blood pressure 170/90 even on metoprolol. Monitored for 2 hours then released to significant other. Continued to be symptomatic with tachycardia and hypertension for 6 hours post injection.
Patient completed Moderna COVID series 4/27/2021 and 5/24/2021. Patient then received Pfizer on 8/14/2021 Lot#- FC3181 and then received another Pfizer dose on 9/4/2021 Lot number listed on this report.
Severe headache, fever of 102, tremors, body aches, nightmares. Fever lasted for 36 hours, but was kept <100 with Tylenol.
Patient received a dose of Covid 19 vaccine that was not concentrated enough. Diluent used to mix 6 dose vial was 0.8mL rather than 1.8mL. Pt was called and checked on for adverse reactions, patient reported no symptoms other than sore arm.
20 mins post Moderna booster, pt developed a few minutes of "warmth" over small area of left chest with NO other symptoms. Subsided spontaneously. No pressure, shortness of breath, arm or neck discomfort. No history of heart disease and no similar symptoms in the past. No meds, no allergies. Nonsmoker and in good general health.  No distress, comfortable, alert. Neck: full range of motion, unremarkable. Lips: unremarkable. Chest: clear Heart: soft left systolic murmur? No rash BP: 176/90 R 180/90L HR 62 RR14  BP elevated Advised pt could go to ER for evaluation but declined (symptoms had been brief and resolved spontaneously) Denied any other symptoms  Advised to go to ER for any other symptoms or recurrence. Advised f/u BP ASAP with PCP. Pt verbalized understanding and agreed to follow instructions.  MD
VERY TIRED NEXT DAY--RASH IN AREA OF INJECTION ON SECOND DAY AFTER INJECTION WHICH ENLARGED TO FIVE INCHES ON THIRD DAY, FEET VERY ITCHY WITH WIDE SPREAD HIVES ON FEET AND LEGS , ALSO ON HANDS AND LOWER ARMS, DOCTOR VISIT FOUR DAYS AFTER INJECTION, DR. PRESCRIBED ANTIHISTAMINE AND STEROID, BY DAY SIX THE HIVES WERE FLAT RED SPOTS AND NOT ITCHY --DOCTOR AT CLINIC HAS ALSO FILED REPORT
My longstanding low-level vertigo was exacerbated:  it went from a minor annoyance (never above 3/10) to keeping my immobile in bed, unable to do anything (10/10).  This lasted almost a week, with ups and downs.  It was bad.  No idea if it was related to the vaccine, but my working diagnosis for the vertigo (dating to before the vaccine) is vestibular migraine, hormonally and stress triggered, so I wonder if the vaccine was a stressor and/or affected my hormones.
(M,61-65 years old) did not respond significantly to any of the tested streotypes; This spontaneous report was received from a non-peer reviewed article referring to a male patient aged from 60 to 65. The patient was not vaccinated with any pneumococcal vaccines before and no history of previous pneumonia. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On an unknown date (reported as "during the 2017 and 2018 seasons"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) to prevent pneumococcal infections.  The patient did not respond significantly to any of the tested stereotypes (therapy non-responder). The outcome of the event, and the causal relationship between therapy non-responder and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) were not reported.    This case was received from the same reporter with 2305USA002183, 2305USA003458, and 2305USA003459.
spots on face on 31MAR96 that worsened throughout the day;awakened on 1APR96 w/face, lips & eyes swollen;seen in ER that day;stated was given a shot of adrenalin 7 some antihistamines & pred to take home
On November 2 about 30 minutes after the injection I became dizzy. On November 3 I still felt light headed and nausea with pain around a 5 in right arm all day. The night of November 3 I noticed large welts on right arm.  On November 4 the welts continued into my armpit and into the right side of my chest along with significant pain and swelling in right arm, under arm and chest.  I took Benadryl the afternoon and night of November 4 because I was traveling.  November 5 I took more Benadryl and the swelling began to dissipate.  Through out Noveber 5 the swelling,pain and welts continued to improve with the help of Benadryl.  By November 7 all swelling, pain and welts had resolved.
diarrhea tingling of the face (for over 24 hours at this point) fatigue severe body aches
I got the shot on January 26, at the fairgrounds At 12:45 PM, Went  home By 330  pm my hand is swelling And I couldn?t even get my rings off. I had pains from my neck all the way down to my hand. Then on the 27th in the morning when I woke up my whole face was swollen lips eyes cheeks and it was burning like fire.
Exactly 8 hours after the injection I had an acute attack of gout.  This is day 8.  I did nothing to provoke it.  None in months.; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269, Expiry date was not reported), via an unspecified route of administration on 10Feb2021 11:15 (at the age of 69-years-old) in Arm Left as dose 1, single for COVID-19 immunization. The Patient Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. The Patient had no known allergies. The patient had not received other vaccine in 4 weeks. The Patient had not diagnosed with COVID-19 prior to vaccination and the patient had not tested for COVID-19 post vaccination. On 10Feb2021 18:00, the patient experienced exactly 8 hours after the injection she had an acute attack of gout and this is day 8. She did nothing to provoke it and none in months. The Patient received treatment for the adverse event was unknown. The outcome for the event was recovering.  Follow-up attempts completed. No further information expected.
Breakthrough COVID-19 case with symptom onset 7/24/2021: weakness, cough, body aches, nausea, cough, congestion, anorexia, shortness of breath. Hospitalized 7/31/2021 for unknown duration.  Death 8/27/2021. COD reported by ICP Acute respiratory failure with hypoxia, COVID-19 pneumonia,  pulmonary edema, Acute kidney failure
This spontaneous report was received from a Licensed Practical Nurse and refers to a 4-month-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally (dose was not reported) lot # N004812 with expiration date on 04-OCT-2018. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) 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) dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       AE submitted via chatbot. no concomitant medications and treatment medications was provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
10/3/2013 evening - sweats, dizziness. 10/3-10/4 all night: sweats, very dizzy, severe joint pain legs and arms. 10/4 all day: very dizzy, headache, sweats, sleep most of day.
Develop shortness of breath. In January I had Covid. Called the doctor on June 4 and a register nurse took the message for the doctor. The doctor called me back and said to put cold compress pads in my chest and recommend some pills. I took those for 1 week but on June 11 I could not breath and went to the emergency room and the doctor said not to take the 2nd dose of the vaccine. I got diagnosed with Pneumonia and have been taking antibiotics. I feel better but still feel sick. Next appointment with the doctor is June 9, 2021.
Pt reports he felt weak and diaphoretic shortly after receiving vaccine. Denies dizziness or lightheadedness. Given water and crackers and transported to med obs #1 via wheelchair. Pt prefers to sit on side of bed, rather than lying down in stretcher. No s/s of distress noted. Pt reports resolution of symptoms. Registration called to bedside to schedule pt for second dose per his request, prior to d/c to home. VS are as follows: 1300: BP 145/95, HR 85, RR 17, O2 sat 96% on RA. 1305: BP 127/87, HR 79, RR 16, O2 sat 97% on RA; 1310: BP 137/94, HR 77, RR 17, O2 sat 97% on RA.
PATIENT STATED THAT SHE FELT FAINT. PATIENT FELL TO THE FLOOR, HAD A SEIZURE, AND VOMITED. PATIENT WAS THAN TAKEN TO THE ER.