chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin irritation beneath injection site bandage initially noticed on 6/29 but did not get a good look until bandaid was removed on 7/1. At that point in time it was an irritated red, slightly swollen area about nickel size. My son complained a bit of arm pain in ensuing days - which we attributed to usual vaccine muscle soreness. However on 7/3 evening, we discovered the spot had quadrupled in size, spreading under his arm, over to his shoulder blade, with new spots arising in armpit. Visited ER that night.
On about Jan 19th, 2021, I experienced the onset of loose stools. I took Imodium and ate more fiber and nothing helped. I called the doctor for about 2 weeks later, and on March 2nd, I had a colonoscopy to further investigate why I was having the diarrhea for the last 6 weeks. This is still ongoing.
Headache, SkinRash, NauseaVomiting, Swollen lower lip only on injection side of body. Narrative:
Myalgia & Angioedema Narrative:  sore arm for 2 days. on 7th day after 1st vaccine injection had swelling if the lymph nodes on the neck that lasted for 3 days. client was at her chemotherapy appointment and had provider assess her swollen neck. providers sent in a strep test that came back negative.
Pain in left upper arm (to be expected)...however also have experienced joint pain in left elbow and in left hand on day after receiving the vaccine.
I received the vaccine about 3:55pm yesterday and within minutes a red area had developed around the site and it was itching. In the next 10 minutes the rash had spread to the entire portion of my upper body and was burning/itching like crazy. I was sent downstairs to the ED after being threatened with an epi pen that I refused (I was breathing fine, no throat itching or closing up feelings). Rash went away after about an hour, I did have some dizziness too with it. I was given a steroid shot. But now it?s been about 20 hours and I feel absolutely terrible! Headache, fatigue, nausea, diarrhea, body aches. Red around the injection site and arm is sore.
Chills; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  In MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills). The outcome of the chills was not reported.  It was unknown if the reporter considered the chills to be related to Shingrix.  It was unknown if the company considered the chills to be related to Shingrix.  Additional Information: GSK Receipt Date: 27-APR-2023 The patient self-reported that, she had experienced chills with dose 1 of Shingrix and was concerned if the dose 2 side effects would be as severe . The reporter had consented to follow-up.
Chest wall tenderness, sided, Shortness of breath on exertion, rash on abdomen, and fatigue. I am writing him up for possible Myocarditis: Echo/ Holter Monitor. Patient is improving, will also monitor for any more symptoms.
After 3 minutes of vaccination patient went into a sweat & said she didn't feel good she sat down passed out unconscious with eyes rolled back. We put her laid down on floor & she then had a seizure for about 20-25 seconds.
1-3-2021 10:30 PM Itchy legs rash on legs and arms took hot shower went to bed went away by morning. 1-4-2021  12:00 PM started to have itchty hands itchy back itchy legs itchy elbows rash around eyes  got home at 5:00 PM had rash on legs, back, arms, eyes, took Benadryl 25 mg took shower the itchy slightly eased and rash lightened up but didn't go away. went to bed. 1-5-2021 6:00 am woke up rash almost gone on back but had itchy ankles and wrists and the back of my arms. took Benadryl 25 mg before work got to work and had extremely itchy hands and slight rash in all the same spots. and itching has became less after 6 hours. 1-5-2021 12:23 pm filled out this form
Inflammatory fasciitis; cervical lymph nodes; This is a spontaneous report from a contactable physician reporting for another physician (Orthopedic surgeon).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) on 12Jan2021 in left arm via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It's unknown if the patient had any known allergies. It's not provided if the patient had had COVID prior the vaccination or had every tested post the vaccination. The patient received the second dose of the vaccine on 12Jan2021 Tuesday and by Thursday 14Jan2021 he experienced severe left upper girdle pain in her shoulder and neck. Eventually he was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. This was considered as an unusual post vaccine response. The patient was worried as he didn't know how transient or permanent this condition would be. Magnetic resonance imaging (MRI) on an unspecified date showed cervical lymph nodes and reports of lymphadenopathy from the clinical trial were discussed. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fasciitis cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Received DTap booster on 2/9/10 in left arm IM. On 2/11/ parent called office stating arm red and hard. Told outline area, gave Benadryl with ice if sx increase to come in. On 2/12/10 left arm still red but not hard. Came office right should large area of erythema. (Mother worked area where injection given on right arm although documented left arm. Put on Cefadroxil Bro x10d.
Tightness in my chest began the evening of January 11, after I ate dinner. It progressively got worse, especially if I lied down. I slept fitfully. It was still present the next day. I consulted an on-call nurse who advised I should go to urgent care, or I could try an antacid if I thought this might be heartburn. I took the antacid, and felt better; but the pain and tightness came and went the rest of the week. I went to the urgent care January 15. After triage, the nurse advised me to go to the emergency room, which I did. I was at the ER for approximately 3 hours (9 am to noon) on that day. The tightness in my chest disappeared completely on Sunday, when I rested; but has returned on and off since Monday. I have an appointment to see my primary doctor on January 25, for follow-up.
day of vaccine (4/16/21): extreme dizziness  4/20/21: extremely cold and blue hands and feet  4/26/21: numbness/tingling in face, hands, and legs 4/28/21: heart palpitations that ended up being frequent PVCs, PACs, SVT. Also dysautonomia... HR increases AT LEAST 30 BPM upon standing 4/29/21: very bad and unbearable headaches accompanied by vomiting 5/2/21: seizures started  Around this time, symptoms of psychosis also started Was admitted to the hospital 4 times starting 5/3/21 up until this date 9/27/21 Symptoms have not gone away, if anything they are now worse. Most recently, I am now experiencing terrible body aches, memory problems, and neck pain. Those are somewhat new symptoms
Chills, aches, nausea evening of vaccination - these symptoms gone next morning but right arm remained sore with pain radiating to right neck and shoulder - difficulty raising arm over head no redness or swelling at injection site.
first dose a year ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, an year ago from the date of reporting).   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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. No information from the reporter was given during the chat. No information given about the patient receiving the second dose of the vaccine till the time of reporting. The reporter did not consent to follow up.
Vaccine Underdose; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Vaccine Underdose).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant Follow-up appended: Patient details (Age group) was added.
moderate/severe induration & pain @ site of vax (lt deltoid) worsened p/4-5 days;
Patient received injection 10/08/2003 TC to office on 10/09/2003 to state large red, raised area at injection site.  Measures 5m wide by 2 in tall.  Also complained of vomiting sudden onset this AM.  Benadryl 25mg three times a day, and cold pack to area.  Advised to call office if any further problems.
Pfizer vaccine was stored outside of manufacturer's recommendation. Specifically, the vaccine was frozen longer than recommended. Patient did not have any adverse events.
Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a stroke and received alteplase at a non-facility (Medical Center)  5 days after receiving COVID-19 vaccination.
Days following dose 2, I began having fluid retention and elevated blood pressure.  Over time, it has worsened.  I am now having dizzy spells that can last 10 minutes to 6 hours up to twice a day, confusion/brain fog and heart flutters/elevated heart rate usually accompanied with fatigue.  My previous doctor treated me by increasing the metoprolol and adding hydrochlorothiazide for fluid retention.  I saw a new healthcare provider who is sending me to a cardiologist, neurologist, lipidologist and endocrinologist to figure out what is going  on.  I can not function in daily life. I cannot stand when dizzy and cannot drive.  Symptoms appear to be worsening.  In the meantime, he prescribed Ubrelvy to rule out migraines.  None of this appeared until after dose 2 of Pfizer.
Patient started noticing leg pain in both of her knees, left ankle, and left calf. It is a throbbing pain that is worse in the morning and gets better as the patient starts using it more.  Patient says she started noticing the pain in early April and has never had this problem before. She made an md appointment for May 18th.
This spontaneous report was received from a registered nurse regarding a male patient of unknown age. The patient's medical history, concurrent conditions or concomitant medication were not reported.   On an unspecified date in 2015 (also reported as three years ago), the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported); and experienced a localized rash in the area of the injection and then a generalized rash all in the body. The outcome of the events was unknown. The relationship between the vaccine and the events was unknown.
Case number PHHY2012US051970 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received INFLUENZA from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She was vaccinated with INFLUENZA (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unspecified date after vaccination, she experienced anxiety. The outcome of pregnancy was not reported. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after administration of INFLUENZA vaccine.
Severe radiating chest pain began 5/24/2021. Symptoms were intermittent for the next 2-3 days. On 5/26/2021 around 10:00 AM, while completely sedentary, heart rate increased to 180 bpm. EMS was called to the home and BP was taken on the ambulance. BP was 190/100 so recommendation to go the ER was followed. While in the ER, a chest CT with contrast was given to rule out blood clot. CT scan was normal. EKG was performed to rule out heart attack; EKG was normal. Blood work was administered and all returned normal. IV was administered and I was prescribed Metoprolol, discharged home with the advice to follow up with cardiology. For the following week, I was having ongoing palpitation, chest pain , tachycardia, elevated blood pressure, and insomnia. On 6/9/2021, similar presentation occurred. Time of occurrence was approximately 11:30 AM. I took a sleeping pill around 10:30 PM and fell asleep. I was awakened approximately 1 hour later which palpitation and tachycardia. My heart felt like it was pounding out of my chest and like it was fluttering. I took my blood pressure at home and it was 200/100. I made the decision to go the ER. In the ER, a chest xray was performed and returned normal. Again EKG was performed to rule out heart attack and returned normal. Blood work was performed and CK total was elevated at 295. Otherwise unremarkable. I was discharged with no diagnosis other than palpitation and told to follow up with cardiology. I was placed on a Holter heart montior that was worn for approximately 2 weeks to determine if heart was in arrhythmia or atrial fibrillation. Results were normal.
During a review of the local Health Dept. internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Almost immediately, tongue went numb/had tingling, throat felt tight with some difficulty swallowing, lasted then rest of the day and into the evening until I took Benadryl
Give influenza vaccines in left deltoid on 11/4/19. Initially had localized achiness and pain but 1 week later developed redness, swelling and tenderness. The pain continued in the left deltoid area. Continues to have pain but does have decreased ROM including difficulty removing jacket. Determined to have post influenza vaccine subdeltoid bursitis. Will start Physical therapy 2-3 times per week, take Ibuprofen prn and continue to use warm packs.
got the flu shot 5 times still got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 30-Nov-2020.  This case involves a patient of unknown demographics who got the flu shot 5 times still got the flu (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu shot 5 times still got the flu (influenza) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. Patient never got sick unless got shot.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not resolved for the event.  There will be no information available on the batch number for this case.
Immunization was at 10:00am. At approximately 6:15 he had a seizure with a temperature prior to this. During seizure he stopped breathing.
Red rash; It's like a bad sunburn, it's burning; It's itching; It's peeling; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), SKIN BURNING SENSATION (It's like a bad sunburn, it's burning), PRURITUS (It's itching) and SKIN EXFOLIATION (It's peeling) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement. Concurrent medical conditions included Celiac disease.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), SKIN BURNING SENSATION (It's like a bad sunburn, it's burning), PRURITUS (It's itching) and SKIN EXFOLIATION (It's peeling). The patient was treated with CLOBETASOL PROPIONATE at a dose of UNK dosage form and DOXYCYCLINE at a dose of UNK dosage form. At the time of the report, RASH ERYTHEMATOUS (Red rash), SKIN BURNING SENSATION (It's like a bad sunburn, it's burning), PRURITUS (It's itching) and SKIN EXFOLIATION (It's peeling) outcome was unknown. Not Provided          No Concomitant medication details was provided.    This case was linked to MOD-2021-114607 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up received on 26-Jun-2021:No New Information was added
back pain at site of old injury (disc) immediately after second dose.  Progressed to neurologic symptoms in right leg including pain, numbness, and clonus that lasted 6 months, did intensive PT. no trauma or any other cause.
Woke up; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Woke up) and HEADACHE (Headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (Woke up) and HEADACHE (Headache). At the time of the report, SLEEP DISORDER (Woke up) and HEADACHE (Headache) outcome was unknown.            For four days after second vaccination, the patient had been waking up by a severe headache.  No relevant concomitant medications were reported. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   Reporter did not allow further contact
11 days after lost all feeling in my legs and arms. Could not walk or move. Stiff muscles, extreme pain. Still in pain and dont have complete function of my body
8 cm. erythema at site, slightly warm. Applying ice to area 10-20 mins several times/day.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. My husband was a chief in the national guard. He held that position for 11 years. In August of 1999, my husband was scheduled to receive the first of a series of anthrax inoculations. Because of a previously scheduled vacation, he was not able to have the required first shot and was then ordered to begin his series in October of the same year with another unit. He received two inoculations in October and a third in April 2000. Although I am not able to recall the exact dates, it was during that spring that my children and I started changes in their father. He began experiencing extremely severe bouts of diarrhea. At times, they were so severe that he couldn't control himself and make it to the bathroom. In 25 years of marriage he never complained of headaches, but suddenly he began having such severe headaches he was incapacitated. Perhaps the most striking symptom his family noticed was his mental changes. He had frequent mood changes and his memory failed him so badly he could not remember people he had known for years, daily routes he drove, conversations with people. Our children and I seriously discussed the possibility of Alzheimer's, although it happened very quickly, not slowly. During this time, he also began experiencing what he believed to be low back pain due to a back problem he had experienced some years ago. He began seeing a chiropractor that helped him in the past, but this time there was no relief. After the first of the year (2001) he began a slight limp and at the end of February he went on exercise and ti was there he had his first fall. After that fall, he fell quite often and had a very noticeable gait due to foot drop. By a holiday weekend, our son graduated from high school and he had to go to the ceremony in a wheelchair. The next week, we had to take him by ambulance to the ER due to breathing difficulties and by mid June he never got out of bed again and had been placed on a ventilator. He was tested for many diseases and all the doctors could conclude was that he had ALS. He has symptoms that are not associated with ALS and there are things that doctors are unable to explain to us because they are not associated with ALS, but in the end it is what they feel it is. He was in the hospital for 8 months while doctors tried to figure out his diagnosis. In January 2002, we brought him home with home nursing care. He is not on a ventilator, feeding tube, totally paralyzed. We have no communication with him except occasionally I am able to get a yes or no answer by watching his eyes to see his iris move ever so slightly. We are assured he understands as he has had EKG's, etc. that are normal. He is now trapped in his body with absolutely no communication with the rest of the world. D/C Summary received from hospital which revealed final dx: ALS, multiple decubiti, multiple episodes of MRSA sepsis & pneumonia, respiratory failure, chronic pain & anxiety.  PEG, trach & vent dependent at home. Received vaccine records from military.