chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I broke out in horrific hives one week after my first booster shot. The hives moved around all over my body. I was on Prednisone, Triamcinolone, hydroxyzine, and Zyrtec. I still am. The itching was intense and only quelled by taking 4 Zyrtetc a day, plus hydroxyzine and Pepcid. My second booster was on 6/1/22, Moderna 054A22A, at a pharmacy. The same exact thing happened exactly a week after the dose. Intense itching, start of hives. I called my allergenist, who put me on a higher dose of antihistamines and steroids. He said it is an autoimmune reaction to the vaccine, and may last years. If I miss even one antihistamine pill, the itching is very noticeable. I've missed work because of the hives and itching. I've also had joint pain after both boosters in my elbows and knees. Nothing to note for the original 2 vaccines except for fatigue, nausea, muscle aches, and headache.
diaphoresis, pallor and fainting within ~ 5 minutes of vaccination; rescue squad was called, child stabilized and mom chose not to go to ER via rescue
Patient became light headed & woozy. She felt better after drinking water, her blood pressure was 118/72 HR 60. She left after she felt better about 15 minutes.
Patient was due for first COVID vaccine - per age I administered COVID - Moderna 0.5mL to patient at 12:15 PM today 11/08/2021. Patient did not show signs of any reaction to vaccine.
CHILLS; LOW ENERGY; MUSCLE ACHES; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach issues, nerve pain, high blood pressure, diabetes pain, non smoker, and non alcohol user, and other pre-existing medical conditions included patient have unspecified allergy. patient did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0U1A21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. Concomitant medications included lisinopril for blood pressure, gabapentin for nerve pain, hydrocodone for pain, menthol/methyl salicylate for pain, pantoprazole for stomach issue, ascorbic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, potassium, sucralfate, and zinc.  On 07-JUN-2021, the subject experienced chills. On 07-JUN-2021, the subject experienced low energy. On 07-JUN-2021, the subject experienced muscle aches. On 07-JUN-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, low energy, muscle aches, and low grade fever. This report was non-serious.
Within 24 hrs after receiving the immunizations listed below, patient's rt. arm began itching at the varicella site, then she noticed swelling and warmth to touch.  She used Benadryl (O) and put cold packs on her arm overnight.  On 3/25/09 the swelling and pain in her rt. arm was worse so she went to the ER and the MD gave her Rx for Percocet and instructed her to continue using the Benadryl and cold packs.  3/26/09 - Since her arm was even more swollen and red and warm, patient went to facility, the PA diagnosed cellulitis in her rt. arm and prescribed a course of Zithromax for her.  3/27/09 - TC to patient and she states the swelling is not worse and there are no signs of streaks going up her arm, etc.  Taking the antibiotics and also the Percocet for pain.  3/30/09 - patient reports she developed a rash over the weekend on her neck and rt. shoulder with some pustules noted.  Does say she is feeling a little better today, rash is fading, but is still taking Percocet for the pain.  4/9/09 - Office visit with patient to complete the VAERS form.  States she is feeling much better.
The day after being vaccinated, patient complained of feeling physically unwell and "zombie" like. Pain and swelling began on arm. The next day his arm swelled from the shoulder to the wrist, and pain was 9/10. Patient went to ER, they instructed icing, elevation. Swelling was better the next day, but had rash on entire body.
Patient came in on 8/10/19 with Approx. 9cm in diameter circular erythematic, swollen Rash no left upper arm. She went to local urgent care and was diagnosed with bacterial infection And given antibiotics for a 7 day course. Pt is doing Better.
Shingles onset of back pain April 30, 2021. Progressed with outbreak of rash on May 10, 2021.
soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going to take my late night showers I looked at it and it had blister on it; blister; didn't sleep well/Didn't sleep well; sore arm; Around the skin it is discolored; This is a spontaneous report from a contactable consumer  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 08:15 at a single dose for COVID-19 immunization.  Medical history included covid-19 around 15Jun or 16Jun2020 and did the quarantine.  The patient's concomitant medications were not reported. Patient had soreness and tiredness the next day after vaccination on 16Jan2021 and took TYLENOL every 4 hours. She was concerned because on 16Jan2021, when she was going to take shower, it looked bruised, and blister on it. Patient didn't know what to do. Patient applied ice packs. The patient had patches, blister on top of that and it was not at the injection site. It's where she applied the ice. That was on 15Jan2021. She also didn't sleep well on 15Jan2021. She took ibuprofen but was not running a fever with no itching. Around the skin it was discolored on Jan2021. Patient was scheduled to get the 2nd dose in 3 weeks. Patient took her Pfizer Vaccine (Covid Vaccine) on Friday morning the 15th approximately 8:15 in the morning. Other than a sore arm on Friday she was okay. They told her to put ice pack on it for soreness. So she did that afternoon. On 16Jan2021, she looked at it in the morning It looked like bruise on the arm, not where she gave patient the injection but down a little below her arm and it looked like a bruise and then in the afternoon she was going to take my late night showers I looked at it and it had blister on it. She took Ibuprofen. She didn't have fever. She felt herself today. On 16Jan2021, in the morning she did feel tired and she did take afternoon nap for about 2-3 hours because before that she didn't sleep well. She already knew that she need at least 8 hours.  Patient height was reported as about 5'3.Outcome of the event soreness was not recovered while for the remaining events was unknown. The reporter considered the events as non-serious.  Information on lot number/batch number was requested.  Follow-up (17Jan2021): New information received from a contactable consumer included: new event (sore arm), patient weight, and event details.
I administered the  Fluzone high dose to the patient and she is 64 years of age. There was no adverse outcomes.
Initial report was received from a health care professional on 30 March 2011. A 47 year-old female with a history of right arm bursitis from seven of more years ago had received on 25 March 2011 a first dose intramuscular right deltoid injection of ADACEL, lot number U3553CA (sanofi pasteur Ltd. lot number C3677) and unspecified amount of time later experienced muscular-skeletal pain with limited range of motion and a small nodule at the injection site. According to the reporter, the patient was unable to raise her arm above her head or bring her arm across the front of her chest without pain. Treatments were not reported. The patient had no illness at the time of vaccination and had no other vaccinations within four weeks prior to the suspect vaccine. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received 17 May 2011 from a health care professional. ADACEL had been administered with a 25 gauge 1 inch needle. The patient was seen by their primary care provider in early April. An x-ray was performed and showed negative for disease. She received corrective treatment with Methylprednisolone injection x 1 into the bursa and a course of PT (physical therapy). On 11 May 2011, the patient was fully recovered with no lasting effects. Documents held by sender: none.
Pt was ok after vaccines was given, 5 minutes after the vaccine the patient walked out of the room, and once he arrived to the door he hit his head on the door and slowly started to fall. Pt did not hit the floor, was carried to the first patient room where he was laid down with feet raised. Pt was given ice packs and water to help.
Severe: Fatigue, shaking chills, generalized aches, clammy skin, pain. Difficulty moving Moderate: nausea. Mild: fever, headache.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 99.6 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Pt safety incident post 1st Maderna vaccine About 12m after administration in the post vaccine observation area Pt stated she was dizzy and hot BP was taken 125/85 p112 Pt states she had not eaten or drank anything this morning She was provided another water bottle  and able to drink 1.5 bottles also able to drink small can of regular Coca cola and an apple sauce snack as well as a large banana completely Since the temperature in the room was  getting warm the AC was turned down to make room cooler A cool pak was applied to back of pts neck she verbalized she was feeling better and was grateful  for our care. Reminded pt to eat and drink prior to her next vaccine in 4 wks Pt was walked  to her Uber ride in stable condition. Safety report filed.
joint ache, nausea, fatigue,  no appetite, no taste, very weak, difficult swallowing, memory problems,. Start evening of 2/25 to present - 3/22/21  Emergency room treatment: blood profile, X-rays, Cat Scan, urine analysis, etc.  All OK.
itching and redness at injection site; redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 3XR3X, expiry date 12th September 2022) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix. On 3rd November 2020, immediately after receiving Shingrix, the patient experienced injection site itching and injection site erythema. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site itching and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with dose of Shingrix. The patient had itching and redness at injection site straightway after getting vaccine. The patient took antihistamine to decrease reaction. Till the time of reporting reaction were not recovered. No other information was provided. The reporter consent to follow up.
24 hours after vaccine I had some mild side effects such as aches and low grade temperature, but nothing really significant. 12 hours after that, I experienced tightness in my chest that lasted and was a bit scary. My whole chest was tight for 10 minutes and then I relaxed. That night I took my blood pressure and it was 210/105 which was very scary. I ended up going to local Urgent Care and they did a complete work up and checked for heart attack and did a D-dimer for blood clots. I was at local UC for a couple of hours and my blood pressure went back to normal and stayed normal. I monitored it for a couple of weeks and it was fine after that.
I received my Pfizer Bivalent Booster on 11/03/2022. My adverse event started on 01/14/2023 in the morning as soon as I woke up around 07:00AM. I had severe pain in my stomach. It wasn't like a normal pain. It was on my left side. I tried to go to my doctor's office on the 01/16/2023 but since it was a holiday I had to schedule it for 01/17/2023 at 11:00AM. They asked me what was going on and about different issues I had with my stomach. They told me to get a X-ray done. It was normal. They also asked me to get a CT scan on 01/18/2023. When the results came in they diagnosed me with diverticulitis. They gave me IV with saline solution and also antibiotics. I went back for the rest of the week for IV infusion. They gave me an oral antibiotics to take as well. They prescribed with clindamycin which I started taking on 01/21/2023 for 10 days. They also told me to take probiotics over the counter.
Bleeding at injection site; lightheaded; chills and shivering; tired and sleepy; achy all over; Sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date and had no problems).   On 20-JUN-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced light headedness (Verbatim: lightheaded), chills (Verbatim: chills and shivering), tiredness (Verbatim: tired and sleepy), general body pain (Verbatim: achy all over) and sleepiness (Verbatim: Sleepy). On 20-JUN-2023, the patient experienced injection site hemorrhage (Verbatim: Bleeding at injection site). The outcome of the injection site hemorrhage was resolved and the outcome of the light headedness, chills, tiredness, general body pain and sleepiness were not resolved.   It was unknown if the reporter considered the injection site hemorrhage, light headedness, chills, tiredness, general body pain and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage, light headedness, chills, tiredness, general body pain and sleepiness to be related to Shingrix.   Additional Information: GSK receipt date: 21-Jun-2023 The patient received a dose of Shingrix and this time had the injection site bled (down her arm) after shot given. In June 2023, hours later the patient experienced lightheadedness, chills and shivering and had been achy all over. The patient also been sleepy and tired. Referred to health care professional. The reporter did not consent to follow-up.
Vaccine administered, and report of dizziness and lightheadedness occured immediately.  Temperature elevated over the next 3 hours.  Rash noted on upper aspect of legs and reported swelling of tongue.  Evaluated at the Emergency Room and anaphalaxis ruled out.  Discharged home from ER.  Returned to ER on 9/4/21 for continued complaints.  Evaluated and discharged.
Skin discoloration; COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4289413-00.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", SARS-COV-2 TEST POSITIVE (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "COVID-19 virus test positive"; SKIN DISCOLOURATION (non-serious), outcome "recovering", described as "Skin discoloration". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. The action taken for risankizumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The event COVID-19 was reported as non-serious. The reporter's causality for the event(s) of COVID-19 POSITIVE with SKYRIZI (RISANKIZUMAB) was not provided and for the event(s) of Scaling Down Considerably, But Still Remains Marks/ Discoloration with SKYRIZI (RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event(s) COVID-19 and Scaling Down Considerably, But Still Remains Marks/ Discoloration with PFIZER BIONTECH COVID-19 VACCINE was probable.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available.
Pt recvd 3 doses of Engerix-B  & did not seroconvert;
All over body aches, hot, cold, sleeplessness, extreme fatigue, exhaustion, headache, welt at injection site, injection site swollen, hot, soar, and itchy. Symptoms lasting 5 days after injection.
Approximately 2 hours after vaccine was given , the patient complained of lightheadedness and upset stomach. Afebrile, denied any symptoms of adverse reactions.  On 12/14/2000, the employee called Employee Health stating she was ill and had not been able to work the afternoon of 12/12 or 12/13 "due to" R/O body aches, GI upset, redness, edema, and tenderness at the site of the injection. Employee seen on 12/14/2000 at 15:00 with redness of 3 inch by 4 inch and 2 inch by 2 inch edema at the left deltoid. On 12/20/2000 follow-up call to employee made, patient states "feels fine", no redness, "pea size knot" at site, no GI disturbance. Instructed to call Employee Health or go to ER if any change. Symptoms of adverse reaction reviewed thoroughly with employee on 12/12, 12/14 and 12/20/2000.
patient called the afternoon of 12/22/20 to say that she began having a rash develop behind her ears after getting her vaccine yesterday. The rash continued to expand on to her face. She began taking her regular allergy meds and I believe some Benadryl and the rash started to subside. Advised pt to contact her doctor if it worsened and she said she would, but believed it was getting better.
Rash at injection site approximately 4- 5 days after; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 12:30 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included dystonia and penicillin allergy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 04Feb2021 at 14:45 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. On 02Mar2021 at 00:00, the patient experienced rash at injection site approximately 4- 5 days after the vaccination. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash at injection site was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given a 2nd Havrix Hep A after receiving one 7 wks earlier. Contacted spoke with provider, contacted Guardian (grandmother),  Immunization and GSK - vaccine specialist. Was advised by employee at GSK, that the patient would need to receive another booster shot after last dose.
Hand pain; Did not receive the second dose yet because of the availability; This case was reported by a consumer via call center representative and described the occurrence of pain in hand in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in hand and product supply issue. On an unknown date, the outcome of the pain in hand and product supply issue were unknown.   It was unknown if the reporter considered the pain in hand to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that she got the first dose of the Shingrix about 2 years back at a pharmacy. The patient had hand pain post vaccination. Till the time of reporting the patient did not receive the second dose because of the availability. Complete information could not be obtained as patient did not respond to questions. The reporter did not consent to follow up.
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A fib" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrocodein, reaction(s): "Allergy"; Flagyl, reaction(s): "Allergy"; Cipro, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for treatment of COVID-19 from 18Apr2023 to 23Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175656 same patient/reporter, different drug/event;
Small, dark-colored fleck of particulate noted in vaccine vial when withdrawing subsequent doses. No particulate observed by vaccinating RN upon withdrawal of this patient's dose in the syringe or vaccine vial.