chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bleeding flare; Diarrhea flare; This is a solicited report received from marketing program based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4066686-00). A contactable consumer (patient) reported that a 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, TOZINAMERAN, Solution for injection), via intramuscular on 14Aug2021 (at age of 45 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Daily dose: CF (as reported) for Moderate to Severe Ulcerative Colitis. No relevant medical history. No known allergies. No concomitant drugs taken. The patient experienced bleeding flare and diarrhea flare on an unspecified date.  The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date. The outcome of events was recovering. The causality as per reporter (Drug/Vaccine) for events and PFIZER BIONTECH COVID-19 VACCINE was Possible, for events and HUMIRA was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, A possible causal relationship between reported events and suspect product BNT162B2 cannot be completely 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.
Received PROQUAD and Hep A on 06/28/2017, uneventful 6/29/17. On 6/30/17, hives developed, rushed her to ER. Upon arrival, the hives (Urticaria) resolved (gone) completely. Doc in ER said its reaction to vaccination. Not seen in office since then, no hives after 6/30/2017.
8/17 - swollen eyes and cough 8/26 - sore throat, cough, hurt all over, wheezing, drainage.  Had no voice.  Covid test was negative.  Got steroid shot. 8/27-8/29 - same symptoms plus dizziness 8/31 - no better.  Had a lot of trouble breathing.  Went back to dr.  Got antibiotics and inhaler. 9/1 - voice finally came back and started feeling better 10/28 - same symptoms as above.  Got steroid shot.   10/31 - no better.  Went back to dr and got antibiotics.   11/2 - finally got voice back 11/2
Moderna COVID-19 Vaccine Patient came to clinic stating he was positive for COVID back in December and received his first vaccine on 01/08/2021.  He states that evening he became ill as if he had COVID ag ain with complaints of fever, fatigue, chilling, aching vomitting and headache.  This last through Saturday night.  He felt much better on Sunday but is still very fatigued even today.  (01/14/2021).  He is concerned about taking the 2nd vaccine.
Vomiting; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 25Jan2021 (Lot number: EL9262) at the age of 69 years as dose 1, single and administration date 20Feb2021 (Lot number: EL9267) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomiting". Therapeutic measures were not taken as a result of vomiting.  Additional information: The patient was not admitted to the hospital due to the event.  No follow-up attempts are possible. No further information is expected.
Vaccine administered on 11-12-02 within 48 hours right deltoid became red, swollen with blotchy rash, warm to touch. Shoulder and elbow involved. Medrol dose pack and Cipro 500 bid x 10 que
The patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022.) in an 83-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2022 at 2:18 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 11-May-2022 at 2:18 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  The patient had not taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination and also not had any acute illness at the time of vaccination and up to 1 month before.  Hcp reported they administer a vaccine that expired on the 29Apr2022 to less 5 patients which was the dose administered after 30-day Use By Date or after manufacturer date of expiry.   Number of vials and date the vial was initially stored in the refrigerator were unknown.   The vial did not undergo any temperature excursions.  The event does not caused the patient to seek the medical care.  It was unknown if the event most likely caused by Mrna-1273 and the patient experienced a similar events in the past.   Treatment details were not given.   This case was linked to MOD-2022-573908 (Patient Link).
U07.1 - COVID-19 J12.82 - Pneumonia due to coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified
This spontaneous report was received from an office manager and refers to a 1 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 25-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
woke up in the middle of the night; shivering; shaking; feverish, general malaise; muscle aches and pains; headache.  Lasted about 36 hours.  Patient took ibuprofen; acetaminophen.
About 1 hour and 40 minutes later I suddenly couldn't breathe--felt like a bag of bricks on my chest and my stomach swelled and I had intense cramping.  I took a benadryl---the intense cramps lasted for about 4 hours.   I didn't go to the hospital to be monitored as I didn't want to spend the money for nothing, so I monitored.
This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a nurse concerning a 6 month old patient who, on 28-OCT-2008, was vaccinated with dose 1 of ROTATEQ. No symptoms reported. No product quality complaint. Additional information has been requested.
so sick; Initial information was received on 30-Nov-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient) via social media.  This case is linked to case 2020SA346200. (same reporter)  This case involves a female patient (age unspecified) who had so sick (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient had so sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Event was assessed as non-serious.    On an unknown date: Virus check was performed but result not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported for event.  Author/Reporter comment:  Product Name: Product name was not provided. Since this is a public post on the Sanofi Site we are assuming the consumer is referring to the Sanofi flu vaccine.  There will be no information available on the batch number for this case.
DECEMBER 1ST: SRE AND MILD SWELLING ON VACCINATION SITE. DECEMBER 2ND: NUMBING SENSATION OF LEFT FOOT AND TOES, MILD PAIN OF LEFT KNEE. BY THAT EVENING LEFT HAND FELT WEIRD AND THEN NUMB. DECEMBER 3: LEFT FOOT NUMBING SENSTATION, LEFT SIDE OF FACE FELT WEIRD AND NUMB, MILD EARACHE, MOUTH FELT WEIRD. BY THAT NIGHT MOUTH HAD GONE NUMB AND I BIT MY TONGE, ARMPITS TENDER AND SWOLLEN.  DECEMBER 4: PERSISTENT EARACHE, LEFT SIDE FEELS NUMB, DECEMBER 8. MOST SYMPTOMS HAVE GONE AWAY EXEPT FOR LEFT FOOT NUMBNESS AT SOLE OF FEET AND ARMPITS STILL VERY TENDER
Son called and stated that his father had a seizure after receiving a flu vaccination. Son stated that father transported to ER by ambulance & is ok now.
I woke up the morning of 8/24/21 with a raised rash on my left arm right where my vaccine was given. My left arm is still very sore as well. This is occurring 5 days after I received my Moderna vaccine.
This spontaneous report was received from an unknown age female consumer via company representative reporting on herself. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date in 2017 (also reported as "last year"), the patient was vaccinated with hepatitis b vaccine (manufacturer unknown), (dose, frequency, dose number, route, anatomical location, lot number and expiration date were not reported), for prophylaxis, as part of her job-related immunization requirements. No other suspect or concomitant therapies were reported. On an unknown date in 2017 (also reported as "ever since the shot"), the patient had been suffering from multiple unexplained allergic reactions (multiple allergies), that she never had before the "shot". At the time of reporting, the outcome of multiple allergies and the causal relationship between the multiple allergies and the therapy with hepatitis b vaccine (manufacturer unknown) were unknown.
I'm having spasms in the area in my kidneys. My Microscopic Colitis became inflamed along with all of my other organs. Increase in Bilateral neuropathy in both legs. My L5 S1 burns most of the time. My C5 C6 pinched nerve increased burning in both arms and my hands. Stiffness on the right side of my neck and head. I do not have Covid. We test at the facility that I live at regularly. This is disrupting my sleep. I am still dealing with this at this time.
Pfizer-BioNTech COVID-19 Vaccine Swollen lymph nodes (lymphadenopathy) left/right armpit. Left predominantly.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 19-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
The pt experienced pain in left deltoid with shoulder flexing or if I lean on my elbow, protraction of left shoulder in are where shot was given.
Waxing and waning headache and dizziness for a week after administration.  Seen in office 4 days later.  Afebrile, not orthostatic, normal vitals and exam.  Treated conservatively with NSAID. Can fax note, if desired.
Tenderness, redness, warmth, bump at injection site a little over a week after vaccination
5 mins- red itchy rash 1 hour- took zyrtec (benadryl allergy) 2 hours- itchy throat, shortness of breathe 230- diarrhea and nausea  230- given IV steroids  400- feeling better sent  home with instructions to return to ER is symptoms return and to continue with oral antihistamines
The patient experienced fever and malaise and other symptoms similar to when he had pneumonia. They ended up taking him to the emergency room and he was treated there and released.
Upper left arm area. Within an hour, sore, achy, warm-area grew to approx. 3" round circle at injection site. By 2 days, upper part still sore, then a band across the lower part of bicep, the width of two fingers, and thickness swelled-and a rash. Down near the elbow crease, below the rash band and swelling a lump and rash in a rough circle. All dissipated withing 2 days of rash. NOT a shingles rash. October 13 - my right arm had broken out in shingles on lower inside of arm, in two places.  Got medicine immediately within 2 hours of the rash coming out. Completely cleared by Oct 23.   Flu shot given Oct 31st.
delayed cutaneous hypersensitivity reaction Narrative:  next to injection site, rash was itchy, onset 3 days and resolved within 5 days.  Other Relevant History:
Fever, chills, body aches for 24 hrs and fatigue and some shortness of breath for a week
7 days p/vax, PT developed "hives"; was seen in ER & given "a shot" & antihistamines to take for several days;
I started with a sore throat. Then, irritated sinuses. Nasal and sinus congestion followed. My smell was off. I had chest congestion that never really developed into a cough. I had severe headaches and body aches along with low energy and overall fatigue. I visited with a doctor virtually. He prescribed nasal spray and throat spray.
1st shot, 07/23/2021 woke up early in morning with chills, sweating, fever, severe headache, very weak, extremely tired. Pain in left arm at injection site with red, hot, hard area about 3" diameter, by the end of day, entire arm was red, hot, and very swollen to wrist. Itchy. Took 4 days for that to go away. Stayed in bed sleeping most of day and kept taking tylenol, and drinking water. I did not take any of my normal meds that day. Barely ate anything. 07/24/2021; Just rested most of day still tired and still severe headache, all other symptoms were gone except arm problem Headache took 3 days to go away fully. Has watery diarrhea 2X within 1 hour that day, then I was good.  2nd shot; felt good most of day, til 08/20/2021 at 1:30am. Had chills, Fever, even with 5 blankets and fully clothed with socks on for most of the night, Somewhere around 6am I woke up drenched in sweat, but still chills. I was very tired all day, headache but not as severe as 1st shot headache. Took tylenol all day (as soon as I got in my car to leave) with water as much as I could drink, to stay hydrated. Didn't really eat much. Constipated for 3 days this time. Slept for 18 hours. The next day still tired, rested all day sleeping about 12 hours. Next day good as new.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received Paxlovid from 12Mar2023 to 17Mar2023 as treatment for the event.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dizzy, nausea, chills, body aches on 1/29. Gradual left lower leg pain and rash starting 1/30. Had to go to urgent care on 2/1/21 and missed work for 2 days.
On the 15th day after vaccination with Pfizer vaccine, I got dizzy for a few seconds while laying on my couch. Within a few hour after that I started with loud ringing in my right ear; this happens to be the same side I was vaccinated on. That same night I got a headache and was throwing up. The louder ringing in my ear lasted few about two and a half weeks. Since then is has gradually been subsiding.
Ptn received second dose of Moderna Vaccine at a 21 day interval not 28.
tiredness; sore arm; aches and pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Oct2021 14:34 (Lot number: EW0187) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), intramuscular, administered in deltoid left, administration date 01Oct2021 (Lot number: UJ716AB, Expiration Date: 30Jun2022) as dose 1, 0.5 ml single. Relevant medical history included: "crohns disease-in remission" (unspecified if ongoing); "Denies current use of tobacco", stop date: 2011, notes: Denies current use of tobacco. Positive history of tobacco use cigarettes 1 pack per day X20.00 years quit 2011. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); CALCIUM 600 WITH VITAMIN D3 (ongoing); FISH OIL [COD-LIVER OIL] (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 06Mar2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 27Mar2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 02Oct2021 01:30, outcome "recovered" (Oct2021), described as "tiredness"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2021 01:30, outcome "recovered" (Oct2021), described as "sore arm"; PAIN (non-serious) with onset 02Oct2021 01:30, outcome "recovered" (Oct2021), described as "aches and pains". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pain in extremity, pain. Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: no. Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Since the vaccination, has the patient been tested for COVID-19: No. known allergies: no. Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? No. Patient is postmenopausal. Vital Signs: BP Temp F: 97.60 HR: temp scan. Encounter for immunization: Patient received both Pfizer Covid booster and Influenza vaccine without incident.  No follow-up attempts are possible. No further information is expected.