chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My left leg, it started when I fell asleep during the night, it started to feel numb; Side of my ankle on the left side, my left leg ankle outside is numb and its numb over down to my foot; I got up and shook it of with my foot and so, everyday it is goes worse and worse; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ZW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 09:30 (at the age of 64-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included diabetes. Concomitant medication included Naproxen taken for pain, a muscle relaxer; and dapagliflozin propanediol monohydrate, metformin hydrochloride (XIGDUO) taken for diabetes. The patient previously received first dose of BNT162B2 (Lot number: ER8729) in Arm Left on 06Apr2021 (1:30 in afternoon) for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient stated, "I would say around the 10th of this month, I was waking up with my left leg, it started when I fell asleep during the night, it started to feel numb, I got up and shook it with my foot and so, everyday it is goes worse and worse but I can't, side of my ankle on the left side, my left leg ankle outside is numb and its numb over down to my foot and I can't move my foot back so it's like my foot is numb and it stays that way and it has not gone away" on an unspecified date in May2021. When probed for time of vaccination again, the patient stated that "No, it's not but I remember on 29th, it was at, the first shot was on 1:30 in afternoon, you know the second shot was on 9:30, it was early, right after the open". No treatment received for the events. There was no investigation assessment and lab test. The outcome of event numbness in feet was not recovered and was unknown for other events.
High fever (no temp available), limp staring into space, non responsive to mom's voice for approx 25 to 30 minutes;
POTS; joint pain; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 18-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2010 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS) and arthralgia. According to reporter, the events were related to the suspect therapy.
many little dots/hives/hives are located on the left side of the back; itchy back; pin prick little bump on her back; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-SEP-2023, the patient received Arexvy (left arm). On 11-SEP-2023, 3 days after receiving Arexvy, the patient experienced papular rash (Verbatim: pin prick little bump on her back). On 12-SEP-2023, the patient experienced hives (Verbatim: many little dots/hives/hives are located on the left side of the back) and pruritus (Verbatim: itchy back).  The patient was treated with hydrocortisone (Hydrocortisone Cream). The outcome of the hives, pruritus and papular rash were unknown.   It was unknown if the reporter considered the hives, pruritus and papular rash to be related to Arexvy.     It was unknown if the company considered the hives, pruritus and papular rash to be related to Arexvy.   Additional Information: GSK Receipt date: 12-SEP-2023 The patient self-reported this case. The patient noticed a pin prick little bump on her back.  On reporting day, the patient experienced an itchy back along with many little dots/hives. The patient was using 2.5 percent Hydrocortisone cream on the hives, which was effective. The patient reported that the hives were located on the left side of the back. The reporter consented to follow up with healthcare professional.
Patient had critically low thrombocytopenia (low platelets) discovered via lab.  Platelets had previously been normal.
arm pain; body aches; This is a spontaneous report from a contactable consumer (patient) via Pfizer- sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on 06Aug2021 11:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient explains that she got her first dose and patient experiencing body aches and arm pain on an unspecified date in Aug2021. She took Tylenol but mentions that it does not work for her. She would like to take ibuprofen and wants to know if it would be ok or is Tylenol the only thing recommended. Therapeutic measures were taken as a result of arm pain and body aches. The outcome of the events was unknown.  Information about batch/lot number has been requested.
She started off getting very fussy during feedings and was very sleepy (approx. 10:00 am). Within 8-10 hours she began vomiting every 45 minutes, refused all bottles, and was extremely lethargic. We called the emergency pediatrics line and they advised we watch her closely and try giving her Pedialyte if she would tolerate it. By approximately 11:30 pm, she had jelly-like blood in her stool. At that time we took her to the children's emergency room where they diagnosed her with intussusception. They were able to release the blockage with an air enema.
tenderness; redness; This case was reported by a physician via call center representative and described the occurrence of tenderness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tenderness and erythema. On an unknown date, the outcome of the tenderness and erythema were unknown.   It was unknown if the reporter considered the tenderness and erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed tenderness and redness following that resolved after a few days. For tolerances of 2nd dose, refer case US2020140210, reported by same reporter for the same patient. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140210:same reporter
6 hours after first vaccination patient developed generalized itching over the face, hair line, ears, feet and hands with an associated red rash in these locations.
Pt. received her first dose of Moderna vaccine in her left arm on 3/11/21 and began having symptoms on 3/13/21. She noticed a heaviness feeling in her right shoulder extending to her elbow with her right arm feeling limp and her right hand cold. She spoke with her doctor's office on 3/17/21. Her symptoms have continued.
Second dose of Jynneos was administered on day 18 instead on day 28; Case reference number US-BN-2022-002180 is a spontaneous case report initially received on 31-Aug-2022 from other health care professional via Communication (reference number: USBAV22-1237) and concerns a male patient.  The patient's relevant medical history and concomitant medications were not reported.  On 12-Aug-2022, the patient was vaccinated with first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis.  On 30-Aug-2022, 18 days after the first dose, the patient was vaccinated with second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced adverse event.  Additional information received on 31-Aug-2022 from Bavarian Nordic included local BN number.  The case is linked with US-BN-2022-002181, US-BN-2022-002182, US-BN-2022-002183, US-BN-2022-002184 due to the same reporter.; Reporter's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
Patient reported shot given at approximately 12pm on 10/29/12 & at approximately 3pm same day, he developed a rash from his left shoulder to elbow. Applied ice & went away by end of day.
A rash occurred the day after vaccination. It has continued to spread into the shape of a circle. Itchy and a little pain.
Pt accidentally given full 0.5 mL dose as 4th dose instead of 0.25 mL.  Pt is immunocompromised and currently on chemotherapy.  Pt reported no side effects or problems with vaccine 24 hours later, pt not upset about getting a full dose instead of half dose.
Poly Myalgia Rumatica: an auto-immune disease, very painful shoulders, painful hips, tired.  Also, diarrhea with may be microscopic colitis, but it was not able to be confirmed, but also cleared up with the prednisone.
P.S. was given Pfizer for second dose vaccine.  First dose was Moderna.  Pt had vaccine with Pfizer as first dose, however it was Moderna.
My arm had stopped hurting and showed no symptoms. Then this morning the injection site was slightly raised again and slightly red. Now there is a 2 inch diameter, red welt.
Fatigue, Loss of appetite  Fever of 101.5F for 24hours  Chills  Body Aches  Woke up Sunday morning the 25th of April with very minor fatigue and 98.2F Completely normal feeling by mid morning Sunday the 25th of April
About 5 minutes after receiving vaccine, patient passed out unconscious and woke up about a minute later.; This is a spontaneous report received from a contactable consumer (patient). A 27-years-old male patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 11:55 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient about 5 minutes after receiving vaccine, passed out unconscious and woke up about a minute later. Treatment received for the event was unknown. Event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered.  Information about lot/batch number has been requested
Received Friday.  Injection site had a 2 in. diameter of hard tissue and very red.  Went back Sat. morning to talk to pharmacist and he said just side effect.  Sat night 6in. dia. of red area, and hardness.  Facial checks very red, no temp, nose stopped up.  Took Tylenol and helped.  Sunday morning arm red to elbow.  Just left arm.  Monday entire upper body red to waist.  Down both arms, chest to waist.  Went to Dr. office and asked to see my dr. nurse.  She looked at it and said Dr. needed to see this.  She said it was not just a rash but solid red.  Checked temp, breathing, throat, etc.  Still no temp.  Told me to never take moderna or pfizer. This will be added to known allergy list.  Told me to take zertec.  I bought the generic brand.  Took for approximately 5 days.  Knot is arm took longer to go away.
Diarrhea; HCT level has been low; Patient states that his butt hurt.; tired; Soreness in the arm; A spontaneous report (United States) was received from a Consumer concerning a 66 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in the arm(Pain in extremity), tired(Fatigue), diarrhea, patient states that his butt hurt(Musculoskeletal pain), hct level has been low(Haematocrit decreased).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Jan 2021, the patient experienced the events soreness in the arm. tired. On an unknown date, the patient experienced the events Diarrhea. Patient states that his butt hurt., HCT level has been low.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, soreness in the arm, tired, diarrhea, patient states that his butt hurt, hct level has been lowwas not reported.
Heart Attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Vial Opened 11/24/21 at 812AM   Do not use after 212pm (6 hours from dilution)  Vaccine was administered to this patient at 244pm -32 minutes after expiration time.
He ( female to male transgender) started with tingling in left arm and hand, then itching in different places. Then developed hives on face and back.  Given benadryl about 15 min after very first symptom started.  The hives and itching stopped and he never needed epinephrine.  Never had respiratory or throat symptoms.  He was discharged home and needed no further treatment later.
STILL HAD PAIN IN ARMS; HEADACHE IN THE FRONT OF HEAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced still had pain in arms, and headache in the front of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still had pain in arms, and headache in the front of head. This report was non-serious.
Headaches, multiple rashes on both sides of abdomen, right arm, lower left side of back, two on lower chest areas.  Rashes similar to food allergy rashes.
56 yr pt with hx of multiple abd surgeries came to ER with c/o generalized abd pain associated with nausea and vomiting. She had last BM 24 hrs ago. seen in ER, CT done shows dilated small bowel loops with transition likely in distal ileum suggestive of SBO.No CP,SOB,N,V,D,LOC.
On day 10 I experienced numb tongue, symptoms became worse the following day.  I reported to the ER and was diagnosed with Bells Palsy. Not sure vaccine had anything to do with it.
-Swollen lymph nodes palpated on the armpit and under the injection sites -Fatigue
Information has been received from a consumer concerning her daughter, who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular while she was 2 months pregnant. The consumer stated her daughter was almost five and a half to six months pregnant when she started having pains in her side, went to the doctor and was told everything was ok and went home. The next week her pains started again and then felt like contractions, and when she went to the doctor she was already dilated around four or more centimeters and they couldn't stop her contractions. The consumer reported that the baby was born and then died (No further details provided). The mother's experience is reported in WAES 0810USA02499. Upon internal review, preterm labor was determined to be an other important medical event. Additional information has been requested.
dermal fillers swelling; A spontaneous report (United States) was received from a non-heath care professional concerning an unknown patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin swelling.  The patient's medical history included 2 reports of dermal fillers swelling prior to vaccine administration. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received unknown dose of mRNA-1273 for prophylaxis of COVID-19 infection. After 2 days of administration of COVID vaccine, the patient experienced with 3rd episode of dermal fillers swelling. The 1st two dermal fillers swelling were reported prior to vaccine administration.  Laboratory details were not provided.  Treatment details were not provided.   Action taken with mRNA-1273 in response to the events was not reported.   Th outcome of the event at the time of the report were unknown.  The relationship of the reporter assessed event, dermal fillers swelling to the study drug was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Red blisters on hands/feet appeared 7-10 days after 1st vaccine and around 2 weeks after 2nd vaccine.  Treated with topical steroid creams which provided minor relief, but did not completely resolve the issue.  Bumps were almost gone except for a few on right hand when I got the 2nd vaccine.  Then came back in slightly different areas within 2 weeks of 2nd dose.
1 of 4 pts vaxed from the same lot exp an adverse event; pt exp inject site react (10 cm diameter); react bright red, swelling & warm to touch; rx'd w/ASA; following day had sinus/cold sx;
Pt recv vax on 12/3/98; on 12/9/98 pt exp vax site red & puffy; tx=ice
I had side effects; 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 VACCINATION COMPLICATION (I had side effects) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had side effects). At the time of the report, VACCINATION COMPLICATION (I had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
varicella rash; This spontaneous report was received from a physician and refers to a 20-month-old female patient. The patient had no pertinent medical history, drug reactions or allergies and concomitant medications.  On approximately May 2021 (reported as about 8 months ago), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, dose number, vaccination site, route of administration, lot # and expiration date were not provided).  On an unknown date, the patient developed a varicella rash. On 19-JAN-2022, the patient was seen in an emergency department (ED) for the rash. The action taken with suspect vaccine and outcome of the event were unknown.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.