chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd vaccine- slight tenderness; shortness of breath; fever for 24 hours started 12 hours after shot/ 101 fever for about 24 hrs; triggered my IBS; walking dog up a hill and felt like pass out; fatigue/ extreme fatigue; This is a spontaneous report from a contactable consumer, the patient via Pfizer Sponsored Program. A 67-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot mumber: EN5318 and expiration date not reported), via an unspecified route of administration, administered in left arm on 13Feb2021 13:30 (at the age of 67 years) as dose 2, single for covid-19 immunization; and tetanus vaccine, via an unspecified route of administration in left arm on 22Jan2021 (lot number and expiration date not reported), for an unspecified indication. Medical history included ongoing irritable bowel syndrome and osteoporosis. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot mumber: EL3246 and expiration date not reported) via an unspecified route of administration, administered in right arm on 20Jan2021 10:15 (at the age of 67 years) as dose 1, single for covid-19 immunization. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19, since the vaccination. Concomitant medications were not reported. On 14Feb2021, patient experienced slight tenderness, fever for 24 hours started 12 hours after shot/ 101 fever for about 24 hrs, shortness of breath, and got triggered irritable bowel syndrome. On an unknown date patient had fatigue/ extreme fatigue and while walking dog up a hill patient felt like she was going to pass out. All symptoms resolved the 15Feb2021. One week later, on 20Feb2021, the patient again experienced fatique and severe shortness of breath with slight exertion recured and persisting as of 22Feb2021. Patient did not take any treatment for the events. The outcome of event slight tenderness, and fever was recovered on 15Feb2021, shortness of breath and fatigue/ extreme fatigue was recovered with sequel and for triggered irritable bowel syndrome and walking dog up a hill and felt like pass out was unknown.  No follow up attempts are needed. No further information is expected.
Post vaccination pt reported pain in epigastric region related to anxiety and difficulty breathing. Pt transferred to med obs via hospital bed. Pt was given apple juice and water to drink while resting. Pt required a translator. Pt released at 1700. Vitals as follows: 1644 LYING BP 141/80 HR 107 SPO2 99 1656 LYING BP 123/82 HR 101 SPO2 97 1659 SEATED BP 148/81 HR 105 SPO2 96
No adverse event; patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, 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 27-Oct-2022, the patient experienced UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) 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 (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine).    No concomitant drug was reported. The patient received 0.25 mL dose instead of 0.5 mL dose (Lot #: 061F22A, Expiration date: 16MAY2023) of  the Moderna COVID-19 bivalent vaccine The patient had not reported any adverse reactions at that time. No treatment drug was reported. This case contains information for the 8th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277: US-MODERNATX, INC.-MOD-2022-666284: US-MODERNATX, INC.-MOD-2022-666280:
Right foot swollen up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Right foot swollen up) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right foot swollen up). At the time of the report, PERIPHERAL SWELLING (Right foot swollen up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inconclusive (Inconclusive) Results were not reported..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was not having any concomitant medication at the time of report. Treatment information was not provided.  The patient had consulted an orthopedic surgeon and had scheduled an appointment with cardiologist.   This case was linked to MOD-2021-209275.
Information has been received from a physician concerning an older than 32 weeks old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (strength, frequency and route unknown, lot # L027070 and expiration date 30-APR-2017) (inappropriate schedule of drug administration). This was outside of the recommended dosing schedule. No adverse effect was reported. Additional information has been requested.
1) sore arm beginning the evening of the day I got the shot, 4/1/21, lasted 3 days until 4/4/21 2) moderate headache beginning on 4/2/21 at 3PM - took 2 tylenol tabs that got rid of the headache within the hour.  3) Nausea, small amount of diarrhea beginning on 4/2/21 at 3 PM, lasted until 10 PM same day 4) slight fatigue beginning on 4/2/21 at 3 PM, lasted until the evening of 4/3/21.
19DEC91 pt c/o discomfort @ inject site, area warm to touch w/erythema, firmness palpated 1/2 dollar size x 1 wk; referred to MD 19DEC91 MD recommended pt to inc Ansaid to 3-4 days; 23DEC91 pt reports sx resolved;
On 08-02-2010, my healthy 18 year old doctor started to complain of an extreme ear ache and head ache, this happened in the morning.  Later that day she told me that she was unable to taste on the right side of her tongue.  On the morning of 08-03-2010 she complained that her right eye felt funny.  She then went out for the day with friends.  When she came back at around 4:00 PM. Her right side of her face was paralyzed.  We took her to the ER and they dx her with Bells Palsy.  They prescribed her steroids and a viral antibiotic.  On 8/06/10 she went to see Dr. for a follow up from the ER.  She is unable to close her right eye and she is unable to smile on the right side.  She is unable to taste on the right side.  She is tired all of the time.  We were told that there is an 85% chance she could recover fully and a 15% the damage will be permanent.
pt recv vax 24OCT97 & woke next morning w/aching in arm, causing pain when lifts arm to take clothes off & on;has nausea;today is 27OCT97 & sx are the same;pain in shoulder joint;
Information has been received from a physician concerning a 21 year old female patient with no pertinent medical history reported who on 20-NOV-2006, 29-JAN-2007 and on 24-MAY-2007 was vaccinated with the first, second and third 0.5 mL doses of GARDASIL intramuscularly, respectively. It was reported that on 23-MAY-2008 the patient was diagnosed with type 2 diabetes (with increased glucose levels). The patient sought medical attention with an office visit. It was reported that the patient was originally started on metformin (manufacturer unspecified). It was reported that the patient was on insulin pump. The patient had not recovered at the time of the report. Additional information has been requested.
This spontaneous report was received per an e-mail from a consumer (a patient's parent) via a company representative and refers to a 11-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient received a vaccine series of M-M-R II injection (albumin status: unknown; dose, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. On an unspecified date, the patient developed mumps. The outcome of mumps was unknown at the time of the report. The causality assessment was not reported. Additional information is not expected since the reporter details were not provided.
pt recv vax & devel a varicella-like rash around the hair line & stomach;
In August, I started feeling lethargic. I had lose of energy. I was confused at time. My wife noticed it. I went to the doctor. They did a COVID-19 test, which came out positive. They did blood work.
This case involves an unknown age and unknown gender patient who reported only time I got sick was 20 years ago when I got a flu shot while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "only time I got sick was 20 years ago when I got a flu shot" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (ONLY time I got sick was 20 years ago when I got a flu shot). At time of reporting, the outcome was Unknown for the event only time I got sick was 20 years ago when I got a flu shot.
Considerable swelling and redness below where the vaccine has been administered. Muscle hardness. Inability to lift arm even to the shoulder level.
Guillain-Barré Syndrome; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 74-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.  Additional details were provided as follows: The patient self-reported this case. At the time of reporting, the patient's age was 75 years. The age at vaccination was unknown. The reporter stated that, she had Guillain-Barre Syndrome with a flu shot last year (2020).  The reporter also stated that, her healthcare professional wanted her to get the Shingrix. The reporter was concerned of the recent warnings for Shingrix.  The reporter did not consent to follow up. No other information was provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 14-APR-2015 (reported as "today"), the patient was vaccinated with an expired dose of PNEUMOVAX23 injection (lot # K005957 with expiry date: 08-MAR-2015; strength, dose and route of administration unspecified). No concomitant medications were reported. No adverse experience was observed or reported. Additional information has been requested.
kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation.  Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications.  Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning.  She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning.  She kind of fainted.  She was walking from one room to the next and she just gave out.  It has improved and she is not really dizzy any more.  She is having a little fatigue though. Chills began at 06:30 and they come and go.  She is going through menopause and it could have something to do with it.  She was unable to answer outcome for this. She just wants the headache to stop.  She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00.  When she first got it, she did not feel it.  As the day progressed, she could feel the pain.  Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills  07:00-07:30.  She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving.  Information on the lot/batch number has been requested.
Pt became limp @ aprox 9PM on 13JUN91 same day as inject; Taken to ER, appeared stable; Later seen by pvt MD;
Chills, body aches, rigors, headache, nausea-persistent, intermittent
It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 29 year old male states that the site of injection is sore and red. He denies any other discomfort. He has not been exposed to the influenza vaccination. States he has a positive history of allergy to Pencillin. Follow up #1 06/18/02: During internal auditng of all files,it was deemed necessary to amend the report by updating the Adverse Eventscoding (Added Medication Error, re-ranked Adverse Events).
Sore, for 5 months, at the site where he got his vaccine, after second dose.; Muscle pain, after second dose.; thought the pain would be gone; This is a spontaneous report from a contactable consumer(patient). A 93-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on 12Feb2021 (at the age of 92-years-old) at single dose for covid-19 immunisation in drug store. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (MANUFACTURER UNKNOWN, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation, the patient stated his first vaccination was perfect. The patient experienced sore, for 5 months, at the site where he got his vaccine and Muscle pain and pain after second dose. He thought the pain would be gone in a couple of days. The patient stated he had been to his doctor, and the doctor told him that she cannot do anything about his symptoms. The patient stated the doctor didn't do anything and told him to wait, maybe 6 months, he called the drug store, where he received the vaccine, and they told him they just give the vaccines, they don't make recommendations. The outcome of the events was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report was received from a medical assistant, concerning multiple patients of unknown age and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were administered improperly stored PROQUAD, subcutaneously, for prophylaxis, lot #R002936, albumin status rHA and expiration date 29-JUL-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored Merck Sterile Diluent. No adverse effects were reported. The temperatures of excursion were reported as 6 degrees F to 14 degrees F during a time frame of 1 hour and 15 minutes and 28.5 degrees F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA009440; US-009507513-1808USA009441; US-009507513-1808USA009442; US-009507513-1808USA009443; US-009507513-1808USA009444; US-009507513-1808USA009445; US-009507513-1808USA009446; US-009507513-1808USA009447.
Onset of itchy red rash on torso within a short time, maybe 3 to 4 days after injection.  It was bad enough that I got appointment with dermatologist 14 days after the Shringrix shot.  She diagnosed Grover's disease, which was confirmed by pathology.  I then started taking 1000 IU of Vitamin A and using topical steroids.  Grover's has not subsided as of 2/8/2022, six months later.  Tried higher strength topical steroids, tried Ivermectin (15 mg on first day with permethrin 5% topical, repeat once one week later), various OTC lotions, benadril spray for itch.  Now not much response to the topical steroids.  Trying CBD lotion.
This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis b antibody negative in a 50-year-old male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 30th October 2019, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th November 2019, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 2nd May 2020, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 2nd May 2020, not applicable after receiving Twinrix, Twinrix Pre-Filled Syringe Device, Twinrix and Twinrix Pre-Filled Syringe Device, not applicable after receiving Twinrix, Twinrix Pre-Filled Syringe Device, Twinrix and Twinrix Pre-Filled Syringe Device and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced hepatitis b antibody negative and therapy non-responder. On an unknown date, the outcome of the hepatitis b antibody negative, therapy non-responder and drug dose administration interval too long were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient completed 3 dose series of Twinrix but the patient was not immune to hep b (titer done), which led to hepatitis B antibody negative and therapy non-responder. the patient received 3rd dose of Twinrix on 2nd May 2020, which was later than the recommended interval, which led to lengthening of vaccination schedule. The reporter asked if the patient need to start the whole series again. The reporter consented to follow up. No other details. This case has been linked to US2022000441, reported by the same reporter.
she started with COVID symptoms/she had nauseas/ fever; still so sick/felt physically very sick; abdominal pain; constipation; fatigue; GI distress is overwhelming; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she started with COVID symptoms/she had nauseas/ fever), ILLNESS (still so sick/felt physically very sick), ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation) and FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 04-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Apr-2023, the patient experienced COVID-19 (she started with COVID symptoms/she had nauseas/ fever), ILLNESS (still so sick/felt physically very sick), ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (GI distress is overwhelming). At the time of the report, COVID-19 (she started with COVID symptoms/she had nauseas/ fever), ILLNESS (still so sick/felt physically very sick), ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (GI distress is overwhelming) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had First dose on 14 Jan 2021 Lot number 026L20A, second dose on 11 Feb 2021 Lot number 012M20A, third dose on 04Nov2021 Lot number 062E21A, fourth dose on 14Jul2022 Lot number 038A22A. she received the flu vaccine in November or December 2019 and 4 weeks after the 5th dose of the Moderna Covid-19 vaccine.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732071 (E2B Linked Report).
Metallic taste in mouth 2 days Fatigue ongoing Very sore arm 3 days
Pt seen on 3/13/03 after MMR given on 3/11/03. L arm with erythema covering 2/3 of circumference of shoulder. Tx: Atarax. Thought to be an Arthrus reaction.