chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On May 13th patient awoke with acute left shoudler/chest pain which progressed to pleuritic pain.  Pain and pressure worse when lying down.  Went to ED 5/14/21 and received labs includind d-dimer/trop and EKG with Echo.  Given aspirin and NTG.  Studies were normal and she was diagnosed with acute idiopathic pericarditis
Headache, dizziness, fever, stiffness in neck and shoulders, nausea
Patient reported lethargy, dizziness, diarrhea, and a cold clammy feeling the next morning after receiving her vaccine. She reported lying down when symptoms began and sleeping for about 2-3 hours and her symptoms had resolved upon waking.
Mom advised child received routine vaccines on 4/8/2016 to include Varicella (Merck K010441) and MMR (Merck K016154) to left thigh and Hep A (SK X22PA) and influenza (SK U5320AA) to right thigh, child reported to the health prior to vaccine with no recent illness. About 4/15/2016 child developed a fever of 102.7 that mom treated with TYLENOL. 4/17/2016 child's fever was 104.2 and mom noted child's right thigh was red in area vaccines were given and some red dots on left leg, stomach and arms. Child seen by medical 4/18/2016 where providers noted a 4x1 cm irregular shaped erythema area with mild induration to right thigh that was not warm or TTP, no restriction in ROM of leg. No other skin rashes/macules, etc documented. A soft tissue x-ray of area did not reveal an abscess but did show increased echo texture of SQ tissue seen in setting of edema or cellulitis. Providers prescribed 10 day course clindamycin for presumed MRSA and diagnosed URI (had concurrent symptoms of runny nose, congestion and fever). Follow up on 4/21/16 with HCP and other office reported redness resolving with no fever and right thigh measured at 3.5x2 cm patchy erythema. Mom advised child had no immediate adverse reactions to vaccines. Mom advised they did take a walk at the park on 4/17/16 otherwise no travel or exposure to others ill.
Patient received a vaccine that was expired due to a temperature excursion ( temp between 8-14.5 degrees C for 7hr and 48 minutes). Pfizer contacted and advised to revaccinate. Patient rescheduled and received valid dose on 03/19/21. This was the patient's second dose.
NO ADVERSE EVENT OCCURED.  PATIENT WAS UNDER AGED, HOWEVER PER PARENT CONSENT VACCINE WAS ADMINISTED
I started out fine waited the 15 minutes and no change.  But within 45 I started Itching everywhere, hurting, tongue felt weird, talking was difficult.  I was very dizzy and as described by my co-workers I looked drunk and confused.  I had a rash on my face that according to my co workers was like I scratched my face.  I was very flush.  Walking was very unbalanced.    I took two Benadryl at work and my sister had to pick me up from work and take me home.  Where I slept for quite some time.  When I woke up I was not as confused  but was still not all together.  The next day I was just tired and sore.
Vaccine given more than 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given more than 12 hours after first puncture) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given more than 12 hours after first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given more than 12 hours after first puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
sweating; was kind of low for a while; flu symptoms; was cold when he went to bed; dizziness; fever/a lot of fever/fever was 101; chills; tiredness/Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING ABNORMAL (was kind of low for a while), INFLUENZA (flu symptoms), FEELING COLD (was cold when he went to bed) and DIZZINESS (dizziness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LA0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), FEELING ABNORMAL (was kind of low for a while), INFLUENZA (flu symptoms), FEELING COLD (was cold when he went to bed), DIZZINESS (dizziness), PYREXIA (fever/a lot of fever/fever was 101), CHILLS (chills) and FATIGUE (tiredness/Felt tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating), INFLUENZA (flu symptoms), FEELING COLD (was cold when he went to bed), DIZZINESS (dizziness), PYREXIA (fever/a lot of fever/fever was 101), CHILLS (chills) and FATIGUE (tiredness/Felt tired) outcome was unknown and FEELING ABNORMAL (was kind of low for a while) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever was 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.   This case was linked to MOD-2021-353325, MOD-2021-353320 (Patient Link).
Chest congestion, cough, O2 Sat desaturation, weakness, SOB. Hospice doctor felt it was viral pneumonia COVID-19 booster.
He had a pretty bad rash on his back; He was not feeling too well, yeah he fell asleep he is not feeling very well; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0178), via an unspecified route of administration on 15May2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8736). On an unknown date, the patient had a pretty bad rash on his back, he was not feeling too well, he fell asleep he was not feeling very well. The seriousness for both events was not specified by reporter. The outcome of the events was unknown.  Information on the lot/batch was available, Additional information has been requested.
Immunization Dtap given left upper deltoid, one day later slight erythema slight firmness at site.
Induration of L thigh in area of injections.  Much worse than the normal reaction, with associated erythema and duskiness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 at 12:15 as dose 3 (booster), single (Lot number: FK9893) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2022) Positive, notes: On 4th day after finishing Paxlovid, tested positive; (10Aug2022) Negative, notes: after 3 days of testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: On 4th day after finishing Paxlovid, tested positive after 3 days of testing negative. Symptom so far appear to be a mild sore throat. No Known allergies.   No follow-up attempts are possible. No further information is expected.
Approx. 8-9 hrs after receiving shot, I woke up with my lips, tongue, eyes, and other tissues in mouth swollen. It was hard to swallow and getting hard to breath. Went to ER where the gave me antihistaminic and Steroid shots.
pain in my body; pain in head; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (patient had chicken pox in childhood). Family history included shingles (patient mother suffered from shingles disease).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: pain in my body ) and headache (Verbatim: pain in head). The outcome of the general body pain and headache were resolved (duration 2 days).   It was unknown if the reporter considered the general body pain and headache to be related to Shingles vaccine.     It was unknown if the company considered the general body pain and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023. This case was reported by a patient via interactive digital media. This vaccine hurts, patient felt pain in the whole body and head for almost 2 days.  The patient had chicken pox in childhood and patient mother suffered from shingles disease, so it was better to prevent it.  The patient saw a TV ad that on shingles disease, a pain of 2 days was better than feeling worse for two weeks. The follow-up could not be possible as no contact details were available.
5 days after receiving my shot, I developed 2 large patches of hives (approx. 2 inches across), one at the injection site and another on my shoulder.  I also have hives on my the back of my neck and a small patch on my chest.
Patient received vaccines on 4-30-2018. Came back to the office on 5-4-2018 with left arm pain, redness, tenderness, raised 3x3 area and warmth to the touch. Was dx with cellulitis and given BACTRIM. Went to ED on 5-7-2018, no changes in treatment. Returned to PCP office on 5-9-2018 for a f/u and area was improving.
No reaction to the vaccine except sore arm. I only took TYLENOL. Several months later, I saw an eye doctor in January, I had a cataract on my eye right, my eye is stable, they run tests for my falling, I saw a Cardio doctor due to my age, recommend exercise. I saw a Neurologist. I had nerve pain on my back of neck, doctor said it was a nerve compression due to my arthritis. They send me for a physical therapy.
Information has been received from an unspecified reporter via a website of the internet referring to a 41 year old female patient with widespread warts. On an unknown date the patient was vaccinated with unidentified Merck HPV vaccine (name and lot number not provided) (dose, dose# and route unknown). The patient had not received treatment for her warts for 10 years, but many of her warts cleared about six months after she received the HPV vaccine (therapeutic response unexpected). The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Several days after receiving the bivalent booster, vaginal bleeding was noted. This woman is postmenopausal with no menses since at least 2016. Also noted was significant abdominal discomfort.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 84-year-old female patient who received SHINGRIX (batch number JC92P ? the reported lot number dose not match with any GSK lot number, expiry date November 2020) for prophylaxis. On 5th August 2018, the patient received the 1st dose of SHINGRIX. On 6th August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The pharmacist reported that a patient experienced a rash on their left deltoid. The patient was counseled by the pharmacist to apply hydrocortisone.
A non-serious, spontaneous report of sore and "bruise" on the nose has been received from a patient's mother concerning her seven-year-old child subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on an unspecified date. On 21-Sep-2009, the patient developed a sore and "bruise" on the nose. The outcome of the adverse events is unknown.
hasn't been feeling well; A patient received second dose and experienced extreme tiredness; A patient received second dose and experienced Body aches; A patient received second dose and experienced soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (hasn't been feeling well), FATIGUE (A patient received second dose and experienced extreme tiredness), MYALGIA (A patient received second dose and experienced Body aches) and INJECTION SITE PAIN (A patient received second dose and experienced soreness of arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol, Depression, Anxiety and BPH. Concomitant products included BUSPIRONE for Anxiety, TAMSULOSIN for BPH, BENAZEPRIL and AMLODIPINE for Blood pressure, ATORVASTATIN for Cholesterol, ESCITALOPRAM for Depression.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced MALAISE (hasn't been feeling well), FATIGUE (A patient received second dose and experienced extreme tiredness), MYALGIA (A patient received second dose and experienced Body aches) and INJECTION SITE PAIN (A patient received second dose and experienced soreness of arm). At the time of the report, MALAISE (hasn't been feeling well) had not resolved and FATIGUE (A patient received second dose and experienced extreme tiredness), MYALGIA (A patient received second dose and experienced Body aches) and INJECTION SITE PAIN (A patient received second dose and experienced soreness of arm) outcome was unknown.            No treatment information was provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   This case was linked to MOD-2021-209217 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Significant FU. Concomitant medications and events added.
Body aches, fatigue, mild headache, eyes hurt.  Feel feverish but have no fever
Patient called pharmacy on 8/23/18 complaining of follow up letter. She brought up that after receiving shot at pharmacy she had to be put on antibiotic for a week due to cellulitis. She said it was knot warm to touch.
itchy throat, cough, tickle in throat, throat felt tight administered Fexofenadine 60 mg tablet by mouth observed patient additional 30 minutes. patient states symptoms subsided after 10 minutes of receiving Fexofenadine 60 mg talet
This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 29 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported), which was administered one day before the reaction. On an unspecified date, 8 hours after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema, swelling on lips, uvula and mouth, generalised urticarial, pruritus, rash, shortness of breath and cough. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. She received treatment with oral antihistamines and oral H2 blockers and oral steroids. The outcome was recovered and the patient was referred to PCP (primary care physician). Reporter's comments: The attributed trigger was vaccine.
Patient inadvertently received the second dose in the series of phizer covid vaccines one week early. Patient should have received the vaccine on 5/14/21, and instead received the second dose on 5/5/21.  First dose of phizer covid vaccine was administered on 4/23/21. Patient currently has had no side effects from this vaccine error.
PATIENT WAS BROUGHT TO PHARMACY FOR SECOND DOSE COVID VACCINE, AFTER ANOTHER PHARMACY WAS OUT. PATIENT DID NOT HAVE VACCINE RECORD BUT PATIENT AND PATIENT REPRESENTATIVE BOTH ASKED FOR MODERNA VACCINE. UPON ENTERING VACCINE, IT WAS DISCOVERED THAT PATIENT HAD RECEIVED PFIZER AS THE FIRST DOSE IN JUNE 2021. PATIENT WAS OK WHEN I CONTACTED HIM.
Information from mom. On 01/25/01, infant was fussy that evening, temp 99, Tylenol every 4 hours. On 01/26/01, Temp was 101 - 102 during the day, Tylenol every 4 hours, temp was 103 approximately 7 PM. On 01/27/01, 5 AM, taken to the hospital, temp 105.5 "rectal", fussy. crying, couldn't sleep; ER gave Tylenol.
This is a spontaneous report obtained from a contactable physician through a Pfizer sale representative. A patient (age and gender unknown) received the first dose of intramuscular PREVNAR 13 0.5 ml, single on an unspecified date. The patient experienced an allergic reaction to PREVNAR 13, local skin reaction at injection site, described as severe rash, which resolved upon giving BENADRYL and steroid shot. Lasted for about a week.
Patient said he experienced swelling, malaise and overall sickness. He did not feel well for 3 days.
Fever to 101 for 5 hours, nausea, headache, malaise, all symptoms improved after 5 hours with use of acetaminophen
c/o chest heaviness, tightness and pain in center of chest approx 4 - 5 hours after flu shot.  At onset also experienced "tickle" in her throat and frequent dry cough. Last flu shot approx 10 years ago - no significant reaction.  Treated at work site w/emergency oxygen; in ambulance (by patient report) with IV Benadryl resulting in 70% reduction in CP. On  continuous high flow oxygen in ER.  Diagnosis "allergy to flu vaccine".   Discharged approximately 2 hours after arriving in ER w/ Rx for Prednisone (per ER discharge sheet).  Patient stated that she was also to continue Benadryl and Zyrtec.
I?ve had neurological problems since vaccination 3x weeks ago. I?m suffering from brain fog and dizziness. I have aura (blurred vision). I can feel the vaccine in my spine. I?m having skin sensitivities and muscle aches.
Measles like rash all over body. It began on the left side of my body starting on my (7/24/ left breast, then my left arm, (7/25)left side of my face, left side of upper lip, behind ear and hand. 7/26 it began to spread to the right side of my body and my stomach. The rash is very itchy. In the beginning most were skin colored , but now on my breasts and stomach they have turned red.
Began as low grade fever and night sweats on 4/5/21.   After two weeks began having difficulty breathing, and fever reached 102°F and was more constant.  Pulse rate increased by almost 50% over 2-1/2 weeks. On 4/23/21, after 2-1/2 weeks of increasing fever, pulse rate, and breathing difficulty, pulse rate shot up past 200 so I went to the ER. Kept in ER for 4 days, was on oxygen for first 3 days. Diagnosed with Pericardial Effusion caused by Viral Pericarditis. Treated with anti-inflammatory medications. Have had two more SVT (SupraVentricular Tachycardia) episodes since; had to go back to ER for one of them Slowly recovering over several weeks.
Pt recvd 2 doses of vax & on 30MAY91 pt recvd 1st dose of the 2nd series of Hep B vax; pt exp flu-like sx w/rt upper quad pain, diarrhea, nausea, body aches, weakness & shakiness; pt recovered;
vaginal bleeding (did bloodwork to check for thrombocytopenia - was negative); fever & chills - this happened the night after the vaccine - continued for 3 days; upper respiratory infection - the fever and chills morphed into this over the following days; cystic acne outbreak (this took about 3 weeks to show up - but was unrelated to anything else in my lifestyle/diet so the only conclusion I can draw is it was from the vaccine).
Hard knot; Itchiness; Slight swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard knot), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE SWELLING (Slight swelling) and VACCINATION SITE ERYTHEMA (Redness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure since 2004, Cardiomyopathy since 2004, Lactose intolerance (causes gas and diarrhea  .) since 1988 and Egg allergy (Egg yolk-causes gas and diarrhea .) since 2003. Concomitant products included SIMVASTATIN, LISINOPRIL, NITROGLYCERIN, FUROSEMIDE (LASIX [FUROSEMIDE]) and METOPROLOL for an unknown indication.    On 03-Feb-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard knot), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE SWELLING (Slight swelling) and VACCINATION SITE ERYTHEMA (Redness). On 20-Feb-2021, VACCINATION SITE INDURATION (Hard knot), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE SWELLING (Slight swelling) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Updated patient demographic details (Height, weight), other relevant history ( current conditions and allergy), Negative re-challenge and date of re-challenge. Added vaccine facility information, concomitant medications, event end date, intensity and causality as reported was changed to Possible. Site of injection was Left shoulder.