chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; loss of appetite; nausea; vomiting; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (body aches), DECREASED APPETITE (loss of appetite), NAUSEA (nausea) and VOMITING (vomiting) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Nuts, shellfish, dairy) and Environmental allergy. Concomitant products included CITALOPRAM for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (body aches), DECREASED APPETITE (loss of appetite), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, PAIN (body aches), DECREASED APPETITE (loss of appetite), NAUSEA (nausea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient tested negative for covid-19 on 11-Jan-2021 and 13-jan-2021.
Both vaccinations gave deep aching mostly in my entire legs.  First shot, was also over most of body.  Second shot, deep ache mostly in left leg.  Very fatigued.  Taking  Ibuprofen as directed on bottle but it didn?t help pain very much.
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP)  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
Swelling, redness. Very warm to touch, pain at site and itchiness  that persisted for 12 days.
2 weeks after second shot pt. experienced: feet burning, hand burning, night sweats, chest pain, can't do flight of stairs without being out of breath, sore joints, fatigue
Sunday night started having severe shortness of breath.  Starting Monday, patient started having chest pains and went to the ER to be evaluated.
After second dose: Brain fog 3 hours after injection, followed by chills, possible fever, and headache for about 40 hours
Vaccine was expired at time of administration. It was past the 10 week time frame in the refrigerator. 03/28/2022 was 70 days from date placed in fridge.
Tinnitus; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 14Jan2021, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Feb2021, the patient experienced onset of tinnitus and can't recall the exact date in there, all he can recall, it was the beginning of Feb2021 and can't recall if it was after the 1st dose or after the 2nd. After the booster dose in Oct2021, the tinnitus became worse described as it was worsening and has continued. The outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Second dose, as of the time of the call, had not yet been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 20-year-old female 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.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-SEP-2022 Reporters comment: The patients received the 1st dose on 29th August 2022 of Twinrix intending to complete the accelerated schedule, but it had been two weeks since dose one. Second dose, as of the time of the reporting, had not yet been administered. The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive the second dose which led to incomplete course of vaccination.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HAB (Twinrix) (batch number 4f3yy, expiry date 1st January 2023) 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.   On 10th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The reporter called to report that a patient was inadvertently given an expired dose of Twinrix.  The patient information and vaccine information provided, but reporter wished to not give information about themselves. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Pt who received both anthrax #2 and primary SPV on the same day (11/7/05). Approximately 12 days later, he noticed he was having chest pain while out on the town with friends. He decided to go home and go to bed, thinking he had over exerted himself in the previous days. He woke up during the night with increasing chest pain (10/10) and SOB secondary to chest pain and was sent to be seen at the local hospital. A complete work up was done and he was diagnosed as having coronary artery spasm. He was hospitalized for 4 days and placed on quarters for 4 more days after discharge. He was sent home on nifedipine and isosorbide. He was then placed on a profile and returned to the states in March of 2006 for follow up. Since the original episode he has had 2 more episodes of CP which he did not seek attention for the first time, but on 5/20/06 he got evaluated at the cardiac work up was normal. He was evaluated by a cardiologist on 5/06 and all test results normal. The nifedipine and isosorbide were stopped at that time.
patient received his second Moderna Covid-19 vaccination and he told me that he experienced tinnitus in his ears.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (patient received his second Moderna Covid-19 vaccination and he told me that he experienced tinnitus in his ears.) in a 46-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (patient received his second Moderna Covid-19 vaccination and he told me that he experienced tinnitus in his ears.). At the time of the report, TINNITUS (patient received his second Moderna Covid-19 vaccination and he told me that he experienced tinnitus in his ears.) outcome was unknown.            No concomitant medication was reported.                   No treatment medication was reported.
I have a rash iitching all over My body, since the next day of my vacunation, third dosis on January 10, 2022.
Pfizer-BioNTech COVID-19 Vaccine on 1/12/2021, patient experienced extreme fatigue and lightheadedness after receiving the vaccine.  Patient did not go to ED for evaluation.
Mother states that client developed a pinpoint red raised red rash on his trunk and back within one hour after vaccination. No other sx, mother gave him BENADRYL for itchiness. PHN advised her to contact clients PMP to discuss this.
pt recv vax 25NOV95 & 1NOV97 pt devel chickenpox (30 lesions)
pt recvd vax 13JUN95 & pt tested hepatitis B antigen positive on 15JUN95;pt tested core E antibody neg,hepatitis B E antigen neg,& anti-HBe neg;pt was not treated;3 repeat tests of hep B surface antigen were neg;
Vasovagal syncope after immunization administered. Patient lied down cool cloth to forehead, examined by physician.
side eyes lasted for 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of gaze palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced gaze palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the gaze palsy was recovered/resolved.   It was unknown if the reporter considered the gaze palsy to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter stated that his/her side eyes lasted for 4 days. The reporter mentioned, it was horrible and he/she afraid to get the second dose. Follow-up would not possible as no contact details were available.
Vertigo, slurred speech, difficult swallowing, numbness on left side of face/chin area; extreme weakness in both arms and both legs but more pronounced in left arm & left leg; blurred vision, extreme fatigue
1st - arm pain and heaviness from shot - 1 day after shot - took Tylenol 2nd - mild itching on face and head - 3 -4 days after shot - did not recognize it as a reaction - no treatment given 3rd - difficulty breathing, asthma attack, full body covered with hives - 5 days after shot - took Benadryl for 24 hours -  went to urgent care the next morning and was given steroid medication to take each day for a week,  directed to continued to take Benadryl until steroids stop the hives 4th - second respiratory reaction with coughing and difficulty breathing - took an extra Benadryl.
Pain radiating down left arm from site of injection upon certain movements. Bruise lasted 8-10 days then pain didn't get better.
It has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine) in a male patient of an unknown age 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 PRODUCT DOSE OMISSION ISSUE (It has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine) outcome was unknown.        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.   Concomitant medication was not provided.  Patient stated that he wanted to get Johnson & Johnson Covid-19 Vaccine, since they have not gotten their second dose of  Moderna Covid-19 Vaccine. Pharmacist also mentioned that it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine. Patient did not experience any side effects after first dose.  No treatment information was provided.   This case was linked to MOD-2021-279675 (Patient Link).
Pts. mother called in today to report a reaction her daughter had to the PENTACEL vac. on 1/28/2010, pt woke up with a cold, which turned out to be bronchiolitis. After being diagnosed pt. was hospitalized for 5 days, but did recover.
Extremely loud tinnitus. Bilateral. A high ringing, hissing sound that does not change.
Patient stated she had Hives on her face from just below her eyes to her neck. They were around her mouth. Patient took a Benadryl. The next day her symptoms had improved but her skin is really dry now and her chest was red and itchy.
1 year old female with Sturge-Weber syndrome. History obtained from grandmother-care-giver: Large local reaction receiving Varicella, MMR and Hib 3 on 5/25/04. Systemic symptoms include fever (101ax.) "Off and on", poor appetite, irritability and crying with restless sleep x 4 days (until 5/29/2004). Caregiver also describes scattered "small, pinkish bumps- like Roseola on her legs and arms; "a few larger lesions on her chest- one or two with scabs". None on her face. Treated with Tylenol, tepid baths and offered "lots of juice". Appetite and disposition improving. Appetite "better today". Drinking liquids, "eating small amounts of yogurt, happier and playing"
Information has been received from a physician concerning a female with a family history of rheumatoid arthritis and Lupus who in April 2008, was vaccinated intramuscularly with a first dose of GARDASIL (lot # unspecified).  It was reported that on an unspecified date post vaccination (date reported as "few weeks later") the blood test was performed and the readings showed that there was an increase in patient's sedimentation rate.  Unspecified medical attention was sought.  It was reported that the patient went for more "blood work" where the readings went back to normal.  Additional information has been requested.
Five hours after receiving the Pneumovax vaccine, individual complained of itching at injection site with large amount of swelling to bicep area. Also had redness to bicep. Denied any hives.
Ear Infection; Initial Report Received on 14-DEC-2022  This is a spontaneous report, received from a female patient, who received HEPLISAV B for hepatitis B immunisation.  There was no medical history reported for the patient.  Concomitant medications were not reported.  On 16-NOV-2022, dose 1 of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # 43528-002-01), was administered in the left arm (route not specified) for hepatitis B immunisation which was administered at a pharmacy.    On 04-DEC-2022, 18 days after vaccination with HEPLISAV B, the patient experienced an ear infection.    On 14-DEC-2022, she finished a course of Augmentin (amoxicillin/clavulanic) and went back to the doctor due to fluid in the ear.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
As of 11/20/2023, I am approx. 17.5 weeks pregnant, delivery date is estimated to be April 28, 2024. Adverse events are not severe, less than 24 hrs after injection: sore right arm, body aches, and fatigue. Symptoms were noticed when I woke up around 10:00 AM I only wanted to report due to being pregnant and if it helps with data research.
he started to get really dizzy; Mouth swollen.; Lips were swollen; Nose swollen; Feeling really tired; Next day he reported a fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, MOUTH SWELLING, LIP SWELLING, SWELLING, and FATIGUE in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IRON for an unknown indication.   On 21-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 DIZZINESS, MOUTH SWELLING, LIP SWELLING, SWELLING, FATIGUE, PYREXIA, and HEADACHE. At the time of the report, DIZZINESS, MOUTH SWELLING, LIP SWELLING, SWELLING, FATIGUE, PYREXIA, and HEADACHE outcome was unknown.            Concomitant products includes Blood pressure medication and Diabetes medication was also reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above on 26-Aug-2021, the follow up received contains non significant information that is contact information updated.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), in Aug2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Waldenstrom's Macroglobulinemea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flexeril, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound 3 days after cleared initial symptoms and negative home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was Unknown. Anti viral details: product: COVID 19 treatment, brand: Paxlovid, treatment start date: Mar2022, treatment stop date: Mar2022 indication: Preventative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a 4 year old white male who on 10-APR-2007 was vaccinated with the first dose Proquad (Lot # 657265/0293U) IM. On 11-APR-2007, the patient experienced fever up to 104.1 x 2 days. Subsequently on 13-APR-2007, the patient recovered from fever up to 104.1 x 2 days. No further information is available.
shortly p/getting the vax pt collapsed almost arreflectic for a few mins & recovered;
One week following vaccination itching area began. Small raised area 11/2 inch across.  Barely raised.
Flu symptoms; One side of her face was burning up; Injection arm swelled up with a baseball sized lump; Injection arm lump was really really really hot to the touch; Fever of 101 degree F; Rash that was getting bigger on her injection arm (from shoulder to about mid-upper arm); Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), BURNING SENSATION (One side of her face was burning up), VACCINATION SITE MASS (Injection arm swelled up with a baseball sized lump), VACCINATION SITE PAIN (Injection arm lump was really really really hot to the touch) and PYREXIA (Fever of 101 degree F) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017P21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired). On 30-Oct-2021, the patient experienced INFLUENZA (Flu symptoms), BURNING SENSATION (One side of her face was burning up), VACCINATION SITE MASS (Injection arm swelled up with a baseball sized lump), VACCINATION SITE PAIN (Injection arm lump was really really really hot to the touch), PYREXIA (Fever of 101 degree F) and VACCINATION SITE RASH (Rash that was getting bigger on her injection arm (from shoulder to about mid-upper arm)). At the time of the report, INFLUENZA (Flu symptoms), BURNING SENSATION (One side of her face was burning up), VACCINATION SITE MASS (Injection arm swelled up with a baseball sized lump), VACCINATION SITE PAIN (Injection arm lump was really really really hot to the touch), PYREXIA (Fever of 101 degree F), VACCINATION SITE RASH (Rash that was getting bigger on her injection arm (from shoulder to about mid-upper arm)) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of 101 Degree F.         No concomitant medications provided. No treatment medications provided.  Second dose on 25Mar2021 (Lot # 008B21? , Patient can't determine the last letter).   This case was linked to MOD-2021-374785 (Patient Link).
Covid monitoring documentation. PT admitted 1/16/22 documented to have positive covid. PT received Moderna 03/23/21 Lot 045A21A for dose 1. Dose 2 was Moderna given on 04/20/21 Lot 038B21A.
Began as soreness around injection site on upper left arm, next day soreness moves down arm towards hand. By 14th day middle and ring fingers becomes partially paralyzed. Followed Dr.s order, taking 800mg ibpro. every 6 hours, pain is greatly increased with ANY movement. Apply Salonpas medicated pads - no relief.
Pt did not respond to the vax series; 1MAR92 Hep B surface Antibody titer neg;
There was a needle malfunction and the patient received less than half of the correct dose of the vaccine.  The patient was then given a full dose of the vaccine.  No adverse reactions were noted after the administration of the vaccine.