chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slept most of the next day; Stomach discomfort; Feeling of brain fogginess; Body ache; Chills; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Slept most of the next day), ABDOMINAL DISCOMFORT (Stomach discomfort), FEELING ABNORMAL (Feeling of brain fogginess), MYALGIA (Body ache) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach discomfort), FEELING ABNORMAL (Feeling of brain fogginess), MYALGIA (Body ache), CHILLS (Chills) and NAUSEA (Nausea). On 10-Apr-2021, the patient experienced SOMNOLENCE (Slept most of the next day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept most of the next day), ABDOMINAL DISCOMFORT (Stomach discomfort), FEELING ABNORMAL (Feeling of brain fogginess), MYALGIA (Body ache), CHILLS (Chills) and NAUSEA (Nausea) had resolved.            Concomitant products included multivitamins. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD21-077255 (E2B Linked Report).; Sender's Comments:  MOD21-077255:
Rash and mild fever.  I have given him fever reducer medication (Tylenol), and it seems to bring down the temperature.
Narrative: COVID infection following COVID vaccine series 03/04, Pfizer, dose #1 03/26, Pfizer, dose #2 09/01 pt cc: chills, cough, fatigue, fever, headache, loss of taste or smell, myalgias, rhinorrhea, sore throat exposure: unknown 09/03 SARS-COV-2 Variant Sequencing result: pending 09/04 pt admit to ED cc: chest pain dx: Chest pain r/t COVID LOS: 1 09/04 COVID swab, result: detected 09/04 FIBRINOGEN: 469 09/04 DDIMER: 0.34 09/04 CRP: 4.959 09/04 PT/INR 13.8/1.23 09/04 BinaxNOW COVID-19 Ag: DETECTED 09/04 CXR impression: No radiographic evidence of acute cardiopulmonary pathology. 09/04 CT Head impression: 1. No CT evidence of acute large territory infarction or intracranial hemorrhage. 2. Mild paranasal sinus disease.
C/O pain in (L) arm, pt sts he feels like there is something inside the muscle since 10/10/15. C/O fatigue and tenderness at injection site.
Patient admitted to hospital 7/29/2022 on Observation Status with complaints of weakness, increased fatigue, subjective fever, chills, chronic n/v, diarrhea, lack of taste, epigastric pain, sob, myalgias, HA, sore throat.  Patient was tested for COVID-19 and was positive on 7/29/2022.
Pt had blood vessel burst in finger on left hand (opposite side of where shot received), severe bruising and soreness, starting in AM of next morning. Pt also has increased aches/pains.
3 days post injection new onset rash at injection site (left deltoid) with erythema and pruritis.  pt presents today, 16 days post injection, with complaints of soreness to ULE with  persistant rash with erythema and pruritis.
Dizzy; nauseous; a strong taste of metal in my mouth; Extreme gas; This is a spontaneous report from a contactable consumer (patient). This 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 14Jan2021 15:15 for Covid-19 immunisation. The patient medical history was not reported.  Concomitant medication included ibuprofen (IBUPROFEN). The patient previously took Augmentin and experienced allergy. On 16Jan2021 07:15, the patient experienced dizzy, nauseous, a strong taste of metal in my mouth, extreme gas. The outcome of the events was unknown.   The vaccine was administered at Hospital Facility. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination.   Information on the Lot/batch number has been requested.
After day of vaccine, swelling in arm and soreness, baby stopped moving, or very small movements, very unusual for a highly active baby. Baby was able to move around more, and I was participant. Pregnancy: Currently 31 weeks pregnant, due September 18th, 2021. Normal pregnancy.
When I called the patient to remind her of needing the 2nd dose she told me she would not be getting the 2nd shot due to the pain and numbness/tingling she had from the first vaccine. She stated that it took about 4 months for it to feel better.
largest fever blister on their upper lips; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (largest fever blister on their upper lips) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Fever blister. Previously administered products included for Product used for unknown indication: flu vaccine. Past adverse reactions to the above products included Swollen lymph nodes with flu vaccine. Concurrent medical conditions included Overweight (Patient states that they weight about 240 lbs.). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (largest fever blister on their upper lips). The patient was treated with DOCOSANOL (ABREVA) for Fever blister, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (largest fever blister on their upper lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Vitamin (Melaleuca peak performance total health 50+) as concomitant drug product.  Patient took the 2nd dose on 08-Apr-2021and lot no. 028A21A.   This case was linked to MOD-2021-387069 (Patient Link).
Onset of numbness of hands and feet, starting 8/7/10. Was hospitalized 8/7/18 to 9/18/18 for Guillain Barre syndrome (GBS)- progressed to respiratory failure and intubation.
Patient received Pfizer BioTech for 3rd dose series instead of the bivalent dose.
Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Bexsero and Bexsero 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: 08-AUG-2022 Reporter's comment: Association reported that a dose of Bexsero was given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Bexsero dose which was already expired on 31st July 2022, which led to expired vaccine used.
have diarrhea and nausea over a week after getting 1st dose; have diarrhea and nausea over a week after getting 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (have diarrhea and nausea over a week after getting 1st dose) and NAUSEA (have diarrhea and nausea over a week after getting 1st dose) 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 DIARRHOEA (have diarrhea and nausea over a week after getting 1st dose) and NAUSEA (have diarrhea and nausea over a week after getting 1st dose). At the time of the report, DIARRHOEA (have diarrhea and nausea over a week after getting 1st dose) and NAUSEA (have diarrhea and nausea over a week after getting 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Tested positive at Nursing home on 9/29/23, presented to ED on 9/30/23 with respiratory symptoms. PCR positive 9/30/23.
3 shots but still had shingles / Suspected vaccination failure; Had shingles, lite case; Have had 3 shots; This case was reported by a consumer via interactive digital media (facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had 3 shots of vaccine which led to extra dose administered. But still the patient had shingles, little case. The patient stated that if he or she did not get the shots he or she would hate to think how bad they would have been. The patient suggested to get the shots. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
REPORTING AN ERROR IN ADMINISTRATION; RECIPIENT IS LESS THAN 18 Y/O
On 2/28/21, had first COVID Shot. On 3/16/21 had  Hysterectomy. On 3/30/21 had second COVID shot. On 4/19/21, was diagnosed with blood clot. The doctor reported that it was not the norm for someone my age and with my good health to get a blood clot after a hysterectomy.
Cellulitis- infection. Initial treatment was  antibiotics orally administered. Second day as symptoms worsened, injection of ceftriaxone.
Bump at injection sight, hot to touch, pain in arm around injection sight, swelling, itching, fatigue, muscle weakness
This case was reported by a consumer via call center representative and described the occurrence of fever in a 7-month-old male patient who received HAVRIX pediatric (batch number PN7GD, expiry date 17th November 2017). Concurrent medical conditions included sickness. Concomitant products included FLUZONE, PENTACEL and PREVNAR. On 15th October 2015, the patient received HAVRIX pediatric (intramuscular) .5 ml. On an unknown date, less than a week after receiving HAVRIX pediatric, the patient experienced fever, and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the fever to be possibly related to HAVRIX pediatric. Additional details provided were as follows: This case was reported by the patient's mother. On 15th October 2015, at 11:00, the patient received a dose of HAVRIX pediatric at an age of 7 months in left leg. This led to an inappropriate age at vaccination. The patient was sick prior vaccination and then became more sick after receiving the vaccine. Specifically the patient experienced fever. The reporter thought that, the patient might be fighting the flu. The reported batch number (PMGD) for HAVRIX pediatric vaccine did not exist and was updated to PN7GD according to the sales database.
Continued fever  from 11 p.m. of the date of injection all the way until midnight the following night.  The first time i took my temperature , in the morning on 05/30/20, it was 101.3 and it had already gone down from the hottest I felt.  I continued to take Tylenol which lowered my fever to 99.6.  When the Tylenol wore off, it returned back to 101.0.  The glands in my neck are still painful to the touch and it spread from one nodule to 2 nodules in my right neck and also to a node in my right armpit.  My neck is still visibly swollen on 5/31/20 on the right side and still hurts, although when i awoke on 05/31/20, my fever was gone.
Myasthenia Gravis, treatment and outcome pending. Ptosis, vertical diplopia, jaw fatigue Positive acetylcholine receptor binding, receptor modulating and receptor blocking antibodies
Significant shortness of breath requiring medical treatment (inhaler and steroid rx) Shortness of breath for 3 days moderate/significant extent. Shortness of breath improved by 1/23/2021 per pt.
This spontaneous report as received from a doctor of pharmacy refers to a 60 years old male patient with allergy to CELEBREX who on 24-AUG-2012, was vaccinated with a dose of ZOSTAVAX (lot# 00172AE, exp date 18-APR-2013). No other co-suspects were reported. Concomitant medications included FLUTAZONE nasal spray, triazolam and etodolac. It was reported that the patient developed a rash following vaccination with ZOSTAVAX. The pharmacist reported that the rash started about 3 or 4 days following vaccination with ZOSTAVAX "approximately on 27-AUG-2012". The rash was described as on the abdomen, painful and about to blister when the pharmacist spoke with the patient. The patient did not have any treatment given. At the time of the reporting, the patient had not recovered. The patient contacted the pharmacist by phone. The relatedness for developed a rash on the abdomen, painful and about to blister following vaccination with ZOSTAVAX was unknown for ZOSTAVAX.  Additional information has been requested.
A serious report was received from a consumer concerning a male adult.  No medical or drug history was reported for this patient.  The patient received FluMist on an unreported date.  A wife's email states "We have questions about whether or not my husband's FluMist vaccine caused his current pericarditis diagnosis".  The patient remained hospitalized at the time of the report.  Additional FluMist dosing is not indicated for this season.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021/doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021/doses administered after more than 1 temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021 at 10:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 10:42 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021/doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021/doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021/doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021/doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 64.42. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 28 Feb 2021 with temperature 27 degrees Fahrenheit at 9 AM and 26 degrees Fahrenheit at 1 PM. This vial was moved to fridge on 24 Feb 2021 and beyond use date for the vial was reported as 26 Mar 2021. Product moved to clinic on 27 Feb 2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Patient became diaphoretic and cold 10 minutes after vaccination.  Vital signs: BP 170/90 , Repeat after 15 mins 165/90 HR 74, SPO2 100%  RR 28 She denied chest pain, syncope,  difficulty breathing, itching. Preferred to go home, refused offer to be transported to Emergency room.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324608, 2018SA324602, 2018SA324605, 2018SA324604, 2018SA324607, 2018SA324609, 2018SA324606 and 2018SA324596. This case involves Elderly female patient received 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot number: UJ048AB, expiry date: 31-Nov-2019, dose in series was not reported) via intramuscular route in left deltoid. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. This was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Uveitis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4341965-00 (Agency).  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 4 (booster), single, intramuscular, administration date Feb2022 (Batch/Lot number: unknown) as dose 3, single, intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UVEITIS (medically significant), outcome "not recovered", described as "Uveitis". The action taken for adalimumab was dosage permanently withdrawn. Clinical course: It was unknown if patient was enrolled in a covid-19 Vaccine Trial. Event did not abate after stopping drug.  The reporter's causality for the event of UVEITIS was not provided for suspect drug humira (adalimumab). The reporter's causality for the event of UVEITIS was possible for suspect drug Pfizer Biontech COVID-19 vaccine (tozinameran).  The reporter considered "uveitis" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Uveitis and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
After 2nd vaccine my eyelids are almost shut every morning with crust baggy puffy eyes and crust developing all day
Pt recv vax on 11/4/98; on same day pt exp hot, flush vax site w/ red blotchy neck, upper chest & upper LA, redness of ears, cough (90 min); tx=Benadryl
Early evening on the 9th I began to feel normal symptoms as described in the information sheet. However, instead of the symptoms decreasing, they began to increase.  The inject was given in my left arm.  My arm was extremely sore. More sore than after past flu injections.  It actually burned when the injection was being administered. My bicep increasingly became more sore to the extent I could hardly use my arm without severe discomfort.  I had an extreme headache about 7:30pm on 9/10.  I was chilled severely, sweating, no appetite and went directly to bed.  I did take ibuprofen and Benadryl.  This did not help any of the symptoms.  As time has gone on, my muscle is extremely sore, hot and my skin is red in the shape of my bicep and swollen.  Where the redness etc stops, so does the pain.  I did not contact the MD on Friday believing the symptoms were normal symptoms. However, by Friday evening I knew the symptoms were not normal but not life threatening.   I did also receive a pneumo shot the same day in the same arm.  I have had that shot before and never had a problem.  The flu shot is the only one that changed.  Therefore, I believe it to be the flu shot.  I will be contacting the doctor on Monday morning 9/13/2010 promptly in the morning.  I am sure I will need to be seen.
This case was reported by a physician via sales representative and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject, who is also a physician received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced not responding to therapy. The subject was once given TWINRIX injection and has no titer for Hepatitis A. Specific details regarding dates, demographics or other information were unknown. At the time of the report no other events were reported.