chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. No concurrent or historical conditions were reported. On or after 27-APR-2016 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L048468, expired date 02-DEC-2017; lot # M000760, expired date 06-JAN-2018) (strength, dose, route unknown). Concomitant medication was not reported. The vaccines were stored under 31F for unspecified duration. No previous temperature excursions. No adverse event was reported. Additional information has been requested.
Woke up at 3AM with severe nystagmus and vertigo. Vomited three times within the course of 30 minutes. Have been dizzy on and off since then.
07/15/2019  Mother states Patient's R. leg is 'swollen, rock hard and with rash". Mother states she is going to take baby to the ER. She reports that Patient had fever on Saturday, but it responded to Tylenol, and he has not had fever since. Baby is taking less formula than usual. 07/06/2019 Case manger called Mother to F/U on yesterday's ER visit and Patient's condition. L/M on V/M requesting return call. Case manger called to ER. Confirmed that Patient was seen in ER yesterday and was treated and released.
Patient is a 45 y.o. female w/out significant PMHx on file who p/w moderate persistent LUE pain that begins at her shoulder and radiates to the center of her palm that began acutely about 5minutes after receiving a flu shot. She mentions that at first the pain was so severe that she was incoherent. The pain is intensified when the site of the flu shot is touched.    She also thought that he throat felt a little bit tight, but did not have any difficulty breathing. Denies any fever or CP. Denies rash, numbness, or tingling.
Patient was given Pfizer pediatric dose (0.2ml) 5-11 years,  instead of Pfizer standard dose (0.3ml) 12 years
Inject hit something solid...shoulder pain immediate...upper deltoid tenderness...pain unresolved .... range of mobility compromised. Limited ability to raise arm above shoulder. Limited ability to raise arm up in front of self.
rash down the arm; Rash near the injection site; Initial information was received on 14-Dec-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to case 2021SA027041 (same reporter).  This case involves 4 patients (unknown demographics) who experienced rash down the arm (rash) and rash near the injection site (vaccination site rash), when received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (beginning of November), the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2016 and expiry date: 30-Jun-2021) via an unknown route in the deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious rash down the arm (rash) and rash near the injection site (vaccination site rash), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  The details of laboratory data were not reported.  The patient was treated with HYDROCORTISONE for the events.  On an unknown date, patients recovered from events.
When calling to get billing information we were notified that patient had passed away. Patient's daughter said patient was having cvd a/s on 2.1.2021 got vaccine 2.2.2021 and passed away 2.5.2021. Cardiologist said not related
Left arm swelling, pain at injection site. Difficulty lifting up arm. Redness over upper arm.
Local Reaction - BLACK AND BLUE MARK ON HER ARM THAT HAS A LUMP IN IT. THE LITTLE LUMP IS WHITE AND THEN THERE IS A DARK COLORED DOT IN THE CENTER. NOT RED LOOKING. NO FEVER. TENDER TO THE TOUCH.  SAID IT FELT LIKE IT WAS PINCHED WHEN TOUCHED.  MOM SAID THAT THIS IMMUNIZATION BLED A LOT WHEN IT WAS GIVEN.
a 16 year old patiend received a dose of Flublok QIV / no AE; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist via Nurse on 24-Oct-2019.  This case is linked to cases 2019SA304580, 2019SA304586, 2019SA304587, 2019SA304589, 2019SA304590, 2019SA304591 and 2019SA304592.  This case involves a 16-year-old patient (unknown gender) who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV]) (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient experienced any adverse event.  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.
Vaccines prior to 11:30 AM 7/1/2009. Represented in office with rash at 6:00pm
Covid-19; Covid-19; Stress/Felt stressed because lot going on; Moderna COVID-19 vaccine (Elasomeran)/Pfizer BioNTech COVID-19 vaccine; Low energy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4141712.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1164826), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "Low energy"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown", described as "Moderna COVID-19 vaccine (Elasomeran)/Pfizer BioNTech COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19"; STRESS (non-serious), outcome "unknown", described as "Stress/Felt stressed because lot going on". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "moderna covid-19 vaccine (elasomeran)/pfizer biontech covid-19 vaccine", "covid-19" and "stress/felt stressed because lot going on" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "low energy" related to BNT162b2, BNT162b2 omi ba.4-5.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and on the compatibility with the drug's known safety profile, the company considers that a causal relationship between the reporter event-drug ineffective, suspected COVID-19,asthenia and stress  and suspect drug BNT162B2 cannot be excluded
no other AE's; administration of 2 doses of PNEUMOVAX23 at a dosing interval outside of the PI recommendations; This spontaneous report was received from a nurse referring to a 71 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 12-FEB-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On 03-DEC-2021, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # U023170, expiration date 19-JAN-2023, 0.5 ml one time) at a dosing interval outside of the PI recommendations (inappropriate schedule of product administration). No other adverse event (AE) was reported.
Narrative:  82 yOM vaccinated x 2 with Moderna vaccine (1st dose 2/4/2021, 2nd dose 3/5/2021) who was admitted on 1/11/22 for treatment of COVID-19 pneumonia after having cough, sore throat, and body aches X 2 days. He was treated with remdesivir x 4 days and dexamethasone x 4 days. Remdesivir was discontinued after 4 days of treatment due to a small increase of LFTs. He was discharged home on 1/14.
Pt was given adult  Td spoke with pt mom  06/08/08, bilateral leg soreness. No anagesics needed.
double pneumonia; 2 weeks later I got flu; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced double pneumonia and 2 weeks later got flu after receiving vaccine Influenza Vaccine.   The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, route, formulation, expiry date not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event of "double pneumonia (pneumonia)" and non-serious event "2 weeks later i got flu (influenza)" (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.    Outcome: Unknown for both the events.  Seriousness criteria: Medically significant for double pneumonia.; Sender's Comments: Sanofi company comment dated 27-Dec-2022: This case involves an unknown age and unknown gender patient who experienced double pneumonia and 2 weeks later got flu after receiving vaccine Influenza Vaccine. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and vaccination history, concurrent illnesses and concomitant vaccinations.
Diarrhea, Fever, Weakness, Aches in joints, pain in right side of back, Nausea, and chills all on March 11, 1.5 days after starting Vivotif oral vaccine.  I could not do anything all day.  Slightly better on March 13, the day after the secon dose of 4.
Right deltoid has a 3 inch rectangular region of erythema, warm to touch 2/11/08 after vaccine administration approximately 4 hours.  Treatment: Ibuprofen, ice applied, prescribed Atarax 10mg/5ml 1-2 tsp qid given.
My wife and I both took the JJ at the sametime/same place.  Both wife and I felt sting during injection.  Next morning, the wife and I were tired.  Body aches and headache.  It's almost 48 hours since vaccination and we both still feel tired and have mild headaches.    Was advised these are all normal side effects, but should be reported anyway.  Side note: Wife had severe dehydration 24 hours after.  I believe this was the only not listed side effect.  No treatments, just waiting it out.  Reactions seem to lesson each day.
Hard lump, hot, with rash inside welt at injection site. Lump is painful,  welt itches and continues to grow in size.
Pt's daughter called pharmacy on 9/10/13 stating pt. had received shingles vaccine on 6/17 13 and arm was still hurting. Stated pt. was sick for 3 weeks after shot and broke out w/ chicken pox. States she can not wash her air in shower b/c can't raise arm. Ask pt. to seek advice from MD. No PCP. So went to ER 9/10.Will call back 9/18. She felt Dr. "wouldn't touch her". She felt he "acted disgusted with her".
She has a lot of allergies; Dermographia of the skin, commented she gets issues with getting hives and things like that.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 09Apr2021 as dose 1, single for covid-19 immunisation and fexofenadine hydrochloride (ALLEGRA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history included Dermographia of the skin from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date on Apr2021, the patient had a lot of allergies and dermographia of the skin (she got issues with getting hives and things like that). She has a lot of allergies and needs to take Allegra everyday. She already had the first dose, but she didn't take her medicine the day of the vaccine. However, she had to start taking it a day or two later. She confirmed she has not had a reaction as far as she knows. She has Dermographia of the skin, commented she gets issues with getting hives and things like that. The reporter asked will it interfere with the potency with vaccine, She also wanted to know if it will cause masking of symptoms if she should have an reaction or if anything to worry about. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Mother states child ran fever nightly since imm on 6/20/05 until 6/25/05 PM he had a febrile seizure. Was taken to the ER. Illness was ruled out. Mother states doctor said it could have been caused by the imm. No further problems. Had history of febrile seizures.
Woke nauseated and fainted while walking to bathroom approximately 2-3 days after vaccine was given. Regained consciousness within a few seconds and experienced no further adverse events. No medical care was sought.
first dose 23Dec2020, arm sore; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 23Dec2020 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm sore after the first dose on 23Dec2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd vax 26JAN93 & the next day pt exp erythema @ the inject sit lt arm, h/a, neck pain; 29JAN93 again presented w/erythema & heat @ the inject site; pt felt might have cellulitis & was started on Keflex;
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided HCP stated that some patients had reported flu like symptoms after receiving the vaccination but did not have details on that
high fever 103.2 started at 2:50 am 2/2/21.  Headache, chills, muscle aches
5 hours after vaccine, i woke up  freezing cold with high fever.  I was vomiting every 15 minutes for 8 hours.  I was dizzy and had a headache as well.  It is one week later and I still get dizzy and feel nauseous but it comes in waves.
Patient received first dose of Moderna vaccine on 1/15/21 and was not aware of pregnancy. On 2/12/21, she called and cancelled her 2nd dose appointment because she found out she was pregnant. On 3/16/21 she contacted the pharmacy to schedule a second dose vaccine appointment because she said she had a miscarriage. Called Moderna to report it and Moderna confirmed to give second dose past the 42 days cdc recommendation instead of restarting the series. Patient received 2nd dose on 3/17/21 and has a follow up appointment with OB/GYN on 3/20/21.
Patient obtained both a flu and COVID vaccine on Monday 1/23/23 and for the next 2 days subsequently felt relatively usual post vaccination including some fevers and lethargy.  Then on Thursday 1/26 developed a GI illness with 2 to 3 days of diarrhea and abdominal pain. Patient presented to the emergency department 1/29/2023 with chest pressure. He was found in his work-up to have elevated troponin to 1700 for which cardiology was consulted. An echocardiogram which showed mild hypokinesis of the basal anterior wall segment but otherwise normal ejection fraction at 56%. He was monitored in the hospital and was found to have rising troponins (peak level 8359), EKG was normal on admission however changed to show inferolateral T wave inversions. Given his progression of hospital course, it was decided to take him to the Cardiac Cath Lab 1/30/2023 which showed normal coronaries.  Given this finding, his most likely clinical scenario fit with myocarditis post COVID-vaccine and recent GI illness, he was started on NSAIDs and colchicine. He was discharged home on 1/31 on colchicine 0.6 mg/day x 3 months and ibuprofen 600 mg 3 times daily x 4 weeks.  He will follow-up with heart doctor in the next 2 to 3 weeks with plan for repeat echocardiogram in 3 months.
Rt arm red & swollen, hot approx 2 1/2in in diameter, pt has had rxn since day of vax;
pt recv vax 30APR96 & 15MAY96 pt exp cont yeast infect;
sore; tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (sore) and FATIGUE (tired) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (2nd shot) in 2021 and Moderna covid-19 vaccine (1st shot) in 2021. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 16-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (sore) and FATIGUE (tired). At the time of the report, PAIN (sore) and FATIGUE (tired) outcome was unknown.        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.   No concomitant information was reported. Suspect product dosage text was reported as booster dose. No treatment information was provided.   Reporter did not allow further contact
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 13:00 as dose 4 (booster), single (Lot number: 9H9694) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: treated with statin. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Mar2022, stop date: 11May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid.
Reported leg rash -both legs 4-9-10 am. Office visit 4-9, tested for possible latex allergy, band aid alcohol = Mom advised to call 4-12 if spots become red.
Strong dizziness till lose the control of the left side of my body, headache, nausea, urgency to evacuate, couldn't control my bladder, left side of the face deformity, was unable to swallow even saliva
Approximately 24 hours after the injection, I began having persistent ice pick headaches, which lasted 1-2 hours. I have a history of these, but they are almost never so intense.  About 25 hours after the injection, I began having intense pain in the center of my chest. It dissipated and returned a couple of times over the next 5 hours or so. The pain was so great that it was difficult to stand, and I came close to passing out. I have not experienced this severe level of pain since about 30 hours post-injection.