chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 55-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 18-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
6/3/16- MENACTRA admin RA/IM at 2:17pm. That eve pt developed local itchiness, started scratching site over next day cont'd scratching, developed swelling, redness at site. Mom took to ER 6/4/16 night. ER tx'd for cellulitis and local rxn. 06/03/2016 c/o stuffy nose and sore throat. HPV and MCV due now. Other Imms UTD for age incl 2015 Flu Vac and TDaP. 06/06/2016 Walk in: Mom present swelling on his right arm. Imms UTD for age incl 2015 Flu, and TDaP. HPV #3 due 10/2016. 06/13/2016 Follow up: Local vaccine reaction and cellulitis. Imm's UTD for age incl 2015 Flu, TDaP, MENACTRA.
couldn't really move for 3 days; feeling sick; One half of her face Sore and "Drippy"; High Fever; Fatigue; numb and droppy about 20; Prickling/Tingling; Decreased level of conciousness; This spontaneous case was reported by a pharmacist and describes the occurrence of FACIAL PAIN (One half of her face Sore and "Drippy"), HYPOAESTHESIA (numb and droppy about 20), MOVEMENT DISORDER (couldn't really move for 3 days), MALAISE (feeling sick) and PARAESTHESIA (Prickling/Tingling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia, Chronic pain, Rash, Throat swelling and Hives since an unknown date. Concurrent medical conditions included Type 2 diabetes mellitus (T2DM), Hypertension (HTN), GERD, Depression, Drug allergy (Cefoxitin - Hives, Rash) and Drug allergy (Lisinopril - Arrhythmia, swelling of throat). Concomitant products included INSULIN ASPART, INSULIN DETEMIR and GLIPIZIDE for Diabetes mellitus non-insulin-dependent, OMEPRAZOLE for GERD, ATENOLOL and LOSARTAN for Hypertension.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced HYPOAESTHESIA (numb and droppy about 20), PARAESTHESIA (Prickling/Tingling) and STUPOR (Decreased level of conciousness). On an unknown date, the patient experienced FACIAL PAIN (One half of her face Sore and "Drippy"), MOVEMENT DISORDER (couldn't really move for 3 days), MALAISE (feeling sick), PYREXIA (High Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FACIAL PAIN (One half of her face Sore and "Drippy"), HYPOAESTHESIA (numb and droppy about 20), MOVEMENT DISORDER (couldn't really move for 3 days), MALAISE (feeling sick), PARAESTHESIA (Prickling/Tingling), STUPOR (Decreased level of conciousness), PYREXIA (High Fever) and FATIGUE (Fatigue) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received and Patient demographic, Medical History, Concomitant medication, Adverse events updated.
This spontaneous report was received from a licensed vocational nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 25-AUG-2015 the patient was vaccinated with improperly stored doses of PROQUAD, lot # reported as: L023111, expiration date: 24-DEC-2016) (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse symptom was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable nurse via Pfizer sale representative. A female patient of unspecified age and ethnicity received the first single dose of TRUMENBA, lot number 1913065, expiry date Sep2016 via an unspecified route of administration, on unknown date. Relevant medical history and concomitant medications were not reported. The patient couldn't move arm for two weeks on unknown date. The outcome of the event was unknown. Follow-up (06AUG2016): Follow-up attempts are completed. No further information is expected.
3/117/2021 woke up w/acute all over muscle/body aches and pains fever, chills, shortness of breath, chest tightness, headache, somewhat nausea acute cramps, diarrhea. Home treatment Tylenol (500mg) took eye lubrication drop and prednisolone called Dr. 3/17/2021 saw Dr's assist, he took temp, BP, and gave me IV fluids. 3/18/2021 we to another clinic and got back adjustment and PT + OT was done by therapists. Told me if I didn't improve within (2-3 hrs) go to Emergency Hosp. Both treatment s worked so didn't go to hospital.  3/22/2021 SUN 0 woke up not feeling well - took TYLENOL, Eye Meds, coffee, went to church and lunch> then approx 1:-1:20 body symptoms returned - not as acute lived on pain meds. 3/29/2021 Back at clinic for PT and OT. Same treatment as above and again 3/29/2021 - Fatigue and TYLENOL all day Note afternoon (2 hrs) nap - > evening hrs soreness only-
got pregnant after first dose; did not get second dose; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PREGNANCY (got pregnant after first dose) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant Medical History reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Oct-2021. On an unknown date, the patient experienced PREGNANCY (got pregnant after first dose) and PRODUCT DOSE OMISSION ISSUE (did not get second dose). At the time of the report, PREGNANCY (got pregnant after first dose) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of a pregnancy which occurred after the first dose of vaccine. No associated AEs were reported for this 35-year-old female patient. In addition, the patient did not complete vaccination course (2nd dose not given). Patient will continue for further monitoring during the pregnancy
Lump to left groin after 2nd Pfizer Covid vaccine, hospitalization on 2/8/21, multiple office visits, specialists, labs, imaging - lump became painful to touch 2/1/2021 and first appointment for this was 2/3/2021. Patient hospitalized 2/8/2021. Diagnosis of Left inguinal lymphadenopathy.
I was feeling funny before bed, but the next morning woke up coughing with a sore throat. I took a home COVID-19 test twice and those were both negative. I went to my doctor and had a PCR test, and it was positive for COVID-19. I have had fatigue, a headache, ended up with an ear infection. I have been coughing as well but the brain fog has really been the biggest issue. I now have a UTI from the antibiotics I was put on as well. At this point I have a lingering cough that comes and goes along with the UTI but I am still testing positive and today is the 9th day. When I got my COVID-19 vaccine I did also have a flu shot but I do not have information for that shot.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient (age not reported) who had a reaction and mother thinks that her daughter may be allergic to Formaldehyde in the FLUZONE, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included flu like symptoms and lots of allergies (ongoing). The patient's past vaccination included flu mist (influenza vaccine). The patient's past medical treatment(s), and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient had a reaction and mother thinks that her daughter may be allergic to Formaldehyde in the FLUZONE (hypersensitivity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included no lab data.) Final diagnosis was had a reaction. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown. List of documents held by sender: none.
About two weeks after 2nd injection of Pfizer vaccine, I developed chest pain and tightness, radiating to left arm. Also, have had palpitations and irregular heartbeat, making it difficult to sleep.  This has continued on and off for all of 2022 to this day.
Patient presented to ED on 11/8/2021 after a fall at home.  She also complained of fatigue and muscle aches.  She was COVID positive.  She became hypoxic and required 2L oxygen.  She was admitted to the hospital and received dexamethasone and remdesivir while in the hospital.   She was discharged on 11/11/2021 without oxygen, but will complete a 10 day course of dexamethasone.   She is vaccinated with 2 doses received in January/February 2021.  She received a booster dose following this hospitalization on 11/29/2021.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 20:00 (Lot number: EL9245) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MAC Lung Infection", start date: 04Aug2020 (unspecified if ongoing); "GERD" (unspecified if ongoing), notes: Chronic; "High Blood Pressure" (unspecified if ongoing), notes: Chronic; "LPR" (unspecified if ongoing), notes: Chronic; "Arthritis" (unspecified if ongoing), notes: Chronic. Concomitant medication(s) included: AMLODIPINE, start date: Aug2020 (ongoing); HCTZ, start date: Aug2020 (ongoing); GAVISCON ADVANCE [POTASSIUM BICARBONATE;SODIUM ALGINATE], start date: Aug2020 (ongoing); TELMISARTAN, start date: May2018 (ongoing). Vaccination history included: Bnt162b2 (1st dose, time administered: 20:15, Lot no: EL1283), administration date: 14Jan2021, when the patient was 73 years old, for Covid-19 immunisation, reaction(s): "nasal congestion", "headache", "Arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm soreness"; HEADACHE (non-serious), outcome "recovered", described as "headache".Additional information: Events did not result to physician and emergency room visit.  No follow up attempts are possible. No further information is expected.
Patient immediately began felling unwell after vaccination.  Patient felt "generally unwell" and in a daze.  Never alleviated, but second dose received.  Patient then developed hypertension, tachycardia and was diagnosed with Afib within 2 weeks of vaccination.  Patient was hospitalized and a pacemaker was placed.
Pneumonia; Very ill; Dysphagia; Got 3 Moderna vaccines; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 040B21A and 043B121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-existing disease.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia). On 06-May-2021, EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines) had resolved. At the time of the report, PNEUMONIA (Pneumonia), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided. Lot number of 3rd dose of mRNA-1273 - 043B121A. Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021 contains no significant information. Updated lot number of 3rd dose of mRNA-1273. On 16-Jun-2021: Updated events - Pneumonia (medically significant), Illness and Dysphagia. Updated historical condition - comorbid conditions.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.
21OCT91 pt recvd Engerix-B 48 hrs p/vax devel rash, hives & palms of hands itchy; 24OCT91 presented to ER where pt was treated w/DPH & Epi; sx discontinued w/tx & the pt was sent home p/3 hrs;
vacciantion faliure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SUMATRIPTAN; VENLAFAXINE; MELATONIN; AREDS 2 VISUAL ADVANTAGE; TRAZODONE. Vaccination history included: moderna coviD-19 vaccine (Dose: 1, Lot # 025A21A), administration date: 01Mar2021, for covid-19 immunization; moderna coviD-19 vaccine (Dose: 2, Lot# 028A21A), administration date: 29Mar2022, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "vacciantion faliure"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Unknown results. Therapeutic measures were taken as a result of covid-19.  Clinical information: The patient received other medications in 2 weeks, anti viral details are for covid-19 treatment Paxlovid with start date 25may2022 and stop date was 29may2022 for the treatment of covid-19. positive antigen test on following negative antigen test.
pt recv vax & lab eval revealed no rubella titer (2 lab results were obtained-one reported that pt had no titer & one reported that had a titer);
Expired Bexsero administered; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 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.   In October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In October 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: 13-Oct-2022 Reporter's comment: The case was received from the other healthcare professional via interactive digital media. The reporter just given Bexsero vaccine that was expired in July 2022. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used. The follow-up could not be possible as no contact details were available. Based upon the narrative, the vaccination date and onset date for medication was captured as October 2022.
vaccine 10/5/21 am, left arm ( pneumovax 23), right arm (quad 65+). 10/5 pm-rt arm sore. 10/6 am-rt arm large knot, swollen, red with heat; lft arm sore. 10/7 am-rt arm knot reducing; lft arm very sore, heat, nauseous, achy, very faint, slept most of day. 10/8 am-rt arm little tender; lft arm large knot, swollen, very red, alot of heat, extremely sore., finger tips numb. 10/9 am-knot gone, large red patch on full bicep, very sensitive to any touch, small amount of heat.
Redness at the injection site; Extreme leg muscle pain; Dry cough; Full blown cold; This case was reported by a consumer and described the occurrence of injection site erythema in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, 1 day after receiving Bexsero, the patient experienced injection site erythema, myalgia, dry cough and cold. On an unknown date, the outcome of the injection site erythema, myalgia, dry cough and cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, myalgia, dry cough and cold to be related to Bexsero.  Additional details were provided as follows: The case was reported by the patient's parent. Few weeks ago from the date of reporting, the patient received dose of Bexsero. The patient stated that, 2days after vaccination the patient experienced extreme leg muscle pain and shortly after (day 3) developed a dry cough which has since turned into a full blown cold.  The patient asked if to continue for 2nd dose though had reaction with 1st dose. The patient's parent did not want to have 2nd dose for the patient untill the patient was recovered from the present cold which may or may not be not be related.
Information has been received from a physician and a nurse practitioner concerning an 80 year old female who on 12-JAN-2009 was vaccinated with a dose of PNEUMOVAX (Lot n. 661529/0868X). The patient reported that on 13-JAN-2008, her arm was swollen and red from the injection site down to her elbow after receiving PNEUMOVAX. The patient sought unspecified medical attention. The patient is being treated with antibiotics. Additional information has been requested.
Eleven hours after injection:  Chills and shivering head to toe so violent seemed verging on convulsions.  Lasted for about an hour.  After that high fever with delirium the entire night, body aches all over.  Unable to sleep due to pain and fever.  Was unable to take temperature.  Second day:  Temperature dropped to 100.5 Extreme muscle pain everywhere, hand became numb for about an hour on the arm of the injection.  Unable to sleep that night as well. Third day:  Sore muscles but not as bad and diarrhea.
Had a large boil at the shot site, developed blood clots in  arm which caused alot of pain.
pt recvd vax & later was seen in ER w/diffuse maculopapular rash; No fever, nl behavior; degree of severity: moderate; Degree of causality: poss related;
Persistent pain, tenderness and intermittent burning at injection site. Onset 2 days after injection. Slight diffuse fullness, "tightness" to muscle without redness or obvious induration.   Referred to PMD if heat, ibuprofen not helping.
Red eyes, severe head ache, hard to hear, tunnel vision, nausea, fever, fatigue, sleeplessness, diarrhea
lupus; butterfly looking rash on face; vomiting; headache; dizzy; calcium in his artery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for Covid-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; BUTTERFLY RASH (medically significant), outcome "unknown", described as "butterfly looking rash on face"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; HEADACHE (non-serious), outcome "unknown", described as "headache"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; VASCULAR CALCIFICATION (non-serious), outcome "unknown", described as "calcium in his artery". The events "lupus", "butterfly looking rash on face", "vomiting", "headache", "dizzy" and "calcium in his artery" were evaluated at the physician office visit. The patient had never in his life shown signs or had Lupus. It did not run anywhere in his family. Around 2 months after his second shot, he woke up vomiting, headache, dizzy and a butterfly looking rash on face. For 3 weeks straight he was dizzy and had rash for even longer. After going to hospital, family doctor, dermatologist and rheumatologist they said he had Lupus, and knew he was seeing a cardiologist for calcium in artery.  The lot number for bnt162b2 was not provided and will be requested during follow up.
disseminated rash, diarrhea, arthralgias; sx tx w/ meds & rest; resolved except mild arthralgias- completely resolved on f/u 17dec
Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unspecified date in 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength, dosage, frequency and route unspecified). On 17-MAR-2016 the patient was vaccinated with another dose of ZOSTAVAX (lot#, strength, dosage and frequency unspecified; subcutaneous). No adverse effects were reported. Additional information has been requested.
Site of injection became red, itchy, warm and tender.  It got larger over a two day period.