chrisvoncsefalvay/vaers-outcomes huggingface dataset:
YEAR OVERDUE FOR SECOND SHOT; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comments: This case was reported by a other health professional via interactive digital media. The patient had about a year overdue for his 2nd dose of Shingrix. The reporter asked did the patient need to restart the entire series. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sunday 04/04/2021 started itching on right side next to breast, no redness or rash. itch got more severe over nigh. 04/05/2021 morning lips dry and burni,g throat and back tongue scratchy. 04/06/2021 severe itching from head to toe still no rash or redness. took benedryl called fam. doctor, told me to continue benedryl till itch subsides. evening severe pain in upper stomach near breast, felt like big bubble /knot, started vomiting and diarhea all night . 04/07/2021 entire body rash and hives, went to ER. said it was severe alergic reaction. gave me prednisone shot, and told me to contact allergist. taking prednisone for 4 days also pepcid and benedryl. it is now 04/09/2021 still itching all over , and diarhea
Itchiness at injection site; Redness at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O3222OA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLYBURIDE and LISINOPRIL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient treated with Benadryl; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Pt was immunized on 3/17/21 and during hospital stay for unrelated illness, pt was found to be COVID positive. Pt did not have any symptoms.
no effects noted; a patient received an expired MMR II; This spontaneous report was received from a medical assistant and refers to a 4-year-old male, patient. The patient's concurrent condition included eczema. The patient had no known drug allergies. His historical vaccines included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid, diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (unspecified), Hib conj vaccine (tet toxoid), pneumococcal conj vaccine (unspecified), pneumococcal 13v conj vaccine, rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) and varicella virus vaccine live (unspecified). His concomitant therapies included diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (KINRIX), varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent. On 07-JAN-2020, the patient was vaccinated with expired second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 ml, subcutaneously in left thigh, lot # N032750, expiration date not reported but upon internal validation established as 20-NOV-2019 for prophylaxis. The person that was preparing the vaccination missed number 19 in the expiration date field and thought that NOV20 meant November 2020. The patient did not experience any adverse event.
hives/hives; welts/welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/hives) and URTICARIA (welts/welts) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergy.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced URTICARIA (hives/hives) and URTICARIA (welts/welts). At the time of the report, URTICARIA (hives/hives) and URTICARIA (welts/welts) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient got hives, then welts that went away. No treatment information were provided. Rechallenge was positive on august 2021.   This case was linked to MOD-2021-304977 (Patient Link).
Patient was administered flu vaccination and in about 15-20 minutes pt. developed rash and redness along upper shoulder and back. Pt. given 25mg of BENADRYL.
High fever, uncontrollable shivering, nauseous, massive headache, dizziness, heart pounding an fluttering, sore at arm. Took tylenol and symptoms subsided by 8 hours. Then another 12 hous of headache and some nausea.
Case number PHEH2013US024411, is an initial spontaneous report received from the physician on 20 Nov 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13012) intramuscularly on 16 Nov 2013. On the same day after vaccination, he fainted and fell down. It was reported that he was not injured by fall. The event outcome was unknown. The seriousness and causality were not reported.
Pfizer 1/14/21, 2/4/21. Positive on 2/20/23
This spontaneous report as received from other health professional refers to a 64 years old female patient. On 08-NOV-2012 at 09:45 AM, the patient was vaccinated with the first dose of ZOSTAVAX lot number reported as aCoeH013938AC subcutaneously (dose and exp. date were not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 09-NOV-2012 at 17:00 PM, the patient experienced red burning sensation on upper chest and right arm that created into a rash about 10 inches diameter. Treatment information was not reported. At the time of report, the patient's outcome was unknown. The relatedness for the patient's events was not reported for ZOSTAVAX. Additional information has been requested.
5/6/99 pt exp 104 fever in pm, 5/7/99 ofc visit temp 102.8, rash over entire body on 5/5/99 temp 98.1, rash subsiding, md dx vax reaction
Patient was given the menactra, bexsero, and hpv vaccine while at our office for her annual well check-up. She received her vaccines around 2:30 pm, and started to feel dizziness and started vomiting around 4pm that same day.  She vomited 4-5 times that day, 8/12/2020. She started to feel a bit better the next day but was feeling very tired.
Patient received HPV and had dizziness which progressed to auditory hallucinations and hospitalization.
nausea, dizziness, fever, feeling like I will pass out, sore and swollen throat
Administered the Moderna COVID 19 vaccine to a 17-year-old by mistake; A spontaneous report was received from a healthcare professional concerning a 17-years old, female patient who was administered the Moderna Covid-19 Vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 (Lot number given as 025L208 but reporter was unsure) intramuscularly for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, product administered to patient of inappropriate age, was resolved on an undisclosed date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # 025L208. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Rash on face and trunk, no difficulty breathing. Benadryl given, improved significantly within 10 minutes, oberved and discharged.
Headache, Myalgia, Fever, head congestion, sore throat, chills, fatigue Narrative:
pt recv vax 10AUG95 & on 25MAR97 pt devel chickenpox consisting of a rash w/30-50 lesions;pt exp no complications, & recovered on approx 1APR97;
Angioedma to top lip. Started with swelling to chin area and the moved to top lip being fully swollen. Seen at urgent care, given decadron injection in left butt cheek
Pt. received Pneumovax and Tetanus/Diphtheria injections on 2-11-04. Pt. returned to office with complains of 4 cm area of erythema with small area of induration in center at site of Tetanus/Dipheria. Patient complained of tenderness and itching to site since injection. Treatment Kelfex 500 mg three times daily for 10 days. Alegra 60 mg twice a day for 10 days. Benadryl as needed, Ice twice a day, Hydrocortisone or Benadryl DP 2-3 a day
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 76 years old female patient who developed red/pink circle was bigger, and it was about 3.5 to 4 inches long and 2 to 2.5 inches across/no pain but this time it did swell up, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Notes: The patient received the flu shot last year and underneath where she received the injection there was a red or pink circle. She said that it was the size of a 50 cent piece and it was 1.5 inches thick and then went away. On 14-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported in the left arm. On an unknown date, the patient developed a non-serious the red/pink circle was bigger, and it was about 3.5 to 4 inches long and 2 to 2.5 inches across/no pain but this time it did swell up following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data reported. Final diagnosis was the red/pink circle was bigger, and it was about 3.5 to 4 inches long and 2 to 2.5 inches across/no pain but this time it did swell up. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered/Resolved on an unknown date for the red/pink circle was bigger, and it was about 3.5 to 4 inches long and 2 to 2.5 inches across/no pain but this time it did swell up.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Blood pressure went up.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6198) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing); "bee venom allergy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: The patient was evaluated by ENT and audiologist. MRI ordered; no causes identified.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/AE, different drug dose;
Urticarial Vasculitis; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 13:00 (Lot number: EWO187) at the age of 61 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing), notes: Healthy with seasonal allergies treated with antihistamine as needed.; "known allergies: Corn" (unspecified if ongoing); "known allergies: Apples" (unspecified if ongoing); "known allergies: Pears" (unspecified if ongoing). The patient did not have COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccine within four weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9264, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM), administration date: 13Feb2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1283, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM), administration date: 23Jan2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 26Aug2021 03:00, outcome "unknown", described as "Booster"; URTICARIAL VASCULITIS (medically significant) with onset 27Aug2021 03:00, outcome "not recovered", described as "Urticarial Vasculitis". The event "urticarial vasculitis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jun2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of urticarial vasculitis and included 300 milligrams Prednisolone tablets.; Sender's Comments: Based on a compatible temporal association, a causality between event and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
patient received an adult dose of Havrix as a 2nd dose by mistake, patient is 3 years of age; patient received an adult dose of Havrix as a 2nd dose by mistake, patient is 3 years of age; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 3-year-old male patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 20-SEP-2023, the patient received the 2nd dose of Havrix adult. On 20-SEP-2023, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: patient received an adult dose of Havrix as a 2nd dose by mistake, patient is 3 years of age) and adult product administered to child (Verbatim: patient received an adult dose of Havrix as a 2nd dose by mistake, patient is 3 years of age).  The outcome of the accidental overdose and adult product administered to child were 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: 20-SEP-2023 The reporter was a pediatrician. The patient received an adult dose of Havrix as a 2nd dose by mistake, patient was 3 years of age, which led to accidental overdose and adult product administered to child. The reporter asked how to proceed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
HEADACHE; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and chills. This report was non-serious.
This spontaneous case was initially received on 25-Nov-2015. The case report was received from a Health Professional and concerns a female patient. Weight: not provided: Height: not provided. The patient has a medical history of Celiac. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza vaccine on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: administered in 2014. No additional drugs suspected. In 2014, after starting treatment with Influenza vaccine the patient experienced Reaction as if she consumed gluten/Reaction to gluten from unspecified flu vaccine. For relevant test results see appropriate report section.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 18-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (lot number: J000202 with expiry date of 09-JAN-2015) (dose, frequency and route unspecified) and MMR II (lot number: J005723 with expiry date of 08-SEP-2015) (dose, frequency and route unspecified). Concomitant medications were not reported. The reporter stated that temperatures of (Merck) VARIVAX and MMR II vaccines have not been monitored since January 2014. The reporter does not known if (Merck) VARIVAX and MMR II had any temperature excursions. No adverse symptoms were reported. The outcome of the events was unknown. The causality of the events with (Merck) VARIVAX and MMR II was not reported. This case is linked to # 1410USA010478 via same reporter link. Additional information has been requested.
Pt developed soreness of arm. Pneumovax given in (extending from shoulder to elbow and toward breast). She also had multiple red swollen nodules. No fever.
9 days p/vax pt states awoke w/pain ? swelling in ankles, knees, elbow, wrists;nerve conduction studies negative;
Patient received  Covid-19 vaccine 1st dose of 3 doses series BUD-expiration date. Patient mother was made aware of the adverse event. Patient had no symptoms or side effect related to the adverse event. Doctor recommended patient to be revaccinated, mother refuse to revaccinate patient. she stated she was not planning on completing the initial series that patient started.
Red, bumpy rash on left side of chest and left shoulder. Rash is itchy - not painful or tingly. Appeared 48 hours after injection to left deltoid muscle. Has not completely resolved after 96 hours after injection. Continues to be itchy, but not painful or tingly. Left deltoid muscle is still sore 96 hours after injection. Patient did NOT experience flu-like symptoms (fever, malaise, etc).
Sore arm starting on day of vaccine and still somewhat sore 3 days later; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Feb2021, the patient experienced sore arm starting on day of vaccine and still somewhat sore 3 days later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event sore arm starting on day of vaccine and still somewhat sore 3 days later was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient began reaction approx. 1-2 hours after injection, raised area 4" x 5" swollen, hot, red, not painful parents took to ER that night follow up clinic next day given Benadryl instructed to use ice. Talked to Mom this AM patient has cleared up.