chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 55 year old female patient with penicillin allergy who was not pregnant reporting on herself. On 07-SEP-2014 the patient was vaccinated with PNEUMOVAX lot # K007773, expiration date: 01-MAY-2015 in the arm (dose and route of administration were not reported). On 08-SEP-2014 (1 day after the patient was vaccinated (also reported as 07-SEP-2014)) the patient experienced flu-like symptoms that include body aches and high fever of 102F. Patient also experienced a lump that was lower than the injection site at the muscle in the patient's arm. She also experienced pain and a red line that traveled from the muscle where the lump was located to the patient's right breast. It was very sore when patient lifted her right hand. She did not seek medical attention. The outcome the events was unkown. Additional information has been requested.
Information has been received from a health professional concerning a 5 year old female who on 01/09/1998 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live. On 01/17/2002 the pt experienced chickenpox all over the body. Unspecified medical attention was sought. It was reported that the pt recovered on 01/17/2002. Additional info has been requested.
This spontaneous report was received from a other health professional refers to a 48 year old male patient with sleep apnea, diabetes and hypertension. The patient's medical history included hypercholesterolemia. On 25-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K008409; expiry: 6) intramuscular. Concomitant therapies included benazepril hydrochloride and omeprazole (manufacturer unknown). On 26-NOV-2014 (also reported as within 2 days prior to 28-NOV-2014), after receiving the dose, patient experienced erythema at the injection site and chills. The erythema was diagnosed as possible cellulitis. As a result, patient was started on cephalexin (manufacturer unspecified). Patient's present status was unspecified. Lab diagnostics studies performed was none. Patient sought medical attention and called had an office visit. There was no product quality complaint (PQC) involved. The outcome of possible cellulitis and chills is unknown. Causality assessment was not reported. Additional information has been requested.
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patients information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter
Vaccine was first stored in refrigerator on 4Jun2022 and administered on 9Jul2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was first stored in refrigerator on 4Jun2022 and administered on 9Jul2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was first stored in refrigerator on 4Jun2022 and administered on 9Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was first stored in refrigerator on 4Jun2022 and administered on 9Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine was first stored in refrigerator on 4Jun2022 and administered on 9Jul2022).    Concomitant product was not provided. Treatment information was not provided.  Patient received half dose.  On 04-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.
The patient received the first dose of GARDASIL 9 at the age of 12 years old and received the 2nd dose of GARDASIL 9 four months later.; no adverse event; This spontaneous report was received from a female patient of unknown age reporting on herself. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient at the age of 12 years old, received the first dose of she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, also reported as four months later, she was administered a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (inappropriate schedule of product administration). No adverse effects reported.  The outcome of inappropriate schedule of product administration was not reported.
Pt received 1st MODERNA covid vaccine at another pharmacy. Pt requested to get 2nd Pfizer covid vaccine at our pharmacy. RPH did not catch the different type of vaccine and administered Pfizer vaccine to pt.
very bad sore throat; Diarrhea; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (Diarrhea) and OROPHARYNGEAL PAIN (very bad sore throat) 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 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced DIARRHOEA (Diarrhea). On 10-Jan-2022, the patient experienced OROPHARYNGEAL PAIN (very bad sore throat). At the time of the report, DIARRHOEA (Diarrhea) and OROPHARYNGEAL PAIN (very bad sore throat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Day of injection I experienced fatigue and chills and sore arm from injection.  Chills lasted the evening fatigue lasted 7 days, sore arm lasted 3 days. On the 9th day after the injection I woke up to a red, hot, sore area at the injection site. Each day the area grew in a circular pattern, hot, redness, soreness. The circular patter grew to the size of a softball. Then on the 6th day it dissipated
Arm swelling L arm 1st noticed 1 d after Dtap, IPV 5cm red/swollen, no cellulitis.
This spontaneous report was received from a physician refers to a 02 month old infant of an unknown gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 09-DEC-2016, 02 month old infant was inadvertently vaccinated with VAQTA injection (lot number/expiry date and dose not reported) for prophylaxis. No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Information has been received from a nurse concerning a 23 year old female patient who in February 2012, was vaccinated with her first dose of 0.5 ml GARDASIL (route, lot # not reported). On 14-MAY-2012, the patient was vaccinated with her second dose of 0.5 ml GARDASIL (route, lot # not reported). Concomitant therapy included SEASONIQUE. On 14-MAY-2012 ("the evening after receiving the second dose") the patient experienced fainting when she got to work and became nauseous, feverish and light-headed upon recovering from the faint. The next day she continued to experience light-headedness and dizziness. The patient had sought medical attention by calling the office. No treatment was given to the patient. At the time of the report, the events improved but the reporter was unsure if the patient would receive the third vaccination. Follow-up information was received from physician's office worker refers to a 23 years old female patient with Human papillomavirus (HPV) who was stressed at the time of vaccination. On 14-MAY-2012 at 10:15 AM, the patient was vaccinated with the second dose of GARDASIL, lot number 670049/1171AA, 0.5ml, intramuscularly in left deltoid. No other co-suspects were reported. On 14-MAY-2012 at 12:00 PM, the patient experienced light-headed, dizziness, feverish, nauseous, fainting. It was reported that the patient stated on 11-JUN-2012, after the injection, she felt tired, later at work she passed out (which the nurse felt was the same as the patient "fainted"). She went home and was dizzy. light-headed and nauseous, also stated she had a fever. It was reported that the patient had no symptoms after this event. The patient's outcome was recovered on 14-MAY-2012. The patient did not seek medical attention/intervention. The relatedness that patient's adverse events was not reported for GARDASIL. Additional information is not expected.
could not controlled body; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (could not controlled body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (could not controlled body). At the time of the report, MOVEMENT DISORDER (could not controlled body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and treatment medications were reported.
Warm/ red cellulitis left upper arm approximately 10 x 10 inches. No nodes. No fever. Started yesterday afternoon approximately 24 hours after vaccine. No problem with previous vaccine.
TIRED  CHILLS  THIRSTY  SLIGHT FEVER  ACHES  PAINS  VERY SLEEPY (2 HR NAP IN AFTERNOON) (1 HOUR NAP AFTER DINNER) 9 HOURS OVERNIGHT SLEEP
Lightheaded Seen by onsite EMTs Pt.CAOX3; pale;diaphoretic, initial v/s WNL. Pt. stated relief after lying supine. Once seated patient c/o lightheaded again. Pt. hypotensive at v/s recheck.  Recheck 88/54 Pt. remained in supine position for extended observation time. Post orthostatic blood pressure , patient remained WNL, CAOX3 Recorded by  Pt. discharged home at 15:15 p.m.
Severe sepsis with acute organ dysfunction - acute respiratory failure, metabolic encephalopathy;he developed a LLL infiltrate and was treated for possible bacterial pneumonia with Rocephin, doxycycline and continued on Solu-Medrol and nebulizer treatments.  He had evidence of CHF so he was given IV Lasix during his hospitalization and his oral dose will be increased from 40 to 60 mg daily until his follow-up appointment to address any further adjustments necessary.  He had slow improvement in his symptoms of wheezing, dyspnea and hypoxia and by the time of discharge he only required 1 liter supplemental O2.  ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
no adverse event; received an unknown number of doses of GARDASIL-9 following a temperature excursion; Information has been received from a medical assistant regarding an unknown number of patients of unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unknown date, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number R029515 with expiration date in 08-JUL-2021 (strength, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a lowest temperature range below 36 degrees Fahrenheit (°F)/ 2°F (34.3F)  (multiple excursions) for the time frame of 13 days, 21 hours and 45 minutes. It was unknown if any previous temperature excursion had occurred and the digital data logger was involved.  No adverse effects were reported in any patients.  This case is non-valid due to lack of patient identifiers.  As of 12-JUN-2020, the medical assistant provided the patient's identifiers for the patients that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that underwent a temperature excursion.  The patient was a 11-years-old female patient, that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 12-DEC-2019.  This case is one of 4 cases received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2006USA005345: US-009507513-1912USA004231: US-009507513-2006USA005344:
nausea, starting 7-3-2014 and on going, physician prescribed reglan to treat but was not helping and patient is going to make doctor appt.
Jittery; Difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING JITTERY (Jittery) and DYSPNOEA (Difficulty breathing) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL SULFATE, ASCORBIC ACID, ATORVASTATIN, CARVEDILOL, ENALAPRIL, FOLIC ACID, HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULPHATE) and SULFASALAZINE for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced FEELING JITTERY (Jittery) and DYSPNOEA (Difficulty breathing). The patient was treated with REMDESIVIR at a dose of UNK dosage form. At the time of the report, FEELING JITTERY (Jittery) and DYSPNOEA (Difficulty breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.   Other treatment medication included antibiotic, blood thinners   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR added
After about 30 minutes baby became unresponsive. Code blue was called. Baby had pulse and was breathing. Her pupils were checked they fell to the side. Baby was taken to ER for further evaluation. Once child was at the ER the baby became alert and started crying.
Died from the Pfizer Covid-19 vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient died from the pfizer covid-19 vaccine on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died from the Pfizer Covid-19 vaccine
Vasovagal reaction immediately upon administration of vaccine.  Patient felt faint, requested to lie down on floor.  Initial blood pressure reading approximately 5 minutes later was 92/54.  Patient did not lose consciousness.  Repeat blood pressure reading approximately 10 minutes after vaccine administration was 122/78 and patient reported feeling better.  Patient was observed for an additional 20 minutes with improvement of symptoms.
No Adverse Event; Nurse reports patient was accidently administered an expired dose of VARIVAX on Jul 17, 2023. Product expired on Jun 28, 2023. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC reported.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot #U020238, expiration date: 28-JUN-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  The reporter informed that the was accidently administered an expired dose of vaccine (expired product administered). No prior temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Persistent Temp elevation above 100 F, chills, pain that lasted for 2 days
Case number PHEH2011US01184 is an initial spontaneous report received from a health care professional on 10 Aug 2011. This report refers to a patient of unknown age group and gender. This patient was given only the MenA lyophilized powder component of Menveo vaccine intramuscularly on an unspecified date. NO other adverse reaction was reported.
A welt and swelling developed at injection site immediately post vaccine administration. An ice pack was applied for about 20 minutes and patient was observed. Swelling started subsiding but wasn't completely gone. The patient was advised to continue applying the ice pack, monitor site for any more redness/rash and any further symptoms.
Suspected mini-stroke 10/3/2022 CVA 10/20/2022
throat swelled, fever, tremors, numbness in hands & feet, difficulty breathing, pain @ inject site, swollen glands in neck, fainting, dizziness, 6 hrs vomitting; ear, throat & sinus infection; slept for 3 days; dime size red knot appeared;
Got the first dose on 15May2021 and have not received the second one yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first dose on 15May2021 and have not received the second one yet) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the first dose on 15May2021 and have not received the second one yet). On 15-May-2021, PRODUCT DOSE OMISSION ISSUE (Got the first dose on 15May2021 and have not received the second one yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Redness and Pain at injection site.  Increased pain with movement. Pain at site and at axillary regions.
slight abdominal discomfort x3 days ER 5/20/21 with admission appendectomy 5/21 /21 Right Bundle Branch Block on EKG (no prior ekg abnormalities)
Intracranial hypertension, headaches, pressure on left side of head, head CT indicated ischemic activity after vaccination left eye, visual problems, weakness left upper rm, weakness and aches lethargy, tiredness heavy sinus pressure, now have sinus bradycardia all of these are continuous since the vaccination
Patient who was inadvertently given an entire undiluted vial for her second shot; Patient who was inadvertently given an entire undiluted vial for her second shot; dizziness; nausea; sore arm; He had to call out of work; This is a spontaneous report from a contactable pharmacist. A 39-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0167 and Expiration Date: Aug2021, NDC number was not reported), via an unspecified route of administration, administered in left arm on 28May2021 as 2nd dose, 0.3 mL, single dose (at the age of 39-years-old) for covid-19 immunisation. Patient had no medical history, and no concomitant medications were used by patient. Patient had no prior vaccinations. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, as 1st dose, single dose (at the age of 39-years-old) for covid-19 immunisation. On 28May2021, patient inadvertently given an entire undiluted vial for her second shot vaccine. On an unspecified date of May2021, patient had dizziness, nausea, a sore arm and had to call out of work for 3 days. The outcome of all the events was unknown.  Additional information is requested
1 day after, lethargy & irritability. 1 1/2 days later, fever, urticaria (OM also). Tylenol Benadryl Amsxil.