chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her son a 13 year old male with no known medical history or allergies who on 13Aug96 was vaccinated SC in the left deltoid with a first dose of varicella virus vaccine live (lot617073/1662B). There was no concomitant medication. On 06Jun05 the pt developed a classic course of varicella. Unspecified medical treatment was sought. No lab diagnostic tests were performed. On approx 14 Jun05 the pt recovered. There was no product quality complaint involved. Follow up information from a physician indicated that the pt's vaccination history included: a first, second, third and fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid on 07Apr92, 12Jun92, 08Aug92 and 10Aug93 respectively; a dose of diphtheria toxoid (+) pertussis acellular 4 component vaccine (+) tetanus toxoid (Acel-Imune) (lot 386911) on 07Feb96 in the left deltoid; a first, second, and third dose of poliovirus vaccine live oral on 07Apr92, 12Jun92, and 10Aug93 respectively; a dose of poliovirus vaccine live oral (lot 0736A) on 07Feb96; a first and second dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 14May93 and 24Jul97 (lot 620094/1334D; in the left arm) respectively; a first, second, third and fourth dose of HIB vaccine (unsp) on 07Apr92, 12Jun92, 08Aug92, and 14May93, respectively; a first, second and third dose of hep B virus vaccine (unsp) on 23Feb94, 23Mar94 and 19Aug94, respectively a first dose of BCG vaccine on 05Mar05; a first and second dose of tuberculin purified protein derivative (Tubersol) on 18Aug97 (lot246311) in the left forearm and 23Jun03 (lot C1430A8); a first, second, and third dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) on 12Nov01 (lot U0707AA), 20Nov02, and 20Oct03, respectively. Additional information has been requested.
Pain in her rectum; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PROCTALGIA (Pain in her rectum) and DIARRHOEA (Diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer since November 2020, Milk allergy (milk intolerance) and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, ANASTROZOLE for an unknown indication.   On 10-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) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PROCTALGIA (Pain in her rectum) and DIARRHOEA (Diarrhea). At the time of the report, PROCTALGIA (Pain in her rectum) and DIARRHOEA (Diarrhea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Lab Data was provided. No treatment medication information was provided Patient taking radiation to treat breast cancer on 25Feb2021 and ended the radiation treatment on 17Mar2021. Patient stated received 15 rounds of radiation treatment. Patient taking Anastrozole for 5 years.   This case was linked to MOD-2021-242430 (Patient Link).
Breakthrough case admission after 2 vaccines Pfizer 3/0/21 lot# EN6207;  Pfizer 3/31/21 lot# Ew0150
Moderna Covid-19 Vaccine EUA  Same day as injection and one day post injection, experienced extreme fatigue and brain fogginess.   Six days post injection, injection site is red, hard and itchy. Injection site is also warm to the touch. No fever. No other side effects at this time.
patient got 4 injections of the vaccine instead of 3 injections; patient got 4 injections of the vaccine instead of 3 injections; It is unknown what the brand name of the HPV vaccine was; No other AE reported; This spontaneous report was received from a consumer referring to her currently 18-year-old daughter. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the first dose of unspecified human papillomavirus (HPV) vaccine (manufacturer unknown), for prophylaxis. On unknown dates, the patient received another 3 doses of vaccine (inappropriate schedule of product administration, extra dose administered). No adverse event was reported.
VOMITING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Parkinson, no smoking, and no alcohol use, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 108609, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.
Headache, Sedation, Myalgia, NauseaVomiting, ARM PAIN Narrative:
Fever up to 103.7 axillary, clear runny nose and congestion.
Tested positive and symptomatic for COVID, fully vaccinated as of 2/25/21
Information has been received from a physician concerning a patient who was vaccinated with a dose of Pneumovax 23. Subsequently the patient experienced pain at the injection site. Unspecified medical attention was sought. The patient was put on VICODIN because the pain was so severe. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Patient had a episode of syncope around 5 minutes of receiving the vaccine. Patient quickly recovered in less than a minute and then returned to normal around 10 minutes.
Paleness, weakness, fast heart beat and dizziness within 30-45 minutes, post vax.
pt recv vax;rash & fever 2-3 days p/ MMR vax;rash on face & stomach;p/ 10 days T 103;seen in er;was told that pt had allergic rxn to MMR;had throat culture,redness & swelling throat;
Fever; Chills; Aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Aches) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRIAMTERENE and MECLIZINE [MECLOZINE] for an unknown indication.   On 28-Jan-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 PYREXIA (Fever), CHILLS (Chills), MYALGIA (Aches) and NAUSEA (Nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Aches) and NAUSEA (Nausea) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up was received. Reporter's email and mailing address were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
shingles; This spontaneous report has been received on 02-APR-2020 from a lawyer, regarding a case in litigation and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and/or zoster-related conditions as prescribed and/or administered by a pharmacist at a pharmacy. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
DIARRHEA; FEVER; This spontaneous report received from a consumer concerned a 6 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced diarrhea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944337, 20210627859 and 20210651237.
COVID-19 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 after 1st dose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, the patient experienced COVID-19 (COVID-19 after 1st dose). At the time of the report, COVID-19 (COVID-19 after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.  Patient called and asked about interval after 2nd dose. The reporter stated that the patient had a deficiency and asked if 2nd dose would make platelets drop. The reporter stated that the patient was due for 2nd dose on 02-Feb-2022.  Company Comment: This is a spontaneous case concerning a 26-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 (COVID-19 after 1st dose) which occurred 12 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 26-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 (COVID-19 after 1st dose) which occurred 12 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
black tongue; nausea; vomitting; diarhea; tired; This case was reported by a other health professional via call center representative and described the occurrence of tongue black in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2020) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th September 2019, 1 days after receiving Shingrix, the patient experienced nausea, vomiting, diarrhea and tiredness. On 20th September 2019, the patient experienced tongue black. On 22nd September 2019, the outcome of the tongue black, nausea, vomiting, diarrhea and tiredness were recovered/resolved.   It was unknown if the reporter considered the tongue black, nausea, vomiting, diarrhea and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. On 20th September 2019, 2 days after receiving Shingrix, the patient experienced black tongue. On 22nd September 2019, all the symptoms were resolved. The reporter did not have other information available for this adverse event at this time. The reporter consented to follow up.
Information has been received from a physician concerning an approximately 7 year old patient who in approximately 1999, at one year of age, was vaccinated with a dose of Varivax. Subsequently, on 3 different occasions, the patient experienced reoccurrences of shingles at different locations. It was unknown if medical attention was sought. Additional information has been requested.
adult received pediatric Engerix-B on 14Jun2022 and 14Jul2022; adult received pediatric Engerix-B on 14Jun2022 and 14Jul2022; adult received pediatric Engerix-B on 14Jun2022 and 14Jul2022; adult received pediatric Engerix-B on 14Jun2022 and 14Jul2022; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 42-year-old female patient who received HBV (Engerix B 10 mcg) (batch number FB9RH, expiry date 21st January 2024) for prophylaxis.   Co-suspect products included HBV (Engerix B 10 mcg) (batch number FB9RH, expiry date 21st January 2024) for prophylaxis.   On 14th July 2022, the patient received the 2nd dose of Engerix B 10 mcg. On 14th June 2022, the patient received the 1st dose of Engerix B 10 mcg. On 14th June 2022, not applicable after receiving Engerix B 10 mcg and unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On 14th July 2022, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose, adult use of a child product, underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's Comments: The reporter stated that adult patient received two doses of pediatric Engerix B. The reporter consented to follow up. Additional supportive information: An adult patient was administered a 2 pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
This spontaneous report as received from a registered nurse refers to a currently 3 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. On 27-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX of lot # N022981 with an expiry date of 23-AUG-2019 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion (Product storage error). The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Neck stiffness; Left Armpit soreness approximately 24-48 hours post-vaccination; Left arm pit soreness (Lymph node); Dose 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Oct2021 12:30 (Lot number: FF8841) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT taken for influenza immunisation, start date: 05Oct2021; PROBIOTICS; IRON; VIT D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose 2, lot number=EL3247, administrator route=Intramuscular, administration time=11:00 AM, location=Right arm), administration date: 18Feb2021, when the patient was 45 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, lot number=EL3247, administrator route=Intramuscular, administration time=11:20 AM, location=Left arm), administration date: 28Jan2021, when the patient was 45 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Oct2021 12:30, outcome "unknown", described as "Dose 3"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 06Oct2021 12:30, outcome "recovered" (13Oct2021), described as "Neck stiffness"; AXILLARY PAIN (non-serious) with onset 06Oct2021 12:30, outcome "recovered" (13Oct2021), described as "Left Armpit soreness approximately 24-48 hours post-vaccination"; LYMPH NODE PAIN (non-serious) with onset 06Oct2021 12:30, outcome "recovered" (13Oct2021), described as "Left arm pit soreness (Lymph node)". Therapeutic measures were not taken as a result of musculoskeletal stiffness. Therapeutic measures were taken as a result of axillary pain, lymph node pain.  Additional information: Other vaccine in four weeks was reported as no. Other medications in two weeks: BC, VitD, Probiotics, Iron supplement. The patient had no known allergies. Prior vaccinations (within 4 weeks) was reported as Flucelvax quad (Manufacturer: Seqirus), Batch/Lot: 309613, via intramuscular in left arm on 05Oct2021. Complete only if a 3rd dose was administered, check one option: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). No covid prior vaccination and no covid tested post vaccination. It was reported that, the patient experienced left armpit soreness approximately 24-48 hours post-vaccination. Stated that, did not immediately make connection between soreness and vaccination. 48hrs: Neck stiffness. The reporter considered the events as non-serious. The events neck stiffness 1 week, armpit soreness in 1 week, treated with aspirin only, was fully recovered. Relevant test was reported as none. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  Follow-up attempts are completed. No further information is expected.
Headache, Myalgia, chills, site pain Narrative:  Other Relevant History:
Patient recieved 2nd dose COVID vaccine and had unresponsive episode in car after monitoring period, staff assessed in car and patient had recovered, staff encouraged family to take to ED for evaluation.   From ER MDs note: EKG was normal sinus rhythm, narrow QRS, delayed transition, minimal lateral st depression V4. Patient IV access on arrival, would Brady down to the 40s 1 time as low as 27 but remained alert, blood pressure is not dip.  Troponin was mildly elevated and decision was made to transfer the patient.  Prior to transfer is necessary to rule out pulmonary embolism, intracranial injury Patient wished to proceed with CT angio chest and noncontrast CT of head which were without acute findings.  Patient given aspirin 81 mg to supplement the 81 mg he had earlier today.  Discussed with hospitalist, patient was accepted in transfer. Suspect this is combination of patient's beta blockade with underlying sinus node dysfunction.  Patient does have prominent lower extremity swelling and suspect pulmonary hypertension despite treatment with CPAP but cannot exclude valvular heart disease.  Patient was went to Hospital.  Symptoms thought to be unlikely from seizure.  Doubt CVA, ongoing cardiac ischemia.
Heart palpitations; Breathing problems; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), DYSPNOEA (Breathing problems) and LETHARGY (Lethargy) 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 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced PALPITATIONS (Heart palpitations), DYSPNOEA (Breathing problems) and LETHARGY (Lethargy). At the time of the report, PALPITATIONS (Heart palpitations), DYSPNOEA (Breathing problems) and LETHARGY (Lethargy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided. It was reported that patient was declining the second dose.
No adverse event; HCP calling to report an expired dose of PEDVAX HIB was given to a patient. No side effects reported. HCP reports the vaccine has not had any temperature excursions. No additional information provided. Additional AE case filed, refer to case #0244908; This spontaneous report was received from a nurse and refers to a 2-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-AUG-2023, the patient started therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, (lot # T037651, has been verified to be a valid lot number, expiration date: 20-JUL-2023), administered for prophylaxis (strength, and route of administration were not provided).  On 03-AUG-2023, HCP called to report an expired dose of PEDVAX HIB was given to a patient (Expired vaccine used). No side effects reported. HCP reports the vaccine has not had any temperature excursions. No additional information provided. No PQC.