chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M2DA and 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity, Gluten intolerance, Shellfish allergy and Allergic contact dermatitis (contact allergy).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, 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 experienced ABDOMINAL PAIN UPPER (Stomach pain). The patient was treated with PARACETAMOL (TYLENOL) from 26-Mar-2021 to 28-Mar-2021 at a dose of 1 dosage form twice a day. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 100.6 (High) 100.6 degrees fahrenheit. On 27-Mar-2021, Body temperature: 100.4 (High) 100.4 degrees fahrenheit. On 28-Mar-2021, Body temperature: 99 (normal) 99 degrees fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   This case was linked to MOD-2021-059765 (Patient Link).
3/10/03 PT came to clinic with c/o red, swollen left upper arm following TD given on 3/5/03.
Systemic: see comments-Medium, Additional Details: pt recieved an expired vial of moderna; vial was punctured on may 30 2021 at 11 am and was not disposed of correctly that night. pt was given the open vial today June 1st.
18 month old received the adult 1 ml dose of Havrix; 18 month old received the adult 1 ml dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-month-old female patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On 16-MAY-2023, the patient received the 2nd dose of Havrix adult 1 ml. On 16-MAY-2023, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: 18 month old received the adult 1 ml dose of Havrix) and inappropriate age at vaccine administration (Verbatim: 18 month old received the adult 1 ml dose of Havrix). The outcome of the overdose and inappropriate age at vaccine administration 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: 16-MAY-2023 The reporter reported that the 18 months old child patient received the adult 1 ml dose of Havrix vaccine. No reactions reported. The vaccine administration facility was the same as primary reporter. Did not consent to follow-up. The patient administered the Havrix adult vaccine to infant which led to inappropriate age at vaccine administration and overdose.
Patient developed rash on face within 2-3 minutes of vaccination. Rash not present on other parts of body. Patient did not have respiratory issues or difficulty breathing.
About a week after the vaccination, I noticed ringing in my left ear. A month later it moved to my right ear. I hear the ringing louder in my left ear than the right. I also have headaches. I went to my doctor and was told it was tinnitus. I was referred to a specialist. I had a brain CT Scan that did not indicate anything and a hearing test. I also got Acupuncture which did not help. This still continues to this day and has never stopped.
Testing positive for covid after receiving covid vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Testing positive for covid after receiving covid vaccine) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Testing positive for covid after receiving covid vaccine). At the time of the report, COVID-19 (Testing positive for covid after receiving covid vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Testing positive for COVID after receiving COVID vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.  It was reported that the reporters friends who received Johnson and Johnson and Pfizer vaccine got infected with COVID 19.
VACCINATOR INJECTED 12 Y/O PATIENT WITH 0.2CC PFIZER PEDS DOSE RATHER THAN THE PFIZER 0.3CC 12 YRS AND UP DOSE
Patient was in her usual state of health at the time of receiving her Moderna booster on 1/18/22. Patient reports receiving the vaccine via IM injection into the left shoulder and within a few hours she developed shoulder pain. Pain has persisted to include throbbing, reduced ROM, effect on daily activities and work, and waking from sleep. These symptoms have been present for 12 days post administration at the time of this writing.
Drug ineffective; COVID-19; Moderna Dose Number: 5 / Pfizer / BioNTech Dose Number:4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: Fk9896) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Oct2022 as dose 5 (booster), single (Lot number: As7165b), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2022, outcome "unknown", described as "Moderna Dose Number: 5 / Pfizer / BioNTech Dose Number:4"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Zoster like rash/Herpes zoster (not diseminated); An immunocompromised patient; This spontaneous report was received from a pediatrician concerning an 8 years-old male patient. The patient's concurrent conditions included an immunocompromised status, his pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On an unspecified date between 2015 and 2018, the patient who was inmmunocompromised was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (contraindicated product administered) administered subcutaneously (formulation, strength, dose, frequency, anatomical injection site, lot number, and expiration date were not provided) for varicella prevention.  On an unknown date, the patient had a Zoster like rash herpes zoster (not disseminated) and sought medical attention. The pediatrician requested to participate in the varicella-zoster virus identification program (VZVIP). It was not reported if the patient received treatment, At the time of the report, the patient had not recovered from the event herpes zoster.   The causal relationship between the event herpes zoster with the suspect therapy was not provided.
Patient had the flu shot by Sanofi on 9/10/ paper work indicates the expiration date as 6/22/ expiration date (yyy-mm-dd): 2022-06-30 with no adverse event; Initial information  was received on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced patient had the flu shot by sanofi on 9/10/ paper work indicates the expiration date as 6/22/ expiration date (yyy-mm-dd): 2022-06-30 with no adverse event while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 10-Sep-2022, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for immunization.    On 10-SEP-2022 the patient developed a non-serious patient had the flu shot by sanofi on 9/10/ paper work indicates the expiration date as 6/22/ expiration date (yyy-mm-dd): 2022-06-30 with no adverse event (expired product administered) (latency same day) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  At time of reporting, the outcome was Unknown for the event patient had the flu shot by sanofi on 9/10/ paper work indicates the expiration date as 6/22/ expiration date (yyy-mm-dd): 2022-06-30 with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient experienced HUMIRA STOPPED WORKING; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Patient experienced HUMIRA STOPPED WORKING) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Patient experienced HUMIRA STOPPED WORKING). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Patient experienced HUMIRA STOPPED WORKING) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an elderly female patient with reported non serious event of Therapeutic product effect decreased (reported as Patient experienced HUMIRA STOPPED WORKING), unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second dose after a month. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with reported non serious event of Therapeutic product effect decreased (reported as Patient experienced HUMIRA STOPPED WORKING), unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second dose after a month. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Rash on her arm after getting 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash on her arm after getting 1st dose) 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 VACCINATION SITE RASH (Rash on her arm after getting 1st dose). At the time of the report, VACCINATION SITE RASH (Rash on her arm after getting 1st dose) outcome was unknown. 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.
abnormal high pitched cry lasting most of the day, f-up 17Jul90 mother thinks cry is childs pain cry.
Patient was given an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 07-APR-2023, the patient received Havrix. On 07-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Patient was given an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 07-Apr-2023  The medical assistant stated that the patient was inadvertently administered with an expired dose of Havrix on the day of reporting. The vaccine administration facility was the same as primary reporter. The medical assistant preferred follow up from safety via email.  There was no further details provided. The reporter consented to follow up. The patient inadvertently received an expired dose of Havrix, which led to expired vaccine used.
Initial report received from a consumer on 02 October 2014. This case pertains to a maternal patient; information for the infant case is captured in 2014SA136364. A female patient (age and date of birth not reported) received ADACEL (lot number and administration details not reported) in February 2013. Prior to her vaccination, she had a history of pertussis in January 2013; after vaccination she developed preeclampsia for the last five months of her pregnancy. Per the reporter, the patient's delivery was difficult, and she developed liver failure post-delivery due to the preeclampsia. Outcome was not reported. Documents held by sender: None.
Participant complaining of numbness along her right arm all the way down to her hands after the receiving the flu shot. Equal and bilateral pulses on both upper extremities. No blanching or loss of color along the right arm. No swelling. No signs or symptoms of acute distress. Possible Brachial Neuritis. The arm was not overly thin, and the location of the shot was appropriate and not too high.
Fever of 104, joint pain, vomiting.  Seen at Medical Care Center, treatment: Ibuprofen, Phenergan. "Parents were told not to have DTaP immunization any further." (She had actually received Tdap.)
Vomiting, stomach pain, extreme lethargy within hours lasting 4 days. Coughing starting day 3
High temperature (101.7) for several hours; could not bring down with Tylenol/Aspirin.  Called Doctor at home; prescribed Benedryl.  Within 4 hours, temp down, feeling better.  Finally well 2 days later; quite weak, though.
Hives/patient started to experience hives on his legs and knees; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/patient started to experience hives on his legs and knees) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045j21a) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.   On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (Hives/patient started to experience hives on his legs and knees). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) for Adverse event, at a dose of 1 dosage form; HYDROCORTISONE for Adverse event, at a dose of 1 dosage form; MICONAZOLE NITRATE (LOTRIMIN AF ANTIFUNGAL) for Adverse event, at a dose of 1 dosage form and UNDECYLENIC ACID (WALGREENS ANTI FUNGAL) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives/patient started to experience hives on his legs and knees) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient was  treated  adverse event  with over-the-counter medicines and was not recovered
pt recv vax & 18hr later pt exp swelling of tongue;no air way obstruction;
A male who wishes to remain anonymous, reported that he received an injection of Tetanus Toxoid Adsorbed, Ultrafined and subsequently developed an injection site reaction characterized by redness, swelling and induration.
fever 102.1, extreme chills, headache, body aches, fatigue, pain at injection site
Zostavax/shingles vaccine administered 1/9/08.    Rash occured at base of spine by the end of the month.  Self treated with Johnson & Johnson Calamine spray 5-7 days.
My hands were shaking uncontrollably (as if I had severe Parkinsons or something) in the middle of the night when I got up to use the bathroom; promptly went back to sleep afraid because of the shaking. The next morning my hands did not seem to be shaking; in the afternoon they shook a bit, but the shaking was mild compared to what happened in the middle of the night. I rested all day (it is currently 2:42 Central Time - I'm still resting and will continue to do so).
suicidal thoughts; Depressed; anxiety; This is a spontaneous report from a contactable consumer reported for self. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 12:45 PM (Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. No known allergies. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included escitalopram received within 2 weeks of vaccination. Historical Vaccine included the first dose of BNT162B2 (lot number: EP7534) on 23Mar2021 02:30 PM in Right arm for COVID-19 Immunization. The patient experienced suicidal thoughts, depressed, anxiety on 16Apr2021, no treatment was received. Outcome of the events was not recovered.  Follow-up attempts completed. No further information is expected.
This spontaneous report was received from a medical assisstant and refers to a 13 year old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-JUL-2017, the patient was vaccinated with GARDASIL 9 injection (strength, dose, frequency, route of administration were not reported, lot reported as #M15008, expiration date unknown) for prophylaxis. On an unknown date in 2017 (reported as after vaccination with GARDASIL 9 the patient experienced syncope, abnormal pain, vomiting and fever. The patient was seen at the hospital on an unspecified date in relation to syncope, however hospitalization was not asssessed as serious criteria for the event. No treatment was administered for the events. The outcome of the events was reported as recovered on an unknown date in 2017. The causality between the events and GARDASIL 9 was not reported.  This is one of several reports received from the same reporter.
This is a serious observational study case initially received on 22-Apr-2019, concerning a 42-year-old, adult female, pregnant subject of body weight 217 lbs, height 63 inches and body mass index (BMI) 38.4, enrolled in a study. The subject's obstetrical history noted that the subject had 3 previous pregnancies with 1 full term live birth, 1 preterm live birth and 1 pregnancy with spontaneous abortion. No birth defects were reported. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 02-Feb-2019. The type of pregnancy was singleton. The pregnancy status of the subject was collected, and the pregnancy complication maternal age greater than 35' was noted. The subject's concomitant medication included prenatal (folic acid, iron) for general health. On 28-Mar-2019, at 7 weeks gestation age, the subject was administered Flu Vaccine Egg Split QIV CSL (influenza vaccine, batch number: YF41608, dose, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly considered as vaccine exposure during pregnancy) for an unknown indication. On 28-Mar-2019, the subject had undergone ultrasound antenatal screening and no major congenital malformations were noted. On 16-Apr-2019, the subject had undergone non-invasive prenatal testing and ultrasound antenatal screening and no major congenital malformations were noted. On an unspecified date in 2019, after vaccination, the subject experienced hypertension. The subject was treated with nifedipine [30 mg, frequency: once a day (qd), orally, from 16-Apr-2019], labetalol [200 mg, frequency: twice a day (bid), orally, from 18-Apr-2019], HCTZ (hydrochlorothiazide, stop date: 16-Apr-2019) and Procardia [nifedipine (reported as Procardia XL), 60 mg, frequency: once a day (qd), orally, from 22-Apr-2019]. The outcome of the event hypertension was not recovered (reported as ongoing). The subject's corrected estimated date of delivery (CEDD) was reported as 03-Nov-2019. The subject's estimated date of delivery (EDD) was reported as 09-Nov-2019.; Reporter's Comments: A 42-year-old pregnant subject experienced hypertension, on an unspecified day after administration of study vaccine at 07 weeks of gestation. The case lacks information on exact temporal relationship between vaccination and reported event, there is no evidence for a biological mechanism that could cause the event and presence of risk factors (advanced maternal age, gestational history, body mass index of 38.4 and ongoing pregnancy). Hence, the event was assessed as not related to the study vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Headache, Fever, sore throat, malaise Narrative:  Per nursing report: "took 2nd Moderna vaccine yesterday on 2-25-21. C/o headache, sore throat and fever. States did not feel well and not at work today [2/26]."  Other Relevant History: