chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itchiness) and HEADACHE (Headache) in a 43-year-old female patient 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 PRURITUS (Itchiness) and HEADACHE (Headache). At the time of the report, PRURITUS (Itchiness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.No concomitant medications are provided by the reporter.
fatigue; dizziness; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIZZINESS (dizziness) and MYALGIA (muscle soreness) in a 29-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 22-Sep-2023, the patient experienced FATIGUE (fatigue), DIZZINESS (dizziness) and MYALGIA (muscle soreness). At the time of the report, FATIGUE (fatigue), DIZZINESS (dizziness) and MYALGIA (muscle soreness) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were reported.  The patient did not experience any additional symptoms/events. No treatment medications were reported.
Information has been received from a physician concerning two females who were vaccinated with Gardasil. Subsequently the patients both developed fever and vomiting. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a physician concerning two females who were vaccinated with GARDASIL. Subsequently the patients both developed fever and vomiting. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. In follow up, it was reported by the physician's nurse that the patient was 14 years old and was vaccinated with her first dose of GARDASIL. The nurse was unsure how long the fever and vomiting lasted. Additional information has been requested.
Felt like her throat was swelling . Swelling noted under eyes . Taken to the Emergency Department
This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient was inadvertently administered frozen Fluarix vaccine (vaccine was exposed to minus 1.0 degree Celsius), which led to incorrect storage of drug. The reporter did not have any information of patient available at hand at the time of reporting and would call back later with patient information. The reporter consented to follow up. This case has been linked to US2021AMR266362 and US2021AMR266361, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR266361:Same reporter; US-GLAXOSMITHKLINE-US2021AMR266362:Same reporter.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pruritus (itchiness in the injection site), vaccination site erythema (redness in the injection site) and vaccination site swelling (swelling in the vaccination area) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030A21A) for COVID-19 immunization. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 17, 2021, patient experienced vaccination site pruritus (itchiness in the injection site), vaccination site erythema (redness in the injection site) and vaccination site swelling (swelling in the vaccination area). On Mar 24, 2021, vaccination site pruritus (itchiness in the injection site), vaccination site erythema (redness in the injection site) and vaccination site swelling (swelling in the vaccination area) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Chest pain 1 week after first dose; This is a spontaneous report from a contactable consumer. A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER COVID19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 2021(Age at vaccination 43-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Pregnancy at time of Vaccination was reported as unknown. Medical history included ehlers-danlos syndrome, autonomic nervous system imbalance from an unknown date and unknown if ongoing Dysautonomia and Ehlers Danlos syndrome, Concomitant medications included hydroxyzine (HYDROXYZINE), diphenhydramine hydrochloride (BENADRYL), thyroid (ARMOUR THYROID), clonazepam (KLONOPIN), curcuma longa (TURMERIC [CURCUMA LONGA], ginger [zingiber officinale rhizome] (GINGER [ZINGIBER OFFICINALE RHIZOME]), ibuprofen taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, serious no for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. patient was not diagnosed with COVID-19. On 2021 the patient experienced chest pain 1 week after first dose. Therapeutic measures were taken as a result of chest pain 1 week after first dose (chest pain). The adverse event result in Emergency room/department or urgent care and also reported no hospitalization prolonged. Outcome of events was recovered on unspecified date of 2021. Information on the lot/batch number has been requested.
Information has been received from a RN concerning a 53 year old white male who on 12/22/99 was vaccinated. Subsequently, he experienced fever, muscle aches and a headache. He was in bed for 3 days "incapacitated". The adverse events were reported as disabling. The reporter expressed concern about the particular lot of vaccine. No further information is available.
No adverse event at all until 8 days later.  Itching, Redness, Swollen, hot to touch at the injection site. area approx. 6 in x 3.  I do not feel bad, but wanted to report this to see if I should get the second shot.
Early start of period by 1 week. Very heavy bleeding (approx 3x more that the normal heavy flow) Also chills, max temperature 99.9 F
Patient had a "different" taste in the mouth and felt that the tip of her tongue was numb, felt lightheaded. BP was taken and it was 131/80.
After 8 days, red at vaccine site and warm and itchy.  Red area is circular.
Patient is a 46-year-old Caucasian male with history of schizophrenia, hypertension, tobacco use and obesity who presents to the emergency room (2/10/2022) with complaints of hemoptysis for the past four days.  In addition, he reports hematemesis, nausea , vomiting , progressive fatigue and new onset blurry vision 2 days ago.  He also reports shortness of breath however he states this is his baseline in the setting of tobacco use.  He denies any fever, chills, headache, dysuria or hematuria.  Of note, patient recently received the 1st dose of the COVID-19 vaccination approximately 2 weeks ago. Review of systems 2/10/2022: malaise/fatigue, blurred vision, cough, hemoptysis, sputum production, nausea, vomiting, rash (
Pt was given Influenza vaccine in error, child was due for deffer ed 4 month vaccines that day. Pt received PO Tylenol in office prior to injection.
Adverse reaction to Larium c/o nausea, depression, very labile and crying easily. Diarrhea, panic anxiety attack. Experienced hallucinations, chest heaviness, fear of death.
Patient was administered injection on 5/25/2018. She reports that redness and soreness at site starting the following day. Patient reports that she medicated with ibuprofen for the soreness/ pain and used ice on the site. Patient returned to our office on 6/1/2018 for an appointment regarding a different aliment and informed clinical staff of reaction at that time. There was a 4"x4" circular red area on right deltoid area, in the upper right side of circle was firm area that is warm and tender to touch. Patient states that she had nausea on 5/26/2018 but wasn't sure if this was related to vaccination. States she has felt a little more "anxious" since vaccination. Denies fever or other symptoms.
Had Varicella vaccine 1/28. 2/3 developed vesicular rash- has spread all over body. No fever, + itchy. No known exposure to patient with varicella. Otherwise healthy girl. Acting fine. Eating and drinking fine [MD].
This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 14:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  Medical history included asthma, gastritis, Penicillin and seasonal allergy .Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; fluticasone (FLUTICASONE) taken for an unspecified indication, start and stop date were not reported; hydrocodone (HYDROCODONE) taken for an unspecified indication, start and stop date were not reported; acetaminophen (ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported; cannabidiol (CANNABIDIOL) taken for an unspecified indication, start and stop date were not reported; salmeterol (SALMETEROL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced nausea  (non-serious) on an unspecified date with outcome of recovering , vomiting (non-serious) on an unspecified date with outcome of recovering , chills  (non-serious) on an unspecified date with outcome of recovering , fatigue (non-serious) on an unspecified date with outcome of recovering. No treatment received.Additional information:Facility type vaccine : Hospital.No other vaccine in four weeks ;No  covid prior vaccination.The patient has not been covid tested post vaccination   the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
pt recvd vax & had a syncopal or vasovagal episode; pt recovered w/o any residual effects; no further details were provided; MD reported 20 pts;
GOT STIFFNESS IN HANDS AND FEET; HIGH FEVER; RIGHT ARM SWELLED UP; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (GOT STIFFNESS IN HANDS AND FEET), PERIPHERAL SWELLING (RIGHT ARM SWELLED UP) and PYREXIA (HIGH FEVER) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-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) 1 dosage form. On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (RIGHT ARM SWELLED UP). In April 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (GOT STIFFNESS IN HANDS AND FEET) and PYREXIA (HIGH FEVER). On 06-Mar-2021, PERIPHERAL SWELLING (RIGHT ARM SWELLED UP) had resolved. In April 2021, PYREXIA (HIGH FEVER) had resolved. In 2021, MUSCULOSKELETAL STIFFNESS (GOT STIFFNESS IN HANDS AND FEET) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.
The child had hives 4 hours after Hep B given. The child was vomiting the day of the injection, complains of throat swelling, but able to breath, also facial swelling, swelling by later.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L008057, expiration date: 01-DEC-2016, oral, dose was unknown). No adverse effects were reported. Additional information has been requested.
pt recv vax 24JUN & on 26JUN had emesis & a fever 104.6ax in PM & febrile sz;has hx of 1 febrile sz in past
Potential AE; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Potential AE) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE). At the time of the report, IMMUNISATION REACTION (Potential AE) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     The patient received the last booster dose in last year and this was patient second booster dose.  No treatment medications were reported.   Reporter did not allow further contact
Vaccination adverse reaction; bump on injection site; ITCH; it is getting larger and has a rash; It is tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), VACCINATION SITE MASS (bump on injection site), VACCINATION SITE PRURITUS (ITCH), VACCINATION SITE RASH (it is getting larger and has a rash) and VACCINATION SITE PAIN (It is tender) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 from January 2020 to an unknown date and CALCIUM from January 2000 to an unknown date for Bone disorder (NOS), ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) from January 2009 to an unknown date for Eye abnormality NOS, HYDROCHLOROTHIAZIDE from January 2005 to an unknown date for Heart disease, unspecified, METOPROLOL from January 2005 to an unknown date for Heart disorder.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-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 VACCINATION COMPLICATION (Vaccination adverse reaction). an unknown date, the patient experienced VACCINATION SITE MASS (bump on injection site) and VACCINATION SITE PAIN (It is tender). an unknown date, the patient experienced VACCINATION SITE PRURITUS (ITCH) and VACCINATION SITE RASH (it is getting larger and has a rash). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), VACCINATION SITE MASS (bump on injection site) and VACCINATION SITE RASH (it is getting larger and has a rash) had resolved and VACCINATION SITE PRURITUS (ITCH) and VACCINATION SITE PAIN (It is tender) outcome was unknown.            The treatment information was unknown.   This case was linked to MOD-2021-026743 (Patient Link).
Achy, chills, headache.   Achiness and chills lasted till around 9 pm the same day the headache lasted for two days
Round red rash, swelling, and warmth at the injection site; Round red rash, swelling, and warmth at the injection site; Round red rash, swelling, and warmth at the injection site; Round red rash, swelling, and warmth at the injection site; A spontaneous report was received from a consumer concerning 4 patients who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a round red rash, swelling, and warmth at the injection site.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On an unknown date, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    Approximately, 8-10 days after the vaccine was given, the patient developed a round red rash, swelling and warmth at the injection site. Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, a round red rash, swelling, and warmth at the injection site were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The patient complained of a "woozy feeling". When examined there were no signs of an allergic reaction. The "woozy feeling" abated with no treatment necessary.
Breakthrough case admission after 2 vaccines Moderna 8/3/21 Lot# 088D;  Moderna 8/31/21 LOt# 088D;
Patient tested positive for Covid; Patient tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 17 year-old patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in deltoid left, administration date 11Apr2021 15:37 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Patient tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (03Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Very sick with headache, joint/skin aches & pains x 2 days, followed by diarrhea, unsettled stomach, fatigue  x 2 days; still have lingering headache, fatigue & stomach upset.  Have never been this sick before after a flu shot.
Dryness / eczema around eyes; eczema around eyes; eczema around eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 12:45 (Lot number: FH8028) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm left, administration date 29Nov2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Feb2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Feb2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: DRY EYE (non-serious) with onset 08Dec2021, outcome "recovering", described as "Dryness / eczema around eyes"; ECZEMA (non-serious), ECZEMA EYELIDS (non-serious) all with onset 08Dec2021, outcome "recovering" and all described as "eczema around eyes". Therapeutic measures were not taken as a result of dry eye, eczema, eczema eyelids.  Additional information: No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
After the first dose she developed a rash on her torso; hives; itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 13Jan2021 (Lot number: EL3249) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Verbatim: Eczema, Diagnosed since she was a child. There were no concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itching"; RASH (non-serious) with onset 16Jan2021, outcome "unknown", described as "After the first dose she developed a rash on her torso"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "hives". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received second and third dose of Pfizer covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Fatigue, pain in my back about the size of a baseball from day of 2nd vaccine shot. Went to hospital 9 days after I couldn't breathe from right side. Was diagnosed with pneumonia infection. After in the hospital I also got pneumonia bacteria in addition to the infection. Needed a chest tube to drain pneumonia out. Stayed in hospital 10 days. Still 16 days from being discharged from the hospital & I'm still fatigued.
FACIAL SWELLING AND REDNESS, WHOLE BODY ITCHING, THROAT REDNESS, TACHYCARDIA