chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid Arthritis; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023MZ0A and 092L22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) outcome was unknown and PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.  No other preexisting condition nor allergy is reported by reporter  Company's comment: This case concerns a  78-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Rheumatoid arthritis, the unexpected non-serious event of Pain in extremity and the expected non-serious event of Fatigue . The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the previous dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  78-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Rheumatoid arthritis, the unexpected non-serious event of Pain in extremity and the expected non-serious event of Fatigue . The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the previous dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Black and Blue injection point. Total arm became infected every lymph gland. Shot should not have been given in breast surgery side, or given mega dose of antibiotic for 7 days. Very painful and lost use of arm due to such carelessness.
Experienced swelling at the injections site; Experienced pain at the injections site.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Experienced swelling at the injections site) and injection site pain (Verbatim: Experienced pain at the injections site.). The outcome of the injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site swelling and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter did not provide any demographic information. Caller was the contact and reports on behalf of his niece. During the call the caller states that his niece previously had received the Shingrix vaccine and experienced pain and swelling at the injections site. Limited details were given during the call. The reporter did not consent to follow up.
Shoulder pain after shot; This is a spontaneous report from a contactable consumer(patient).A 52-years-old non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection,Batch/Lot Number: EJ1685)via intramuscular route of administration, administered in Arm Left on 03Mar2021 at 09:00 (at the age of 52-years-old)as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. There were no any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.On 02Apr2021 at 08:00,the patient experienced Shoulder pain.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021 for a Nasal Swab.The outcome of event was recovering.   Follow-up(13Jul2021): New information received in response to the mail trait sent regarding the confirmation of query. The response included: Clinical information   Follow-up attempts are needed. Further information is requested
No adverse events or treatments.  HPV vaccine given over recommended age.  Pt notified of vaccine administration error.
Severe hives that started on my ears and then spread to face, neck and arms. It's continuing to spread down my legs; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: EL 9264, expiry date: unknown), via an unspecified route of administration in the right arm on 01Feb2021 at 11:00 (at the age of 33-year-old), at dose 2, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. the patient had no known allergies to medications, food, or other products. The historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302) on right arm on 12Jan2021 (at the age of 33-year-old) at 12:00 PM as dose 1 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine within 4 weeks prior to BNT162B2 vaccine. The patient experienced severe hives that started on her ears and then spread to face, neck and arms. It was continuing to spread down her legs. It started on 02Feb2021 and is still going on 11Feb2021. The patient was pregnant at the time of vaccination on 01Feb2021. The date of last menstrual period was on 01Jan2021 and the gestation period was 4 week. The patient is due to deliver on 08Oct2021. The reporter assessed the events as non-serious. The adverse event resulted in the emergency room/department or urgent care. The patient received topical steroids and antihistamines for the events. Outcome of the event Pregnant at the time of vaccination: yes was not resolved and for other event was unknown.
Moderna Covid-19 Vaccine   Red patch, itchy in site of injection which developed on January 11, 2021
Pt seen by MD for well-child exam on 24JUN91; Exam was WNL x/sl conjunctivitis; 12 hrs post vax pt devel fever to 105, 3 short tonic clonic febrile convuls; Seen @ ER; PE revealed opaque rt tympanic membrane; Pt given ATB for rt OM;
stomach upset; Swollen lymph node left arm pit; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3, SINGLE, Location: left arm, Time of administration: 14:45, Route of administration: Intramuscular, Lot number: FD0809), administration date: 01Dec2021, when the patient was 52-year-old, for COVID-19 Immunization, reaction(s): "Malaise", "Swollen Lymph Nodes"; BNT162b2 (DOSE 2, SINGLE, Time of administration: 12:00, Location: Right arm, Lot number: Ep6955), administration date: 25Mar2021, for COVID-19 Immunization, reaction(s): "Fever chills", "About 28 hours post dose 2 headache"; BNT162b2 (DOSE 1, SINGLE, Location: Right arm, Time of administration: 12:30, Lot number: El3248), administration date: 04Mar2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25May2022 at 08:00, outcome "recovering", described as "Swollen lymph node left arm pit"; CHILLS (non-serious) with onset 25May2022 at 08:00, outcome "recovering"; PYREXIA (non-serious) with onset 25May2022 at 08:00, outcome "recovering", described as "fever"; ABDOMINAL DISCOMFORT (non-serious) with onset 25May2022 at 08:00, outcome "recovering", described as "stomach upset". Therapeutic measures were taken as a result of abdominal discomfort, lymphadenopathy, pyrexia, chills. Additional information: AE treatment: Tylenol and motrin. The patient had no COVID prior to vaccination and COVID not tested post vaccination. The patient had no known allergies and other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax & was taken to ER- pt was cyanotic, SOB & diaphoretic;
Sore arm that has become difficult to raise and move in certain positions. When I'm sleeping I wake up in pain if I have rolled on that side. Getting undressed is the hardest. Treatment - ibuprofen, TYLENOL, naproxen, ICY HOT cream.
Patient had seizures for an unknown time and urinated in his seat. Pharmacy is next to an urgent care so the doctor from urgent care checked him in to make sure vitals were stable. Unknown outcome.
Following day severe fatigue  8 days later awoke with extreme vertigo. Unable to move head without vertigo and vomiting. Telehealth prescribed Zofran to control nausea and pedialyte. Vertigo lasted two days, tapering off on the second day.
Lymph node swelling around collar bone area.  Painful.  No redness or swelling over site.
I experienced irregular menstrual bleeding the day after receiving the vaccine; It was very light spotting and only happened once but that is extremely rare for me.; I received the vaccine in my left arm and also woke up the next day with a very itchy rash on my right shoulder.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on 21Sep2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Sep2021, the day after receiving the vaccine around 16:00, the patient experienced irregular menstrual bleeding, it was very light spotting and only happened once but that was extremely rare for the patient. The patient reported that her period was not expected for 2 weeks after that and it was impossible for her to be pregnant. On 22Sep2021, the patient also experienced a very itchy rash on the right shoulder which looked like 6 swollen mosquito bites. The patient was not sure if the rash was related but didn't know what else it could be. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular menstrual bleeding, it was very light spotting and only happened once but that was extremely rare for the patient and a very itchy rash on the right shoulder which looked like 6 swollen mosquito bites was resolved on an unknown date in Sep2021.  No follow-up attempts are possible. No further information is expected.
Approx 4hrs after her dose , R side of face throat, tongue face began to swell. Lasted 20hrs approximately. Throat was swollen, self admin benadryl 50mg , 2 tabs.  ALL of the symptoms has resolved.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 6:38 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On 19-Nov-2021 at 6:38 PM, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. The facility had a temperature excursion for the Moderna Covid-19 vaccine. Patient got administered vaccine that underwent temperature excursion. The vaccines were stored in an ultra cold freezer at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
Got her COVID-19 2nd dose yesterday afternoon, woke up around 0300 hrs this morning with fever, chills, body aches, headache
Information has been received from the patient's mother concerning her 12 month old female daughter, who in 1999 was vaccinated with a dose of MMR II. Concomitant vaccinations included "regular scheduled vaccines". In 1999, the patient stopped talking immediately after receiving the MMR II. The reporter stated that her daughter had a learning disability, and it was very hard to express herself but the patient was highly functioning. The patient sought unspecified medical attention and underwent several unspecified tests (results not reported). At the time of reporting, the patient was 10 year old and had not recovered. Upon internal review, learning disability was considered to be disabling. No further information is available.
Myalgia, Diarrhea, NauseaVomiting, sweating, chills Narrative:
The vial was initially stored in refrigerator on 18-Feb-2022 and was administered on 22-Mar-2022; Vaccine given 3 days past the use by date, the use by date listed was 18-Mar-2022.; vaccine dose 3 administed on 21-Mar-2022, vaccine dose 2 was administered on 31-Oct-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 3 days past the use by date, the use by date listed was 18-Mar-2022.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine dose 3 administed on 21-Mar-2022, vaccine dose 2 was administered on 31-Oct-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 18-Feb-2022 and was administered on 22-Mar-2022) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX) for an unknown indication.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2022 at 8:25 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Mar-2022 at 8:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 3 days past the use by date, the use by date listed was 18-Mar-2022.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine dose 3 administed on 21-Mar-2022, vaccine dose 2 was administered on 31-Oct-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 18-Feb-2022 and was administered on 22-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 3 days past the use by date, the use by date listed was 18-Mar-2022.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine dose 3 administed on 21-Mar-2022, vaccine dose 2 was administered on 31-Oct-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 18-Feb-2022 and was administered on 22-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was initially stored in refrigerator on 18-Feb-2022. Use by date mentioned was 18-Mar-2022. The vial did not undergo temperature excursion. There were no symptoms or side effects reported for the patient. No additional doses treatment or medications were administered in response.  Patient height: 71 inches  No treatment details were reported.  The patient did not take any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and or at the time of the adverse event. The patient had no acute illness at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.
Severe abdominal and uterine cramping that started evening of the vaccination and  lasting sub-sequential  days.
This spontaneous report was received from a registered nurse and refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 20 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA013888:
received 3 doses; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of extra dose administered in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first and second dose received 1 year prior).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, [the patient experienced extra dose administered (Verbatim: received 3 doses). The outcome of the extra dose administered was not reported.   Additional Information: GSK receipt date: 06-Mar-2023  The patient received 3rd doses of Shingrix vaccine because she forgot previous second dose. There were no noted adverse outcome. It was given one year prior. The patient was administered an 3rd dose of Shingrix, which led to extra dose administered.
Pt called about 45 min- 1hr after receiving vaccines - c/o rash on neck. Next day reported to us that this had resolved after 2 doses BENADRYL.
Tenderness; redness; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago from day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site tenderness, injection site erythema and drug dose administration interval too long. On an unknown date, the outcome of the injection site tenderness, injection site erythema and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site tenderness and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient recently received her second injection late, which led to lengthening of vaccination schedule. The patient reported that with the second injection she experienced tenderness and redness at the injection site. The reporter consented to follow up.
He was in his usual state of health on 4/13/22. He received his second Moderna COVID vaccination. The following day he developed pressure-like chest discomfort. He initially presented to Medical Center. Troponin I was 3.3. He was transferred to Hospital where high sensitivity troponin was elevated: 698 -- 669 -- 691 -- 688 -- 677 (12-hour). TTE showed low-normal systolic function, EF 53%.  He was diagnosed with Moderna mRNA vaccine related myocarditis. He was started on colchicine and naproxen with improvement in his symptoms. He was discharged on 4/19. Cardiac MRI was not obtained due to limited imaging availability.
Child began to regress and lose language. Titer test shows extremely high titer. Diagnosed with autism, extremely high rubella titer.