chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CV19-0162272) for COVID-19 vaccination.     Concurrent medical conditions included Wheezing since 30-Dec-2019, Cough on 30-Dec-2019, Weakness since 25-Mar-2020, Tiredness since 25-Mar-2020, Muscle pain since 25-Mar-2020, Pain in arm since 31-Mar-2021, Loss of smell on 24-May-2021, Loss of taste on 24-May-2021, Drug allergy (Allergy to Amoxicillin), Food allergy (Allergy to Banana), Food allergy (Allergy to Becan) and Ragweed allergy. Concomitant products included DOXYCYCLINE from 14-Jan-2021 to an unknown date for Antibiotic therapy, PREDNISONE from 26-May-2021 to an unknown date for Steroid therapy NOS, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), SPRING VALLEY B100 COMPLEX from 31-May-2021 to an unknown date and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved. Not Provided      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.   No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-110178 (E2B Linked Report). This case was linked to MOD-2021-110178 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Medical history, concomitants, patient information, allergies, vaccination facility information are added. On 07-Jul-2021: Follow-up information received on 07-jul-2021 contains No new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110178:Dose 2
Severe pain in upper back joint; broke out in Shingles blisters on 11/06/12.
Fever; A little bit of chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (A little bit of chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (A little bit of chills). At the time of the report, PYREXIA (Fever) and CHILLS (A little bit of chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant products included medicine for heart disease and diabetes.   Treatment information was not provided.
Information has been received from a medical assistant referring to a currently 14 years old patient of unknown gender. The patient's medical history, current condition and concomitant therapy were not provided. On an unknown date, the patient received dose of improperly stored PROQUAD (lot number R017628 with expiration date 18-DEC-2019) subcutaneously for prophylaxis or VARIVAX (route was unknown, lot number R018931 with expiration date 02-JUL-2020; lot number R018777 with expiration date 01-JUL-2020) for prophylaxis(product storage error). The administered doses experienced a temperature excursion ranged from -14 degree Celsius to -10 degree Celsius for 1 hour and 30 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported in the patient.  This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1812USA000016: US-009507513-1811USA012273.
Stiff body; Worried about clotting; Achy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff body), COAGULOPATHY (Worried about clotting) and MYALGIA (Achy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff body), COAGULOPATHY (Worried about clotting) and MYALGIA (Achy). The patient was treated with IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff body), COAGULOPATHY (Worried about clotting) and MYALGIA (Achy) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
currently pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (currently pregnant) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion (During 1st dose of the Moderna Covid-19 vaccine, no genetic or any abnormalities were found that could have caused its fetal demise) on 26-Mar-2021.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 28-Nov-2021 and the estimated date of delivery was 09-Sep-2022. On 14-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (currently pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 14-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (currently pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication provided.   This case was linked to MOD-2022-437685 (Patient Link).
2 Days after injection developed red splotchy raised rash with itching around breasts/chest, across upper back, back of neck and small of back. It gradually subsided, resolved in 5 or 6 days.  I have developed this same rash pattern with itching about 5 or 6 times over  the past 9 years when I had symptoms of a cold/ flu.  Diagnosed many times as a "viral response" rash.  I notified via phone my primary physician,  who believed was a "viral response" to the anti-viral vaccine which I should report. She advised me to get the 2nd dose of vaccine which I did and had the exact same occurrence with the rash/itching again following the same pattern described above.
Dizziness, nausea, lightheaded, weak for a couple days. Patient better now.
Chest is painful and sore in the inside; Ended up not getting the 2nd one; Woke up in the middle of the night to rash; Nausea; Muscle Pain; Hives / Hives for a month; Woke up in the middle of the night to itching / itching all over the body; Sore arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest is painful and sore in the inside), URTICARIA (Hives / Hives for a month), PRURITUS (Woke up in the middle of the night to itching / itching all over the body), PAIN IN EXTREMITY (Sore arm) and DIZZINESS (Dizziness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced URTICARIA (Hives / Hives for a month), PRURITUS (Woke up in the middle of the night to itching / itching all over the body), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), RASH (Woke up in the middle of the night to rash), NAUSEA (Nausea) and MYALGIA (Muscle Pain). On an unknown date, the patient experienced CHEST PAIN (Chest is painful and sore in the inside) and PRODUCT DOSE OMISSION ISSUE (Ended up not getting the 2nd one). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest is painful and sore in the inside), PRURITUS (Woke up in the middle of the night to itching / itching all over the body), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), RASH (Woke up in the middle of the night to rash), NAUSEA (Nausea) and MYALGIA (Muscle Pain) outcome was unknown, URTICARIA (Hives / Hives for a month) had not resolved and PRODUCT DOSE OMISSION ISSUE (Ended up not getting the 2nd one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information include Diphenhydramine, Paracetamol and Naproxen.  Patient was not sure about getting her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow-up information received on 15-MAY-2021: New events added.
Raised red rash began a few hours after the Menactra vaccine was administered. Rash on hands, arms, trunk, legs.  Itchy. Treated with oral Benadryl on 12/7/2011.
pt recvd vax 2JUN95 & 15-20mins p/vax exp achy joints,back,hips,nausea,lightheadedness,& h/a;sx cont;
Information has been received from a registered pharmacist (R. Ph.) concerning a male who in August 2010, was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). Concomitant therapy included prednisone. The reporter stated that patient experienced body joint pain that resolved except in one hand. Reporter didn't know what hand. The patient was diagnosed with Dequervain syndrome and received prednisone. On an unknown date the patient recovered. The patient sought unspecified medical attention. Follow up information has been received which reported that a 60 year old male physician with no illness at time of vaccination and allergy to nonsteroidal anti-inflammatory drug (unspecified) and calcitonin, who in August 2010, was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). In September 2010, the patient experienced joint swelling, fever and myalgias-felt to be serum sickness like syndrome. Prednisone was given for adverse events and symptoms resolved in September 2010. There were no tests done. It was unknown if the patient sought medical attention. Serum sickness like syndrome was considered to be other important medical events. No further information is available.
This spontaneous report as received from a pharmacist via MVCC representative refers to a patient of unknown age. On an unknown date a couple of years ago, the patient was vaccinated with ZOSTAVAX (dose, lot and expiry date unknown). Patient experienced an injections site reaction a couple years ago after vaccination. The pharmacist also reported that the site was red. The outcome of events was unknown. Reporter's causality assessment was not provided. Additional information has been requested.
Suspected Vaccination failure; got the shingles shot and he gave it to him; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The reporter was the patient's friend. The age at vaccination was not reported. After receiving shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
chills; didn't sleep good last night; sore shoulder; Achy; flu like symptoms; muscle aches; fever; little bit of a headache; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN8202; Expiration Date: 30Jun2021) via an unspecified route of administration (age at vaccination 69-year) in arm left on 23Feb2021 as dose 1, 0.3 ml single for COVID-19 immunization. Medical history reported none. There were no concomitant medications. On 26Feb2021 the patient experienced flu like symptoms, muscle aches, fever, little bit of a headache, didn't sleep good last night, achy; on an unspecified date the patient experienced sore shoulder, chills, and didn't sleep good last night. The patient underwent lab tests and procedures which included body temperature: 99.9 on an unspecified date. As reported "the symptoms started this morning when the patient woke up, she didn't sleep good last night, she has a sore shoulder. When the patient got up, she had these other symptoms. The patient has taken some Tylenol, but the Tylenol hasn't had time to kick in. Question asked by the patient if she could get her second dose of the vaccine given that she had these side effects post vaccination. She was scheduled to receive the second dose of the vaccine 3 weeks after dose 1. If she wants to change her appointment date how far she could extend it." Therapeutic measures were taken as a result of sore shoulder, the patient was treated with Tylenol. The clinical outcome of the event flu like symptoms, muscle aches, fever, achy, was not resolved; outcome of little bit of a headache was resolving; while the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.
As of yesterday afternoon 4/7/2021 right arm was itchy and sore as of today, this morning 4/8/2021 there is now a big red circle around injection site and its hot
8 days after vaccine, patient developed a small raised red rash on right arm. Lasted 2-3 days. Patient did ice area and took acetaminophen.
Information has been received on 24-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In November 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route administered by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles. Later in 2012, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
A rash on her chest and face; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162B2 (Pfizer BioNtech COVID19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: FA6780; Expiration Date: 30Sep2021), dose 1 intramuscular, administered in Arm (given in shoulder are, reporter was not sure if it was the left or the right arm) on 31Jul2021 (Age at vaccine 17 year) as dose 1, single for covid-19 immunisation. Vaccination Facility Type was pharmacy/drug store. No additional vaccines administered on Same Date of the Pfizer Suspect. The patient 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 did not have any adverse event prior vaccinations. On 02Aug2021, the patient experienced a rash on her chest and face. The pharmacist was reported that the patient received her first dose of the vaccine on Saturday and today (at the time of report) she developed a little bit of a rash on her chest and on her face. The rash was not serious. She was not sure if it was from the vaccination or from something else. She needs to find out if it was possible. The pharmacist was wondering if this could be from the vaccine and stated it was not listed. The patient did visit to Emergency Room and Physician Office. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient states that she has suffered a shoulder injury from the administration technique. Patient is receiving treatment by her physician.
After getting the second vaccine , I had the lip tingling and chin tingling for about 15 mins after. I also had jaw pains and low blood pressure which had me get me on the stretcher for about 55mins. My teeth also went numb as well. About 12 hours in I had  a burning sensation in my checks and the site where I got my vaccine.   First dose vaccine lot number is EN6200 I received this vaccine on February 26, 2021. With the first vaccine 20-25 after the vaccine I felt like I had a brain freeze, After one hour I had face tingling and throughout that day the face tingling got worse and my face went numb. I had right toe tingling with the first and second vaccine. The muscle spams happened three days after the vaccine and I still have muscle spams today.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with M-M-R II recombinant human albumin (rHA ) or human serum albumin (HSA) (Strength, dose, frequency, route, anatomical location, lot/batch # and expiry date were not reported) for prophylaxis. Other suspect therapies included VARIVAX (Strength, dose, frequency, route, anatomical location, lot/batch # and expiry date were not reported) and sterile diluent. There were no concomitant therapies reported. On an unspecified date, the patient was administered M-M-R II and VARIVAX when the patient was 11 months old due to international travel. No adverse effects reported. Product quality complaint was not involved.
Staff member reports body aches, malaise, and diarrhea to the point of dehydration
This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a Nurse Practitioner concerning a 14 year old female with no history of drug reactions/allergies and a history of asthma who on an unspecified date was vaccinated with Gardasil. Concomitant therapy included several other unspecified vaccines concomitantly and Necon. Subsequently on an unspecified date the patient developed frostbite of the toes/foot. The frostbite occurred some time in February in 40 degree weather outdoors at a football game with socks and shoes. The patient was still experiencing numbness and discoloration of toes. The vaccination was administered at another unspecified practice. The patient sought unspecified medical attention but did not undergo lab tests. As of 30-MAY-2007 the patient was recovering. Additional information has been requested. Further information is not available.
diagnosed with uterine cancer; This spontaneous case was reported by a physician and describes the occurrence of UTERINE CANCER in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21, 040C21A, and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced UTERINE CANCER (seriousness criterion medically significant). The patient was treated with Surgery (Underwent emergency surgery of hysterectomy was done by mid Apr 2021) for Uterine cancer. At the time of the report, UTERINE CANCER outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 08-Sep-2021, SARS-CoV-2 antibody test 0 antibody levels SARS-Cov2 antibody IgG nucleocap and IgM spike were reported as zero.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reported stated the patient was not on any medications before she got the vaccine. The patient had a radiation therapy post six weeks of vaccine administration and not chemotherapy. Treatment information was not provided.  This case concerns a 64 year-old female patient with no reported medical history, who experienced the unexpected serious event of Uterine cancer. The event occurred an unknown number of days after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007B21A) for COVID-19 vaccination.     Medical history was not provided.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided. Concomitant medication information was not provided.   This case was linked to MOD-2021-089388.   Reporter did not allow further contact
TINGLING SENSATION IN RIGHT WRIST/THUMB AREA, NOT PAINFUL. MIDDLE FINGER SENSATION BUT HIS FINGER WAS AMPUTATED BELOW THE KNUCKLE.