chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in arm; Headache; Muscle pain; chills; joint pain; fatigue and tiredness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included ESCITALOPRAM, ROSUVASTATIN, INSULIN, VITAMINS NOS and AMLODIPINE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (chills), ARTHRALGIA (joint pain), FATIGUE (fatigue and tiredness) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Soreness in arm), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (chills), ARTHRALGIA (joint pain), FATIGUE (fatigue and tiredness) and FATIGUE (Tiredness) outcome was unknown.      Treatment information included Tylenol.  Action taken with the drug in response to events was not applicable.  It was reported that the patient does not want to receive any paperwork or provide consent for further follow up.   This case was linked to MOD-2021-069902 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up was received on 17-may-2021. The patient denied the Email ID and said he was doing fine. On 19-May-2021: Follow up was received on 19-May-2021 and does not contain any significant information. The patient denied further follow-up.; Sender's Comments:  MOD-2021-069902:
Since the first dose I had chest pain when touching it and my heart rate went up, I felt really accelerated for a couple of days.  When I had the second dose I felt a bigger pain in my chest and with the minimum effort my hear rate went u and I could felt the force my heart was working. After that, I started to feel sick with a lot of nauseas. I exercise almost every day, so I stopped training to not get accelerated but even going upstairs made me feel very tired.
Patient did not receive the 2nd dose between 25-35 days of receiving the 1st dose/missed his scheduled 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 days of receiving the 1st dose/missed his scheduled 2nd dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L210A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 days of receiving the 1st dose/missed his scheduled 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 days of receiving the 1st dose/missed his scheduled 2nd dose) had resolved.        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 information on concomitant medication were reported. It was reported that, the patient missed his scheduled 2nd dose because he works nightshift and the 2nd dose was only offered during the dayshift.
minor soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The vaccination caused minor soreness for a few days. For tolerance with 2nd dose of Shingrix, refer linked case US2020AMR050134.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, notes: He normally takes aspirin every day and took Ibuprofen the day before his vaccine and asked if this will effect the efficacy. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient had received his first vaccine dose, the patient takes aspirin everyday and took ibuprofen the day before his vaccine and asked if ibuprofen effects the efficacy. The patient took aspirin for a headache 8 hours after vaccine dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: PATIENT STATES THAT THEY TESTED POSITIVE AFTER RECEIVING COVID-19 VACCINATION.  STATES THEY HAD A COVID-19 TEST DONE PRIOR TO THE VACCINATION THAT WAS NEGATIVE, THEN 2 DAYS LATER THEY HAD A POSITIVE COVID TEST AFTER EXPERIENCING SYMPTOMS.
Temp up to 100.7, chills, body aches, headache, nausea lasting  1 1/2 days
Forgetfullness, dizziness, disorientation, intermittent stomach pain, heart palpitations.
Swelling in armpit after covid19 booster injection; Swelling in armpit after covid19 booster injection; This is a spontaneous report from a contactable consumer. A 5-decade-old (also reported as in her 40s) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 11Nov2021 (at the age of 5-decade-old), as dose 3 (booster), single for COVID-19 immunization. The patient had no notable medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single and then as dose 2, single for covid-19 immunization and had no previous reaction to vaccine. The patient experienced swelling in armpit after covid19 booster injection, same side as injection site on 11Nov2021. The patient had seen by a doctor and given scan and x-ray and investigations showed nothing of concern. The outcome of the event was unknown at the time of this report.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Stomach ache, 103.8 fever, runny nose, cough, head congestion. Fever at night for next 6 days.
Swelling at the location; Redness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the location), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tenderness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A29A) for COVID-19 vaccination.     The patient's past medical history included AFib. Concurrent medical conditions included Asthma and Cholesterol. Concomitant products included SIMVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at the location), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tenderness). At the time of the report, VACCINATION SITE SWELLING (Swelling at the location), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported also included steroids for their asthma. No treatment information was provided.  The patient post receiving their first dose of vaccine experienced swelling at the location and developed redness and tenderness that lasted might be for 4 days.  The patient reported that they were taking steroids for their asthma condition. The patient also mentioned that they were very active, did yoga, and used to stretch.   This case was linked to MOD-2021-361771, MOD-2021-362546 (Patient Link).
No additional AE/PQC.; HBP called to report inadvertent administration of PROQUAD after a temperature excursion. Limited patient demographics provided. See AE case #02451226 and #02451227. No additional AE/PQC.   ?    Names of vaccines involved (including lot/exp): PROQU; This spontaneous report was received from Other and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-AUG-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #W016359, expiration date: 16-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 14-AUG-2023, HBP called to report inadvertent administration of PROQUAD after a temperature excursion. Temperature excursion occured for 30 minutes in 7.9 F degree and 30 minutes in 7.3 F degree. Limited patient demographics provided. See AE case #02451226 and #02451227. No additional AE/PQC.   Lot Number W016359 is valid for V221.
No additional adverse event reported; improperly stored vaccine administered; This spontaneous report was received from a medical assistant and refers to a 10-year-old female patient. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 13-NOV-2019, the patient was vaccinated with improperly stored dose of virus vaccine live (oka/merck) (VARIVAX) injection, lot number R006221, expiration date 29-FEB-2020 (exact dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported. Administered dose of vaccine experienced temperature excursion of 36 Fahrenheit degree (F) for 48 hours and 30 minutes. There was no previous temperature excursions. Digital data logger was involved.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. On 2nd March 2019, the patient received SHINGRIX (intramuscular). On 3rd March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovering/resolving. The reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient began to experience swelling at the site of injection on Sunday and it has continued to swell. At the time of report, the swelling was smaller than softball but larger than golf ball. There was no pain. No further information provided.
received dose of Moderna vaccine after excursion; reported that he administered 4 doses of an affected vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (reported that he administered 4 doses of an affected vial) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (reported that he administered 4 doses of an affected vial). On 09-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (reported that he administered 4 doses of an affected vial) had resolved.       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.   Concomitant and treatment drugs were not provided.  The vaccine was actually delivered by McKesson on Thursday, 05-Aug-2021 and kept in the cooler box. On the evening of 08-Aug-2021, the pharmacist realized the vaccines were still in the shipping packaging and contacted the pharmacist on duty. The pharmacist on duty opened the packaging and visually observed that the vials were in a liquid state. When she clicked the tag alert, it showed a red X. She did not note the condition of the Phase Change Gelpack material in the shipping container. The pharmacist on duty put a glycol thermometer in the empty cooler overnight which showed the temperature range was 32-37 F, however the vaccine had already been moved to the refrigerator. The pharmacist also checked the Moderna excursion tool, which said to quarantine the vials. Due to the fact that the vaccine was in liquid state upon opening the packaging, the pharmacist used the Moderna Excursion Tool and labeled the vaccine 30 Day Use by Date as 03Sep2021 based on the results. Referred to Walmart's home office and Moderna for guidance.
Itchy hives all over body (face, neck, torso, arms, hands, legs) after recieving Hepatitis A shot. Steroids (prednisone) and Benadryl given. Hives bumps shrunk after 12 hours. Bright, pink/red spots continued for at least three days.
Starting within hours after getting shot with jaw and facial achiness, then the next day swollen, painful lymph gland on right side back of neck, then next day golf ball size swollen, painful lymph gland right armpit, was instructed to go to urgent care by physician I work with.  Also had general achiness with pain in hands/wrists, then a week later noticed facial flushing and low grade temp 99.2.  Follow-up appointment with MD on 11/3/15 who advised it could take up to 6 weeks for lymph node to fully resolve and also advised before ever getting another flu shot to have allergy testing.  I am an RN and have gotten the flu shot for many years and never had a reaction before this.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a month over due for 2nd 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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (a month over due for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a month over due for 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Relevant concomitant medications was reported. Treatment information was not provided.
Dyspnea starting <1week after second dose, persistent over last 3 weeks, worse with exertion, improved with rest.
Given vaccine 7/10/17. Mom called 7-11-17 and stated that by the time they got home from the office, patient started c/o not feeling well. Patient had diarrhea, lethargy, and a temp of 101-102, and sore throat.
Vaccinated 05/12/2003 with DTAP fvzv.  Mom came in 05/14/2003 with child complaning of redness, and swelling on left deltoid.  Child had high temperature and vomiting.  Crying a lot at house.
Chills; headache; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 14:45(at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, genetic asymptomatic carrier for familial mediterranean fever and iodine allergy. In the year 2019 the patient received yellow fever vaccine, measles, mumps, rubella vaccine and hepatitis A and B vaccine and experienced very strong reactions including a golf-ball sized ball in her arm on the 3rd hepatitis A and hepatitis B dose that required steroids to bring it down. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 10Mar2021 at 07:15 for COVID-19 immunisation. After the first dose of the vaccination, on 10Mar2021, after three hours, at 10:15, the patient experienced chills and on the next day, 11Mar2021, the patient experienced a hangover-type headache. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. For the second dose, the hangover-type headache started on the same day as the shot, 31Mar2021 and experienced sporadic chills on day 2. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the event. The clinical outcome of the events chills and headache were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever 102.1, stuffy/runny nose, whiny, clingy, little cough, sleepy although unable to sleep well would jump/twitch/jerk while sleeping finally. Balance - would crawl instead walk when did get down, not eat or drink well but nursed fairly well and often. 12/01 fever 103.1 same 12/02 fever 101.2 stuffy/runny nose, developed a slight rash on upper legs feeling a bit better, more like self. 12/03 no fever, still bit stuffy, still little rash, almost normal.
Information has been received from a healthcare worker (certificated medical assistant) referring to a 13 year old child patient. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (lot # and dose were not reported). Additional information has been requested.
PATIENT CALLED PHARMACY DAY AFTER VACCINE REPORTING HIVES AND NO DIFFICULTY BREATHING.  I TOLD HIM TO TAKE 2 BENADRYL AND IF IT DIDN'T GET ANY BETTER OR IF IT GOT WORSE TO GO TO THE ER OR CALL 911.
One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052B22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial).    No relevant concomitant medications were reported.  There was a couple who were receiving their bivalent booster doses. One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial. The vaccines were drawn in the pharmacy and taken out to the patients to administer. Unfortunately, after video review could not verify which patient received the correct dose. This case is created for male patient.  The lot for the bivalent vaccine was AS7162B.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-649436 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-649436:same reporter
This spontaneous report as received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 11-JAN-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot # N019251, expiry date: 20-DEC-2018) and properly stored dose of sterile diluent (lot # and expiry date unknown) for prophylaxis. Reporter stated that the vaccine was exposed to temperature between -14 C to -10 C for 12 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported.
1st dose was Moderna, 2nd dose was Johnson and Johnson.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose was Moderna, 2nd dose was Johnson and Johnson.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose was Moderna, 2nd dose was Johnson and Johnson.). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose was Moderna, 2nd dose was Johnson and Johnson.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact