chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Vertigo
Clinical narrative: DIZZINESS; VERTIGO; JOINT PAIN IN SHOULDER AND RADIATED TO LEGS; HEADACHE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: type 2 diabetes, non-smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient was previously treated with paracetamol for body pain, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride for body pain, and dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol for body pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included dulaglutide for type 2 diabetes, insulin aspart for type 2 diabetes, and insulin glargine for type 2 diabetes. On 08-MAY-2021, the patient experienced dizziness. On 08-MAY-2021, the patient experienced vertigo. On 08-MAY-2021, the patient experienced joint pain in shoulder and radiated to legs. On 08-MAY-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, vertigo, joint pain in shoulder and radiated to legs, and headache on 09-MAY-2021. This report was non-serious. This case, involving the same patient is linked to 20211115070.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia, Skin warm
Clinical narrative: skin is really hot; felt really awful/bad; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (skin is really hot), FEELING ABNORMAL (felt really awful/bad), CHILLS (chills) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 041L20A and 019B21A) for COVID-19 vaccination.     No Medical history information reported.  Concomitant products included SOTALOL for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced SKIN WARM (skin is really hot), FEELING ABNORMAL (felt really awful/bad), CHILLS (chills) and PYREXIA (Fever). In October 2021, SKIN WARM (skin is really hot), FEELING ABNORMAL (felt really awful/bad), CHILLS (chills) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was reported.  It was reported that symptoms occurred 24 hours after the booster shot and lasted approximately 8 hours.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up received on 01-NOV-2021 contains Significant information. Outcome of events updated.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise
Clinical narrative: she was not feeling well; Diarrhea/diarrhea up until yesterday and is unsure if she has it today; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea/diarrhea up until yesterday and is unsure if she has it today) and MALAISE (she was not feeling well,) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021 at 5:00 PM, the patient experienced DIARRHOEA (Diarrhea/diarrhea up until yesterday and is unsure if she has it today). On an unknown date, the patient experienced MALAISE (she was not feeling well,). At the time of the report, DIARRHOEA (Diarrhea/diarrhea up until yesterday and is unsure if she has it today) had not resolved and MALAISE (she was not feeling well,) outcome was unknown.            Patient mentions that two weeks prior to the booster shot she took some antibiotics  No Treatment Information were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow up received contains Reporters address added, Mentioned about Booster dose, Event & Event Outcome updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days; multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported Doses were administered on and after 14Sep2021   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received on 03-Nov-2021 contains no new information. On 04-Nov-2021: Follow up received includes Batch number added and narrative was updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients were administered an expired dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients were administered an expired dose of the Moderna vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients were administered an expired dose of the Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (10 patients were administered an expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up document contains No New Information On 04-Nov-2021: Significant follow-up( Reporter added-HCP, events added, PT details added)
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: I have diarrhea; I've been very tired since I had it; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I have diarrhea) and FATIGUE (I've been very tired since I had it) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. lot: 026D21A and lot: 013M20A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, LOSARTAN, MIRTAZAPINE (MIRTAZAPIN) and LEVOTHYROXINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced FATIGUE (I've been very tired since I had it). On an unknown date, the patient experienced DIARRHOEA (I have diarrhea). At the time of the report, DIARRHOEA (I have diarrhea) and FATIGUE (I've been very tired since I had it) outcome was unknown.            No concomitant medications were reported No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow up received, contact details(email) updated. On 04-Nov-2021: Follow up received, contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: got a fever,; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (got a fever,) 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 29-Oct-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PYREXIA (got a fever,). At the time of the report, PYREXIA (got a fever,) had resolved.            No concomitant medications were reported. No treatment medications were reported. Patient experienced the symptom after receiving second dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow- up contains significant information where patient reported that she has been recovered. On 04-Nov-2021: the follow up document contains non significant information( email updated)
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received vaccine after expiry date) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 049E21A) for COVID-19 immunization. No medical history reported. On Oct 29, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Oct 29, 2021, patient administered expired product (patient received vaccine after expiry date). On Oct 29, 2021, administered expired product (patient received vaccine after expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient received first dose of Pfizer vaccine on an unspecified date; second dose of Pfizer vaccine on Mar 31, 2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Pain in extremity, Underdose
Clinical narrative: Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; Arm sore for a day; Fatigue for 24 hrs; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm sore for a day), FATIGUE (Fatigue for 24 hrs.), EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Cholesterol and Hypertension. Concomitant products included SIMVASTATIN (ZOCOR) for Hyperlipidemia, ATENOLOL for Hypertension, LEVOTHYROXINE SODIUM (LEVOXYL) for Hypothyroidism.    On 29-Oct-2021 at 1:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore for a day) and FATIGUE (Fatigue for 24 hrs.). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm sore for a day) and FATIGUE (Fatigue for 24 hrs.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided. Date the vial was initially stored in the refrigerator: 28-Oct-2021, 4.30pm   This case was linked to MOD-2021-377957 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: reporter information, patient information, medical history, concomitants and events updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rash
Clinical narrative: Very tired; Rash on her torso (stomach, chest and back)/rash came just on abdominal area. It was a flat rash. When she pressed it, it was white.; Chills; Fever; Swollen lymph nodes under the arm she got the injection in/ swollen gland under my left armpit size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her torso (stomach, chest and back)/rash came just on abdominal area. It was a flat rash. When she pressed it, it was white.), FATIGUE (Very tired), LYMPHADENOPATHY (Swollen lymph nodes under the arm she got the injection in/ swollen gland under my left armpit size of a baseball), CHILLS (Chills) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 032B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes under the arm she got the injection in/ swollen gland under my left armpit size of a baseball). On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 30-Oct-2021, the patient experienced RASH (Rash on her torso (stomach, chest and back)/rash came just on abdominal area. It was a flat rash. When she pressed it, it was white.). On an unknown date, the patient experienced FATIGUE (Very tired). On 29-Oct-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 31-Oct-2021, RASH (Rash on her torso (stomach, chest and back)/rash came just on abdominal area. It was a flat rash. When she pressed it, it was white.) had resolved. At the time of the report, FATIGUE (Very tired) and LYMPHADENOPATHY (Swollen lymph nodes under the arm she got the injection in/ swollen gland under my left armpit size of a baseball) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not reported.   This case was linked to MOD-2021-373326 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant follow-up received include additional information of reporter, patient and events (Start and stop dates and outcome) and new events added. On 04-Nov-2021: Non Significant follow-up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (pre-existing asthma, well controlled) since 1994, Blood pressure high (well controlled) since 2012, Type II diabetes mellitus (well controlled) since 2012, Anxiety, High cholesterol since 2012, Drug allergy (Lisinopril allergy), Immune system disorder NOS (hypersensitive immune system) and Allergic reaction to analgesics (codeine allergy). Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, METFORMIN HYDROCHLORIDE (METFORMIN ER) for Diabetes, ROSUVASTATIN for High cholesterol, AMLODIPINE for Hypertension, ALPRAZOLAM (XANAX), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and IRON for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CHEST PAIN (chest pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 02-Apr-2021, CHEST PAIN (chest pain) had resolved.      It was reported that 15 minutes after first dose patient experienced chest pain that resolved and also after the second dose.   This case was linked to MOD-2021-369443, MOD-2021-370380 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up information received on 03 Nov 2021 includes updated Medical history, anatomical location of vaccine administration updated. On 04-Nov-2021: follow up received included no new information. On 05-Nov-2021: Significant follow up (stop date of event updated)
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day; Body aches; Vomiting; Chills; muscle pains; High temperature 101.8/fever; Fatigue/lying in bed; Headache; Joint Pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (muscle pains) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced TACHYCARDIA (Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (muscle pains), PYREXIA (High temperature 101.8/fever), FATIGUE (Fatigue/lying in bed), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea). On 31-Oct-2021, TACHYCARDIA (Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (muscle pains), PYREXIA (High temperature 101.8/fever), FATIGUE (Fatigue/lying in bed), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 101.8 (High) 101.8. On 30-Oct-2021, Heart rate: 150 (High) Heart rate went above like 150.         No concomitant medications were provided.  No treatment medications were provided.  Patient experienced increased heartbeat after having the booster dose. Patient was using a Fit Bit and it said she had exercised for 103 minutes and her rate ranged from about 120-150 beats per minute. It would go up more if she was walking around, but it stayed over 120 beats per minute no matter what she did. Patient stated that the increased heart rate only occurred with the 3rd dose.   This case was linked to MOD-2021-373635 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received contains significant information, patient details, vaccination details and event details updated.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day; Body aches; Vomiting; Chills; muscle pains; High temperature 101.8/fever; Fatigue/lying in bed; Headache; Joint Pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (muscle pains) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced TACHYCARDIA (Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (muscle pains), PYREXIA (High temperature 101.8/fever), FATIGUE (Fatigue/lying in bed), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea). On 31-Oct-2021, TACHYCARDIA (Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (muscle pains), PYREXIA (High temperature 101.8/fever), FATIGUE (Fatigue/lying in bed), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 101.8 (High) 101.8. On 30-Oct-2021, Heart rate: 150 (High) Heart rate went above like 150.         No concomitant medications were provided.  No treatment medications were provided.  Patient experienced increased heartbeat after having the booster dose. Patient was using a Fit Bit and it said she had exercised for 103 minutes and her rate ranged from about 120-150 beats per minute. It would go up more if she was walking around, but it stayed over 120 beats per minute no matter what she did. Patient stated that the increased heart rate only occurred with the 3rd dose.   This case was linked to MOD-2021-373635 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received contains significant information, patient details, vaccination details and event details updated.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vomiting
Clinical narrative: Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day; Body aches; Vomiting; Chills; muscle pains; High temperature 101.8/fever; Fatigue/lying in bed; Headache; Joint Pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (muscle pains) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced TACHYCARDIA (Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (muscle pains), PYREXIA (High temperature 101.8/fever), FATIGUE (Fatigue/lying in bed), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea). On 31-Oct-2021, TACHYCARDIA (Heart rate went above like 150/really high, fast heart rate/ heart rate was high the entire day), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (muscle pains), PYREXIA (High temperature 101.8/fever), FATIGUE (Fatigue/lying in bed), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 101.8 (High) 101.8. On 30-Oct-2021, Heart rate: 150 (High) Heart rate went above like 150.         No concomitant medications were provided.  No treatment medications were provided.  Patient experienced increased heartbeat after having the booster dose. Patient was using a Fit Bit and it said she had exercised for 103 minutes and her rate ranged from about 120-150 beats per minute. It would go up more if she was walking around, but it stayed over 120 beats per minute no matter what she did. Patient stated that the increased heart rate only occurred with the 3rd dose.   This case was linked to MOD-2021-373635 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received contains significant information, patient details, vaccination details and event details updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vaccination complication, Vaccination site pruritus, Vomiting
Clinical narrative: Little reaction; Felt weak all day; Vomited 11 times; Arm got itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Little reaction), ASTHENIA (Felt weak all day), VACCINATION SITE PRURITUS (Arm got itchy at the injection site) and VOMITING (Vomited 11 times) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 006B21A and 031M20A) for COVID-19 vaccination.   No Medical History information was reported.  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) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (Arm got itchy at the injection site). On 31-Oct-2021, the patient experienced ASTHENIA (Felt weak all day) and VOMITING (Vomited 11 times). On an unknown date, the patient experienced VACCINATION COMPLICATION (Little reaction). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Little reaction), ASTHENIA (Felt weak all day), VACCINATION SITE PRURITUS (Arm got itchy at the injection site) and VOMITING (Vomited 11 times) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Little reaction to the Covid booster they got 28-Oct-2021 afternoon.  Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received on 02-Nov-2021 contains significant information, first and second dosage regimen added, event details added and treatment medication added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: possible application of expired vaccines.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible application of expired vaccines.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (possible application of expired vaccines.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (possible application of expired vaccines.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Non-Significant follow up appended-Contact information ,dose no updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Several administrations of the vaccine after vial expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Several administrations of the vaccine after vial expired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.   On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Several administrations of the vaccine after vial expired). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Several administrations of the vaccine after vial expired) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Non-Significant follow up appended-Reporter contact information updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to my second dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to my second dose of Moderna) in a 71-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to my second dose of Moderna). At the time of the report, VACCINATION COMPLICATION (Reaction to my second dose of Moderna) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Added reporter's Email address.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  No treatment information was provided. The vial was initially stored in the refrigerator on 21-Oct-2021. The vaccine was expired on 24-Oct-2021. Patient experienced no adverse events after the vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up information received contains Additional details related to the Event.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient was given 0.25 ml for her second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given 0.25 ml for her second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 039D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Patient was given 0.25 ml for her second dose). On 01-Nov-2021, ACCIDENTAL UNDERDOSE (Patient was given 0.25 ml for her second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  No treatment medication were reported.  Patient is not immunocompromised. HCP was asking what to do and if the patient should receive another half dose.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received booster half shot past 12 hour post puncture; This spontaneous case was reported by an other health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received booster half shot past 12 hour post puncture) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster half shot past 12 hour post puncture). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received booster half shot past 12 hour post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-372131 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: bursitis came back since the last couple of months; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (bursitis came back since the last couple of months) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bursitis (on and off since 7 years ago). Concomitant products included CORTISONE for Bursitis.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BURSITIS (bursitis came back since the last couple of months). At the time of the report, BURSITIS (bursitis came back since the last couple of months) outcome was unknown.            No treatment information were given.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: normal post shot malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (normal post shot malaise) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-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 (normal post shot malaise). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (normal post shot malaise) outcome was unknown.            Concomitant medications was not provided by the reporter.  Patient reported that they already got the first 2 doses of the Moderna vaccine, and after the second dose he had a normal post shot malaise. He took an aspirin to feel better.   This case was linked to MOD-2021-371905 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms; Dizziness; Nausea; Pain in her joints; Chills, but no fever; Soreness in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (Dizziness), NAUSEA (Nausea) and ARTHRALGIA (pain in her joints) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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. In October 2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm). On 02-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (Dizziness), NAUSEA (Nausea), ARTHRALGIA (pain in her joints) and CHILLS (chills, but no fever). In October 2021, PAIN IN EXTREMITY (soreness in her left arm) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (Dizziness), NAUSEA (Nausea), ARTHRALGIA (pain in her joints) and CHILLS (chills, but no fever) outcome was unknown.            No concomitant medications were reported  No treatment information was provided
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Neuralgia, Tremor
Clinical narrative: nerve pain; shaking; weakness/cannot hold coffee; pain across biceps; This spontaneous case was reported by a nurse and describes the occurrence of NEURALGIA (nerve pain), TREMOR (shaking), ASTHENIA (weakness/cannot hold coffee) and MYALGIA (pain across biceps) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 NEURALGIA (nerve pain), TREMOR (shaking), ASTHENIA (weakness/cannot hold coffee) and MYALGIA (pain across biceps). At the time of the report, NEURALGIA (nerve pain), TREMOR (shaking), ASTHENIA (weakness/cannot hold coffee) and MYALGIA (pain across biceps) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Blood test, Chills, Hypertension
Clinical narrative: Blood pressure went incredibly high 208/108; Shaking uncontrollably; Aches; Extremely high anxiety; Emergency said it was probably side effects from the vaccine; Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went incredibly high 208/108) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced HYPERTENSION (Blood pressure went incredibly high 208/108) (seriousness criterion medically significant), TREMOR (Shaking uncontrollably), PAIN (Aches), ANXIETY (Extremely high anxiety), VACCINATION COMPLICATION (Emergency said it was probably side effects from the vaccine), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, HYPERTENSION (Blood pressure went incredibly high 208/108), TREMOR (Shaking uncontrollably), PAIN (Aches), ANXIETY (Extremely high anxiety), VACCINATION COMPLICATION (Emergency said it was probably side effects from the vaccine), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Blood pressure measurement: 208/108 (High) Blood pressure 208/108 incredibly high.. On 28-Oct-2021, Blood test: normal (normal) blood test normal..         Concomitant product was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a 57-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hypertension. The event occurred 1 day after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hypertension. The event occurred 1 day after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Tremor, Vaccination complication
Clinical narrative: Blood pressure went incredibly high 208/108; Shaking uncontrollably; Aches; Extremely high anxiety; Emergency said it was probably side effects from the vaccine; Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went incredibly high 208/108) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced HYPERTENSION (Blood pressure went incredibly high 208/108) (seriousness criterion medically significant), TREMOR (Shaking uncontrollably), PAIN (Aches), ANXIETY (Extremely high anxiety), VACCINATION COMPLICATION (Emergency said it was probably side effects from the vaccine), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, HYPERTENSION (Blood pressure went incredibly high 208/108), TREMOR (Shaking uncontrollably), PAIN (Aches), ANXIETY (Extremely high anxiety), VACCINATION COMPLICATION (Emergency said it was probably side effects from the vaccine), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Blood pressure measurement: 208/108 (High) Blood pressure 208/108 incredibly high.. On 28-Oct-2021, Blood test: normal (normal) blood test normal..         Concomitant product was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a 57-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hypertension. The event occurred 1 day after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hypertension. The event occurred 1 day after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.