chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Baseball size bump in the arm for 2 weeks after the vaccine; Arm starting to turn red but/arm got red from the shoulder to the elbow; it was hot; Swollen; Felt like a bad burn; it was painful; Itched; Covid arm; Not feel good; little bit of an achy arm/Aches; Lowgrade fever; Chills/had chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Baseball size bump in the arm for 2 weeks after the vaccine), MYALGIA (little bit of an achy arm/Aches), VACCINATION COMPLICATION (Not feel good), VACCINATION SITE ERYTHEMA (Arm starting to turn red but/arm got red from the shoulder to the elbow) and FEELING HOT (it was hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 028A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced MYALGIA (little bit of an achy arm/Aches), PYREXIA (Lowgrade fever) and CHILLS (Chills/had chills). On 25-Oct-2021, the patient experienced VACCINATION COMPLICATION (Not feel good). On 26-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm starting to turn red but/arm got red from the shoulder to the elbow), FEELING HOT (it was hot), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Felt like a bad burn), VACCINATION SITE PAIN (it was painful), VACCINATION SITE PRURITUS (Itched) and VACCINATION COMPLICATION (Covid arm). On an unknown date, the patient experienced VACCINATION SITE MASS (Baseball size bump in the arm for 2 weeks after the vaccine). At the time of the report, VACCINATION SITE MASS (Baseball size bump in the arm for 2 weeks after the vaccine), VACCINATION COMPLICATION (Not feel good), FEELING HOT (it was hot), VACCINATION SITE PAIN (Felt like a bad burn), VACCINATION SITE PRURITUS (Itched), VACCINATION COMPLICATION (Covid arm), PYREXIA (Lowgrade fever) and CHILLS (Chills/had chills) outcome was unknown, MYALGIA (little bit of an achy arm/Aches) had not resolved and VACCINATION SITE ERYTHEMA (Arm starting to turn red but/arm got red from the shoulder to the elbow), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (it was painful) was resolving.            Patient stated that she was immunosuppressed.  Concomitant medications included several medications.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Baseball size bump in the arm for 2 weeks after the vaccine; Arm starting to turn red but/arm got red from the shoulder to the elbow; it was hot; Swollen; Felt like a bad burn; it was painful; Itched; Covid arm; Not feel good; little bit of an achy arm/Aches; Lowgrade fever; Chills/had chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Baseball size bump in the arm for 2 weeks after the vaccine), MYALGIA (little bit of an achy arm/Aches), VACCINATION COMPLICATION (Not feel good), VACCINATION SITE ERYTHEMA (Arm starting to turn red but/arm got red from the shoulder to the elbow) and FEELING HOT (it was hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 028A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced MYALGIA (little bit of an achy arm/Aches), PYREXIA (Lowgrade fever) and CHILLS (Chills/had chills). On 25-Oct-2021, the patient experienced VACCINATION COMPLICATION (Not feel good). On 26-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm starting to turn red but/arm got red from the shoulder to the elbow), FEELING HOT (it was hot), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Felt like a bad burn), VACCINATION SITE PAIN (it was painful), VACCINATION SITE PRURITUS (Itched) and VACCINATION COMPLICATION (Covid arm). On an unknown date, the patient experienced VACCINATION SITE MASS (Baseball size bump in the arm for 2 weeks after the vaccine). At the time of the report, VACCINATION SITE MASS (Baseball size bump in the arm for 2 weeks after the vaccine), VACCINATION COMPLICATION (Not feel good), FEELING HOT (it was hot), VACCINATION SITE PAIN (Felt like a bad burn), VACCINATION SITE PRURITUS (Itched), VACCINATION COMPLICATION (Covid arm), PYREXIA (Lowgrade fever) and CHILLS (Chills/had chills) outcome was unknown, MYALGIA (little bit of an achy arm/Aches) had not resolved and VACCINATION SITE ERYTHEMA (Arm starting to turn red but/arm got red from the shoulder to the elbow), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (it was painful) was resolving.            Patient stated that she was immunosuppressed.  Concomitant medications included several medications.  No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lethargy
Clinical narrative: no energy; she felt lethargic; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy) and LETHARGY (she felt lethargic) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced ASTHENIA (no energy) and LETHARGY (she felt lethargic). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-Oct-2021, ASTHENIA (no energy) and LETHARGY (she felt lethargic) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported that she does not take any regular medications. No treatment details were reported. Patient reported that she experienced lethargic with no energy after first shot which was unlike her.   This case was linked to MOD-2021-373431 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: another patient under age of 18 who received the first dose; 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (another patient under age of 18 who received the first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (another patient under age of 18 who received the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (another patient under age of 18 who received the first dose) 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.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: numbness, burning and tingling in hands; Burning and tingling in hand; tingling in hand; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness, burning and tingling in hands), BURNING SENSATION (Burning and tingling in hand) and PARAESTHESIA (tingling in hand) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness, burning and tingling in hands), BURNING SENSATION (Burning and tingling in hand) and PARAESTHESIA (tingling in hand). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness, burning and tingling in hands), BURNING SENSATION (Burning and tingling in hand) and PARAESTHESIA (tingling in hand) outcome was unknown.            No concomitant drugs were reported. treatment drug reported were muscle relaxants.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: arm soreness; 99.4 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and PYREXIA (99.4 degree fever) in a 73-year-old male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and PYREXIA (99.4 degree fever). At the time of the report, PAIN IN EXTREMITY (arm soreness) and PYREXIA (99.4 degree fever) had resolved. Not Provided          No concomitant and treatment drugs were provided.   This case was linked to MOD-2021-363235, MOD-2021-363252 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a little reaction to the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a little reaction to the first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder, Neurological disorder NOS and Immunocompromised.    On 02-Mar-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 COMPLICATION (a little reaction to the first dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; NAPROXEN for Adverse event, at an unspecified dose and frequency and TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (a little reaction to the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant low dose steroid , antibiotic was reported.  Treatment ice cool compresses was reported.  Patient state they had the flu shot one week prior to the third dose which was given on 24-Oct-2021,in the same arm.   This case was linked to MOD-2021-373419, MOD-2021-373418 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Achiness; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness), PYREXIA (Fever) and FATIGUE (Tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (take several medications), Cardiac disorder and Neurological disorder NOS.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 MYALGIA (Achiness), PYREXIA (Fever) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; NAPROXEN for Adverse event, at an unspecified dose and frequency and TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Achiness), PYREXIA (Fever) and FATIGUE (Tired) outcome was unknown.            Patient was having medication for neurological condition and cardiac condition. Patient was also having antibiotics and low dose steroids as concomitant medication for unknown indication.  Treatment medication included Ice cool compresses   This case was linked to MOD-2021-373406, MOD-2021-373419 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Vaccination site reaction
Clinical narrative: Achiness; More of a reaction; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), VACCINATION SITE REACTION (More of a reaction), FATIGUE (Tired) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A, 039D21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder, Neurological disorder NOS and Immunocompromised.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achiness), VACCINATION SITE REACTION (More of a reaction), FATIGUE (Tired) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; NAPROXEN for Adverse event, at an unspecified dose and frequency and TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Achiness), VACCINATION SITE REACTION (More of a reaction), FATIGUE (Tired) and PYREXIA (Fever) outcome was unknown.            Patient takes medication for a cardiac condition, medication for a neurological condition, lowdose steroid and antibiotics Patient also reported getting flu shot two weeks before taking booster dose. Patient also used ice and cool compresses for treatment.   This case was linked to MOD-2021-373406 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Constipation, Diarrhoea, Feeling hot
Clinical narrative: Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.; Around 9am on November 2, 2021, she began to feel stomach pain; Around 9am on November 2, 2021, she began to experienced diarrhea; Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.; Chills; Felt unusually warm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING HOT (Felt unusually warm), ABDOMINAL PAIN UPPER (Around 9am on November 2, 2021, she began to feel stomach pain), DIARRHOEA (Around 9am on November 2, 2021, she began to experienced diarrhea), FLATULENCE (Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.) and CONSTIPATION (Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced FEELING HOT (Felt unusually warm) and CHILLS (Chills). On 02-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Around 9am on November 2, 2021, she began to feel stomach pain), DIARRHOEA (Around 9am on November 2, 2021, she began to experienced diarrhea) and FLATULENCE (Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.). On 03-Nov-2021, the patient experienced CONSTIPATION (Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.). At the time of the report, FEELING HOT (Felt unusually warm), ABDOMINAL PAIN UPPER (Around 9am on November 2, 2021, she began to feel stomach pain), DIARRHOEA (Around 9am on November 2, 2021, she began to experienced diarrhea), FLATULENCE (Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.), CONSTIPATION (Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.) and CHILLS (Chills) outcome was unknown.            No concomitant medication was provided No treatment received by the patient
Sex: F
Vaccine: COVID19
Symptoms: Flatulence
Clinical narrative: Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.; Around 9am on November 2, 2021, she began to feel stomach pain; Around 9am on November 2, 2021, she began to experienced diarrhea; Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.; Chills; Felt unusually warm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING HOT (Felt unusually warm), ABDOMINAL PAIN UPPER (Around 9am on November 2, 2021, she began to feel stomach pain), DIARRHOEA (Around 9am on November 2, 2021, she began to experienced diarrhea), FLATULENCE (Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.) and CONSTIPATION (Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced FEELING HOT (Felt unusually warm) and CHILLS (Chills). On 02-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Around 9am on November 2, 2021, she began to feel stomach pain), DIARRHOEA (Around 9am on November 2, 2021, she began to experienced diarrhea) and FLATULENCE (Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.). On 03-Nov-2021, the patient experienced CONSTIPATION (Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.). At the time of the report, FEELING HOT (Felt unusually warm), ABDOMINAL PAIN UPPER (Around 9am on November 2, 2021, she began to feel stomach pain), DIARRHOEA (Around 9am on November 2, 2021, she began to experienced diarrhea), FLATULENCE (Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.), CONSTIPATION (Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.) and CHILLS (Chills) outcome was unknown.            No concomitant medication was provided No treatment received by the patient
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1st dose administered 16-Jun-2021 (beyond 30-day mark after being refrigerated); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose administered 16-Jun-2021 (beyond 30-day mark after being refrigerated)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic hepatitis C (Started treatment with Harvoni x 12 weeks on 18/Aug/2021) since 2021, Hypertension since 22-Apr-2021, Osteoarthritis since 22-Apr-2021, Major depression since 18-Jan-2018 and CVA (History of CVA). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] from 19-Nov-2020 to an unknown date for CVA, LEDIPASVIR, SOFOSBUVIR (HARVONI) from 18-Aug-2021 to an unknown date for Chronic hepatitis C, AMLODIPINE from 22-Apr-2021 to an unknown date for Hypertension, QUETIAPINE from 19-Jan-2021 to an unknown date for Major depression, NAPROXEN from 19-Feb-2021 to an unknown date for Osteoarthritis.    On 16-Jun-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose administered 16-Jun-2021 (beyond 30-day mark after being refrigerated)). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (1st dose administered 16-Jun-2021 (beyond 30-day mark after being refrigerated)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The Moderna vaccine was stored in the refrigerator on 20-Apr-2021.  No adverse events reported by patient.   This case was linked to MOD-2021-369042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: No new information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Paraesthesia
Clinical narrative: leg tingled; Body ache all over; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (leg tingled), MYALGIA (Body ache all over), CHILLS (chills) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (penicillin-rash). Concomitant products included LEVOTHYROXINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. In March 2021, the patient experienced PARAESTHESIA (leg tingled), MYALGIA (Body ache all over), CHILLS (chills) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (leg tingled), MYALGIA (Body ache all over), CHILLS (chills) and FATIGUE (tiredness) had resolved.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Mostly tired/ Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Mostly tired/ Fatigue) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) 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 FATIGUE (Mostly tired/ Fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Mostly tired/ Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  No treatment information was provided.  After first dose, the patient experienced fatigue, headache and was mostly tired.   This case was linked to MOD-2021-373427, MOD-2021-373467 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue/mostly tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/mostly tired) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 029K20A) 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 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue/mostly tired) and HEADACHE (Headache). At the time of the report, FATIGUE (Fatigue/mostly tired) and HEADACHE (Headache) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  After second dose, the patient experienced fatigue, headache and was mostly tired.   This case was linked to MOD-2021-373466, MOD-2021-373427 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Gait disturbance, Musculoskeletal stiffness, Vaccination complication
Clinical narrative: feel really bad/feeling really knocked out/not feeling good; feel so bad can hardly walk/so stiff; feel so bad can hardly walk/so stiff; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feel really bad/feeling really knocked out/not feeling good), GAIT DISTURBANCE (feel so bad can hardly walk/so stiff) and MUSCULOSKELETAL STIFFNESS (feel so bad can hardly walk/so stiff) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 48C21A, 023M20A and 042LA0A) for COVID-19 vaccination.     No Medical History information was reported.   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 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (feel really bad/feeling really knocked out/not feeling good), GAIT DISTURBANCE (feel so bad can hardly walk/so stiff) and MUSCULOSKELETAL STIFFNESS (feel so bad can hardly walk/so stiff). At the time of the report, VACCINATION COMPLICATION (feel really bad/feeling really knocked out/not feeling good), GAIT DISTURBANCE (feel so bad can hardly walk/so stiff) and MUSCULOSKELETAL STIFFNESS (feel so bad can hardly walk/so stiff) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 100 (High) fever of 100.         Concomitant medication details was not reported.   Treatment details was not reported.  In Nov-2021, symptoms started to appear.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) 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 information was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Therapeutic response unexpected
Clinical narrative: Shoulder hurts; got the booster and within 2 hours, the back pain had ease, the soreness in the glutes had eased/ pain was decreasing so patient thought this was a secret to back pain; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (got the booster and within 2 hours, the back pain had ease, the soreness in the glutes had eased/ pain was decreasing so patient thought this was a secret to back pain) and ARTHRALGIA (Shoulder hurts) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, DD1A2V and 044A217) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (got the booster and within 2 hours, the back pain had ease, the soreness in the glutes had eased/ pain was decreasing so patient thought this was a secret to back pain). On an unknown date, the patient experienced ARTHRALGIA (Shoulder hurts). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (got the booster and within 2 hours, the back pain had ease, the soreness in the glutes had eased/ pain was decreasing so patient thought this was a secret to back pain) and ARTHRALGIA (Shoulder hurts) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-373497 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (made an error by giving  a shot from a vile that had been punctured 19 hours prior) 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 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (made an error by giving  a shot from a vile that had been punctured 19 hours prior). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (made an error by giving  a shot from a vile that had been punctured 19 hours prior) had resolved. Not Provided          No concomitant medications were provided.  No treatment information was provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: within 1 day, she was totally free of back pain, free of knee pain, free of muscle pain that she has had for 50 years; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (within 1 day, she was totally free of back pain, free of knee pain, free of muscle pain that she has had for 50 years) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A217 and DD1A2V) for COVID-19 vaccination.     Concurrent medical conditions included Back pain (had for 50 years), Knee pain (had for 50 years) and Muscle pain (had for 50 years).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (within 1 day, she was totally free of back pain, free of knee pain, free of muscle pain that she has had for 50 years). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (within 1 day, she was totally free of back pain, free of knee pain, free of muscle pain that she has had for 50 years) outcome was unknown.            Concomitant medication product was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-373482 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of unexpected therapeutic response (now she has no gouty arthritis pain) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's medical history included gouty arthritis. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had an unexpected therapeutic response (now she has no gouty arthritis pain). At the time of the report, unexpected therapeutic response (now she has no gouty arthritis pain) outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered dose past the manufacture expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after the second shot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031M20A) 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) (Intramuscular) 1 dosage form. On 30-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 CHILLS (Chills after the second shot). At the time of the report, CHILLS (Chills after the second shot) outcome was unknown.            No concomitant medication was provided.  No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. The vaccine was removed from freezer on 14-Oct-2021 into refrigerator and never opened before the administration day and the temperature was never compromised.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) 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) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information regarding first or second dose were provided. No concomitant medications were reported. No treatment medications were reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling hot
Clinical narrative: Extremely dizzy; Face got very very hot; Couldn't breathe; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely dizzy), FEELING HOT (Face got very very hot) and DYSPNOEA (Couldn't breathe) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 (First dose (lot EN6202)) on 07-Mar-2021 and Pfizer COVID-19 (Second dose (lot EN6208)) on 28-Mar-2021.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced DIZZINESS (Extremely dizzy), FEELING HOT (Face got very very hot) and DYSPNOEA (Couldn't breathe). On 31-Oct-2021, DIZZINESS (Extremely dizzy), FEELING HOT (Face got very very hot) and DYSPNOEA (Couldn't breathe) had resolved.            Concomitant product use was not provided by the reporter. No Treatment information was provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) 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 information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: unknown amount of patients may have received doses of vials of the Moderna COVID19 vaccine after 30-day Use By Date; 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 (unknown amount of patients may have received doses of vials of the Moderna COVID19 vaccine after 30-day Use By Date) 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 (unknown amount of patients may have received doses of vials of the Moderna COVID19 vaccine after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (unknown amount of patients may have received doses of vials of the Moderna COVID19 vaccine after 30-day Use By Date) 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 concomitants and treatment drugs are provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: Sore arm; sweaty; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HYPERHIDROSIS (sweaty) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) on 19-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included METFORMIN and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HYPERHIDROSIS (sweaty). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HYPERHIDROSIS (sweaty) outcome was unknown.            Concomitant medications include Heart medication. No treatment details were reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vaccination site pain
Clinical narrative: feeling dizzy; Feeling weak; sore arm  at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), ASTHENIA (Feeling weak) and VACCINATION SITE PAIN (sore arm  at the injection site) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm  at the injection site). On 27-Apr-2021, the patient experienced DIZZINESS (feeling dizzy) and ASTHENIA (Feeling weak). At the time of the report, DIZZINESS (feeling dizzy), ASTHENIA (Feeling weak) and VACCINATION SITE PAIN (sore arm  at the injection site) 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.   Concomitant medication were not provided Treatment medication were not reported.   This case was linked to MOD-2021-373440 (Patient Link).