chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue (I felt tired) and vaccination site pain (soreness at injection site on left arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 25, 2021, patient experienced fatigue (I felt tired) and vaccination site pain (soreness at injection site on left arm). At the time of the report, fatigue (I felt tired) and vaccination site pain (soreness at injection site on left arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-358252 (patient link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tired; Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and VACCINATION SITE PAIN (Sore injection site arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 25-Mar-2021, the patient experienced FATIGUE (Tired) and VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, FATIGUE (Tired) and VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-358235 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided. Patient reported that her daughter had a sore arm after both of her doses .   This case was linked to MOD-2021-358289 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Illness, Insomnia, Muscle spasms, Restless legs syndrome
Clinical narrative: Horrible leg cramps multiple times a day 1 week after first shot; Restless leg syndrome multiple times a day  1 week after first shot; Numb Legs multiple times a day  1 week after first shot; Can not sleep at nights multiple times a day  1 week after first shot; Sick as a dog for 2 days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Horrible leg cramps multiple times a day 1 week after first shot), RESTLESS LEGS SYNDROME (Restless leg syndrome multiple times a day  1 week after first shot), HYPOAESTHESIA (Numb Legs multiple times a day  1 week after first shot), INSOMNIA (Can not sleep at nights multiple times a day  1 week after first shot) and ILLNESS (Sick as a dog for 2 days after the first shot) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced MUSCLE SPASMS (Horrible leg cramps multiple times a day 1 week after first shot), RESTLESS LEGS SYNDROME (Restless leg syndrome multiple times a day  1 week after first shot), HYPOAESTHESIA (Numb Legs multiple times a day  1 week after first shot), INSOMNIA (Can not sleep at nights multiple times a day  1 week after first shot) and ILLNESS (Sick as a dog for 2 days after the first shot). At the time of the report, MUSCLE SPASMS (Horrible leg cramps multiple times a day 1 week after first shot), RESTLESS LEGS SYNDROME (Restless leg syndrome multiple times a day  1 week after first shot), HYPOAESTHESIA (Numb Legs multiple times a day  1 week after first shot), INSOMNIA (Can not sleep at nights multiple times a day  1 week after first shot) and ILLNESS (Sick as a dog for 2 days after the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that he explained his side effects to his pharmacist and the pharmacist told him that his side effects are not normal that he should call Moderna. He declined providing the pharmacist's information. He states that his pharmacist told him that there are other patients whom received the Moderna COVID-19 vaccine and ended up with leg cramps and restless leg syndrome.          Patient states that he wants to take legal action and  requested the case number and MI agent provided it to him. Concomitant medication use was unknown Treatment information was unknown
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Peripheral swelling, Pruritus
Clinical narrative: Covid arm - huge, egg shaped; Itchy; Swollen arm; General malaise; Very bad chills which lasted for a day; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm - huge, egg shaped), PRURITUS (Itchy), PERIPHERAL SWELLING (Swollen arm), MALAISE (General malaise) and CHILLS (Very bad chills which lasted for a day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE REACTION (Covid arm - huge, egg shaped), PRURITUS (Itchy) and PERIPHERAL SWELLING (Swollen arm). In 2021, the patient experienced MALAISE (General malaise), CHILLS (Very bad chills which lasted for a day) and HEADACHE (Headache). In 2021, MALAISE (General malaise), CHILLS (Very bad chills which lasted for a day) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE REACTION (Covid arm - huge, egg shaped), PRURITUS (Itchy) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication were provided.  No treatment information were provided.   This case was linked to MOD-2021-358382 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm - huge, egg shaped; Itchy; Swollen arm; General malaise; Very bad chills which lasted for a day; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm - huge, egg shaped), PRURITUS (Itchy), PERIPHERAL SWELLING (Swollen arm), MALAISE (General malaise) and CHILLS (Very bad chills which lasted for a day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE REACTION (Covid arm - huge, egg shaped), PRURITUS (Itchy) and PERIPHERAL SWELLING (Swollen arm). In 2021, the patient experienced MALAISE (General malaise), CHILLS (Very bad chills which lasted for a day) and HEADACHE (Headache). In 2021, MALAISE (General malaise), CHILLS (Very bad chills which lasted for a day) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE REACTION (Covid arm - huge, egg shaped), PRURITUS (Itchy) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication were provided.  No treatment information were provided.   This case was linked to MOD-2021-358382 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Movement disorder
Clinical narrative: I can't straighten my arm; my elbow hurts a lot; 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 MOVEMENT DISORDER (I can't straighten my arm) and ARTHRALGIA (my elbow hurts a lot) 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 MOVEMENT DISORDER (I can't straighten my arm) and ARTHRALGIA (my elbow hurts a lot). At the time of the report, MOVEMENT DISORDER (I can't straighten my arm) and ARTHRALGIA (my elbow hurts a lot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided   This case was linked to MOD-2021-303250 (Patient Link).
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant or treatment medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Back pain, Crying, Pain
Clinical narrative: Asthma got worse; Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg; Lower back pain; Terrible pain just to put feet on the floor / pain never went away; Hurt so much she was badly crying in pain every day; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), PAIN (Terrible pain just to put feet on the floor / pain never went away), CRYING (Hurt so much she was badly crying in pain every day), ASTHMA (Asthma got worse) and ARTHRALGIA (Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028ACCA and 040AZIA) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included PREDNISONE and SALBUTAMOL SULFATE (VENTOLINE [SALBUTAMOL SULFATE]) for Asthma.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced BACK PAIN (Lower back pain), PAIN (Terrible pain just to put feet on the floor / pain never went away), CRYING (Hurt so much she was badly crying in pain every day) and ARTHRALGIA (Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg). On an unknown date, the patient experienced ASTHMA (Asthma got worse). At the time of the report, BACK PAIN (Lower back pain), PAIN (Terrible pain just to put feet on the floor / pain never went away), CRYING (Hurt so much she was badly crying in pain every day) and ARTHRALGIA (Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg) had not resolved and ASTHMA (Asthma got worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, X-ray: normal (normal) nothing is in her knee.         Treatment includes steroid shot at two different times.  Patient initially went back to work, but it hurt so much she was badly crying in pain every day and had to quit job after working there for five years. Patient went to urgent care in June. Though patient asthma got aggravated she used her usual medications only.   This case was linked to MOD-2021-358732 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Asthma got worse; Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg; Lower back pain; Terrible pain just to put feet on the floor / pain never went away; Hurt so much she was badly crying in pain every day; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), PAIN (Terrible pain just to put feet on the floor / pain never went away), CRYING (Hurt so much she was badly crying in pain every day), ASTHMA (Asthma got worse) and ARTHRALGIA (Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028ACCA and 040AZIA) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included PREDNISONE and SALBUTAMOL SULFATE (VENTOLINE [SALBUTAMOL SULFATE]) for Asthma.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced BACK PAIN (Lower back pain), PAIN (Terrible pain just to put feet on the floor / pain never went away), CRYING (Hurt so much she was badly crying in pain every day) and ARTHRALGIA (Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg). On an unknown date, the patient experienced ASTHMA (Asthma got worse). At the time of the report, BACK PAIN (Lower back pain), PAIN (Terrible pain just to put feet on the floor / pain never went away), CRYING (Hurt so much she was badly crying in pain every day) and ARTHRALGIA (Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg) had not resolved and ASTHMA (Asthma got worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, X-ray: normal (normal) nothing is in her knee.         Treatment includes steroid shot at two different times.  Patient initially went back to work, but it hurt so much she was badly crying in pain every day and had to quit job after working there for five years. Patient went to urgent care in June. Though patient asthma got aggravated she used her usual medications only.   This case was linked to MOD-2021-358732 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Alopecia, Dyspnoea, Fatigue, Hypotonia
Clinical narrative: Arms go limp; Patient reports experiencing hairloss; Patient reports experiencing stomach upset; Shortness of breath, I can't breathe; Patient report experiencing fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTONIA (Arms go limp), ALOPECIA (Patient reports experiencing hairloss), ABDOMINAL DISCOMFORT (Patient reports experiencing stomach upset), DYSPNOEA (Shortness of breath, I can't breathe) and FATIGUE (Patient report experiencing fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-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 HYPOTONIA (Arms go limp), ALOPECIA (Patient reports experiencing hairloss), ABDOMINAL DISCOMFORT (Patient reports experiencing stomach upset), DYSPNOEA (Shortness of breath, I can't breathe) and FATIGUE (Patient report experiencing fatigue). At the time of the report, HYPOTONIA (Arms go limp) outcome was unknown and ALOPECIA (Patient reports experiencing hairloss), ABDOMINAL DISCOMFORT (Patient reports experiencing stomach upset), DYSPNOEA (Shortness of breath, I can't breathe) and FATIGUE (Patient report experiencing fatigue) was resolving.            Concomitant medication was not provided. Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: She also felt pain; Felt like whole body was stabbing me; She also got a fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She also felt pain), MYALGIA (Felt like whole body was stabbing me) and PYREXIA (She also got a fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZIA) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included PREDNISONE and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for Asthma.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (She also felt pain), MYALGIA (Felt like whole body was stabbing me) and PYREXIA (She also got a fever). On 19-Mar-2021, PAIN (She also felt pain), MYALGIA (Felt like whole body was stabbing me) and PYREXIA (She also got a fever) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2021-358713 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Nasopharyngitis
Clinical narrative: Cold; Headache; Shivering; 4 hours after first shot developed sickness; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (4 hours after first shot developed sickness), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMIN B12 [VITAMIN B12 NOS], SUCRALFATE (CARAFATE), VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]) and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (4 hours after first shot developed sickness). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering). In April 2021, ILLNESS (4 hours after first shot developed sickness) had resolved. At the time of the report, NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.  The patient had the worst headache of her life and feeling so cold felt like ice in veins.   This case was linked to MOD-2021-358836 (Patient Link).
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received the third dose of the vaccine even though I am not immunocompromised.; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received the third dose of the vaccine even though I am not immunocompromised.) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received the third dose of the vaccine even though I am not immunocompromised.). At the time of the report, EXTRA DOSE ADMINISTERED (Received the third dose of the vaccine even though I am not immunocompromised.) had resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that they received the third dose of the Moderna COVID-19 vaccine even though they were not immunocompromised. The patient stated that they received the first dose in JAN-2021, exact date, lot, arm, and expiration date was unknown. The patient reported that they were experiencing bad side effects after the first dose and really bad side effects after the second dose. The patient did not specifically mention side effects just referred to them as bad and really bad and the side effects had resolved by the time of the call 19-OCT-2021.   This case was linked to MOD-2021-358998 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My husband had a sore arm after receiving the third dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (My husband had a sore arm after receiving the third dose). In 2021, VACCINATION SITE PAIN (My husband had a sore arm after receiving the third dose) had resolved.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-358998 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Vaccine used; vial undergo temperature excursions; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (vial undergo temperature excursions) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (vial undergo temperature excursions). On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 17-Oct-2021, PRODUCT STORAGE ERROR (vial undergo temperature excursions) had resolved. On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Pharmacist stated that they discovered they administered approximately 3 doses of the Moderna vaccine after the expiration time. Wanted to know if we had guidance about how to proceed, see if patients have to be called for re-vaccination. Doses were administered today 12-14 hs after the expiration time of a vial that had already been punctured. Vial was opened on Sunday afternoon so expiration was on Sunday midnight. Date the vial was initially stored in the refrigerator: Friday morning 15-Oct-2021 from 8 AM - 11 AM. On 17-Oct-2021 at afternoon, vial was punctured. After the first puncture it was kept at room temperature. Total amount of time the vial was exposed to room temperature range (80 to 250C= 460 to 77 OF): anywhere from 24-26 hs when they were administered.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was exposed to room temperature from 24-26 hs when they administered; received dose after expiration time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after expiration time) and PRODUCT STORAGE ERROR (vial was exposed to room temperature from 24-26 hs when they administered) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after expiration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was exposed to room temperature from 24-26 hs when they administered). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose after expiration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (vial was exposed to room temperature from 24-26 hs when they administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood test, Computerised tomogram, Head discomfort, Headache
Clinical narrative: tinnitus; paraesthesia; pressure; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (tinnitus), PARAESTHESIA (paraesthesia), HEAD DISCOMFORT (pressure) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 TINNITUS (tinnitus), PARAESTHESIA (paraesthesia), HEAD DISCOMFORT (pressure) and HEADACHE (headache). At the time of the report, TINNITUS (tinnitus) had not resolved and PARAESTHESIA (paraesthesia), HEAD DISCOMFORT (pressure) and HEADACHE (headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: normal (normal) Normal. On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Patient mentioned all the events occurred on right side  No Treatment information was reported.   This case was linked to MOD-2021-300927, MOD-2021-295926 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, SARS-CoV-2 test, Tinnitus
Clinical narrative: tinnitus; paraesthesia; pressure; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (tinnitus), PARAESTHESIA (paraesthesia), HEAD DISCOMFORT (pressure) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 TINNITUS (tinnitus), PARAESTHESIA (paraesthesia), HEAD DISCOMFORT (pressure) and HEADACHE (headache). At the time of the report, TINNITUS (tinnitus) had not resolved and PARAESTHESIA (paraesthesia), HEAD DISCOMFORT (pressure) and HEADACHE (headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: normal (normal) Normal. On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Patient mentioned all the events occurred on right side  No Treatment information was reported.   This case was linked to MOD-2021-300927, MOD-2021-295926 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine administered after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccine administered after temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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 PRODUCT STORAGE ERROR (vaccine administered after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (vaccine administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: missed their menstrual cycle after their second shot of their COVID 19 vaccine.; This is a spontaneous report from a contactable Pfizer colleague and a contactable Nurse reported for three adolescent female patients. This is 2nd of 3 reports.  An adolescent non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was unknown whether the patient was diagnosed with Covid prior to vaccination or was tested for COVID-19 post vaccination. On an unspecified date, after second shot of Covid-19 vaccine the patient missed her menstrual cycle. It was unknown if the patient receives any treatment in response to the event. The outcome of the event was not resolved.  The lot number for [bnt162b2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202100929375 Same reporter/drug/AE, different patient;-PFIZER INC-202100930371 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Inflammation, Mass, Pain
Clinical narrative: Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Fever; Chills; Body pain; This is a spontaneous report from a contactable consumer (Patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA7484), via an unspecified route of administration, administered in right arm on 17Jul2021 at 11:15 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has not taken any vaccination 4 weeks prior to COVID-19 Vaccine. On 20Jul2021, the patient experienced Got a lump under my armpit and it hurts, and it's Inflamed, and I feel like a burning sensation; It's just swollen, Fever, Chills, and Body pain. Patient already checked to see if there was like a bite or something or ingrowth but she didn't grow any like armpit hair. Therapeutic measures were taken as a result of fever, chills and body pain which included Advil tablet. Patients second dose was schedule on 07Aug2021. The outcome for all the events was unknown.  Follow-Up (09Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Fever; Chills; Body pain; This is a spontaneous report from a contactable consumer (Patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA7484), via an unspecified route of administration, administered in right arm on 17Jul2021 at 11:15 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has not taken any vaccination 4 weeks prior to COVID-19 Vaccine. On 20Jul2021, the patient experienced Got a lump under my armpit and it hurts, and it's Inflamed, and I feel like a burning sensation; It's just swollen, Fever, Chills, and Body pain. Patient already checked to see if there was like a bite or something or ingrowth but she didn't grow any like armpit hair. Therapeutic measures were taken as a result of fever, chills and body pain which included Advil tablet. Patients second dose was schedule on 07Aug2021. The outcome for all the events was unknown.  Follow-Up (09Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test, Skin mass, Urticaria
Clinical narrative: This is a spontaneous report from a contactable Physician. This Physician reported for a 80-year-old female patient that: A 80-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EN0203), via intramuscular route, administered right arm as dose 2, single on 02Mar2021 11:00 (at the age of 80-year-old) for covid-19 immunisation at hospital. Medical history included hypertension from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medication included amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: E18982), via intramuscular route, administered right arm as dose 1, single on 09Feb2021 11:00 (at the age of 80-year-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination was Norvasc. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. ON 16Mar2021, the patient has had a persistent diffuse body rash that was very pruritic. It began as urticarial rash then those resolved but she had small nodules under her skin and then a popular diffuse rash appeared and was persisted. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Jun2021. Therapeutic measures were taken as a result of adverse events with steroids after 4 weeks of persistent rash and now antihistamines. Adverse event resulted in doctor or other healthcare professional office/clinic visit. At the time of this report, the outcome of event urticarial rash was recovered on unspecified date in 2021; the outcome of all other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Feeling hot, Pain in extremity, Swelling
Clinical narrative: swelling in her armpit and its warm and a knot; swelling in her armpit and its warm and a knot; swelling in her armpit and its warm and a knot; soreness in her arm; This is a spontaneous report from a contactable consumer(patient).  A female patient of unspecified age had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EX3599) via an unspecified route of administration in arm left on 26Jul2021 15:350 as DOSE 1, SINGLE for covid-19 immunization.The patient medical history and concomitant were not reported. On an unspecified date the patient had experienced swelling in her armpit and its warm and a knot . The patient knew she would have soreness in her arm but she has so much swelling in her armpit and its warm and a knot, wasn't sure if this was a side effect and had a question if it was swollen lymph node. The clinical outcome of the events was unknown.  Information on lot/ batch number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Migraine
Clinical narrative: migraines might be getting worse since she took Ibuprofen; she experienced migraine; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 18-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: FA7485), dose 2 via an unspecified route of administration, administered in arm left (left shoulder) on 30Jul2021 at 14:00 or 15:00 (age at vaccination 18 years old) as DOSE 2, SINGLE for covid-19 immunisation at pharmacy. The patient medical history was not reported. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (AUROVELA 1/20) via oral from an unspecified date and ongoing at 1x/day (taking for over a year, about a year and two or three months) for birth control. Historical vaccine included first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EW0198) via an unspecified route of administration in left arm (shoulder) on 09Jul2021 at 10:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This report was not related to a study or programme. On 30Jul2021 (then 1-2 hrs later after getting vaccinated), the patient experienced migraine, headache and migraines might be getting worse since she took ibuprofen. About an hour or two hours after the second dose her migraines started and have been consistent ever since. She had contacts and curly hair and her hair was tight and thrown in a bun, since that was usually why she gets headaches, she took her contacts and hair out of bun but she was still getting the migraines. She usually takes tylenol and usually it worked. She clarified that she took ibuprofen (Lot: 9KE3036A, Expiration: Jul2021) not tylenol. Reported her migraines might be getting worse since she took Ibuprofen around 9:30 this morning and still has a headache. She got her second shot of the pfizer covid vaccine on friday. The doctor told her that symptoms usually last about 24 hours or 48 hours at the longest. Reported it had been 4 days and she has constantly had migraines. Asked if this was normal. The adverse event did not result in physician's office visit or emergency room visit. Therapeutic measures were taken as a result of migraine, headache, migraines might be getting worse since she took ibuprofen. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself that, A 36-years-old female patient received tofacitinib citrate (XELJANZ XR, Formulation: Prolonged-release tablet, Strength: 11mg), via oral from Feb2021 (Batch/Lot Number: EA8738) and ongoing, at 11 mg, once a day (take 1 tablet by mouth once daily) for an unspecified indication; bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing Patients indication for xeljanz: rheumatoid arthritis with rheumatoid factor multi site w/o org/sys involve. Concomitant medication included iron taken for an unspecified indication, paracetamol (TYLENOL) taken for an unspecified indication, prednisone taken for pain, hydroxychloroquine sulfate (HYDROXYCHLOROQUINE SULFATE) taken for an unspecified indication. Patient reported she received the 1st Pfizer covid vaccine and held Xeljanz for a week before and after the vaccine per her MDs instructions. Reports as a result she experienced manageable pain in h). CEP Xeljanz low risk month 6 call completed with HIPAA verified patient. Provided review of prescribed regimen, reviewed educational topics and completed the adherence medications scale (ARMS-7). Patient reported she received the 1st Pfizer Covid vaccine and held Xeljanz for a week before and after the vaccine per her MDs instructions. Reported as a result she experienced manageable pain in her waist and fingers in the morning but that the pain subsided as the day progressed. Reported her 2nd vaccine dose is due on 17Aug and she will be holding the medication again for 1 week before and after the vaccine. Reported she has an appointment with her RA tomorrow including bloodwork. Reports she takes prednisone as needed for severe pain. Agreed to educational mailers and declined to speak with a pharmacist. Warm transferred patient to patient care coordinator to schedule delivery. AE report completed. The action taken in response to the events for tofacitinib citrate was dose not changed. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Illness
Clinical narrative: making me so sick; elevated blood pressure; This is a spontaneous report from a contactable consumer or other non hcp (patient), based on information received by Pfizer (manufacturer control number: EC-2020-078599) license party for bnt162b2.  A female non-pregnant patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization, lenvatinib mesilate (LENVIMA), oral from 24Jul2020 (Batch/Lot Number: 156216) to an unspecified date, at 10 mg, once daily for Malignant neoplasm of endometrium. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced new elevated blood pressure and making her so sick on an unspecified date. Patient further stated she missed about 5 doses of Lenvima after 2nd COVID vaccine due to the vaccine making her so sick. The action taken in response to the event(s) for lenvatinib mesilate was unknown. The outcome of events was unknown.  Causality Assessment for Illness as Per reporter and Per Company was Not reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain
Clinical narrative: felt tired; hurting; This is a spontaneous report based on the information received by a contactable consumer via Pfizer (Manufacturer Report Number: 2021SA24821).  A 55-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE (reported as TOZINAMERAN, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, for COVID-19 immunization and Kevzara (SARILUMAB, Solution for injection, dosage, frequency and route unknown, with an unknown batch number and expiry date) on an unspecified date for unspecified indication. In the context of COVID19 crisis, the batch number and expiration date were not requested. The patient past medical history, medical treatment, family history and concomitant medications were not reported. On an unspecified date, the patient felt tired and hurting (unknown latency) while being treated with sarilumab (Kevzara) and tozinameran (BNT162B2). It was not reported if the patient received a corrective treatment for the events. Action taken with sarilumab (Kevzara) was unknown. At time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.