chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of underdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional office reported a patient of theirs who was administered Shingrix at a pharmacy said she did not get a full dose because the vaccine leaked out of the syringe, which led to underdose. The healthcare professional did not have pharmacy information but was contacting patient to get it.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 14 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced off label use. On 20-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211217956, 20211218548, 20211218297 and 20211221204.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5 ML OF VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-NOV-2021, the patient experienced received 2.5 ml of vaccine. On 20-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5 ml of vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219871, 20211220129, 20211220916, 20211220152, 20211219681, 20211219953, 20211220145, 20211220155, 20211165041, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202199, 20211202193, 20211202161, 20211201963, 20211201450, 20211201443, 20211201392, 20211201351, 20211201304, 20211201286, 20211201179, 20211220697 and 20211220928.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-NOV-2021, the patient experienced administered 2.5ml of the vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220129, 20211220619, 20211220155, 20211220145, 20211220250, 20211220262, 20211220916, 20211165041, 20211200723, 20211200752, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202250, 20211202371, 20211165041, 20211202199, 20211202193, 20211202161, 20211201963, 20211201450, 20211201443, 20211201392, 20211201351, 20211201304, 20211201286, 20211201179, 20211201168, 20211200994, 20211201082, 20211200723, 20211200717, 20211219681, 20211200675, 20211220527, 20211220697 and 20211220928.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 31-OCT-2020 for prophylactic vaccination. No concomitant medications were reported.  On 31-OCT-2021, the patient experienced administered 2.5ml of the vaccine. On 31-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220129, 20211220146, 20211220916, 20211220152, 20211219926, 20211219871, 20211220301, 20211220145, 20211220527, 20211220250, 20211165041, 20211200723, 20211200752, 20211201046, 20211201228, 20211201963, 20211201450, 20211201443, 20211201392, 20211201351, 20211201304, 20211201286, 20211201179, 20211201168, 20211200994, 20211201082, 20211200723, 20211200717, 20211219681 and 20211200675.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced administered 2.5ml of the vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220129, 20211220146, 20211220152, 20211219681, 20211165041, 20211165041, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202250, 20211202371, 20211165041, 20211200675, 20211200717, 20211200723, 20211201082, 20211200994, 20211201168, 20211201179, 20211201286, 20211201304, 20211201351, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202193, 20211202199, 20211219871 and 20211220301.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5 ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) 2.5 ml, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-NOV-2021, the patient experienced received 2.5 ml of the vaccine. On 20-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5 ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220146, 20211219681, 20211219953, 20211220152, 20211220152, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202250, 20211202371, 20211165041, 20211200675, 20211200717, 20211200723, 20211201082, 20211200994, 20211201168, 20211201179, 20211201286, 20211219871, 20211220527, 20211220697 and 20211220928.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: OVERDOSE (RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) 2.5 ml, administered on 31-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-OCT-2021, the patient experienced overdose (received 2.5ml of the janssen covid-19 vaccine). On 31-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the overdose (received 2.5ml of the janssen covid-19 vaccine) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220178, 20211220537, 20211220177, 20211220552, 20211220155, 20211220619, 20211220152, 20211220697, 20211220146, 20211220754, 20211220764, 20211219953, 20211220916, 20211220948, 20211219714, 20211219701, 20211219871, 20211219686, 20211219681, 20211219926 and 20211219731.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: Clots in her lung and legs; Arm sore; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Clots in her lung and legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In February 2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 13-Mar-2021, the patient experienced THROMBOSIS (Clots in her lung and legs) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) at a dose of 5 mg twice a day. At the time of the report, THROMBOSIS (Clots in her lung and legs) outcome was unknown and PAIN IN EXTREMITY (Arm sore) had resolved.            No concomitant medications were provided.  On 13-Mar-2021 the patient was in hospital with clots in her lung and legs. The patient also mentioned that other people had clots.  Company comment This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of thrombosis and a non-serious event. The event thrombosis (AESI) occurred approximately 1 month and 14 days after the second dose of mRNA-1273. The rechallenge is not applicable because the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of thrombosis and a non-serious event. The event thrombosis (AESI) occurred approximately 1 month and 14 days after the second dose of mRNA-1273. The rechallenge is not applicable because the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: M
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 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, IRBESARTAN and ATORVASTATIN for an unknown indication.    On 18-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 PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of couple of motrin. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-405832, MOD-2021-405834 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: hard to sleep; if she moved her arm the soreness came out; She felt achy; a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard to sleep), PAIN IN EXTREMITY (if she moved her arm the soreness came out), MYALGIA (She felt achy) and VACCINATION SITE PAIN (a little soreness at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INSOMNIA (hard to sleep), PAIN IN EXTREMITY (if she moved her arm the soreness came out), MYALGIA (She felt achy) and VACCINATION SITE PAIN (a little soreness at the injection site). At the time of the report, INSOMNIA (hard to sleep), PAIN IN EXTREMITY (if she moved her arm the soreness came out), MYALGIA (She felt achy) and VACCINATION SITE PAIN (a little soreness at the injection site) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-406400, MOD-2021-406409 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Off label use
Clinical narrative: Non immunocompromised received third full shot; Non immunocompromised received third full shot; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Non immunocompromised received third full shot) and ACCIDENTAL OVERDOSE (Non immunocompromised received third full shot) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0462B21A, 429L21A and 007M20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN, SPIRONOLACTONE, ESCITALOPRAM, LOSARTAN, TRAVOPROST, ZONISAMIDE and LEVOTHYROXINE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced OFF LABEL USE (Non immunocompromised received third full shot) and ACCIDENTAL OVERDOSE (Non immunocompromised received third full shot). On 30-Aug-2021, OFF LABEL USE (Non immunocompromised received third full shot) and ACCIDENTAL OVERDOSE (Non immunocompromised received third full shot) had resolved.            Patient's weight was provided as 235 with unspecified units.  Concomitant products included femorol.  No treatment medication was reported.   This case was linked to MOD-2021-406561.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of tinnitus in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced tinnitus. At the time of the report, tinnitus outcome: unknown. No concomitant medications or treatment information reported. The patient developed mild tinnitus after getting the second shot.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: punctured vial more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (punctured vial more than 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) 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 EXTRA DOSE ADMINISTERED (punctured vial more than 20 times). At the time of the report, EXTRA DOSE ADMINISTERED (punctured vial more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The doctor's assistant stated that They have been administering Moderna COVID19 Vaccine, but the pharmacist has been puncturing the vials more than 20 times. They want to talk about what to do about those folks who received those extra doses. There were four extra punctures yesterday 07Dec2021 with lot number 032F21A. There were three extra punctures on 03Dec2021 with lot number 032F21A. There were five extra punctures on 19Nov2021 with lot number 032F21A. They don't know which patients received the extra doses on those dates. There is a total of 72 patients who were vaccinated with doses that were drawn more than 20 times on those three dates.  No concomitant medications were reported No treatment medications were reported
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: Body aches after first dose; Body Malaise after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches after first dose) and MALAISE (Body Malaise after first dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0141720A, 006B21A and 012F21A) 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) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (Body aches after first dose) and MALAISE (Body Malaise after first dose). At the time of the report, PAIN (Body aches after first dose) and MALAISE (Body Malaise after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications were reported. No Treatment mediations were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm, Electrocardiogram, Magnetic resonance imaging, Pain, Pulmonary function test
Clinical narrative: Aorta aneurysm/ Chest pain/ Feels chest muscle being pulled; Could walk around feel pain; This spontaneous case was reported by a consumer and describes the occurrence of AORTIC ANEURYSM (Aorta aneurysm/ Chest pain/ Feels chest muscle being pulled) and PAIN (Could walk around feel pain) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 013L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced AORTIC ANEURYSM (Aorta aneurysm/ Chest pain/ Feels chest muscle being pulled) and PAIN (Could walk around feel pain). At the time of the report, AORTIC ANEURYSM (Aorta aneurysm/ Chest pain/ Feels chest muscle being pulled) and PAIN (Could walk around feel pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: normal (normal) Normal. In 2021, Magnetic resonance imaging: abnormal (abnormal) Aorta aneurysm was detected. In 2021, Pulmonary function test: normal (normal) Lungs were normal too.         No relevant concomitant medications were reported. No treatment information was provided.  Patient had chest pain. Patient visited physician and series of test have been conducted such MRI, aorta aneurysm was detected. EKG was normal and lungs were normal too. Patient walk around feel pain sometimes in chest like chest muscles being pulled away. Patient was doing physician follow-up in Feb-2022.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Vomiting
Clinical narrative: Pain in the stomach; Vomiting; Chills after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in the stomach), VOMITING (Vomiting) and CHILLS (Chills after vaccine ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in the stomach), VOMITING (Vomiting) and CHILLS (Chills after vaccine ). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Pain in the stomach), VOMITING (Vomiting) and CHILLS (Chills after vaccine ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was under no concomitant medication
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Insomnia, Pain in extremity
Clinical narrative: pain on arms; pain on lower back; cannot sleep; joint pain/pain on knees/pain on both shoulders; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on arms), BACK PAIN (pain on lower back), INSOMNIA (cannot sleep) and ARTHRALGIA (joint pain/pain on knees/pain on both shoulders) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046Z1A and 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Surgery (she had knee surgery in March and took Diclofenac at that time) in March 2021. Concomitant products included ATORVASTATIN and CARVEDILOL for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PAIN IN EXTREMITY (pain on arms), BACK PAIN (pain on lower back), INSOMNIA (cannot sleep) and ARTHRALGIA (joint pain/pain on knees/pain on both shoulders). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and DICLOFENAC for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain on arms) and BACK PAIN (pain on lower back) was resolving, INSOMNIA (cannot sleep) outcome was unknown and ARTHRALGIA (joint pain/pain on knees/pain on both shoulders) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She stated she has been living with joint pain ever since second dose. She reports that she was otherwise healthy before the dose. She reports that the joint pain was not as severe and was 4-5 days a week in the beginning but is now all the time. She reported, I look like I'm 90 when I wake up in the morning instead of 64.' She mentioned she will not get the booster.   This case was linked to MOD-2021-406548 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Feeling cold, Headache
Clinical narrative: Her heart rate went to 120 or 130 for about 24 hours; Chest pain/Chest achiness; Chest discomfort; What feels like a cool breeze internally in her chest; chills; nausea; headache; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Her heart rate went to 120 or 130 for about 24 hours), CHEST PAIN (Chest pain/Chest achiness), CHEST DISCOMFORT (Chest discomfort), FEELING COLD (What feels like a cool breeze internally in her chest) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's thyroiditis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-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 HEART RATE INCREASED (Her heart rate went to 120 or 130 for about 24 hours), CHEST PAIN (Chest pain/Chest achiness), CHEST DISCOMFORT (Chest discomfort), FEELING COLD (What feels like a cool breeze internally in her chest), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HEART RATE INCREASED (Her heart rate went to 120 or 130 for about 24 hours) had resolved, CHEST PAIN (Chest pain/Chest achiness), CHEST DISCOMFORT (Chest discomfort) and FEELING COLD (What feels like a cool breeze internally in her chest) had not resolved and CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Heart rate: 120 to 130 (High) Heart rate went to 120 to 130 for about 24 hours..     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. The heart rate and rhythm were normal afterwards. The patient also informed that on 13-Dec-2019 after being on vacation, the patient ended up in the hospital with flu like symptoms, pneumonia, thyroid toxicosis, & an elevated heart rate of 100 to 120.   This case was linked to MOD-2021-406603, MOD-2021-406622, MOD-2021-406763 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nausea
Clinical narrative: Her heart rate went to 120 or 130 for about 24 hours; Chest pain/Chest achiness; Chest discomfort; What feels like a cool breeze internally in her chest; chills; nausea; headache; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Her heart rate went to 120 or 130 for about 24 hours), CHEST PAIN (Chest pain/Chest achiness), CHEST DISCOMFORT (Chest discomfort), FEELING COLD (What feels like a cool breeze internally in her chest) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's thyroiditis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-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 HEART RATE INCREASED (Her heart rate went to 120 or 130 for about 24 hours), CHEST PAIN (Chest pain/Chest achiness), CHEST DISCOMFORT (Chest discomfort), FEELING COLD (What feels like a cool breeze internally in her chest), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HEART RATE INCREASED (Her heart rate went to 120 or 130 for about 24 hours) had resolved, CHEST PAIN (Chest pain/Chest achiness), CHEST DISCOMFORT (Chest discomfort) and FEELING COLD (What feels like a cool breeze internally in her chest) had not resolved and CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Heart rate: 120 to 130 (High) Heart rate went to 120 to 130 for about 24 hours..     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. The heart rate and rhythm were normal afterwards. The patient also informed that on 13-Dec-2019 after being on vacation, the patient ended up in the hospital with flu like symptoms, pneumonia, thyroid toxicosis, & an elevated heart rate of 100 to 120.   This case was linked to MOD-2021-406603, MOD-2021-406622, MOD-2021-406763 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: feverish; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish) and CHILLS (chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (patient did have high blood pressure a year a go from licorice tea) since 2020.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 PYREXIA (feverish) and CHILLS (chills). At the time of the report, PYREXIA (feverish) and CHILLS (chills) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-406572, MOD-2021-406578 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Ear discomfort, Feeling abnormal, Gastrointestinal pain
Clinical narrative: felt like everything was inflamed; guts hurt; chest kind of felt weird but not too alarming; ear clogged/ear felt like there is pressure behind it; felt like if holding nose and blowing; joints hurt; 101.6 fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like everything was inflamed), GASTROINTESTINAL PAIN (guts hurt), CHEST DISCOMFORT (chest kind of felt weird but not too alarming), EAR DISCOMFORT (ear clogged/ear felt like there is pressure behind it) and NASAL DISCOMFORT (felt like if holding nose and blowing) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 038A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high.On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 23-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 FEELING ABNORMAL (felt like everything was inflamed), GASTROINTESTINAL PAIN (guts hurt), CHEST DISCOMFORT (chest kind of felt weird but not too alarming), EAR DISCOMFORT (ear clogged/ear felt like there is pressure behind it), NASAL DISCOMFORT (felt like if holding nose and blowing), ARTHRALGIA (joints hurt) and PYREXIA (101.6 fever). At the time of the report, FEELING ABNORMAL (felt like everything was inflamed), GASTROINTESTINAL PAIN (guts hurt), CHEST DISCOMFORT (chest kind of felt weird but not too alarming), EAR DISCOMFORT (ear clogged/ear felt like there is pressure behind it), NASAL DISCOMFORT (felt like if holding nose and blowing), ARTHRALGIA (joints hurt) and PYREXIA (101.6 fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Heart rate increased: high (High) resting heart rate was high like 85 after sitting when normally it's 60.Concomitant medications were not reported. Patient checked blood pressure today and noticed resting heart rate was high like 85 after sitting when normally it's 60. He was not taking any medication after experiencing any of the symptoms. He had never tested positive for Covid. He had no medical history of heart issues but had high blood pressure a year a go from licorice tea.This case was linked to MOD-2021-406577, MOD-2021-406572 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Nasal discomfort, Pyrexia
Clinical narrative: felt like everything was inflamed; guts hurt; chest kind of felt weird but not too alarming; ear clogged/ear felt like there is pressure behind it; felt like if holding nose and blowing; joints hurt; 101.6 fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like everything was inflamed), GASTROINTESTINAL PAIN (guts hurt), CHEST DISCOMFORT (chest kind of felt weird but not too alarming), EAR DISCOMFORT (ear clogged/ear felt like there is pressure behind it) and NASAL DISCOMFORT (felt like if holding nose and blowing) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 038A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high.On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 23-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 FEELING ABNORMAL (felt like everything was inflamed), GASTROINTESTINAL PAIN (guts hurt), CHEST DISCOMFORT (chest kind of felt weird but not too alarming), EAR DISCOMFORT (ear clogged/ear felt like there is pressure behind it), NASAL DISCOMFORT (felt like if holding nose and blowing), ARTHRALGIA (joints hurt) and PYREXIA (101.6 fever). At the time of the report, FEELING ABNORMAL (felt like everything was inflamed), GASTROINTESTINAL PAIN (guts hurt), CHEST DISCOMFORT (chest kind of felt weird but not too alarming), EAR DISCOMFORT (ear clogged/ear felt like there is pressure behind it), NASAL DISCOMFORT (felt like if holding nose and blowing), ARTHRALGIA (joints hurt) and PYREXIA (101.6 fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Heart rate increased: high (High) resting heart rate was high like 85 after sitting when normally it's 60.Concomitant medications were not reported. Patient checked blood pressure today and noticed resting heart rate was high like 85 after sitting when normally it's 60. He was not taking any medication after experiencing any of the symptoms. He had never tested positive for Covid. He had no medical history of heart issues but had high blood pressure a year a go from licorice tea.This case was linked to MOD-2021-406577, MOD-2021-406572 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient who received 0.25mL instead of 3rd 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient who received 0.25mL instead of 3rd 0.5mL dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 13-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient who received 0.25mL instead of 3rd 0.5mL dose). On 13-Nov-2021, ACCIDENTAL UNDERDOSE (Immunocompromised patient who received 0.25mL instead of 3rd 0.5mL dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Contusion, Eye contusion, Eye swelling, Swelling face
Clinical narrative: bruising on abdomen; bump above left eyebrow; left eye was completely black and swollen shut, closed over like angioedema; left eye was completely black and swollen shut, closed over like angioedema; This spontaneous case was reported by a pharmacist and describes the occurrence of EYE CONTUSION (left eye was completely black and swollen shut, closed over like angioedema), SWELLING FACE (bump above left eyebrow), CONTUSION (bruising on abdomen) and EYE SWELLING (left eye was completely black and swollen shut, closed over like angioedema) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for an unknown indication.    No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced EYE CONTUSION (left eye was completely black and swollen shut, closed over like angioedema) and EYE SWELLING (left eye was completely black and swollen shut, closed over like angioedema). On 20-Nov-2021 at 2:00 AM, the patient experienced SWELLING FACE (bump above left eyebrow). On an unknown date, the patient experienced CONTUSION (bruising on abdomen). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE CONTUSION (left eye was completely black and swollen shut, closed over like angioedema), SWELLING FACE (bump above left eyebrow), CONTUSION (bruising on abdomen) and EYE SWELLING (left eye was completely black and swollen shut, closed over like angioedema) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient saw PCP doctor who ruled out angioedema. Gets monoclonal antibodies and suspects clotting or bleeding issue for bruising of abdomen. Patient was instructed to do cold compress and Tylenol. Patient was told this is impact injury.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) 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 VACCINATION COMPLICATION (bad reaction). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Alternative email.  2 vials that were first punctured on 30-Nov-2021 and put on the refrigerator since then.  Concomitant medications were not provided.  Treatment information was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: He immediately developed a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 22Feb2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 22Feb2021, outcome "not recovered", described as "He immediately developed a headache". Additional information: The patient received the vaccine 10 days ago. It has been 10 days and he still has not gotten rid of the headache. The patient wants to know what he should do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in left arm, administration date 03Mar2021 at 17:30 (Lot number: EL3248) at the age of 44 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; VITAMIN D [COLECALCIFEROL]; METAMUCIL REGULAR; FISH OIL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "Arm is sore". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pharyngitis
Clinical narrative: throat infection; sore throat; a bit of soreness of the arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Information Team for a Pfizer sponsored program. The reporter is the patient. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergies" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PHARYNGITIS (non-serious), outcome "unknown", described as "throat infection"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a bit of soreness of the arm". Therapeutic measures were taken as a result of pharyngitis. Additional information: Treatment for pharyngitis included antibiotics prescribed 4 months ago but were never used. The patient will continue taking the antibiotics until 06Mar2021, for a 7 day period, twice a day (as reported). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red place that was moving down her arm from where she got the shot; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the arm, administration date 26Feb2021 (Lot number: EN6198) at the age of 82 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Lot Number: EL9269), administration date: Feb2021, for COVID-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 27Feb2021, outcome "not recovered", described as "red place that was moving down her arm from where she got the shot".  Additional information: The patient also described the event as big red blotch that was 2 inches down from where she got the shot. This second shot was on 26Feb2021 and she noticed the red spot almost immediately, she would say the next morning and it seemed to be getting bigger. She confirmed it was ongoing and has worsened. She clarified the spot was 2 inches down from the needle injection site so the reddened area was not directly over the injection site it was 2 inches down from that. The red area was probably over an inch wide.   No follow-up attempts are possible. No further information is expected.