chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Grip strength decreased, Headache, Influenza like illness, Musculoskeletal pain
Clinical narrative: Around 12:30 am on 10/24/21 I started to have very bad chills and pain in my entire left arm. Especially the joints. I started experiencing body aches as well. Around 1:30 am on 10/24/21, I started having severe chest pain. There was a stabbing sensation going in through my heart out to my shoulder blade. The pain radiated from my heart into my left collar bone, armpit, shoulder and jaw. There was a loss of grip strength in my left hand and I had a very bad headache. Around 5:30am I got very nauseous and started to vomit. Around 8:00 am I noticed swelling in my left armpit. The flu like symptoms only lasted 24 hours, but the chest pain continued. I went to ED on 10/26/21 and they said it was muscular. I went to Cardiologist on 11/1 and they said the vaccine most likely triggered my pericarditis.  I did also receive my flu vaccine on 10/23/21 (in right arm). I did not add it because I did not know which one it was.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Around 12:30 am on 10/24/21 I started to have very bad chills and pain in my entire left arm. Especially the joints. I started experiencing body aches as well. Around 1:30 am on 10/24/21, I started having severe chest pain. There was a stabbing sensation going in through my heart out to my shoulder blade. The pain radiated from my heart into my left collar bone, armpit, shoulder and jaw. There was a loss of grip strength in my left hand and I had a very bad headache. Around 5:30am I got very nauseous and started to vomit. Around 8:00 am I noticed swelling in my left armpit. The flu like symptoms only lasted 24 hours, but the chest pain continued. I went to ED on 10/26/21 and they said it was muscular. I went to Cardiologist on 11/1 and they said the vaccine most likely triggered my pericarditis.  I did also receive my flu vaccine on 10/23/21 (in right arm). I did not add it because I did not know which one it was.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Submaxillary gland enlargement, Vomiting, X-ray normal
Clinical narrative: Around 12:30 am on 10/24/21 I started to have very bad chills and pain in my entire left arm. Especially the joints. I started experiencing body aches as well. Around 1:30 am on 10/24/21, I started having severe chest pain. There was a stabbing sensation going in through my heart out to my shoulder blade. The pain radiated from my heart into my left collar bone, armpit, shoulder and jaw. There was a loss of grip strength in my left hand and I had a very bad headache. Around 5:30am I got very nauseous and started to vomit. Around 8:00 am I noticed swelling in my left armpit. The flu like symptoms only lasted 24 hours, but the chest pain continued. I went to ED on 10/26/21 and they said it was muscular. I went to Cardiologist on 11/1 and they said the vaccine most likely triggered my pericarditis.  I did also receive my flu vaccine on 10/23/21 (in right arm). I did not add it because I did not know which one it was.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dyspnoea, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: Headache, shortness of breath, face swelling, body hives,  upper torso - neck, shoulder,  arm and shoulder blade pain.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Swelling face, Urticaria
Clinical narrative: Headache, shortness of breath, face swelling, body hives,  upper torso - neck, shoulder,  arm and shoulder blade pain.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: 19 hrs later chills, fatigue, fever. 26 hours after sever pain under left arm and left side of breast.  Arm sore lymph?s feel swollen. Continuing into 48 hrs now
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 19 hrs later chills, fatigue, fever. 26 hours after sever pain under left arm and left side of breast.  Arm sore lymph?s feel swollen. Continuing into 48 hrs now
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The nurse is reporting that a patinet received improperly stored VARIVAX; No additional AE were reported; This spontaneous report was received from a Licensed Practical Nurse and refers to a 10-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On and unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (route of administration was not reported), lot #  U016065 and expiration date 20-MAY-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 0.3 degree celsius (°C) for 2 hours and 34 minutes on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.  This is one of several reports received from the same reporter.  As of 29-OCT-2021, all telephone attempts trying to obtain additional information has been unsuccessful. No further information is available.; Sender's Comments:  US-009507513-2110CHN006820: US-009507513-2110USA006418: US-009507513-2110USA006855:
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Eye injury
Clinical narrative: damage to her right eye and loss of vision; damage to her right eye and loss of vision; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered damage to her right eye and loss of vision. As a result of these symptoms, she was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. She also had incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was related.   Upon internal review, loss of vision was determined to be medically significant. The events of damage to her right eye and loss of vision were assessed as disabled.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Pain in extremity
Clinical narrative: A BIT OF AN UPSET STOMACH; SORE ARM; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a bit of an upset stomach, sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, a bit of an upset stomach and headache was not reported. This report was non-serious.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination complication
Clinical narrative: The pain travels throughout the body/the pain is still with me; Wants to speak a specialist about the Moderna covid19 vaccine that he received, and his medical status after the shots.3 days after 2nd dose i been having severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The pain travels throughout the body/the pain is still with me), VACCINATION COMPLICATION (Wants to speak a specialist about the Moderna covid19 vaccine that he received, and his medical status after the shots.) and HEADACHE (3 days after 2nd dose i been having severe headaches) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (The pain travels throughout the body/the pain is still with me), VACCINATION COMPLICATION (Wants to speak a specialist about the Moderna covid19 vaccine that he received, and his medical status after the shots.) and HEADACHE (3 days after 2nd dose i been having severe headaches). At the time of the report, PAIN (The pain travels throughout the body/the pain is still with me) had not resolved and VACCINATION COMPLICATION (Wants to speak a specialist about the Moderna covid19 vaccine that he received, and his medical status after the shots.) and HEADACHE (3 days after 2nd dose i been having severe headaches) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Significant Follow Up Appended; Reporter's Email; Patient age added; Events Added;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: booster given 5 months after 2nd Moderna dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given 5 months after 2nd Moderna dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 31-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given 5 months after 2nd Moderna dose). On 31-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given 5 months after 2nd Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Patient received half booster dose.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20a and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle fatigue, Myalgia, Pain
Clinical narrative: Achiness worsened; Muscles are fatigue; Soreness in her whole body,body was achy,muscles are in pain,muscles are with soreness; Headache worsened; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness worsened), MUSCLE FATIGUE (Muscles are fatigue), MYALGIA (Soreness in her whole body,body was achy,muscles are in pain,muscles are with soreness) and HEADACHE (Headache worsened) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 PAIN (Achiness worsened), MUSCLE FATIGUE (Muscles are fatigue), MYALGIA (Soreness in her whole body,body was achy,muscles are in pain,muscles are with soreness) and HEADACHE (Headache worsened). At the time of the report, PAIN (Achiness worsened), MUSCLE FATIGUE (Muscles are fatigue) and MYALGIA (Soreness in her whole body,body was achy,muscles are in pain,muscles are with soreness) had not resolved and HEADACHE (Headache worsened) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-370173 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Loss of personal independence in daily activities, Muscle fatigue, Muscular weakness
Clinical narrative: After the booster she was down for 4 days; It feels like she has covid since April; muscle weakness; changed her livelihood,it is very hard to live every day; pain; muscle fatigue; Body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (After the booster she was down for 4 days), FEELING ABNORMAL (It feels like she has covid since April), MUSCULAR WEAKNESS (muscle weakness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (changed her livelihood,it is very hard to live every day) and PAIN (pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 002B21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (After the booster she was down for 4 days), FEELING ABNORMAL (It feels like she has covid since April), MUSCULAR WEAKNESS (muscle weakness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (changed her livelihood,it is very hard to live every day), PAIN (pain), MUSCLE FATIGUE (muscle fatigue), MYALGIA (Body ache) and PYREXIA (fever). The patient was treated with IBUPROFEN at a dose of 400 mg. At the time of the report, ASTHENIA (After the booster she was down for 4 days), FEELING ABNORMAL (It feels like she has covid since April), MUSCULAR WEAKNESS (muscle weakness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (changed her livelihood,it is very hard to live every day), PAIN (pain), MUSCLE FATIGUE (muscle fatigue), MYALGIA (Body ache) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.             Treatment medication include Pain medicine.   This case was linked to MOD-2021-370162 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: After the booster she was down for 4 days; It feels like she has covid since April; muscle weakness; changed her livelihood,it is very hard to live every day; pain; muscle fatigue; Body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (After the booster she was down for 4 days), FEELING ABNORMAL (It feels like she has covid since April), MUSCULAR WEAKNESS (muscle weakness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (changed her livelihood,it is very hard to live every day) and PAIN (pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 002B21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (After the booster she was down for 4 days), FEELING ABNORMAL (It feels like she has covid since April), MUSCULAR WEAKNESS (muscle weakness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (changed her livelihood,it is very hard to live every day), PAIN (pain), MUSCLE FATIGUE (muscle fatigue), MYALGIA (Body ache) and PYREXIA (fever). The patient was treated with IBUPROFEN at a dose of 400 mg. At the time of the report, ASTHENIA (After the booster she was down for 4 days), FEELING ABNORMAL (It feels like she has covid since April), MUSCULAR WEAKNESS (muscle weakness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (changed her livelihood,it is very hard to live every day), PAIN (pain), MUSCLE FATIGUE (muscle fatigue), MYALGIA (Body ache) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.             Treatment medication include Pain medicine.   This case was linked to MOD-2021-370162 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache over the weekend; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache over the weekend) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced HEADACHE (Headache over the weekend). At the time of the report, HEADACHE (Headache over the weekend) outcome was unknown. Not Provided          No concomitant medication information provided by the reporter. No treatment information provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Right hand tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Right hand tingling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20Q) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PARAESTHESIA (Right hand tingling). On 26-Jan-2021, PARAESTHESIA (Right hand tingling) had resolved.        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 concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-370489, MOD-2021-374893 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 1 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (1 degree fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included AFib (2yrs ago.) in 2019. Concurrent medical conditions included Cancer (Has no lymph nodes in right arm due to having cancer.). Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM and LEVOTHYROXINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (1 degree fever). At the time of the report, PYREXIA (1 degree fever) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-370407, MOD-2021-370846 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 009C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 20 days between 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days between 1st and 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Contrast media allergy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days between 1st and 2nd dose). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days between 1st and 2nd dose) had resolved.      Patient was not taking any daily medication but used to take tummy medicine but stopped it.   This case was linked to MOD-2021-370468 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Nausea
Clinical narrative: pretty sick from the last vaccine; felt kind of queasy after the first dose; like having a bad case of the flu for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like having a bad case of the flu for 24 hours), ILLNESS (pretty sick from the last vaccine) and NAUSEA (felt kind of queasy after the first dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 089A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 INFLUENZA LIKE ILLNESS (like having a bad case of the flu for 24 hours), ILLNESS (pretty sick from the last vaccine) and NAUSEA (felt kind of queasy after the first dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (like having a bad case of the flu for 24 hours) had resolved and ILLNESS (pretty sick from the last vaccine) and NAUSEA (felt kind of queasy after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-370441 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction after the second shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (Reaction after the second shot). At the time of the report, VACCINATION COMPLICATION (Reaction after the second shot) had resolved.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-370480 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I got the 1st dose of the Moderna Covid-19 vaccine. I was tired.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I got the 1st dose of the Moderna Covid-19 vaccine. I was tired.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (I got the 1st dose of the Moderna Covid-19 vaccine. I was tired.). At the time of the report, FATIGUE (I got the 1st dose of the Moderna Covid-19 vaccine. I was tired.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details was not reported by the reporter.   This case was linked to MOD-2021-370421 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Illness, Inappropriate schedule of product administration, Myalgia
Clinical narrative: felt sick; arm bruises; not being able to feel; neck pain; neck swollen on the side where she got the vaccine; lungs hurt; muscle pain; severe headaches; not receiving 2nd dose on proper time; blood clots on the arm; arm swollen 1-2 weeks after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots on the arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021c21a and 001c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced THROMBOSIS (blood clots on the arm) (seriousness criterion medically significant). In October 2021, the patient experienced PERIPHERAL SWELLING (arm swollen 1-2 weeks after the 2nd dose). On an unknown date, the patient experienced ILLNESS (felt sick), CONTUSION (arm bruises), SENSORY LOSS (not being able to feel), NECK PAIN (neck pain), SWELLING (neck swollen on the side where she got the vaccine), PULMONARY PAIN (lungs hurt), MYALGIA (muscle pain), HEADACHE (severe headaches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and METHYLPREDNISOLONE for Muscle pain, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clots on the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time) outcome was unknown and ILLNESS (felt sick), CONTUSION (arm bruises), SENSORY LOSS (not being able to feel), NECK PAIN (neck pain), SWELLING (neck swollen on the side where she got the vaccine), PULMONARY PAIN (lungs hurt), PERIPHERAL SWELLING (arm swollen 1-2 weeks after the 2nd dose), MYALGIA (muscle pain) and HEADACHE (severe headaches) had not resolved.            No concomitant medication details were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Peripheral swelling, Pulmonary pain, Sensory loss, Swelling
Clinical narrative: felt sick; arm bruises; not being able to feel; neck pain; neck swollen on the side where she got the vaccine; lungs hurt; muscle pain; severe headaches; not receiving 2nd dose on proper time; blood clots on the arm; arm swollen 1-2 weeks after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots on the arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021c21a and 001c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced THROMBOSIS (blood clots on the arm) (seriousness criterion medically significant). In October 2021, the patient experienced PERIPHERAL SWELLING (arm swollen 1-2 weeks after the 2nd dose). On an unknown date, the patient experienced ILLNESS (felt sick), CONTUSION (arm bruises), SENSORY LOSS (not being able to feel), NECK PAIN (neck pain), SWELLING (neck swollen on the side where she got the vaccine), PULMONARY PAIN (lungs hurt), MYALGIA (muscle pain), HEADACHE (severe headaches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and METHYLPREDNISOLONE for Muscle pain, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clots on the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time) outcome was unknown and ILLNESS (felt sick), CONTUSION (arm bruises), SENSORY LOSS (not being able to feel), NECK PAIN (neck pain), SWELLING (neck swollen on the side where she got the vaccine), PULMONARY PAIN (lungs hurt), PERIPHERAL SWELLING (arm swollen 1-2 weeks after the 2nd dose), MYALGIA (muscle pain) and HEADACHE (severe headaches) had not resolved.            No concomitant medication details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 13 patients.; 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 13 patients.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 13 patients.). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 13 patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-372320 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Non-significant follow up
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue
Clinical narrative: Feels a  little bit woozy; Lingering fatigue; Occasional chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feels a  little bit woozy), FATIGUE (Lingering fatigue) and CHILLS (Occasional chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21(B or 6), 037K20A and 023M20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included SERTRALINE for Anxiety, AMLODIPINE for Blood pressure, ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Hypothyroidism, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Feels a  little bit woozy), FATIGUE (Lingering fatigue) and CHILLS (Occasional chills). The patient was treated with NAPROXEN SODIUM for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Feels a  little bit woozy), FATIGUE (Lingering fatigue) and CHILLS (Occasional chills) outcome was unknown.            This case was linked to MOD-2021-371333 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-glomerular basement membrane disease
Clinical narrative: Anti-GBM disease; This literature-non-study case was reported in a literature article and describes the occurrence of ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM disease) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:     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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM disease) (seriousness criterion medically significant). The patient was treated with CYCLOPHOSPHAMIDE for Anti-GBM disease, at an unspecified dose and frequency. At the time of the report, ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM disease) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM disease) to be possibly related.    Concomitant product use was not provided by the reporter.   Treatment information was not provided. Patient was also treated with Steroids and plasma exchange.  This is a literature case concerning a 60-year-old, female patient with no relevant history, who experienced the unexpected serious event of  ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM). The event occurred approximately 1 to 14 days after the administration of  a dose of mRNA-1273 Moderna vaccine ( doen´t clarify if it was 1st or 2nd dose). The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-371390, MOD-2021-371390 (Patient Link).; Sender's Comments: This is a literature case concerning a 60-year-old, female patient with no relevant history, who experienced the unexpected serious event of  ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM). The event occurred approximately 1 to 14 days after the administration of  a dose of mRNA-1273 Moderna vaccine ( doen´t clarify if it was 1st or 2nd dose). The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: flu like symptoms; chills; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 023M20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE for Anxiety, ATORVASTATIN for Cholesterol, AMLODIPINE for Hypertension, LEVOTHYROXINE for Hypothyroidism, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) had resolved.            No Treatment details after second dose were reported.   This case was linked to MOD-2021-371290 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: 2 hours after the dose today she noticed a bruise at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (2 hours after the dose today she noticed a bruise at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE in October 2021.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced INJECTION SITE BRUISING (2 hours after the dose today she noticed a bruise at the injection site). At the time of the report, INJECTION SITE BRUISING (2 hours after the dose today she noticed a bruise at the injection site) outcome was unknown.            Patient experienced Bruise with flu shot taken a couple of weeks ago and patient also stated she had not taken any treatments.  No concomitant medications were reported.   This case was linked to MOD-2021-372938 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess, Computerised tomogram abnormal, Culture, Dysphagia, Epiglottitis
Clinical narrative: Pt had a fever the night of the vaccine. Woke up with a swollen throat, unable to swallow saliva. Found to have a left palatine tonsil abscess, an epiglottal abscess and epiglottitis.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Peritonsillar abscess, Pharyngeal swelling, Pyrexia, White blood cell count normal
Clinical narrative: Pt had a fever the night of the vaccine. Woke up with a swollen throat, unable to swallow saliva. Found to have a left palatine tonsil abscess, an epiglottal abscess and epiglottitis.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Hypertension, Myocarditis
Clinical narrative: High Blood Pressure & high vitals. Dizziness. Fatigue. Diagnosis was Myocarditis. Treatment is a Beta Blocker. And only mild exercise for at least 6 months.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Epiglottitis, Oropharyngeal pain
Clinical narrative: Pt developed a sore throat and then epiglottis, no signs of an abscess.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Mild aches and pains throughout body and joints for approximately 9 hours.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Elevated heart rate for 6 hours
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: Fever,body aches, headaches, stomach ache, chills, nausea.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever,body aches, headaches, stomach ache, chills, nausea.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: redness (baseball diameter), warm, hard lump, sometimes itchy on upper right arm after Moderna booster.Zyrtec taken nightly for allergies.  still active for +4 days
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored ROTATEQ was administered; This spontaneous report was received from a medical assistant, referring to a 6-month-old patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 20-AUG-2021, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1691141, expiration date 01-NOV-2021; strength and dose detail were not reported) orally for prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 12.1 degrees Celsius for 1 hour. There was no previous temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's husband had a terrible case of shingles, still had pain 21 months later). Previously administered products included shingles vaccine with an associated reaction of pain in extremity (received first dose on an unknown date and experienced sore arm, refer case US2021AMR226597). Concurrent medical conditions included fibromyalgia.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the second shingle shot with no side effects except a sore arm.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226600:Same reporter US-GLAXOSMITHKLINE-US2021AMR226597:Same reporter