chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Peripheral swelling
Clinical narrative: and little feeling when shot was given; numbing kind of feeling; swelling in right hand; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (and little feeling when shot was given), HYPOAESTHESIA (numbing kind of feeling) and PERIPHERAL SWELLING (swelling in right hand) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J covid-19 vaccine (1st dose and Lot number 1808609.) on 26-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J covid-19 vaccine.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (and little feeling when shot was given), HYPOAESTHESIA (numbing kind of feeling) and PERIPHERAL SWELLING (swelling in right hand). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of Unknown. At the time of the report, FEELING ABNORMAL (and little feeling when shot was given) and HYPOAESTHESIA (numbing kind of feeling) outcome was unknown and PERIPHERAL SWELLING (swelling in right hand) was resolving.            No concomitant medication information was provided.  Reporter states that swelling was on hand and not near injection site.   24 hours after getting the moderna booster, patient noticed swelling in right hand, numbing kind of feeling, and little feeling when shot was given. when shot was given.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore arm; A little bit of headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (A little bit of headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (A little bit of headache). At the time of the report, VACCINATION SITE PAIN (Sore arm) and HEADACHE (A little bit of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient stated that after receiving the 1st dose of the Moderna COVID 19 vaccine they had sore arm and a little bit of headache.   This case was linked to MOD-2021-395798 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness
Clinical narrative: Atrial fibrillation; Lightheadedness/Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (6 years ago).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced DIZZINESS (Lightheadedness/Dizziness). On 22-Oct-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and DIZZINESS (Lightheadedness/Dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Treatment was not reported. The Concomitant medication was not reported. Patient mentioned she had a stent placed in her heart 6 years ago and sees her doctor on a regular basis.  Company Comment: This case concerns a 63 year-old, female patient with a history of Stent placement, who experienced the serious unexpected AESI of Atrial fibrillation. The event occurred approximately 7 months 3 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The medical history, of Stent placement remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow up report contains Reporter information ,Patient demographics ,dosage information and new events of atrial fibrillation , palpitation and dizziness  are added and case upgraded to serious .; Sender's Comments: This case concerns a 63 year-old, female patient with a history of Stent placement, who experienced the serious unexpected AESI of Atrial fibrillation. The event occurred approximately 7 months 3 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The medical history, of Stent placement remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Illness, Pyrexia, Vaccination complication
Clinical narrative: Regular side effects; Severe chills; Slight fever; Sick for one day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for one day), VACCINATION COMPLICATION (Regular side effects), CHILLS (Severe chills) and PYREXIA (Slight fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic (it is well maintained, she is not on any medications), Legal blindness, as defined and Constipation (trouble going to the bathroom).Concomitant products included SENNOSIDE A+B (SENOKOT) for Constipation, CYCLOPENTOLATE HYDROCHLORIDE (CYCLOGEL) for Legal blindness, as defined. On 26-Feb-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 ILLNESS (Sick for one day), VACCINATION COMPLICATION (Regular side effects), CHILLS (Severe chills) and PYREXIA (Slight fever). At the time of the report, ILLNESS (Sick for one day) had resolved and VACCINATION COMPLICATION (Regular side effects), CHILLS (Severe chills) and PYREXIA (Slight fever) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.This case was linked to MOD-2021-396251, MOD-2021-396265 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pruritus, Rash, Vaccination site rash
Clinical narrative: Regular side effects; Severe chills; Slight fever; Sick for one day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for one day), VACCINATION COMPLICATION (Regular side effects), CHILLS (Severe chills) and PYREXIA (Slight fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic (it is well maintained, she is not on any medications), Legal blindness, as defined and Constipation (trouble going to the bathroom).Concomitant products included SENNOSIDE A+B (SENOKOT) for Constipation, CYCLOPENTOLATE HYDROCHLORIDE (CYCLOGEL) for Legal blindness, as defined. On 26-Feb-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 ILLNESS (Sick for one day), VACCINATION COMPLICATION (Regular side effects), CHILLS (Severe chills) and PYREXIA (Slight fever). At the time of the report, ILLNESS (Sick for one day) had resolved and VACCINATION COMPLICATION (Regular side effects), CHILLS (Severe chills) and PYREXIA (Slight fever) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.This case was linked to MOD-2021-396251, MOD-2021-396265 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Illness, Pyrexia, Vaccination complication
Clinical narrative: Severe, severe, severe itching inside the body/itching starts on the top of her feet, back, all over her body/it is not topical; Rash near the site of injection and under her arm pit; Rash near the site of injection; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe, severe, severe itching inside the body/itching starts on the top of her feet, back, all over her body/it is not topical), RASH (Rash near the site of injection and under her arm pit), VACCINATION SITE RASH (Rash near the site of injection) and PYREXIA (Low grade fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 019B21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (it is well maintained and not on any medications), Legal blindness, as defined (Legally blind) and Constipation (Trouble going to the bathroom). Concomitant products included SENNOSIDE A+B (SENOKOT) for Constipation, CYCLOPENTOLATE HYDROCHLORIDE (CYCLOGEL) for Legal blindness   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 29-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 PRURITUS (Severe, severe, severe itching inside the body/itching starts on the top of her feet, back, all over her body/it is not topical), RASH (Rash near the site of injection and under her arm pit), VACCINATION SITE RASH (Rash near the site of injection) and PYREXIA (Low grade fever). The patient was treated with LORATADINE (CLARITINE) for Itching, at a dose of UNK, qd and CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (Severe, severe, severe itching inside the body/itching starts on the top of her feet, back, all over her body/it is not topical) had not resolved, RASH (Rash near the site of injection and under her arm pit) and VACCINATION SITE RASH (Rash near the site of injection) had resolved and PYREXIA (Low grade fever) outcome was unknown.            It mentioned that the patient is maintaining her diabetes well so she is not on any medication for it. She is suffering with itching all over for about 6 months. She took a lot of unspecified labs and tests for itching, she is taking Claritin every day, once the Claritin completes its 24 hour cycle itching comes back. she takes Senokot at night time and duration of rash was reported as a week/week and half.   This case was linked to MOD-2021-396251 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pruritus, Rash, Vaccination site rash
Clinical narrative: Severe, severe, severe itching inside the body/itching starts on the top of her feet, back, all over her body/it is not topical; Rash near the site of injection and under her arm pit; Rash near the site of injection; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe, severe, severe itching inside the body/itching starts on the top of her feet, back, all over her body/it is not topical), RASH (Rash near the site of injection and under her arm pit), VACCINATION SITE RASH (Rash near the site of injection) and PYREXIA (Low grade fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 019B21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (it is well maintained and not on any medications), Legal blindness, as defined (Legally blind) and Constipation (Trouble going to the bathroom). Concomitant products included SENNOSIDE A+B (SENOKOT) for Constipation, CYCLOPENTOLATE HYDROCHLORIDE (CYCLOGEL) for Legal blindness   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 29-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 PRURITUS (Severe, severe, severe itching inside the body/itching starts on the top of her feet, back, all over her body/it is not topical), RASH (Rash near the site of injection and under her arm pit), VACCINATION SITE RASH (Rash near the site of injection) and PYREXIA (Low grade fever). The patient was treated with LORATADINE (CLARITINE) for Itching, at a dose of UNK, qd and CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (Severe, severe, severe itching inside the body/itching starts on the top of her feet, back, all over her body/it is not topical) had not resolved, RASH (Rash near the site of injection and under her arm pit) and VACCINATION SITE RASH (Rash near the site of injection) had resolved and PYREXIA (Low grade fever) outcome was unknown.            It mentioned that the patient is maintaining her diabetes well so she is not on any medication for it. She is suffering with itching all over for about 6 months. She took a lot of unspecified labs and tests for itching, she is taking Claritin every day, once the Claritin completes its 24 hour cycle itching comes back. she takes Senokot at night time and duration of rash was reported as a week/week and half.   This case was linked to MOD-2021-396251 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Inappropriate schedule of product administration, Pyrexia, Swelling
Clinical narrative: Received Moderna Covid-19 vaccine as a booster dose after Novovax; Severe Swelling; cramped stomach; feverish; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Severe Swelling), ABDOMINAL PAIN UPPER (cramped stomach), PYREXIA (feverish) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine as a booster dose after Novovax) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Novavax (in a clinical trial at location) in December 2020. Past adverse reactions to the above products included No adverse event with Novavax.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced SWELLING (Severe Swelling), ABDOMINAL PAIN UPPER (cramped stomach) and PYREXIA (feverish). On 22-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine as a booster dose after Novovax). On 22-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine as a booster dose after Novovax) had resolved. At the time of the report, SWELLING (Severe Swelling), ABDOMINAL PAIN UPPER (cramped stomach) and PYREXIA (feverish) outcome was unknown.            No Concomitant Medications details were provided. No Treatment Medications details were provided. Area of severe swelling was not specified.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Influenza A) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 029L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN E [VITAMIN E NOS] for an unknown indication.   On 26-Jan-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Influenza A). At the time of the report, INFLUENZA (Influenza A) outcome was unknown.            No treatment medication was provided.  The patient would like to know when can he take his Moderna booster dose.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: flu like symptoms lasted only a day; body aches lasted only a day; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms lasted only a day) and MYALGIA (body aches lasted only a day) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006N20A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms lasted only a day) and MYALGIA (body aches lasted only a day). On 18-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms lasted only a day) and MYALGIA (body aches lasted only a day) had resolved.            Patient is taking Several medications and vitamins did not provide further details.  No treatment medication was provided by reporter.   This case was linked to MOD-2021-396401 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Dysphagia, Headache, Muscular weakness
Clinical narrative: left side of throat was not working properly; would cause lot of pain; could feel heaviness on left side of the face; no strength in the left arm; had pain in the left shoulder and left elbow; headaches in left eye; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (left side of throat was not working properly), PAIN ( would cause lot of pain), DISCOMFORT (could feel heaviness on left side of the face), MUSCULAR WEAKNESS (no strength in the left arm) and ARTHRALGIA (had pain in the left shoulder and left elbow) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DYSPHAGIA (left side of throat was not working properly). In July 2021, the patient experienced PAIN ( would cause lot of pain), DISCOMFORT (could feel heaviness on left side of the face), MUSCULAR WEAKNESS (no strength in the left arm), ARTHRALGIA (had pain in the left shoulder and left elbow) and HEADACHE (headaches in left eye). At the time of the report, DYSPHAGIA (left side of throat was not working properly), PAIN ( would cause lot of pain), DISCOMFORT (could feel heaviness on left side of the face), MUSCULAR WEAKNESS (no strength in the left arm), ARTHRALGIA (had pain in the left shoulder and left elbow) and HEADACHE (headaches in left eye) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he got the shot in the left arm and lasted for a month and was living on scrambled eggs and apple sauce as nothing else would go down and pain was radiated down from spine all the way down to shoulder and into the hand. Patient had no power to hold up bottle of water or cell phone  No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: left side of throat was not working properly; would cause lot of pain; could feel heaviness on left side of the face; no strength in the left arm; had pain in the left shoulder and left elbow; headaches in left eye; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (left side of throat was not working properly), PAIN ( would cause lot of pain), DISCOMFORT (could feel heaviness on left side of the face), MUSCULAR WEAKNESS (no strength in the left arm) and ARTHRALGIA (had pain in the left shoulder and left elbow) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DYSPHAGIA (left side of throat was not working properly). In July 2021, the patient experienced PAIN ( would cause lot of pain), DISCOMFORT (could feel heaviness on left side of the face), MUSCULAR WEAKNESS (no strength in the left arm), ARTHRALGIA (had pain in the left shoulder and left elbow) and HEADACHE (headaches in left eye). At the time of the report, DYSPHAGIA (left side of throat was not working properly), PAIN ( would cause lot of pain), DISCOMFORT (could feel heaviness on left side of the face), MUSCULAR WEAKNESS (no strength in the left arm), ARTHRALGIA (had pain in the left shoulder and left elbow) and HEADACHE (headaches in left eye) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he got the shot in the left arm and lasted for a month and was living on scrambled eggs and apple sauce as nothing else would go down and pain was radiated down from spine all the way down to shoulder and into the hand. Patient had no power to hold up bottle of water or cell phone  No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of booster shot from vial punctured past 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of booster shot from vial punctured past 12 hours) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of booster shot from vial punctured past 12 hours). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of booster shot from vial punctured past 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  HCP stated the vial was received and put in freezer on 5 Nov 2021 then was pulled out of freezer to thaw the day of being punctured at 11:30 AM on 22 Nov 2021. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received which contains primary source, patient demographics and AE additional information were updated.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Normal chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Normal chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Normal chills) and HEADACHE (Headache). In March 2021, CHILLS (Normal chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient experienced normal chills and headache for a day or two after the first dose.   This case was linked to MOD-2021-395644, MOD-2021-395645 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Hypokinesia, Muscle twitching, Nausea
Clinical narrative: really strong reaction to that; for three days, she was in bed; awake 6 hours in 3 days/laying in bed; terrible shakes; muscle jerking/breasts are jumping up and down; couldn't eat; nauseous; wasn't just chills; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (really strong reaction to that), HYPOKINESIA (for three days, she was in bed), SOMNOLENCE (awake 6 hours in 3 days/laying in bed), TREMOR (terrible shakes) and MUSCLE TWITCHING (muscle jerking/breasts are jumping up and down) in a 63-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.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 VACCINATION COMPLICATION (really strong reaction to that), HYPOKINESIA (for three days, she was in bed), SOMNOLENCE (awake 6 hours in 3 days/laying in bed), TREMOR (terrible shakes), MUSCLE TWITCHING (muscle jerking/breasts are jumping up and down), FEEDING DISORDER (couldn't eat), NAUSEA (nauseous) and CHILLS (wasn't just chills). At the time of the report, VACCINATION COMPLICATION (really strong reaction to that), HYPOKINESIA (for three days, she was in bed), SOMNOLENCE (awake 6 hours in 3 days/laying in bed), TREMOR (terrible shakes), MUSCLE TWITCHING (muscle jerking/breasts are jumping up and down), FEEDING DISORDER (couldn't eat), NAUSEA (nauseous) and CHILLS (wasn't just chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported. Patient  had an antibody test three weeks ago on 01Nov2021, but it said "20 plus".
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor, Vaccination complication
Clinical narrative: really strong reaction to that; for three days, she was in bed; awake 6 hours in 3 days/laying in bed; terrible shakes; muscle jerking/breasts are jumping up and down; couldn't eat; nauseous; wasn't just chills; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (really strong reaction to that), HYPOKINESIA (for three days, she was in bed), SOMNOLENCE (awake 6 hours in 3 days/laying in bed), TREMOR (terrible shakes) and MUSCLE TWITCHING (muscle jerking/breasts are jumping up and down) in a 63-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.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 VACCINATION COMPLICATION (really strong reaction to that), HYPOKINESIA (for three days, she was in bed), SOMNOLENCE (awake 6 hours in 3 days/laying in bed), TREMOR (terrible shakes), MUSCLE TWITCHING (muscle jerking/breasts are jumping up and down), FEEDING DISORDER (couldn't eat), NAUSEA (nauseous) and CHILLS (wasn't just chills). At the time of the report, VACCINATION COMPLICATION (really strong reaction to that), HYPOKINESIA (for three days, she was in bed), SOMNOLENCE (awake 6 hours in 3 days/laying in bed), TREMOR (terrible shakes), MUSCLE TWITCHING (muscle jerking/breasts are jumping up and down), FEEDING DISORDER (couldn't eat), NAUSEA (nauseous) and CHILLS (wasn't just chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported. Patient  had an antibody test three weeks ago on 01Nov2021, but it said "20 plus".
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Tenderness
Clinical narrative: when she touches her skin it hurts really bad, mostly on the leg and back; felt nauseous; bad, kind of tired bad; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (when she touches her skin it hurts really bad, mostly on the leg and back), NAUSEA (felt nauseous) and FATIGUE (bad, kind of tired bad) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Thyroid disorder NOS. Concomitant products included TAMOXIFEN, LEVOTHYROXINE SODIUM (SYNTHYROID), VITAMINS NOS and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced TENDERNESS (when she touches her skin it hurts really bad, mostly on the leg and back), NAUSEA (felt nauseous) and FATIGUE (bad, kind of tired bad). At the time of the report, TENDERNESS (when she touches her skin it hurts really bad, mostly on the leg and back), NAUSEA (felt nauseous) and FATIGUE (bad, kind of tired bad) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-396314, MOD-2021-396316 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received the full series of the GARDASIL-9 vaccine after the age of 45; no adverse event; This spontaneous report was received from a female patient who was currently in her 50's, who was reporting on herself, via a company representative. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. She had previously received series of human papillomavirus vaccine (HPV) manufactured by GSK.  On an unknown date (after the age of 45), the patient received the full series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 03-NOV-2021, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, lot # T000702, 0.5 milliliter in the left arm for prophylaxis (route not reported) which had expired on 01-OCT-2021 (expired product administered). The patient did not experienced any adverse event.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; Medical assistant reports administration of an improperly stored dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 19-month-old male patient. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On an unspecified date, the hepatitis a vaccine, inactivated (VAQTA) was improperly stored at below 36 degrees Fahrenheit (°F) (34.7 F) for 25 minutes; below 36 degrees Fahrenheit (°F) (35.4F) for 5 hours; below 36 degrees Fahrenheit (°F) (35.6F) for 3 hours with 20 minutes; below 36 degrees Fahrenheit (°F) (35.9F) for 25 minutes; below 36 degrees Fahrenheit (°F) (35.7F) for 25 minutes; BELOW 36 degrees Fahrenheit (°F) (35.2F) for 3 hours with 20 minutes; below 36 degrees Fahrenheit (°F) (33.8F) for 18 hours with 20 minutes; below 36 degrees Fahrenheit (°F) (32. 1F) for 23 hours with 45 minutes and below 36 degrees Fahrenheit (°F) (32.5F) for 9 hours with 35 minutes.  On 28-OCT-2021, the patient was vaccinated with the improperly stored hepatitis a vaccine, inactivated (VAQTA) at a dose reported as 0.5 milliliter (ml) one time (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported; lot number T031201 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 14-JUN-2022) for prophylaxis (product storage error).  No previously temperature excursions were reported. No other adverse event (AE) was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2111USA003202: US-009507513-2111USA003125: US-009507513-2111USA003270:
Sex: M
Vaccine: PPV
Symptoms: Vaccination site induration
Clinical narrative: Site is now hard; This spontaneous report was received from the patient's couple via Agency, regarding a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 24-NOV-2021, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) and the same date the vaccination site was hard (vaccination site induration).  At the reporting date, the event was not resolved and the reporter assessed the causal relationship between the event and vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) as related.
Age: 65.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction or side effect was experienced; Pneumovax 23 administered on 02-SEP-2014 and PREVNAR 13 administered on 05-MAY-2015; This spontaneous report was received from a physician via a Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (# 1810USA005885), concerning a 66-year-old male patient.  On 02-SEP-2014 (at 65 years old), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumococcal (PPSV23)) (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported) as prophylaxis, and on 05-MAY-2015, patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (reported as pneumococcal (PCV13)) (strength, dose, route of administration, anatomical location, indication, lot number, and expiration date were not reported) (inappropriate schedule of product administration). It was stated that no adverse reaction or side effect was experienced due to the patient's vaccination.; Sender's Comments:  US-009507513-1810USA005885:
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Skin discolouration
Clinical narrative: sick; turned green; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and skin discoloration. On an unknown date, the outcome of the sickness and skin discoloration were unknown.   It was unknown if the reporter considered the sickness and skin discoloration to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingles vaccine and turned green and felt very sick from it. The reporter who was 54 years old and spoke to his/her physician yesterday (day before reporting) about perhaps getting a vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pain, Pyrexia
Clinical narrative: FEVER; CHILLS; UPSET STOMACH; PAIN; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, upset stomach and pain. The patient was treated with ibuprofen and paracetamol (Acetaminophen). On an unknown date, the outcome of the fever, chills, upset stomach and pain were unknown.   It was unknown if the reporter considered the fever, chills, upset stomach and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the 2nd dose of Shingrix for shingles and experienced symptoms of chills, fever and upset stomach.  The patient asked recommendation for a pain reliever as he/she got Ibuprofen and Acetaminophen. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at the vaccination was not reported. The reporter reported that patient had received only 4 doses of Dtap vaccine at an inappropriate age. Health care professional asked Medical information for recommendations on how to proceed. According to the CDC -patient should be administered a Tdap which was indicated for 10 and older in place of the 5th dose of Dtap, which led to inappropriate age at vaccine administration. Consent to follow up was granted by email.
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of hives in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2017-2018 season) (batch number 4XH59, expiry date 2nd June 2018) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2017-2018 season and Fluarix Tetra Pre-Filled Syringe Device. On 28th November 2021, more than 2 years after receiving Fluarix Quadrivalent 2017-2018 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2017-2018 season and Fluarix Tetra Pre-Filled Syringe Device. Additional details were provided as follows. The age at vaccination was not reported. The reporter stated that, the patient received Fluarix Quadrivalent 2017-2018 season and developed hives. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose one of Shingrix on August 2, 2018  / never returned for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never returned for the second dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient was now interested in completing the series. No additional details provided at the time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14 years old patient was administered with Infanrix; administered with Infanrix by mistake; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th November 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 19th November 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient administered with Infanrix by mistake instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: liquid dripped out during administration; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect dose administered in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On 25th November 2021, the patient received the 1st dose of Shingrix. On 25th November 2021, unknown after receiving Shingrix, the patient experienced incorrect dose administered. On an unknown date, the outcome of the incorrect dose administered was unknown.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The reporter stated that, some of the vaccine liquid dripped out during administration and the reporter not sure if the patient received the full dose of Shingrix, which led to incorrect dose administered. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain, Paraesthesia
Clinical narrative: Prickly feeling; Painful; 2nd dose a year and a half after first dose; This case was reported by a consumer via call center representative and described the occurrence of paresthesia in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received one and half year ago).   In October 2021, the patient received the 2nd dose of Shingrix (intramuscular). In October 2021, 1 day after receiving Shingrix, the patient experienced paresthesia, pain and drug dose administration interval too long. On an unknown date, the outcome of the paresthesia was not recovered/not resolved and the outcome of the pain was unknown and the outcome of the drug dose administration interval too long was recovered/resolved.   It was unknown if the reporter considered the paresthesia and pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient had the second dose of Shingrix about a month ago, and approximately a year and a half after her first dose, which led to drug dose administration interval too long. The patient had no reaction to the first dose.  The patient state that the next day after the second dose that any time she starts any activity that leads to her perspiring she begins to feel a painful prickly feeling all over her body from her legs to the top of her head. The reporter consented to follow-up.