chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: vaccine administered on 2/13, reaction on 2/21.  Site itching, redness, 2 swollen areas.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Headache, muscle aches, arm pain, fever - for 48h Headaches continued for 7 days
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: a patient received an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.  On 26-JAN-2021, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA (recombinant Human albumin) (PROQUAD) 1 injection (strength, route of administration and anatomical site of vaccination were not reported, lot # S021620, expiration date reported and validated as 09-JAN-2021) for prophylaxis (expired product administered). No further questions, no further adverse events (AE).
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; an expired GARDASIL 9 vaccine dose was administered to a patient; This spontaneous report as received from a pharmacist refers to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # R003557, expiration date reported as November 2020 and upon internal validation established as 20-NOV-2020 (route of administration and anatomical location were not reported). No adverse event was reported. The reporting pharmacist inquired whether he needed to repeat the dose.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE details are available.; improperly stored vaccine administered.; This spontaneous report was received from a administrator referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On 29-JAN-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # S027460, expiration date 02-MAR-2021) for prophylaxis. The vaccine administered experienced temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit, with an average of 9.3 degrees Fahrenheit for 15 minutes and 6 degrees Fahrenheit to 14 degrees Fahrenheit, with an average of 9.1 degrees Fahrenheit for 15 minutes as recorded by a data logger. There was no previous temperature excursion. No additional adverse event details were available.
Age: 1.08
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Age: 1.17
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 14-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Age: 1.92
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 23-moths-old patient of unknown gender. Concurrent conditions, medical history and concomitant therapies were not provided.  On 19-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no adverse event; vaccine improperly stored and administered/ Temperature: 27-OCT-2020 BELOW 36 degrees F (35.70F)/ 14-OCT-2020 ABOVE 47 degrees F (64.36 F); This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 18-NOV-2020, the patient was vaccinated with incorrectly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T011167 with expiration date on 27-MAY-2022 (route of administration was unknown) for prophylaxis. The vaccine underwent a temperature excursions of 35.7 degrees Fahrenheit for 1 hour and 30 minutes on 27-OCT-2020, 30.2 degrees Fahrenheit for 1 hour and 30 minutes on 28-OCT-2020 and 64.36 degrees Fahrenheit for 3 hours on 14-NOV-2020. Digital data logger was involved. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by health care providers for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about November 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 19-AUG-2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered/not resolved. The reporter regarded the event as related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of herpes zoster to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got the shot and two days later I had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that the shot works, it would give you shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Inflammation, Mobility decreased, Pyrexia
Clinical narrative: red inflammed arm; red inflammed arm; fever; could not use my arm; awful pain in my back; This case was reported by a consumer via interactive digital media and described the occurrence of inflammation in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles (under the left breast and around the back) and neuropathic pain (around the heart).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced inflammation, erythema of extremities, fever, mobility decreased and back pain. Shingles vaccine was discontinued. On an unknown date, the outcome of the inflammation, erythema of extremities, fever and mobility decreased were recovered/resolved and the outcome of the back pain was not recovered/not resolved.   It was unknown if the reporter considered the inflammation, erythema of extremities, fever, mobility decreased and back pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that he/she took 1st dose for the shingles vaccine and had bad reaction so could not take the 2nd dose and it was awful. The patient's arm started out with a coin size red inflamed arm and then fever set in, and he/she could not use arm, lasted a couple weeks so the physician said no for the 2nd dose. At the time of reporting, the patient had awful pain in back. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: sore arm at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient commented had a mild case in 2008, but nothing since and the patient was glad to receive the dose. The patient experienced sore arms at the injection site. For tolerance of 2nd dose, refer case US2021AMR025893. The follow-up would not possible as no contact details were available. This case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025865:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same reporter US-GLAXOSMITHKLINE-US2021AMR025893:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Vaccination site pain
Clinical narrative: Second shot at gap of 35 days; Left arm sore; Bodyache; This spontaneous report was received from consumer on 05-feb-2021, concerning a 75 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). and she had experienced sore arm, body ache and Inappropriate schedule of vaccine administered.  The patient's medical history was not provided. Concomitant  medication also not provided.   The patient received suspect product  mRNA-1273 on 05/Jan/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:025L20A) intramuscularly on the left arm  for prophylaxis of COVID-19 infection  On 05 Jan 2021, the patient received her first shot in her left arm. She experienced a sore arm for 2 days and body ache for a couple of hours following the vaccination. On 25 Jan 2021, at surgical center she received steroid epidural injection in her back for pain, her Moderna Vaccine is scheduled 2 days after the steroid shot. But, she was able to reschedule her second dose 5 weeks from 1st shot that is on coming Tuesday 09Feb2021. Caller enquired having second shot at gap of 35 days is fine.  Having a steroid injection prior to Moderna COVID Vaccine is safe and will it have any effect on the vaccine effectiveness.  Action taken with the second dose of mRNA-1273  in response to the event was not reported; Reporter's Comments: This case concerns a 75-year-old female who had NS expected adverse events of Vaccination site pain and Myalgia occurring 1 day after the first dose of mRNA-1273. She had a NS unexpected event of Inappropriate schedule of vaccine administered without associated AEs after a delay in the second dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the adverse events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: when vaccine was being administered, the needle disconnected from the syringe; caused some vaccine to end up on the patient's arm; incorrectly administered dose; A spontaneous report was received from a pharmacist (PharmD) concerning a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced when vaccine was being administered, the needle disconnected from the syringe (device connection issue) that caused some vaccine to end up on the patient's arm (exposure via skin contact) and an incorrectly administered dose (underdose).  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number: 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   When the vaccine was being administered, the needle disconnected from the syringe.  This caused some of the vaccine to end up on the patient's arm and an incorrectly administered dose.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The events, when vaccine was being administered, the needle disconnected from the syringe that caused some vaccine to end up on the patient's arm, and an incorrectly administered dose, were considered recovered/resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of device connection issue, exposure via skin contact and underdose with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Fatigue, Vaccination site pain
Clinical narrative: got pain in the arm; fatigue; chills; Vaccinated from a prefilled syringe that surpassed 6 hours; A spontaneous report was received from a pharmacist who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain in the arm, fatigue, chills following vaccination from a prefilled syringe that has surpassed six hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (BATCH # 041L20A) on 02 Feb 2021 intramuscularly in the left arm for prophylaxis against COVID-19 infection.   Pharmacist received first dose on 02 Feb 2020 to left non dominant arm. Pharmacist stated I got pain in the arm, fatigue, chills after the dose. Pharmacist stated they were conducting clinics at hospital site, extra unused doses in syringe were brought back to pharmacy, and being used for administering other patients for last two weeks that were in syringes for over six hours. HCP (healthcare professional) wanted to know how long it can be stable in syringe, as she knew punctured vials needed to be discarded after six hours but what about dose in syringe. Also, she asked if they could transport in syringe to different sites and conditions to maintain for transport when they are in syringes. Approximately thirty patients were administered from those syringes. HCP stated that it was first dose for all patients. HCP does not know any information on those patients except, was one of the recipients of dose of vaccine from that syringe. Consented for safety follow-up with reporter. Pregnancy status unknown, age not provided. No further information was reported.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events was unknown.  The reporter did not provide an assessment for the events, got pain in the arm, fatigue, chills and vaccinated from a prefilled syringe that surpassed six hours.; Reporter's Comments: This report refers to a case of "Expired Product Administration" of  mRNA-1273, lot #  # 041L20A with  associated adverse events of limb discomfort, fatigue and chills. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Exposure via skin contact, Injection site swelling, Product administration error, Underdose
Clinical narrative: arm was slight red; lump appeared at injection site; administer went past muscle to the bone; when administrator removed needle, fluid rolled down arm; unsure if received any vaccine; A spontaneous report was received from a consumer, who was also a 69-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administrator went past muscle to the bone (product administration error), when administrator removed needle, fluid rolled down arm (exposure via skin contact), unsure if received any vaccine (underdose), arm was slight red (erythema), and lump appeared at injection site (injection site mass).  The patient's medical history was not provided.  Concomitant medications included levothyroxine sodium and lovastatin.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the vaccine administrator went past the muscle to the bone.  When the administrator removed the needle, fluid rolled down the patient's arm.  The patient was unsure of she received any vaccine.  The patient also reported her arm was slight red and a lump appeared at the injection site.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events, administrator went past muscle to the bone; when administrator removed needle, fluid rolled down arm; and unsure if received any vaccine, was considered recovered/resolved on 05 Feb 2021.  The outcome of the events, arm was slight red and lump appeared at injection site, was unknown.; Reporter's Comments: This report refers to a case of product administration error, exposure via skin contact, underdose, injection site erythema, and injection site mass for mRNA-1273, unknown lot #, with no associated AEs.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Joint range of motion decreased, Malaise, Neck pain
Clinical narrative: Couldn't feel arm; Couldn't feel arm and had no range in motion; Pain in upper shoulder area by his neck; Thinks the administration was done incorrectly; Aching in legs as if he was getting sick; Aching in legs as if he was getting sick; Pain in upper shoulder area by his neck; A spontaneous report was received from a nurse concerning her son, who was a 44-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced couldn't feel arm and had no range in motion (hypoaesthesia, joint range of motion decreased), pain in upper shoulder area by the neck (arthralgia, neck pain), thinks administration was done incorrectly (product administration error), and aching in legs as if was getting sick (arthralgia, malaise).  The patient's medical history was not provided.  Concomitant medication included escitalopram.  On 04 Feb 2021, on the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 030L20A) in the left arm for prophylaxis of COVID-19 infection.  On 04 Feb 2021, a couple of hours after the vaccination, the patient couldn't feel his arm and he had no range in motion.  He also had pain in his upper shoulder area by his neck.  The reporter thought the administration was done incorrectly but she "wasn't there to conform 100%."  At night on 04 Feb 2021 and 05 Feb 2021, the patient had aching in his legs "as if he was getting sick."  Treatment for the events included ibuprofen which helped, and the patient was feeling better at the time of this report.  Action taken with mRNA-1273 in response to the events was not reported.   The events, couldn't feel arm and had no range in motion, pain in upper shoulder area by the neck, and aching in legs as if was getting sick, were considered recovering/resolving at the time of this report.  The event, thinks administration was done incorrectly, was considered recovered/resolved on 04 Feb 2021.; Reporter's Comments: This case concerns a 44-year-old male who experienced NS unexpected events of hypoaesthesia, joint range of motion decreased, arthralgia, neck pain, product administration error, malaise, and NS expected arthralgia.  The events occurred 1 day after the first dose of mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-012275: US-MODERNATX, INC.-MOD-2021-012263:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administration error
Clinical narrative: Couldn't feel arm; Couldn't feel arm and had no range in motion; Pain in upper shoulder area by his neck; Thinks the administration was done incorrectly; Aching in legs as if he was getting sick; Aching in legs as if he was getting sick; Pain in upper shoulder area by his neck; A spontaneous report was received from a nurse concerning her son, who was a 44-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced couldn't feel arm and had no range in motion (hypoaesthesia, joint range of motion decreased), pain in upper shoulder area by the neck (arthralgia, neck pain), thinks administration was done incorrectly (product administration error), and aching in legs as if was getting sick (arthralgia, malaise).  The patient's medical history was not provided.  Concomitant medication included escitalopram.  On 04 Feb 2021, on the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 030L20A) in the left arm for prophylaxis of COVID-19 infection.  On 04 Feb 2021, a couple of hours after the vaccination, the patient couldn't feel his arm and he had no range in motion.  He also had pain in his upper shoulder area by his neck.  The reporter thought the administration was done incorrectly but she "wasn't there to conform 100%."  At night on 04 Feb 2021 and 05 Feb 2021, the patient had aching in his legs "as if he was getting sick."  Treatment for the events included ibuprofen which helped, and the patient was feeling better at the time of this report.  Action taken with mRNA-1273 in response to the events was not reported.   The events, couldn't feel arm and had no range in motion, pain in upper shoulder area by the neck, and aching in legs as if was getting sick, were considered recovering/resolving at the time of this report.  The event, thinks administration was done incorrectly, was considered recovered/resolved on 04 Feb 2021.; Reporter's Comments: This case concerns a 44-year-old male who experienced NS unexpected events of hypoaesthesia, joint range of motion decreased, arthralgia, neck pain, product administration error, malaise, and NS expected arthralgia.  The events occurred 1 day after the first dose of mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-012275: US-MODERNATX, INC.-MOD-2021-012263:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Hypertrophic cardiomyopathy, Hypoaesthesia
Clinical narrative: Hypertrophic Cardiomyopathy; Chest Pain; Chest Pressure; Numbness in Left Arm; Back Pain; A spontaneous report was received from a nurse concerning herself, a 41-years-old, female patient who experienced hypertrophic cardiomyopathy, chest pain, chest pressure, numbness in left arm, and back pain.   The patient's medical history was not provided.  concomitant medications included metoprolol, omeprazole and acetylsalicylic acid.   On 21 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 [Lot number 0412L0A] intramuscularly in the for prophylaxis of COVID-19 infection.   On 25 Jan 2021, four days after the vaccine administration, the patient started experiencing chest pain, chest pressure, numbness in left arm, back pain and hypertrophic cardiomyopathy and was hospitalized in emergency room for 48 hours from 25 Jan 2021 to 26 Jan 2021. The event hypertrophic cardiomyopathy was also considered to be medically significant. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events chest pain, chest pressure, numbness in left arm, back pain and hypertrophic cardiomyopathy were considered unknown at the time of this report.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; A spontaneous report was received from a consumer concerning a 58-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient was died.  The patient's medical history was reported as underlying health issue. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, patient with underlying health issue died after getting the Moderna COVID-19 vaccine.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on an unknown date. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 58-year-old female who died on unknown date after first dose of mRNA-1273, lot # unknown. Very limited information regarding this event has been provided at this time, therefore it is difficult to assess a cause and effect relationship. No further information will be available. Of note, patient's medical history included unknown underlying health issues.; Reported Cause(s) of Death: Unknown cause of death
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hot flush, Hypersensitivity, Pain in extremity
Clinical narrative: Difficulty breathing; Allergic reaction; Pain in the arm that radiated up to the neck; Hot and cold flashes; Hot and cold flashes; A spontaneous report was received from a consumer, who was also a 43-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction, hot and cold flashes, difficulty breathing and pain in the arm that radiated up to the neck.  The patient's medical history, as provided by the reporter, included asthma and allergies.  Concomitant medications were not reported.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 026L20A; expiration date: 28 Jul 2021) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, four hours after vaccination, the patient experienced hot and cold flashes and pain in his arm that radiated up to his neck. He had some food and went to bed.  The next day, on 16 Jan 2021, the patient had an "adverse reaction, allergic reaction". This event was considered to be medically significant. treatments at home but had no relief.  The patient still had trouble breathing so he went to the emergency room as his physician told him to.  He was given three more nebulizers of ipratropium bromide (+) albuterol sulfate, steroids, diphenhydramine hydrochloride, and famotidine but he still had trouble breathing.  Therefore, the patient was admitted into the hospital for observation.  The patient was discharged on 17 Jan 2021 with two to three bags of normal saline and four bags of "lactose ringers".  In addition, his physician put him on a steroid and inhaler.  Action taken with mRNA-1273 in response to the events were not reported.  The outcomes of the events, allergic reaction, difficulty breathing, hot and cold flashes, and pain in the arm that radiated up to the neck, were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's significant medical history included asthma and allergies.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Extra dose administered, Interchange of vaccine products, Somnolence
Clinical narrative: got 3 vaccinations; Sore; Sleepy; Chills; Temp of 99.6°F; Interchanged covid-19 products; A spontaneous report was received from a consumer concerning a 66-years-old female patient, who received 3 doses of the COVID-19 vaccine. After the 2nd Moderna shot her arm got sore she felt sleepy, got the chills and had an elevated temp of 99.6°F, Interchanged covid-19 products.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Rosuvastatin 10mgxDay, Paroxetine 20mgxDay, Alendronate 70mg 1xWeek.     The patient received her first of two planned doses of mRNA-1273 (Lot # 027L20A) on 06 Jan 2021.  On 03 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot #013M20A) intramuscularly for prophylaxis of COVID-19 infection.    Caller states that she received 3 doses of the COVID-19 vaccine.  She received the Moderna vaccine on 06 Jan 2021 from a pharmacy.  Then on Monday 01 Feb 2021 she received the 1st dose of the Pfizer's vaccine (and had a sore arm). The Pfizer's dose is EL9265.  The pharmacy called for the 2nd Moderna dose on 03 Feb 2021. After the 2nd Moderna arm got sorer, she felt sleepy, got the chills and had a raised temperature of 99.6°F.  Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, sore arm, she felt sleepy, got the chills and had an elevated temp of 99.6°F, Interchanged covid-19 products were unknown/not reported.; Reporter's Comments: This case concerns a 66-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot: 013M20A), reporting Extra dose administered and Interchange of vaccine products, associated with Vaccination site pain, Somnolence, Chills and Pyrexia. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: got 3 vaccinations; Sore; Sleepy; Chills; Temp of 99.6°F; Interchanged covid-19 products; A spontaneous report was received from a consumer concerning a 66-years-old female patient, who received 3 doses of the COVID-19 vaccine. After the 2nd Moderna shot her arm got sore she felt sleepy, got the chills and had an elevated temp of 99.6°F, Interchanged covid-19 products.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Rosuvastatin 10mgxDay, Paroxetine 20mgxDay, Alendronate 70mg 1xWeek.     The patient received her first of two planned doses of mRNA-1273 (Lot # 027L20A) on 06 Jan 2021.  On 03 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot #013M20A) intramuscularly for prophylaxis of COVID-19 infection.    Caller states that she received 3 doses of the COVID-19 vaccine.  She received the Moderna vaccine on 06 Jan 2021 from a pharmacy.  Then on Monday 01 Feb 2021 she received the 1st dose of the Pfizer's vaccine (and had a sore arm). The Pfizer's dose is EL9265.  The pharmacy called for the 2nd Moderna dose on 03 Feb 2021. After the 2nd Moderna arm got sorer, she felt sleepy, got the chills and had a raised temperature of 99.6°F.  Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, sore arm, she felt sleepy, got the chills and had an elevated temp of 99.6°F, Interchanged covid-19 products were unknown/not reported.; Reporter's Comments: This case concerns a 66-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot: 013M20A), reporting Extra dose administered and Interchange of vaccine products, associated with Vaccination site pain, Somnolence, Chills and Pyrexia. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age; A spontaneous report was received from a healthcare professional concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) (product administered to patient of inappropriate age).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Jan 2021, the patient received her first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  The Director of Medical Operations called in stating that it was reveled on 12 Jan 2021 that a patient in his clinic received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age. The administration was made in error.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, patient received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second shot early; A spontaneous report was received from a Reporter like a nurse concerning a 63 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  event inappropriate schedule of vaccine administered.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the anatomical location for prophylaxis of COVID-19 infection.  The patient is scheduled to receive his second shot on 19-FEB-2021, but received the vaccine (early) on, 09-FEB-2021.   Action taken with mRNA-1273 in response to the events was not reported.   On 09-feb-2021, the outcome of the events was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose 20 days after the 1st one; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient received the 2nd dose 20 days after the 1st one.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that the patient received their second dose 20 days after receiving their first vaccination.   Action taken with study drug was not applicable as the subject had already received both scheduled doses  The outcome of the event, the patient received the 2nd dose 20 days after the 1st one was resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot# unknown) with no associated AEs reported after the second dose.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave vaccine to 17 year old; A spontaneous report was received from a nurse concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, gave vaccine to a 17-year-old/inappropriate age of dose of administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient received the vaccine resulting in the event of inappropriate age of dose of administration.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, gave vaccine to a 17-year-old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 013M20A with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a person who received 2 doses of the vaccine in a fairly quick succession; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported the patient had received 2 doses of the vaccine in a fairly quick succession.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that the patient received both doses of the vaccine in a fairly quick succession.  Action taken with study drug was not applicable as the subject had already received both scheduled doses  The outcome of the event, a person who received 2 doses of the vaccine in a fairly quick succession was resolved.; Reporter's Comments: This report refers to a case of "Product administration error" for mRNA-1273, lot # unknown. with no associated adverse events..