chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous haemorrhage
Clinical narrative: Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.; Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.; Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.|1; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or around 19-AUG-2014, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (anatomical location, administration route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the vaccine, the patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Later, the patient was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) vaccine, mental an emotional distress due to resulting physical limitations and seriousness of his condition; the patient sustained severe and permanent personal injuries. Patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. At the time of the report, the outcome of posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye was not recovered. The reporter considered the posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye to be related to Zoster Vaccine Live (ZOSTAVAX). The events of posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye were considered to be disabling. Upon internal review, the posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye were considered as medically significant event.
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Skin lesion
Clinical narrative: post-herpetic neuralgia; skin lesions developed on his head and forehead; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not reported. In or around February 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) being administered, the pt developed skin lesions on his head and forehead, and this resulted in post-herpetic neuralgia in his upper body, particularly the shoulders, that also persisted to the present. The pt first learned of the link between zoster vaccine live (ZOSTAVAX) and injuries such those from which he (also reported as she, conflicting information) suffered, on or about 22-DEC-2018, when a friend shared information found on website. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not presented prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his 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 of the company's wrongful conduct, 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 events was considered as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was considered as related.   Skin lesions and post-herpetic neuralgia were considered as disabling.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of the fluids squirted out and the individual did not receive the full dose of the vaccine; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and some of the fluids squirted out and the individual did not receive the full dose of the vaccine.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the pharmacist administered the Moderna COVID-19 vaccine to her coworker and during vaccine administration, some of the fluids squirted out and the individual did not received the full dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, some of the fluids squirted out and the individual did not receive the full dose of the vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of incorrect dose administered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine leaked out at injection site; A spontaneous report was received from a pharmacy intern concerning a 29 year-old, male patient who received Moderna's COVID-19 vaccine(mRNA-1273)  and experienced the events, vaccine leaked out at injection site and possible error in administration of the vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient removed the bandage placed over the injection site and reported clear liquid underneath the bandage. The reporter states that the vaccine leaked out at the injection site and a lot of the vaccine got out. The reporter states this may be due to error in the administration of the vaccine.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The events, vaccine leaked out at injection site and possible error in administration of the vaccine, were considered resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a 29 year old, male patient.  The patient's medical history is not provided.  The patient experienced the unexpected event of administration of incomplete dose (vaccine leaked out at injection site) after  the administration of the first dose of mRNA-1273 on 4 Jan 2021.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered with less than optimal dose (0.45 mL); A spontaneous report was received from pharmacist concerning a 66-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced incomplete dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 5 Jan 2021 (Lot number 039K20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. During the administration, the pharmacist did not push the plunger correctly all the way, and the patient did not receive the full dose. After measuring what was left in the barrel of the syringe, they estimated that the patient received only 0.45 mL of the vaccine instead of 0.5 ml.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, incomplete dose administered, was considered resolved on 5 Jan 2021.; Reporter's Comments: This is a report of 66-year-old female patient, who was administered less than optimal dose (0.45 mL) (incomplete dose administered) mRNA-1273, lot # 039K20-2A. There were no reported adverse events associated with this case of incomplete dose administered
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: O.45ml of Vaccine Was Administered; A spontaneous report was received from pharmacist concerning a 70-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced incomplete dose administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 5 Jan 2021 (Lot number 039K20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. During the administration, the pharmacist did not push the plunger correctly all the way, and the patient did not receive the full dose. After measuring what was left in the barrel of the syringe, they estimated that the patient received only 0.45 mL of the vaccine instead of 0.5 mL.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, incomplete dose administered, was considered resolved on 5 Jan 2021.; Reporter's Comments: This case concerns a 70 year old, female patient.  The patient's medical history is not provided.  The patient experienced the unexpected event of administration of incorrect dose (0.45 mL of the vaccine instead of 0.5 mL) of the first dose of the mRNA-1273 (Lot number 039K20-2A) on 5 Jan 2021.  There was no reported adverse reaction associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; A spontaneous report was received from a physician, who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction.  The patient's medical history was not provided. No concomitant medications were reported.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, after vaccination, the patient experienced anaphylactic reaction. No treatment information for the event was reported.  The Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event, anaphylactic reaction, was not reported.; Reporter's Comments: This case concerns a female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced a serious event of anaphylactic reaction. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the onset of the event on the day of vaccination, a causal relationship cannot be excluded and the event was considered possibly related to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administed to a 17 year old; A spontaneous report was received from a Certified in Public Health (CPH) concerning a 17-years old patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced the event, product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on an unknown date, intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the CPH reported that one of their local hospitals administered a dose of Moderna vaccine in error to the 17-years old patient.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, product administered to patient of inappropriate age, was resolved on unknown date.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered dose from punctured vial left out at room temperature for over 9 hours; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who was administered dose from punctured vial left out at room temperature for over 9 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, a pharmacist reported that the facility's clinic administered a dose of the vaccine to a patient from a punctured vial that was left out at room temperature for 9 hours. The pharmacist was unable to provide any information about the patient or vial. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered dose from punctured vial left out at room temperature for over 9 hours, was considered resolved on an unknown date.   The reporter did not provide an assessment for the event, administered dose from punctured vial left out at room temperature for over 9 hours.; Reporter's Comments: This report refers to a case of a patient administered dose from punctured vial left out at room temperature for over 9 hours (Expired product administered) for mRNA-1273. Lot #  was not provided. There were no reported adverse events associated with this case of administered dose from punctured vial left out at room temperature for over 9 hours
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered Vaccine that was a punctured vial and stored at room temperature for more than 6 hours; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered a vaccine from a punctured vial stored at room temperature for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026020A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 05 Jan 2021, a pharmacist administered the vaccine to the patient from a vial that had been previously punctured and stored at room temperature for a total of 18 hours. The patient reported no adverse reactions. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, administered a vaccine from a punctured vial stored at room temperature for more than 6 hours, was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Syringe leaked and not sure how much Vaccine was administered; A spontaneous report was received from a pharmacist concerning a patient of unknown age who received Moderna's COVID-19 vaccine and experienced syringe leaked and not sure how much vaccine was administered.  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 intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, a pharmacist reported that liquid leaked out of a syringe while the nurse was injecting and is not sure how much of the vaccine was applied to the patient. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, syringe leaked and not sure how much vaccine was administered, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown, reporting syringe leaked  and not sure how much vaccine was administered without any associated adverse events.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine leaked out of the deltoid muscle; A spontaneous report was received from a healthcare professional concerning a 49-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccine leaked out of the deltoid muscle.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient received the mRNA-1273 vaccine using a one inch needle. Right after administration, the vaccine leaked out of the deltoid muscle of the patient's arm. The patient's vaccinator thought the patient received half the dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, vaccine leaked out of the deltoid muscle, was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 039K20A. There were no reported AEs associated with this case of incorrect dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine injected subcutaneously; A spontaneous report was received from a healthcare professional concerning a female consumer who received Moderna's COVID-19 vaccine subcutaneously, instead of intramuscularly (IM) on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.     On 05 Jan 2021, a patient was administered mRNA-1273 subcutaneously in her arm, instead of IM.  There was no report of adverse event experienced by the patient. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, vaccine given to a patient subcutaneously instead of IM, was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of a female consumer who received Moderna's COVID 19 vaccine subcutaneously, instead of intramuscularly (IM) on her arm for mRNA-1273. The vaccine lot number was not provided. There were no reported AEs associated with this case of female consumer who received Moderna's COVID-19 vaccine subcutaneously, instead of intramuscularly on her arm.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: 17 year old administered vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old consumer who received Moderna's COVID-19 vaccine and was at an inappropriate age at vaccine administration.                           The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 or 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.     On 29 or 30 Dec 2020, a 17-year-old patient was given the vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine. No adverse events were reported.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, inappropriate age at vaccine administration, was considered resolved.; Reporter's Comments: This report refers to a case of 17- year-old patient who was administered vaccine outside the lower age limit for Moderna's mRNA-1273 vaccine, lot # unknown, Exp. unknown. There were no reported AEs associated with this case of vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: Freezer dropped down to -16.8 degree Fahrenheit; Freezer dropped down to -16.8 degree F and the vaccine was administered.; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine) mRNA-1273 and experienced product storage error and product administration error.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28-Dec-2020, the supply of vaccine was received by the nurse's facility. Following receipt, the freezer the vaccine was stored in dropped down to -16.8 degrees Fahrenheit for an unknown amount of time.  On an unknown date, prior to the medical error, the patients received one of two planned doses of mRNA-1273 (Lot number 039K20A, expiration date 20 Jun 2021) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection. The patient was administered with the improperly stored product and experienced product administration error.  No adverse events were reported.   Treatment information was not provided.   Action taken in response to the event was not provided.   The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of Product storage error  for mRNA-1273, lot # 039K20A. There were no reported adverse events associated with this case of Product storage error.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Dyspnoea, Feeling hot, Flushing
Clinical narrative: Trouble breathing; Nauseated; Heart Palpitations; Hot, felt flush; A spontaneous report was received from a nurse concerning a 61 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, hot, felt flushed, heart palpitations, nauseated and trouble breathing.   The patient's medical history, as provided by the reporter, included myocardial infarction. Concomitant medications reported included sertraline hydrochloride.    On 30 Dec 2020, approximately 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient was walked to the waiting room to wait 15-20 minutes following vaccination. At 3:50 pm the patient began to feel hot and flushed. The patient started having heart palpitations and felt nauseated. The patient was assisted by a nurse and approximately 20 minutes later, patient reported feeling better. The patient was instructed to wait another 30 minutes before leaving the clinic. At 4:30 pm, the patient stated that she was not feeling well, reporting heart palpitations, flushing and trouble breathing. Patient was taken to the hospital via emergency medical services at 4:43pm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events,  hot, felt flushed, heart palpitations, nauseated, and trouble breathing, was unknown..; Reporter's Comments: This case concerns a 61 year old, female patient, with medical history of Myocardial Infarction, who experienced a serious, unexpected events of hot flush, heart palpitations, nausea and trouble breathing.  The event occurred 20 minutes after administration of the first dose of mRNA-1273 (Lot number: 011J20A). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the onset of the event, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hot flush, Nausea, Oxygen saturation, Palpitations
Clinical narrative: Trouble breathing; Nauseated; Heart Palpitations; Hot, felt flush; A spontaneous report was received from a nurse concerning a 61 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, hot, felt flushed, heart palpitations, nauseated and trouble breathing.   The patient's medical history, as provided by the reporter, included myocardial infarction. Concomitant medications reported included sertraline hydrochloride.    On 30 Dec 2020, approximately 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient was walked to the waiting room to wait 15-20 minutes following vaccination. At 3:50 pm the patient began to feel hot and flushed. The patient started having heart palpitations and felt nauseated. The patient was assisted by a nurse and approximately 20 minutes later, patient reported feeling better. The patient was instructed to wait another 30 minutes before leaving the clinic. At 4:30 pm, the patient stated that she was not feeling well, reporting heart palpitations, flushing and trouble breathing. Patient was taken to the hospital via emergency medical services at 4:43pm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events,  hot, felt flushed, heart palpitations, nauseated, and trouble breathing, was unknown..; Reporter's Comments: This case concerns a 61 year old, female patient, with medical history of Myocardial Infarction, who experienced a serious, unexpected events of hot flush, heart palpitations, nausea and trouble breathing.  The event occurred 20 minutes after administration of the first dose of mRNA-1273 (Lot number: 011J20A). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the onset of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Dose was adminstered outside of the 6 hour timeframe from the first puncture of the vial; A spontaneous report was received from a healthcare facility administrator concerning a patient who received Moderna's COVID-19 (mRNA-1273) Vaccine and experienced expired product administered.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30 Dec 2020, a vial containing Moderna's COVID-19 Vaccine was thawed, and the vial was punctured. Afterwards, the vial was placed back into refrigeration overnight.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection from the same vial. The dose given was outside of the six-hour timeframe from the first puncture of the vial.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event, expired product administered, was not provided.   The event, expired product administered, was considered recovered/resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history is not provided.  The event occurred 31 Dec 2020 during administration of the first dose of mRNA-1273. This report refers to a case of out of specification product use where, mRNA-1273 was given outside of the 6 hour timeframe from the first puncture of the vial.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Oxygen saturation, Oxygen saturation decreased, Oxygen saturation decreased
Clinical narrative: Osats down to 80; Pulse upwards of 130; A spontaneous report was received from a health care professional, concerning a 93-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Osats down to 80 and pulse upwards of 130.   The patient's medical history, as provided by the reporter, included hypertension and heart disease. Concomitant product use was not provided.    On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, around 20 minutes after vaccination, the patient's oxygen saturation was down to 80 and she had a pulse upwards of 130. The patient was given 3-4 L of oxygen, but did not respond, so, epinephrine was administered. Emergency medical services (EMS) was called. The patient's oxygen saturation was around 90 with pulse ranging from 80-120 after EMS arrived.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, Osats down to 80 and pulse upwards of 130, was unknown.; Reporter's Comments: This case concerns a 93 year-old, female patient with medical history of hypertension and heart disease, who experienced events of oxygen saturation decreased and heart rate increased. The events occurred approximately 20 minutes after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient receiving 2 doses of the Moderna vaccine on the same day; A report was received from a physician concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced incorrect dose administered.   The patient's medical history and relevant concomitant medications were not reported.   On an unknown date the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient received a second dose of vaccine the same day.  No adverse events were observed. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, incorrect dose administered, was resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting that patient received two doses of vaccine on the same day without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity, Motor dysfunction
Clinical narrative: Severe allergic reaction; Dizziness; Made her dysfunctional; A spontaneous report was received from a female patient who received Moderna's COVID-19 Vaccine and experienced severe allergic reaction and dizziness.  The patient's reported medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 for infection prophylaxis.  On an unknown date, the patient had a severe allergic reaction and reported that she had dizziness that made her dysfunctional. Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, severe allergic reaction and dizziness, was considered not resolved.; Reporter's Comments: This case concerns a female subject with who experienced serious unexpected events of hypersensitivity and dizziness. The event occurred an unspecified time after the first dose of mRNA-1273. Based on the current available information, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Incorrect route of product administration
Clinical narrative: Cellulitis in arm; Given into fatty part of the arm not the muscle; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and it was given to her in the fatty part of the arm, not the muscle and developed cellulitis in her arm .   The patient's medical history was not provided. Concomitant product use was not reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the reporter thinks that the patient was given the vaccine into the fatty part of her arm, not the muscle part.   On an unknown date, after vaccine administration, the patient developed cellulitis in her arm.  It was massive, red, and itchy. It started small and now 6-8 inches. Lot and expiration date unknown. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the event, cellulitis in arm, was not reported. The outcome of the event, given into fatty part of the arm, not the muscle, was considered resolved on 23 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a female patient (unknown age), who experienced the event of cellulitis in her arm. The event occurred on an unknown date after a dose of mRNA-1273 vaccine administration. Based on the current limited available information and possible temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Headache, Pain
Clinical narrative: diarrhea; headache; bodyache; no appetite; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported, expiration date: Mar2021), via an unspecified route of administration on the left arm, from 05Jan2021 at a single dose for Covid-19 immunisation. Medical history included blood pressure (abnormal).  Concomitant medication included ongoing hydrochlorothiazide for blood pressure. On 06Jan2021, the patient has had body aches, headache and no appetite. On 08Jan2021, she had diarrhea. She was going to work today but was unable to because she had to run to the bathroom. She has gone to the bathroom 6 times. She called her doctor at 7:30am but has not heard back. She is unsure what to do. She is asking if these are side effects of the vaccine. She is unsure if the lot number on the card is SK4176 or PK4176. Outcome of the events was not recovered.  Information on lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chest pain, Headache, Heart rate
Clinical narrative: HR maintaining 120+ at rest; Fever 103.5; extreme body aches; headaches; 8/10 pain in L axillary and chest area; 8/10 pain in L axillary and chest area; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly on the left arm, first dose on 17Dec2020 07:15 and second dose on 08Jan2021 07:15, both at a single dose for COVID-19 immunization. There were no medical history nor concomitant medications (within two weeks of vaccination). The patient was not diagnosed with/did not have COVID-19 prior to vaccination, did not receive other vaccines in four weeks prior to vaccination, had no known allergies to medications, food, or other products, and was not pregnant. The most recent COVID-19 vaccine was administered at a hospital facility. On 07Jan2021 18:00, the patient experienced fever 103.5, extreme body aches, headaches 8/10 pain in left axillary and chest area, and HR maintaining 120+ at rest. The patient underwent lab tests and procedures which included COVID test post vaccination with a curative oral swab: negative on 08Jan2021. No treatment was received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain, Pain assessment, Pyrexia, SARS-CoV-2 test
Clinical narrative: HR maintaining 120+ at rest; Fever 103.5; extreme body aches; headaches; 8/10 pain in L axillary and chest area; 8/10 pain in L axillary and chest area; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly on the left arm, first dose on 17Dec2020 07:15 and second dose on 08Jan2021 07:15, both at a single dose for COVID-19 immunization. There were no medical history nor concomitant medications (within two weeks of vaccination). The patient was not diagnosed with/did not have COVID-19 prior to vaccination, did not receive other vaccines in four weeks prior to vaccination, had no known allergies to medications, food, or other products, and was not pregnant. The most recent COVID-19 vaccine was administered at a hospital facility. On 07Jan2021 18:00, the patient experienced fever 103.5, extreme body aches, headaches 8/10 pain in left axillary and chest area, and HR maintaining 120+ at rest. The patient underwent lab tests and procedures which included COVID test post vaccination with a curative oral swab: negative on 08Jan2021. No treatment was received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Off label use, Pain
Clinical narrative: Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; This is a spontaneous report from a Non-contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) via intramuscular into left arm on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose for covid-19 immunization. No covid prior vaccination. The patient known allergies included Cytotec, peanuts, lentils, peas, chick peas and other medical history included Asthma, migraines, kidney stone. There is no other vaccine administered in four weeks. Other medications in two weeks included multi vitamins, vit B2 and magnesium. On 09Jan2021, the patient experienced Fevers, chills, body aches, headache, sore arm and no treatment involved. No covid tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; This is a spontaneous report from a Non-contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) via intramuscular into left arm on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose for covid-19 immunization. No covid prior vaccination. The patient known allergies included Cytotec, peanuts, lentils, peas, chick peas and other medical history included Asthma, migraines, kidney stone. There is no other vaccine administered in four weeks. Other medications in two weeks included multi vitamins, vit B2 and magnesium. On 09Jan2021, the patient experienced Fevers, chills, body aches, headache, sore arm and no treatment involved. No covid tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever, 100.6 F TO 100.9 F; This is a spontaneous report from a contactable pharmacist reportin for herself.  A 54-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL1283) vaccine  , in the right arm  on 08Jan2021 18:15 at  single dose for covid-19 immunisation .  Medical history included rhinitis allergic , seasonal allergy , drug hypersensitivity from an unknown date and unknown if ongoing.  Concomitant medication included cetirizine hydrochloride (CETIRIZINE [CETIRIZINE HYDROCHLORIDE]), estrogens conjugated (PREMARIN).  The patient previously took tramadol and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity. The patient received the first dose of BNT162b2 on 18Dec2020.  The patient experienced fever, between 100.6 °F and  100.9 °F  on 09Jan2021 10:30 with outcome of recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Fatigue, Headache
Clinical narrative: Temperature 99.3; nausea; headache; body aches; fatigue; left hip pain; This is a spontaneous report from a contactable healthcare professional (patient) reported for herself that a 57-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685), via intramuscular at left arm, on 31Dec2020 12:30, at single dose for COVID-19 immunisation. Medical history included ongoing chronic fatigue syndrome, fibromyalgia, sun allergy and lactose intolerant (allergy). Concomitant medications were not reported. Patient did not have COVID prior vaccination. Patient did not receive other vaccine in four weeks nor other medications in two weeks. The patient experienced temperature 99.3, nausea, headache, bodyaches, fatigue, left hip pain, all on 01Jan2021 15:45, no treatment was received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered in Jan2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Temperature 99.3; nausea; headache; body aches; fatigue; left hip pain; This is a spontaneous report from a contactable healthcare professional (patient) reported for herself that a 57-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685), via intramuscular at left arm, on 31Dec2020 12:30, at single dose for COVID-19 immunisation. Medical history included ongoing chronic fatigue syndrome, fibromyalgia, sun allergy and lactose intolerant (allergy). Concomitant medications were not reported. Patient did not have COVID prior vaccination. Patient did not receive other vaccine in four weeks nor other medications in two weeks. The patient experienced temperature 99.3, nausea, headache, bodyaches, fatigue, left hip pain, all on 01Jan2021 15:45, no treatment was received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered in Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Left-sided tender supraclavicular lymph node; This is a spontaneous report from a contactable Physician(patient). This 40-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EK4176), intramuscular at left arm on 09Jan2021 09:15 at single dose for covid-19 immunisation.  Medical history included Eosinophilic Esophagitis, chronic constipation, allergy to tree nuts.  Concomitant medication included macrogol 3350 (MIRALAX). Patient previously received first dose BNT162B2 (Lot number: EH9899) intramuscular at left arm on 19Dec2020 14:30 at single dose for covid-19 immunisation. The patient experienced Left-sided tender supraclavicular lymph node developed the morning after 2nd dose of COVID vaccine on 10Jan2021 06:30 with outcome of recovering. No treatment was received. There was no other vaccine in four weeks, no covid prior vaccination, covid tested post vaccination. Event was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Muscle pain throughout torso; Sore throat; Head ache that comes and goes; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL3246), via an unspecified route of administration, on 06Jan2021 at 12:00 AM, at single dose, for COVID-19 immunisation. Medical history included allergy to some antibiotics. Concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced muscle pain throughout torso, sore throat and head ache that comes and goes all on 09Jan2021 at 07:00 PM with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative on 07Jan2021.