chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 48-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 48-year-old subject who experienced the unlisted event of administered vaccine that was not stored in recommended temperature. The sponsor considers the event as Unassessable, because the event is a storage error.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Syringe malfunctioned and leaking during administration; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced syringe malfunctioned and leaking during administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, a health care provider administered the mRNA-1273 vaccine to a patient.  During the administration, the syringe malfunctioned and leaked during administration.  The health care provider was uncertain if the patient received the full dose of the vaccine or how much of the vaccine was spilled. The patient had no observable symptoms and did not receive any treatment for the event.  Action taken with mRNA-1273 in response to the event was not reported.   The event, syringe malfunctioned and leaking during administration, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, syringe malfunctioned and leaking during administration, to study drug.; Reporter's Comments: This case concerns a  patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.; Sender's Comments: No adverse event
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered at inappropriate site, Product administration error
Clinical narrative: Did not think vaccination was given in her deltoid muscle in upper left arm; A report was received from a consumer, who is also a nurse and a 29-year-old, female patient participating in the mRNA-1273 Emergency Use Program and who did not think vaccination was given in her deltoid muscle in upper left arm.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020. On 22 Dec 2020, at the same time as the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.    The patient, a nurse practitioner working on the front line, stated that she did not think the health care provider injected the vaccine in her actual deltoid muscle because she is skinny.  To her, the injection seemed further back. She was not having any side effects from the injection.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, does not think vaccination was given in her deltoid muscle in upper left arm, was considered unknown.   The reporter did not provide an assessment for the event, does not think vaccination was given in her deltoid muscle in upper left arm.; Reporter's Comments: This case concerns a 29-year-old, female patient who experienced the unlisted event of product administration error- did not think vaccination was given in her deltoid muscle in upper left arm. The event occurred the same day after the first dose of Moderna COVID-19 Vaccine administration. The reporter causality assessment for the event was not provided. The reported event is more of a human error and noting the subject's thin built, the event was unlikely related to Moderna COVID-19 Vaccine.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 31-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 31-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 46-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 46-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 28-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 28-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 29-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 29-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 48-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 48-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 23-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 23-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 61-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 61-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated AE.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 30-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 30-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 47-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 47-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 73-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 73-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 79-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 79-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 49-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 49-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 43-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 43-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 56-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 56-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 57-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 57-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 39-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 39-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Product administration error
Clinical narrative: Patient bleeding was more than usual; Needle of the syrine inadvertently came out of arm and drip; A report was received from a pharmacist concerning a 34-year-old patient who was participating in mRNA-1273 Emergency Use Program and experienced the events, product administration error and bleeding more than usual.  The patients' medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020. On 23 Dec 2020, at the same time as the events, the patient received their first of two planned doses of mRNA-1273 (lot 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Dec 2020, when the patient was receiving the vaccine, the needle of the syringe inadvertently came out of the patient's arm and two drips of the dose dripped out of the syringe. The needle was replaced and the remaining dose in the syringe was administered to the patient at a close site of the original injection site on left arm. The patient bleeding was more than usual and is under post vaccination protocol. Treatment for the events was not provided.  The outcome of the events, product administration error and bleeding more than usual, was not reported.   Action taken with mRNA-1273 in response to the events was not provided.  The reporter assessment of causality of events, product administration error, bleeding more than usual, was not provided.; Reporter's Comments: This case concerns a 34-year-old, patient who experienced the unlisted events of injection site bleeding and product administration error. The events of injection site bleeding and product administration error occurred on the same day after the first dose of Moderna COVID-19 Vaccine administration. The reporter causality assessment for the events was not provided. Due to the temporal association between onset of injection site bleeding and the administration of the vaccine, a causal relationship cannot be excluded. Additional information regarding the reason for the bleeding, patient's medical history and concomitant medication details are required for further assessment. However, the needle of the syringe slipping out of the arm is more of a human error. The event of product administration error was unlikely related to Moderna COVID-19 Vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Employee did not receive full dose because needle broke and some of the vaccine liquid ran down their arm; A spontaneous report (United States) was received from a pharmacist's assistant concerning a 57-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.  On 23 Dec 2020, during vaccine administration, the patient experienced incorrect dose administered. During the patient's vaccination, the needle came off the syringe and some of the vaccine liquid leaked down the patient's arm. The reporter felt that the needle was not tightened enough prior to administering the vaccine. No treatment was administered for the event.  Action taken with mRNA-1273 in response to the event was not reported.  The event, incorrect dose administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a 57 year old, female, patient. The patient's medical history is not provided. The patient experienced an unexpected event of incomplete dose administered. The event occurred on 23 Dec 2020 during administration of the first dose of mRNA-1273 (Lot number: 039K20A). The sponsor considered the event as not related to mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The vaccine ran down from the injection site to the elbow; A spontaneous report was received from a healthcare facility staff member concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, vaccine ran down from the injection site to the elbow.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. During vaccine administration, the syringe that comes with the vaccine popped off and the vaccine ran down from the injection site to the elbow. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, vaccine ran down from the injection site to the elbow, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of incomplete dose administered. This event occurred the same day of vaccine administration. The reporter did not provide the causality assessment for the events. The event is more of a mechanical error and was assessed as not related to Moderna COVID-19 Vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: had an occurrence on Monday of an outbreak of herpes; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse reporting for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took valaciclovir hydrochloride (VALTREX). Patient stated "I stopped taking my Valtrex a week before getting the vaccine. I got the vaccine on Friday. I started having symptoms again and started taking it again". Patient also stated "I've been told that effectiveness of flu vaccine might not be as good for people taking this medication". Patient was inquiring about taking Valtrex medication before/during her 2 dose vaccine. She stated that she is a nurse in healthcare and she received an email. She received her first dose of the Covid vaccine on a Friday and had an occurrence on Monday of an outbreak of herpes. She stated she was taking Valtrex to suppress her symptoms for a year and stopped taking her medication a week before receiving the vaccine. She stated that she tested for Covid a week before receiving the vaccine as well due to exposure at work. She stopped the medication and panicked thinking it would have an interaction since reading information regarding flu vaccine. Patient states she could not get up with HCP regarding stopping her Valtrex so she called Pfizer. She spoke to someone at Pfizer that asked her if it would be okay to relay her information to someone else and she said yes. Then she received a weird email from [Company name] that said they were made aware a person that was under your care received the flu vaccine. Patient states she does not administer vaccines, she works at the hospital. Patient states she called the company and they did not have any information. She also called her HCP who told her to contact Pfizer to see what the email is all about. Her HCP told her to restart her medication and there is no interaction with Valtrex. Her HCP informed her that the only time she should stop taking her Valtrex is if she was receiving the shingles vaccine or a live vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Feeling abnormal, Headache
Clinical narrative: Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown.  Information on the batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Muscle spasms, Myalgia, Pain
Clinical narrative: Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown.  Information on the batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Screaming
Clinical narrative: Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown.  Information on the batch/lot number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain
Clinical narrative: sore throat, cough, and headache; sore throat, cough, and headache; sore throat, cough, and headache; This is a spontaneous report from a contactable nurse.  A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration on 24Dec2020 as single dose for COVID-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced sore throat, cough, and headache on an unspecified date. No treatment was given for the events. The outcome of sore throat, cough, and headache was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal pain, Malaise, Pain, Pyrexia
Clinical narrative: throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contracted COVID-19; thought she had contracted COVID-19; tired; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration on left arm on 17Dec2020 at 19:15, at a single dose for vaccination.  Medical history included ongoing ulcerative colitis, onset date was unknown, but when she was about 25 years of age.  Concomitant medication included ongoing azathioprine for ulcerative colitis, started probably 5-10 years ago and taken daily since. In the past, she took different products for ulcerative colitis off and on when she had an episode. This patient reported she was administered her first Pfizer COVID-19 Vaccine injection on 17Dec2020 and was just kind of tired on 17Dec2020; but she had onset of serious reactions to the COVID-19 Vaccine starting 18Dec2020 for 2 days straight and then as suddenly as the events started they suddenly stopped after 2 days with no lasting effects. She called to ask if there is any data about if the second dose of the COVID-19 Vaccine will be just like the first shot or if the events are just hit or miss; she is really hoping not to be that sick again with the second dose. Serious reactions to the COVID-19 Vaccine further described as sick for like 2 days straight. Afternoon of 18Dec2020 she was throwing up; had fever; body aches; thought she had contracted COVID-19 in between injection and onset of symptoms; she had no lung issues; her whole body hurt; she could not stop throwing up; her whole intestines hurt; it was horrible; she could not hold anything down for like 2 straight days and then just left on 20Dec2020. Scheduled date for second dose was on 06Jan2021, she has no plan to change dose schedule. The outcome of the event of tired recovered in Dec2020, while other events recovered on 20Dec2020.