chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: COVID-19 vaccine to a 16 year old; A spontaneous report was received from a nurse concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, COVID-19 vaccine to a 16 year old.  The patient's medical history was not provided. Concomitant medications were not reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported. The reporter stated, the patient would like to receive dose two to complete the vaccine series.    The event, COVID-19 vaccine to a 16 year old, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 16-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of drug administered to patient of inappropriate age. The event is assessed as not related to Moderna COVID-19 Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site; Redness and swelling at the injection site; Given in her lower arm in her tricep area and possibly given subcutaneously; A spontaneous report was received from a nurse who was a 27-year old, female patient who received the Moderna COVID-19 vaccine and experienced given in her lower arm in her tricep area and possibly given subcutaneously and redness and swelling at the injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 026L20A) subcutaneously in her lower arm tricep area for prophylaxis of COVID-19 infection.  On 29 Dec 2020, during vaccine administration, the patient noticed the vaccine was not being administered in her deltoid, but instead possibly subcutaneously in her lower arm, in the tricep area. She was unsure of the needle size as she did not see if at the time of vaccination. She reported experiencing injection site redness and swelling, which she typically experiences when getting the flu vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, given in her lower arm in her tricep area and possibly given subcutaneously, was considered resolved on 29 Dec 2020. The outcome of the events, redness and swelling at the injection site, was not reported.   The reported assessed the events, redness and swelling at the injection site, as related to study drug.; Reporter's Comments: This case concerns a 27-year old, female subject, who experienced a non-serious event of injection site redness, injection site swelling, and wrong route of administration. The event of injection site redness, injection site swelling was expected, and wrong route of administration was unexpected. The events occurred one day after first dose of mRNA-1273, lot # 026L20a. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: vaccine leaked out of patient's arm after administration; A spontaneous report  was received from a healthcare professional concerning a 55-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, vaccine leaked out of patient's arm after administration.  The patient's medical history was not provided. Concomitant product use was not reported.  On 30 Dec 2020 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 30 Dec 2020 some of the vaccine went into the patient's arm and then leaked back out.  The health care professional estimated the leakage amount to be about two drops or 0.1 mL. The patient had no other adverse events or reactions. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, vaccine leaked out of patient's arm after administration, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # Lot #037K20A. There were no reported AEs associated with this case of incorrect dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccination potentially administered below the deltoid muscle; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, vaccination potentially administered below the deltoid muscle.   The patient's medical history was not provided. No relevant concomitant medications were reported   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot #025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, a nurse administered the vaccine to the patient. Later, the nurse questioned whether it was given in the deltoid, or inadvertently administered slightly below the deltoid muscle. The patient reported no symptoms and no treatment was provided for the event.   Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, vaccine potentially administered below the deltoid muscle, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product administered at inappropriate site for mRNA-1273, Lot #025J20-2A.  There were no reported AEs associated with this case of Product administered at inappropriate site.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Product leaked out and dripped down her arm; Product leaked out and dripped down her arm; A spontaneous report was received from a healthcare facility staff member  who was a 44-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the product leaked out and dripped down her arm.   The patient's medical history was not provided. Concomitant product use was not provided.   On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 0011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, some of the product leaked out of the syringe and dripped down the patient's arm during vaccination. She denied experiencing any side effects. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, product leaked out and dripped down her arm, was not provided.   The outcome of the events, product leaked out and dripped down her arm, was considered recovered on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered and exposure via skin contact for mRNA-1273 (Lot number: 0011J20A). There were no reported AEs associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Syringe leaked and the patient did not receive full dose; Vaccine leaked on patient or nurse's skin; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, the syringe leaked and the patient did not receive full dose, and the vaccine leaked on the patient or nurse's skin.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the pharmacist called to report that when they vaccinated the patient, the syringe leaked and the patient did not receive the full dose. The pharmacist stated that they are not sure if the vaccine leaked on the patient or on the nurse's skin. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, the syringe leaked and the patient did not receive full dose and the vaccine leaked on the patient or nurse's skin, were considered resolved on 30 Dec 2020.; 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 and Exposure via skin contact without any associated adverse events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of the vaccine leaked out of the arm, like 2 drop; A spontaneous report was received from a non-health professional concerning a 66-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the vaccine leaked out of the arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (lot number: 011J20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, during vaccine administration, some of the vaccine leaked out of the patient's arm. She estimates leakage of approximately 2 drops. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, some of the vaccine leaked out of the arm, was considered resolved on 30 DEC 2020.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Incorrect dose administered without any associated adverse events.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine leaked out while being administered; A spontaneous report was received from a 60-year-old, female nurse, who was also the patient, who received Moderna's COVID-19 vaccine and experienced vaccine leaked out while being administered.   The patient's medical history was not provided. Concomitant product use was not reported.  On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the vaccine leaked out while being administered. There was a puddle on the floor about the size of a quarter. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.   The event, vaccine leaked out while being administered, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (Lot number: 025J20-2A).  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertent administration of Moderna COVID-19 Vaccine to a 17 year old patient; A spontaneous report was received from a nurse concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inadvertent administration of Moderna COVID-19 vaccine to a 17 year old patient.   The patient's medical history and concomitant product use were not provided.  On 29-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29-Dec-2020, the 17-year-old patient received the vaccine.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, inadvertent administration of Moderna COVID-19 vaccine to a 17 year old patient, was considered recovered on 29 Dec 2020.; 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.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave vaccine to a 17 year old; A spontaneous report was received from a healthcare facility staff member concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, gave vaccine to a 17 year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the healthcare staff member reported the Moderna COVID vaccine was given to a 17 year old patient. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, gave vaccine to a 17 year old, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Pain, Syncope
Clinical narrative: Fainting; Dizziness; Body ache; Joint pain; A spontaneous report was received from a 22-year-old female consumer, who received Moderna's COVID-19 vaccine and experienced dizziness, fainting, joint pain, and body aches.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Dec 2020 at 13:30, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 31 Dec 2020, after vaccine administration, the patient experienced dizziness, fainting, joint pain, and body aches. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the events, dizziness, fainting, joint pain, and body aches, was not reported.; Reporter's Comments: This case concerns a 22 year-old, female patient, who experienced events of dizziness, fainting, joint pain, and body aches. The events occurred on the same day after the first 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: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: some of the vaccine leaked out and only got about 0.3 ml dose; A spontaneous report  was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and some of the vaccine leaked out and she estimates she only got about 0.3 ml dose.  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.   Nurse called to report she had a patient who received the mRNA-1273 vaccine and stated some of the vaccine leaked out and she estimated she only got about a 0.3 mL dose. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The event, some of the vaccine leaked out and she estimates she only got about 0.3 ml dose, was considered resolved.; Reporter's Comments: This case concerns a female patient of unreported age. The patient's medical history is not provided. The patient experienced an unexpected event of incomplete dose administered as some vaccine leaked out (only about 0.3ml dose given to patient). The event occurred on an unknown date during administration of the first dose of mRNA-1273. The sponsor considered the event as not related to mRNA-1273.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered, Injection site pain
Clinical narrative: some of the dose gushed down/ran down her arm and lost some of it; some of the dose gushed down/ran down her arm and lost some of it; Soreness in the right arm at injection site; A spontaneous report was received from a consumer, who was a 36-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the dose gushed down/ran down her arm and lost some of it and soreness in the right arm at injection site.  The patient's medical history was not provided. Concomitant product use was not reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, during vaccine administration, some of the vaccine dose gushed down/ran down the patient's arm and some of the dose was lost. On the same day, the patient began experiencing soreness in her right arm, at the injection site.    Action taken with mRNA-1273 in response to the events was not provided.  The event, some of the dose gushed down/ran down her arm and lost some of it, was considered resolved on 30 Dec 2020. The outcome of the event, soreness in the right arm at injection site, was not reported.; Reporter's Comments: This case concerns a 36 year old, female,  patient. The patient's medical history is not provided. The patient experienced an unexpected event of inappropriate dose administration as some of the dose gushed down her arm and lost some of it. The patient also experienced an expected event of soreness at the injection site. The events occurred on 30 Dec 2020 during the administration of the first dose of mRNA-1273.  The sponsor considered the event, soreness at the injection site as related to mRNA-1273. Pain at the site of injection is listed on the company's fact sheet for the healthcare providers. The sponsor considered the event of inappropriate dose administration and exposure via skin (as some of the dose gushed down the arm) as not related to mRNA-1273.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from vial which had been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 44-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial which had been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for COVID-19 infection prophylaxis.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered vaccine from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns the 44-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273)  from a vial ,which had been punctured for more than 6 hours. On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. Reported event is unlisted for COVID-19 Vaccine (mRNA-1273) and causality assessment was assessed as not applicable.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: 17-Year-old patient was vaccinated; Sore arm; A spontaneous report was received from a nurse concerning a 17-year-old female patient who received Moderna's COVID-19 Vaccine and experienced sore arm and 17-year-old patient was vaccinated.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The vaccine was administered at a University's campus.  On 30 Dec 2020, the patient, a medical assistant, received the vaccine and did not inform the vaccinator of her age until after the vaccine was given. The patient experienced a sore arm after receiving the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, 17-year-old patient was vaccinated, was resolved on 30 Dec 2020. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 17 year old, female, patient.  The patient's medical history is not provided. The event occurred on 30 Dec 2020 during administration of the first dose of the mRNA-1273, lot # 026L20A. This report refers to an unexpected event of administration of mRNA-1273 to patient of inappropriate age (17 year old). The patient had an expected event of pain in arm during the injection.   The sponsor considered the event of vaccine administration to patient of inappropriate age as not related to mRNA-1273. The event of pain in arm is related to mRNA-1273 as 'pain at the site of injection' is the listed event on the company's fact sheet for the healthcare providers.
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Vaccination complication
Clinical narrative: Very serious reaction 12 minutes later; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a very serious reaction 12 minutes later.   The patient's medical history was not reported. Concomitant product use was not reported.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, within 12 minutes of vaccine administration, the patient experienced a very serious reaction. The patient was taken to the emergency room (ER) via emergency medical services (EMS). No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, very serious reaction 12 minutes later, was not reported.; Reporter's Comments: This case concerns an female, who experienced a serious unexpected event of vaccination complication. The event occurred approximately 12 minutes after first dose of mRNA-1273, (Lot# unknown) administration. There is no information available regarding medical history and concomitant medications. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report  was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range.  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. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, 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 Product storage error without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report  was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. 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. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, 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 Product storage error without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. 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. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, 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 Product storage error without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report (United States) was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range.  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. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, 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 Product storage error without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. 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. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, 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 Product storage error without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Did not receive a full dose; A spontaneous report was received from a nurse concerning a 37-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and did not receive the full dose.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 025J202A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The nurse reported that a possible administration error may have occurred because she did not screw on the hub properly. The patient did not receive a full dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The event, patient did not receive the full dose, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a 37-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J202A), reporting did not receive a full dose without any associated adverse events.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Person who first dose of Moderna vaccine...was a 17 year old; 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 01 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 01 JAN 2021, 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 on 01 Jan 2021.; Reporter's Comments: This case concerns a 17 year old patient.  The patient's medical history is not provided.  The event occurred on 01 Jan 2021 during administration of the first dose of the mRNA-1273. This report refers to a case of medication error where mRNA-1273  has been administered to the patient of inappropriate age.  There were no reported adverse  reaction associated with this case.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Joint range of motion decreased, Product administered at inappropriate site
Clinical narrative: Loss of range of motion; Can't sleep; Pain at the injection site; Vaccine was given in the left deltoid bursa instead of the deltoid muscle; A spontaneous report was received from a 65 year-old, female physician, who is also the patient, who received Moderna's COVID-19 vaccine and experienced vaccine was given in the left deltoid bursa instead of the deltoid muscle, loss of range of motion, can't sleep, and pain at the injection site. The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramurally in the left deltoid bursa for prophylaxis of COVID-19 infection. On 02 Jan 2021, the patient reported she had been given the vaccine in the wrong location. The vaccine was given in the left deltoid bursa instead of the deltoid muscle. The patient was also experiencing loss of range of motion, pain at the injection site, and she also can't sleep. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The event vaccine was given in the left deltoid bursa instead of the deltoid muscle was considered resolved on 02 Jan 2021. The events loss of range of motion, can't sleep, and pain at the injection site were considered not recovered/not resolved.; Reporter's Comments: This report refers to a case of 65 year old female patient who experienced non-serious unexpected events of vaccine was given in the left deltoid bursa instead of the deltoid muscle for mRNA-1273, lot #  011L20A. The patient experienced loss of range of motion, pain at the injection site, and can't sleep. Onset latency was not provided.  De-challenge and re-challenge are not applicable. Based on the information provided the events of vaccine was given in the left deltoid bursa instead of the deltoid muscle, loss of range of motion and can't sleep are assessed as unlikely related to mRNA-1273 as this is due to product administration error. The event of pain at the injection site is included in the known safety profile of the vaccine, hence a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock; A spontaneous report was received from a female consumer who received Moderna's COVID-19 Vaccine and experienced anaphylactic shock.  The patient's medical history was not provided. No concomitant product use was reported.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, after vaccine administration, the patient experienced anaphylactic shock and was taken to the hospital. No treatment information was provided.  On 01 Jan 2021, the patient reported feeling much better.  Action taken with mRNA-1273 in response to the event was not reported.  The event, anayphylactic shock, was considered resolved on 01 Jan 2021.; 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 the serious unlisted event of anaphylactic shock. 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: F
Vaccine: COVID19
Symptoms: Needle issue, Underdose
Clinical narrative: Needle fell off of the cartridge; Couple of drops of vaccine fell onto elbow; A spontaneous report was received from a healthcare professional, who was also a female patient, who received Moderna's COVID-19 Vaccine, and experienced needle fell off the cartridge, and couple drops of vaccine fell onto her elbow.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, 0 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, during vaccine administration, the patient reported the needle fell off the cartridge when the nurse was injecting the vaccine, and a couple drops of vaccine fell onto her elbow. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, needle fell off the cartridge, and couple drops of vaccine fell onto her elbow, were considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a female patient of an unknown age. The patient's medical history and concomitant medications were not provided. The patient experienced a non serious event of needle fell off the cartridge, and couple of drops of vaccine fell onto her elbow. The event occurred on the same day as the first dose of the mRNA-1273. Very limited information regarding this event has been provided at this time.  Additional information is required for further assessment.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to 16 year old; A spontaneous report  was received from a pharmacist concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to a 16 year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 1 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 1 Jan 2021, vaccine was given to a 16-year-old, per the pharmacist. The patient had no reported adverse reactions. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to 16 year old, was considered resolved on 1 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.   There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of the dose squirted out on her; A spontaneous report was received from a health care professional, concerning a 54-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incomplete dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly, in right arm, for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient stated that some of the dose squirted out on her.  No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, incomplete dose administered, was considered resolved on 02 Jan 2021.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old was inadvertently given the Moderna COVID 19 vaccine; A spontaneous report (United States) was received from a pharmacist concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 16 year old received vaccine. The patient's medical history was not provided. Concomitant medications were not reported. On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 025J20A) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the Moderna COVID-19 vaccine was inadvertently given to the patient by one of their staff with the consent of the parent. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was unknown.   The event, 16 year old received vaccine, was considered resolved on 24 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # 025J20A. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Dyspnoea, Dyspnoea exertional
Clinical narrative: Achy neck; Stiff neck; Monocyte was high; Diarrhea; Passed out; Very dizzy; Chills; Headache; Fatigue; Walking across a room takes breath out; Lightheaded; A spontaneous report was received from a consumer, who was a 29-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the events, passed out, very dizzy, lightheaded, fatigue, walking across a room takes breath out, headache, chills, diarrhea, monocyte was high, and stiff and achy neck.   The patient's medical history was not provided.  Concomitant product use included acetylsalicylic acid.  On 31 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  During the morning hours of 01 Jan 2021, the patient passed out, felt dizzy, lightheaded, fatigued, had a headache, and chills. The patient reported that walking across a room took the breath out of her.    On 02 Jan 2021 the patient experienced diarrhea in the evening.   On 03 Jan 2021 the patient presented to the emergency room but was not admitted. Her monocyte count was high, but other lab results were normal.  Her headache was treated with anti-migraine medication intravenously.  She stated she was still experiencing dizziness and her neck was still achy and stiff.  No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, passed out, lightheaded, fatigue, walking across a room takes breath out, headache, chills, diarrhea, and monocyte was high, was unknown.  The events, dizziness and stiff and achy neck, were considered not resolved.; Reporter's Comments: This case concerns a 29-year-old female patient  with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot 0371C20A), and who experienced the serious unlisted event of Syncope, the non-serious listed events of diarrhea, chills, headache, and fatigue, and the non-serious unlisted events of Dizziness, Monocyte count increased, Musculoskeletal stiffness, Dizziness (lightheadedness), Neck pain, and Dyspnoea.  Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  The events may be explained by an undiagnosed viral illness based on the constellation of symptoms and elevated monocyte count.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Loss of consciousness, Monocyte count, Monocyte count increased
Clinical narrative: Achy neck; Stiff neck; Monocyte was high; Diarrhea; Passed out; Very dizzy; Chills; Headache; Fatigue; Walking across a room takes breath out; Lightheaded; A spontaneous report was received from a consumer, who was a 29-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the events, passed out, very dizzy, lightheaded, fatigue, walking across a room takes breath out, headache, chills, diarrhea, monocyte was high, and stiff and achy neck.   The patient's medical history was not provided.  Concomitant product use included acetylsalicylic acid.  On 31 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  During the morning hours of 01 Jan 2021, the patient passed out, felt dizzy, lightheaded, fatigued, had a headache, and chills. The patient reported that walking across a room took the breath out of her.    On 02 Jan 2021 the patient experienced diarrhea in the evening.   On 03 Jan 2021 the patient presented to the emergency room but was not admitted. Her monocyte count was high, but other lab results were normal.  Her headache was treated with anti-migraine medication intravenously.  She stated she was still experiencing dizziness and her neck was still achy and stiff.  No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, passed out, lightheaded, fatigue, walking across a room takes breath out, headache, chills, diarrhea, and monocyte was high, was unknown.  The events, dizziness and stiff and achy neck, were considered not resolved.; Reporter's Comments: This case concerns a 29-year-old female patient  with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot 0371C20A), and who experienced the serious unlisted event of Syncope, the non-serious listed events of diarrhea, chills, headache, and fatigue, and the non-serious unlisted events of Dizziness, Monocyte count increased, Musculoskeletal stiffness, Dizziness (lightheadedness), Neck pain, and Dyspnoea.  Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  The events may be explained by an undiagnosed viral illness based on the constellation of symptoms and elevated monocyte count.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Syncope
Clinical narrative: Achy neck; Stiff neck; Monocyte was high; Diarrhea; Passed out; Very dizzy; Chills; Headache; Fatigue; Walking across a room takes breath out; Lightheaded; A spontaneous report was received from a consumer, who was a 29-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the events, passed out, very dizzy, lightheaded, fatigue, walking across a room takes breath out, headache, chills, diarrhea, monocyte was high, and stiff and achy neck.   The patient's medical history was not provided.  Concomitant product use included acetylsalicylic acid.  On 31 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  During the morning hours of 01 Jan 2021, the patient passed out, felt dizzy, lightheaded, fatigued, had a headache, and chills. The patient reported that walking across a room took the breath out of her.    On 02 Jan 2021 the patient experienced diarrhea in the evening.   On 03 Jan 2021 the patient presented to the emergency room but was not admitted. Her monocyte count was high, but other lab results were normal.  Her headache was treated with anti-migraine medication intravenously.  She stated she was still experiencing dizziness and her neck was still achy and stiff.  No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, passed out, lightheaded, fatigue, walking across a room takes breath out, headache, chills, diarrhea, and monocyte was high, was unknown.  The events, dizziness and stiff and achy neck, were considered not resolved.; Reporter's Comments: This case concerns a 29-year-old female patient  with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot 0371C20A), and who experienced the serious unlisted event of Syncope, the non-serious listed events of diarrhea, chills, headache, and fatigue, and the non-serious unlisted events of Dizziness, Monocyte count increased, Musculoskeletal stiffness, Dizziness (lightheadedness), Neck pain, and Dyspnoea.  Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  The events may be explained by an undiagnosed viral illness based on the constellation of symptoms and elevated monocyte count.