chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: No available appointment for second dose of vaccine; Sore arm; A spontaneous report was received from a 58 year old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and there was no available appointment for second dose of vaccine and developed a sore arm.   The patient's medical history included hypertension. Concomitant medications reported included unspecified hypertension medications.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, after vaccine administration, the patient was a little sore for a day and a half.  On 31 Dec 2020, the patient reported that her second dose of the vaccine should be on 25 Jan 2021 and that there was no available appointment for her. It had been recommended to the patient that she receive her second dose within 36 days of the first dose. No treatment was administered for the events.  Action taken with mRNA-1273 in response to the events was unknown.  The event, developed a sore arm, was considered resolved on 29 Dec 2020. The event, no available appointment for second dose of vaccine was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 58 year-old female, who experienced a non-serious expected event of pain in extremity and Inappropriate schedule of Product administration. The event occurred soon after the first dose of mRNA-1273, lot # 025J20-2A. Based on the current available information and temporal association between the use of the product and the start date of the event, for the event of pain in extremity a causal relationship cannot be excluded. There was no reported AE associated with this case of Inappropriate schedule of Product administration.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Patient received vaccine past the six hour expiration date; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient received vaccine past the six hour expiration date.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received an mRNA-1273 vaccine dose that was past the six-hour expiration date. The first dose from the vial had been administered more than six hours before the patient received their dose. The patient did not experience any adverse events. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The event, patient received vaccine past the six hour expiration date, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # 025L20a. There were no reported AEs associated with this case of out of specification product use.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Patient received vaccine past the six hour expiration date; A spontaneous report was received from a nurse concerning a patient who received MODERNA's COVID-19 vaccine (mRNA-1273) and the patient received vaccine past the six hour expiration date.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received an mRNA-1273 vaccine dose that was past the six-hour expiration date. The first dose from the vial had been administered more than six hours before the patient received their dose. The patient did not experience any adverse events. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The event, patient received vaccine past the six hour expiration date, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # 025L20A. There were no reported adverse events associated with this case of out of specification product use.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Patient received vaccine past the six hour expiration date; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient received vaccine past the six hour expiration date.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient received an mRNA-1273 vaccine dose that was past the six-hour expiration date. The first dose from the vial had been administered more than six hours before the patient received their dose. The patient did not experience any adverse events. Treatment information was not provided.      Action taken with mRNA-1273 in response to the event was not reported.  The event, patient received vaccine past the six hour expiration date, was considered resolved on 01 Jan 2021.; Reporter's Comments: This case concerns a  patient of unknown age and gender.  The patient's medical history is not provided.  The event occurred on 01 Jan 2021, when the patient received the first dose of the mRNA-1273  (Lot number: 025L20A), past the six hour expiration date. This report refers to a case of Product administration error where mRNA-1273(Lot number: 025L20A)  was given past 6 hours of opening the vial. There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Patient received vaccine past the six hour expiration date; A spontaneous report was received from a nurse concerning a 46-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient received vaccine past the six hour expiration date.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received an mRNA-1273 vaccine dose that was past the six-hour expiration date. The first dose from the vial had been administered more than six hours before the patient received his dose. The patient did not experience any adverse events. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The event, patient received vaccine past the six hour expiration date, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 46 year old, male patient.  The patient's medical history is not provided.  The event occurred on 31 Dec 2020, when the patient was given the first dose of the mRNA-1273  (Lot number: 025L20A), past the six hour expiration date. This report refers to a case of Product administration error where mRNA-1273(Lot number: 025L20A)  was given past 6 hours of opening the vial. There were no reported AEs associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vaccine given from vial outside of 6 hour storage window; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced expired product administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an undisclosed date, a vial containing mRNA-1273 was punctured and stored refrigerated for over six hours.  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 from the vial that had been punctured over six hours ago, and the patient experienced expired product administered.  Action taken with mRNA-1273 in response to the event was not reported.  The event, expired product administered, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient of unknown age and gender.  The patient's medical history is not provided. This report refers to a case of out of specification product use for mRNA-1273 on an unknown date.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave a 16 year old male a COVID-19 injection; A spontaneous report was received from a pharmacist concerning a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, gave a 16-year-old male a COVID-19 injection.   The patient's medical history was not provided.  No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, a nurse gave a 16-year-old patient a COVID-19 injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, gave a 16-year-old male a COVID-19 injection, was considered resolved.; 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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to pediatric patient; A spontaneous report was received from a nurse concerning a 16 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine was administered to a pediatric patient.  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 #026L20A) on 31 Dec 2020, intramuscularly in the left arm, for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the Moderna vaccine was administered by error to a pediatric patient. The patient experiences no symptoms and was absolutely fine.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine was administered to a pediatric patient, 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 026L20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product storage error
Clinical narrative: Given vaccine 12 hours after vial was punctured; Sore arm; A spontaneous report was received from a healthcare professional who was also a 37-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced product storage error and sore arm.  The patient's medical history was not provided.  Concomitant products included alprazolam.  On 31 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced product storage error when she received a dose of vaccine taken from a vial that had been punctured 12 hours before. She also experienced a sore arm.  Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the event, product storage error, was resolved on 31 Dec 2020.  The outcome of the event, sore arm, was unknown.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273 and concerns a 37 year-old, female patient, who experienced the event of pain in extremity. The event occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Product administration error
Clinical narrative: Very hot. Warm to touch; Large area of redness around his arm; Doubt if the shot was done intramuscularly; A spontaneous report was received from a nurse concerning a 55 year-old, male patient who received Moderna's COVID-19 vaccine and experienced a large area of redness around his arm, Very hot. Warm to the touch, and doubt if the shot was done intramuscularly.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included regular medication for cholesterol, triglycerides and antidepressant.    On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in their left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient experienced a very large area of redness around his arm. Very hot. Warm to touch. The reporter noted that the person administering the vaccine did not have the right technique, and they doubt if the shot was done intramuscularly. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The events large area of redness around his arm and Very hot. Warm to the touch were considered not recovered/not resolved. The event doubt if the shot was done intramuscularly was considered recovered/resolved on 27 Dec 2020.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 and concerns a 55 year-old, male patient, who experienced the events of injection site warmth and erythema. The event occurred 9 days after the first and only dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 17 year old received the vaccine.  The patient's medical history was not provided. No concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the 17-year-old patient received the mRNA-1273 vaccine. The patient did not experience any symptoms and did not receive any treatments.   Action taken with mRNA-1273 in response to the event was unknown.  The event, 17 year old received the vaccine, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of 17- year-old female patient who received the mRNA-1273 vaccine (Inappropriate age at vaccine administration)  Lot # was not provided. There were no reported AEs associated with this case of Incomplete dose administered
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Incorrect dose administered
Clinical narrative: A good portion of the vaccine ran on arm; A good portion of the vaccine ran on arm; The needle and the syringe separated; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, the needle and the syringe separated and a good portion of the vaccine on arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   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, during vaccine administration, the needle and syringe separated and a good portion the vaccine ran down the patient's arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, the needle and the syringe separated and a good portion of the vaccine ran on arm, were considered resolved on 29 Dec 2020.; Reporter's Comments: This report refers to a case of out of incorrect dose administered, exposure via skin contact and device connection issue for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of incorrect dose administered, exposure via skin contact and device connection issue.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Facial paralysis, Fatigue, Hypoaesthesia
Clinical narrative: Part of face a little paralyzed; Part of face numb; Chills; Tiredness; A spontaneous report was received from a health care professional, who was a 45 year-old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced chills, tiredness, part of face numb, and part of face a little paralyzed.   The patient's medical history included type 1 diabetes. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the evening after vaccine administration, the patient experienced chills and tiredness.  On 31 Dec 2020 the patient woke up with his face numb and a little paralyzed. At the time of reporting, the patient mentioned that the numbness and paralysis on his face had been like that for various days and was still ongoing. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills and tiredness, was unknown. The outcome of the events, part of face numb and part of face a little paralyzed, was considered not resolved.; Reporter's Comments: This case concerns a 45 year old male patient with medical history of type I diabetes, who experienced a serious unexpected event of Facial paralysis, a NS unexpected event of Hypoaesthesia, and NS expected events of Chills and Fatigue. The events of Chills and Fatigue occurred on the same day when the patient received the first of two planned doses of mRNA-1273. The events of Facial paralysis and Hypoaesthesia occurred the next day of administration of mRNA-1273. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain, Pain
Clinical narrative: Muscle pull; A spontaneous report was received from a physician, concerning an 84-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pull.   The patient's medical history was not provided.  Concomitant medications included blood thinners.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, on the same day of vaccine administration, the patient experienced severe pain in the arm, shoulder, and front of his chest into his back. He was taken to the emergency room (ER) where he was diagnosed with a muscle pull and was admitted to the hospital for one night. Treatment for the event included 500mg paracetamol. At the time of the report, the patient was still experiencing symptoms.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, muscle pull, was considered not resolved.; Reporter's Comments: Company comment: This case concerns an 84-year-old male patient, who experienced unexpected serious event of muscle pull. The event occurred 1 days after the administration of the first and only dose of the Moderna's COVID-19 vaccine (mRNA-1273). Based on the known cause for muscle pull which is mostly due to an overstretched or torn muscle, the event is assessed as unlikely related to mRNA-1273 administration.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Poor quality product administered
Clinical narrative: Vaccinated with shaken vaccine; Pain at the injection site; A spontaneous report was received from a pharmacist concerning a 24 year-old female patient who received Moderna's COVID-19 vaccine and experienced vaccinated with shaken vaccine and pain at the injection site.                           The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.     On 04 Jan 2021, the reporter stated that the technician shook the vial while administering the vaccine on an unknown date.They also reported that symptoms included pain at the injection site.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, vaccinated with shaken vaccine was considered resolved. The outcome of the event, pain at the injection site, was unknown.; Reporter's Comments: This case concerns a 24 year-old female, who experienced a non-serious expected event of injection site pain and wrong technique in product usage process. The event occurred soon (exact time not provided) after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the start date of the event, for the event of injection site pain a causal relationship cannot be excluded. There was no reported AE associated with this case of wrong technique in product usage process.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-002858: US-MODERNATX, INC.-MOD-2021-002872: US-MODERNATX, INC.-MOD-2021-002862:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Poor quality product administered, Pyrexia
Clinical narrative: Vaccinated with shaken vaccine; Pain at the injection site; Mild fever; A spontaneous report was received from a pharmacist concerning a 56-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccinated with shaken vaccine, pain at the injection site, and mild fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, approximately 0 days prior to the onset of the event, vaccinated with shaken vaccine, and 1 day prior to the onset of the events, pain at the injection site, and mild fever the next day,  the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   During vaccine administration, the patient noticed the vaccinating technician shook the vial while administering the vaccine. One day after vaccination, the patient experienced pain at the injection site and mild fever. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, vaccinated with shaken vaccine, was considered resolved on an unknown date. The outcome of the events, pain at the injection site and mild fever were unknown.; Reporter's Comments: Company comment: This case concerns a 56-year old, male subject, who experienced a non-serious expected event of Injection site pain and pyrexia, and non-serious unexpected event of wrong technique in product usage process. The event of injection site pain and pyrexia occurred 1 days after the first dose of mRNA-1273, lot # unknown. Treatment details not available. Very limited information regarding this event/s has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-002862: US-MODERNATX, INC.-MOD-2021-002848: US-MODERNATX, INC.-MOD-2021-002858: US-MODERNATX, INC.-MOD-2021-002872: US-MODERNATX, INC.-MOD-2021-002858:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Poor quality product administered
Clinical narrative: Vaccinated with shaken vaccine; pain at the injection site; A spontaneous report  was received from a pharmacist concerning a 57-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine that was shaken and pain at the injection site.   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 an undisclosed date intramuscularly for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the reporter stated that  on a undisclosed date, the technician shook the vial while administering the vaccine to the patient. They also reported that symptoms included pain at the injection site.  No treatment information was provided  Action taken with mRNA-1273 in response to the events, the technician shook the vial while administering the vaccine and pain at the injection site, was not provided.   The events, the technician shook the vial while administering the vaccine was considered recovered/resolved.   The outcome of the events, pain at the injection site was not reported.; Reporter's Comments: This case concerns a 57-year-old  male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Out of specification product use and Injection site pain.  Based on the known safety profile and temporal association between vaccination and onset of the event, a causal relationship cannot be excluded, and the event Injection site pain is considered possibly related to the vaccine.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-002858: US-MODERNATX, INC.-MOD-2021-002848: US-MODERNATX, INC.-MOD-2021-002872:
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Incomplete dose; A spontaneous report was received from a pharmacist concerning an unidentified patient who received Moderna's COVID-19 Vaccine (mRNA-1273)and experienced incomplete dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, approximately 0 days prior to the onset of the event, the patient received their first/second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the vaccinating pharmacist reported when they pulled the needle of the syringe from the patient's arm, it seemed like the entire dose of vaccine came out. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, while pulling the needle of the syringe from patient's arm, it seems the entire dose of the vaccine came out, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to the case of a patient who during administration of Moderna's mRNA-1273 vaccine (lot # unknown, Exp. Unknown) when they pulled the needle of the syringe from the patient's arm, it seemed like the entire dose of vaccine came out. There were no reported AEs associated with this case of when they pulled the needle of the syringe from the patient's arm, it seemed like the entire dose of vaccine came out.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Poor quality product administered
Clinical narrative: Vaccinated with shaken vaccine; pain at the injection site; A spontaneous report  was received from a pharmacist concerning a 36 year-old female patient who received Moderna's COVID-19 vaccine and experienced the technician shook the vial while administering the vaccine and pain at the injection site.                           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 in the right arm for prophylaxis of COVID-19 infection.     On 04 Jan 2021, the reporter stated that the technician shook the vial while administering the vaccine. They also reported that symptoms included pain at the injection site.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, technician shook the vial while administering the vaccine was considered resolved. The outcome of the event, pain at the injection site, was unknown.; Reporter's Comments: This report refers to a case of Out of specification product use for mRNA-1273 and concerns a 36 year-old, female patient, who experienced the event of injection site pain. The event occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-002862: US-MODERNATX, INC.-MOD-2021-002858: US-MODERNATX, INC.-MOD-2021-002848:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 8 hours of refrigeration instead of 6 hours; A spontaneous report was received from a physician concerning a 36-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered vaccine after 8 hours of refrigeration instead of 6 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A, Exp. date: 25 May 2021) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient was administered with a vaccine dose that had been stored in the refrigerator for 8 hours due to a misunderstanding with the instructions. 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 after 8 hours of refrigeration instead of 6 hours, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of 36- year-old female patient who experienced non-serious unexpected event of patient was administered vaccine after 8 hours of refrigeration instead of 6 hours.(Expired product administered) for mRNA-1273, lot # 025J20A, Exp. date: 25 -May -021. There were no reported AEs associated with this case of administered vaccine after 8 hours of refrigeration instead of 6 hours.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Loss of consciousness, Malaise, Seizure
Clinical narrative: I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included R.A.D., osteopenia, migraine with aura, the patient had previously suffered episodes of vasal vagal syncopy when she got the flu or other severe illnesses, and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included atenolol, atorvastatin, azelastine, and fluticasone. The patient previously took gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced allergies. The morning after receiving the vaccine, she felt quite sick, like she had the flu. When she got up from bed and went to the bathroom to urinate, she became very lightheaded and dizzy. She attempted to return to bed, but passed out on the bedroom floor before she could get to the bed, and seized while she was unconscious. Once she came to, she was helped to bed and, after about 90 minutes, felt much better, and got up, and ate food and had coffee. All events occurred at 07:30 AM on 09Jan2021. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Fall, Loss of consciousness, Malaise
Clinical narrative: Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started to bleed; Humongous scar on her nose; In her hand there's a rash with different dots/red; She has petechiae/rash on the forearm; hit her face; knocked out, hit her nose; This is a spontaneous report from a contactable physician. This physician reported that a 30-year-old female patient (daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blacked out, fainted, felt very unwell, nauseous, chills, fell, knocked out, hit her nose, started to bleed, humongous scar on her nose, in her hand there's a rash with different dots/red, she has petechiae/rash on the forearm, all on an unspecified date in Jan2021. The Caller wanted information on side effects specifically looking at platelet or clotting or bleeding issues. Her daughter, (female, age 29 date of birth) received the 2nd dose of Pfizer vaccine, received it at the (State name), last night. She felt very unwell, nauseous, chills, and then blacked out, fell, knocked out, hit her nose, started to bleed; fainted and hit her face, didn't stop bleeding for 2 hours. There's a humongous scar on her nose. It took 2 hours to stop bleeding. She's going to urgent care today. Her daughter was healthy, yesterday was 2nd dose. In her hand, there's a rash with different dots/red. She has petechiae/rash on the forearm. Thankfully it (bleeding) did stop. The outcome of events for 'knocked out, hit her nose, started to bleed' was resolved on an unspecified date, for other events was unknown. The case was reported as non-serious.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based solely on a chronological association a causal relationship between events blacked out  and fainted and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal injury, Nausea, Petechiae, Rash, Rash erythematous
Clinical narrative: Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started to bleed; Humongous scar on her nose; In her hand there's a rash with different dots/red; She has petechiae/rash on the forearm; hit her face; knocked out, hit her nose; This is a spontaneous report from a contactable physician. This physician reported that a 30-year-old female patient (daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blacked out, fainted, felt very unwell, nauseous, chills, fell, knocked out, hit her nose, started to bleed, humongous scar on her nose, in her hand there's a rash with different dots/red, she has petechiae/rash on the forearm, all on an unspecified date in Jan2021. The Caller wanted information on side effects specifically looking at platelet or clotting or bleeding issues. Her daughter, (female, age 29 date of birth) received the 2nd dose of Pfizer vaccine, received it at the (State name), last night. She felt very unwell, nauseous, chills, and then blacked out, fell, knocked out, hit her nose, started to bleed; fainted and hit her face, didn't stop bleeding for 2 hours. There's a humongous scar on her nose. It took 2 hours to stop bleeding. She's going to urgent care today. Her daughter was healthy, yesterday was 2nd dose. In her hand, there's a rash with different dots/red. She has petechiae/rash on the forearm. Thankfully it (bleeding) did stop. The outcome of events for 'knocked out, hit her nose, started to bleed' was resolved on an unspecified date, for other events was unknown. The case was reported as non-serious.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based solely on a chronological association a causal relationship between events blacked out  and fainted and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Scar, Syncope
Clinical narrative: Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started to bleed; Humongous scar on her nose; In her hand there's a rash with different dots/red; She has petechiae/rash on the forearm; hit her face; knocked out, hit her nose; This is a spontaneous report from a contactable physician. This physician reported that a 30-year-old female patient (daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blacked out, fainted, felt very unwell, nauseous, chills, fell, knocked out, hit her nose, started to bleed, humongous scar on her nose, in her hand there's a rash with different dots/red, she has petechiae/rash on the forearm, all on an unspecified date in Jan2021. The Caller wanted information on side effects specifically looking at platelet or clotting or bleeding issues. Her daughter, (female, age 29 date of birth) received the 2nd dose of Pfizer vaccine, received it at the (State name), last night. She felt very unwell, nauseous, chills, and then blacked out, fell, knocked out, hit her nose, started to bleed; fainted and hit her face, didn't stop bleeding for 2 hours. There's a humongous scar on her nose. It took 2 hours to stop bleeding. She's going to urgent care today. Her daughter was healthy, yesterday was 2nd dose. In her hand, there's a rash with different dots/red. She has petechiae/rash on the forearm. Thankfully it (bleeding) did stop. The outcome of events for 'knocked out, hit her nose, started to bleed' was resolved on an unspecified date, for other events was unknown. The case was reported as non-serious.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based solely on a chronological association a causal relationship between events blacked out  and fainted and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia
Clinical narrative: Muscle, joint and back aches; Muscle, joint and back aches; Muscle, joint and back aches; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date not reported), via an unspecified route of administration on the left arm on 08Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included appendicectomy in 2000. Concomitant medication included alprazolam (XANAX), linaclotide (LINZESS), fluoxetine (FLUOXETINE), buprenorphine hydrochloride, naloxone hydrochloride (BUPRENORPHINE/NALOXONE). The patient received first dose of bnt162b2 (lot number and expiration date not reported) on an unspecified date for COVID-19 immunization. The patient experienced muscle, joint and back aches on 09Jan2021 22:00. No treatment was given in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Redness, itching, hives on and around injection site; Redness, itching, hives on and around injection site; hives on and around injection site approximately 5 hours; This is a spontaneous report from a contactable nurse who reported for herself, a 37-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown) at the Workplace clinic, intramuscular in the right arm on 08Jan2021 at 16:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Patient had no COVID prior to vaccination, and was not COVID tested post vaccination. The patient was not pregnant. There were no concomitant medications. The patient previously took and had known allergies to morphine and Hep B vaccine preservative. The patient previously received the first dose of BNT162B2 (unknown lot number) on 18Dec2020 at 11:45 AM, at 36 years of age, via intramuscular in the right arm for COVID-19 immunization. On 08Jan2021 at 21:15, the patient experienced redness, itching, hives on and around injection site approximately 5 hours after 2nd dose, still present 2 days later. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; Information on lot/batch cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful and enlarged left axillary lymphadenopathy; Painful and enlarged left axillary lymphadenopathy; This is a spontaneous report from a contactable physician. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 21Dec2020 08:15 at a [SINCLE DOSE] and (lot number EK9231),via an unspecified route of administration on 08Jan2021 10:30 at a [SINCLE DOSE] for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin (e.c.) and experienced drug hypersensitivity. On 09Jan2021, the patient experienced painful and enlarged left axillary lymphadenopathy. The outcome of the event was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Taste disorder, Vaccination site hypoaesthesia, Vaccination site pain
Clinical narrative: Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number has been requested.