chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Atelectasis, Chest discomfort, Computerised tomogram, Fatigue
Clinical narrative: Extremely fatigued; Tightness in sternum; Bilateral leg weakness; Difficulty in walking; Atelectasis; Anaphylactic shock; A spontaneous report was received from a consumer who was a 42-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, extreme fatigue, tightness in sternum, atelectasis, extreme bilateral leg weakness, and difficulty walking.   The patient's medical history included allergy to shellfish, bee sting, and mushrooms. No concomitant medications were 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, five minutes after receiving the vaccine, the patient experienced anaphylactic shock. Some of the symptoms experienced included chest tightness, difficulty breathing, throat swelling, and weakness. The patient was transported to the hospital by the emergency medical services (EMS). Treatment for the event included epinephrine several times.   On 01 Jan 2021, the patient experienced extreme fatigue, tightness in sternum, and weakness at home. She returned to the hospital where she was admitted. It was noted that a computed tomography (CT) scan revealed atelectasis. The patient also experienced extreme bilateral leg weakness and difficulty walking. The patient was advised to be placed in a nursing home/rehabilitation center.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, anaphylactic shock, extreme fatigue, tightness in sternum, atelectasis, extreme bilateral leg weakness, and difficulty walking, was unknown.; Reporter's Comments: This case concerns a 42- year old, female patient with medical history of allergy to shellfish, bee sting and mushrooms, who experienced a serious, unexpected event of anaphylactic shock, chest discomfort, muscular weakness, gait disturbance, fatigue, and atelectasis. The event of anaphylactic shock occurred 5 minutes after first dose of the mRNA-1273. The event of chest discomfort, muscular weakness, gait disturbance, fatigue, and atelectasis occurred 2 days after first dose of the mRNA-1273. The treatment included epinephrine. 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..
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: Extremely fatigued; Tightness in sternum; Bilateral leg weakness; Difficulty in walking; Atelectasis; Anaphylactic shock; A spontaneous report was received from a consumer who was a 42-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, extreme fatigue, tightness in sternum, atelectasis, extreme bilateral leg weakness, and difficulty walking.   The patient's medical history included allergy to shellfish, bee sting, and mushrooms. No concomitant medications were 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, five minutes after receiving the vaccine, the patient experienced anaphylactic shock. Some of the symptoms experienced included chest tightness, difficulty breathing, throat swelling, and weakness. The patient was transported to the hospital by the emergency medical services (EMS). Treatment for the event included epinephrine several times.   On 01 Jan 2021, the patient experienced extreme fatigue, tightness in sternum, and weakness at home. She returned to the hospital where she was admitted. It was noted that a computed tomography (CT) scan revealed atelectasis. The patient also experienced extreme bilateral leg weakness and difficulty walking. The patient was advised to be placed in a nursing home/rehabilitation center.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, anaphylactic shock, extreme fatigue, tightness in sternum, atelectasis, extreme bilateral leg weakness, and difficulty walking, was unknown.; Reporter's Comments: This case concerns a 42- year old, female patient with medical history of allergy to shellfish, bee sting and mushrooms, who experienced a serious, unexpected event of anaphylactic shock, chest discomfort, muscular weakness, gait disturbance, fatigue, and atelectasis. The event of anaphylactic shock occurred 5 minutes after first dose of the mRNA-1273. The event of chest discomfort, muscular weakness, gait disturbance, fatigue, and atelectasis occurred 2 days after first dose of the mRNA-1273. The treatment included epinephrine. 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..
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pericarditis
Clinical narrative: Pericarditis; Severe chest pain; A spontaneous report was received from a 56 year-old, female consumer, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pericarditis and severe chest pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020, approximately five days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 0011JZ0A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient went to the emergency room due to severe chest pain.   On 05 Jan 2021, the patient went to see the cardiologist and was diagnosed with pericarditis. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, pericarditis and severe chest pain, was unknown.; Reporter's Comments: This case concerns a 56 year old, female patient. The patient's medical history was not provided. The patient experienced a serious, unexpected event of pericarditis and severe chest pain. The event of severe chest pain occurred 5 days and the event of pericarditis occurred after 6 days after first dose of mRNA-1273 (Lot number: 0011JZ0A). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the mRNA-1273 and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Cellulitis had spread across the top of her arm; warm to touch; itchy; Chills; red blotch on arm; A spontaneous report was received from a nurse who was an 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, itchy, red blotch on arm, warm to touch, and cellulitis spread across the top of her arm.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient woke up experiencing chills, was itchy, and had a red blotch on her arm that was warm to touch.   On 06 Jan 2021, the patient reported the cellulitis had spread across the top of her arm. Treatment for the event included cefalexin.  On 07 Jan 2021, the patient reported that the redness was still there, but it was getting better and had not spread.  Action taken with mRNA-1273 in response to the events was not provided.  The events, chills, itchy, red blotch on arm, warm to touch, and cellulitis spread across the top of her arm, were considered resolving.; Reporter's Comments: This case concerns a 54 year-old, female patient, who experienced events of chills, itchy, red blotch on arm, warm to touch, and cellulitis spread across the top of her arm. The events of chills, itchy, red blotch on arm, warm to touch occurred 9 days after the first dose and the event of cellulitis occurred 10 days 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Hyperhidrosis, Injection site pain, Loss of consciousness
Clinical narrative: Passed out; Felt weak; Sweaty; Could not walk; Arm still sore at the left arm injection site; A spontaneous report was received from a consumer, who was an 80-year-old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out, felt weak, sweaty, couldn't walk, and arm still sore at the left arm injection site.   The patient's medical history was not provided. Concomitant product use was not reported.  On 05 Jan 2021, 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 05 Jan 2021, the patient woke up real sweaty at 3 am. She got up and went to the bathroom and passed out. The patient reported that she fell on the commode then got to the floor because she felt weak and could not walk. Once she regained her strength, she returned to bed.   On 07 Jan 2021, the patient reported that her arm was still sore at the injection site and continued to feel weak. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, passed out, sweaty, and couldn't walk were considered resolved on 06 Jan 2021. The outcome of the events, felt weak and arm still sore at the left arm injection site, were considered not resolved.; Reporter's Comments: This case concerns an 80-year-old 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 Loss of consciousness, the non-serious listed event of Injection site pain, and the non-serious unlisted events of Asthenia, Hyperhidrosis, and Gait disturbance.  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.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Cellulitis; Warmth; A lot of redness; Swelling in the arm right at the area where I had it injected; Enlarged lymph noes; Arm soreness; A spontaneous report was received from a physical therapist, who was also a 30-years old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed arm soreness, injection site redness, injection site warmth, injection site swelling, cellulitis, and enlarged lymph nodes.   The patient's medical history and concomitant medications were not reported.   On 26 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient experienced arm soreness.    On 01 Jan 2021, she experienced swollen lymph nodes.    On 02 Jan 2021, she experienced redness, warmth, and swelling at the injection site.  She was diagnosed with cellulitis.  Treatment included clindamycin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, arm soreness, swollen lymph nodes, redness, warmth, and swelling at the injection site, were not reported.; Reporter's Comments: This case concerns a 30-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of cellulitis, the non-serious listed events of lymphadenopathy, injection site erythema, injection site swelling, and arm soreness, and the non-serious unlisted event of injection site warmth.  Based on the current available information and the temporal association between the use of the product and the onset of events at the site of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Cellulitis; Warmth; A lot of redness; Swelling in the arm right at the area where I had it injected; Enlarged lymph noes; Arm soreness; A spontaneous report was received from a physical therapist, who was also a 30-years old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed arm soreness, injection site redness, injection site warmth, injection site swelling, cellulitis, and enlarged lymph nodes.   The patient's medical history and concomitant medications were not reported.   On 26 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient experienced arm soreness.    On 01 Jan 2021, she experienced swollen lymph nodes.    On 02 Jan 2021, she experienced redness, warmth, and swelling at the injection site.  She was diagnosed with cellulitis.  Treatment included clindamycin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, arm soreness, swollen lymph nodes, redness, warmth, and swelling at the injection site, were not reported.; Reporter's Comments: This case concerns a 30-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of cellulitis, the non-serious listed events of lymphadenopathy, injection site erythema, injection site swelling, and arm soreness, and the non-serious unlisted event of injection site warmth.  Based on the current available information and the temporal association between the use of the product and the onset of events at the site of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Injection site redness; Cellulitis at the injection site; A spontaneous report was received from a pharmacist, concerning a 70-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced cellulitis at the injection site and injection site redness.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced redness at the injection site.  On 05 Jan 2021, twelve days after vaccination, the patient experienced cellulitis at the injection site and had to consult at an urgent care. Treatment for the event included amoxicillin/clavulanante.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, cellulitis at the injection site and injection site redness, was unknown.; Reporter's Comments: This case concerns a 70 year-old, female patient, who experienced events of cellulitis at the injection site and injection site redness. The event of cellulitis occurred 14 days after the first and last dose of mRNA-1273 vaccine administration. The event of injection site redness occurred after the first dose of vaccine on an unknown date. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administer vaccine to the patient immediately from the fridge she doesn't put it at the room temprature; A spontaneous report was received from a nurse concerning a patient who was participating in the mRNA-1273 Emergency Use Program and experienced administer vaccine to the patient immediately from the fridge, not at room temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   Prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   A nurse called to report vaccine administered to patient immediately from the fridge, not at room temperature.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine to the patient immediately from the fridge, not room temperature, was considered resolved.  The reporter did not provide an assessment for the event, incorrect dose administered.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of out of specification product use.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site haemorrhage, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Not sure whether received full dose; Vaccinated way too high; Bleeding a lot; Extreme pain in her arm; Can't lift her arm; A spontaneous report was received from a 39-year-old, female nurse, who was also a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced not sure if she received the full dose, vaccination site too high next to her shoulder bone, bleeding at injection site and extreme pain in her arm that she was not able to lift her arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 08 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 JAN 2021, the patient experienced not sure if she received the full dose, vaccination site too high next to her shoulder bone, bleeding at injection site and extreme pain in her arm that she was not able to lift arm.  Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, not sure if she received the full dose and vaccination site was too high next to her shoulder bone were resolved on 08 Jan 2021. The  outcomes of the events, bleeding at injection site and extreme pain in her arm that she was not able to lift her arm, were unknown.; Reporter's Comments: This spontaneous report refers to a case a 39-year-old patient who experienced events of incorrect dose administration, vaccination site too high next to her shoulder bone, bleeding at injection site and extreme pain in her arm that she was not able to lift her arm for mRNA-127 (Lot number 012L20A, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors a causal association between the events of bleeding at injection site and extreme pain in her arm that she was not able to lift her arm and vaccine administration cannot be excluded. The other events of vaccinated way too high and incomplete dose administered are assessed as not applicable
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Poor quality product administered
Clinical narrative: Normal flu-like symptoms; Soreness in their arms; Vaccinated 18 hours after puncture of the vial; A spontaneous report was received from a physician concerning a patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced product storage error, normal flu-like symptoms, and pain in arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient was vaccinated with a product that was outside of the 6-hour window from when the vial was punctured. The patient also experienced normal flu-like symptoms and arm soreness.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event product storage error was considered recovered/resolved on 07 Jan 2021.  The outcome of the events flu-like symptoms and pain in arm was unknown.  The reporter did not provide an assessment for the events product storage error, flu-like symptoms, and pain in arm..; Reporter's Comments: This case concerns a patient, who experienced non-serious unexpected events of out of specification product use, influenza like illness and pain in extremity. There were no reported AEs associated with this case of out of specification product use. The event of, influenza like illness and pain in extremity occurred on an unspecified date after mRNA-1273 (lot # unknown) administration. The treatment details were not provided. 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 events, a causal relationship cannot be excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling cold, Painful respiration, Paraesthesia oral, Tongue discomfort
Clinical narrative: Chest hurting; Breathing becomes painful; Tingling sensation on her tongue and says that it feels bigger than normal; Tingling sensation on her tongue and says that it feels bigger than normal; Feeling cold; A spontaneous report was received from a healthcare professional concerning a 23-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest hurting, breathing became painful, tingling tongue, tongue discomfort, feeling cold.   The patient's medical history was not provided.  No concomitant medications were provided.  On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 012L20A) for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the patient experienced a tingling sensation on her tongue and felt that it was bigger than normal.  She was given Diphenhydramine as an intervention.  The patient started to feel cold.  After 20 minutes, breathing became painful and her chest was hurting.  The patient was given epinephrine and was transported to the hospital for continued monitoring.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, chest hurting, breathing became painful, tingling tongue, tongue discomfort, feeling cold, was considered were not recovered/resolved.; Reporter's Comments: This case concerns a 23-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 012L20A), and who experienced the serious unlisted events of Chest pain and Painful respiration and the non-serious unlisted events of tingling tongue, tongue discomfort, and feeling cold.  Patient was treated with Benadryl and EpiPen prior to being transferred to hospital.  Based on the current available information and temporal association between vaccination and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Vaccine administerred to a 16-year-old; Sore arm; Slight dizziness; A spontaneous report was received from a pharmacist concerning a 16-year-old, female patient, who received Moderna COVID-19 vaccine (mRNA-1273) and vaccine was administered to a 16-year-old, who experienced a sore arm and slight dizziness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the pharmacist called to report that they administered the Moderna COVID-19 vaccine to a 16-year-old patient. On 10 Jan 2021, upon following up, the patient reported that she experienced a sore arm and slight dizziness beginning 09 Jan 2021 and that these events had resolved on 10 Jan 2021.  No treatment information was provided.  The event vaccine administered to a 16-year-old was resolved on 09 Jan 2021.  The events sore arm and slight dizziness were resolved on 10 Jan 2021.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 16-year old, female patient.  The patient's medical history is not provided.  The event occurred on 09 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.  The patient experienced a sore arm and slight dizziness after the injection for a day. 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.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect route of product administration, Injection site mass
Clinical narrative: Soft lump; Felt some of the vaccine drop down my arm; She thinks she got the injection sub-Q; A spontaneous report was received from a nurse concerning a 66-year old, female patient was participating in the mRNA-1273 Emergency Use Program and the patient felt some of the vaccine drip down her arm and she thinks got the injection sub-Q because the administrator used a small needle and she bunched it up instead of holding it taut, and the patient experienced soft lump.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (011J20A) for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the patient felt some of the vaccine drip down her arm during administration. The reporter believes the injection was given subcutaneously because the administrator used a small needle and pinched the skin rather than holding it taut. After injection, the patient had a soft lump.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events injection given subcutaneously and some of the vaccine dripped down her arm, were considered resolved. The outcome of the event soft lump was unknown.  The reporter did not provide an assessment for the event.; Reporter's Comments: This case concerns a 66-year old female subject (medical history not provided) who experienced a non-serious event of injection site lump. The event occurred the same day after first dose of the vaccine (lot #: 001J20A) medication administration. The subject also felt that she was injected with the vaccine subcutaneously (incorrect route of product administration) and felt some of the vaccine drips down her arm (incomplete dose administered), but with no reported AEs. Based on temporal association between the use of the product and the start date of the event of injection site lump, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Decreased appetite, Electrocardiogram abnormal, Pain, Pyrexia
Clinical narrative: Found dead at home slumped on the floor; Loss of appetite; Body aches; Feverish; A spontaneous report was received from a physician, concerning a 65-years-old male patient, who received Moderna's COVID-19 Vaccine and experienced feverish, body aches, loss of appetite, and death.  The patient's medical history, as provided by the reporter, included diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia. Concomitant medications reported included metformin, glimepiride, lisinopril, atorvastatin, aspirin, methimazole, propranolol, and cilostazol.   On 05 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 037k20a) for COVID-19 infection prophylaxis.  On an unknown date in Jan 2021, some time after receiving the vaccine, the patient was feeling feverish with body aches and loss of appetite.  On 09 Jan 2021 at approximately 21:30, the patient was found dead at home slumped on the floor. According to the paramedics, the patient was dead longer than when his wife found him, and no resuscitation was performed.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, feverish, body aches, loss of appetite, was considered resolved. The patient died on 09 Jan 2021. The cause of death was not reported.  The reporter assessed the event, death, as not related to Moderna's COVID-19 Vaccine. The reporter did not provide assessment for the events, feverish and body aches, in relation to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 65 year old male patient with medical history of diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia, who experienced the serious unexpected event of death, non-serious unexpected event of loss of appetite, and non-serious expected events of fever and body pain.  The event of death occurred 5 days after the first dose of mRNA-1273. The events of fever, body pain and loss of appetite occurred an unspecified period of time after the first dose of mRNA-1273.  Very limited information regarding these events 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.   Definitive causal association is confounded by age and medical history of diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Unsure if the injection was intramuscular or subcutaneous; A spontaneous report was received from a healthcare professional concerning a patient, who was participating in the mRNA-1273 Emergency Use Program and the patient was unsure if the injection was intramuscular (IM) or subcutaneous (SQ).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 08-Jan-2021, the patient received the vaccine by injection but was unsure if the injection was IM or SQ. The patient was concerned about administration error. The patient had no known symptoms.  No known treatments were reported.  Action taken with mRNA-1273 in response to the event was not reported.   The event, patient was unsure if the injection was IM or SQ, was resolved on 08-Jan-2021.  The reporter did not provide a causality assessment of the event.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 800 doses were affected, about 800 have been given to patients.; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) given to 800 patients after possible temperature excursion.   The patient's medical history was not provided. No concomitant medications were provided.  On 04 Jan 2021, prior to the onset of the event(s), the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient received a vaccine dose that thawed out of the recommended temperature range.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event product storage error was considered recovered/resolved on 04 Jan 2021.  The reporter did not provide an assessment for the event product storage error.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product storage error.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered the vaccine to a 16 year old individual; A report was received from a pharmacist concerning a 16-year old male patient who was participating in the mRNA-1273 Emergency Use Program and inadvertently administered the vaccine to a 16 year old individual.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient, who was 16 at the time, received the first dose of vaccine. The vaccinating pharmacist did not realize until after the fact. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event inadvertently administered the vaccine to a 16 year old individual was considered resolved on 09 Jan 2021.  The reporter did not provide an assessment for the event.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given the moderna vaccine sooner than scheduled; A spontaneous report was received from a nurse concerning a patient who was participating in the mRNA-1273 Emergency Use Program and received the vaccine sooner than scheduled.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05-Jan-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The reporter reported that the patient received vaccine sooner than scheduled. The first dose was administered on 23-Dec-2020 and the second dose on 05 Jan 2021.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event inappropriate schedule of product administration was considered resolved on 05 Jan 2021.  The reporter did not provide an assessment of the event inappropriate schedule of product administration.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Inappropriate schedule of product administration.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product administered to patient of inappropriate age
Clinical narrative: A spontaneous report was received from a consumer concerning a 17-year-old female patient who was the pediatric patient received vaccine and the patient experienced light headache.   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# 037K20A) on 07-Jan-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient's mother reported that her 17-year-old daughter received the Moderna vaccine on 07-Jan-2021.  She stated that the provider of the clinic where her daughter was vaccinated was unaware of the patient's age.  She also stated that since the clinic had become aware of the patient's age, the second dose of the vaccine would not be administered to the patient unless she was enrolled in the clinical trial.  Additionally, the patient's mother reported that following the vaccine, the only side effect experienced by the patient was a headache.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event pediatric patient received vaccine was considered resolved.  The outcome of the event light headache was not reported.   The reporter did not provide a causality assessment of the events pediatric patient received vaccine and a light headache.; Reporter's Comments: This case concerns a 17 year old, female patient, who experienced non-serious unexpected events of product administered to patient of inappropriate age and a non-serious expected event of headache. There were no reported AEs associated with this case of product administered to patient of inappropriate age for mRNA-1273 (lot # 037K20A). The event of headache occurred on an unspecified date after mRNA-1273 (lot # 037K20A) administration. The treatment details were not provided. 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 events, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Delirium, Discomfort, Fall
Clinical narrative: Weak; Collapsed; Delirium; Night sweats; Chills; Discomfort; Did not sleep at all that night; A spontaneous report was received from a physician, who was also an 80-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and felt weak.   The patient's medical history, as provided by the reporter, included type II diabetes, diabetic neuropathy, heart failure, acid reflux, and urinary retention. Concomitant medications included metformin, gabapentin, furosemide, spironolactone, omeprazole, and tamsulosin.   On 06 Jan 2021, 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 the evening of 06 Jan 2021, hours after vaccination, the patient began feeling chills and discomfort. Overnight he began to experience night sweats and did not sleep at all.   During the night on 07 Jan 2021, the patient experienced night sweats and had delirium. When he tried to get out of bed, he collapsed. No treatment information was provided.   On 11 Jan 2021 and 12 Jan 2021, the patient began to feel better. He no longer had night sweats or delirium. He returned to his exercise routine at about 50 percent of what he normally did although he continued to feel weak.  Action taken with mRNA-1273 in response to the events was not provided, although the patient reported he was not sure if he would take the second dose.  The outcome for the events, night sweats and delirium, was considered resolved. The outcome for the events, chills, discomfort, did not sleep at all, and collapsed, was considered resolving. The event, weak, was considered not resolved.  The reporter assessed the events, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and weak, as related to Moderna's COVID-19 vaccine due to feeling well before the vaccine and feeling more or less disabled after receiving it.; Reporter's Comments: This case concerns a 80-year-old, male subject with medical history of type II diabetes and diabetic neuropathy, who experienced a serious unexpected event of delirium and non-serious unexpected event of asthenia, discomfort, insomnia, fall, and night sweats, and non-serious expected event of chills. The event of discomfort, insomnia, chills and night sweats occurred 1 day; the event of delirium, and fall occurred 2 days and asthenia occurred 6 days after mRNA-1273 administration.  The subject was on metformin for diabetes ty II and gabapentin for diabetic neuropathy, Lasix and spironolactone for heart failure, omeprazole for acid reflux and Flomax for urinary retention. Treatment details not provided. 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Night sweats
Clinical narrative: Weak; Collapsed; Delirium; Night sweats; Chills; Discomfort; Did not sleep at all that night; A spontaneous report was received from a physician, who was also an 80-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and felt weak.   The patient's medical history, as provided by the reporter, included type II diabetes, diabetic neuropathy, heart failure, acid reflux, and urinary retention. Concomitant medications included metformin, gabapentin, furosemide, spironolactone, omeprazole, and tamsulosin.   On 06 Jan 2021, 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 the evening of 06 Jan 2021, hours after vaccination, the patient began feeling chills and discomfort. Overnight he began to experience night sweats and did not sleep at all.   During the night on 07 Jan 2021, the patient experienced night sweats and had delirium. When he tried to get out of bed, he collapsed. No treatment information was provided.   On 11 Jan 2021 and 12 Jan 2021, the patient began to feel better. He no longer had night sweats or delirium. He returned to his exercise routine at about 50 percent of what he normally did although he continued to feel weak.  Action taken with mRNA-1273 in response to the events was not provided, although the patient reported he was not sure if he would take the second dose.  The outcome for the events, night sweats and delirium, was considered resolved. The outcome for the events, chills, discomfort, did not sleep at all, and collapsed, was considered resolving. The event, weak, was considered not resolved.  The reporter assessed the events, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and weak, as related to Moderna's COVID-19 vaccine due to feeling well before the vaccine and feeling more or less disabled after receiving it.; Reporter's Comments: This case concerns a 80-year-old, male subject with medical history of type II diabetes and diabetic neuropathy, who experienced a serious unexpected event of delirium and non-serious unexpected event of asthenia, discomfort, insomnia, fall, and night sweats, and non-serious expected event of chills. The event of discomfort, insomnia, chills and night sweats occurred 1 day; the event of delirium, and fall occurred 2 days and asthenia occurred 6 days after mRNA-1273 administration.  The subject was on metformin for diabetes ty II and gabapentin for diabetic neuropathy, Lasix and spironolactone for heart failure, omeprazole for acid reflux and Flomax for urinary retention. Treatment details not provided. 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.
Sex: F
Vaccine: COVID19
Symptoms: Death, Erythema, Skin warm, Swelling
Clinical narrative: death of unknown cause; Swelling on Right side of the neck and under chin; Warmth on right side of neck and under chin; Redness on right side of neck and under chin; A spontaneous report was received from a healthcare professional concerning an 89-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of redness, warmth and swelling on right side of neck and under chin, and death of unknown cause.  The patient's medical history included Alzheimer's and chronic obstructive pulmonary disease (COPD). No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced the events of redness, warmth and swelling on right side of neck and under chin. There was no indication that the patient was transferred out to hospital, which was unlikely because she was under hospice care.  On 01 Jan 2021, the patient died due to an unknown cause of death.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 01 Jan 2020. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 89-year-old, female subject with a medical history of Alzheimer's and chronic obstructive pulmonary disease (COPD) who experienced redness, warmth and swelling on R side of neck and under chin and expired from an unknown cause. The events of redness, warmth and swelling on R side of neck and under chin occurred 2 days after administration of the first and only dose of the mRNA-1273 vaccine and patient expired 4 days after mRNA-1273 vaccine administration.  Lot # of the vaccine was not provided.  De-challenge and re-challenge are not applicable.  The events of redness, warmth and swelling on R side of neck and under chin are temporarily associated with the administration of the mRNA-1273 and thus, a causal relationship cannot be excluded. Due to limited information, the fatal outcome was considered unrelated to mRNA-1273 administration pending additional information.  Fatal outcome is confounded by the patient's underlying condition and advanced age.; Reported Cause(s) of Death: Unknown cause of death