chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity, Pruritus, Rash
Clinical narrative: About two weeks after first moderna does I ended up having Shingles.  A ton of pain  and rash in the middle of my back down right shoulder and right arm. Was treated on 1/31 at urgent care with antiviral and gapapentin  for pain. So far its been about 3 weeks..rash has scabbed still having some itching and pain.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site induration, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Right upper arm became very swollen, hard, and painful to the point that I could not raise my arm or touch the spot.  I also had a fever and headache.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Right upper arm became very swollen, hard, and painful to the point that I could not raise my arm or touch the spot.  I also had a fever and headache.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I have welts that itch under my chin and on my left outer ear
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated
Clinical narrative: Patient told doctor that his blood sugar went up (>400) after his first COVID-19 vaccine and he was hospitalized.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Gait disturbance, Impaired driving ability, Vertigo
Clinical narrative: next morning she had dizziness; chills; was diagnosed with vertigo; could hardly walk / did not feel comfortable driving a car by herself for / 30 days; did not feel comfortable driving a car by herself; This case was reported by a consumer and described the occurrence of dizziness in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot, tetanus, pneumonia, hepatitis and old shingles shot. Concurrent medical conditions included arthritis.   On 10th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2019, 1 days after receiving Shingrix, the patient experienced dizziness, chills, walking difficulty and activities of daily living impaired. On 16th October 2019, the patient experienced vertigo. On an unknown date, the outcome of the dizziness, chills, vertigo, walking difficulty and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the dizziness, chills, vertigo, walking difficulty and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in right arm. After receiving 1st dose of Shingrix, the patient experienced dizziness and chills, could hardly walk and vertigo 10 days or so. The patient did not feel comfortable driving a car by herself for at least 30 days. The patient reports never got the 2nd dose of the Shingrix vaccine because of the reaction that occurred from the 1st dose. The patient states that she has received many injections throughout her life without any problems. Not all information was available. The patient gave permission to follow-up with their HCP, and provided the following contact information.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypokinesia, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: couldn't move; flu like symptoms; headache; in bed all day; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2021, the patient received the 2nd dose of Shingrix. On 29th January 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, bedridden and mobility decreased. The patient was treated with naproxen (Aleve). In January 2021, the outcome of the influenza-like symptoms, headache and bedridden were recovered/resolved. On 31st January 2021, the outcome of the mobility decreased was recovered/resolved.   The reporter considered the influenza-like symptoms, headache, bedridden and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  After receiving 2nd dose of Shingrix, the patient experienced reaction like flu like symptoms, she was in bed all day with a headache and couldn't move. The patient went to bed at 6:30 pm the day of the vaccination and awoke at 9:30 am the following morning. By that Sunday afternoon, the patient could get up and move again. The reporter consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Throat tightness, Visual impairment
Clinical narrative: Vision not clear; Pounding of chest; throat felt contracted; A report was received from a healthcare professional concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced vision not clear, pounding of chest, and throat felt contracted.  The patient's medical history, as provided by the reporter, included asthma and hypoglycemia. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 15 minutes 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 30 Dec 2020, 15 minutes following vaccine administration, the subject's vision became unclear, and she described everything seeming hazy and smoky. Her throat then began to feet contracted and her chest was pounding. The patient was transported to the emergency room (ER) via an ambulance. Her electrocardiogram (EKG) result was normal, while blood pressure and blood sugar results were increased. She remained in the ER overnight but was not admitted. Her vision returned to normal 5 pm the same day. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, vision not clear, was considered resolved on 30 Dec 2020. The outcome of the events, pounding of chest, and throat felt contracted were unknown.   The reporter did not provide an assessment for the events, vision not clear, pounding of chest, and throat felt contracted.; Reporter's Comments: 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.  The Patient's medical history of asthma and hypoglycemia remains as confounders.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Convulsing; Mild diarrhea; Fatigue; Mild bladder infection; Sweating; Pain; Fever; Nausea; Chills; A spontaneous report was received from a consumer concerning a 77-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, fatigue, and mild diarrhea.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 15 Jan 2021, approximately the night of prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient developed pain, fever, nausea and chills.   On 16 Jan 2021, the patient entire body started convulsing and sweating. She developed pain; entire body ached with uncontrollable body jerking. Patient was taken to the hospital, where she received intravenous fluid and paracetamol and was diagnosed with a very mild bladder infection.  On an unknown date, the patient had mild diarrhea and fatigue.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, diarrhea, and fatigue was not reported.; Reporter's Comments: This case concerns a 77 year old, female patient, who experienced serious unexpected event of seizure, and non-serious unexpected event of hyperhidrosis and cystitis, and non-serious expected events of nausea, pyrexia, chills, diarrhea and fatigue. The event of pain, pyrexia, nausea, chills occurred 1 day (same day) date after mRNA-1273 (Lot# 011L20A), while the event of seizure, hyperhidrosis, and cystitis occurred 2 day (same day) date after mRNA-1273 (Lot# 011L20A). The event of diarrhea and fatigue occurred on an unspecified date after mRNA-1273 (Lot# 011L20A). Treatment included IV fluids and Tylenol. 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. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Seizure
Clinical narrative: Convulsing; Mild diarrhea; Fatigue; Mild bladder infection; Sweating; Pain; Fever; Nausea; Chills; A spontaneous report was received from a consumer concerning a 77-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, fatigue, and mild diarrhea.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 15 Jan 2021, approximately the night of prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient developed pain, fever, nausea and chills.   On 16 Jan 2021, the patient entire body started convulsing and sweating. She developed pain; entire body ached with uncontrollable body jerking. Patient was taken to the hospital, where she received intravenous fluid and paracetamol and was diagnosed with a very mild bladder infection.  On an unknown date, the patient had mild diarrhea and fatigue.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, diarrhea, and fatigue was not reported.; Reporter's Comments: This case concerns a 77 year old, female patient, who experienced serious unexpected event of seizure, and non-serious unexpected event of hyperhidrosis and cystitis, and non-serious expected events of nausea, pyrexia, chills, diarrhea and fatigue. The event of pain, pyrexia, nausea, chills occurred 1 day (same day) date after mRNA-1273 (Lot# 011L20A), while the event of seizure, hyperhidrosis, and cystitis occurred 2 day (same day) date after mRNA-1273 (Lot# 011L20A). The event of diarrhea and fatigue occurred on an unspecified date after mRNA-1273 (Lot# 011L20A). Treatment included IV fluids and Tylenol. 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. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypoaesthesia, Oxygen saturation, Paraesthesia
Clinical narrative: Numbness of face, tongue, throat; Tingling of face, tongue, throat; A spontaneous report was received from a health care professional concerning a 60-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness and tingling of face, tongue and throat.  The patient's medical history was Rheumatoid arthritis, hypertension and possible allergy to diphenhydramine and meperidine. No relevant concomitant medications were reported.   On 13 Jan 2021 at 10:11 A.M., prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 13 Jan 2021 at 10:15 A.M., after receiving the vaccine, patient started to experience numbness and tingling of face, tongue and throat.  Initial examination included lungs angiogram, which indicated regular tachycardia. Findings included swelling of lips and tongue, and uvula midplane, not deviated. The patient was moved on an observation area. Emergency medical services (EMS) were notified. Intramuscular (IM) epinephrine was administered at 10:23 A.M. At 10:25 A.M. the patient's vital signs included blood pressure 185/87, heart rate 128, respiratory rate 20, and oxygen saturation 100%. A second IM epinephrine treatment was given at 10:26 A.M. At 10:29 A.M. the patient's vital signs included blood pressure 185.87, heart rate 134, and oxygen saturation 100%. At 10:29 A.M. treatment included oral diphenhydramine. Next dose of IM epinephrine failed; a fourth dose was given at 10:35 A.M. At 10:45 A.M., EMS arrived, and the patient was taken to the emergency room.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, numbness and tingling of face, tongue and throat was unknown.; Reporter's Comments: This case concerns a 60 year-old, female patient, who experienced events of numbness and tingling of face, tongue and throat. The events occurred within minutes after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Physical examination, Respiratory rate
Clinical narrative: Numbness of face, tongue, throat; Tingling of face, tongue, throat; A spontaneous report was received from a health care professional concerning a 60-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness and tingling of face, tongue and throat.  The patient's medical history was Rheumatoid arthritis, hypertension and possible allergy to diphenhydramine and meperidine. No relevant concomitant medications were reported.   On 13 Jan 2021 at 10:11 A.M., prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 13 Jan 2021 at 10:15 A.M., after receiving the vaccine, patient started to experience numbness and tingling of face, tongue and throat.  Initial examination included lungs angiogram, which indicated regular tachycardia. Findings included swelling of lips and tongue, and uvula midplane, not deviated. The patient was moved on an observation area. Emergency medical services (EMS) were notified. Intramuscular (IM) epinephrine was administered at 10:23 A.M. At 10:25 A.M. the patient's vital signs included blood pressure 185/87, heart rate 128, respiratory rate 20, and oxygen saturation 100%. A second IM epinephrine treatment was given at 10:26 A.M. At 10:29 A.M. the patient's vital signs included blood pressure 185.87, heart rate 134, and oxygen saturation 100%. At 10:29 A.M. treatment included oral diphenhydramine. Next dose of IM epinephrine failed; a fourth dose was given at 10:35 A.M. At 10:45 A.M., EMS arrived, and the patient was taken to the emergency room.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, numbness and tingling of face, tongue and throat was unknown.; Reporter's Comments: This case concerns a 60 year-old, female patient, who experienced events of numbness and tingling of face, tongue and throat. The events occurred within minutes after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Erythema, Heart rate, Oropharyngeal oedema
Clinical narrative: Periorbital swelling; Generalized facial edema; Oropharyngeal edema; Felt faint; Tingling lip; Facial redness; Appears pale; A spontaneous report was received from a healthcare professional concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness.   The patient's medical history was not provided. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, at 0845, 7 minutes after receiving the Moderna COVID-19 vaccine, the patient arrived for observation at urgent care. The patient stated she felt faint and her lip was starting to "feel swollen" and tingling. Initial vital signs were: blood pressure  147/79, heart rate  69, respirations  20 and oxygen saturation  99 percent. A nurse practitioner and doctor evaluated the patient and noted patient had oropharyngeal edema and lungs were clear to auscultation (CTA).   At 0851, diphenhydramine 25 milligrams orally was given with no effect. Facial redness and edema worsened.  At 0855, epinephrine 3 milligrams was given with improvement, but after 5 minutes, facial redness and lower lip worsened.   At 0902, a second dose of epinephrine was given.  At 0903, vital signs were: blood pressure  162/87, heart rate  104, respirations  20 and oxygen saturation  100 percent on 4 liters of oxygen. Facial redness and edema improved but still had swelling and tingling of lower lip.  At 0909, emergency medical services (EMS) were called and patient was transported to emergency room/department.   Treatment for the event included diphenhydramine, epinephrine and oxygen.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness, were considered unknown.; Reporter's Comments: This case concerns a 56-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of periorbital swelling, facial swelling, oropharyngeal edema and unexpected events of Paraesthesia oral, erythema, pallor and dizziness. The events occurred 8 minutes after the first dose of mRNA-1273 (Lot number: 041L20A) administration. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pallor, Paraesthesia oral, Periorbital swelling, Respiratory rate
Clinical narrative: Periorbital swelling; Generalized facial edema; Oropharyngeal edema; Felt faint; Tingling lip; Facial redness; Appears pale; A spontaneous report was received from a healthcare professional concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness.   The patient's medical history was not provided. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, at 0845, 7 minutes after receiving the Moderna COVID-19 vaccine, the patient arrived for observation at urgent care. The patient stated she felt faint and her lip was starting to "feel swollen" and tingling. Initial vital signs were: blood pressure  147/79, heart rate  69, respirations  20 and oxygen saturation  99 percent. A nurse practitioner and doctor evaluated the patient and noted patient had oropharyngeal edema and lungs were clear to auscultation (CTA).   At 0851, diphenhydramine 25 milligrams orally was given with no effect. Facial redness and edema worsened.  At 0855, epinephrine 3 milligrams was given with improvement, but after 5 minutes, facial redness and lower lip worsened.   At 0902, a second dose of epinephrine was given.  At 0903, vital signs were: blood pressure  162/87, heart rate  104, respirations  20 and oxygen saturation  100 percent on 4 liters of oxygen. Facial redness and edema improved but still had swelling and tingling of lower lip.  At 0909, emergency medical services (EMS) were called and patient was transported to emergency room/department.   Treatment for the event included diphenhydramine, epinephrine and oxygen.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness, were considered unknown.; Reporter's Comments: This case concerns a 56-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of periorbital swelling, facial swelling, oropharyngeal edema and unexpected events of Paraesthesia oral, erythema, pallor and dizziness. The events occurred 8 minutes after the first dose of mRNA-1273 (Lot number: 041L20A) administration. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Periorbital swelling; Generalized facial edema; Oropharyngeal edema; Felt faint; Tingling lip; Facial redness; Appears pale; A spontaneous report was received from a healthcare professional concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness.   The patient's medical history was not provided. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, at 0845, 7 minutes after receiving the Moderna COVID-19 vaccine, the patient arrived for observation at urgent care. The patient stated she felt faint and her lip was starting to "feel swollen" and tingling. Initial vital signs were: blood pressure  147/79, heart rate  69, respirations  20 and oxygen saturation  99 percent. A nurse practitioner and doctor evaluated the patient and noted patient had oropharyngeal edema and lungs were clear to auscultation (CTA).   At 0851, diphenhydramine 25 milligrams orally was given with no effect. Facial redness and edema worsened.  At 0855, epinephrine 3 milligrams was given with improvement, but after 5 minutes, facial redness and lower lip worsened.   At 0902, a second dose of epinephrine was given.  At 0903, vital signs were: blood pressure  162/87, heart rate  104, respirations  20 and oxygen saturation  100 percent on 4 liters of oxygen. Facial redness and edema improved but still had swelling and tingling of lower lip.  At 0909, emergency medical services (EMS) were called and patient was transported to emergency room/department.   Treatment for the event included diphenhydramine, epinephrine and oxygen.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness, were considered unknown.; Reporter's Comments: This case concerns a 56-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of periorbital swelling, facial swelling, oropharyngeal edema and unexpected events of Paraesthesia oral, erythema, pallor and dizziness. The events occurred 8 minutes after the first dose of mRNA-1273 (Lot number: 041L20A) administration. 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: Anaphylactic reaction, Blood pressure measurement, Heart rate, Oxygen saturation
Clinical narrative: Anaphylactic reaction; A spontaneous report was received from a healthcare professional concerning a 24-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Anaphylactic reaction.  The patient's medical history included allergy to milk. No concomitant medications were reported.  On 12 Jan 2021, 5  10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The patient experienced chest tightness and tachycardia symptoms following which she was transported via gurney to the observation area. The patient looked sleepy and had trouble arousing her. The blood pressure was at 140/80 mmHg, heart rate was in the 90s to 100s heartbeats per minute. The patient's breath sound decreased bilaterally. It was also noted that her throat felt uncomfortable. The reporter stated that anaphylaxis reaction was suspected due to the rapid decline in status. Following an increasing heart rate and complaints of chest discomfort the patient was treated with a dose one of epinephrine pen. It was noted after a minute or two the patient's chest felt better. Her blood pressure was stable at 140/80's mmHg, the heart rate initially increased to 110 and then back down to 100 about 5 minutes after the first dose. At about 8 minutes from dose one of epinephrine pen, the patient's heart rate increased to 160 and developed additional symptoms of chest tightness again so a second dose of Epinephrine pen was administered. The patient was somnolent but protecting airway. Oxygen was added 2 liters after second dose of epinephrine pen. The patient's oxygen saturation dropped right around second dose of epinephrine pen to 94% but about 2-3 minutes later it was back at 98%. The paramedics arrived 5 minutes after second dose of epinephrine pen and care was transferred to them. The patient was transported in a stable condition.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the Anaphylactic reaction was unknown.; Reporter's Comments: This case concerns a 24 year old, female patient, who experienced serious unexpected event of Anaphylactic reaction. The event occurred 1 day (5-10 min) after mRNA-1273 (Lot# Unknown). Treatment included EpiPen (2 doses). 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. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: Anaphylaxis; Hives; A spontaneous report was received from a healthcare professional concerning a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis and hives.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021 at 4:50 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021 at 4:50 pm, after receiving the vaccine, the patient experienced anaphylaxis and hives. She was given epinephrine and 50 mg of diphenhydramine. Emergency Medical Services (EMS) and the fire department were called.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, anaphylaxis and hives, were unknown.; Reporter's Comments: This case concerns a 31 year old, female patient, who experienced serious unexpected event of Anaphylactic reaction, a non-serious unexpected event of urticaria. The event occurred 1 day (few min) after mRNA-1273 (Lot# Unknown). Treatment included EpiPen. 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. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Pyrexia, Seizure
Clinical narrative: seizure; signs of confusion; Fever; shoulder pain; A spontaneous report was received from a husband, concerning a 26-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder pain, fever, signs of confusion and a seizure.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 intramuscularly (lot number: unknown). On 29 Jan 2021, the patient received the second of two planned doses of mRNA-1273 intramuscularly (lot number: unknown) for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient's husband reported that patient experienced shoulder pain, 10-12 hours later the patient started to have a fever.   On 30 Jan 2021, the patient had signs of confusion and then suffered a seizure and was taken to the hospital. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the events, shoulder pain, fever, signs of confusion and a seizure, were unknown.; Reporter's Comments: This case concerns a 26-year-old, female patient, who experienced a serious unexpected event of Seizure, non-serious unexpected event of Confusional state, and non-serious expected events of Pyrexia and Arthralgia. The events of Pyrexia and Arthralgia occurred on the same day after second of two planned doses  of mRNA-1273, lot # unknown. The events of Seizure and Confusional state occurred approximately 2 days after second of two planned doses of mRNA-1273, lot # unknown. Treatment information is not provided.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Neck pain, Neuralgia, Pain
Clinical narrative: Minor stroke; Weak muscles; Terible pain in neck and lower back; Terible pain in neck and lower back; Nerve pain; Achy; Injection site reaction; A spontaneous report was received from a consumer who was also a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced C, injection site reaction, and achy.  The patient's medical history was not provided. Concomitant medications were not reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, after vaccine administration, the patient experienced injection site reaction.  On 22 Jan 2021, she was feeling achy.   On 23 Jan 2021, she had nerve pain that felt like cutting on the back, legs, and arms.  On 24 Jan 2021, the patient's muscles were weak and were not working or responsive on both sides.   On 25 Jan 2021, the patient could not control her left hand and weakness was more predominant on left side. The patient went to the doctor and was hospitalized with minor stroke for 24 hours. The patient stated that she was still experiencing terrible pain in neck and lower back.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, minor stroke, weak muscles, nerve pain, injection site reaction, and achy, was unknown. The outcome of event, terrible pain in neck and lower back, was considered not resolved.; Reporter's Comments: Based on the current available information and evidence of a temporal association between mRNA-1273 use and the onset of injection site reaction and achy, a causal relationship cannot be excluded. There is limited information to asses causality for the events of injection site reaction, and achy.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old vaccinated with the Moderna COVID 19 vaccine; A spontaneous report  was received from a dentist concerning a 17 years-old, female patient who was received the Moderna COVID 19 vaccine and product administered to patient of inappropriate age.  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 (Lot # not provided) (route of administration and injection site not provided) on 05 Jan 2021 for prophylaxis of COVID-19 infection.  On 05 Jan 2021, a 17 years-old patient was vaccinated with the Moderna COVID-19 vaccine. The patient's father (dentist) was asking for guidance as both of his daughters were vaccinated but only one of them received the second dose as the local health department did not allow one to get the second dose. Reporter also inquired about time of appearance of the side effects.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event 17 year old vaccinated with the Moderna COVID 19 vaccine was unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: spontaneous report was received from a consumer concerning a , White male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced first dose of the Moderna COVID-19 vaccine at 16 years of age / Product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the 16-year-old patient received the Moderna vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, first dose of the Moderna COVID-19 vaccine  / Product administered to patient of inappropriate age, was resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number: 026220A). There were no Associated AEs with this product administered to inappropriate age,
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Myalgia, Nasal congestion
Clinical narrative: A spontaneous report was received from a consumer concerning a 19-year-old-male of unknown race and ethnicity patient who felt very sick, headache, nose is stuffy, body chills, severe body ache, trembling, fever of 102F, rust colored spots on hands and fingers after receiving the Moderna's mRNA-1273 vaccine by accident. The patient's medical history was not provided.  Concomitant product use was not provided by the reporter. Additional suspected products included Pfizer vaccine. On 01 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received 1 dose of mRNA-1273 (Batch number not provided) intramuscularly in the for prophylaxis of COVID-19 infection. Caller received the mRNA vaccine by accident. The first vaccine dose received by the patient was Pfizer. The patient went to Walgreens and was offered the 2nd dose, he didn't know that he would be receiving the Moderna's mRNA-1273 vaccine. The patient received the Moderna mRNA-1273 vaccine on 01 Feb 2021 at 4pm, the next day, 02 Feb 2021 he felt very sick, headache, nose is stuffy, body chills, severe body ache, trembling, fever of 102F, rust colored spots on hands and fingers. LOT # of the vaccine was not listed in the vaccine card. Agreed to follow up call. Treatment for the event included baby aspirin. The outcome of events he felt very sick, headache, nose is stuffy, body chills, severe body ache, trembling, fever of 102F, rust colored spots on hands and fingers were unknown. The outcome of event wrong vaccine administered was considered recovered.; Reporter's Comments: This report refers to a case of Wrong product administered for mRNA-1273 with lot number not provided and several adverse events. 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.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vaccination complication, Wrong product administered
Clinical narrative: A spontaneous report was received from a consumer concerning a 19-year-old-male of unknown race and ethnicity patient who felt very sick, headache, nose is stuffy, body chills, severe body ache, trembling, fever of 102F, rust colored spots on hands and fingers after receiving the Moderna's mRNA-1273 vaccine by accident. The patient's medical history was not provided.  Concomitant product use was not provided by the reporter. Additional suspected products included Pfizer vaccine. On 01 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received 1 dose of mRNA-1273 (Batch number not provided) intramuscularly in the for prophylaxis of COVID-19 infection. Caller received the mRNA vaccine by accident. The first vaccine dose received by the patient was Pfizer. The patient went to Walgreens and was offered the 2nd dose, he didn't know that he would be receiving the Moderna's mRNA-1273 vaccine. The patient received the Moderna mRNA-1273 vaccine on 01 Feb 2021 at 4pm, the next day, 02 Feb 2021 he felt very sick, headache, nose is stuffy, body chills, severe body ache, trembling, fever of 102F, rust colored spots on hands and fingers. LOT # of the vaccine was not listed in the vaccine card. Agreed to follow up call. Treatment for the event included baby aspirin. The outcome of events he felt very sick, headache, nose is stuffy, body chills, severe body ache, trembling, fever of 102F, rust colored spots on hands and fingers were unknown. The outcome of event wrong vaccine administered was considered recovered.; Reporter's Comments: This report refers to a case of Wrong product administered for mRNA-1273 with lot number not provided and several adverse events. 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.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact
Clinical narrative: vaccine liquid dripped on his arm; needle wasn't connected very well to the plastic part of the syringe; A spontaneous report was received from a 74 year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the needle wasn't connect well, so the liquid dripped on his arm.   There were no medical history or concomitant medications reported.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) on 07 Jan 2021. On 03 Feb 2021 the patient received their second of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  After receiving the vaccine, the patient reported that the needle wasn't connect very well to the plastic part of the syringe so the liquid dripped on his arm. According to the nurse, nothing was administered so she went ahead and administered a newfull dose. No treatment information was provided.  Action taken with study drug was not applicable as the subject had already received both scheduled doses.  The outcomes of the events vaccine liquid dripped on his arm and needle wasn't connected very well to the plastic part of the syringe were considered resolved on 03 Feb 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Device connection issue and Exposure via skin contact without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Malaise, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Feels very ill; Feeling tired; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling tired, feeling very ill, and tested positive for COVID-19.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 07 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient felt tired and sick.   On 13 Jan 2021, the patient was admitted to the hospital where he tested positive for COVID-19. He felt very ill.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was not reported.; Reporter's Comments: This spontaneous report concerns a male patient who experienced feeling tired, feeling very ill, and tested positive for COVID-19. The events of feeling tired, feeling very ill started one day after the administration of mRNA-1273 vaccine (Lot number: unknown, expiration date: unknown) and  6 days after the vaccine administration, the patient tested positive for COVID-19. Based on the information provided, the known etiology of the disease and the timing from vaccine administration to COVID diagnosis, a causal association between the reported events and mRNA-1273  vaccine administration is unlikely.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Was vaccinated with less than half of the dose; Situation with a syringe in which the patient was vaccinated with less than half of the dose; A spontaneous report was received from a health care professional concerning a patient, unknown age, who was vaccinated with less than half of the dose of Moderna's COVID-19 Vaccine (mRNA-1273).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   The health care professional reported there was a situation with a syringe in which the patient was vaccinated with less than half of the dose. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events vaccinated with less than half of the dose and situation with a syringe in which the patient was vaccinated with less than half of the dose, was considered resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273. There were no reported AEs associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Did not receive full dose of first vaccine; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive a full dose of her first Vaccine.    The patient's medical history was not provided.  Concomitant product use was not provided.  On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273, (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient reported that she did not received full dose.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The event was considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273 with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received vaccine; A spontaneous report was received from a nurse concerning a 17-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 17-year old received vaccine.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Feb 2021, the Moderna COVID vaccine was given to a 17- year- old. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 17-year old received vaccine, was considered resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received dose 7 days prior to the indicated second dose date; A spontaneous report was received from a healthcare professional concerning a 57-year-old, male patient who received a second dose of Moderna's COVID-19 vaccine administered seven days prior to the indicated second dose date.  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 number:032H20A) unknown route of administration on 14 Jan 2021.   On 04 Feb 2021, patient received their second of two planned doses of mRNA-1273 (Lot number: 043L20A) unknown route of administration for prophylaxis of COVID-19 infection.  The patient got the first dose of mRNA-1273 vaccine on 14 Jan 2021 and second dose should have been in on 11 Feb 2021 but got it on 04 Feb 2021 at 15:42, seven days prior to the indicated second dose date. No treatment information was provided.  The patient received both scheduled dose of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event, vaccine administered seven days prior to the indicated second dose was considered resolved on 04 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect schedule of product administered for mRNA-1273 (Lot number: 043L20A) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Product administered to patient of inappropriate age
Clinical narrative: Dizziness; Headache; patient is 16- years old; A spontaneous report was received from a non-health professional concerning a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the events dizziness, headache, and vaccine given to a 16-year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in their arm for prophylaxis of COVID-19 infection.   On 06 Feb 2021, a father called stating his son was given the Moderna COVID vaccine. His son is 16-years old and had a headache and dizziness after the shot. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events dizziness and headache were not provided. The outcome of the event, patient is 16- years old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of  Product administered to patient of inappropriate age for mRNA-1273, lot # 028L20A. 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