chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sinusitis
Clinical narrative: nose was clogged; sinus infection; A spontaneous report was received from a consumer concerning a 69-year-old, female patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who had experienced sinus infection, and her nose was clogged.  The patient's medical history, was not provided by the reporter.   Concomitant medications were not reported.    The patient received their first of two planned dose of mRNA-1273 on 2/Feb/2021. Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: unknown) for prophylaxis of COVID-19 infection .   Experienced sinus infection, and her nose was clogged.   No lab data was reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, sinus infection, and her nose was clogged were unknown.   The reporter did not provide an assessment for the events,sinus infection, and her nose was clogged.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Urticaria
Clinical narrative: broke out in hives on both arms and legs; red itching area at the injection site; sore arm; A spontaneous report was received from a consumer concerning a 65 year old, female patient who experienced arm sore, hives on both arms and legs, injection site redness and itching.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 4-Feb-2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031L20A) via unknown route for prophylaxis of COVID-19 infection.   On 5-Feb-2021, she had a sore arm. On 11-Feb-2021, a week later she had a red itching area at the injection site and then broke out in hives on both arms and legs.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.  The events, arm sore, hives, injection site redness and itching, were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Heart rate increased, Hypersensitivity, Hypoaesthesia
Clinical narrative: Both thighs are burning; Spasm in left thigh; she thinks she had an allergic reaction; Sore arm; Whole face started to feel numb; Tounge started to feel numb; Fast heartbeat; Dizziness; A spontaneous report was received from a (Consumer) concerning a  50 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness, both thighs are burning, spasm in left thigh, she thinks she had an allergic reaction) list.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On 23-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the Left Arm for prophylaxis of COVID-19 infection.    On 23-JAN-2021, The patient experienced the events list (sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness). On 24-JAN-2021, The patient experienced the events list (both thighs are burning, spasm in left thigh)   Laboratory details was not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the event(s) (sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness) was unknown.   At the time of this report, the outcome of the event(s) (both thighs are burning, spasm in left thigh) was recovered.   The reporter assessed the event(s), [sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness, both thighs are burning, spasm in left thigh], as related to study drug.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Muscle spasms, Pain in extremity
Clinical narrative: Both thighs are burning; Spasm in left thigh; she thinks she had an allergic reaction; Sore arm; Whole face started to feel numb; Tounge started to feel numb; Fast heartbeat; Dizziness; A spontaneous report was received from a (Consumer) concerning a  50 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness, both thighs are burning, spasm in left thigh, she thinks she had an allergic reaction) list.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On 23-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the Left Arm for prophylaxis of COVID-19 infection.    On 23-JAN-2021, The patient experienced the events list (sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness). On 24-JAN-2021, The patient experienced the events list (both thighs are burning, spasm in left thigh)   Laboratory details was not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the event(s) (sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness) was unknown.   At the time of this report, the outcome of the event(s) (both thighs are burning, spasm in left thigh) was recovered.   The reporter assessed the event(s), [sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness, both thighs are burning, spasm in left thigh], as related to study drug.
Sex: M
Vaccine: COVID19
Symptoms: Extensive swelling of vaccinated limb, Rash, Vaccination site induration, Vaccination site warmth
Clinical narrative: Arm swelling; Arm hard at touch; Arm  rash; Arm hot at the touch; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site swelling,induration,hot to touch and rash.  The patient's medical history was not reported. Concomitant medication was not reported.  13-FEB-2021,Prior to the onset of the events, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection.  Patient started experiencing arm swelling and hard at the touch,arm warm at the touch.  No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events is Unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypersensitivity, Myalgia, Pyrexia
Clinical narrative: reaction for about 2 weeks; chills; muscle ache; fever; enhanced taste; fatigue; A spontaneous report was received from a (Health Care Professional) concerning of an unknown age of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Reaction for about 2 weeks, Chills, Muscle ache, Fever, Enhanced taste, Fatigue.  The patient's passed medical history was not provided. The patient's take Lipitor and Baby aspirin 81mg concomitant medication.  On 21 Jan 2021 ,  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) in the Left upper Arm for prophylaxis of COVID-19 infection.   The patient got the first dose of Moderna vaccine then afterwards, patient experienced Reaction for about 2 weeks, Chills, Muscle ache, Fever, Enhanced taste, Fatigue  No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.    At this time of the report, the outcome of the event(s) Reaction for about 2 weeks, Chills, Muscle ache, Fever, Enhanced taste, Fatigue were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: reaction for about 2 weeks; chills; muscle ache; fever; enhanced taste; fatigue; A spontaneous report was received from a (Health Care Professional) concerning of an unknown age of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Reaction for about 2 weeks, Chills, Muscle ache, Fever, Enhanced taste, Fatigue.  The patient's passed medical history was not provided. The patient's take Lipitor and Baby aspirin 81mg concomitant medication.  On 21 Jan 2021 ,  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) in the Left upper Arm for prophylaxis of COVID-19 infection.   The patient got the first dose of Moderna vaccine then afterwards, patient experienced Reaction for about 2 weeks, Chills, Muscle ache, Fever, Enhanced taste, Fatigue  No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.    At this time of the report, the outcome of the event(s) Reaction for about 2 weeks, Chills, Muscle ache, Fever, Enhanced taste, Fatigue were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: 10 inch in diameter circle of redness around the injection site of the vaccine; arm was sore with a 10 inch diameter of redness around the injection site of the vaccine; A spontaneous report was received from a consumer concerning 79 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore with a 10 inch in diameter circle of redness around the injection site of the vaccine.   The patient's medical history was not reported.  Concomitant medications were reported as the patient took diabetic medication.  On 26 Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) via intramuscular in left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, same day of first dose of vaccination the patient experienced arm was sore with a 10-inch diameter of redness around the injection site of the vaccine.  On an unknown date in 2021, the patient experienced mild sore arm reaction, but redness has not gone away.  Laboratory test was not done.  Treatment information was not provided.  All the events occurred after first dose of vaccination.  The outcomes of the event remain unknown.  Action taken with mRNA-1273 in response to the events are unknown; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014617:
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea 4-5 times in 12 hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (Diarrhea 4-5 times in 12 hours) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced DIARRHOEA (Diarrhea 4-5 times in 12 hours). At the time of the report, DIARRHOEA (Diarrhea 4-5 times in 12 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment information and concomitant medication were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Fatigue; Fever >101 F; Red Injection site; Itchy injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever >101 F), INJECTION SITE ERYTHEMA (Red Injection site) and INJECTION SITE PRURITUS (Itchy injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever >101 F), INJECTION SITE ERYTHEMA (Red Injection site) and INJECTION SITE PRURITUS (Itchy injection site). At the time of the report, FATIGUE (Fatigue), INJECTION SITE ERYTHEMA (Red Injection site) and INJECTION SITE PRURITUS (Itchy injection site) outcome was unknown and PYREXIA (Fever >101 F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include ibuprofen tablets. No conc0mitant medication was reported.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.  Fatigue, fever, injection site redness and injection site  itchiness are consistent with the product safety profile.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site started itching; Hard; Swollen; Quarter size red circle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site started itching), INJECTION SITE INDURATION (Hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Quarter size red circle) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE, AMLODIPINE, LOSARTAN, MONTELUKAST, VITAMIN D NOS, PRAVASTATIN, IBANDRONATE SODIUM (BONIVA), METFORMIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INJECTION SITE PRURITUS (Injection site started itching), INJECTION SITE INDURATION (Hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Quarter size red circle). On 05-Feb-2021, INJECTION SITE PRURITUS (Injection site started itching), INJECTION SITE INDURATION (Hard) and INJECTION SITE ERYTHEMA (Quarter size red circle) had resolved and INJECTION SITE SWELLING (Swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include Tylenol.   Action taken with second dose of mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (comments: patient has multiple malignancy).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 15-Feb-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, COVID-19: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment informations was not provided. Patients concomitant medicines include steroids, chemotherapy and immunosuppressants.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked; Sender's Comments: Based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Vaccination site pain
Clinical narrative: extreme fatigue; chills; nausea; soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), NAUSEA (nausea), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (extreme fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 24-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (soreness at the injection site). On 25-Jan-2021, the patient experienced FATIGUE (extreme fatigue). On 26-Jan-2021, CHILLS (chills), NAUSEA (nausea), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (extreme fatigue) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, vaccination site induration, vaccination site pain, nausea, and fatigue are consistent with the product safety profile
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: vey sore arm; Headache; nausea; Dizzy for a minute,; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy for a minute,), PAIN IN EXTREMITY (vey sore arm), HEADACHE (Headache) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     no medical history reported.  The patient's past medical history included Influenza (Reaction to the flu shot). Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PROBIOTICS FREEZE for an unknown indication, ANTIHISTAMINES and EPINEPHRINE (EPIPEN).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Dizzy for a minute,). On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (vey sore arm), HEADACHE (Headache) and NAUSEA (nausea). On 12-Feb-2021, DIZZINESS (Dizzy for a minute,) had resolved. On 13-Feb-2021, NAUSEA (nausea) had resolved. On 15-Feb-2021, PAIN IN EXTREMITY (vey sore arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not reported.Concomitant medication also include melatonin.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and nausea are consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: redness at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE RASH (rash at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041620A and 016M20A) for COVID-19 vaccination.     no history was reported.  Concomitant products included WARFARIN for Heart valve replacement.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 18-Jan-2021, the patient experienced NAUSEA (Nausea). On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.            No treatment information was provided.    Patient reported about a historical procedure mechanical valve implant.  action taken with mRNA-123 is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy at time of vaccination; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. The patient's last menstrual period was on 05-Jan-2021 and the estimated date of delivery was 13-Oct-2021. On 11-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 11-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular),is not applicable.; Sender's Comments: This case concerns a 26-Year-old female, Para1 gravida 2, who received mRNA-1273 while pregnant (vaccine exposure during pregnancy) The patient's last menstrual period was 05-Jan-2021 a, estimated date of conception was 13-Oct-2021and estimated due date is 13-Oct-2021. the event of vaccine exposure during pregnancy is assessed as not applicable
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported . No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Vaccination site pain, injection is consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Lip blister
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of LIP BLISTER (blister on upper lip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced LIP BLISTER (blister on upper lip). At the time of the report, LIP BLISTER (blister on upper lip) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment or concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication
Clinical narrative: Reaction to the vaccine; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the vaccine) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to the vaccine) and RASH (Rash). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Reaction to the vaccine) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Muscle tightness, Urticaria
Clinical narrative: mouth and lips felt numb; tightness under the collar bone on the same side as injection; two hives developed on her face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (mouth and lips felt numb), MUSCLE TIGHTNESS (tightness under the collar bone on the same side as injection) and URTICARIA (two hives developed on her face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021 at 11:40 AM, the patient experienced HYPOAESTHESIA ORAL (mouth and lips felt numb), MUSCLE TIGHTNESS (tightness under the collar bone on the same side as injection) and URTICARIA (two hives developed on her face). At the time of the report, HYPOAESTHESIA ORAL (mouth and lips felt numb) and MUSCLE TIGHTNESS (tightness under the collar bone on the same side as injection) outcome was unknown and URTICARIA (two hives developed on her face) was resolving. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPOAESTHESIA ORAL (mouth and lips felt numb), MUSCLE TIGHTNESS (tightness under the collar bone on the same side as injection) and URTICARIA (two hives developed on her face) to be possibly related.    Treatment information and concomitant medications were not provided. Patient reports the areas stayed numb and tingling for a few hours. The hives have gone down now ~ 5:30pm. She stated she has this type of reaction with IV contrast and has to take 150 mg of prednisone, 50 mg of Benadryl before IV contrast for scans. She has her 2nd dose scheduled in one month.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site pink spot; Injection site warm; Injection site itchy; Injection site pain; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site pink spot), INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 14-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site pink spot), INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy). On 09-Feb-2021, INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Injection site pink spot), INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information and concomitant medications were not provided.   Reporter did not allow further contact; Sender's Comments: The reported event(s), [arm pain, injection site pink spot, injection site raised, injection warm and injection site itchy], were considered medically significant to mRNA-1273. (As listed for the study drug)
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Peripheral swelling, Vaccination site erythema, Vaccination site haemorrhage
Clinical narrative: Headache; Arm was swollen and bruised; Redness around the injection site; Injection site bled; Arm was swollen and bruised; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PERIPHERAL SWELLING (Arm was swollen and bruised), VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE HAEMORRHAGE (Injection site bled) and CONTUSION (Arm was swollen and bruised) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced HEADACHE (Headache), PERIPHERAL SWELLING (Arm was swollen and bruised), VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE HAEMORRHAGE (Injection site bled) and CONTUSION (Arm was swollen and bruised). The patient was treated with MELOXICAM on 17-Jan-2021 at a dose of 15 mg. At the time of the report, HEADACHE (Headache), PERIPHERAL SWELLING (Arm was swollen and bruised), VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE HAEMORRHAGE (Injection site bled) and CONTUSION (Arm was swollen and bruised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Herpes zoster, Hypertension
Clinical narrative: Arm pain; neck swollen; high blood pressure; chest still tight; body aches everywhere,; blisters in mouth; Fatigued; Headache; swollen lymph nodes in the neck; Shingles on roof of mouth and stomach; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on roof of mouth and stomach), PAIN IN EXTREMITY (Arm pain), SWELLING (neck swollen), HYPERTENSION (high blood pressure) and CHEST DISCOMFORT (chest still tight) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L204 and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's disease in 2001 and Anxiety in 2001. Concurrent medical conditions included Hypothyroidism in 2002 and Blood pressure high in 2001. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, METOPROLOL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 13-Jan-2021, the patient experienced HERPES ZOSTER (Shingles on roof of mouth and stomach). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), SWELLING (neck swollen), HYPERTENSION (high blood pressure), CHEST DISCOMFORT (chest still tight), PAIN (body aches everywhere,), ORAL MUCOSAL BLISTERING (blisters in mouth), FATIGUE (Fatigued), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph nodes in the neck). At the time of the report, HERPES ZOSTER (Shingles on roof of mouth and stomach) had resolved, PAIN IN EXTREMITY (Arm pain), SWELLING (neck swollen), CHEST DISCOMFORT (chest still tight), PAIN (body aches everywhere,), ORAL MUCOSAL BLISTERING (blisters in mouth), FATIGUE (Fatigued), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph nodes in the neck) outcome was unknown and HYPERTENSION (high blood pressure) had not resolved.            Treatment included anti-viral medicine, famber, for shingles. she was given a second prescription because she got shingles on her stomach   This case was linked to MOD-2021-097373 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Medical history, concomitant medications, therapy details and new events were added. Patient age was updated.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oral mucosal blistering, Pain, Pain in extremity, Swelling
Clinical narrative: Arm pain; neck swollen; high blood pressure; chest still tight; body aches everywhere,; blisters in mouth; Fatigued; Headache; swollen lymph nodes in the neck; Shingles on roof of mouth and stomach; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on roof of mouth and stomach), PAIN IN EXTREMITY (Arm pain), SWELLING (neck swollen), HYPERTENSION (high blood pressure) and CHEST DISCOMFORT (chest still tight) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L204 and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's disease in 2001 and Anxiety in 2001. Concurrent medical conditions included Hypothyroidism in 2002 and Blood pressure high in 2001. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, METOPROLOL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 13-Jan-2021, the patient experienced HERPES ZOSTER (Shingles on roof of mouth and stomach). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), SWELLING (neck swollen), HYPERTENSION (high blood pressure), CHEST DISCOMFORT (chest still tight), PAIN (body aches everywhere,), ORAL MUCOSAL BLISTERING (blisters in mouth), FATIGUE (Fatigued), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph nodes in the neck). At the time of the report, HERPES ZOSTER (Shingles on roof of mouth and stomach) had resolved, PAIN IN EXTREMITY (Arm pain), SWELLING (neck swollen), CHEST DISCOMFORT (chest still tight), PAIN (body aches everywhere,), ORAL MUCOSAL BLISTERING (blisters in mouth), FATIGUE (Fatigued), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph nodes in the neck) outcome was unknown and HYPERTENSION (high blood pressure) had not resolved.            Treatment included anti-viral medicine, famber, for shingles. she was given a second prescription because she got shingles on her stomach   This case was linked to MOD-2021-097373 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Medical history, concomitant medications, therapy details and new events were added. Patient age was updated.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE RASH (rash at the injection site). At the time of the report, INJECTION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment or concomitant medication reported. Patient reports rash 9days after 1st dose of the moderna vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash in the neck below the jaw; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (Rash in the neck below the jaw) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash in the neck below the jaw). At the time of the report, VACCINATION SITE RASH (Rash in the neck below the jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Treatment information or concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: unspecified side effect; This spontaneous case was reported by a patient and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information or concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Vaccination site anaesthesia, Vaccination site pruritus
Clinical narrative: numbness on injection site; knot on her left shoulder blade; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (numbness on injection site), MASS (knot on her left shoulder blade) and VACCINATION SITE PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ANAESTHESIA (numbness on injection site), MASS (knot on her left shoulder blade) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE ANAESTHESIA (numbness on injection site), MASS (knot on her left shoulder blade) and VACCINATION SITE PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information or concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia oral, Pain in extremity
Clinical narrative: numbness around the lip; felt thingness around the skin of the lips; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness around the lip), FEELING ABNORMAL (felt thingness around the skin of the lips) and PAIN IN EXTREMITY (sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma and Thrombosis. Concomitant products included PARACETAMOL (TYLENOL).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (numbness around the lip), FEELING ABNORMAL (felt thingness around the skin of the lips) and PAIN IN EXTREMITY (sore arm). On 26-Jan-2021, HYPOAESTHESIA ORAL (numbness around the lip) and FEELING ABNORMAL (felt thingness around the skin of the lips) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information reported. Patient only took two Tylenol prior taking the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Injection site pruritus, Pyrexia, Rash macular
Clinical narrative: Burning; Itching; Really red and really big blotchy reaction at the site of injection; Glands in her armpit are sore; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Burning), INJECTION SITE PRURITUS (Itching), RASH MACULAR (Really red and really big blotchy reaction at the site of injection), AXILLARY PAIN (Glands in her armpit are sore) and PYREXIA (Low grade fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K 20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INJECTION SITE PAIN (Burning), INJECTION SITE PRURITUS (Itching), RASH MACULAR (Really red and really big blotchy reaction at the site of injection), AXILLARY PAIN (Glands in her armpit are sore) and PYREXIA (Low grade fever). At the time of the report, INJECTION SITE PAIN (Burning), INJECTION SITE PRURITUS (Itching), RASH MACULAR (Really red and really big blotchy reaction at the site of injection), AXILLARY PAIN (Glands in her armpit are sore) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include ice and hydrocortisone cream. No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Somnolence
Clinical narrative: Headache and Stomachache; stomachache; Feeling sleepy , needs to sleep all the time; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache and Stomachache), ABDOMINAL PAIN UPPER (stomachache) and SOMNOLENCE (Feeling sleepy , needs to sleep all the time) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0777027310) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache and Stomachache), ABDOMINAL PAIN UPPER (stomachache) and SOMNOLENCE (Feeling sleepy , needs to sleep all the time). At the time of the report, HEADACHE (Headache and Stomachache), ABDOMINAL PAIN UPPER (stomachache) and SOMNOLENCE (Feeling sleepy , needs to sleep all the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications or treatment information provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Feeling of body temperature change, Headache, Hyperhidrosis
Clinical narrative: nearly passed out while groceryshopping; Shaking; body feels Cold and then hot; sometimes sweating; i am not myself; head hurts; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (nearly passed out while groceryshopping), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (body feels Cold and then hot), HYPERHIDROSIS (sometimes sweating) and FEELING ABNORMAL (i am not myself) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (nearly passed out while groceryshopping), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (body feels Cold and then hot), HYPERHIDROSIS (sometimes sweating), FEELING ABNORMAL (i am not myself) and HEADACHE (head hurts). At the time of the report, DIZZINESS (nearly passed out while groceryshopping), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (body feels Cold and then hot), HYPERHIDROSIS (sometimes sweating), FEELING ABNORMAL (i am not myself) and HEADACHE (head hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information or concomitant medications were provided.