chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood lactic acid, Malaise, Nasopharyngitis, Pain
Clinical narrative: wake up every few hours; did not sleep well; really cold; lactic acid feeling; felt pretty sick; felt off in his body; terrible aches in his arms; fever; terrible aches in his shoulders; pain; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling) and MALAISE (felt pretty sick) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Infection. Concomitant products included CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) and METRONIDAZOLE for Infection.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 11-Feb-2021, the patient experienced SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling), MALAISE (felt pretty sick), MALAISE (felt off in his body), PAIN IN EXTREMITY (terrible aches in his arms), PYREXIA (fever), ARTHRALGIA (terrible aches in his shoulders) and PAIN (pain). On 12-Feb-2021, SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling), MALAISE (felt pretty sick), MALAISE (felt off in his body), PAIN IN EXTREMITY (terrible aches in his arms), PYREXIA (fever), ARTHRALGIA (terrible aches in his shoulders) and PAIN (pain) had resolved.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality sleep, Pyrexia, Sleep disorder
Clinical narrative: wake up every few hours; did not sleep well; really cold; lactic acid feeling; felt pretty sick; felt off in his body; terrible aches in his arms; fever; terrible aches in his shoulders; pain; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling) and MALAISE (felt pretty sick) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Infection. Concomitant products included CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) and METRONIDAZOLE for Infection.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 11-Feb-2021, the patient experienced SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling), MALAISE (felt pretty sick), MALAISE (felt off in his body), PAIN IN EXTREMITY (terrible aches in his arms), PYREXIA (fever), ARTHRALGIA (terrible aches in his shoulders) and PAIN (pain). On 12-Feb-2021, SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling), MALAISE (felt pretty sick), MALAISE (felt off in his body), PAIN IN EXTREMITY (terrible aches in his arms), PYREXIA (fever), ARTHRALGIA (terrible aches in his shoulders) and PAIN (pain) had resolved.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Slight swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Slight swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Bruise, Abdominal discomfort and Swelling.    On 25-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Slight swelling). At the time of the report, VACCINATION SITE SWELLING (Slight swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-034823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: ADR form with pictures
Sex: F
Vaccine: COVID19
Symptoms: Headache, Motion sickness, Nausea, Vomiting
Clinical narrative: MOTION SICKNESS; HEADACHES; NAUSEA; VOMITING; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (MOTION SICKNESS), HEADACHE (HEADACHES), NAUSEA (NAUSEA) and VOMITING (VOMITING) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported. ).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOTION SICKNESS (MOTION SICKNESS), HEADACHE (HEADACHES), NAUSEA (NAUSEA) and VOMITING (VOMITING). At the time of the report, MOTION SICKNESS (MOTION SICKNESS), HEADACHE (HEADACHES), NAUSEA (NAUSEA) and VOMITING (VOMITING) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face
Clinical narrative: tingling in face; swollen right side of face; A spontaneous report was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling in face/paraesthesia, swollen right side of face/swelling face.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, approximately one hour after the vaccination, patient experienced the event(s) tingling in face/paraesthesia, swollen right side of face/swelling face.  Treatment information was provided as Benadryl and generic zyrtec.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tingling in face/paraesthesia, swollen right side of face/swelling face was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Pain, Pruritus, Rash, Swelling
Clinical narrative: Hurts; Swelling; Red patch; Bug bite; Itching; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching/pruritus, looked like a bug bite/arthropod bite, hurts/pain, feels like a bump inside/swelling, red patch/rash.  The patient's medical history included diabetes mellitus type-2, hip replacement. Concomitant medications reported were Metformin, Spironolactone, Lipitor, Micardis, Amoxicillin for drug use for unknown indication.  On 24 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the events itching/pruritus, looked like a bug bite/arthropod bite, hurts/pain, red patch/rash. On 4 Mar 2021, the patient experienced the event feels like a bump inside/swelling. Treatment details included Cortisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itching/pruritus, looked like a bug bite/arthropod bite, hurts/pain,feels like a bump inside/swelling, red patch/rash were considered not resolved.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Bad Headache; Chills; Extremely Exhausted; Queasy; A spontaneous report  was received from a (Consumer) concerning a- 23 years old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced Extremely Exhausted, Queasy, Bad Headache and Chills. The patient's medical history not included. No relevant concomitant medications were reported.   On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:010A21A) intramuscular for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced events extremely exhausted and queasy. On 03 March 2021, the patient experienced events bad headache and exhausted again and had chills.   Laboratory details not provided. No treatment details included. Action taken with mRNA-1273 in response to the events was not reported.  On 27 Feb 2021, the outcome of the event Queasy was Resolved. At the time of this report, the outcome of the events Extremely Exhausted, Bad Headache and chills was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Metamorphopsia, Rash macular, Somnolence, Vaccination site erythema
Clinical narrative: Drowsy; Rash Spot; Distorted Vision; Had a bad reaction; Reactions to the vaccine as they were pretty strange; Sore Arm; Red Spots; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction) and VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), OMEPRAZOLE and ROPINIROLE HYDROCHLORIDE (ROPIDOPIN) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction), VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange), VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Spots). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction), VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange), VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned  that she had a bad reaction because she had covid before the pandemic, and it  was the antibodies that attacked the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: New events feeling abnormal, vaccination site reaction were added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: Drowsy; Rash Spot; Distorted Vision; Had a bad reaction; Reactions to the vaccine as they were pretty strange; Sore Arm; Red Spots; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction) and VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), OMEPRAZOLE and ROPINIROLE HYDROCHLORIDE (ROPIDOPIN) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction), VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange), VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Spots). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction), VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange), VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned  that she had a bad reaction because she had covid before the pandemic, and it  was the antibodies that attacked the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: New events feeling abnormal, vaccination site reaction were added.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effect unknown; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effect unknown) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effect unknown). At the time of the report, ADVERSE EVENT (Side effect unknown) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: OutcomeTCS document attached
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: vaccination site got a little warm; vaccination site got a little red; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccination site got a little red, vaccination site got a little warm.  The patient's medical history was not provided.  relevant concomitant products usage were not reported by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) vaccination site got a little red, vaccination site got a little warm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), vaccination site got a little red, vaccination site got a little warm was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on arm and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm and shoulder) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on arm and shoulder). At the time of the report, RASH (rash on arm and shoulder) outcome was unknown.            This case was linked to MOD-2021-034817 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypokinesia, Off label use, Peripheral swelling, Pyrexia
Clinical narrative: Patient did not receive 2nd dose on her HCP's medical advice/recommendation; Fever that was 102; Severe vertigo with spinning right to left and up and down; Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers; Red streaks down her arm; Red streaks are hot; could not move her elbow; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation), PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers), ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot) and VERTIGO (Severe vertigo with spinning right to left and up and down) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 02-Mar-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot), HYPOKINESIA (could not move her elbow) and VOMITING (Throwing up). On 02-Mar-2021 at 10:00 PM, the patient experienced PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers). On 03-Mar-2021, the patient experienced VERTIGO (Severe vertigo with spinning right to left and up and down). On an unknown date, the patient experienced OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation) and PYREXIA (Fever that was 102). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation), ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot), VERTIGO (Severe vertigo with spinning right to left and up and down), PYREXIA (Fever that was 102) and VOMITING (Throwing up) outcome was unknown and PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers) and HYPOKINESIA (could not move her elbow) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Health care provider gave her letter stating she could skip 2nd dose as she had severe reaction for the first dose.  No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow-up appended
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Vertigo, Vomiting
Clinical narrative: Patient did not receive 2nd dose on her HCP's medical advice/recommendation; Fever that was 102; Severe vertigo with spinning right to left and up and down; Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers; Red streaks down her arm; Red streaks are hot; could not move her elbow; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation), PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers), ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot) and VERTIGO (Severe vertigo with spinning right to left and up and down) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 02-Mar-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot), HYPOKINESIA (could not move her elbow) and VOMITING (Throwing up). On 02-Mar-2021 at 10:00 PM, the patient experienced PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers). On 03-Mar-2021, the patient experienced VERTIGO (Severe vertigo with spinning right to left and up and down). On an unknown date, the patient experienced OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation) and PYREXIA (Fever that was 102). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation), ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot), VERTIGO (Severe vertigo with spinning right to left and up and down), PYREXIA (Fever that was 102) and VOMITING (Throwing up) outcome was unknown and PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers) and HYPOKINESIA (could not move her elbow) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Health care provider gave her letter stating she could skip 2nd dose as she had severe reaction for the first dose.  No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow-up appended
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed the second dose for 52 days now; A spontaneous report was received from a Pharmacist concerning herself, 88 years- old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and missed the second dose for 52 days now.  No patient's medical history was reported. No relevant concomitant medications were reported.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  As of 04 March 2021, the patient reported that she missed the second dose for 52 days now.  No Laboratory investigations were provided. No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   At the time of this report, the outcome of the event, missed the second dose for 52 days now was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash; itchy; This spontaneous case was reported by an other and describes the occurrence of RASH (Rash) and PRURITUS (itchy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0316(orL)20A) for COVID-19 vaccination.     No Medical History information was reported.   No concomitant medication of the patient was reported.  On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On 03-Mar-2021, the patient experienced RASH (Rash) and PRURITUS (itchy).   At the time of the report, RASH (Rash) and PRURITUS (itchy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Red and Swollen Entire Left Arm; Red Injection Site; Swollen Injection Site; Reaction Spread to the entire Left Arm; Enlarged Lymph Node in the Left Armpit.; Red and Swollen Entire Left Arm; A spontaneous report was received from a healthcare professional concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced the event(s) red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Red and Swollen Entire Left Arm; Red Injection Site; Swollen Injection Site; Reaction Spread to the entire Left Arm; Enlarged Lymph Node in the Left Armpit.; Red and Swollen Entire Left Arm; A spontaneous report was received from a healthcare professional concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced the event(s) red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Dizziness, Fatigue, Headache
Clinical narrative: had a lot of the general side effects; fast heartbeat; dizziness; fatigue; headache; muscle pain; chills; fever; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever.  The patient's medical history was not provided. Concomitant medications reported were Synthroid for drug use for unknown indication.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever.  Treatment details included ASPIRIN.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Pyrexia
Clinical narrative: had a lot of the general side effects; fast heartbeat; dizziness; fatigue; headache; muscle pain; chills; fever; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever.  The patient's medical history was not provided. Concomitant medications reported were Synthroid for drug use for unknown indication.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever.  Treatment details included ASPIRIN.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: fever of 100.5°F and Head ache; fever of 100.5°F and Head ache; the arm is sore at the injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 100.5°f(Pyrexia) , head ache(Headache), the arm is sore at the injection site(Injection site pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) fever of 100.5°F and Head ache, the arm is sore at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event(s), fever of 100.5°f and head ache, the arm is sore at the injection site was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Swollen lips; 6 inch whelps on her torso, hip and butt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (6 inch whelps on her torso, hip and butt) and LIP SWELLING (Swollen lips) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history not reported).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced URTICARIA (6 inch whelps on her torso, hip and butt). On an unknown date, the patient experienced LIP SWELLING (Swollen lips). At the time of the report, URTICARIA (6 inch whelps on her torso, hip and butt) and LIP SWELLING (Swollen lips) outcome was unknown.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) and mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.; Reporter's Comments: 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: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Hyperhidrosis
Clinical narrative: Temperature; Sweats; A Spontaneous report was received from consumer  concerning a unspecified age, female patient , Modern's COVID-19 vaccine(mRNA 1273) and experienced temperature and sweats. The patient medical history was not provided by the reporter. Concomitant medications were not provided by the reporter. On unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 , via unknown  route and unknown anatomical location for prophylaxis of COVID-19 infection. After receiving the first dose the patient experienced Temperature and sweats.  Treatment history was not provided by the reporter. Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event temperature and sweats were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Rash, Rosacea
Clinical narrative: tinny taste in the back of my mouth; rash on my arm; face was pink; A spontaneous report was received from a consumer, concerning  a 70 years adult female patient, who received Moderna COVID-19 Vaccine and experienced 1 dose.  The patient's medical history was not provided.  The concomitant products was not provided.  On  04-Mar-2021,prior to the onset of events,the patient received the first dose of  mRNA-1273(lot number: 029AD1A) and route of administration is  unknown route for COVID-19 infection prophylaxis.   The treatment includes that  Patient reports putting Benadryl on her arm today 04Mar2021.  Action taken with mRNA-1273 in response to the events were not reported.  The Outcome of the event (Rash,Dysgeusia,Rosacea) was considered to be not resolved at the time of this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Erythema, Peripheral swelling, Pruritus
Clinical narrative: swollen; red; itchy; COVID arm; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen, red, itchy, covid arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event(s) swollen, red, itchy, covid arm.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 11 Feb 2021 the outcome of event(s), swollen, itchy, covid arm was resolved. The outcome of event(s), red was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate, Heart rate increased, Muscle spasms, Myalgia
Clinical narrative: Severe joint pain; Muscle pain in chest and arms; Really bad leg cramps; Legs feel like sciatic overload; Heart rate went up to between 92-98 beats per; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (Really bad leg cramps), SCIATICA (Legs feel like sciatic overload), HEART RATE INCREASED (Heart rate went up to between 92-98 beats per), ARTHRALGIA (Severe joint pain) and MYALGIA (Muscle pain in chest and arms) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Ear infection (Reported data: In the past month I had two Rocephin shots for ear infections.  Treatment: Rocephin shots) in January 2021. Previously administered products included for Product used for unknown indication: Flu shot on 16-Dec-2020 and Pneumovax shot on 28-Dec-2020. Concurrent medical conditions included Type II diabetes mellitus.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MUSCLE SPASMS (Really bad leg cramps), SCIATICA (Legs feel like sciatic overload), HEART RATE INCREASED (Heart rate went up to between 92-98 beats per) and MYALGIA (Muscle pain in chest and arms). On an unknown date, the patient experienced ARTHRALGIA (Severe joint pain). In February 2021, MUSCLE SPASMS (Really bad leg cramps) had resolved. At the time of the report, SCIATICA (Legs feel like sciatic overload), HEART RATE INCREASED (Heart rate went up to between 92-98 beats per), ARTHRALGIA (Severe joint pain) and MYALGIA (Muscle pain in chest and arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Heart rate: 92-98 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment for the events included steroids.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Severe joint pain; Muscle pain in chest and arms; Really bad leg cramps; Legs feel like sciatic overload; Heart rate went up to between 92-98 beats per; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (Really bad leg cramps), SCIATICA (Legs feel like sciatic overload), HEART RATE INCREASED (Heart rate went up to between 92-98 beats per), ARTHRALGIA (Severe joint pain) and MYALGIA (Muscle pain in chest and arms) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Ear infection (Reported data: In the past month I had two Rocephin shots for ear infections.  Treatment: Rocephin shots) in January 2021. Previously administered products included for Product used for unknown indication: Flu shot on 16-Dec-2020 and Pneumovax shot on 28-Dec-2020. Concurrent medical conditions included Type II diabetes mellitus.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MUSCLE SPASMS (Really bad leg cramps), SCIATICA (Legs feel like sciatic overload), HEART RATE INCREASED (Heart rate went up to between 92-98 beats per) and MYALGIA (Muscle pain in chest and arms). On an unknown date, the patient experienced ARTHRALGIA (Severe joint pain). In February 2021, MUSCLE SPASMS (Really bad leg cramps) had resolved. At the time of the report, SCIATICA (Legs feel like sciatic overload), HEART RATE INCREASED (Heart rate went up to between 92-98 beats per), ARTHRALGIA (Severe joint pain) and MYALGIA (Muscle pain in chest and arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Heart rate: 92-98 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment for the events included steroids.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to the company on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.            Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: No specific follow-up information recorded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats) 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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced HYPERHIDROSIS (sweats). At the time of the report, HYPERHIDROSIS (sweats) outcome was unknown.            The patient reported that she had temperature and sweats following her first dose of vaccine. Concomitant and treatment details were not reported.   This case was linked to MOD-2021-034865, MOD-2021-034850 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Pain in the left shoulder going to elbow; Fatigue; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left shoulder going to elbow), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left shoulder going to elbow), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in the left shoulder going to elbow), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Booster Given Too Early-
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: Feel like shut. High fever. Body aches.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Confusional state, Diarrhoea
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Flushing, Headache
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site swelling, Lethargy, Nausea, Pain
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Pyrexia, Rash, Tinnitus
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Fever-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium