chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Insomnia, Tremor
Clinical narrative: fast heart beat; chills; not able to sleep; shaken up without any temperature; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat), CHILLS (chills), INSOMNIA (not able to sleep) and TREMOR (shaken up without any temperature) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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) Dose 1. On 15-Feb-2021, the patient experienced HEART RATE INCREASED (fast heart beat), CHILLS (chills), INSOMNIA (not able to sleep) and TREMOR (shaken up without any temperature). At the time of the report, HEART RATE INCREASED (fast heart beat), CHILLS (chills) and INSOMNIA (not able to sleep) outcome was unknown and TREMOR (shaken up without any temperature) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment or concomitant medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Injection site induration, Pain in extremity, Rash
Clinical narrative: back pain; leg pain; headache; rash developed on stomach; bump at injection site; arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (bump at injection site), PAIN IN EXTREMITY (arm was painful), BACK PAIN (back pain), PAIN IN EXTREMITY (leg pain) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE INDURATION (bump at injection site) and PAIN IN EXTREMITY (arm was painful). On 11-Feb-2021, the patient experienced BACK PAIN (back pain), PAIN IN EXTREMITY (leg pain), HEADACHE (headache) and RASH (rash developed on stomach). At the time of the report, INJECTION SITE INDURATION (bump at injection site), PAIN IN EXTREMITY (arm was painful), BACK PAIN (back pain), PAIN IN EXTREMITY (leg pain), HEADACHE (headache) and RASH (rash developed on stomach) outcome was unknown.            No treatment or concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Swelling
Clinical narrative: Very hot to touch; Initial swelling/ Came back larger than 2 inches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Initial swelling/ Came back larger than 2 inches) and FEELING HOT (Very hot to touch) in a 65-year-old female patient 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) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced SWELLING (Initial swelling/ Came back larger than 2 inches). On 22-Jan-2021, the patient experienced FEELING HOT (Very hot to touch). On 19-Jan-2021, SWELLING (Initial swelling/ Came back larger than 2 inches) had not resolved. At the time of the report, FEELING HOT (Very hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. She put on cool packs/wet towels but the swelling is getting bigger and bigger.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; headache; fever went up to 100.6F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache) and PYREXIA (fever went up to 100.6F) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 15-Feb-2021, the patient experienced CHILLS (chills), HEADACHE (headache) and PYREXIA (fever went up to 100.6F). At the time of the report, CHILLS (chills), HEADACHE (headache) and PYREXIA (fever went up to 100.6F) had not resolved.            No treatment or concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: 4 inches wide by 2.5 inches long rash on the injection site; warm  to touch; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (4 inches wide by 2.5 inches long rash on the injection site), INJECTION SITE WARMTH (warm  to touch) and INJECTION SITE PRURITUS (Itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE RASH (4 inches wide by 2.5 inches long rash on the injection site), INJECTION SITE WARMTH (warm  to touch) and INJECTION SITE PRURITUS (Itchy). At the time of the report, INJECTION SITE RASH (4 inches wide by 2.5 inches long rash on the injection site), INJECTION SITE WARMTH (warm  to touch) and INJECTION SITE PRURITUS (Itchy) 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 or concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M204) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension, Thyroid disorder, High cholesterol and Penicillin allergy. Concomitant products included AMLODIPINE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site was swelling; injection site was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was swelling) and VACCINATION SITE PRURITUS (injection site was itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included RALOXIFENE HCL for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swelling) and VACCINATION SITE PRURITUS (injection site was itchy). On 16-Feb-2021, VACCINATION SITE PRURITUS (injection site was itchy) had resolved. At the time of the report, VACCINATION SITE SWELLING (injection site was swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Influenza like illness, Nausea
Clinical narrative: Rash all over abdomen; Tired; Like a flu; Chills; Temperature/ Running temperature; Nausea; A spontaneous report was received from a consumer  concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  chills, nausea, like a flu,  very tired, running temperature ,rash all over abdomen, still fever 99.9 -99.3 °F.   The patient's medical history, as provided by the reporter, included breast cancer of both sides and had a major surgery was under radiation treatment. Concomitant medications reported included letrozole drug used for unknown indication.   On 03 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A or 039L20A) intramuscularly  for prophylaxis of COVID-19 infection and On 03 Feb 2021  prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, prior to receiving mRNA-1273, the patient felt chills, nausea, like a flu, running temperature , and on 04 Feb 2021  very tired, and on 05 Feb 2021 rash all over abdomen, still fever 99.9 -99.3 °F.   Treatment for the events included Alvin and Benadryl for rash. Action taken with mRNA-1273 in response to the events was not reported.   The events,chills, nausea, like a flu , were considered resolved on 03 Feb 2021 and the outcome of the events running temperature,very tired and rash all over the abdomen was unknown.; Sender's Comments:  MOD-2021-011677:Same patient, 1st dose of Moderna Covid-19 vaccine US-MODERNATX, INC.-MOD-2021-014794:Same patient, 2nd dose of Moderna Covid-19 vaccine
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash all over abdomen; Tired; Like a flu; Chills; Temperature/ Running temperature; Nausea; A spontaneous report was received from a consumer  concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  chills, nausea, like a flu,  very tired, running temperature ,rash all over abdomen, still fever 99.9 -99.3 °F.   The patient's medical history, as provided by the reporter, included breast cancer of both sides and had a major surgery was under radiation treatment. Concomitant medications reported included letrozole drug used for unknown indication.   On 03 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A or 039L20A) intramuscularly  for prophylaxis of COVID-19 infection and On 03 Feb 2021  prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, prior to receiving mRNA-1273, the patient felt chills, nausea, like a flu, running temperature , and on 04 Feb 2021  very tired, and on 05 Feb 2021 rash all over abdomen, still fever 99.9 -99.3 °F.   Treatment for the events included Alvin and Benadryl for rash. Action taken with mRNA-1273 in response to the events was not reported.   The events,chills, nausea, like a flu , were considered resolved on 03 Feb 2021 and the outcome of the events running temperature,very tired and rash all over the abdomen was unknown.; Sender's Comments:  MOD-2021-011677:Same patient, 1st dose of Moderna Covid-19 vaccine US-MODERNATX, INC.-MOD-2021-014794:Same patient, 2nd dose of Moderna Covid-19 vaccine
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Rash on both arms and upper back; itching on arms and upper back; pain in same arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on both arms and upper back), PRURITUS (itching on arms and upper back) and PAIN IN EXTREMITY (pain in same arm) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (Rash on both arms and upper back) and PRURITUS (itching on arms and upper back). 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in same arm). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) on 16-Feb-2021 at an unspecified dose and frequency. On 11-Feb-2021, PAIN IN EXTREMITY (pain in same arm) had resolved. At the time of the report, RASH (Rash on both arms and upper back) and PRURITUS (itching on arms and upper back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: Knot in injection site; Itchiness (injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Knot in injection site) and INJECTION SITE PRURITUS (Itchiness (injection site)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE MASS (Knot in injection site) and INJECTION SITE PRURITUS (Itchiness (injection site)). At the time of the report, INJECTION SITE MASS (Knot in injection site) and INJECTION SITE PRURITUS (Itchiness (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and MALAISE (does not feel well) 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 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and MALAISE (does not feel well). At the time of the report, NAUSEA (Nausea) and MALAISE (does not feel well) had not resolved.            No treatment or concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Headache
Clinical narrative: face had swelled up; diarrhea; hard coughing; bad headache; chills; nauseous; weak; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (hard coughing), HEADACHE (bad headache), CHILLS (chills), NAUSEA (nauseous) and ASTHENIA (weak) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced COUGH (hard coughing), HEADACHE (bad headache), CHILLS (chills), NAUSEA (nauseous) and ASTHENIA (weak). On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 04-Feb-2021, the patient experienced SWELLING FACE (face had swelled up). At the time of the report, COUGH (hard coughing), HEADACHE (bad headache), CHILLS (chills), NAUSEA (nauseous), ASTHENIA (weak), DIARRHOEA (diarrhea) and SWELLING FACE (face had swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Patient went to the emergency room on 06-FEB-2021 and was given a shot and medications for the swelling (patient unsure of the names).  She was also given medication to pre-medicate for the second vaccine and was instructed to take them the day before, day of, and day after - Banophen 25mg and Famotidine 20mg.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Swelling face
Clinical narrative: face had swelled up; diarrhea; hard coughing; bad headache; chills; nauseous; weak; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (hard coughing), HEADACHE (bad headache), CHILLS (chills), NAUSEA (nauseous) and ASTHENIA (weak) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced COUGH (hard coughing), HEADACHE (bad headache), CHILLS (chills), NAUSEA (nauseous) and ASTHENIA (weak). On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 04-Feb-2021, the patient experienced SWELLING FACE (face had swelled up). At the time of the report, COUGH (hard coughing), HEADACHE (bad headache), CHILLS (chills), NAUSEA (nauseous), ASTHENIA (weak), DIARRHOEA (diarrhea) and SWELLING FACE (face had swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Patient went to the emergency room on 06-FEB-2021 and was given a shot and medications for the swelling (patient unsure of the names).  She was also given medication to pre-medicate for the second vaccine and was instructed to take them the day before, day of, and day after - Banophen 25mg and Famotidine 20mg.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Nausea
Clinical narrative: diarrhea; weakness; nausea; A spontaneous report was received from a consumer concerning a 92-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea,  asthenia, and nausea.  The patient's medical history included back and body pain. Products known to have been used by the patient, within two weeks prior to the event, included warfarin, oxycodone, acetylsalicylic acid, and hydrocodone.  On 09 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 007M20A) for prophylaxis of Covid-19 infection.   The patient stated that she is experiencing weakness, nausea, and had diarrhea. No further information was provided. Treatment information was unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The events, diarrhea, weakness, and nausea, were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded. Nausea is consistent with the known safety profile of mRNA-1273.  However asthenia is confounded by concomitant use of  oxycodone  and hydrocodone and patient's advanced age.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Oropharyngeal discomfort, Pain in extremity, Pruritus
Clinical narrative: Severe itching startedted on my palms; Pails of hand extremely red; Welts and hives; Felt like my mody was on fire / burning sensation; A sore arm like getting a flu shot; Swelling of upper airway; Sensation of throat closing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Severe itching started on my palms), ERYTHEMA (Pails of hand extremely red), URTICARIA (Welts and hives), BURNING SENSATION (Felt like my mody was on fire / burning sensation) and PAIN IN EXTREMITY (A sore arm like getting a flu shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Severe itching startedted on my palms), ERYTHEMA (Pails of hand extremely red), URTICARIA (Welts and hives), BURNING SENSATION (Felt like my mody was on fire / burning sensation), PAIN IN EXTREMITY (A sore arm like getting a flu shot), SWELLING (Swelling of upper airway) and OROPHARYNGEAL DISCOMFORT (Sensation of throat closing). At the time of the report, PRURITUS (Severe itching startedted on my palms), ERYTHEMA (Pails of hand extremely red), URTICARIA (Welts and hives), BURNING SENSATION (Felt like my mody was on fire / burning sensation), PAIN IN EXTREMITY (A sore arm like getting a flu shot), SWELLING (Swelling of upper airway) and OROPHARYNGEAL DISCOMFORT (Sensation of throat closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-014232 (E2B Linked Report). This case was linked to MOD-2021-014232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 contains non-significant information :updated reporters e-mail address. On 26-May-2021: Follow up received on 26 May 2021 contains significant information: Added new events.; Sender's Comments:  MOD-2021-014232:Serious report
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Severe itching startedted on my palms; Pails of hand extremely red; Welts and hives; Felt like my mody was on fire / burning sensation; A sore arm like getting a flu shot; Swelling of upper airway; Sensation of throat closing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Severe itching started on my palms), ERYTHEMA (Pails of hand extremely red), URTICARIA (Welts and hives), BURNING SENSATION (Felt like my mody was on fire / burning sensation) and PAIN IN EXTREMITY (A sore arm like getting a flu shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Severe itching startedted on my palms), ERYTHEMA (Pails of hand extremely red), URTICARIA (Welts and hives), BURNING SENSATION (Felt like my mody was on fire / burning sensation), PAIN IN EXTREMITY (A sore arm like getting a flu shot), SWELLING (Swelling of upper airway) and OROPHARYNGEAL DISCOMFORT (Sensation of throat closing). At the time of the report, PRURITUS (Severe itching startedted on my palms), ERYTHEMA (Pails of hand extremely red), URTICARIA (Welts and hives), BURNING SENSATION (Felt like my mody was on fire / burning sensation), PAIN IN EXTREMITY (A sore arm like getting a flu shot), SWELLING (Swelling of upper airway) and OROPHARYNGEAL DISCOMFORT (Sensation of throat closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-014232 (E2B Linked Report). This case was linked to MOD-2021-014232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 contains non-significant information :updated reporters e-mail address. On 26-May-2021: Follow up received on 26 May 2021 contains significant information: Added new events.; Sender's Comments:  MOD-2021-014232:Serious report
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Pain in the arm; Lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN IN EXTREMITY (Pain in the arm) and PAIN (Lot of pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025M20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN and HCTZ 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 15-Feb-2021, the patient experienced PYREXIA (Fever), PAIN IN EXTREMITY (Pain in the arm) and PAIN (Lot of pain). At the time of the report, PYREXIA (Fever), PAIN IN EXTREMITY (Pain in the arm) and PAIN (Lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Pruritus
Clinical narrative: Lump; itching; Redness; This spontaneous case was reported by a patient and describes the occurrence of NODULE (Lump), PRURITUS (itching) and ERYTHEMA (Redness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (Lump), PRURITUS (itching) and ERYTHEMA (Redness). At the time of the report, NODULE (Lump), PRURITUS (itching) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: arm became warm; arm became  pink; arm became inflamed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm became warm), VACCINATION SITE DISCOLOURATION (arm became  pink) and VACCINATION SITE INFLAMMATION (arm became inflamed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL and VITAMINS NOS for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE WARMTH (arm became warm), VACCINATION SITE DISCOLOURATION (arm became  pink) and VACCINATION SITE INFLAMMATION (arm became inflamed). On 31-Dec-2020, VACCINATION SITE WARMTH (arm became warm), VACCINATION SITE DISCOLOURATION (arm became  pink) and VACCINATION SITE INFLAMMATION (arm became inflamed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information included warm compress on the arm.   This case was linked to US-MODERNATX, INC.-MOD-2021-014829 (E2B Linked Report). This case was linked to MOD-2021-014829 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014829:
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: itchiness on the injection site; a small rash was noticed on the injection site area; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a 55-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, itchiness on the injection site(Injection site itching) and a small rash was noticed on the injection site area (Injection site rash).  No medical history was reported. Concomitant medications reported included,Synthroid, Bystolic, vitamins B12-C-B3 and stomach medications.  On 09-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch No:031L20A) through an unknown route of administration, on the right arm for prophylaxis of COVID-19 infection.  On 16-Feb-2021, the patient experienced events, itchiness on the injection site(Injection site itching) and a small rash was noticed on the injection site area (Injection site rash).  No Laboratory details were provided.  No Treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events reported, itchiness on the injection site(Injection site itching) and a small rash was noticed on the injection site area (Injection site rash) was considered unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis
Clinical narrative: Sweating; Severe Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and DIARRHOEA (Severe Diarrhea) 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 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating) and DIARRHOEA (Severe Diarrhea). At the time of the report, HYPERHIDROSIS (Sweating) and DIARRHOEA (Severe Diarrhea) outcome was unknown.            No treatment or concomitant medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site pain
Clinical narrative: 31 weeks pregnant; sore arm after administration of the vaccine; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (31 weeks pregnant) and VACCINATION SITE PAIN (sore arm after administration of the vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Jul-2020 and the estimated date of delivery was 13-Apr-2021. On 13-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (31 weeks pregnant) and VACCINATION SITE PAIN (sore arm after administration of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 13-Feb-2021, EXPOSURE DURING PREGNANCY (31 weeks pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm after administration of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: No specific follow-up information recorded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Joint warmth, Rash erythematous, Swelling
Clinical narrative: Rush on joint; swelling; really hot; like burning inside; A spontaneous report was received from a (Reporter consumer) concerning a  Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events   The patient's medical history was not provided. No relevant concomitant medications were reported.    On Date 15Feb2021, prior to the onset of the events, the patient received their first planned doses of mRNA-1273 (lot/batch: 007A20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  she received the 1st dose of the Moderna vaccine on 15Feb2021, 12 hours after receiving the vaccine she had a red rush on the joint, not other places of the body, it was swelling, really hot, like burning inside like something was on fire, she took an antihistaminic and put some ice and after one hour the symptoms went away. No symptoms ongoing. No other symptoms reported. Patient is allergic to Sulphur.  Laboratory details was not provided  Treatment she took the anti histamines for the event and after it have been subsided  Action taken with mRNA-1273 in response to the events was not reported.  The out come of the event is recovered and resolved after she took the anti histamine and it was an non serious case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness/tenderness; A spontaneous report  was received from a 73-year old female patient who received mRNA-1273 vaccine and experienced soreness in arm/pain extremity.  No medical history and No relevant concomitant medications were provided by the reporter.  On 03 Feb 2021, prior to the onset of events, the patient received their dose of two planned doses of mRNA-1273 (Batch number unknown) via intramuscular route for prophylaxis of COVID-19 infection.   On 16 Feb 2021, patient experienced arm soreness/tenderness. No treatment medication was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was unknown at the time of this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood sugar level rose after the 1st dose by 65mg/dl; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar level rose after the 1st dose by 65mg/dl) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes mellitus. Concomitant products included METFORMIN.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar level rose after the 1st dose by 65mg/dl). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar level rose after the 1st dose by 65mg/dl) outcome was unknown.            Treatment details was not reported by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Feels Warm at injection site; 3X3 rash at injection site; Itchy at injection site; Swollen at injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (Feels Warm at injection site), VACCINATION SITE RASH (3X3 rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M208) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Feels Warm at injection site), VACCINATION SITE RASH (3X3 rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, VACCINATION SITE WARMTH (Feels Warm at injection site), VACCINATION SITE RASH (3X3 rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details was not reported by the reported. Treatment details not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: The site of injection was warm; Feels a little lump; The site of injection was itching; Site of injection was red; The site of injection was tender; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (The site of injection was warm), VACCINATION SITE MASS (Feels a little lump), VACCINATION SITE PRURITUS (The site of injection was itching) and VACCINATION SITE ERYTHEMA (Site of injection was red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (The site of injection was warm), VACCINATION SITE MASS (Feels a little lump), VACCINATION SITE PRURITUS (The site of injection was itching), VACCINATION SITE ERYTHEMA (Site of injection was red) and VACCINATION SITE PAIN (The site of injection was tender). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (The site of injection was warm), VACCINATION SITE MASS (Feels a little lump), VACCINATION SITE PRURITUS (The site of injection was itching), VACCINATION SITE ERYTHEMA (Site of injection was red) and VACCINATION SITE PAIN (The site of injection was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: The site of injection was warm; Feels a little lump; The site of injection was itching; Site of injection was red; The site of injection was tender; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (The site of injection was warm), VACCINATION SITE MASS (Feels a little lump), VACCINATION SITE PRURITUS (The site of injection was itching) and VACCINATION SITE ERYTHEMA (Site of injection was red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (The site of injection was warm), VACCINATION SITE MASS (Feels a little lump), VACCINATION SITE PRURITUS (The site of injection was itching), VACCINATION SITE ERYTHEMA (Site of injection was red) and VACCINATION SITE PAIN (The site of injection was tender). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (The site of injection was warm), VACCINATION SITE MASS (Feels a little lump), VACCINATION SITE PRURITUS (The site of injection was itching), VACCINATION SITE ERYTHEMA (Site of injection was red) and VACCINATION SITE PAIN (The site of injection was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: large redness on arm of injection; swelling on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (large redness on arm of injection) and VACCINATION SITE SWELLING (swelling on arm of injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (large redness on arm of injection) and VACCINATION SITE SWELLING (swelling on arm of injection). On 15-Feb-2021, VACCINATION SITE SWELLING (swelling on arm of injection) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (large redness on arm of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment information included antihistamine, Tylenol, hot and cold compression.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Injection site induration, Injection site swelling, Pain in extremity
Clinical narrative: Hot to touch; Almost like hives; Itchy; Very hard; Swollen at injection site; Red arm; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of DRY SKIN (Hot to touch), PAIN IN EXTREMITY (Sore arm), URTICARIA (Almost like hives), ERYTHEMA (Red arm) and PRURITUS (Itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no relevant medical history reported). Concomitant products included ROSUVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red arm). On 12-Feb-2021, the patient experienced DRY SKIN (Hot to touch), URTICARIA (Almost like hives), PRURITUS (Itchy), INJECTION SITE INDURATION (Very hard) and INJECTION SITE SWELLING (Swollen at injection site). At the time of the report, DRY SKIN (Hot to touch), URTICARIA (Almost like hives), PRURITUS (Itchy), INJECTION SITE INDURATION (Very hard) and INJECTION SITE SWELLING (Swollen at injection site) had not resolved and PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red arm) had resolved.        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 medications included OTC vitamins. Treatment included ice pack.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hot to touch; Almost like hives; Itchy; Very hard; Swollen at injection site; Red arm; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of DRY SKIN (Hot to touch), PAIN IN EXTREMITY (Sore arm), URTICARIA (Almost like hives), ERYTHEMA (Red arm) and PRURITUS (Itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no relevant medical history reported). Concomitant products included ROSUVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red arm). On 12-Feb-2021, the patient experienced DRY SKIN (Hot to touch), URTICARIA (Almost like hives), PRURITUS (Itchy), INJECTION SITE INDURATION (Very hard) and INJECTION SITE SWELLING (Swollen at injection site). At the time of the report, DRY SKIN (Hot to touch), URTICARIA (Almost like hives), PRURITUS (Itchy), INJECTION SITE INDURATION (Very hard) and INJECTION SITE SWELLING (Swollen at injection site) had not resolved and PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red arm) had resolved.        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 medications included OTC vitamins. Treatment included ice pack.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction). At the time of the report, VACCINATION COMPLICATION (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  No treatment medications provided.   Reporter did not allow further contact