chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dizziness; body ache; fever; headache; chills; muscle ache; fatigue; blood pressure increased to 210/180; heat rate was 117; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN (body ache), BLOOD PRESSURE INCREASED (blood pressure increased to 210/180), HEART RATE INCREASED (heat rate was 117) and PYREXIA (fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L120A) 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 medical history reported.). Concomitant products included LEVOTHYROXINE.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure increased to 210/180) and HEART RATE INCREASED (heat rate was 117). On 21-Jan-2021, the patient experienced DIZZINESS (dizziness), PAIN (body ache), PYREXIA (fever), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), PAIN (body ache), BLOOD PRESSURE INCREASED (blood pressure increased to 210/180), PYREXIA (fever), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache) and FATIGUE (fatigue) had resolved and HEART RATE INCREASED (heat rate was 117) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood pressure measurement: 210/180. On 20-Jan-2021, Heart rate: 117.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Tylenol and Zyrtec
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle spasms from his neck to his feet; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms from his neck to his feet) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for an unknown indication.  The patient's past medical history included Blood pressure, Diabetes and Lupus syndrome. Concurrent medical conditions included Drug allergy (penicillin allergy).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced MUSCLE SPASMS (muscle spasms from his neck to his feet). At the time of the report, MUSCLE SPASMS (muscle spasms from his neck to his feet) outcome was unknown.   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.  No concomitant medications were provided Treatment ibuprofen
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: site of the injection was warm; site of the injection was warm intense itching; Redness; swelling of the site of the injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (site of the injection was warm), VACCINATION SITE PRURITUS (site of the injection was warm intense itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (swelling of the site of the injection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE WARMTH (site of the injection was warm), VACCINATION SITE PRURITUS (site of the injection was warm intense itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (swelling of the site of the injection). On 31-Dec-2020, VACCINATION SITE WARMTH (site of the injection was warm), VACCINATION SITE PRURITUS (site of the injection was warm intense itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (swelling of the site of the injection) 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 product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: no new information On 15-Apr-2021: Patient is a physician and did not seek medical attention for the side effects.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Feeling cold, Myalgia
Clinical narrative: loose stools; awoke feeling chilled; Sore Arm; Fever 100.8; Nausea; Body Aches; Vomiting; Was tired that evening; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (loose stools), FEELING COLD (awoke feeling chilled), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever 100.8) and NAUSEA (Nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included GERD since 2007. Concomitant products included OMEPRAZOLE for GERD.    On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Was tired that evening). On 20-Jan-2021, the patient experienced DIARRHOEA (loose stools), FEELING COLD (awoke feeling chilled), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever 100.8), NAUSEA (Nausea), MYALGIA (Body Aches) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 1 g and IBUPROFEN (oral) at a dose of 600 mcg. On 20-Jan-2021, FATIGUE (Was tired that evening) had resolved. On 21-Jan-2021, DIARRHOEA (loose stools), FEELING COLD (awoke feeling chilled), PYREXIA (Fever 100.8), NAUSEA (Nausea), MYALGIA (Body Aches) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 100.4 (High) 100.4 degree Fahrenheit and 101 (High) 101 degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable   This case was linked to MOD-2021-237097 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information received and added patient race and ethnic group, medical history, concomitant medication and new events.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: loose stools; awoke feeling chilled; Sore Arm; Fever 100.8; Nausea; Body Aches; Vomiting; Was tired that evening; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (loose stools), FEELING COLD (awoke feeling chilled), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever 100.8) and NAUSEA (Nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included GERD since 2007. Concomitant products included OMEPRAZOLE for GERD.    On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Was tired that evening). On 20-Jan-2021, the patient experienced DIARRHOEA (loose stools), FEELING COLD (awoke feeling chilled), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever 100.8), NAUSEA (Nausea), MYALGIA (Body Aches) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 1 g and IBUPROFEN (oral) at a dose of 600 mcg. On 20-Jan-2021, FATIGUE (Was tired that evening) had resolved. On 21-Jan-2021, DIARRHOEA (loose stools), FEELING COLD (awoke feeling chilled), PYREXIA (Fever 100.8), NAUSEA (Nausea), MYALGIA (Body Aches) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 100.4 (High) 100.4 degree Fahrenheit and 101 (High) 101 degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable   This case was linked to MOD-2021-237097 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information received and added patient race and ethnic group, medical history, concomitant medication and new events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: warm; red; arm feel a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm feel a little sore), INJECTION SITE WARMTH (warm) and INJECTION SITE ERYTHEMA (red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm feel a little sore). On 25-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm) and INJECTION SITE ERYTHEMA (red). The patient was treated with ALCOHOL at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm feel a little sore), INJECTION SITE WARMTH (warm) and INJECTION SITE ERYTHEMA (red) was resolving.        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.   No concomitant medications were provided Treatment Rubbed with alcohol and took Tylenol. Reporter said patient was fine now.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Event outcome updated from Unknown to Recovering/Resolving.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gastrointestinal pain, Nausea, Vomiting
Clinical narrative: Severe bowel pain; Pain in the shoulder; Nausea; Vomiting; Chills/shakes; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL PAIN (Severe bowel pain), ARTHRALGIA (Pain in the shoulder), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills/shakes) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced GASTROINTESTINAL PAIN (Severe bowel pain), ARTHRALGIA (Pain in the shoulder), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills/shakes). On 17-Jan-2021, VOMITING (Vomiting) had resolved. On 18-Jan-2021, GASTROINTESTINAL PAIN (Severe bowel pain), ARTHRALGIA (Pain in the shoulder), NAUSEA (Nausea) and CHILLS (Chills/shakes) 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.   No concomitant medications were provided No treatment information provided    This case was linked to MOD21-11685 (E2B Linked Report).; Sender's Comments:  MOD21-11685:Crosslinked: Same reporter
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Lymphadenopathy
Clinical narrative: Delayed redness at the injection site; Delayed induration at the injection site; Delayed onset of regional lymphadenopathy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Delayed onset of regional lymphadenopathy), INJECTION SITE ERYTHEMA (Delayed redness at the injection site) and INJECTION SITE INDURATION (Delayed induration at the injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.  On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Delayed onset of regional lymphadenopathy).   On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Delayed redness at the injection site) and INJECTION SITE INDURATION (Delayed induration at the injection site).   At the time of the report, LYMPHADENOPATHY (Delayed onset of regional lymphadenopathy) outcome was unknown and INJECTION SITE ERYTHEMA (Delayed redness at the injection site) and INJECTION SITE INDURATION (Delayed induration at the injection site) was resolving.      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. No treatment information was provided.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: aching in top of arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching in top of arm) and ARTHRALGIA (soreness) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRALGIA (soreness). On 22-Jan-2021, the patient experienced PAIN (aching in top of arm). On 17-Jan-2021, ARTHRALGIA (soreness) outcome was unknown. At the time of the report, PAIN (aching in top of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided treatment information provided as Took an aspirin to relax it.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness that was about 3 inches and it was hot to the touch and swollen; redness that was about 3 inches and it was hot to the touch and swollen; redness that was about 3 inches and it was hot to the touch and swollen; lump on her arm that was itchy; lump on her arm that was itchy; Soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (redness that was about 3 inches and it was hot to the touch and swollen), VACCINATION SITE INDURATION (lump on her arm that was itchy), VACCINATION SITE PRURITUS (lump on her arm that was itchy), MYALGIA (Soreness) and VACCINATION SITE ERYTHEMA (redness that was about 3 inches and it was hot to the touch and swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K20A) 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 reported medical history).    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Jan-2021, the patient experienced MYALGIA (Soreness). On 22-Jan-2021, the patient experienced VACCINATION SITE INDURATION (lump on her arm that was itchy) and VACCINATION SITE PRURITUS (lump on her arm that was itchy). On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (redness that was about 3 inches and it was hot to the touch and swollen), VACCINATION SITE ERYTHEMA (redness that was about 3 inches and it was hot to the touch and swollen) and VACCINATION SITE SWELLING (redness that was about 3 inches and it was hot to the touch and swollen). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) ongoing since an unknown date at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (redness that was about 3 inches and it was hot to the touch and swollen), VACCINATION SITE INDURATION (lump on her arm that was itchy), VACCINATION SITE PRURITUS (lump on her arm that was itchy), MYALGIA (Soreness), VACCINATION SITE ERYTHEMA (redness that was about 3 inches and it was hot to the touch and swollen) and VACCINATION SITE SWELLING (redness that was about 3 inches and it was hot to the touch and swollen) outcome was unknown.        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.   No concomitant medications were provided Treatment Keflex and Valacyclovir
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: redness that was about 3 inches and it was hot to the touch and swollen; redness that was about 3 inches and it was hot to the touch and swollen; redness that was about 3 inches and it was hot to the touch and swollen; lump on her arm that was itchy; lump on her arm that was itchy; Soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (redness that was about 3 inches and it was hot to the touch and swollen), VACCINATION SITE INDURATION (lump on her arm that was itchy), VACCINATION SITE PRURITUS (lump on her arm that was itchy), MYALGIA (Soreness) and VACCINATION SITE ERYTHEMA (redness that was about 3 inches and it was hot to the touch and swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K20A) 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 reported medical history).    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Jan-2021, the patient experienced MYALGIA (Soreness). On 22-Jan-2021, the patient experienced VACCINATION SITE INDURATION (lump on her arm that was itchy) and VACCINATION SITE PRURITUS (lump on her arm that was itchy). On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (redness that was about 3 inches and it was hot to the touch and swollen), VACCINATION SITE ERYTHEMA (redness that was about 3 inches and it was hot to the touch and swollen) and VACCINATION SITE SWELLING (redness that was about 3 inches and it was hot to the touch and swollen). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) ongoing since an unknown date at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (redness that was about 3 inches and it was hot to the touch and swollen), VACCINATION SITE INDURATION (lump on her arm that was itchy), VACCINATION SITE PRURITUS (lump on her arm that was itchy), MYALGIA (Soreness), VACCINATION SITE ERYTHEMA (redness that was about 3 inches and it was hot to the touch and swollen) and VACCINATION SITE SWELLING (redness that was about 3 inches and it was hot to the touch and swollen) outcome was unknown.        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.   No concomitant medications were provided Treatment Keflex and Valacyclovir
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Erythema, Feeling hot
Clinical narrative: developed burning, hot and redness on her face; hot and redness on her face; redness on her face; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (developed burning, hot and redness on her face), FEELING HOT (hot and redness on her face), ERYTHEMA (redness on her face) and CHILLS (Chills) in a 67-year-old female patient 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 BURNING SENSATION (developed burning, hot and redness on her face), FEELING HOT (hot and redness on her face), ERYTHEMA (redness on her face) and CHILLS (Chills). At the time of the report, BURNING SENSATION (developed burning, hot and redness on her face), FEELING HOT (hot and redness on her face) and ERYTHEMA (redness on her face) had resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient received treatment with diphenhydramine (Benadryl).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: Little soreness in the arm; Small knot that went away; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness in the arm) and VACCINATION SITE MASS (Small knot that went away) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little soreness in the arm) and VACCINATION SITE MASS (Small knot that went away). At the time of the report, PAIN IN EXTREMITY (Little soreness in the arm) and VACCINATION SITE MASS (Small knot that went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   This case was linked to MOD-2021-212827, MOD-2021-212827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received included Outcome updated. And patient told that he is doing ok, no need to send an email, he did not share email. He did share that he did get the 2nd dose of the vaccine.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Soreness in arm; Fever; Chills; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 20-Jan-2021, PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Not Provided      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.   No concomitant medications were provided No treatment information provided    This case was linked to MOD21-11658 (E2B Linked Report).; Sender's Comments:  MOD21-11658:Crosslinked: Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild and soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild and soreness in right arm) 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 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (mild and soreness in right arm). At the time of the report, PAIN IN EXTREMITY (mild and soreness in right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information received on TCR FUP- patient declined further FUP stating they are feeling fine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Cough, Dyspnoea, Exercise electrocardiogram
Clinical narrative: Viral syndrome; Vomiting; Fatigue; fever; cough; Chest pain; Shortness of breath; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (cough), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VIRAL INFECTION (Viral syndrome) and VOMITING (Vomiting) in a 34-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.     Concurrent medical conditions included Vaccination site erythema (delayed effects) and Induration (induration at vaccination site( delayed effects)).    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced COUGH (cough), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (fever). On an unknown date, the patient experienced VIRAL INFECTION (Viral syndrome). At the time of the report, COUGH (cough), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VIRAL INFECTION (Viral syndrome), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Negative) Negative. On an unknown date, Exercise electrocardiogram: (Negative) negative.     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.   No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Patient date of birth has been updated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Viral infection, Vomiting
Clinical narrative: Viral syndrome; Vomiting; Fatigue; fever; cough; Chest pain; Shortness of breath; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (cough), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VIRAL INFECTION (Viral syndrome) and VOMITING (Vomiting) in a 34-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.     Concurrent medical conditions included Vaccination site erythema (delayed effects) and Induration (induration at vaccination site( delayed effects)).    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced COUGH (cough), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (fever). On an unknown date, the patient experienced VIRAL INFECTION (Viral syndrome). At the time of the report, COUGH (cough), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VIRAL INFECTION (Viral syndrome), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Negative) Negative. On an unknown date, Exercise electrocardiogram: (Negative) negative.     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.   No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Patient date of birth has been updated.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Left wrist swollen, potential reaggravated carpel tunnel; middle finger on the left hand was swollen and unable to bend; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Left wrist swollen, potential reaggravated carpel tunnel), MUSCULOSKELETAL STIFFNESS (middle finger on the left hand was swollen and unable to bend) and VACCINATION SITE PAIN (Tenderness at injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at injection site). On 23-Jan-2021, the patient experienced JOINT SWELLING (Left wrist swollen, potential reaggravated carpel tunnel) and MUSCULOSKELETAL STIFFNESS (middle finger on the left hand was swollen and unable to bend). The patient was treated with HYDROCODONE at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Left wrist swollen, potential reaggravated carpel tunnel), MUSCULOSKELETAL STIFFNESS (middle finger on the left hand was swollen and unable to bend) and VACCINATION SITE PAIN (Tenderness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter. No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information received in TCR FUP- Patient declined further FUP stating everything has been taken care of.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site movement impairment, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: oval/ oblong red mark on the site of the injection; discomfort with movement; itching on the injection arm; swelling on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (discomfort with movement), VACCINATION SITE PRURITUS (itching on the injection arm), VACCINATION SITE SWELLING (swelling on the injection arm) and VACCINATION SITE ERYTHEMA (oval/ oblong red mark on the site of the injection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (discomfort with movement), VACCINATION SITE PRURITUS (itching on the injection arm) and VACCINATION SITE SWELLING (swelling on the injection arm). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (oval/ oblong red mark on the site of the injection). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (discomfort with movement), VACCINATION SITE PRURITUS (itching on the injection arm), VACCINATION SITE SWELLING (swelling on the injection arm) and VACCINATION SITE ERYTHEMA (oval/ oblong red mark on the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The side effects came back again around the 20Jan2021  No concomitant medications were provided Treatment Aleve- when she received the shot
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Vaccination site warmth
Clinical narrative: Arm swelling; Arm redness; Arm warmness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), ERYTHEMA (Arm redness) and VACCINATION SITE WARMTH (Arm warmness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), ERYTHEMA (Arm redness) and VACCINATION SITE WARMTH (Arm warmness). At the time of the report, PERIPHERAL SWELLING (Arm swelling), ERYTHEMA (Arm redness) and VACCINATION SITE WARMTH (Arm warmness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the events included Tyelnol (paracetamol).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (Positive COVID-19). At the time of the report, COVID-19 (Positive COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: pain at the injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 SITE PAIN (pain at the injection site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 24 weeks pregnant received 2 doses of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (24 weeks pregnant received 2 doses of vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (24 weeks pregnant received 2 doses of vaccine). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (24 weeks pregnant received 2 doses of vaccine) had resolved.            No concomitant medications were reported. No treatment medications were reported. Patient was 24 weeks pregnant at the time of vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-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 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Apr-2021. On 14-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 14-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) 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.   No concomitant medications were provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Cough, Dyspnoea, Fatigue
Clinical narrative: Positive covid test; harsh cough; sore throat; some difficulty breathing; fatigue; achy joints; A spontaneous report was received from a Patient, HCP  and other HCP concerning a  63Years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like  harsh cough, sore throat, some difficulty of breathing, fatigue, achy joints, positive Covid test.  The patient's medical history was not reported.  No Relevant concomitant medications were reported like    On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.      On date 21st Jan 2021, The patient experienced the event like  harsh cough, sore throat, some difficulty of breathing, fatigue, achy joints. On date 22nd Jan 2021, The patient was tested positive for Covid-19  Laboratory details not provided.    Treatment information was provided.   Nyquil Tylenol    Action taken with mRNA-1273 in response to the events was not reported.       The outcome of the events are unknown.; Reporter's Comments: This case concerns a 63-year-old female who experienced nonserious unexpected events of COVID-19 along with NS unexpected events of cough, dyspnea, sore throat and NS expected events of fatigue, arthralgia.  The events occurred 12 days as after the first dose of mRNA-1273. Treated with Nyquil and Tylenol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Positive covid test; harsh cough; sore throat; some difficulty breathing; fatigue; achy joints; A spontaneous report was received from a Patient, HCP  and other HCP concerning a  63Years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like  harsh cough, sore throat, some difficulty of breathing, fatigue, achy joints, positive Covid test.  The patient's medical history was not reported.  No Relevant concomitant medications were reported like    On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.      On date 21st Jan 2021, The patient experienced the event like  harsh cough, sore throat, some difficulty of breathing, fatigue, achy joints. On date 22nd Jan 2021, The patient was tested positive for Covid-19  Laboratory details not provided.    Treatment information was provided.   Nyquil Tylenol    Action taken with mRNA-1273 in response to the events was not reported.       The outcome of the events are unknown.; Reporter's Comments: This case concerns a 63-year-old female who experienced nonserious unexpected events of COVID-19 along with NS unexpected events of cough, dyspnea, sore throat and NS expected events of fatigue, arthralgia.  The events occurred 12 days as after the first dose of mRNA-1273. Treated with Nyquil and Tylenol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: freezing cold hands; tingly hands, kinda numb/from my knees down lots of tingling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (freezing cold hands) and PARAESTHESIA (tingly hands, kinda numb/from my knees down lots of tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (freezing cold hands) and PARAESTHESIA (tingly hands, kinda numb/from my knees down lots of tingling). At the time of the report, PERIPHERAL COLDNESS (freezing cold hands) and PARAESTHESIA (tingly hands, kinda numb/from my knees down lots of tingling) 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   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: No specific follow-up information recorded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: hardness at site; redness; a little swelling; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), VACCINATION SITE INDURATION (hardness at site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (a little swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis (she had arthritis in her knees and shoulder). Concomitant products included LOSARTAN, CENTRUM SILVER WOMEN 50+, EZETIMIBE, PAROXETINE and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 25-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hardness at site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (a little swelling). The patient was treated with IBUPROFEN (ADVIL ARTHRITIS PAIN) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm), VACCINATION SITE INDURATION (hardness at site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (a little swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received and contains Non- significant information. Like Contact Information
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INFECTION (infection). At the time of the report, INFECTION (infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient started taking antibiotics for an infection on 22-JAN-2021. She stopped taking them that very same day because she read that it might affect the effectivity of the vaccine. In Follow up patient stated that her husband had similar reaction but did not know about whether husband report it or not.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received 9/JUN/2021 included No new significant Information