chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 80-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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eyelid pain, Headache, Pain, Throat tightness
Clinical narrative: Pain in both eyes above the eye lids; having trouble breathing; body aches/left side hurts from my head to my big toe; obstruction in my throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYELID PAIN (Pain in both eyes above the eye lids), DYSPNOEA (having trouble breathing), PAIN (body aches/left side hurts from my head to my big toe), THROAT TIGHTNESS (obstruction in my throat) and HEADACHE (headache) in a 69-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 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYELID PAIN (Pain in both eyes above the eye lids), DYSPNOEA (having trouble breathing), PAIN (body aches/left side hurts from my head to my big toe), THROAT TIGHTNESS (obstruction in my throat) and HEADACHE (headache). At the time of the report, EYELID PAIN (Pain in both eyes above the eye lids), DYSPNOEA (having trouble breathing), PAIN (body aches/left side hurts from my head to my big toe), THROAT TIGHTNESS (obstruction in my throat) and HEADACHE (headache) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19 test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ( Covid-19 test) in a 79-year-old male 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 COVID-19 ( Covid-19 test). At the time of the report, COVID-19 ( Covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received on 07-Jul-2021 reporter information updated.NNI
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Hypoaesthesia oral, Sensitive skin, Tenderness
Clinical narrative: throat was tender; tongue felt numb; face felt sensitive; Minor allergic reaction; A spontaneous report was received from a Consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events throat was tender, tongue felt numb, face felt sensitive, minor allergic reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events throat was tender. tongue felt numb, face felt sensitive, minor allergic reaction.  Treatment details included none  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, throat was tender, On an unknown date the outcome of events, tongue felt numb, On an unknown date the outcome of events, face felt sensitive, On an unknown date the outcome of events, minor allergic reaction was not reported.  Based on  comment, code Injection site warmth to Vaccination site warmth
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Joint swelling, Lymphadenopathy
Clinical narrative: he lymph nodes on her lower neck, in line with her shoulder, onthe side of the injection sitebecame swollen; in line with her shoulder, on the side of the injection site, became swollen; Redness around area of injection site; A spontaneous report  was received on 17 Feb 2021,   from a Consumer concerning a 39-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness around area of injection site, swollen lymph nodes next to neck, in line with her shoulder, on the side of the injection site, became swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the events redness around area of injection site . On 13 Feb 2021, the patient experienced the events swollen lymph nodes next to neck. in line with her shoulder. On the side of the injection site, became swollen.  Treatment details included Antibiotics  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, redness around area of injection site, On an unknown date the outcome of events, swollen lymph nodes next to neck, On an unknown date the outcome of events, in line with her shoulder, On an unknown date the outcome of events, on the side of the injection site, On an unknown date the outcome of events, became swollen was not reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection, COVID-19, Chills, Feeling cold, Nasal congestion
Clinical narrative: tested positive for COVID-19 infection; felt cold; congestion sometime after receiving the first dose; bacterial congestion; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID-19 infection), FEELING COLD (felt cold), NASAL CONGESTION (congestion sometime after receiving the first dose), BACTERIAL INFECTION (bacterial congestion) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: MEASLES and MUMPS AND RUBELLA VACCINE in May 2020. Concurrent medical conditions included Hearing aid user.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19 infection), FEELING COLD (felt cold), NASAL CONGESTION (congestion sometime after receiving the first dose), BACTERIAL INFECTION (bacterial congestion) and CHILLS (chills). At the time of the report, COVID-19 (tested positive for COVID-19 infection), FEELING COLD (felt cold), NASAL CONGESTION (congestion sometime after receiving the first dose), BACTERIAL INFECTION (bacterial congestion) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medications were provided. Patient was prescribed antibiotic medication for bacterial congestion.   This case was linked to MOD-2021-273575 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: The follow up document contain no new information. On 02-Aug-2021: Significant Follow up received and felt cold and nasal congestion was added as events. Second dose case was linked. Action taken was updated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 infection; felt cold; congestion sometime after receiving the first dose; bacterial congestion; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID-19 infection), FEELING COLD (felt cold), NASAL CONGESTION (congestion sometime after receiving the first dose), BACTERIAL INFECTION (bacterial congestion) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: MEASLES and MUMPS AND RUBELLA VACCINE in May 2020. Concurrent medical conditions included Hearing aid user.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19 infection), FEELING COLD (felt cold), NASAL CONGESTION (congestion sometime after receiving the first dose), BACTERIAL INFECTION (bacterial congestion) and CHILLS (chills). At the time of the report, COVID-19 (tested positive for COVID-19 infection), FEELING COLD (felt cold), NASAL CONGESTION (congestion sometime after receiving the first dose), BACTERIAL INFECTION (bacterial congestion) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medications were provided. Patient was prescribed antibiotic medication for bacterial congestion.   This case was linked to MOD-2021-273575 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: The follow up document contain no new information. On 02-Aug-2021: Significant Follow up received and felt cold and nasal congestion was added as events. Second dose case was linked. Action taken was updated.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Pyrexia, Rhinorrhoea
Clinical narrative: A spontaneous report was received from other healthcare professional concerning a 54-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lost sense of taste and smell, sore in arm, covid, a little fever and runny nose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient experienced the a little fever and runny nose. On 12 Jan 2021, the patient was diagnosed with covid. On an unknown date, the patient had lost sense of taste and smell and in the areas the patient touched, the next day sore in arm. The patient did not receive any treatment for the events sore in arm and covid and treatment information for the events lost sense of taste and smell, a little fever and runny nose was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events lost sense of taste and smell was recovering (gaining back taste and smell). The outcome of the events a little fever and runny nose was recovered on 17 Jan 2021. The outcome of the events sore in arm and covid was not provided.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported event- vaccination site pain and the administration of the mRNA-1273 cannot be excluded. However, the event of Covid-19 is Unlikely related to mRNA-1273 and a very limited information regarding the event (anosmia, ageusia) has been provided. However, the events- rhinorrhea, pyrexia might be explained by the concurrent COVID-19. Further information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: A spontaneous report was received from other healthcare professional concerning a 54-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lost sense of taste and smell, sore in arm, covid, a little fever and runny nose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient experienced the a little fever and runny nose. On 12 Jan 2021, the patient was diagnosed with covid. On an unknown date, the patient had lost sense of taste and smell and in the areas the patient touched, the next day sore in arm. The patient did not receive any treatment for the events sore in arm and covid and treatment information for the events lost sense of taste and smell, a little fever and runny nose was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events lost sense of taste and smell was recovering (gaining back taste and smell). The outcome of the events a little fever and runny nose was recovered on 17 Jan 2021. The outcome of the events sore in arm and covid was not provided.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported event- vaccination site pain and the administration of the mRNA-1273 cannot be excluded. However, the event of Covid-19 is Unlikely related to mRNA-1273 and a very limited information regarding the event (anosmia, ageusia) has been provided. However, the events- rhinorrhea, pyrexia might be explained by the concurrent COVID-19. Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Low grade fever; Aches; Extreme Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches), FATIGUE (Extreme Fatigue), CHILLS (Chills) and PYREXIA (Low grade fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 25-Jan-2021, the patient experienced MYALGIA (Aches), FATIGUE (Extreme Fatigue) and CHILLS (Chills). On 28-Jan-2021, the patient experienced PYREXIA (Low grade fever). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MYALGIA (Aches), FATIGUE (Extreme Fatigue), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up received on 31-MAY-2021 and patient denied further follow up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: fingers on both hands had little bumps and were sore and swollen; fingers were sore; fingers swollen; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (fingers on both hands had little bumps and were sore and swollen), PAIN IN EXTREMITY (fingers were sore) and PERIPHERAL SWELLING (fingers swollen) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     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 06-Feb-2021, the patient experienced NODULE (fingers on both hands had little bumps and were sore and swollen), PAIN IN EXTREMITY (fingers were sore) and PERIPHERAL SWELLING (fingers swollen). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, NODULE (fingers on both hands had little bumps and were sore and swollen), PAIN IN EXTREMITY (fingers were sore) and PERIPHERAL SWELLING (fingers swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications included acetaminophen.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI. Patient declined follow-up
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site rash
Clinical narrative: Rash that was present on the injection arm that continued onto her mid back; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash that was present on the injection arm that continued onto her mid back) and HEADACHE (Headache) in a 25-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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Headache). On 10-Feb-2021, the patient experienced INJECTION SITE RASH (Rash that was present on the injection arm that continued onto her mid back). At the time of the report, INJECTION SITE RASH (Rash that was present on the injection arm that continued onto her mid back) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of thisevent, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Paraesthesia, Product dose omission issue
Clinical narrative: Missed dose; Dizzy; Tingling in hands and feet; Achy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PARAESTHESIA (Tingling in hands and feet), PAIN (Achy) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (Dizzy), PARAESTHESIA (Tingling in hands and feet) and PAIN (Achy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), PARAESTHESIA (Tingling in hands and feet) and PAIN (Achy) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: New event missed dose was added. Outcome was updated for the event pain.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: muscle ache; fatigue; Chills; little bit fever; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle ache), FATIGUE (fatigue), CHILLS (Chills) and PYREXIA (little bit fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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 an unknown date, the patient experienced MYALGIA (muscle ache), FATIGUE (fatigue), CHILLS (Chills) and PYREXIA (little bit fever). At the time of the report, MYALGIA (muscle ache), FATIGUE (fatigue), CHILLS (Chills) and PYREXIA (little bit fever) 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.   Concomitant medication was not reported. Treatment medication was not reported.     Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: its hot; swelling; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events vaccination site swelling, and vaccination site warmth.  The patient's medical history was not reported.  Concomitant products information was not reported.  On unspecified date prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (batch number:unknown) for prophylaxis of COVID-19 infection.   On unspecified date, the patient reported to have taken the second dose of the vaccine in the same arm and the arm have swelling and hotness.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   On 16 Feb 2021 the outcome of the events swelling and hotness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pruritus
Clinical narrative: Arm itching; Little fatigue; muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little fatigue), MYALGIA (muscle pain), CHILLS (chills) and PRURITUS (Arm itching) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. On 14-Feb-2021, the patient experienced FATIGUE (Little fatigue), MYALGIA (muscle pain), CHILLS (chills) and PRURITUS (Arm itching). On 15-Feb-2021, FATIGUE (Little fatigue), MYALGIA (muscle pain) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (Arm itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: admitted to the hospital Feb 2nd with shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (admitted to the hospital Feb 2nd with shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HERPES ZOSTER (admitted to the hospital Feb 2nd with shingles). At the time of the report, HERPES ZOSTER (admitted to the hospital Feb 2nd with shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Influenza like illness, Pyrexia, Rash
Clinical narrative: sort of like having the flu; upset stomach; skin rash; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (sort of like having the flu), PYREXIA (fever), RASH (skin rash) and ABDOMINAL DISCOMFORT (upset stomach) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (sort of like having the flu), PYREXIA (fever), RASH (skin rash) and ABDOMINAL DISCOMFORT (upset stomach). On 15-Feb-2021, INFLUENZA LIKE ILLNESS (sort of like having the flu), PYREXIA (fever), RASH (skin rash) and ABDOMINAL DISCOMFORT (upset stomach) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not take any treatment medication.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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.    On 16-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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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.    On 16-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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reported that no follow up is needed. The patient has recovered.   No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: NNI   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a consumer, concerns herself a female patient, of unspecified age, who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced: didn't feel well and tested positive for COVID-19. The patient's medical history and concomitant medications not reported. On Jan 17, 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (batch/lot# unknown), via unknown route, for prophylaxis of COVID-19 infection. On Jan 17, 2021, patient experienced the event(s) didn't feel well. On Jan 22, 2021, patient experienced the event: tested positive for COVID-19. No treatment information provided. Action taken with mRNA-1273 in response to the events not reported. The outcome of didn't feel well and tested positive for COVID-19: unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Vertigo
Clinical narrative: vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after; vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after; vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vertigo, dizziness and hypotension.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after the first dose of vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, vertigo, dizziness and kind of low blood pressure sensation now and then for about three weeks after the first dose of vaccine was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Illness, Myalgia, Pyrexia
Clinical narrative: fell sick; Went trough heck  and back, got all the symptoms, body ache, fever, coughing, diarrhea; it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea; it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea; it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea; had a minor sore from the injection and that's was it; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (had a minor sore from the injection and that's was it), ILLNESS (fell sick), PAIN (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), PYREXIA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) and COUGH (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) in a 69-year-old male patient 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 reported medical history).    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 INJECTION SITE PAIN (had a minor sore from the injection and that's was it). On 24-Jan-2021, the patient experienced ILLNESS (fell sick), PAIN (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), PYREXIA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), COUGH (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) and DIARRHOEA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea). At the time of the report, INJECTION SITE PAIN (had a minor sore from the injection and that's was it), ILLNESS (fell sick), PAIN (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), PYREXIA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), COUGH (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) and DIARRHOEA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol was used for treatment.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fell sick; Went trough heck  and back, got all the symptoms, body ache, fever, coughing, diarrhea; it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea; it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea; it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea; had a minor sore from the injection and that's was it; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (had a minor sore from the injection and that's was it), ILLNESS (fell sick), PAIN (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), PYREXIA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) and COUGH (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) in a 69-year-old male patient 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 reported medical history).    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 INJECTION SITE PAIN (had a minor sore from the injection and that's was it). On 24-Jan-2021, the patient experienced ILLNESS (fell sick), PAIN (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), PYREXIA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), COUGH (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) and DIARRHOEA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea). At the time of the report, INJECTION SITE PAIN (had a minor sore from the injection and that's was it), ILLNESS (fell sick), PAIN (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), PYREXIA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), COUGH (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) and DIARRHOEA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol was used for treatment.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Influenza like illness, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Hot arm; Arm started itching; Really red arm; Swollen like a size of tennis ball around vaccine site; Felt like catching the flu; Had cold and needed extra cover to make me warm; Arm ached little more than 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ached little more than 1st dose), INFLUENZA LIKE ILLNESS (Felt like catching the flu), FEELING COLD (Had cold and needed extra cover to make me warm), VACCINATION SITE WARMTH (Hot arm) and VACCINATION SITE PRURITUS (Arm started itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA-LEVODOPA-B), LEVOTHYROXINE and FAMOTIDINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm ached little more than 1st dose). On 15-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like catching the flu) and FEELING COLD (Had cold and needed extra cover to make me warm). On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Really red arm) and VACCINATION SITE SWELLING (Swollen like a size of tennis ball around vaccine site). At the time of the report, PAIN IN EXTREMITY (Arm ached little more than 1st dose), INFLUENZA LIKE ILLNESS (Felt like catching the flu), FEELING COLD (Had cold and needed extra cover to make me warm), VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Really red arm) and VACCINATION SITE SWELLING (Swollen like a size of tennis ball around vaccine site) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Mailing address was mentioned
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot arm; Arm started itching; Really red arm; Swollen like a size of tennis ball around vaccine site; Felt like catching the flu; Had cold and needed extra cover to make me warm; Arm ached little more than 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ached little more than 1st dose), INFLUENZA LIKE ILLNESS (Felt like catching the flu), FEELING COLD (Had cold and needed extra cover to make me warm), VACCINATION SITE WARMTH (Hot arm) and VACCINATION SITE PRURITUS (Arm started itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA-LEVODOPA-B), LEVOTHYROXINE and FAMOTIDINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm ached little more than 1st dose). On 15-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like catching the flu) and FEELING COLD (Had cold and needed extra cover to make me warm). On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Really red arm) and VACCINATION SITE SWELLING (Swollen like a size of tennis ball around vaccine site). At the time of the report, PAIN IN EXTREMITY (Arm ached little more than 1st dose), INFLUENZA LIKE ILLNESS (Felt like catching the flu), FEELING COLD (Had cold and needed extra cover to make me warm), VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Really red arm) and VACCINATION SITE SWELLING (Swollen like a size of tennis ball around vaccine site) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Mailing address was mentioned
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous report received from a consumer, concerns a 71-year-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced redness around the injection site, bumpiness around the injection site and itchiness around the injection site. The patient's medical history not provided. No concomitant medications reported. On Jan 18, 2021, prior to the onset of the events, patient received the first of two planned doses of mRNA-1273 (batch/lot# 012L20A), via unknown route, for prophylaxis of COVID-19 infection. On Jan 25, 2021, patient experienced redness around the injection site, bumpiness around the injection site and itchiness around the injection site. Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events not reported. The outcome of redness around the injection site, bumpiness around the injection site and itchiness around the injection site-considered to be unknown. Sender's comments: Based on the information provided and the established safety profile of mRNA-1273 vaccine, a causal association between the event of headache and the product use cannot be excluded. Vaccination site redness, itching and swelling are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Sore Arm Injection Site; Headache; A spontaneous report was received from a consumer concerning himself of 66 years old male patient who experienced sore arm injection Site/injection site pain, headache/headache.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) on 30 Jan 2021, intramuscularly at upper arm for prophylaxis of COVID-19 infection.    On 30 Jan 2021 the patient experienced sore arm at injection site and headache. She took 3 Advil tablets before receiving the vaccine. She took two more Advil tablet after the event. Treatment of the event included Advil.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events sore arm injection site and headache was considered resolved.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot; a red spot one inch below the injection; painful; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a red spot one inch below the injection), VACCINATION SITE PAIN (painful), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (hot) in a 79-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a red spot one inch below the injection), VACCINATION SITE PAIN (painful), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (hot). At the time of the report, VACCINATION SITE ERYTHEMA (a red spot one inch below the injection), VACCINATION SITE PAIN (painful), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (hot) outcome was unknown.            Concomitant medications reported were blood pressure pills, cholesterol pills. Treatment details was not included.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Low grade fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, CHILLS (Chills) and PYREXIA (Low grade fever) 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness of the face and neck) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 HYPOAESTHESIA (numbness of the face and neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness of the face and neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.