chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: aching all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching all over her body) 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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (aching all over her body). At the time of the report, PAIN (aching all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: pink redness (not bright) and itchiness on the injection site; pink redness (not bright) and itchiness on the injection site; arm hurt on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (pink redness (not bright) and itchiness on the injection site), VACCINATION SITE ERYTHEMA (pink redness (not bright) and itchiness on the injection site) and VACCINATION SITE PAIN (arm hurt on the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Hypercholesterolaemia. Concomitant products included METFORMIN for an unknown indication.    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 VACCINATION SITE PRURITUS (pink redness (not bright) and itchiness on the injection site), VACCINATION SITE ERYTHEMA (pink redness (not bright) and itchiness on the injection site) and VACCINATION SITE PAIN (arm hurt on the injection site). At the time of the report, VACCINATION SITE PRURITUS (pink redness (not bright) and itchiness on the injection site), VACCINATION SITE ERYTHEMA (pink redness (not bright) and itchiness on the injection site) and VACCINATION SITE PAIN (arm hurt on the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication and cholesterol medication. Treatment medication was not reported.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product known safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) 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 relevant concomitant medications were reported.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Herpes zoster, Pain in extremity, Paraesthesia
Clinical narrative: It is Shingles; Slightly itchy; Small bumpy rashes; Tingling; Strange symptom; Weird sensation to my skin just the epidermis; Sore arm; Extreme fatigue; A spontaneous report was received from a healthcare professional concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events strange symptom/symptom masked, weird sensation to skin just the epidermis/feeling abnormal, small rash(small clusters, small bumpy rashes)/rash, slightly itchy/pruritus, sore arm/pain in extremity, extreme fatigue/ fatigue, tingling/paraesthesia and shingles/herpes zoster.  The patient's medical history was not provided. Concomitant medications reported were Vitamin D NOS.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route in the left upper arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events, sore arm and extreme fatigue. On 06 Feb 2021, the patient experienced the events, strange symptom, weird sensation on skin just the epidermis just around my right hip, small rash went from the pelvic to all the way around the hip area. On 8 Feb 2021, the patient experienced the events, small clusters, small bumpy rashes that are slightly itchy, tingling, her doctor thought the symptoms might be of shingles brought by the vaccine. No treatment details were included.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, strange symptom, weird sensation to skin just the epidermis, small rash, small clusters, small bumpy rashes, slightly itchy, sore arm, extreme fatigue, tingling and shingles were unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue and rash are consistent with the product known safety profile. Some vaccines have been known to exacerbate latent herpes zoster. Patient has a history of shingles
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Symptom masked
Clinical narrative: It is Shingles; Slightly itchy; Small bumpy rashes; Tingling; Strange symptom; Weird sensation to my skin just the epidermis; Sore arm; Extreme fatigue; A spontaneous report was received from a healthcare professional concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events strange symptom/symptom masked, weird sensation to skin just the epidermis/feeling abnormal, small rash(small clusters, small bumpy rashes)/rash, slightly itchy/pruritus, sore arm/pain in extremity, extreme fatigue/ fatigue, tingling/paraesthesia and shingles/herpes zoster.  The patient's medical history was not provided. Concomitant medications reported were Vitamin D NOS.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route in the left upper arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events, sore arm and extreme fatigue. On 06 Feb 2021, the patient experienced the events, strange symptom, weird sensation on skin just the epidermis just around my right hip, small rash went from the pelvic to all the way around the hip area. On 8 Feb 2021, the patient experienced the events, small clusters, small bumpy rashes that are slightly itchy, tingling, her doctor thought the symptoms might be of shingles brought by the vaccine. No treatment details were included.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, strange symptom, weird sensation to skin just the epidermis, small rash, small clusters, small bumpy rashes, slightly itchy, sore arm, extreme fatigue, tingling and shingles were unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue and rash are consistent with the product known safety profile. Some vaccines have been known to exacerbate latent herpes zoster. Patient has a history of shingles
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the right side of her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the right side of her chest) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012C20I) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 RASH (Rash on the right side of her chest). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash on the right side of her chest) 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.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product known safety
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Fatigue, Headache, Pain
Clinical narrative: losing the voice; very achy, with severe body aches and headaches /Soreness; very achy, with severe body aches and headaches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (losing the voice), PAIN (very achy, with severe body aches and headaches /Soreness), HEADACHE (very achy, with severe body aches and headaches) and FATIGUE (fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. In February 2021, the patient experienced APHONIA (losing the voice), PAIN (very achy, with severe body aches and headaches /Soreness), HEADACHE (very achy, with severe body aches and headaches) and FATIGUE (fatigue). At the time of the report, APHONIA (losing the voice), PAIN (very achy, with severe body aches and headaches /Soreness), HEADACHE (very achy, with severe body aches and headaches) and FATIGUE (fatigue) outcome was unknown. Not Provided          Treatment medications were not provided Action taken with mRNA-1273 in response to the event was not applicable; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fatigue are consistent with the product known safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Painful respiration
Clinical narrative: sore breathing; sore underarm; This spontaneous case was reported by a consumer and describes the occurrence of PAINFUL RESPIRATION (sore breathing) and AXILLARY PAIN (sore underarm) 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 medical history reported).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAINFUL RESPIRATION (sore breathing) and AXILLARY PAIN (sore underarm). At the time of the report, PAINFUL RESPIRATION (sore breathing) and AXILLARY PAIN (sore underarm) 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.  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.; Sender'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.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash, Vaccination site erythema
Clinical narrative: he had injection site reaction like redness; rash; sore for 2-3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (he had injection site reaction like redness), RASH (rash) and MYALGIA (sore for 2-3 weeks) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 VACCINATION SITE ERYTHEMA (he had injection site reaction like redness), RASH (rash) and MYALGIA (sore for 2-3 weeks). At the time of the report, VACCINATION SITE ERYTHEMA (he had injection site reaction like redness), RASH (rash) and MYALGIA (sore for 2-3 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product known safety profile.
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 a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: SIDE EFFECTS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (SIDE EFFECTS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (SIDE EFFECTS). At the time of the report, VACCINATION COMPLICATION (SIDE EFFECTS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.; Sender's Comments: There is limited information provided in this case.  In addition to the missing onset and vaccination dates, the symptoms were not described.  Hence, it is not possible to assess this report at this time.  Additional information is being requested
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID-19 and the product use is assessed as unlikely.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (chills) and NAUSEA (nausea). At the time of the report, CHILLS (chills) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included-blood pressure medications. No treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: On 22-APR-2021 a follow up was received which contained no new information
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received an incomplete first dose of the Moderna COVID-19 vaccine; A spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and might have received an incomplete first dose of the vaccine.  The patient's medical history was not provided. No concomitant product use was reported.  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Feb 2021, the patient might have received an incomplete first dose of the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, received an incomplete first dose of the vaccine, was considered resolved on 25 Feb 2021.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273, (lot # unknown) with no associated AEs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Rash erythematous, Rash pruritic
Clinical narrative: Red rash which was spreading down to the left hand; Itchy rash which was spreading down to the left hand; Soreness; Headaches; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash which was spreading down to the left hand), RASH PRURITIC (Itchy rash which was spreading down to the left hand), PAIN (Soreness), HEADACHE (Headaches) and MYALGIA (Muscle aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Scleroderma (Diagnosed in 2018).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash which was spreading down to the left hand), RASH PRURITIC (Itchy rash which was spreading down to the left hand), PAIN (Soreness), HEADACHE (Headaches) and MYALGIA (Muscle aches). At the time of the report, RASH ERYTHEMATOUS (Red rash which was spreading down to the left hand), RASH PRURITIC (Itchy rash which was spreading down to the left hand), PAIN (Soreness), HEADACHE (Headaches) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included immunosuppressive drugs for scleroderma.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Tremor
Clinical narrative: Got little involuntary movements; Tremors and which was mild; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Tremors and which was mild) and DYSKINESIA (Got little involuntary movements) 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 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced TREMOR (Tremors and which was mild). On 29-Jan-2021, the patient experienced DYSKINESIA (Got little involuntary movements). At the time of the report, TREMOR (Tremors and which was mild) and DYSKINESIA (Got little involuntary movements) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; A spontaneous report was received from a Medical Assistant concerning 11 patients who received Moderna's COVID-19 vaccine (mRNA-1273) that underwent a product temperature excursion.  The patient's medical history was not provided. Concomitant product use was not provided.  On 18-Feb-2021 or 19-Feb-2021, 11 patients received their second dose of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection.  On 23-Feb-2021 the reporter called to report an excursion. A vial of mRNA-1273 was in the freezer for 5 hours and reached a maximum temperature of 28 degrees Fahrenheit (F). According to the Healthcare Provider, the vial was half frozen and half liquid state upon visual inspection. A Healthcare Provider took the vial out of the freezer and stored it in the refrigerator at max temperature of 40-41 degrees F. for 4 hours. Then the vial was stored at room temperature for 4 hours. A maximum temperature of 70 F was reached before administering to patients.  The patients received both scheduled doses of mRNA-1273 prior to discovery of the event;  therefore action taken with the drug in response to the event is not applicable.  The outcome of the event, product temperature excursion, was recovered/resolved on an unknown date.; Reporter's Comments: This report refers to a case of Product temperature excursion issue for mRNA-1273, lot # unknown, with no associated AEs.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: skin started to burn; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (skin started to burn) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.    Co-suspect product included non-company product NITROFURANTOIN for an unknown indication.    Concurrent medical conditions included Drug allergy (Nitrofurantoin) since 19-Dec-2020.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started NITROFURANTOIN (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced SKIN BURNING SENSATION (skin started to burn). At the time of the report, SKIN BURNING SENSATION (skin started to burn) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-significant Follow-up
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching at injection site; swelling at injection site; MILD PAIN at injection site; Redness at injection sie; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (MILD PAIN at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection sie) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (left side).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (MILD PAIN at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection sie). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (MILD PAIN at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection sie) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Lethargy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy), CHILLS (Chills), COUGH (covid caused lingering cough), DECREASED APPETITE (NO appetite) and LETHARGY (lethargic) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced LETHARGY (lethargic). On an unknown date, the patient experienced ASTHENIA (no energy), CHILLS (Chills), COUGH (covid caused lingering cough), DECREASED APPETITE (NO appetite), PAIN (Body ache) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (no energy), CHILLS (Chills), COUGH (covid caused lingering cough), DECREASED APPETITE (NO appetite), LETHARGY (lethargic), PAIN (Body ache) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills and pyrexia are consistent with the product safety profile.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy), CHILLS (Chills), COUGH (covid caused lingering cough), DECREASED APPETITE (NO appetite) and LETHARGY (lethargic) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced LETHARGY (lethargic). On an unknown date, the patient experienced ASTHENIA (no energy), CHILLS (Chills), COUGH (covid caused lingering cough), DECREASED APPETITE (NO appetite), PAIN (Body ache) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (no energy), CHILLS (Chills), COUGH (covid caused lingering cough), DECREASED APPETITE (NO appetite), LETHARGY (lethargic), PAIN (Body ache) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills and pyrexia are consistent with the product safety profile.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Pain, Pruritus, Rash
Clinical narrative: Itching; Within 30 mins, I got hives; Face was flushed; Redness on my cheeks/ red; Sore; Rash on the chest; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), URTICARIA (Within 30 mins, I got hives), RASH (Rash on the chest), FLUSHING (Face was flushed) and ERYTHEMA (Redness on my cheeks/ red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SALBUTAMOL (ALBUTEROL HFA), ALENDRONATE SODIUM (ALENDRONATE), ALPRAZOLAM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AZELASTINE, BUPROPION, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CITALOPRAM, IRON, HYDRALAZINE, IRBESARTAN and METHIMAZOLE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itching), URTICARIA (Within 30 mins, I got hives), RASH (Rash on the chest), FLUSHING (Face was flushed), ERYTHEMA (Redness on my cheeks/ red) and PAIN (Sore). At the time of the report, PRURITUS (Itching), URTICARIA (Within 30 mins, I got hives), RASH (Rash on the chest), FLUSHING (Face was flushed), ERYTHEMA (Redness on my cheeks/ red) and PAIN (Sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Itching; Within 30 mins, I got hives; Face was flushed; Redness on my cheeks/ red; Sore; Rash on the chest; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), URTICARIA (Within 30 mins, I got hives), RASH (Rash on the chest), FLUSHING (Face was flushed) and ERYTHEMA (Redness on my cheeks/ red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SALBUTAMOL (ALBUTEROL HFA), ALENDRONATE SODIUM (ALENDRONATE), ALPRAZOLAM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AZELASTINE, BUPROPION, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CITALOPRAM, IRON, HYDRALAZINE, IRBESARTAN and METHIMAZOLE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itching), URTICARIA (Within 30 mins, I got hives), RASH (Rash on the chest), FLUSHING (Face was flushed), ERYTHEMA (Redness on my cheeks/ red) and PAIN (Sore). At the time of the report, PRURITUS (Itching), URTICARIA (Within 30 mins, I got hives), RASH (Rash on the chest), FLUSHING (Face was flushed), ERYTHEMA (Redness on my cheeks/ red) and PAIN (Sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: body aches; muscle pain; joint pain; fatigue; swelling at the injection site; redness at the injection site; tenderness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE PAIN (tenderness to the touch at the injection site), PAIN (body aches) and MYALGIA (muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PAIN (tenderness to the touch at the injection site). On 22-Jan-2021, the patient experienced PAIN (body aches), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (fatigue). At the time of the report, INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PAIN (tenderness to the touch at the injection site) had resolved and PAIN (body aches), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site (Pain, Swelling, and Erythema), arthralgia, myalgia and fatigue are consistent with the product safety profile.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: body aches; muscle pain; joint pain; fatigue; swelling at the injection site; redness at the injection site; tenderness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE PAIN (tenderness to the touch at the injection site), PAIN (body aches) and MYALGIA (muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PAIN (tenderness to the touch at the injection site). On 22-Jan-2021, the patient experienced PAIN (body aches), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (fatigue). At the time of the report, INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PAIN (tenderness to the touch at the injection site) had resolved and PAIN (body aches), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site (Pain, Swelling, and Erythema), arthralgia, myalgia and fatigue are consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warm area; Could feel the temperature change; Had a red warm area; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Warm area), PYREXIA (Could feel the temperature change) and VACCINATION SITE ERYTHEMA (Had a red warm area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm area), PYREXIA (Could feel the temperature change) and VACCINATION SITE ERYTHEMA (Had a red warm area). At the time of the report, VACCINATION SITE WARMTH (Warm area), PYREXIA (Could feel the temperature change) and VACCINATION SITE ERYTHEMA (Had a red warm area) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little bit sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Penicillin allergy since an unknown date.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (a little bit sore). At the time of the report, PAIN (a little bit sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Had diarrhea 4 times in the day) in a 77-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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DIARRHOEA (Had diarrhea 4 times in the day). At the time of the report, DIARRHEA (Had diarrhea 4 times in the day) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea
Clinical narrative: Abdominal crampng; gas bloating; Severe/explosive Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Severe/explosive Diarrhea), ABDOMINAL DISTENSION (gas bloating) and ABDOMINAL PAIN (Abdominal crampng) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 06-Jan-1980 and Obesity since 06-Jan-1980. Concomitant products included BIOTIN from 13-Aug-2008 to an unknown date, IRON from 13-Aug-2008 to an unknown date and MAGNESIUM from 13-Aug-2008 to an unknown date for Vitamin supplementation.   On 09-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021 at 4:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Severe/explosive Diarrhea). On 09-Feb-2021 at 5:00 AM, the patient experienced ABDOMINAL DISTENSION (gas bloating). On 09-Feb-2021 at 6:00 AM, the patient experienced ABDOMINAL PAIN (Abdominal crampng). On 12-Feb-2021, DIARRHOEA (Severe/explosive Diarrhea), ABDOMINAL DISTENSION (gas bloating) and ABDOMINAL PAIN (Abdominal crampng) had resolved.        Patient mentioned she takes blood pressure medications and thyroid medications (unspecified).  Medical Doctor informed patient to drink only clear broth for two days which she did. Patient stated she was unable to leave the house because of the explosive diarrhea event.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Moderna ADR form completed by reporter. Patient, event and outcome information updated.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain, Peripheral swelling, Pruritus
Clinical narrative: arm became swollen down to the elbow; induration; erythema; pain down to the side; arm pruritus; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm became swollen down to the elbow), INDURATION (induration), ERYTHEMA (erythema), PAIN (pain down to the side) and PRURITUS (arm pruritus) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 25-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 SWELLING (arm became swollen down to the elbow), INDURATION (induration), ERYTHEMA (erythema), PAIN (pain down to the side) and PRURITUS (arm pruritus). At the time of the report, PERIPHERAL SWELLING (arm became swollen down to the elbow), INDURATION (induration), ERYTHEMA (erythema), PAIN (pain down to the side) and PRURITUS (arm pruritus) 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.   Treatment details included None.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Freezing phenomenon, Headache
Clinical narrative: freezing; sweating; body ache; difficulty in breathing; no strength; chills; headache; injection site pain; Nausea; arm muscles ache; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (freezing), HYPERHIDROSIS (sweating), PAIN (body ache), DYSPNOEA (difficulty in breathing) and ASTHENIA (no strength) in a 68-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 COVID-19 in October 2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FREEZING PHENOMENON (freezing), HYPERHIDROSIS (sweating), PAIN (body ache), DYSPNOEA (difficulty in breathing), ASTHENIA (no strength), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (injection site pain), NAUSEA (Nausea) and MYALGIA (arm muscles ache). At the time of the report, FREEZING PHENOMENON (freezing), HYPERHIDROSIS (sweating), PAIN (body ache), DYSPNOEA (difficulty in breathing), ASTHENIA (no strength), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (injection site pain), NAUSEA (Nausea) and MYALGIA (arm muscles ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking Heart medication, Blood pressure medication, Take some more medication but do not remember right now. Patient treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site pain, chills, nausea, myalgia, and headache  are consistent with the product safety profile