chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vomiting
Clinical narrative: site of injection is red, swollen, and itchy; site of injection is red, swollen, and itchy; site of injection is red, swollen, and itchy; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of injection is red, swollen, and itchy), VOMITING (Vomiting), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (site of injection is red, swollen, and itchy) and VACCINATION SITE SWELLING (site of injection is red, swollen, and itchy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VOMITING (Vomiting) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection is red, swollen, and itchy), VACCINATION SITE ERYTHEMA (site of injection is red, swollen, and itchy) and VACCINATION SITE SWELLING (site of injection is red, swollen, and itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Jan-2021, VOMITING (Vomiting) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PRURITUS (site of injection is red, swollen, and itchy), VACCINATION SITE ERYTHEMA (site of injection is red, swollen, and itchy) and VACCINATION SITE SWELLING (site of injection is red, swollen, and itchy) 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 the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pruritus
Clinical narrative: tender lymph node; lump at the injection site; red, indurated, and itchy lump; red, indurated, and itchy lump; red, indurated, and itchy lump; This spontaneous case was reported by a nurse and describes the occurrence of LYMPH NODE PAIN (tender lymph node), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE PRURITUS (red, indurated, and itchy lump), VACCINATION SITE INDURATION (red, indurated, and itchy lump) and VACCINATION SITE ERYTHEMA (red, indurated, and itchy lump) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (tender lymph node), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE PRURITUS (red, indurated, and itchy lump), VACCINATION SITE INDURATION (red, indurated, and itchy lump) and VACCINATION SITE ERYTHEMA (red, indurated, and itchy lump). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LYMPH NODE PAIN (tender lymph node), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE PRURITUS (red, indurated, and itchy lump), VACCINATION SITE INDURATION (red, indurated, and itchy lump) and VACCINATION SITE ERYTHEMA (red, indurated, and itchy lump) had not 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Heaviness in the chest; A spontaneous report was received from a consumer concerning a 21-year-old, female patient who received Moderna's COVID-19 vaccine and experienced heaviness in the chest/chest discomfort.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 14 Jan 2021, approximately 12:30 pm prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of COVID-19 infection.    On 14 Jan 2021 at 14:03 pm , after she received the mRNA-1273 vaccination, the patient experienced heaviness in the chest.   Treatment information was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, heaviness in the chest/chest discomfort, was considered unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 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 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) 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.   Reporter did not allow further contact; Reporter's Comments: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273. Further information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red rash; Itching rash in my arm,; This spontaneous case was reported by a consumer and describes the occurrence of   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 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Treatment information was not 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest pain, Dizziness, Electrocardiogram
Clinical narrative: Chest pain; Very dizzy; Woke up very Weak; arm very sore; severe body ache; Fever 101.5 F; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), DIZZINESS (Very dizzy), ASTHENIA (Woke up very Weak), PAIN IN EXTREMITY (arm very sore) and PAIN (severe body ache) in a 52-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.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Psoriasis. Concomitant products included TAMOXIFEN for Breast cancer, APREMILAST (OTEZLA) for Psoriasis.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced PAIN (severe body ache) and PYREXIA (Fever 101.5 F). On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (arm very sore). On 30-Dec-2020, the patient experienced DIZZINESS (Very dizzy) and ASTHENIA (Woke up very Weak). On 30-Dec-2020 at 11:00 PM, the patient experienced CHEST PAIN (Chest pain). On 31-Dec-2020, CHEST PAIN (Chest pain), DIZZINESS (Very dizzy), ASTHENIA (Woke up very Weak), PAIN IN EXTREMITY (arm very sore), PAIN (severe body ache) and PYREXIA (Fever 101.5 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Body temperature: 101.5 °F. In December 2020, Electrocardiogram: ??dec2020 Normal. In December 2020, Myocardial necrosis marker: Normal.     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 for the event included paracetamol and morphine.  Company Comment: 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chest pain; Very dizzy; Woke up very Weak; arm very sore; severe body ache; Fever 101.5 F; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), DIZZINESS (Very dizzy), ASTHENIA (Woke up very Weak), PAIN IN EXTREMITY (arm very sore) and PAIN (severe body ache) in a 52-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.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Psoriasis. Concomitant products included TAMOXIFEN for Breast cancer, APREMILAST (OTEZLA) for Psoriasis.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced PAIN (severe body ache) and PYREXIA (Fever 101.5 F). On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (arm very sore). On 30-Dec-2020, the patient experienced DIZZINESS (Very dizzy) and ASTHENIA (Woke up very Weak). On 30-Dec-2020 at 11:00 PM, the patient experienced CHEST PAIN (Chest pain). On 31-Dec-2020, CHEST PAIN (Chest pain), DIZZINESS (Very dizzy), ASTHENIA (Woke up very Weak), PAIN IN EXTREMITY (arm very sore), PAIN (severe body ache) and PYREXIA (Fever 101.5 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Body temperature: 101.5 °F. In December 2020, Electrocardiogram: ??dec2020 Normal. In December 2020, Myocardial necrosis marker: Normal.     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 for the event included paracetamol and morphine.  Company Comment: 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pain in extremity, Skin warm, Swelling
Clinical narrative: arm was a little bit red; arm was sore; warm to touch; clear outline where the vaccine was at, 4 inches across, taut; swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN WARM (warm to touch), INFLAMMATION (clear outline where the vaccine was at, 4 inches across, taut), SWELLING (swollen), ERYTHEMA (arm was a little bit red) and PAIN IN EXTREMITY (arm was sore) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SKIN WARM (warm to touch), INFLAMMATION (clear outline where the vaccine was at, 4 inches across, taut) and SWELLING (swollen). On an unknown date, the patient experienced ERYTHEMA (arm was a little bit red) and PAIN IN EXTREMITY (arm was sore). At the time of the report, SKIN WARM (warm to touch), INFLAMMATION (clear outline where the vaccine was at, 4 inches across, taut), SWELLING (swollen) and ERYTHEMA (arm was a little bit red) outcome was unknown and PAIN IN EXTREMITY (arm was sore) 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. 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pain in extremity
Clinical narrative: Blood that was starting to appear in the white of her eye; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and OCULAR HYPERAEMIA (Blood that was starting to appear in the white of her eye) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Macular degeneration ((age related) The patient was taking prescribed eye drops.).    On 07-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 08-Jan-2021, the patient experienced OCULAR HYPERAEMIA (Blood that was starting to appear in the white of her eye). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK. On 14-Jan-2021, OCULAR HYPERAEMIA (Blood that was starting to appear in the white of her eye) had resolved. In January 2021, PAIN IN EXTREMITY (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  On 04 Feb 2021, patient received the second dose of vaccination in the left arm and no adverse event was reported. Treatment information included eye drops.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25 Jun 2021 included reporter information, rechallenge was updated, events stop date and outcome was updated.; 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: near syncope, dizziness; near syncope, dizziness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (near syncope, dizziness) and DIZZINESS (near syncope, dizziness) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PRESYNCOPE (near syncope, dizziness) and DIZZINESS (near syncope, dizziness). At the time of the report, PRESYNCOPE (near syncope, dizziness) and DIZZINESS (near syncope, dizziness) 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 considered PRESYNCOPE (near syncope, dizziness) and DIZZINESS (near syncope, dizziness) to be not applicable.    Reporter did not allow further contact; 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site cellulitis
Clinical narrative: some cellulitis at the site of injection.; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (some cellulitis at the site of injection.) and LYMPHADENOPATHY (Swollen lymph nodes) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALLERGY MEDICATION for Allergy, PROGESTOGENS AND ESTROGENS, FIXED COMBINATIONS for Birth control.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 14-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (some cellulitis at the site of injection.). At the time of the report, VACCINATION SITE CELLULITIS (some cellulitis at the site of injection.) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: I am having side effects; 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 side effects/adverse reaction.  The patient's medical history was not provided. Concomitant product use was not provided.  On 31 Dec 2020, the patient received their dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that the patient experienced side effects. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, having side effects was considered as not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: 6x6 area, looks like bruise but doesn't hurt like a bruise, red and purpleish-blue; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (6x6 area, looks like bruise but doesn't hurt like a bruise, red and purpleish-blue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included TRASTUZUMAB (HERCEPTIN) and PERTUZUMAB (PERJETA) for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced CONTUSION (6x6 area, looks like bruise but doesn't hurt like a bruise, red and purpleish-blue). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency and LORATADINE at an unspecified dose and frequency. At the time of the report, CONTUSION (6x6 area, looks like bruise but doesn't hurt like a bruise, red and purpleish-blue) 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.; Sender's Comments: Based on the current available information and the temporal association between the use of the prodcut and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was unknown.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: grade 3 swelling of the lymph nodes 5-6 days after getting the Moderna vaccine; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (grade 3 swelling of the lymph nodes 5-6 days after getting the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (grade 3 swelling of the lymph nodes 5-6 days after getting the Moderna vaccine). At the time of the report, LYMPHADENOPATHY (grade 3 swelling of the lymph nodes 5-6 days after getting the Moderna vaccine) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medial history).    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 RASH (rash). On 08-Jan-2021, RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, SARS-CoV-2 antibody test negative, Tinnitus
Clinical narrative: middle ear congestion; ringing in the ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR CONGESTION (middle ear congestion) and TINNITUS (ringing in the ears) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Negative for past history of COVID-19 diagnosis).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced TINNITUS (ringing in the ears). On an unknown date, the patient experienced EAR CONGESTION (middle ear congestion). The patient was treated with FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Ear congestion, at an unspecified dose and frequency and PREDNISONE for Ear congestion, at an unspecified dose and frequency. At the time of the report, EAR CONGESTION (middle ear congestion) and TINNITUS (ringing in the ears) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test negative: (Negative) negative for past history of COVID-19..         No concomitant medications were reported.  The patient reported ringing in one ear beginning on 31-Dec-2020 and second ear began ringing on 01-Jan-2021. The patient reports ringing in both ear continues until present (30-Mar-2021). The patient reported visiting her family physician and an ENT regarding her symptoms, was diagnosed with middle ear congestion and was prescribed prednisone and Flonase for 6 weeks.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Updated reporter address, patient demographics, suspect product details (second dose), new events and treatment information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Covid-19 tested positive; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19 tested positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Covid-19 tested positive). At the time of the report, COVID-19 (Covid-19 tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive patient received Moderna COVID19 vaccine but tested positive.     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.   This case concerns a patient of unknown age and gender who experienced the nonserious unexpected event of COVID-19.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced the nonserious unexpected event of COVID-19.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Arm started itching; bright red area about the size of the palm of her hand; This spontaneous case was reported by a consumer and describes the occurrence of   in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), VITAMIN D NOS, CYANOCOBALAMIN (B12-VITAMIIN), CALCIUM and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       TUMERIC SUPPLEMENT used as a Concomitant medication; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Nausea, Paraesthesia
Clinical narrative: vertigo dizziness symptoms; eye bluriness; diarrhea; tingling in my feet and hands; dizziness; nausea; fatigue; hot; inflamed; ITCHY; bad reaction size of a baseball; red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VERTIGO (vertigo dizziness symptoms), VISION BLURRED (eye bluriness) and DIARRHOEA (diarrhea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy, Radioactive iodine therapy and Dermal filler injection (dermal fillers under the eyes) in 2020. Concomitant products included LEVOTHYROXINE for Thyroidectomy.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (ITCHY), VACCINATION SITE SWELLING (bad reaction size of a baseball) and VACCINATION SITE ERYTHEMA (red). On an unknown date, the patient experienced VERTIGO (vertigo dizziness symptoms), VISION BLURRED (eye bluriness), DIARRHOEA (diarrhea), PARAESTHESIA (tingling in my feet and hands), DIZZINESS (dizziness), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VERTIGO (vertigo dizziness symptoms), DIARRHOEA (diarrhea), PARAESTHESIA (tingling in my feet and hands), DIZZINESS (dizziness), VACCINATION SITE PRURITUS (ITCHY), VACCINATION SITE SWELLING (bad reaction size of a baseball), VACCINATION SITE ERYTHEMA (red) and FATIGUE (fatigue) had not resolved and VISION BLURRED (eye bluriness) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: 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.; 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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: vertigo dizziness symptoms; eye bluriness; diarrhea; tingling in my feet and hands; dizziness; nausea; fatigue; hot; inflamed; ITCHY; bad reaction size of a baseball; red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VERTIGO (vertigo dizziness symptoms), VISION BLURRED (eye bluriness) and DIARRHOEA (diarrhea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy, Radioactive iodine therapy and Dermal filler injection (dermal fillers under the eyes) in 2020. Concomitant products included LEVOTHYROXINE for Thyroidectomy.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (ITCHY), VACCINATION SITE SWELLING (bad reaction size of a baseball) and VACCINATION SITE ERYTHEMA (red). On an unknown date, the patient experienced VERTIGO (vertigo dizziness symptoms), VISION BLURRED (eye bluriness), DIARRHOEA (diarrhea), PARAESTHESIA (tingling in my feet and hands), DIZZINESS (dizziness), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VERTIGO (vertigo dizziness symptoms), DIARRHOEA (diarrhea), PARAESTHESIA (tingling in my feet and hands), DIZZINESS (dizziness), VACCINATION SITE PRURITUS (ITCHY), VACCINATION SITE SWELLING (bad reaction size of a baseball), VACCINATION SITE ERYTHEMA (red) and FATIGUE (fatigue) had not resolved and VISION BLURRED (eye bluriness) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: 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.; 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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vertigo, Vision blurred
Clinical narrative: vertigo dizziness symptoms; eye bluriness; diarrhea; tingling in my feet and hands; dizziness; nausea; fatigue; hot; inflamed; ITCHY; bad reaction size of a baseball; red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VERTIGO (vertigo dizziness symptoms), VISION BLURRED (eye bluriness) and DIARRHOEA (diarrhea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy, Radioactive iodine therapy and Dermal filler injection (dermal fillers under the eyes) in 2020. Concomitant products included LEVOTHYROXINE for Thyroidectomy.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (ITCHY), VACCINATION SITE SWELLING (bad reaction size of a baseball) and VACCINATION SITE ERYTHEMA (red). On an unknown date, the patient experienced VERTIGO (vertigo dizziness symptoms), VISION BLURRED (eye bluriness), DIARRHOEA (diarrhea), PARAESTHESIA (tingling in my feet and hands), DIZZINESS (dizziness), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VERTIGO (vertigo dizziness symptoms), DIARRHOEA (diarrhea), PARAESTHESIA (tingling in my feet and hands), DIZZINESS (dizziness), VACCINATION SITE PRURITUS (ITCHY), VACCINATION SITE SWELLING (bad reaction size of a baseball), VACCINATION SITE ERYTHEMA (red) and FATIGUE (fatigue) had not resolved and VISION BLURRED (eye bluriness) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: 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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse effects; A spontaneous report was received from a consumer of an unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some adverse effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) prophylaxis of COVID-19 infection.   On Unknown date, the patient experienced some adverse effects. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event some adverse effects 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I am pregnant, I got the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant, I got the vaccine) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Hearing loss on 29-Aug-1989. Concurrent medical conditions included Pregnancy.    On 07-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Oct-2020 and the estimated date of delivery was 17-Aug-2021. On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant, I got the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (I am pregnant, I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment   This is a case of product exposure during pregnancy with no associated AEs for this  female of unknown age.  The causality for this event remains as not applicable.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this  female of unknown age.  The causality for this event remains as not applicable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen normal
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Alcoholic (Alcohol use- social-Prior Aug 2020) in August 2020. Concurrent medical conditions included Drug allergy and Drug allergy. Concomitant products included DOXYLAMINE SUCCINATE (UNISOM 2) for Sleep disorder, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 21-Jul-2020 and the estimated date of delivery was 27-Apr-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2020, Pregnancy test: positive (Positive) positive. On 12-Jan-2021, Blood glucose: not provided (Inconclusive) Not provided. On 12-Jan-2021, Ultrasound antenatal screen normal: normal (normal) everything looked great, no abnormalities.     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.   Other concomitant medication included fiber gummy.  No treatment information was provided. Estimated date of conception was 7 Jul 2020. Genetic test was resulted into negative genetic testing, CF, negative Downs Company comment:This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live-full term birth) on 17-Dec-2017. Concurrent medical conditions included Generalised anxiety disorder. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Generalized anxiety disorder, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care.    On 09-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Oct-2020 and the estimated date of delivery was 09-Jul-2021. On 09-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 09-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Patient was 14 weeks pregnant at the time of this report. Patient had an ultrasound scan on 23 Dec 2020 (results not reported).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date on the event a causal relationship is possible.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) 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.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.