chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't get second dose, coming in for second dose, first dose was given more than 3 months ago) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't get second dose, coming in for second dose, first dose was given more than 3 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't get second dose, coming in for second dose, first dose was given more than 3 months ago) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Sensitivity to weather change, Skin burning sensation
Clinical narrative: Sores all over her body that burn, itch, hurt and spread (worse when it's humid); Sores all over her body that burn; Sores all over her body that itch; Sores all over her body that spread (worse when it's humid); Sores all over her body that hurt; Rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Sores all over her body that burn, itch, hurt and spread (worse when it's humid)), SKIN BURNING SENSATION (Sores all over her body that burn), PRURITUS (Sores all over her body that itch), SENSITIVITY TO WEATHER CHANGE (Sores all over her body that spread (worse when it's humid)) and PAIN (Sores all over her body that hurt) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SKIN LESION (Sores all over her body that burn, itch, hurt and spread (worse when it's humid)), SKIN BURNING SENSATION (Sores all over her body that burn), PRURITUS (Sores all over her body that itch), SENSITIVITY TO WEATHER CHANGE (Sores all over her body that spread (worse when it's humid)), PAIN (Sores all over her body that hurt) and RASH (Rash). At the time of the report, SKIN LESION (Sores all over her body that burn, itch, hurt and spread (worse when it's humid)), SKIN BURNING SENSATION (Sores all over her body that burn), PRURITUS (Sores all over her body that itch), SENSITIVITY TO WEATHER CHANGE (Sores all over her body that spread (worse when it's humid)), PAIN (Sores all over her body that hurt) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include antidepressant. Symptoms started after the second dose. The patient went to Emergency Room and also consulted general practitioner and dermatologist. Patient had a biopsy and the results were unspecified. Treatment medications included steroid shot and cream.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: Sores all over her body that burn, itch, hurt and spread (worse when it's humid); Sores all over her body that burn; Sores all over her body that itch; Sores all over her body that spread (worse when it's humid); Sores all over her body that hurt; Rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Sores all over her body that burn, itch, hurt and spread (worse when it's humid)), SKIN BURNING SENSATION (Sores all over her body that burn), PRURITUS (Sores all over her body that itch), SENSITIVITY TO WEATHER CHANGE (Sores all over her body that spread (worse when it's humid)) and PAIN (Sores all over her body that hurt) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SKIN LESION (Sores all over her body that burn, itch, hurt and spread (worse when it's humid)), SKIN BURNING SENSATION (Sores all over her body that burn), PRURITUS (Sores all over her body that itch), SENSITIVITY TO WEATHER CHANGE (Sores all over her body that spread (worse when it's humid)), PAIN (Sores all over her body that hurt) and RASH (Rash). At the time of the report, SKIN LESION (Sores all over her body that burn, itch, hurt and spread (worse when it's humid)), SKIN BURNING SENSATION (Sores all over her body that burn), PRURITUS (Sores all over her body that itch), SENSITIVITY TO WEATHER CHANGE (Sores all over her body that spread (worse when it's humid)), PAIN (Sores all over her body that hurt) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include antidepressant. Symptoms started after the second dose. The patient went to Emergency Room and also consulted general practitioner and dermatologist. Patient had a biopsy and the results were unspecified. Treatment medications included steroid shot and cream.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Headache, Magnetic resonance imaging
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), DIZZINESS (Dizziness- I couldn't drive), HEADACHE (Headache), PYREXIA (Mild fever) and PRODUCT DOSE OMISSION ISSUE (Received the 1st & only dose of the Moderna Covid-19 vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Mild fever). On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness I couldn't drive). On 06-Jul-2021, the patient experienced MIGRAINE (Migraine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the 1st & only dose of the Moderna Covid-19 vaccine). At the time of the report, MIGRAINE (Migraine), DIZZINESS (Dizziness I couldn't drive), HEADACHE (Headache) and PYREXIA (Mild fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Received the 1st & only dose of the Moderna Covid-19 vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Magnetic resonance imaging: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Product dose omission issue, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), DIZZINESS (Dizziness- I couldn't drive), HEADACHE (Headache), PYREXIA (Mild fever) and PRODUCT DOSE OMISSION ISSUE (Received the 1st & only dose of the Moderna Covid-19 vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Mild fever). On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness I couldn't drive). On 06-Jul-2021, the patient experienced MIGRAINE (Migraine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the 1st & only dose of the Moderna Covid-19 vaccine). At the time of the report, MIGRAINE (Migraine), DIZZINESS (Dizziness I couldn't drive), HEADACHE (Headache) and PYREXIA (Mild fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Received the 1st & only dose of the Moderna Covid-19 vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Magnetic resonance imaging: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sore throat; Developed a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Developed a cold) and OROPHARYNGEAL PAIN (Sore throat) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced NASOPHARYNGITIS (Developed a cold). On 03-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 05-Jul-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, NASOPHARYNGITIS (Developed a cold) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest pain, Condition aggravated, Fatigue, Heart rate
Clinical narrative: Pain; Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks; She got worse and worse; Compression of the heart; Being very tired; Could not sleep; Blue color on her chest,It looks like when someone hits something and the skin has a blue color; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHEST PAIN (Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks), CONDITION AGGRAVATED (She got worse and worse), SKIN DISCOLOURATION (Blue color on her chest,It looks like when someone hits something and the skin has a blue color) and INSOMNIA (Could not sleep) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced SKIN DISCOLOURATION (Blue color on her chest,It looks like when someone hits something and the skin has a blue color). On 05-Jul-2021, the patient experienced INSOMNIA (Could not sleep). On 06-Jul-2021, the patient experienced CARDIAC DISCOMFORT (Compression of the heart) and FATIGUE (Being very tired). On an unknown date, the patient experienced PAIN (Pain), CHEST PAIN (Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks) and CONDITION AGGRAVATED (She got worse and worse). On 06-Jul-2021, CARDIAC DISCOMFORT (Compression of the heart) and FATIGUE (Being very tired) had resolved. At the time of the report, PAIN (Pain), CHEST PAIN (Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks), CONDITION AGGRAVATED (She got worse and worse), SKIN DISCOLOURATION (Blue color on her chest,It looks like when someone hits something and the skin has a blue color) and INSOMNIA (Could not sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient was not recovered on 26 Jun 2021. And patient was hospitalized for 3-4 hours on 06 Jul 2021. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received. Two new events were added which are cardiac discomfort and fatigue.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Skin discolouration
Clinical narrative: Pain; Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks; She got worse and worse; Compression of the heart; Being very tired; Could not sleep; Blue color on her chest,It looks like when someone hits something and the skin has a blue color; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHEST PAIN (Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks), CONDITION AGGRAVATED (She got worse and worse), SKIN DISCOLOURATION (Blue color on her chest,It looks like when someone hits something and the skin has a blue color) and INSOMNIA (Could not sleep) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced SKIN DISCOLOURATION (Blue color on her chest,It looks like when someone hits something and the skin has a blue color). On 05-Jul-2021, the patient experienced INSOMNIA (Could not sleep). On 06-Jul-2021, the patient experienced CARDIAC DISCOMFORT (Compression of the heart) and FATIGUE (Being very tired). On an unknown date, the patient experienced PAIN (Pain), CHEST PAIN (Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks) and CONDITION AGGRAVATED (She got worse and worse). On 06-Jul-2021, CARDIAC DISCOMFORT (Compression of the heart) and FATIGUE (Being very tired) had resolved. At the time of the report, PAIN (Pain), CHEST PAIN (Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks), CONDITION AGGRAVATED (She got worse and worse), SKIN DISCOLOURATION (Blue color on her chest,It looks like when someone hits something and the skin has a blue color) and INSOMNIA (Could not sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient was not recovered on 26 Jun 2021. And patient was hospitalized for 3-4 hours on 06 Jul 2021. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received. Two new events were added which are cardiac discomfort and fatigue.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Unable to get 2nd vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get 2nd vaccination) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-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 PRODUCT DOSE OMISSION ISSUE (Unable to get 2nd vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get 2nd vaccination) had resolved.            The patient was unable to get second dose because the vaccine facility did not schedule the second dose and then never had the Moderna vaccine in stock. No relevant concomitant medications were reported. No treatment information was reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Product administration interrupted, Product availability issue
Clinical narrative: Product administration interrupted; Product unavailable due to pandemic; Did not receive his 2nd dose between day 25 and 35; Fever of 102; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted), PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic), PRODUCT DOSE OMISSION ISSUE (Did not receive his 2nd dose between day 25 and 35), FATIGUE (Fatigue) and PYREXIA (Fever of 102) in a 36-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 June 2020.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced PYREXIA (Fever of 102) and NAUSEA (Nausea). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted), PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic) and PRODUCT DOSE OMISSION ISSUE (Did not receive his 2nd dose between day 25 and 35). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted), PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic), PRODUCT DOSE OMISSION ISSUE (Did not receive his 2nd dose between day 25 and 35) and PYREXIA (Fever of 102) had resolved and FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 102 (High) 102.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No relevant concomitant medications were reported.  No treatment information was reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: Product administration interrupted; Product unavailable due to pandemic; Did not receive his 2nd dose between day 25 and 35; Fever of 102; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted), PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic), PRODUCT DOSE OMISSION ISSUE (Did not receive his 2nd dose between day 25 and 35), FATIGUE (Fatigue) and PYREXIA (Fever of 102) in a 36-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 June 2020.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced PYREXIA (Fever of 102) and NAUSEA (Nausea). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted), PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic) and PRODUCT DOSE OMISSION ISSUE (Did not receive his 2nd dose between day 25 and 35). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted), PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic), PRODUCT DOSE OMISSION ISSUE (Did not receive his 2nd dose between day 25 and 35) and PYREXIA (Fever of 102) had resolved and FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 102 (High) 102.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No relevant concomitant medications were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received and contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: given expired vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    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 EXPIRED PRODUCT ADMINISTERED (given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-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 EXPIRED PRODUCT ADMINISTERED (given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given expired vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.   Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Feeling abnormal, Formication, Headache
Clinical narrative: had double vision; > 35 days past first dose; headrush; Could not lay still; Felt as if she was going to faint; felt like bugs were crawling on her head and body; she could strongly taste the vaccine in her mouth; had a panic attack; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt as if she was going to faint), FORMICATION (felt like bugs were crawling on her head and body), TASTE DISORDER (she could strongly taste the vaccine in her mouth), PANIC ATTACK (had a panic attack) and DIPLOPIA (had double vision) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Vibramycin and Flu shot. Past adverse reactions to the above products included Crawling sensation with Flu shot and Vibramycin. Concomitant products included LOSARTAN POTASSIUM for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Felt as if she was going to faint), TASTE DISORDER (she could strongly taste the vaccine in her mouth), PANIC ATTACK (had a panic attack), FEELING ABNORMAL (Could not lay still) and HEADACHE (headrush). 04-Mar-2021, the patient experienced FORMICATION (felt like bugs were crawling on her head and body). On an unknown date, the patient experienced DIPLOPIA (had double vision) and PRODUCT DOSE OMISSION ISSUE (> 35 days past first dose). At the time of the report, DIZZINESS (Felt as if she was going to faint), FORMICATION (felt like bugs were crawling on her head and body), TASTE DISORDER (she could strongly taste the vaccine in her mouth), PANIC ATTACK (had a panic attack), DIPLOPIA (had double vision), FEELING ABNORMAL (Could not lay still), PRODUCT DOSE OMISSION ISSUE (> 35 days past first dose) and HEADACHE (headrush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concurrent conditions were reported. No concomitant medications were reported. Patient reported that she felt very tingly like she had bugs crawling in her head and her body, after 10-15 minutes of vaccination. The patient waited for 45 minutes after the vaccination before she was able to drive home. Later, on the same day, the patient felt a headrush that lasted all night and she could not stay still that night. A week and a half later, she had a double vision. Caller inquired if she can still receive the second dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Product dose omission issue, Taste disorder
Clinical narrative: had double vision; > 35 days past first dose; headrush; Could not lay still; Felt as if she was going to faint; felt like bugs were crawling on her head and body; she could strongly taste the vaccine in her mouth; had a panic attack; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt as if she was going to faint), FORMICATION (felt like bugs were crawling on her head and body), TASTE DISORDER (she could strongly taste the vaccine in her mouth), PANIC ATTACK (had a panic attack) and DIPLOPIA (had double vision) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Vibramycin and Flu shot. Past adverse reactions to the above products included Crawling sensation with Flu shot and Vibramycin. Concomitant products included LOSARTAN POTASSIUM for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Felt as if she was going to faint), TASTE DISORDER (she could strongly taste the vaccine in her mouth), PANIC ATTACK (had a panic attack), FEELING ABNORMAL (Could not lay still) and HEADACHE (headrush). 04-Mar-2021, the patient experienced FORMICATION (felt like bugs were crawling on her head and body). On an unknown date, the patient experienced DIPLOPIA (had double vision) and PRODUCT DOSE OMISSION ISSUE (> 35 days past first dose). At the time of the report, DIZZINESS (Felt as if she was going to faint), FORMICATION (felt like bugs were crawling on her head and body), TASTE DISORDER (she could strongly taste the vaccine in her mouth), PANIC ATTACK (had a panic attack), DIPLOPIA (had double vision), FEELING ABNORMAL (Could not lay still), PRODUCT DOSE OMISSION ISSUE (> 35 days past first dose) and HEADACHE (headrush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concurrent conditions were reported. No concomitant medications were reported. Patient reported that she felt very tingly like she had bugs crawling in her head and her body, after 10-15 minutes of vaccination. The patient waited for 45 minutes after the vaccination before she was able to drive home. Later, on the same day, the patient felt a headrush that lasted all night and she could not stay still that night. A week and a half later, she had a double vision. Caller inquired if she can still receive the second dose.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Hyperphagia, Muscular weakness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NECK PAIN (neck pain), HYPERPHAGIA (she has been eating alot), WEIGHT FLUCTUATION (she went from 128lbs to 120lbs and now she is 123lbs) and DIZZINESS (she felt a little dizzy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herniated disc. Concurrent medical conditions included Anemia, Sickle cell trait and Thalassaemia. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced BACK PAIN (back pain), NECK PAIN (neck pain), HYPERPHAGIA (she has been eating alot), WEIGHT FLUCTUATION (she went from 128lbs to 120lbs and now she is 123lbs) and FATIGUE (felt tired). On an unknown date, the patient experienced DIZZINESS (she felt a little dizzy) and MUSCULAR WEAKNESS (muscle weakness). The patient was treated with Physical therapy for Neck pain. At the time of the report, BACK PAIN (back pain), NECK PAIN (neck pain) and FATIGUE (felt tired) had resolved and HYPERPHAGIA (she has been eating alot), WEIGHT FLUCTUATION (she went from 128lbs to 120lbs and now she is 123lbs), DIZZINESS (she felt a little dizzy) and MUSCULAR WEAKNESS (muscle weakness) outcome was unknown. No treatment information was provided. This case was linked to MOD-2021-248120 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up Receive on 06-JUL-2021. Follow up contains the information about second dose and event of second dose On 27-Jul-2021: Additional information included medical history and event details.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Weight fluctuation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NECK PAIN (neck pain), HYPERPHAGIA (she has been eating alot), WEIGHT FLUCTUATION (she went from 128lbs to 120lbs and now she is 123lbs) and DIZZINESS (she felt a little dizzy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herniated disc. Concurrent medical conditions included Anemia, Sickle cell trait and Thalassaemia. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced BACK PAIN (back pain), NECK PAIN (neck pain), HYPERPHAGIA (she has been eating alot), WEIGHT FLUCTUATION (she went from 128lbs to 120lbs and now she is 123lbs) and FATIGUE (felt tired). On an unknown date, the patient experienced DIZZINESS (she felt a little dizzy) and MUSCULAR WEAKNESS (muscle weakness). The patient was treated with Physical therapy for Neck pain. At the time of the report, BACK PAIN (back pain), NECK PAIN (neck pain) and FATIGUE (felt tired) had resolved and HYPERPHAGIA (she has been eating alot), WEIGHT FLUCTUATION (she went from 128lbs to 120lbs and now she is 123lbs), DIZZINESS (she felt a little dizzy) and MUSCULAR WEAKNESS (muscle weakness) outcome was unknown. No treatment information was provided. This case was linked to MOD-2021-248120 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up Receive on 06-JUL-2021. Follow up contains the information about second dose and event of second dose On 27-Jul-2021: Additional information included medical history and event details.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gastrooesophageal reflux disease, Mobility decreased, Pain, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Welts), PRURITUS (Itches), SWELLING (Swelling), PAIN (Hurt) and MOBILITY DECREASED (Barely move) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Welts), PRURITUS (Itches), SWELLING (Swelling), PAIN (Hurt), MOBILITY DECREASED (Barely move), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), RASH (Breakout in rash/breakouts) and ARTHRALGIA (Joint pain). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE) for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Welts), PRURITUS (Itches), SWELLING (Swelling), PAIN (Hurt), MOBILITY DECREASED (Barely move), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), RASH (Breakout in rash/breakouts) and ARTHRALGIA (Joint pain) outcome was unknown. Concomitant medications reported include Blood pressure medication. Patient consulted several doctors including her primary care, dermatologist, and allergist. Treatment information reported includes being treated with steroid shots, steroids pills, and stuff for her stomach acid reflux.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Welts), PRURITUS (Itches), SWELLING (Swelling), PAIN (Hurt) and MOBILITY DECREASED (Barely move) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Welts), PRURITUS (Itches), SWELLING (Swelling), PAIN (Hurt), MOBILITY DECREASED (Barely move), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), RASH (Breakout in rash/breakouts) and ARTHRALGIA (Joint pain). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE) for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Welts), PRURITUS (Itches), SWELLING (Swelling), PAIN (Hurt), MOBILITY DECREASED (Barely move), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), RASH (Breakout in rash/breakouts) and ARTHRALGIA (Joint pain) outcome was unknown. Concomitant medications reported include Blood pressure medication. Patient consulted several doctors including her primary care, dermatologist, and allergist. Treatment information reported includes being treated with steroid shots, steroids pills, and stuff for her stomach acid reflux.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 067C21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). At the time of the report, PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information included Vicks NyQuil. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). On 28-May-2021, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Massive intestinal distress was really, really bad for 4 weeks), ABDOMINAL DISTENSION (Really bad bloating after every meal/Her main symptoms are bloating and stomach ache) and ABDOMINAL PAIN UPPER (Regularly stomach ached and rumbled/Main symptoms are bloating and stomach ache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Massive intestinal distress was really, really bad for 4 weeks). an unknown date, the patient experienced ABDOMINAL DISTENSION (Really bad bloating after every meal/Her main symptoms are bloating and stomach ache) and ABDOMINAL PAIN UPPER (Regularly stomach ached and rumbled/Main symptoms are bloating and stomach ache). At the time of the report, ABDOMINAL DISCOMFORT (Massive intestinal distress was really, really bad for 4 weeks) had resolved and ABDOMINAL DISTENSION (Really bad bloating after every meal/Her main symptoms are bloating and stomach ache) and ABDOMINAL PAIN UPPER (Regularly stomach ached and rumbled/Main symptoms are bloating and stomach ache) outcome was unknown. No relevant concomitant medications were reported. No treatment information was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (I have red in my arm), PRURITUS (It itches) and PAIN (It sores) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced ERYTHEMA (I have red in my arm), PRURITUS (It itches) and PAIN (It sores). The patient was treated with HISTAMINE for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 mg. At the time of the report, ERYTHEMA (I have red in my arm), PRURITUS (It itches) and PAIN (It sores) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fear, Feeling abnormal, Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion in the mind), TINNITUS (Noise in her ears like "shh"), DIZZINESS (Dizziness when she moves), FEELING ABNORMAL (Brain fog) and FEAR (Fear that symptoms won't go away) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 037C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included Valsartan; Amlodipine [Amlodipine Besilate]; Atenolol; Omeprazole; Vitamins NOS for an unknown indication. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced CONFUSIONAL STATE (Confusion in the mind). On an unknown date, the patient experienced TINNITUS (Noise in her ears like "shh"), DIZZINESS (Dizziness when she moves), FEELING ABNORMAL (Brain fog) and FEAR (Fear that symptoms won't go away). At the time of the report, CONFUSIONAL STATE (Confusion in the mind), TINNITUS (Noise in her ears like "shh"), DIZZINESS (Dizziness when she moves), FEELING ABNORMAL (Brain fog) and FEAR (Fear that symptoms won't go away) outcome was unknown. Other Concomitant medications included unspecified medication for high blood pressure in the morning, Vitamin for bone, unspecified medication for heartburn acid and unspecified eye drops for an unknown indication. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up document received on 19-JUL-2021. Updated events and concomitant medications. On 06-Aug-2021: Non Significant Follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: I have not had a menstrual cycle since I have taken the Moderna Covid-19 Vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (I have not had a menstrual cycle since I have taken the Moderna Covid-19 Vaccine.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced AMENORRHOEA (I have not had a menstrual cycle since I have taken the Moderna Covid-19 Vaccine.). At the time of the report, AMENORRHOEA (I have not had a menstrual cycle since I have taken the Moderna Covid-19 Vaccine.) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medication was reported.  Treatment information not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: walking difficulty; Knee pain; This spontaneous case was reported by a non-health professional and describes the occurrence of GAIT DISTURBANCE (walking difficulty) and ARTHRALGIA (Knee pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (walking difficulty) and ARTHRALGIA (Knee pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, GAIT DISTURBANCE (walking difficulty) and ARTHRALGIA (Knee pain) outcome 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. Action taken with mRNA-1273 in response to the event was not applicable.