chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Product dose omission issue
Clinical narrative: Very bad cold; Second shot Delayed; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Very bad cold) and PRODUCT DOSE OMISSION ISSUE (Second shot Delayed) 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 06-May-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 NASOPHARYNGITIS (Very bad cold) and PRODUCT DOSE OMISSION ISSUE (Second shot Delayed). At the time of the report, NASOPHARYNGITIS (Very bad cold) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Second shot Delayed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Received 1st shot on May 6 and was due to get second shot on June 2 but had a very bad cold and hence canceled appointment.  No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Underdose
Clinical narrative: vaccimore than half of vaccine leaked out patient received second dose in opposite arm; The vaccine leaked out and the patient believed they did not receive at least half of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-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 EXTRA DOSE ADMINISTERED (vaccimore than half of vaccine leaked out patient received second dose in opposite arm) and UNDERDOSE (The vaccine leaked out and the patient believed they did not receive at least half of the vaccine) 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 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXTRA DOSE ADMINISTERED (vaccimore than half of vaccine leaked out patient received second dose in opposite arm) and UNDERDOSE (The vaccine leaked out and the patient believed they did not receive at least half of the vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (vaccimore than half of vaccine leaked out patient received second dose in opposite arm) and UNDERDOSE (The vaccine leaked out and the patient believed they did not receive at least half of the vaccine) had resolved.            Concomitant product details was not reported.  Treatment details was not reported .
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of vaccination site pruritus (itchiness and swelling on injection site after a week) and vaccination site swelling (swelling on injection site after a week) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pruritus (itchiness and swelling on injection site after a week) and vaccination site swelling (swelling on injection site after a week). At the time of the report, vaccination site pruritus (itchiness and swelling on injection site after a week) and vaccination site swelling (swelling on injection site after a week) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The patient developed itchiness and swelling on injection site after a week. Concomitant medications, laboratory data and treatment information not reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Off label use
Clinical narrative: Dizzy Spells after a few weeks after the first dose; whether to schedule 2nd dose  outside the window; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy Spells after a few weeks after the first dose) and OFF LABEL USE (whether to schedule 2nd dose  outside the window ) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-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 DIZZINESS (Dizzy Spells after a few weeks after the first dose) and OFF LABEL USE (whether to schedule 2nd dose  outside the window ). At the time of the report, DIZZINESS (Dizzy Spells after a few weeks after the first dose) and OFF LABEL USE (whether to schedule 2nd dose  outside the window ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Pain in random places all over her body /Aches in random places all over her body; Swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in random places all over her body /Aches in random places all over her body) and LYMPHADENOPATHY (Swollen lymph node) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 025J20-2A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM (ATIVAN) and LORAZEPAM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-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 PAIN (Pain in random places all over her body /Aches in random places all over her body) and LYMPHADENOPATHY (Swollen lymph node). At the time of the report, PAIN (Pain in random places all over her body /Aches in random places all over her body) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.            No treatment was provided. The action taken with mRNA-1273 in response to the event was not applicable.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Rhinorrhoea
Clinical narrative: Loss of appetite; Sniffles; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (Loss of appetite) and RHINORRHOEA (Sniffles) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LAMOTRIGINE (LAMICTAL), TOPIRAMATE (TOPAMAC), METOPROLOL and POTASSIUM for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and RHINORRHOEA (Sniffles). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DECREASED APPETITE (Loss of appetite) and RHINORRHOEA (Sniffles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-037319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received and contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects after 2nd shot (reporter mom); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after 2nd shot (reporter mom)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after 2nd shot (reporter mom)). At the time of the report, VACCINATION COMPLICATION (Side effects after 2nd shot (reporter mom)) outcome was unknown.            No treatment was reported. No concomitant medications were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: General malaise like after getting the flu shot,; Arm hurt at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise like after getting the flu shot,) and VACCINATION SITE PAIN (Arm hurt at the site of injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 09-Feb-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 MALAISE (General malaise like after getting the flu shot,) and VACCINATION SITE PAIN (Arm hurt at the site of injection). At the time of the report, MALAISE (General malaise like after getting the flu shot,) and VACCINATION SITE PAIN (Arm hurt at the site of injection) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. no concomitant medications are provided. treatment to the events not reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for High cholesterol.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea). At the time of the report, DIARRHOEA (severe diarrhea) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-048259 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Myalgia
Clinical narrative: Tightening in her chest, not like heart attack bad, but still some tightening/Tightness in the Chest; Muscle pain; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightening in her chest, not like heart attack bad, but still some tightening/Tightness in the Chest), MYALGIA (Muscle pain) and CHILLS (Chills) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 036021A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced CHEST DISCOMFORT (Tightening in her chest, not like heart attack bad, but still some tightening/Tightness in the Chest), MYALGIA (Muscle pain) and CHILLS (Chills). At the time of the report, CHEST DISCOMFORT (Tightening in her chest, not like heart attack bad, but still some tightening/Tightness in the Chest), MYALGIA (Muscle pain) and CHILLS (Chills) outcome was unknown.            The patient has not taken any medicine for treatment and does not take any medications daily. Action taken with mRNA-1273 with respect to event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: The follow-up was received on 16-JUN-2021 and had non-significant information: Updated patient contact information
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Protein urine, Renal disorder, Urine abnormality
Clinical narrative: significant kidney damage; This spontaneous case was reported by a consumer and describes the occurrence of PROTEIN URINE PRESENT (urine had 1.8mg of protein/ he was spilling 1,150mg of protein) and RENAL DISORDER (significant kidney damage) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced PROTEIN URINE PRESENT (urine had 1.8mg of protein/ he was spilling 1,150mg of protein). On an unknown date, the patient experienced RENAL DISORDER (significant kidney damage). At the time of the report, PROTEIN URINE PRESENT (urine had 1.8mg of protein/ he was spilling 1,150mg of protein) and RENAL DISORDER (significant kidney damage) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Protein urine: 1.8 milligram. On 25-May-2021, Protein urine: 1150 milligram. On 25-May-2021, Urine abnormality: abnormal.     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.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received about 2 months after First dose) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not received about 2 months after First dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received about 2 months after First dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose administered from vial that had been in refrigerator for 32 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered from vial that had been in refrigerator for 32 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered from vial that had been in refrigerator for 32 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose administered from vial that had been in refrigerator for 32 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymphadenopathy, Myalgia, Pain in extremity, Photopsia
Clinical narrative: Toe pain; Breast pain; one eye will flash a little bit; Swollen lymph node; Pain in random places all over her body; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node), MYALGIA (Pain in random places all over her body), PAIN IN EXTREMITY (Toe pain), BREAST PAIN (Breast pain) and PHOTOPSIA (one eye will flash a little bit) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM (ATIVAN) and LORAZEPAM for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node), MYALGIA (Pain in random places all over her body), PAIN IN EXTREMITY (Toe pain), BREAST PAIN (Breast pain) and PHOTOPSIA (one eye will flash a little bit). At the time of the report, LYMPHADENOPATHY (Swollen lymph node), MYALGIA (Pain in random places all over her body), PAIN IN EXTREMITY (Toe pain), BREAST PAIN (Breast pain) and PHOTOPSIA (one eye will flash a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 patients given vaccine dose from vial that was in refrigeration for 40-41 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients given vaccine dose from vial that was in refrigeration for 40-41 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients given vaccine dose from vial that was in refrigeration for 40-41 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients given vaccine dose from vial that was in refrigeration for 40-41 days) 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 medication were reported No treatment medication were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Headache, Nausea, Pain, Sinusitis
Clinical narrative: arthritis; sinus problem; some aches; queasiness off and on; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis), SINUSITIS (sinus problem), PAIN (some aches), NAUSEA (queasiness off and on) and HEADACHE (headaches) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012AQ1A and 011M2EA) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (some aches), NAUSEA (queasiness off and on) and HEADACHE (headaches). On an unknown date, the patient experienced ARTHRITIS (arthritis) and SINUSITIS (sinus problem). At the time of the report, ARTHRITIS (arthritis), SINUSITIS (sinus problem), PAIN (some aches) and HEADACHE (headaches) outcome was unknown and NAUSEA (queasiness off and on) was resolving.            Concomitant medications were not provided. Treatment taken as 7UP (beverage).   This case was linked to MOD-2021-037316 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Dizziness after second vaccine dose; Looses balance, but not in a bad shape after second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness after second vaccine dose) and BALANCE DISORDER (Looses balance, but not in a bad shape after second vaccine dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced DIZZINESS (Dizziness after second vaccine dose) and BALANCE DISORDER (Looses balance, but not in a bad shape after second vaccine dose). At the time of the report, DIZZINESS (Dizziness after second vaccine dose) and BALANCE DISORDER (Looses balance, but not in a bad shape after second vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided  Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Since the shot all of this has happened) 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 COVID-19 (in Dec 2020 and Feb 2021). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Since the shot all of this has happened). At the time of the report, VACCINATION COMPLICATION (Since the shot all of this has happened) outcome was unknown. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling like pins and needles in her feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling like pins and needles in her feet) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopause (takes hormone replacement therapy twice a week.) and Panic attacks. Concomitant products included ALPRAZOLAM (XANAX) for Panic attacks.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PARAESTHESIA (tingling like pins and needles in her feet). At the time of the report, PARAESTHESIA (tingling like pins and needles in her feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.  Patient said that it turns out side effects and needed back surgery.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19 Jul 2021 contains non-significant information
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I got swollen lymnodes on my collar done, they went down; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (I got swollen lymnodes on my collar done, they went down) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-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 LYMPHADENOPATHY (I got swollen lymnodes on my collar done, they went down). At the time of the report, LYMPHADENOPATHY (I got swollen lymnodes on my collar done, they went down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant therapy information was provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-224993 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long should general side effects of the 2nd dose of the COVID-19 vaccine last?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long should general side effects of the 2nd dose of the COVID-19 vaccine last?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long should general side effects of the 2nd dose of the COVID-19 vaccine last?). At the time of the report, VACCINATION COMPLICATION (How long should general side effects of the 2nd dose of the COVID-19 vaccine last?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) 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 14-Jun-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 VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. Patient started vomiting three days after vaccination. No treatment information given.   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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Constant headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Constant headaches). At the time of the report, HEADACHE (Constant headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Gait disturbance, Hypoaesthesia, Muscular weakness, Sensory loss
Clinical narrative: No feeling in feet; Legs are weak; Cannot walk without assistance; Feet are 100% numb/Numbness traveling higher up the leg, into thighs and hips; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY LOSS (No feeling in feet), MUSCULAR WEAKNESS (Legs are weak), GAIT DISTURBANCE (Cannot walk without assistance) and HYPOAESTHESIA (Feet are 100% numb/Numbness traveling higher up the leg, into thighs and hips) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21 and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Panic attacks and Menopause (She takes hormone replacement therapy twice a week for Menopause). Concomitant products included ALPRAZOLAM (XANAX) for Panic attacks.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced SENSORY LOSS (No feeling in feet), MUSCULAR WEAKNESS (Legs are weak), GAIT DISTURBANCE (Cannot walk without assistance) and HYPOAESTHESIA (Feet are 100% numb/Numbness traveling higher up the leg, into thighs and hips). The patient was treated with GABAPENTIN at an unspecified dose and frequency; DULOXETINE at an unspecified dose and frequency and METFORMIN for Diabetes, at an unspecified dose and frequency. At the time of the report, SENSORY LOSS (No feeling in feet), MUSCULAR WEAKNESS (Legs are weak), GAIT DISTURBANCE (Cannot walk without assistance) and HYPOAESTHESIA (Feet are 100% numb/Numbness traveling higher up the leg, into thighs and hips) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood glucose: 103 (normal) sugar was 103.         Patient was taking Hormone replacement therapy for menopause  Patient reported that she needed back surgery   This case was linked to MOD-2021-224955 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received: Outcome of the events was updated to resolved.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess limb, Chills
Clinical narrative: Abscess 2-3 days later on his left arm (same arm that was injected); chills/shivering; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS LIMB (Abscess 2-3 days later on his left arm (same arm that was injected)) and CHILLS (chills/shivering) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 19B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABSCESS LIMB (Abscess 2-3 days later on his left arm (same arm that was injected)) and CHILLS (chills/shivering). At the time of the report, ABSCESS LIMB (Abscess 2-3 days later on his left arm (same arm that was injected)) and CHILLS (chills/shivering) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-054273 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen gland  on neck; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (swollen gland  on neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen gland  on neck). At the time of the report, LYMPHADENOPATHY (swollen gland  on neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications reported. no treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: The ones on my right are still noticeable but have; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (The ones on my right are still noticeable but have) 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (The ones on my right are still noticeable but have). At the time of the report, LYMPHADENOPATHY (The ones on my right are still noticeable but have) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-224959 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: and is shaking; she is having fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (and is shaking), PYREXIA (she is having fever) and HEADACHE (headache) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (and is shaking), PYREXIA (she is having fever) and HEADACHE (headache). At the time of the report, TREMOR (and is shaking), PYREXIA (she is having fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown.            Concomitant medications were not reported  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was administered 1st dose from vial that has been punctured and refrigerated for 23 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered 1st dose from vial that has been punctured and refrigerated for 23 hours) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE, CETIRIZINE HYDROCHLORIDE (CETRIZINE), CLONAZEPAM, CLOTRIMAZOLE, ESTRADIOL, NORETHISTERONE ACETATE (COMBIPATCH), DULOXETINE, HYDROXYZINE, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (IPRATROPIUM/ALBUTEROL), LAMOTRIGINE, LISINOPRIL, METOPROLOL, OMEPRAZOLE, FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]), BREXPIPRAZOLE (REXULTI) and TRIAMCINOLONE for an unknown indication.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered 1st dose from vial that has been punctured and refrigerated for 23 hours). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (A patient was administered 1st dose from vial that has been punctured and refrigerated for 23 hours) 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.   The reporter was a Nurse practitioner who called to report an adverse event that happened at their facility, where a patient was given 1st dose of Moderna COVID-19 from a vial that has been punctured and was refrigerated for 23 hours. The reporter said that a 10-doses multi-dose vial was punctured on 15-Jun-2021 morning at 10:30AM and stayed in refrigerator through last night and was administered to a patient as a 1st dose of vaccination series today, on 16-Jun-2021 at 9AM.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: unable to get second dose n timeframe because of unrelated knee surgery and rehab for the surgery; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (unable to get second dose n timeframe because of unrelated knee surgery and rehab for the surgery) 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 Knee surgery NOS.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (unable to get second dose n timeframe because of unrelated knee surgery and rehab for the surgery). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (unable to get second dose n timeframe because of unrelated knee surgery and rehab for the surgery) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient had an unrelated knee surgery, and then rehab for it was keeping her from getting the second dose.  No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Vaccination site pain
Clinical narrative: I was feeling sick; Kind of chilled; My second shot my arm hurt me extremely bad; Little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I was feeling sick), CHILLS (Kind of chilled), VACCINATION SITE PAIN (My second shot my arm hurt me extremely bad) and FATIGUE (Little bit tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (I was feeling sick), CHILLS (Kind of chilled) and VACCINATION SITE PAIN (My second shot my arm hurt me extremely bad). an unknown date, the patient experienced FATIGUE (Little bit tired). At the time of the report, MALAISE (I was feeling sick), CHILLS (Kind of chilled), VACCINATION SITE PAIN (My second shot my arm hurt me extremely bad) and FATIGUE (Little bit tired) was resolving.            Concomitant medications were not provided. Treatment information was not reported.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Rash papular
Clinical narrative: Widespread bumpy rash all over her body; Arm and legs were weak; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULAR WEAKNESS (Arm and legs were weak) and RASH PAPULAR (Widespread bumpy rash all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, GUAIFENESIN (MUCINEX), OMEPRAZOLE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), SUCRALFATE (CARAFATE), DOCUSATE SODIUM (COLACE), MONTELUKAST SODIUM (SINGULAIR), IPRATROPIUM BROMIDE (ATROVENT), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), CALCIUM CARBONATE (GAVISCON ACID BREAKTHROUGH FORMULA), CYCLOBENZAPRINE, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Jun-2021, the patient experienced MUSCULAR WEAKNESS (Arm and legs were weak). On 16-Jun-2021, the patient experienced RASH PAPULAR (Widespread bumpy rash all over her body). At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULAR WEAKNESS (Arm and legs were weak) and RASH PAPULAR (Widespread bumpy rash all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Myalgia, Peripheral swelling, Tenderness
Clinical narrative: Warm knot on my arm; Tenderness; Warm knot on my arm; Sore; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Warm knot on my arm), TENDERNESS (Tenderness), FEELING HOT (Warm knot on my arm) and MYALGIA (Sore) 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 11-Jun-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 PERIPHERAL SWELLING (Warm knot on my arm), TENDERNESS (Tenderness), FEELING HOT (Warm knot on my arm) and MYALGIA (Sore). At the time of the report, PERIPHERAL SWELLING (Warm knot on my arm), TENDERNESS (Tenderness), FEELING HOT (Warm knot on my arm) and MYALGIA (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medication reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose not given in allowed time; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not given in allowed time) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-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 (Second dose not given in allowed time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not given in allowed time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.