chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination complication
Clinical narrative: had a pretty mild reaction to second dose; the patient's arm swelled up each time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a pretty mild reaction to second dose) and PERIPHERAL SWELLING (the patient's arm swelled up each time) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 VACCINATION COMPLICATION (had a pretty mild reaction to second dose) and PERIPHERAL SWELLING (the patient's arm swelled up each time). At the time of the report, VACCINATION COMPLICATION (had a pretty mild reaction to second dose) outcome was unknown and PERIPHERAL SWELLING (the patient's arm swelled up each time) had not resolved.            The patient was on concomitant medication, but does not specify which ones.  No treatment information was provided.   This case was linked to MOD-2022-474781, MOD-2022-474811 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Mass, Pain in extremity, Peripheral swelling
Clinical narrative: er arm swelled up each time. Her arm is still swollen up from the booster; General sickness; Her arm is still swollen up from the booster, dose, it is a pretty good sized lump and is sore.; pretty good sized lump; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (er arm swelled up each time. Her arm is still swollen up from the booster), ILLNESS (General sickness), PAIN IN EXTREMITY (Her arm is still swollen up from the booster, dose, it is a pretty good sized lump and is sore.), MASS (pretty good sized lump) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 038B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (er arm swelled up each time. Her arm is still swollen up from the booster), ILLNESS (General sickness), PAIN IN EXTREMITY (Her arm is still swollen up from the booster, dose, it is a pretty good sized lump and is sore.), MASS (pretty good sized lump) and HEADACHE (headache). At the time of the report, PERIPHERAL SWELLING (er arm swelled up each time. Her arm is still swollen up from the booster) had not resolved and ILLNESS (General sickness), PAIN IN EXTREMITY (Her arm is still swollen up from the booster, dose, it is a pretty good sized lump and is sore.), MASS (pretty good sized lump) and HEADACHE (headache) outcome was unknown.            The patient reported reactions after receiving the Moderna COVID-19 booster dose on 04-Feb-2022. The patient after the booster dose reported a headache again, general sickness, and their arm swelled up each time. The patient's arm was still swollen up from the booster dose, it was a pretty good sized lump and was sore.  The patient was on concomitant medication but does not specify which ones.   No treatment information was provided.   This case was linked to MOD-2022-474781, MOD-2022-474799 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021 at 2:50 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021 at 2:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses). On 26-Nov-2021 at 2:50 AM, EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided Reported that 2 vials removed from -20C freezer at 12:30pm, 11/16/21, thawed for 30 min at room temp,drawn up and placed in fridge(3.8C)for duration of clinic,from 1pm-4pm on 11/26/21. Patient was not immunocompramised.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021 at 1:36 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not immunocompromised.  No concomitant medications were reported.  Vials were stored in a vaccine freezer set to -20 C. On 12 Nov 2021, vial was placed on counter at room temperature for 30 minutes to thaw and vaccine was drawn up and then placed in vaccine in fridge for the duration of the clinic, and was taken out when patient was ready to receive. Temperature readings of fridge were at 3.8 C . No temperature excursions were noted during the administration of the vaccine.  No treatment medications were reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Got 0.25 mL instead of 0.50 mL as a first dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Got 0.25 mL instead of 0.50 mL as a first dose) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (Got 0.25 mL instead of 0.50 mL as a first dose). On 24-Jan-2022, ACCIDENTAL UNDERDOSE (Got 0.25 mL instead of 0.50 mL as a first dose) had resolved.            No concomitant medication information was provided. No treatment medication were provided.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: while also being hot; hard; red; Arm pain for approximately 1 week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (while also being hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (Arm pain for approximately 1 week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE WARMTH (while also being hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (Arm pain for approximately 1 week). In February 2021, VACCINATION SITE WARMTH (while also being hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (Arm pain for approximately 1 week) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient had no significant past medical history and had no previous COVID-19 infection.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-474893, MOD-2022-474895 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: while also being hot; hard; red; Arm pain for approximately 1 week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (while also being hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (Arm pain for approximately 1 week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE WARMTH (while also being hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (Arm pain for approximately 1 week). In February 2021, VACCINATION SITE WARMTH (while also being hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (Arm pain for approximately 1 week) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient had no significant past medical history and had no previous COVID-19 infection.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-474893, MOD-2022-474895 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: while also being hot; hard; red; Arm pain for approximately 1 week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (while also being hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (Arm pain for approximately 1 week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE WARMTH (while also being hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (Arm pain for approximately 1 week). In February 2021, VACCINATION SITE WARMTH (while also being hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (Arm pain for approximately 1 week) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient had no significant past medical history and had no previous COVID-19 infection.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-474893, MOD-2022-474895 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: while also being hot; hard; red; Arm pain for approximately 1 week; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (while also being hot), INDURATION (hard), ERYTHEMA (red) and PAIN IN EXTREMITY (Arm pain for approximately 1 week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-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 SKIN WARM (while also being hot), INDURATION (hard), ERYTHEMA (red) and PAIN IN EXTREMITY (Arm pain for approximately 1 week). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN WARM (while also being hot), INDURATION (hard) and ERYTHEMA (red) outcome was unknown and PAIN IN EXTREMITY (Arm pain for approximately 1 week) had resolved.            Patient had no significant past medical history and had no previous COVID-19 infection. No concomitant medications were provided by the reporter.   This case was linked to MOD-2022-474847, MOD-2022-474895 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: while also being hot; hard; red; Arm pain for approximately 1 week; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (while also being hot), INDURATION (hard), ERYTHEMA (red) and PAIN IN EXTREMITY (Arm pain for approximately 1 week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-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 SKIN WARM (while also being hot), INDURATION (hard), ERYTHEMA (red) and PAIN IN EXTREMITY (Arm pain for approximately 1 week). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN WARM (while also being hot), INDURATION (hard) and ERYTHEMA (red) outcome was unknown and PAIN IN EXTREMITY (Arm pain for approximately 1 week) had resolved.            Patient had no significant past medical history and had no previous COVID-19 infection. No concomitant medications were provided by the reporter.   This case was linked to MOD-2022-474847, MOD-2022-474895 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: while also being hot; hard; red; Arm pain for approximately 1 week; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (while also being hot), INDURATION (hard), ERYTHEMA (red) and PAIN IN EXTREMITY (Arm pain for approximately 1 week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-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 SKIN WARM (while also being hot), INDURATION (hard), ERYTHEMA (red) and PAIN IN EXTREMITY (Arm pain for approximately 1 week). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN WARM (while also being hot), INDURATION (hard) and ERYTHEMA (red) outcome was unknown and PAIN IN EXTREMITY (Arm pain for approximately 1 week) had resolved.            Patient had no significant past medical history and had no previous COVID-19 infection. No concomitant medications were provided by the reporter.   This case was linked to MOD-2022-474847, MOD-2022-474895 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Arm gradually felt tingly like it is asleep; Arm gradually felt more numb; Arm hurt for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Arm gradually felt tingly like it is asleep), PAIN IN EXTREMITY (Arm hurt for 2 weeks) and HYPOAESTHESIA (Arm gradually felt more numb) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04SY21A, 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Arm gradually felt tingly like it is asleep), PAIN IN EXTREMITY (Arm hurt for 2 weeks) and HYPOAESTHESIA (Arm gradually felt more numb). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Arm gradually felt tingly like it is asleep) and HYPOAESTHESIA (Arm gradually felt more numb) outcome was unknown and PAIN IN EXTREMITY (Arm hurt for 2 weeks) had resolved.            No concomitant medications were reported.  Patient stated that she had no significant past medical history and no previous COVID-19 infection.   This case was linked to MOD-2022-474847, MOD-2022-474893 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: Arm gradually felt tingly like it is asleep; Arm gradually felt more numb; Arm hurt for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Arm gradually felt tingly like it is asleep), PAIN IN EXTREMITY (Arm hurt for 2 weeks) and HYPOAESTHESIA (Arm gradually felt more numb) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04SY21A, 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Arm gradually felt tingly like it is asleep), PAIN IN EXTREMITY (Arm hurt for 2 weeks) and HYPOAESTHESIA (Arm gradually felt more numb). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Arm gradually felt tingly like it is asleep) and HYPOAESTHESIA (Arm gradually felt more numb) outcome was unknown and PAIN IN EXTREMITY (Arm hurt for 2 weeks) had resolved.            No concomitant medications were reported.  Patient stated that she had no significant past medical history and no previous COVID-19 infection.   This case was linked to MOD-2022-474847, MOD-2022-474893 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Arm gradually felt tingly like it is asleep; Arm gradually felt more numb; Arm hurt for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Arm gradually felt tingly like it is asleep), PAIN IN EXTREMITY (Arm hurt for 2 weeks) and HYPOAESTHESIA (Arm gradually felt more numb) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04SY21A, 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Arm gradually felt tingly like it is asleep), PAIN IN EXTREMITY (Arm hurt for 2 weeks) and HYPOAESTHESIA (Arm gradually felt more numb). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Arm gradually felt tingly like it is asleep) and HYPOAESTHESIA (Arm gradually felt more numb) outcome was unknown and PAIN IN EXTREMITY (Arm hurt for 2 weeks) had resolved.            No concomitant medications were reported.  Patient stated that she had no significant past medical history and no previous COVID-19 infection.   This case was linked to MOD-2022-474847, MOD-2022-474893 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Rash and Faint lines going down back of left arm and on the outside of left arm; Rash and Faint lines going down back of left arm and on the outside of left arm / faint red line on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash and Faint lines going down back of left arm and on the outside of left arm) and VACCINATION SITE ERYTHEMA (Rash and Faint lines going down back of left arm and on the outside of left arm / faint red line on left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 04-Feb-2022, the patient experienced VACCINATION SITE RASH (Rash and Faint lines going down back of left arm and on the outside of left arm) and VACCINATION SITE ERYTHEMA (Rash and Faint lines going down back of left arm and on the outside of left arm / faint red line on left arm). At the time of the report, VACCINATION SITE RASH (Rash and Faint lines going down back of left arm and on the outside of left arm) and VACCINATION SITE ERYTHEMA (Rash and Faint lines going down back of left arm and on the outside of left arm / faint red line on left arm) was resolving.            Patient was instructed by physician to take Benadryl and to watch reactions. Patient was also instructed to go to ER if she developed difficulty breathing or swallowing. Concomitant medications were not reported. Treatment details were not provided
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen armpit; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (Swollen armpit) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced LYMPHADENOPATHY (Swollen armpit). At the time of the report, LYMPHADENOPATHY (Swollen armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received the booster on Thursday.  No treatment medication was reported.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Gout, Nausea, Rash
Clinical narrative: felt sick to the gout; stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,; feel a pressure in their stomach; diarrhea.; a little of a  rash in their face/rash around the eyes/little rash in  their feet,; feels like through up; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (felt sick to the gout), SWELLING (stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,), ABDOMINAL DISCOMFORT (feel a pressure in their stomach), DIARRHOEA (diarrhea.) and RASH (a little of a  rash in their face/rash around the eyes/little rash in  their feet,) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042s21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Throat sore and Cold. Previously administered products included for Product used for unknown indication: Johnson & Johnson on 04-Feb-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Asthma and Blood disorder NOS. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 19-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced GOUT (felt sick to the gout), SWELLING (stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,), ABDOMINAL DISCOMFORT (feel a pressure in their stomach), DIARRHOEA (diarrhea.), RASH (a little of a  rash in their face/rash around the eyes/little rash in  their feet,) and NAUSEA (feels like through up). At the time of the report, GOUT (felt sick to the gout), SWELLING (stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,), ABDOMINAL DISCOMFORT (feel a pressure in their stomach), DIARRHOEA (diarrhea.), RASH (a little of a  rash in their face/rash around the eyes/little rash in  their feet,) and NAUSEA (feels like through up) outcome was unknown.            No treatment medication was provided Patient reported concomitant product for blood pressure
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: felt sick to the gout; stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,; feel a pressure in their stomach; diarrhea.; a little of a  rash in their face/rash around the eyes/little rash in  their feet,; feels like through up; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (felt sick to the gout), SWELLING (stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,), ABDOMINAL DISCOMFORT (feel a pressure in their stomach), DIARRHOEA (diarrhea.) and RASH (a little of a  rash in their face/rash around the eyes/little rash in  their feet,) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042s21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Throat sore and Cold. Previously administered products included for Product used for unknown indication: Johnson & Johnson on 04-Feb-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Asthma and Blood disorder NOS. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 19-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced GOUT (felt sick to the gout), SWELLING (stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,), ABDOMINAL DISCOMFORT (feel a pressure in their stomach), DIARRHOEA (diarrhea.), RASH (a little of a  rash in their face/rash around the eyes/little rash in  their feet,) and NAUSEA (feels like through up). At the time of the report, GOUT (felt sick to the gout), SWELLING (stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,), ABDOMINAL DISCOMFORT (feel a pressure in their stomach), DIARRHOEA (diarrhea.), RASH (a little of a  rash in their face/rash around the eyes/little rash in  their feet,) and NAUSEA (feels like through up) outcome was unknown.            No treatment medication was provided Patient reported concomitant product for blood pressure
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Myalgia
Clinical narrative: Patient felt body ache; Patient received 0.5ML instead of 0.25ML; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Patient felt body ache) and ACCIDENTAL OVERDOSE (Patient received 0.5ML instead of 0.25ML) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (primary doses) in November 2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient received 0.5ML instead of 0.25ML). On an unknown date, the patient experienced MYALGIA (Patient felt body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Myalgia, at an unspecified dose and frequency. On 05-Feb-2022, ACCIDENTAL OVERDOSE (Patient received 0.5ML instead of 0.25ML) had resolved. At the time of the report, MYALGIA (Patient felt body ache) outcome was unknown.            Concomitant product information was not provided.  Patient was worried because of the side effects.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Myalgia
Clinical narrative: patient felt body ache; received booster dose 0.5ML instead of 0.25ML; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (patient felt body ache) and ACCIDENTAL OVERDOSE (received booster dose 0.5ML instead of 0.25ML) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (received booster dose 0.5ML instead of 0.25ML). On an unknown date, the patient experienced MYALGIA (patient felt body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Myalgia, at an unspecified dose and frequency. On 05-Feb-2022, ACCIDENTAL OVERDOSE (received booster dose 0.5ML instead of 0.25ML) had resolved. At the time of the report, MYALGIA (patient felt body ache) outcome was unknown.            No concomitant medications were provided.  The patient and the wife received the Booster shot of Moderna on 05-Feb-2022. However both of them received 0.5ML instead of 0.25ml.   This case was linked to MOD-2022-474971 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 1:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not reported.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: She had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. In 2021, PAIN IN EXTREMITY (She had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After a day or two, the soreness went away. It was not too bad.  The patient states she never had a history of COVID positive. The patient had no known allergies and no other health conditions.   This case was linked to MOD-2022-475042, MOD-2022-475046 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: She had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. In 2021, PAIN IN EXTREMITY (She had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After a day or two, the soreness went away. It was not too bad.  The patient states she never had a history of COVID positive. The patient had no known allergies and no other health conditions.   This case was linked to MOD-2022-475042, MOD-2022-475046 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Still having a sore arm/When she move it, it hurts like hell/muscle is hurting really bad/it hurts to move her arm; Around where she got the shot it hurts really bad when she does certain things/hurts to move/hurting started pretty much right after vaccination; The person put it in the wrong spot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Still having a sore arm/When she move it, it hurts like hell/muscle is hurting really bad/it hurts to move her arm), VACCINATION SITE PAIN (Around where she got the shot it hurts really bad when she does certain things/hurts to move/hurting started pretty much right after vaccination) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The person put it in the wrong spot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) for Thyroid disorder NOS.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced VACCINATION SITE PAIN (Around where she got the shot it hurts really bad when she does certain things/hurts to move/hurting started pretty much right after vaccination) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The person put it in the wrong spot). On 07-Feb-2022, the patient experienced MYALGIA (Still having a sore arm/When she move it, it hurts like hell/muscle is hurting really bad/it hurts to move her arm). The patient was treated with ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 27-Nov-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The person put it in the wrong spot) had resolved. At the time of the report, MYALGIA (Still having a sore arm/When she move it, it hurts like hell/muscle is hurting really bad/it hurts to move her arm) and VACCINATION SITE PAIN (Around where she got the shot it hurts really bad when she does certain things/hurts to move/hurting started pretty much right after vaccination) had not resolved.            The patient states the hurting started pretty much right after the vaccination, so it's been two months now. The patient states she never had a history of COVID positive. The patient has no known allergies and no other health conditions.   This case was linked to MOD-2022-475010, MOD-2022-475042 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: Still having a sore arm/When she move it, it hurts like hell/muscle is hurting really bad/it hurts to move her arm; Around where she got the shot it hurts really bad when she does certain things/hurts to move/hurting started pretty much right after vaccination; The person put it in the wrong spot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Still having a sore arm/When she move it, it hurts like hell/muscle is hurting really bad/it hurts to move her arm), VACCINATION SITE PAIN (Around where she got the shot it hurts really bad when she does certain things/hurts to move/hurting started pretty much right after vaccination) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The person put it in the wrong spot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) for Thyroid disorder NOS.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced VACCINATION SITE PAIN (Around where she got the shot it hurts really bad when she does certain things/hurts to move/hurting started pretty much right after vaccination) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The person put it in the wrong spot). On 07-Feb-2022, the patient experienced MYALGIA (Still having a sore arm/When she move it, it hurts like hell/muscle is hurting really bad/it hurts to move her arm). The patient was treated with ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 27-Nov-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The person put it in the wrong spot) had resolved. At the time of the report, MYALGIA (Still having a sore arm/When she move it, it hurts like hell/muscle is hurting really bad/it hurts to move her arm) and VACCINATION SITE PAIN (Around where she got the shot it hurts really bad when she does certain things/hurts to move/hurting started pretty much right after vaccination) had not resolved.            The patient states the hurting started pretty much right after the vaccination, so it's been two months now. The patient states she never had a history of COVID positive. The patient has no known allergies and no other health conditions.   This case was linked to MOD-2022-475010, MOD-2022-475042 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm [after first two doses] After a day or two, the soreness went away.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm [after first two doses] After a day or two, the soreness went away.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was not reported by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 PAIN IN EXTREMITY (sore arm [after first two doses] After a day or two, the soreness went away.). At the time of the report, PAIN IN EXTREMITY (sore arm [after first two doses] After a day or two, the soreness went away.) had resolved.            No treatment medications provided by the reporter.     This case was linked to MOD-2022-475010, MOD-2022-475046 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: sore arm [after first two doses] After a day or two, the soreness went away.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm [after first two doses] After a day or two, the soreness went away.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was not reported by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 PAIN IN EXTREMITY (sore arm [after first two doses] After a day or two, the soreness went away.). At the time of the report, PAIN IN EXTREMITY (sore arm [after first two doses] After a day or two, the soreness went away.) had resolved.            No treatment medications provided by the reporter.     This case was linked to MOD-2022-475010, MOD-2022-475046 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Elderly, immunocomprised patient had 2 primary vacs in Jan and Feb of 21 and booster Oct 21. When should she take the 3rd primary vac?; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Elderly, immunocomprised patient had 2 primary vacs in Jan and Feb of 21 and booster Oct 21. When should she take the 3rd primary vac?) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ACCIDENTAL UNDERDOSE (Elderly, immunocomprised patient had 2 primary vacs in Jan and Feb of 21 and booster Oct 21. When should she take the 3rd primary vac?). In October 2021, ACCIDENTAL UNDERDOSE (Elderly, immunocomprised patient had 2 primary vacs in Jan and Feb of 21 and booster Oct 21. When should she take the 3rd primary vac?) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: No issues with eyes other than needing glasses; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (No issues with eyes other than needing glasses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L204) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced EYE DISORDER (No issues with eyes other than needing glasses). At the time of the report, EYE DISORDER (No issues with eyes other than needing glasses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medication were reported.  No treatment medication were reported.  It was reported that on 25 Feb 2021 patient went to optomiticist for first eye exam.   This case was linked to MOD-2022-475104 (Patient Link).