chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Had a 103 degree F fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a 103 degree F fever) 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 Drug use for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (Had a 103 degree F fever). At the time of the report, PYREXIA (Had a 103 degree F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, Body temperature: 103 (High) 103 degree Fahrenheit fever.         No concomitant products were reported.  No treatment information was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Has shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Has shingles) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HERPES ZOSTER (Has shingles). At the time of the report, HERPES ZOSTER (Has shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported. Patient has scheduled her second dose on 15 Feb 2021 and wanted to start treatment and asked an antiviral drug can conflict her second dose which was scheduled.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Presyncope, Secretion discharge
Clinical narrative: feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm; a lot of mucus/excessive spitting; feeling like she would faint; fatigue; muscle pain; swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm), SECRETION DISCHARGE (a lot of mucus/excessive spitting), PRESYNCOPE (feeling like she would faint), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067h21a, 012m20a and 013l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-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 FEELING ABNORMAL (feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm), SECRETION DISCHARGE (a lot of mucus/excessive spitting), PRESYNCOPE (feeling like she would faint), FATIGUE (fatigue), MYALGIA (muscle pain) and VACCINATION SITE SWELLING (swelling in the injection site). At the time of the report, FEELING ABNORMAL (feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm), SECRETION DISCHARGE (a lot of mucus/excessive spitting), PRESYNCOPE (feeling like she would faint), FATIGUE (fatigue), MYALGIA (muscle pain) and VACCINATION SITE SWELLING (swelling in the injection site) outcome was unknown.            Treatment medication contains medication for congestion.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm; a lot of mucus/excessive spitting; feeling like she would faint; fatigue; muscle pain; swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm), SECRETION DISCHARGE (a lot of mucus/excessive spitting), PRESYNCOPE (feeling like she would faint), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067h21a, 012m20a and 013l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-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 FEELING ABNORMAL (feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm), SECRETION DISCHARGE (a lot of mucus/excessive spitting), PRESYNCOPE (feeling like she would faint), FATIGUE (fatigue), MYALGIA (muscle pain) and VACCINATION SITE SWELLING (swelling in the injection site). At the time of the report, FEELING ABNORMAL (feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm), SECRETION DISCHARGE (a lot of mucus/excessive spitting), PRESYNCOPE (feeling like she would faint), FATIGUE (fatigue), MYALGIA (muscle pain) and VACCINATION SITE SWELLING (swelling in the injection site) outcome was unknown.            Treatment medication contains medication for congestion.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph node under left arm been very large/swollen; Painful when my arm is touching my body; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (lymph node under left arm been very large/swollen) and LYMPH NODE PAIN (Painful when my arm is touching my body) 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 24-Dec-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced LYMPHADENOPATHY (lymph node under left arm been very large/swollen) and LYMPH NODE PAIN (Painful when my arm is touching my body). At the time of the report, LYMPHADENOPATHY (lymph node under left arm been very large/swollen) and LYMPH NODE PAIN (Painful when my arm is touching my body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Lymphadenitis, Vaccination site pain
Clinical narrative: Stomach pain; Diarrhea; Inflammation of the armpit limp nodes that is really pain full; Pain in the right arm where the vaccine was administered; Eruption in the right arm where the vaccine was applied.; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), LYMPHADENITIS (Inflammation of the armpit limp nodes that is really pain full), VACCINATION SITE PAIN (Pain in the right arm where the vaccine was administered) and VACCINATION SITE RASH (Eruption in the right arm where the vaccine was applied.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), LYMPHADENITIS (Inflammation of the armpit limp nodes that is really pain full), VACCINATION SITE PAIN (Pain in the right arm where the vaccine was administered), VACCINATION SITE RASH (Eruption in the right arm where the vaccine was applied.) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), LYMPHADENITIS (Inflammation of the armpit limp nodes that is really pain full), VACCINATION SITE PAIN (Pain in the right arm where the vaccine was administered), VACCINATION SITE RASH (Eruption in the right arm where the vaccine was applied.) and FATIGUE (Very tired) outcome was unknown.            No concomitant medication details was provided. no reaction during the main vaccination series. took Tylenol but was not very effective
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Stomach pain; Diarrhea; Inflammation of the armpit limp nodes that is really pain full; Pain in the right arm where the vaccine was administered; Eruption in the right arm where the vaccine was applied.; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), LYMPHADENITIS (Inflammation of the armpit limp nodes that is really pain full), VACCINATION SITE PAIN (Pain in the right arm where the vaccine was administered) and VACCINATION SITE RASH (Eruption in the right arm where the vaccine was applied.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), LYMPHADENITIS (Inflammation of the armpit limp nodes that is really pain full), VACCINATION SITE PAIN (Pain in the right arm where the vaccine was administered), VACCINATION SITE RASH (Eruption in the right arm where the vaccine was applied.) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), LYMPHADENITIS (Inflammation of the armpit limp nodes that is really pain full), VACCINATION SITE PAIN (Pain in the right arm where the vaccine was administered), VACCINATION SITE RASH (Eruption in the right arm where the vaccine was applied.) and FATIGUE (Very tired) outcome was unknown.            No concomitant medication details was provided. no reaction during the main vaccination series. took Tylenol but was not very effective
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Tachycardia, Vaccination complication, Vertigo
Clinical narrative: tachycardia; chest pain; vertigo; several other issues after the second dose of the Moderna Covid vaccine; extreme fatigue; This spontaneous case was reported by a physician and describes the occurrence of TACHYCARDIA (tachycardia), CHEST PAIN (chest pain), VERTIGO (vertigo), VACCINATION COMPLICATION (several other issues after the second dose of the Moderna Covid vaccine) and FATIGUE (extreme fatigue) 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, the patient experienced TACHYCARDIA (tachycardia), CHEST PAIN (chest pain), VERTIGO (vertigo), VACCINATION COMPLICATION (several other issues after the second dose of the Moderna Covid vaccine) and FATIGUE (extreme fatigue). At the time of the report, TACHYCARDIA (tachycardia), CHEST PAIN (chest pain), VERTIGO (vertigo), VACCINATION COMPLICATION (several other issues after the second dose of the Moderna Covid vaccine) and FATIGUE (extreme fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drug information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A booster was administered to a patient to a underaged patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A booster was administered to a patient to a underaged patient.) 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 an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A booster was administered to a patient to a underaged patient.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A booster was administered to a patient to a underaged patient.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Sore arm after 1st and 2nd dose; flu-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in an adult 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) and INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-427771, MOD-2021-427775 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm for 1 week (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm for 1 week (1st dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (COVID arm for 1 week (1st dose)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and Wound care for Vaccination site reaction. At the time of the report, VACCINATION SITE REACTION (COVID arm for 1 week (1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient did not have allergies.  Concomitant medications were not provided by reporter.  Patient's received Cold showers as treatment.   This case was linked to MOD-2021-428091, MOD-2021-428092 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is very much hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very much hurting) 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.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (Arm is very much hurting). At the time of the report, PAIN IN EXTREMITY (Arm is very much hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication reported. No Treatment medication reported. Patient reported that after getting the Moderna shot ten days ago, their arm was very much hurting.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site extravasation
Clinical narrative: Patient did not get the full booster dose/couple of drops ran down her ar/some of it came back out of her arm; some of it came back out of her arm/couple of drops ran down her arm; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient did not get the full booster dose/couple of drops ran down her ar/some of it came back out of her arm) and INJECTION SITE EXTRAVASATION (some of it came back out of her arm/couple of drops ran down her arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 03-Jun-2021 and Pfizer on 24-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Patient did not get the full booster dose/couple of drops ran down her ar/some of it came back out of her arm) and INJECTION SITE EXTRAVASATION (some of it came back out of her arm/couple of drops ran down her arm). On 27-Dec-2021, INCORRECT DOSE ADMINISTERED (Patient did not get the full booster dose/couple of drops ran down her ar/some of it came back out of her arm) and INJECTION SITE EXTRAVASATION (some of it came back out of her arm/couple of drops ran down her arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: her left arm at injection site was itching; Swelling at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (her left arm at injection site was itching), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2021, the patient experienced VACCINATION SITE PRURITUS (her left arm at injection site was itching), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (her left arm at injection site was itching), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) was resolving.            No concomitant medications were reported.  Beginning on 24 December 2021, her left arm at injection site was itching with swelling and redness. Patient stated that she put alcohol pads and peroxide on the injection site area and her arm was getting better.
Sex: U
Vaccine: COVID19
Symptoms: Breast pain, Lymphadenopathy, Myalgia
Clinical narrative: causing pain  down the side of my left breast; there is a lump under my armpit on the left side; and immediately after it my whole arm hurt from shoulder then it went to my thumb an; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAST PAIN (causing pain  down the side of my left breast), LYMPHADENOPATHY (there is a lump under my armpit on the left side) and MYALGIA (and immediately after it my whole arm hurt from shoulder then it went to my thumb an) 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 an unknown date, the patient experienced BREAST PAIN (causing pain  down the side of my left breast), LYMPHADENOPATHY (there is a lump under my armpit on the left side) and MYALGIA (and immediately after it my whole arm hurt from shoulder then it went to my thumb an). At the time of the report, BREAST PAIN (causing pain  down the side of my left breast), LYMPHADENOPATHY (there is a lump under my armpit on the left side) and MYALGIA (and immediately after it my whole arm hurt from shoulder then it went to my thumb an) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Inappropriate schedule of product administration, Incorrect dose administered, Oropharyngeal pain
Clinical narrative: Slight sore throat; instead of getting .25ml he got .5ml; inappropriate schedule of vaccine administered; feeling fatigued; physical and mental state not fine; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Slight sore throat), FEELING ABNORMAL (physical and mental state not fine), INCORRECT DOSE ADMINISTERED (instead of getting .25ml he got .5ml), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) and FATIGUE (feeling fatigued) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041Z1A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. In December 2021, the patient experienced FEELING ABNORMAL (physical and mental state not fine) and FATIGUE (feeling fatigued). On 22-Dec-2021, the patient experienced INCORRECT DOSE ADMINISTERED (instead of getting .25ml he got .5ml) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 27-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Slight sore throat). On 22-Dec-2021, INCORRECT DOSE ADMINISTERED (instead of getting .25ml he got .5ml) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Slight sore throat), FEELING ABNORMAL (physical and mental state not fine) and FATIGUE (feeling fatigued) outcome was unknown.            No concomitant medications was provided. The patient does not take any medications and also has not contacted his HCP.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Flu-like symptoms; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PAIN IN EXTREMITY (sore arm) 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 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PAIN IN EXTREMITY (sore arm). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PAIN IN EXTREMITY (sore arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-427701, MOD-2021-427775 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Painful and itchy hives on multiple places of body after booster that doesn't seem to go away; Painful and itchy hives on multiple places of body after booster that doesn't seem to go away; Painful and itchy hives on multiple places of body after booster that doesn't seem to go away; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away), PRURITUS (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) and PAIN (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away), PRURITUS (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) and PAIN (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away). The patient was treated with LORATADINE (CLARITINE) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away), PRURITUS (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) and PAIN (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) had not resolved.            No Concomitant product use was reported.  The patient stated that they received the booster shot on 07-Dec-2021 and then last week, hives started coming up on multiple places of the body and they were painful and itchy, and they don't seem to go away.  The patient went and talked to their healthcare provider who wasn't aware of these cases of hives and they first thought the patient had the COVID arm, but this seemed to be more than that as the hives were spreading across the body parts. After talking to their healthcare provider last Friday on 24-Dec-2021, the patient was advised to take Claritin, but it doesn't seem to take effect.   This case was linked to MOD-2021-427701, MOD-2021-427771 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Flu-like symptoms after 1st and 2nd dose; Sore arm after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st and 2nd dose) and PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) in a 49-year-old female 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st and 2nd dose) and PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st and 2nd dose) and PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-427793, MOD-2021-427798 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination complication
Clinical narrative: very swollen right foot; she's got some kind of an infection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (very swollen right foot) and VACCINATION COMPLICATION (she's got some kind of an infection) in an 86-year-old female 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 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 PERIPHERAL SWELLING (very swollen right foot) and VACCINATION COMPLICATION (she's got some kind of an infection). At the time of the report, PERIPHERAL SWELLING (very swollen right foot) and VACCINATION COMPLICATION (she's got some kind of an infection) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   It was reported that they had an appointment for the booster shot on 27Dec2021.   Most recent FOLLOW-UP information incorporated above includes: On 26-Dec-2021: Non significant Follow-up received
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Flu-like symptoms after 1st and 2nd dose; Sore arm after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st and 2nd dose) and PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) in a 49-year-old female 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 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st and 2nd dose) and PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st and 2nd dose) and PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient experienced sore arm  and flu-like symptoms for 1 day   This case was linked to MOD-2021-427781, MOD-2021-427798 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Pruritus, Throat tightness, Urticaria
Clinical narrative: hives started coming up on multiple places of the body; they are painful and they don't seem to go away/This hive is all over the body/The hives are red urticaria all over the body; they are painful; itchy and they don't seem to go away; her hands are swollen; She can sense heat on the body part that the hives appear next; throat tightness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives started coming up on multiple places of the body; they are painful and they don't seem to go away/This hive is all over the body/The hives are red urticaria all over the body; they are painful), PRURITUS (itchy and they don't seem to go away), PERIPHERAL SWELLING (her hands are swollen), FEELING HOT (She can sense heat on the body part that the hives appear next) and THROAT TIGHTNESS (throat tightness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Dec-2021, the patient 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 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. In December 2021, the patient experienced URTICARIA (hives started coming up on multiple places of the body; they are painful and they don't seem to go away/This hive is all over the body/The hives are red urticaria all over the body; they are painful), PRURITUS (itchy and they don't seem to go away), PERIPHERAL SWELLING (her hands are swollen), FEELING HOT (She can sense heat on the body part that the hives appear next) and THROAT TIGHTNESS (throat tightness). The patient was treated with PREDNISOLONE for Throat tightness, at an unspecified dose and frequency. In December 2021, THROAT TIGHTNESS (throat tightness) had resolved. At the time of the report, URTICARIA (hives started coming up on multiple places of the body; they are painful and they don't seem to go away/This hive is all over the body/The hives are red urticaria all over the body; they are painful), PRURITUS (itchy and they don't seem to go away), PERIPHERAL SWELLING (her hands are swollen) and FEELING HOT (She can sense heat on the body part that the hives appear next) had not resolved.            The patient was a Pediatrician.  Concomitant medication of the patient was not reported.  The patient was on Prednisolone, for the last 6 days and the throat had calmed down, but the hives did not seem to went away. All symptoms had been persistent. The urticaria still came, then in 20 to 30 minutes it went away and reappeared somewhere else.  Treatment information for rest of the events were not reported by the reporter.   This case was linked to MOD-2021-427781, MOD-2021-427793 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: this morning g I awoke with swelling; pain in my armpit of the injection arm; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING (this morning g I awoke with swelling) and AXILLARY PAIN (pain in my armpit of the injection arm) 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 25-Dec-2021, the patient experienced SWELLING (this morning g I awoke with swelling) and AXILLARY PAIN (pain in my armpit of the injection arm). At the time of the report, SWELLING (this morning g I awoke with swelling) and AXILLARY PAIN (pain in my armpit of the injection arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: report an adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (report an adverse event) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (report an adverse event). At the time of the report, ADVERSE EVENT (report an adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Reporter stated that the adverse event happened to his cousin and that is wasn't an emergency.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No Concomitant Products were reported. No Treatment information was reported.   This case was linked to MOD-2021-427849, MOD-2021-427028 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Feeling tingling in her body everywhere; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Feeling tingling in her body everywhere) and HYPOAESTHESIA (Numbness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in December 2021.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, the patient experienced PARAESTHESIA (Feeling tingling in her body everywhere) and HYPOAESTHESIA (Numbness). At the time of the report, PARAESTHESIA (Feeling tingling in her body everywhere) and HYPOAESTHESIA (Numbness) outcome was unknown.            No concomitants were provided. No treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) 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 April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            No concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-427829 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: had the 2nd jab of moderna; About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long; had the 2nd jab of moderna; About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (had the 2nd jab of moderna; About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) and PRODUCT STORAGE ERROR (had the 2nd jab of moderna; About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) 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.    In October 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (had the 2nd jab of moderna; About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) and PRODUCT STORAGE ERROR (had the 2nd jab of moderna; About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long). In October 2021, EXPIRED PRODUCT ADMINISTERED (had the 2nd jab of moderna; About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) and PRODUCT STORAGE ERROR (had the 2nd jab of moderna; About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-428398 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 26-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Skin discolouration
Clinical narrative: skin turned grey; feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (skin turned grey) and FATIGUE (feeling very tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00a21a and 029l020a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced SKIN DISCOLOURATION (skin turned grey) and FATIGUE (feeling very tired). On 25-Feb-2021, SKIN DISCOLOURATION (skin turned grey) had resolved. At the time of the report, FATIGUE (feeling very tired) outcome was unknown.            Concomitant medication of the patient included high blood pressure pill.  The patient did not receive any corrective treatment for the events; her relatives watched her during the night and her skin color was normal by the next day.  Primary physician of the reporter told her to call Moderna as they had never seen something like that before.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: battling nerve issues; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (battling nerve issues) 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 13-Feb-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 NERVOUS SYSTEM DISORDER (battling nerve issues). The patient was treated with OXYCODONE HYDROCHLORIDE (OXYCONTIN) for Nervous system disorder, at an unspecified dose and frequency. At the time of the report, NERVOUS SYSTEM DISORDER (battling nerve issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was due for the second shot on 14MAR2021. Treatment medication include steroids for battling nerve issues. No concomitant medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Knee arthroplasty
Clinical narrative: knee replacement surgery; This spontaneous case was reported by a consumer and describes the occurrence of KNEE ARTHROPLASTY (knee replacement surgery) 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, the patient experienced KNEE ARTHROPLASTY (knee replacement surgery). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, KNEE ARTHROPLASTY (knee replacement surgery) outcome was unknown.            Patient had taken second Moderna COVID-19 vaccine 2 days ago and had a knee replacement surgery and went to visit doctor and received a cortisone shot on knee. No concomitant drug was reported.