chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter    Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid-19 after first dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced COVID-19 (tested positive for covid-19 after first dose). At the time of the report, COVID-19 (tested positive for covid-19 after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter Treatment information was not provided by reporter
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pharyngeal swelling, Urticaria
Clinical narrative: hives; trouble breathing; throat swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (throat swelling) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 URTICARIA (hives), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (throat swelling). At the time of the report, URTICARIA (hives), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (throat swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: periods of high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (periods of high blood pressure) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (periods of high blood pressure). At the time of the report, HYPERTENSION (periods of high blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Got scheduled second dose in 45 days which is outside the window period; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Got scheduled second dose in 45 days which is outside the window period) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Got scheduled second dose in 45 days which is outside the window period). At the time of the report, OFF LABEL USE (Got scheduled second dose in 45 days which is outside the window period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Her second dose scheduled on 04-SEP-2021 and couldn't take it due to health conditions.  No concomitant medications reported.  No treatment information was reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment for the events were not provided. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 3 days later she got COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (3 days later she got COVID) 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 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced COVID-19 (3 days later she got COVID) (seriousness criterion hospitalization). The patient was hospitalized on sometime in August 2021 due to COVID-19. At the time of the report, COVID-19 (3 days later she got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment of the event included antiviral drugs.  3 days later the patient got covid. While the patient was in the hospital she was tested positive for covid and got antiviral on 11 AUG 2021 and she quarantined for 10 days. The patient is now due for her 2nd dose.  Company comment- Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: What Does it mean when you take the vaccine u get fever; What Does it mean when you take the vaccine u get chill; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (What Does it mean when you take the vaccine u get fever) and CHILLS (What Does it mean when you take the vaccine u get chill) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (What Does it mean when you take the vaccine u get fever) and CHILLS (What Does it mean when you take the vaccine u get chill). At the time of the report, PYREXIA (What Does it mean when you take the vaccine u get fever) and CHILLS (What Does it mean when you take the vaccine u get chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Side effects). At the time of the report, ADVERSE REACTION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: Feeling pretty bad; Have no energy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling pretty bad) and ASTHENIA (Have no energy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling pretty bad) and ASTHENIA (Have no energy). At the time of the report, FEELING ABNORMAL (Feeling pretty bad) and ASTHENIA (Have no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Leg amputation, Thrombosis
Clinical narrative: I had blood clots in my left leg; Ultimately resulted in a below the knee left leg amputation; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (I had blood clots in my left leg) and LEG AMPUTATION (Ultimately resulted in a below the knee left leg amputation) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (I had blood clots in my left leg) (seriousness criteria disability and medically significant) and LEG AMPUTATION (Ultimately resulted in a below the knee left leg amputation) (seriousness criterion disability). At the time of the report, THROMBOSIS (I had blood clots in my left leg) and LEG AMPUTATION (Ultimately resulted in a below the knee left leg amputation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: a little warm to the touch/warm and raised; a little sore/felt like the muscle was a little sore; itch/noticed it was huge/itchy; Huge rash; red/red mark from shoulder to arm/It is walking it's way down to her elbow; pretty big; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash) and VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078CZ1A and 078CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical History was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-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 SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash), VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) and VACCINATION SITE SWELLING (pretty big). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash), VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) and VACCINATION SITE SWELLING (pretty big) outcome was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: a little warm to the touch/warm and raised; a little sore/felt like the muscle was a little sore; itch/noticed it was huge/itchy; Huge rash; red/red mark from shoulder to arm/It is walking it's way down to her elbow; pretty big; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash) and VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078CZ1A and 078CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical History was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-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 SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash), VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) and VACCINATION SITE SWELLING (pretty big). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash), VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) and VACCINATION SITE SWELLING (pretty big) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Dizziness/ Lightheadedness; equilibrium; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/ Lightheadedness) and BALANCE DISORDER (equilibrium) 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 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 DIZZINESS (Dizziness/ Lightheadedness) and BALANCE DISORDER (equilibrium). At the time of the report, DIZZINESS (Dizziness/ Lightheadedness) and BALANCE DISORDER (equilibrium) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness on injection side; itching on injection side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on injection side) and VACCINATION SITE PRURITUS (itching on injection side) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION SITE ERYTHEMA (redness on injection side) and VACCINATION SITE PRURITUS (itching on injection side). At the time of the report, VACCINATION SITE ERYTHEMA (redness on injection side) and VACCINATION SITE PRURITUS (itching on injection side) outcome was unknown.            Reportedly, Patient was willing to know whether redness and itching on injection side  was normal.  Concomitant product use was not provided.  Treatment product information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: The day after I had the vaccine my eyes and face were very swollen; The day after I had the vaccine my eyes and face were very swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (The day after I had the vaccine my eyes and face were very swollen) and EYE SWELLING (The day after I had the vaccine my eyes and face were very swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 pneumonia in April 2021.    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 SWELLING FACE (The day after I had the vaccine my eyes and face were very swollen) and EYE SWELLING (The day after I had the vaccine my eyes and face were very swollen). At the time of the report, SWELLING FACE (The day after I had the vaccine my eyes and face were very swollen) and EYE SWELLING (The day after I had the vaccine my eyes and face were very swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infected after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infected after vaccination) 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 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced INFECTION (Infected after vaccination). At the time of the report, INFECTION (Infected after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: A lady died after getting their second Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (A lady died after getting their second Moderna shot) in a 6-decade-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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  No treatment details were provided.  Company Comment - Very limited information regarding this event has been provided at this time.  Further information is not expected as no consent for follow up was obtained.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information is not expected as no consent for follow up was obtained.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension
Clinical narrative: blood pressure is very low/82 over 35; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (blood pressure is very low/82 over 35) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced HYPOTENSION (blood pressure is very low/82 over 35). At the time of the report, HYPOTENSION (blood pressure is very low/82 over 35) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 82/35 (Low) Blood pressure is very low.         Concomitant product use was not provided.  Treatment product information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration, Thrombosis
Clinical narrative: Blood clot; swelling in his leg; discoloration on leg; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a male 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.    In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), PERIPHERAL SWELLING (swelling in his leg) and SKIN DISCOLOURATION (discoloration on leg). At the time of the report, THROMBOSIS (Blood clot), PERIPHERAL SWELLING (swelling in his leg) and SKIN DISCOLOURATION (discoloration on leg) outcome was unknown.            No Concomitants were reported. No treatments were reported.  Company comment: Very limited information was provided. However, based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be fully excluded. Therefore, causality is assessed as possibly related.; Sender's Comments: Very limited information was provided. However, based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be fully excluded. Therefore, causality is assessed as possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, SARS-CoV-2 antibody test
Clinical narrative: patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included Colonic lymphoma (Malt a type of colon Lymphoma Mucosa Associated Lymphoid tissue) and Chronic lymphocytic leukemia. Previously administered products included for COVID-19 immunisation: Pfizer vaccine (First vaccine EW0162, given in the left arm deltoid muscle) on 22-Apr-2021, Pfizer vaccine (second EW0170 and was given on 11MAY2021) on 11-May-2021. Concurrent medical conditions included Immunocompromised. Concomitant products included RAMIPRIL (ALTACE) and ACALABRUTINIB (CALQUENCE) for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error). On 12-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: less than 0.04 (Negative) SARS-COV-2Spike AB,Quant, S, results were less than .04U/ml per ml..         Concomitant medication also include Gayza infusion last given on 21MAR2021 Completed the series. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Lethargy
Clinical narrative: Feeling very hot body; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling very hot body) and LETHARGY (Lethargic) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feeling very hot body) and LETHARGY (Lethargic). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram. At the time of the report, FEELING HOT (Feeling very hot body) and LETHARGY (Lethargic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  It was reported that patient took two Tylenol of 500 milligram which helped.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Became very ill; Nausea; Running a fever; Pain in my joints/ pain in my elbow; Pain in my underarm; Lymph nodes are the size of a golf ball; Extreme swelling in my left arm; Huge big ball of skin coming out; extreme pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided.  Concomitant products included GABAPENTIN for an unknown indication.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced MALAISE (Became very ill), NAUSEA (Nausea) and PYREXIA (Running a fever). In August 2021, the patient experienced PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball). At the time of the report, MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), NAUSEA (Nausea), PYREXIA (Running a fever), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Skin lesion
Clinical narrative: Became very ill; Nausea; Running a fever; Pain in my joints/ pain in my elbow; Pain in my underarm; Lymph nodes are the size of a golf ball; Extreme swelling in my left arm; Huge big ball of skin coming out; extreme pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided.  Concomitant products included GABAPENTIN for an unknown indication.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced MALAISE (Became very ill), NAUSEA (Nausea) and PYREXIA (Running a fever). In August 2021, the patient experienced PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball). At the time of the report, MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), NAUSEA (Nausea), PYREXIA (Running a fever), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of nasopharyngitis (bad head cold) and nasal congestion in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nasopharyngitis (bad head cold) and nasal congestion. At the time of the report, nasopharyngitis (bad head cold) and nasal congestion outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant production use or treatment medications provided. Reporter did not allow further contact.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (The vaccine put her down for a couple days.) and INFLUENZA LIKE ILLNESS (Felt like she had the flu really bad) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced ASTHENIA (The vaccine put her down for a couple days.) and INFLUENZA LIKE ILLNESS (Felt like she had the flu really bad). At the time of the report, ASTHENIA (The vaccine put her down for a couple days.) and INFLUENZA LIKE ILLNESS (Felt like she had the flu really bad) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medication information provided. No relevant treatment medication information provided. Patient reported that she received her 2nd dose of Moderna vaccine on her left arm on 07-Sep-2021. LOT # 017E21A; This case was linked to MOD-2021-312953 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: feeling side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION COMPLICATION (feeling side effects). At the time of the report, VACCINATION COMPLICATION (feeling side effects) outcome was unknown.         Reportedly, Consent for follow up was accepted.  Concomitant product use was not provided.  Treatment product information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dysphagia, Fatigue, Feeling abnormal
Clinical narrative: Felt like the food was lodged in her lower throat- collar bone area, only occurs with red meat, she can still eat fish; Its difficult to explain, but ever since she has felt wired; Can not remember anything that happened that night; She got tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Felt like the food was lodged in her lower throat- collar bone area, only occurs with red meat, she can still eat fish), FEELING ABNORMAL (Its difficult to explain, but ever since she has felt wired), AMNESIA (Can not remember anything that happened that night) and FATIGUE (She got tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 011A21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included APOAEQUORIN (PREVAGEN [APOAEQUORIN]) and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication.   On 28-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021 at 7:00 PM, the patient experienced FEELING ABNORMAL (Its difficult to explain, but ever since she has felt wired), AMNESIA (Can not remember anything that happened that night) and FATIGUE (She got tired). On 31-Mar-2021, the patient experienced DYSPHAGIA (Felt like the food was lodged in her lower throat- collar bone area, only occurs with red meat, she can still eat fish). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Felt like the food was lodged in her lower throat- collar bone area, only occurs with red meat, she can still eat fish), FEELING ABNORMAL (Its difficult to explain, but ever since she has felt wired), AMNESIA (Can not remember anything that happened that night) and FATIGUE (She got tired) outcome was unknown.            She took Tylenol.   This case was linked to MOD-2021-312916.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gout, Myalgia, Rheumatoid arthritis
Clinical narrative: She is also diagnosed with rheumatoid arthritis; She started experiencing gout; She is complaining sever muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (She is also diagnosed with rheumatoid arthritis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, FUROSEMIDE, LORAZEPAM, LEVOTHYROXINE SODIUM (SYNTHROID), COLECALCIFEROL (VITAMIN D3), PROBENECID, ESOMEPRAZOLE, TIZANIDINE and COLCHICINE (COLCRYS) for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (She is also diagnosed with rheumatoid arthritis) (seriousness criterion medically significant), GOUT (She started experiencing gout) and MYALGIA (She is complaining sever muscle pain). At the time of the report, RHEUMATOID ARTHRITIS (She is also diagnosed with rheumatoid arthritis), GOUT (She started experiencing gout) and MYALGIA (She is complaining sever muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information include steroids.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-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 MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.   This case was linked to MOD-2021-313036, MOD-2021-313035 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Running fever since; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Running fever since) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Running fever since). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PYREXIA (Running fever since) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported by reporter    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had quite a bit of arm pain), MYALGIA (aches for about 24 hrs.) and FATIGUE (tireness) 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-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had quite a bit of arm pain), MYALGIA (aches for about 24 hrs.) and FATIGUE (tireness). At the time of the report, PAIN IN EXTREMITY (had quite a bit of arm pain), MYALGIA (aches for about 24 hrs.) and FATIGUE (tireness) had resolved. It was stated although it was not the official prescribed time for the vaccination we decided to set up the appointment anyway and we had no problem doing so and received the third shot. Mentioned as of today we were both fine and feel a bit more protected. Concomitant medication was not reported.Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Illness, Lymphadenopathy, Myalgia
Clinical narrative: Extremely sick; Heart racing; Very bad sore throat; Very bad cough; Lymph nodes are swollen; Very fatigued; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough) and LYMPHADENOPATHY (Lymph nodes are swollen) 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 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough), LYMPHADENOPATHY (Lymph nodes are swollen), FATIGUE (Very fatigued) and MYALGIA (Sore arm). At the time of the report, ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough), LYMPHADENOPATHY (Lymph nodes are swollen), FATIGUE (Very fatigued) and MYALGIA (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) NEGATIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Palpitations, SARS-CoV-2 test
Clinical narrative: Extremely sick; Heart racing; Very bad sore throat; Very bad cough; Lymph nodes are swollen; Very fatigued; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough) and LYMPHADENOPATHY (Lymph nodes are swollen) 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 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough), LYMPHADENOPATHY (Lymph nodes are swollen), FATIGUE (Very fatigued) and MYALGIA (Sore arm). At the time of the report, ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough), LYMPHADENOPATHY (Lymph nodes are swollen), FATIGUE (Very fatigued) and MYALGIA (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) NEGATIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever 101.2ºF) and myalgia (muscle pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 002F21A) for COVID-19 immunization. No medical history reported. On Aug 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 7, 2021, patient experienced pyrexia (fever 101.2ºF) and myalgia (muscle pain). At the time of the report, pyrexia (fever 101.2ºF) and myalgia (muscle pain) outcome unknown. Diagnostic results: On Sep 7, 2021: Body temperature 101.2°F (high). The patient's concomitant medications included multivitamins. No treatment medications provided.