chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Swelling
Clinical narrative: Swollen right shoulder and right side of neck  after first vaccine; Sore right shoulder and right side of neck  after first vaccine; Sore right shoulder and right side of neck  after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen right shoulder and right side of neck  after first vaccine), NECK PAIN (Sore right shoulder and right side of neck  after first vaccine) and ARTHRALGIA (Sore right shoulder and right side of neck  after first vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced SWELLING (Swollen right shoulder and right side of neck  after first vaccine), NECK PAIN (Sore right shoulder and right side of neck  after first vaccine) and ARTHRALGIA (Sore right shoulder and right side of neck  after first vaccine). On 13-Jul-2021, SWELLING (Swollen right shoulder and right side of neck  after first vaccine), NECK PAIN (Sore right shoulder and right side of neck  after first vaccine) and ARTHRALGIA (Sore right shoulder and right side of neck  after first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient visited her doctor and blood works were done. The doctor told her that what she had was not an allergic reaction, and recommended to receive the second vaccine.  No concomitant medication information provided No treatment medication information provided   This case was linked to MOD-2021-396388 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Erection increased, Semen analysis, Sperm concentration, Therapeutic response unexpected
Clinical narrative: Erection wise it is more often than usual; Erection increased, more than it used to do/Caller states it is not a bad side effect.; Caller stated that instead of getting a booster dose he got a full dose, he stated that the booster is; This spontaneous case was reported by a consumer and describes the occurrence of ERECTION INCREASED (Erection wise it is more often than usual), THERAPEUTIC RESPONSE UNEXPECTED (Erection increased, more than it used to do/Caller states it is not a bad side effect.) and ACCIDENTAL OVERDOSE (Caller stated that instead of getting a booster dose he got a full dose, he stated that the booster is) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Oligospermia in 2017.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Caller stated that instead of getting a booster dose he got a full dose, he stated that the booster is). On an unknown date, the patient experienced ERECTION INCREASED (Erection wise it is more often than usual) and THERAPEUTIC RESPONSE UNEXPECTED (Erection increased, more than it used to do/Caller states it is not a bad side effect.). On 17-Aug-2021, ACCIDENTAL OVERDOSE (Caller stated that instead of getting a booster dose he got a full dose, he stated that the booster is) had resolved. At the time of the report, ERECTION INCREASED (Erection wise it is more often than usual) and THERAPEUTIC RESPONSE UNEXPECTED (Erection increased, more than it used to do/Caller states it is not a bad side effect.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2017, Sperm concentration: low (Low) Low. On an unknown date, Semen analysis: high (High) High semen volume. On an unknown date, Sperm concentration: sky high (High) Sky high.         Symptoms: It was reported that the patient had a medical condition with low sperm count since 2017, and he would not be able to conceive a baby, he stated that it was due to bad eating and drinking habits, after third dose of vaccination he experienced high volume in his sperm count as well as semen volume than any other average men at his age, he did nothing on his diet, he was not sure if vaccine had anything to do with this, he stated it was not a bad side effect. He reported that he received a full dose of booster shot instead of half dose.  No concomitant medications were reported  No treatment medications were reported
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ligament tear and Gout. Concomitant products included MELOXICAM for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant medication also include steroid shot and Meloxicam which are used for his knee No treatment medications were reported.  Patient reported that he is waiting on an MRI for his knee, which has a torn ligament, has gout, and is bone on bone. He received a steroid shot for the knee in the past but that only worked for about 24 hours.   This case was linked to MOD-2021-396001 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Developed a hardness the size of half a dollar, it is red and sore; Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore; Pain, tenderness and swelling in the arm of the injection, the right one; Developed a hardness the size of half a dollar, it is red and sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE PAIN (Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE SWELLING (Pain, tenderness and swelling in the arm of the injection, the right one) and VACCINATION SITE ERYTHEMA (Developed a hardness the size of half a dollar, it is red and sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Patient had a mastectomy in the left side in the past.). Concomitant products included LEVOTHYROXINE, LISINOPRIL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and VITAMINS NOS for an unknown indication.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced VACCINATION SITE INDURATION (Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE PAIN (Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE SWELLING (Pain, tenderness and swelling in the arm of the injection, the right one) and VACCINATION SITE ERYTHEMA (Developed a hardness the size of half a dollar, it is red and sore). At the time of the report, VACCINATION SITE INDURATION (Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE PAIN (Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE SWELLING (Pain, tenderness and swelling in the arm of the injection, the right one) and VACCINATION SITE ERYTHEMA (Developed a hardness the size of half a dollar, it is red and sore) outcome was unknown.            No treatment medication were reported.   This case was linked to MOD-2021-396109, MOD-2021-396130 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: Started seeing black spots like she was going to pass out; Dizzy/light headed; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Started seeing black spots like she was going to pass out) and DIZZINESS (Dizzy/light headed) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PRESYNCOPE (Started seeing black spots like she was going to pass out) and DIZZINESS (Dizzy/light headed). On 30-Apr-2021, PRESYNCOPE (Started seeing black spots like she was going to pass out) and DIZZINESS (Dizzy/light headed) had resolved.            After the second dose the patient was sitting for a few minutes at the site, a minute or 2 after getting the shot she put her head down to look at her phone and soon she got dizzy and light headed and started seeing black spots like she was going to pass out. They gave her water and a few minutes later she felt better. Her HCP told her it could be a side effect or an allergic reaction. No concomitant medications were mentioned. Treatment mentioned water.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Computerised tomogram, Peripheral swelling, Vaccination site swelling
Clinical narrative: Axillary lump; large swelling on the opposite arm; large swelling underneath the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Axillary lump), PERIPHERAL SWELLING (large swelling on the opposite arm) and VACCINATION SITE SWELLING (large swelling underneath the site of injection) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (large swelling underneath the site of injection). On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (large swelling on the opposite arm). On 22-Apr-2021, the patient experienced AXILLARY MASS (Axillary lump). At the time of the report, AXILLARY MASS (Axillary lump) had not resolved and PERIPHERAL SWELLING (large swelling on the opposite arm) and VACCINATION SITE SWELLING (large swelling underneath the site of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Computerised tomogram: swollen lymph nodes (abnormal) swollen lymph nodes.         No concomitant and treatment drugs were reported.  It was reported that he had a CT Scan early this month in Nov which revealed swollen lymph nodes on the same area but he mentioned that this was unrelated as he has other medical conditions. It was reported that a very large soft fatty tissue bulge developed under the arm and patient got his shot in one day after the shot.  A similar bulge developed under his other arm the next day. It was stated that they  were originally double the current but shrank and have remained stable for about 6 months now. They don't seem to be going away. His doctor tells him this was not related to the lymph nodes, but did not have any answer as to what may be the cause.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received and new events were added.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasal congestion, Rash, Rash pruritic, Rhinitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing non stop), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (Congested nose), RHINITIS (Feels like rhinitis) and RASH PRURITIC (Itchy rash, like hives in their two forearms) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 014M20A and D20RPC8) 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 LEVOTHYROXINE, VITAMINS NOS, NUTRAFOL and MELATONIN for an unknown indication.On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SNEEZING (Sneezing non stop), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (Congested nose), RHINITIS (Feels like rhinitis), RASH PRURITIC (Itchy rash, like hives in their two forearms), URTICARIA (Like hives in their two forearms) and RASH (Sometimes the rash appears on their face). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) on 24-Nov-2021 for Sneezing, at a dose of 1 dosage form. At the time of the report, SNEEZING (Sneezing non stop), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (Congested nose), RHINITIS (Feels like rhinitis), RASH PRURITIC (Itchy rash, like hives in their two forearms), URTICARIA (Like hives in their two forearms) and RASH (Sometimes the rash appears on their face) outcome was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing non stop), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (Congested nose), RHINITIS (Feels like rhinitis) and RASH PRURITIC (Itchy rash, like hives in their two forearms) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 014M20A and D20RPC8) 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 LEVOTHYROXINE, VITAMINS NOS, NUTRAFOL and MELATONIN for an unknown indication.On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SNEEZING (Sneezing non stop), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (Congested nose), RHINITIS (Feels like rhinitis), RASH PRURITIC (Itchy rash, like hives in their two forearms), URTICARIA (Like hives in their two forearms) and RASH (Sometimes the rash appears on their face). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) on 24-Nov-2021 for Sneezing, at a dose of 1 dosage form. At the time of the report, SNEEZING (Sneezing non stop), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (Congested nose), RHINITIS (Feels like rhinitis), RASH PRURITIC (Itchy rash, like hives in their two forearms), URTICARIA (Like hives in their two forearms) and RASH (Sometimes the rash appears on their face) outcome was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Swelling
Clinical narrative: she got a golf-ball, ping-pong ball underneath her arm. It's swelling.; didn't feel great; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (she got a golf-ball, ping-pong ball underneath her arm. It's swelling.) and FEELING ABNORMAL (didn't feel great) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced FEELING ABNORMAL (didn't feel great). On 24-Nov-2021, the patient experienced SWELLING (she got a golf-ball, ping-pong ball underneath her arm. It's swelling.). At the time of the report, SWELLING (she got a golf-ball, ping-pong ball underneath her arm. It's swelling.) had not resolved and FEELING ABNORMAL (didn't feel great) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (armpit is swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 23-Nov-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 LYMPHADENOPATHY (armpit is swollen). At the time of the report, LYMPHADENOPATHY (armpit is swollen) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported.No Treatment information was reported. Patient had the booster on Tuesday and is  immunocompromised so patient had the full dose not the booster.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: general arm pain when moving the limbs; itchy sensation; swelling at injection site; redness and tenderness at injection site; swollen lymph nodes under the arm pit area; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (general arm pain when moving the limbs), PRURITUS (itchy sensation), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (redness and tenderness at injection site) and LYMPHADENOPATHY (swollen lymph nodes under the arm pit area) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information as reported by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 23-Nov-2021 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN IN EXTREMITY (general arm pain when moving the limbs), PRURITUS (itchy sensation), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (redness and tenderness at injection site) and LYMPHADENOPATHY (swollen lymph nodes under the arm pit area). At the time of the report, PAIN IN EXTREMITY (general arm pain when moving the limbs), PRURITUS (itchy sensation), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (redness and tenderness at injection site) and LYMPHADENOPATHY (swollen lymph nodes under the arm pit area) had not resolved.            Concomitant medication include for Birth control.  No Treatment information was reported.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash itches, uncomfortable; got a rash on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (rash itches, uncomfortable) and VACCINATION SITE RASH (got a rash on his arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Function kidney decreased and Blood pressure abnormal.   On 15-Nov-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. On 24-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (rash itches, uncomfortable) and VACCINATION SITE RASH (got a rash on his arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (rash itches, uncomfortable) and VACCINATION SITE RASH (got a rash on his arm) outcome was unknown.            Reporter reported that patient had low kidney function and she was concerned taking Benadryl. Furthermore she mentioned that patient was on lot of medication and they were blood pressure related, but she did not specify which ones.  Reporter states that doctor did not think the rash was from the vaccine.   This case was linked to MOD-2021-397536 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash itches, uncomfortable; got a rash on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (rash itches, uncomfortable) and VACCINATION SITE RASH (got a rash on his arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Function kidney decreased and Blood pressure abnormal.   On 15-Nov-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. On 24-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (rash itches, uncomfortable) and VACCINATION SITE RASH (got a rash on his arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (rash itches, uncomfortable) and VACCINATION SITE RASH (got a rash on his arm) outcome was unknown.            Reporter reported that patient had low kidney function and she was concerned taking Benadryl. Furthermore she mentioned that patient was on lot of medication and they were blood pressure related, but she did not specify which ones.  Reporter states that doctor did not think the rash was from the vaccine.   This case was linked to MOD-2021-397536 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash also happened with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash also happened with the first 2 doses) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney function abnormal and Blood pressure abnormal.   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 RASH (rash also happened with the first 2 doses). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash also happened with the first 2 doses) outcome was unknown.            Concomitant medications include for management of Blood pressure.   This case was linked to MOD-2021-397530, MOD-2021-397537 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash also happened with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash also happened with the first 2 doses) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney function abnormal and Blood pressure abnormal.   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 RASH (rash also happened with the first 2 doses). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash also happened with the first 2 doses) outcome was unknown.            Concomitant medications include for management of Blood pressure.   This case was linked to MOD-2021-397530, MOD-2021-397537 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Lymphadenopathy, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted), DIZZINESS (felt faint), PERIPHERAL SWELLING (arm starting to swell up), RASH ERYTHEMATOUS (arm has red patches) and PYREXIA (fever of 102) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced PYREXIA (fever of 102) and HEADACHE (really bad headaches). On an unknown date, the patient experienced SYNCOPE (fainted), DIZZINESS (felt faint), PERIPHERAL SWELLING (arm starting to swell up), RASH ERYTHEMATOUS (arm has red patches) and LYMPHADENOPATHY (glands under arms swollen up). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SYNCOPE (fainted), DIZZINESS (felt faint), PERIPHERAL SWELLING (arm starting to swell up), RASH ERYTHEMATOUS (arm has red patches), PYREXIA (fever of 102), HEADACHE (really bad headaches) and LYMPHADENOPATHY (glands under arms swollen up) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, Body temperature: 102 (High) 102. Concomitant medications were not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Syncope
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted), DIZZINESS (felt faint), PERIPHERAL SWELLING (arm starting to swell up), RASH ERYTHEMATOUS (arm has red patches) and PYREXIA (fever of 102) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced PYREXIA (fever of 102) and HEADACHE (really bad headaches). On an unknown date, the patient experienced SYNCOPE (fainted), DIZZINESS (felt faint), PERIPHERAL SWELLING (arm starting to swell up), RASH ERYTHEMATOUS (arm has red patches) and LYMPHADENOPATHY (glands under arms swollen up). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SYNCOPE (fainted), DIZZINESS (felt faint), PERIPHERAL SWELLING (arm starting to swell up), RASH ERYTHEMATOUS (arm has red patches), PYREXIA (fever of 102), HEADACHE (really bad headaches) and LYMPHADENOPATHY (glands under arms swollen up) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, Body temperature: 102 (High) 102. Concomitant medications were not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: his skin all over feels like it's burning; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (his skin all over feels like it's burning) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-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 SKIN BURNING SENSATION (his skin all over feels like it's burning). At the time of the report, SKIN BURNING SENSATION (his skin all over feels like it's burning) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  Patient got the Johnson and Johnson COVID19 Vaccine in March.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site erythema, Vaccination site paraesthesia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), VACCINATION SITE WARMTH (tingling from the vaccine injection site to the tips of fingers which is hot to touch), VACCINATION SITE SWELLING (the arm that she got the booster shot of vaccine in is still swollen) and VACCINATION SITE ERYTHEMA (vaccination site is red and a huge redness all around the area) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 002B21A and 016C21A) for COVID-19 vaccination.  No Medical History information was reported.On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch) and VACCINATION SITE WARMTH (tingling from the vaccine injection site to the tips of fingers which is hot to touch). On 25-Nov-2021, the patient experienced VACCINATION SITE SWELLING (the arm that she got the booster shot of vaccine in is still swollen) and VACCINATION SITE ERYTHEMA (vaccination site is red and a huge redness all around the area). At the time of the report, VACCINATION SITE PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), VACCINATION SITE WARMTH (tingling from the vaccine injection site to the tips of fingers which is hot to touch), VACCINATION SITE SWELLING (the arm that she got the booster shot of vaccine in is still swollen) and VACCINATION SITE ERYTHEMA (vaccination site is red and a huge redness all around the area) had not resolved. No concomitant medications were reported.No Treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Dizziness, Illness, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), ILLNESS (Major sick, just like covid), VACCINATION SITE MASS (Lump on left arm), CHILLS (Chills) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included OMEPRAZOLE for an unknown indication. On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headedness), ILLNESS (Major sick, just like covid), VACCINATION SITE MASS (Lump on left arm), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Red circle on left arm). At the time of the report, DIZZINESS (Light headedness), ILLNESS (Major sick, just like covid), VACCINATION SITE MASS (Lump on left arm), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Red circle on left arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Antibody test: high (High) High. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Two weeks prior to vaccination, patient had COVID infection and had recovered from COVID. Concomitant included thyroid medication. No treatment medication was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site mass
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), ILLNESS (Major sick, just like covid), VACCINATION SITE MASS (Lump on left arm), CHILLS (Chills) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included OMEPRAZOLE for an unknown indication. On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headedness), ILLNESS (Major sick, just like covid), VACCINATION SITE MASS (Lump on left arm), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Red circle on left arm). At the time of the report, DIZZINESS (Light headedness), ILLNESS (Major sick, just like covid), VACCINATION SITE MASS (Lump on left arm), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Red circle on left arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Antibody test: high (High) High. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Two weeks prior to vaccination, patient had COVID infection and had recovered from COVID. Concomitant included thyroid medication. No treatment medication was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feels dizzy, like she has vertigo), VERTIGO (felt llike she had vertigo), VACCINATION SITE WARMTH (red and hot at injection site), RASH (rash all over her) and VACCINATION SITE RASH (rash all over arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (feels dizzy, like she has vertigo), VERTIGO (felt llike she had vertigo), VACCINATION SITE WARMTH (red and hot at injection site), RASH (rash all over her), VACCINATION SITE RASH (rash all over arm), VACCINATION SITE ERYTHEMA (red and hot at injection site) and VACCINATION SITE SWELLING (injection site swollen up like a golf ball). At the time of the report, DIZZINESS (feels dizzy, like she has vertigo), VERTIGO (felt llike she had vertigo), VACCINATION SITE WARMTH (red and hot at injection site), RASH (rash all over her), VACCINATION SITE RASH (rash all over arm), VACCINATION SITE ERYTHEMA (red and hot at injection site) and VACCINATION SITE SWELLING (injection site swollen up like a golf ball) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient reports she is on no concomitant medication, but sometimes, she takes a water pill. No treatment medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feels dizzy, like she has vertigo), VERTIGO (felt llike she had vertigo), VACCINATION SITE WARMTH (red and hot at injection site), RASH (rash all over her) and VACCINATION SITE RASH (rash all over arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (feels dizzy, like she has vertigo), VERTIGO (felt llike she had vertigo), VACCINATION SITE WARMTH (red and hot at injection site), RASH (rash all over her), VACCINATION SITE RASH (rash all over arm), VACCINATION SITE ERYTHEMA (red and hot at injection site) and VACCINATION SITE SWELLING (injection site swollen up like a golf ball). At the time of the report, DIZZINESS (feels dizzy, like she has vertigo), VERTIGO (felt llike she had vertigo), VACCINATION SITE WARMTH (red and hot at injection site), RASH (rash all over her), VACCINATION SITE RASH (rash all over arm), VACCINATION SITE ERYTHEMA (red and hot at injection site) and VACCINATION SITE SWELLING (injection site swollen up like a golf ball) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient reports she is on no concomitant medication, but sometimes, she takes a water pill. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse effect; 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 VACCINATION COMPLICATION (adverse effect) 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 VACCINATION COMPLICATION (adverse effect). At the time of the report, VACCINATION COMPLICATION (adverse effect) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: symptoms with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptoms with the first 2 doses) in a 53-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 VACCINATION COMPLICATION (symptoms with the first 2 doses). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (symptoms with the first 2 doses) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-398502, MOD-2021-398464 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after second dose). At the time of the report, VACCINATION COMPLICATION (side effects after second dose) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.    This case was linked to MOD-2021-398710 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown. 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 relevant concomitant medications were reported.Treatment information was not reported.This case was linked to MOD-2021-398626 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects/it 5,8 or 12 hours after injection that I may have side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects/it 5,8 or 12 hours after injection that I may have 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 VACCINATION COMPLICATION (side effects/it 5,8 or 12 hours after injection that I may have side effects). At the time of the report, VACCINATION COMPLICATION (side effects/it 5,8 or 12 hours after injection that I may have side effects) 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.   No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2021-398608 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects/it 5,8 or 12 hours after injection that I may have side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects/it 5,8 or 12 hours after injection that I may have 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects/it 5,8 or 12 hours after injection that I may have side effects). At the time of the report, VACCINATION COMPLICATION (side effects/it 5,8 or 12 hours after injection that I may have side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-398600 (Patient Link).