chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Somnolence, Trigger finger
Clinical narrative: little achy; slept all day; Anxious; trigger finder which was better was all bent when I woke up; Tired; Headache; very depressed; very weepy/crying; really sad feeling; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (very depressed), CRYING (very weepy/crying), PAIN (little achy), SOMNOLENCE (slept all day) and ANXIETY (Anxious) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027821A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Spice allergy (chili) and Thyroid disorder. Concomitant products included THYROID (ARMOUR THYROID) from 01-Jan-2000 to an unknown date for Thyroid disorder NOS.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced DEPRESSED MOOD (very depressed), CRYING (very weepy/crying) and MALAISE (really sad feeling). On an unknown date, the patient experienced PAIN (little achy), SOMNOLENCE (slept all day), ANXIETY (Anxious), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), FATIGUE (Tired) and HEADACHE (Headache). The patient was treated with DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for Adverse event, at a dose of 50 milligram once a day; LORAZEPAM for Adverse event, at a dose of .5 milligram twice a day; VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Adverse event, at an unspecified dose and frequency and DESVENLAFAXINE at a dose of 50 mg. At the time of the report, DEPRESSED MOOD (very depressed), CRYING (very weepy/crying) and ANXIETY (Anxious) had not resolved, PAIN (little achy), SOMNOLENCE (slept all day), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), FATIGUE (Tired) and HEADACHE (Headache) had resolved and MALAISE (really sad feeling) was resolving.            She went to neurologist and had EEG  and was seeking for therapy and transcranial magnetic stimulation and breathwork  to try to under control.   This case was linked to MOD-2021-375416, MOD-2021-380319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received added patient's demographics, concomitant and treatment medications were added and new events were added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 62-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        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 information was not provided.  Company Comment -This case concerns a 62-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after an unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after an unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: some people report trouble across their back; 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 MUSCULOSKELETAL DISCOMFORT (some people report trouble across their back) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (some people report trouble across their back). At the time of the report, MUSCULOSKELETAL DISCOMFORT (some people report trouble across their back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Reporter stated that the nurse told her daughter that some people experienced same trouble across their back(muscle pain) after getting the vaccine. Reporter was unable to provide more information regarding these patients.   This case was linked to MOD-2021-377083 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up information received contains non significant information. Reporter statement was added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Feeling abnormal, Inappropriate schedule of product administration, Lip swelling, Oral pain
Clinical narrative: Swollen lips; Swollen face; Can hardly talk; Mouth was hurting/still hurts a lot; Feeling bad last night; Previously received the J and J vaccine and received Moderna Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Mouth was hurting/still hurts a lot), APHASIA (Can hardly talk), LIP SWELLING (Swollen lips), SWELLING FACE (Swollen face) and FEELING ABNORMAL (Feeling bad last night) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE JANSSEN.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Previously received the J and J vaccine and received Moderna Booster dose). On 04-Nov-2021, the patient experienced ORAL PAIN (Mouth was hurting/still hurts a lot) and FEELING ABNORMAL (Feeling bad last night). On 05-Nov-2021, the patient experienced APHASIA (Can hardly talk). On an unknown date, the patient experienced LIP SWELLING (Swollen lips) and SWELLING FACE (Swollen face). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1/2 benadryl. On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Previously received the J and J vaccine and received Moderna Booster dose) had resolved. At the time of the report, ORAL PAIN (Mouth was hurting/still hurts a lot), APHASIA (Can hardly talk), LIP SWELLING (Swollen lips) and SWELLING FACE (Swollen face) had not resolved and FEELING ABNORMAL (Feeling bad last night) outcome was unknown.            No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 10-NOV-2021, contain new events (swollen lips, swollen face) and contact details of reporter are added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swollen lips; Swollen face; Can hardly talk; Mouth was hurting/still hurts a lot; Feeling bad last night; Previously received the J and J vaccine and received Moderna Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Mouth was hurting/still hurts a lot), APHASIA (Can hardly talk), LIP SWELLING (Swollen lips), SWELLING FACE (Swollen face) and FEELING ABNORMAL (Feeling bad last night) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE JANSSEN.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Previously received the J and J vaccine and received Moderna Booster dose). On 04-Nov-2021, the patient experienced ORAL PAIN (Mouth was hurting/still hurts a lot) and FEELING ABNORMAL (Feeling bad last night). On 05-Nov-2021, the patient experienced APHASIA (Can hardly talk). On an unknown date, the patient experienced LIP SWELLING (Swollen lips) and SWELLING FACE (Swollen face). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1/2 benadryl. On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Previously received the J and J vaccine and received Moderna Booster dose) had resolved. At the time of the report, ORAL PAIN (Mouth was hurting/still hurts a lot), APHASIA (Can hardly talk), LIP SWELLING (Swollen lips) and SWELLING FACE (Swollen face) had not resolved and FEELING ABNORMAL (Feeling bad last night) outcome was unknown.            No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 10-NOV-2021, contain new events (swollen lips, swollen face) and contact details of reporter are added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Smallpox
Clinical narrative: He had a horrible small pox looking rash on his entire back and other parts of his body; This spontaneous case was reported by a consumer and describes the occurrence of SMALLPOX (He had a horrible small pox looking rash on his entire back and other parts of his body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SMALLPOX (He had a horrible small pox looking rash on his entire back and other parts of his body). At the time of the report, SMALLPOX (He had a horrible small pox looking rash on his entire back and other parts of his body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Nov-2021, Body temperature: 100 (High) 100. On 08-Nov-2021, Body temperature: 103 (High) 103.         No Concomitant medications were reported. No Treatment information was reported.  Seven days after Moderna booster dose, Patient had experienced disgusting rash pustules all over his body with tremendous itching. It started with a rash, but now it looks like smallpox. It was all over his back and front. It's itching, and he was up all night.He had fever of 100 yesterday 07Nov2021. Today 08Nov2021 it was 103.      Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up includes: Patient demographics (age, DOB),  Lab data were and event details were added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Gait disturbance
Clinical narrative: Had  trouble walking  for a day, it hit like a tone of brick.; Extreme back pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Had  trouble walking  for a day, it hit like a tone of brick.), BACK PAIN (Extreme back pain) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003a21a and 031l20a) for COVID-19 vaccination.     Previously administered products included for Vaccination: Flulaval Quad on 07-Oct-2021 and Shingrix on 07-Oct-2021. Concurrent medical conditions included Blood pressure high, Reflux gastritis, Penicillin allergy and Allergy to antibiotic (Septra). Concomitant products included LISINOPRIL for Blood pressure high, PANTOPRAZOLE SODIUM for Reflux gastritis.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced GAIT DISTURBANCE (Had  trouble walking  for a day, it hit like a tone of brick.) and BACK PAIN (Extreme back pain). On an unknown date, the patient experienced CHILLS (Chills). On 09-Mar-2021, GAIT DISTURBANCE (Had  trouble walking  for a day, it hit like a tone of brick.) and BACK PAIN (Extreme back pain) had resolved. At the time of the report, CHILLS (Chills) had resolved.            After the 2nd Moderna shot, the symptoms were there for about 2 days and then disappeared. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-377083 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Added patient demographics, concomitant drugs, medical history, historical vaccine, updated vaccine details and added two events - Back pain and Chills.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had covid after the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had Covid after the second dose of the Moderna vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced COVID-19 (had covid after the second dose of the Moderna vaccine). At the time of the report, COVID-19 (had covid after the second dose of the Moderna vaccine) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient was suffering of deafness after having COVID.  Company Comment: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected event COVID-19 (AESI) The event occurred on and unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report. The event deafness was deleted because has appeared after COVID-19 infection and no after vaccination. The case is downgrade to non-serious due there is no information in the SD supporting that is medically significant.   This case was linked to MOD-2021-377147, MOD-2021-377148 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected event COVID-19 (AESI) The event occurred on and unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report. The event deafness was deleted because has appeared after COVID-19 infection and no after vaccination. The case is downgrade to non-serious due there is no information in the SD supporting that is medically significant.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: tenderness in the arm were he was injected; Received a vaccine that was 8 days expired; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (tenderness in the arm were he was injected) and EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was 8 days expired) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was 8 days expired). On an unknown date, the patient experienced VACCINATION SITE PAIN (tenderness in the arm were he was injected). On 06-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was 8 days expired) had resolved. At the time of the report, VACCINATION SITE PAIN (tenderness in the arm were he was injected) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. Vial was initially stored in the refrigerator: 14Sep2021 at 1.2°C. Reporter had said the vials actually expired on 29 Oct 2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving a dose from an expired vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving a dose from an expired vial) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026c21a, 032L20A and 025L20A) 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 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving a dose from an expired vial). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (receiving a dose from an expired vial) had resolved.            No concomitant medication was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-376983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received contains Non significant information. On 08-Nov-2021: Follow-up received contain No New information.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: to have problems with their vision in one eye; they have floaters in their eye, they are getting better, but they never have them  before and all of the sudden they have a lot  of them / The floaters are not just "black dots", but rather are "weblike" or "stringy."; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (to have problems with their vision in one eye) and VITREOUS FLOATERS (they have floaters in their eye, they are getting better, but they never have them  before and all of the sudden they have a lot  of them / The floaters are not just "black dots", but rather are "weblike" or "stringy.") in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033f21a, 024M20A and 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, AMLODIPINE, AREDS 2 PLUS MULTI VITAMIN and ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced VISUAL IMPAIRMENT (to have problems with their vision in one eye) and VITREOUS FLOATERS (they have floaters in their eye, they are getting better, but they never have them  before and all of the sudden they have a lot  of them / The floaters are not just "black dots", but rather are "weblike" or "stringy."). At the time of the report, VISUAL IMPAIRMENT (to have problems with their vision in one eye) and VITREOUS FLOATERS (they have floaters in their eye, they are getting better, but they never have them  before and all of the sudden they have a lot  of them / The floaters are not just "black dots", but rather are "weblike" or "stringy.") was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient Reported that  The floaters are not just "black dots", but rather are "weblike" or "stringy." and He has  an appointment with a Retina Specialist set for 11-19-2012.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: significant follow up appended : patient Information, 1st Dose Lot Number and Concomitant Medication.
Sex: U
Vaccine: COVID19
Symptoms: Death, Pyrexia
Clinical narrative: Passed away after getting a 3rd vaccine shot; Fever; 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 DEATH (Passed away after getting a 3rd vaccine shot) in a  patient of an unknown age and gender 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 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 DEATH (Passed away after getting a 3rd vaccine shot) (seriousness criteria death and medically significant) and PYREXIA (Fever). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected event of Death. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring an unknown date. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected event of Death. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring an unknown date. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on trunk , back and Neck 2 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on trunk , back and Neck 2 days after first shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on trunk , back and Neck 2 days after first shot). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on trunk , back and Neck 2 days after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  It was reported that it was like the first dose of Moderna COVID-19 vaccine on a Wednesday, and had a Rash on Friday on trunk , back and Neck. She took Benadryl and the rash disappeared within 24 hours.   This case was linked to MOD-2021-378159 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Somnolence, Vaccination site discomfort, Vaccination site erythema
Clinical narrative: Sleepiness; Arm discomfort/ Heaviness in arm; Pain in the arm/ Tenderness in the arm; Swelling in the arm; Redness in the arm; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness), VACCINATION SITE DISCOMFORT (Arm discomfort/ Heaviness in arm), VACCINATION SITE PAIN (Pain in the arm/ Tenderness in the arm), VACCINATION SITE SWELLING (Swelling in the arm) and VACCINATION SITE ERYTHEMA (Redness in the arm) in a 67-year-old female patient 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 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 SOMNOLENCE (Sleepiness), VACCINATION SITE DISCOMFORT (Arm discomfort/ Heaviness in arm), VACCINATION SITE PAIN (Pain in the arm/ Tenderness in the arm), VACCINATION SITE SWELLING (Swelling in the arm), VACCINATION SITE ERYTHEMA (Redness in the arm), FATIGUE (Tiredness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (PANADOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepiness), VACCINATION SITE DISCOMFORT (Arm discomfort/ Heaviness in arm), VACCINATION SITE PAIN (Pain in the arm/ Tenderness in the arm), VACCINATION SITE SWELLING (Swelling in the arm), VACCINATION SITE ERYTHEMA (Redness in the arm), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.   This case was linked to MOD-2021-378132 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Sleepiness; Arm discomfort/ Heaviness in arm; Pain in the arm/ Tenderness in the arm; Swelling in the arm; Redness in the arm; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness), VACCINATION SITE DISCOMFORT (Arm discomfort/ Heaviness in arm), VACCINATION SITE PAIN (Pain in the arm/ Tenderness in the arm), VACCINATION SITE SWELLING (Swelling in the arm) and VACCINATION SITE ERYTHEMA (Redness in the arm) in a 67-year-old female patient 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 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 SOMNOLENCE (Sleepiness), VACCINATION SITE DISCOMFORT (Arm discomfort/ Heaviness in arm), VACCINATION SITE PAIN (Pain in the arm/ Tenderness in the arm), VACCINATION SITE SWELLING (Swelling in the arm), VACCINATION SITE ERYTHEMA (Redness in the arm), FATIGUE (Tiredness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (PANADOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepiness), VACCINATION SITE DISCOMFORT (Arm discomfort/ Heaviness in arm), VACCINATION SITE PAIN (Pain in the arm/ Tenderness in the arm), VACCINATION SITE SWELLING (Swelling in the arm), VACCINATION SITE ERYTHEMA (Redness in the arm), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.   This case was linked to MOD-2021-378132 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Fatigue, Headache, Limb discomfort, Pruritus
Clinical narrative: arm discomfort; sleepiness; spots on face/spots on breast area/spots on face arms (ongoing); itching; heaviness in arm; allergic reaction after doses 1 and 2, three days after the doses were administered; tenderness in arm; redness in the arm; pain in the arm; tiredness; swelling in the arm/ swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling) and VACCINATION SITE PAIN (tenderness in arm) 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.   In February 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 VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling), VACCINATION SITE PAIN (tenderness in arm), LIMB DISCOMFORT (heaviness in arm), VACCINATION SITE ERYTHEMA (redness in the arm), PRURITUS (itching), RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling), VACCINATION SITE PAIN (tenderness in arm), LIMB DISCOMFORT (heaviness in arm), VACCINATION SITE ERYTHEMA (redness in the arm), PRURITUS (itching), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown and RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant use were reported.  No treatment were reported.   This case was linked to MOD-2021-378138 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received on 08-NOV-2021 contains new events added, dose administration date added.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Somnolence, Vaccination site discomfort, Vaccination site erythema, Vaccination site pain
Clinical narrative: arm discomfort; sleepiness; spots on face/spots on breast area/spots on face arms (ongoing); itching; heaviness in arm; allergic reaction after doses 1 and 2, three days after the doses were administered; tenderness in arm; redness in the arm; pain in the arm; tiredness; swelling in the arm/ swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling) and VACCINATION SITE PAIN (tenderness in arm) 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.   In February 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 VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling), VACCINATION SITE PAIN (tenderness in arm), LIMB DISCOMFORT (heaviness in arm), VACCINATION SITE ERYTHEMA (redness in the arm), PRURITUS (itching), RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling), VACCINATION SITE PAIN (tenderness in arm), LIMB DISCOMFORT (heaviness in arm), VACCINATION SITE ERYTHEMA (redness in the arm), PRURITUS (itching), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown and RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant use were reported.  No treatment were reported.   This case was linked to MOD-2021-378138 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received on 08-NOV-2021 contains new events added, dose administration date added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: arm discomfort; sleepiness; spots on face/spots on breast area/spots on face arms (ongoing); itching; heaviness in arm; allergic reaction after doses 1 and 2, three days after the doses were administered; tenderness in arm; redness in the arm; pain in the arm; tiredness; swelling in the arm/ swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling) and VACCINATION SITE PAIN (tenderness in arm) 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.   In February 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 VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling), VACCINATION SITE PAIN (tenderness in arm), LIMB DISCOMFORT (heaviness in arm), VACCINATION SITE ERYTHEMA (redness in the arm), PRURITUS (itching), RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling), VACCINATION SITE PAIN (tenderness in arm), LIMB DISCOMFORT (heaviness in arm), VACCINATION SITE ERYTHEMA (redness in the arm), PRURITUS (itching), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown and RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant use were reported.  No treatment were reported.   This case was linked to MOD-2021-378138 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received on 08-NOV-2021 contains new events added, dose administration date added.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: has a cold; runny nose; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (has a cold), RHINORRHOEA (runny nose) and SNEEZING (sneezing) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Narcolepsy. Concomitant products included DOXAZOSIN for Blood pressure high, MODAFINIL for Narcolepsy, APIXABAN (ELIQUIS), ATORVASTATIN, SALBUTAMOL (ALBUTEROL HFA), CLOPIDOGREL BISULFATE (PLAVIX), DILTIAZEM, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), ALENDRONATE SODIUM and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced RHINORRHOEA (runny nose) and SNEEZING (sneezing). On an unknown date, the patient experienced NASOPHARYNGITIS (has a cold). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE SULFATE (CORICIDIN D COLD FLU AND SINUS) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (has a cold), RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Started feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Started feeling tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Started feeling tired). The patient was treated with VITAMINS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Started feeling tired) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   This case was linked to MOD-2021-378018, MOD-2021-378030 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, COVID-19, Confusional state, Headache, Impaired work ability
Clinical narrative: Covid positive after immunization; Confusion; Pain; Impaired his ability to work; Eyes becoming hard sensation; Headache/Pain in head; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after immunization), CONFUSIONAL STATE (Confusion), PAIN (Pain), IMPAIRED WORK ABILITY (Impaired his ability to work) and ABNORMAL SENSATION IN EYE (Eyes becoming hard sensation) in a 63-year-old male patient 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 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced COVID-19 (Covid positive after immunization), CONFUSIONAL STATE (Confusion), PAIN (Pain), IMPAIRED WORK ABILITY (Impaired his ability to work), ABNORMAL SENSATION IN EYE (Eyes becoming hard sensation) and HEADACHE (Headache/Pain in head). At the time of the report, COVID-19 (Covid positive after immunization), CONFUSIONAL STATE (Confusion), PAIN (Pain), IMPAIRED WORK ABILITY (Impaired his ability to work) and HEADACHE (Headache/Pain in head) outcome was unknown and ABNORMAL SENSATION IN EYE (Eyes becoming hard sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.  This case concerns a male patient of unknown age with no details relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately more than 15 days after the dose of mRNA- 1273 vaccine, precise number of doses and schedule of vaccination unknown. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of unknown age with no details relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately more than 15 days after the dose of mRNA- 1273 vaccine, precise number of doses and schedule of vaccination unknown. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Covid positive after immunization; Confusion; Pain; Impaired his ability to work; Eyes becoming hard sensation; Headache/Pain in head; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after immunization), CONFUSIONAL STATE (Confusion), PAIN (Pain), IMPAIRED WORK ABILITY (Impaired his ability to work) and ABNORMAL SENSATION IN EYE (Eyes becoming hard sensation) in a 63-year-old male patient 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 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced COVID-19 (Covid positive after immunization), CONFUSIONAL STATE (Confusion), PAIN (Pain), IMPAIRED WORK ABILITY (Impaired his ability to work), ABNORMAL SENSATION IN EYE (Eyes becoming hard sensation) and HEADACHE (Headache/Pain in head). At the time of the report, COVID-19 (Covid positive after immunization), CONFUSIONAL STATE (Confusion), PAIN (Pain), IMPAIRED WORK ABILITY (Impaired his ability to work) and HEADACHE (Headache/Pain in head) outcome was unknown and ABNORMAL SENSATION IN EYE (Eyes becoming hard sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.  This case concerns a male patient of unknown age with no details relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately more than 15 days after the dose of mRNA- 1273 vaccine, precise number of doses and schedule of vaccination unknown. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of unknown age with no details relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately more than 15 days after the dose of mRNA- 1273 vaccine, precise number of doses and schedule of vaccination unknown. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: was extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (was extremely exhausted) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (was extremely exhausted). At the time of the report, FATIGUE (was extremely exhausted) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.