chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) 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 (received dose from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported. Lot number- 011A21A
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lupus nephritis
Clinical narrative: Lupus nephritis flare; This literature-non-study case was reported in a literature article and describes the occurrence of LUPUS NEPHRITIS (Lupus nephritis flare) in a 30-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUPUS NEPHRITIS (Lupus nephritis flare) (seriousness criterion medically significant). At the time of the report, LUPUS NEPHRITIS (Lupus nephritis flare) 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.   Treatment for the event was not reported.  Concomitant medication was not reported.  Company Comment: This literature non-study case concerns a 30-year-old male patient with no details on relevant medical history, who experienced the unexpected serious event of Lupus nephritis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information is available at this moment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   Reporter did not allow further contact; Sender's Comments: This literature non-study case concerns a 30-year-old male patient with no details on relevant medical history, who experienced the unexpected serious event of Lupus nephritis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information is available at this moment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Muscle rigidity, Peripheral swelling
Clinical narrative: Patient's arm swelled; warm; kind of red.; firm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Patient's arm swelled), FEELING HOT (warm), ERYTHEMA (kind of red.) and MUSCLE RIGIDITY (firm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, AMLODIPINE, ASCORBIC ACID, ASPIRIN [ACETYLSALICYLIC ACID], BILBERRY [VACCINIUM MYRTILLUS], ENALAPRIL, GABAPENTIN, GINKGO BILOBA (GINGKO BILOBA), GLUCOSAMINE, HYDROCHLOROTHIAZIDE, SALMON OIL, METOPROLOL, SIMVASTATIN and LIPO FLAVONOID PLUS for an unknown indication.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Patient's arm swelled), FEELING HOT (warm), ERYTHEMA (kind of red.) and MUSCLE RIGIDITY (firm). At the time of the report, PERIPHERAL SWELLING (Patient's arm swelled), FEELING HOT (warm), ERYTHEMA (kind of red.) and MUSCLE RIGIDITY (firm) had resolved.            No treatment medication was reported. Patient had Moderna for the 1st and 2nd dose and did not have any reaction.  This case concerns a 79 year old female  with no reported medical history who experienced  , non-serious, unexpected events of peripheral swelling, feeling hot, erythema and muscle rigidity which occurred on an unknown date after vaccination with the 3rd  dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received on 30-Nov-2021 contains updated the outcome from unknown to recovered and updated address of primary reporter.; Sender's Comments: This case concerns a 79 year old female  with no reported medical history who experienced  , non-serious, unexpected events of peripheral swelling, feeling hot, erythema and muscle rigidity which occurred on an unknown date after vaccination with the 3rd  dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in Ears; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Ringing in Ears) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Graves' disease on 05-Oct-2020, Hemochromatosis in 2021 and Phlebotomy (Phlebotomy3 times, HEPA vaccine 1st dose). Previously administered products included for Product used for unknown indication: Hepatitis A (dose 1). Past adverse reactions to the above products included No adverse event with Hepatitis A. Concurrent medical conditions included Drug allergy (Dilaudid), Cirrhosis liver since 2021, Allergy to antibiotic (E-Mycin), Allergy to antibiotic (Ciprofloxin) and Allergy to antibiotic (Rocephin). Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) and THYROID (ARMOUR THYROID) from 2021 to an unknown date for Graves' disease, ZOLPIDEM TARTRATE (AMBIEN) from 2000 to an unknown date for Insomnia, ASCORBIC ACID, COLLAGEN BOVINE, HYALURONATE SODIUM (VITAL PROTEINS ORIGINAL COLLAGEN PEPTIDES WITH HYALURONIC ACID + VITAMIN C) from 2021 to an unknown date for Supplementation therapy, COLECALCIFEROL (VIT D3) from 2010 to an unknown date for Vitamin D deficiency.    On 12-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021 at 6:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in Ears). At the time of the report, TINNITUS (Ringing in Ears) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered TINNITUS (Ringing in Ears) to be possibly related.    Treatment information not provided by reporter.   This case was linked to MOD-2021-382243, MOD-2021-396175 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died within 24 hours after getting the vaccine; This spontaneous case was reported by a physician and describes the occurrence of DEATH (Died within 24 hours after getting the vaccine) in a 54-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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.  It was stated that the patiet died within 24 hours after getting the vaccine. HCP would like to suggests that the recommendation be made for patients with a cardiac condition or a life threatening disease to be monitored and not be alone after getting the vaccine for 48 hours.  Company comment: This case concerns a 54-year-old female patient with no medical history provided, who eventually died within 24 hours after she received the mRNA-1273 vaccine (serious unexpected event of Death). The cause of death and autopsy results were not provided. It remained unknown which dose of the vaccine the patient received before she died. No further information was provided at the moment. The re-challenge is not applicable as the patient died. Limited information precludes a meaningful medical assessment in this case. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old female patient with no medical history provided, who eventually died within 24 hours after she received the mRNA-1273 vaccine (serious unexpected event of Death). The cause of death and autopsy results were not provided. It remained unknown which dose of the vaccine the patient received before she died. No further information was provided at the moment. The re-challenge is not applicable as the patient died. Limited information precludes a meaningful medical assessment in this case. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue/ fatigue is getting worse everyday; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue/ fatigue is getting worse everyday) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076F21A, 030M20A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ATORVASTATIN, BACLOFEN, SULINDAC and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extreme fatigue/ fatigue is getting worse everyday). At the time of the report, FATIGUE (Extreme fatigue/ fatigue is getting worse everyday) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Vaccination site pain
Clinical narrative: received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs; received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs; received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs), VACCINATION SITE PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) and ARTHRALGIA (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs). On 19-Nov-2021, the patient experienced VACCINATION SITE PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) and ARTHRALGIA (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs). At the time of the report, PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs), VACCINATION SITE PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) and ARTHRALGIA (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) had not resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD-2021-398577 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: A little achy; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little achy) and FATIGUE (Felt tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, HYDROCHLOROTHIAZIDE for an unknown indication.    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 PAIN (A little achy) and FATIGUE (Felt tired). At the time of the report, PAIN (A little achy) and FATIGUE (Felt tired) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-398593 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: site of administration on tight; stiffness on my tight for a week; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness on my tight for a week) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (site of administration on tight) 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 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness on my tight for a week). On 19-Nov-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (site of administration on tight). In November 2021, MUSCULOSKELETAL STIFFNESS (stiffness on my tight for a week) had resolved. On 19-Nov-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (site of administration on tight) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Insomnia, Mobility decreased, Near death experience
Clinical narrative: had a stroke; I almost died; can´t sleep; can´t even move; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) and NEAR DEATH EXPERIENCE (I almost died) in a 69-year-old patient of an unknown 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 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criteria medically significant and life threatening), NEAR DEATH EXPERIENCE (I almost died) (seriousness criterion medically significant), INSOMNIA (can´t sleep) and MOBILITY DECREASED (can´t even move). At the time of the report, CEREBROVASCULAR ACCIDENT (had a stroke), NEAR DEATH EXPERIENCE (I almost died), INSOMNIA (can´t sleep) and MOBILITY DECREASED (can´t even move) outcome was unknown.            Concomitant medications details were not reported by the reporter.Treatment details was not reported by the reporter.  On 27-Oct-2021, patient received the booster dose and last night had a stroke, could not sleep and could not even move. Patient almost died.    Company Comment : This case concerns a  69-year-old, patient of unknown gender with no relevant medical history, who experienced the unexpected events of Cerebrovascular accident, Near death experience, Insomnia, and Mobility decreased. The events occurred approximately 29 days after a dose of mRNA-1273 Vaccine which resulted in a Life threatening situation. The rechallenge was unknown since no information about the events of an earlier dose was disclosed.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  69-year-old, patient of unknown gender with no relevant medical history, who experienced the unexpected events of Cerebrovascular accident, Near death experience, Insomnia, and Mobility decreased. The events occurred approximately 29 days after a dose of mRNA-1273 Vaccine which resulted in a Life threatening situation. The rechallenge was unknown since no information about the events of an earlier dose was disclosed.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke 8 days after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke 8 days after booster shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke 8 days after booster shot) (seriousness criteria medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke 8 days after booster shot) outcome was unknown.            No concomitant medications provided. No treatment medications provided.  A consumer calling to report that their mother had an stroke 8 days after receiving the Moderna booster shot.  Company Comment : This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Cerebrovascular accident. The event occurred on an unknown date after the third dose of mRNA-1273 Vaccine which resulted in a Life threatening situation and Hospitalization. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Cerebrovascular accident. The event occurred on an unknown date after the third dose of mRNA-1273 Vaccine which resulted in a Life threatening situation and Hospitalization. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Thyroid hormones test, Vaccination site pain
Clinical narrative: headaches; sore arm in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and VACCINATION SITE PAIN (sore arm in the arm of the injection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (headaches) and VACCINATION SITE PAIN (sore arm in the arm of the injection). At the time of the report, HEADACHE (headaches) and VACCINATION SITE PAIN (sore arm in the arm of the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid hormones test: high (High) little high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-398519, MOD-2021-398543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Significant follow-up event added
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: had an excursion that went up to 35 degrees F.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (had an excursion that went up to 35 degrees F.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (had an excursion that went up to 35 degrees F.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (had an excursion that went up to 35 degrees F.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red round large spot that looked like a bullet/bullseye on her arm that itched.; red round large spot that looked like a bullet/bullseye on her arm that itched.; red round large spot that looked like a bullet/bullseye on her arm that itched.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (red round large spot that looked like a bullet/bullseye on her arm that itched.), VACCINATION SITE ERYTHEMA (red round large spot that looked like a bullet/bullseye on her arm that itched.) and VACCINATION SITE PRURITUS (red round large spot that looked like a bullet/bullseye on her arm that itched.) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251-70A) for an unknown indication.     Concurrent medical conditions included Blood pressure high. Concomitant products included QUINAPRIL HYDROCHLORIDE (ACCUPRIL) and DILTIAZEM HYDROCHLORIDE (CARTIA XT) for Blood pressure high.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE SWELLING (red round large spot that looked like a bullet/bullseye on her arm that itched.), VACCINATION SITE ERYTHEMA (red round large spot that looked like a bullet/bullseye on her arm that itched.) and VACCINATION SITE PRURITUS (red round large spot that looked like a bullet/bullseye on her arm that itched.). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 11-Feb-2021, VACCINATION SITE SWELLING (red round large spot that looked like a bullet/bullseye on her arm that itched.), VACCINATION SITE ERYTHEMA (red round large spot that looked like a bullet/bullseye on her arm that itched.) and VACCINATION SITE PRURITUS (red round large spot that looked like a bullet/bullseye on her arm that itched.) had resolved.            Treatment also include antihistamine cream. Patient reported buying antihistamine cream and putting it on.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: experience hives on a daily basis/ which were all over her back, neck, arm, legs, and stomach; hives are itchy and last anywhere from 45 minutes to a few hours before moving to a different location; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (experience hives on a daily basis/ which were all over her back, neck, arm, legs, and stomach) and PRURITUS (hives are itchy and last anywhere from 45 minutes to a few hours before moving to a different location) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 012A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 16-Nov-2021, the patient experienced URTICARIA (experience hives on a daily basis/ which were all over her back, neck, arm, legs, and stomach) and PRURITUS (hives are itchy and last anywhere from 45 minutes to a few hours before moving to a different location). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (experience hives on a daily basis/ which were all over her back, neck, arm, legs, and stomach) and PRURITUS (hives are itchy and last anywhere from 45 minutes to a few hours before moving to a different location) outcome was unknown.            No relevant concomitant medications were reported.  9-10 days after receiving the booster dose of the vaccine, patients symptoms started.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Nov-2021 and was forwarded to Moderna on 29-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Sick) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MYCOPHENOLATE MOFETIL for Heart transplant.    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 VACCINATION COMPLICATION (Sick). At the time of the report, VACCINATION COMPLICATION (Sick) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had a bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She had a bad reaction). At the time of the report, VACCINATION COMPLICATION (She had a bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were provided.  Patient stated that she was never able to get the full vaccine due to the problem she had.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: had mild symptoms after 2nd shot and was under the weather for a few days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (had mild symptoms after 2nd shot and was under the weather for a few days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 015L20A) 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 04-Mar-2021, the patient experienced MALAISE (had mild symptoms after 2nd shot and was under the weather for a few days). On 07-Mar-2021, MALAISE (had mild symptoms after 2nd shot and was under the weather for a few days) had resolved.            No concomitant medication  were reported. No Treatment information was provided. This case concerns a 68 year old female with no medical history reported, who experienced non-serious , unexpected event of malaise , which occurred on the same day after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is negative since in the SD report during the 3rd dose this event was not reported to recur. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report   This case was linked to MOD-2021-402762 (Patient Link).; Sender's Comments: This case concerns a 68 year old female with no medical history reported, who experienced non-serious , unexpected event of malaise , which occurred on the same day after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is negative since in the report during the 3rd dose this event was not reported to recur. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling of body temperature change, Myalgia
Clinical narrative: Feeling Hot & Cold; Joint pain; sore body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Feeling Hot & Cold), ARTHRALGIA (Joint pain) and MYALGIA (sore body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 010A21A and 015L20A) 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 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling Hot & Cold), ARTHRALGIA (Joint pain) and MYALGIA (sore body). On 21-Nov-2021, FEELING OF BODY TEMPERATURE CHANGE (Feeling Hot & Cold) had resolved. At the time of the report, ARTHRALGIA (Joint pain) had not resolved and MYALGIA (sore body) was resolving.            Patient is suffering from Heart Condition, it is under control with medicines and is not affected by vaccine. No treatment information was provided by the reporter. No Concomitant medicines were reported.  Company comment- This case concerns a 68 year old female with no reported medical history , who experienced Non-serious , unexpected event of feeling of body temperature change and non-serious , expected events of arthralgia and myalgia which occurred on the day after vaccination with the 3rd dose ( booster dose) of mRNA-1273 vaccine ( moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the events occurred on the 3rd dose and no additional doses will be given and also the outcome of the events not resolved. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-402750 (Patient Link).; Sender's Comments: This case concerns a 68 year old female with no reported medical history , who experienced Non-serious , unexpected event of feeling of body temperature change and non-serious , expected events of arthralgia and myalgia which occurred on the day after vaccination with the 3rd dose ( booster dose) of mRNA-1273 vaccine ( moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the events occurred on the 3rd dose and no additional doses will be given and also the outcome of the events not resolved. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Non-immunocompromised patient got the full third dose (0.5ml); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Non-immunocompromised patient got the full third dose (0.5ml)) 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 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced OVERDOSE (Non-immunocompromised patient got the full third dose (0.5ml)). At the time of the report, OVERDOSE (Non-immunocompromised patient got the full third dose (0.5ml)) had resolved. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered OVERDOSE (Non-immunocompromised patient got the full third dose (0.5ml)) to be not applicable.    No concomitant medication was reported. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021 at 11:30 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. The vial was kept under Moderna recommended temperature range the entire time. There was nothing else wrong except that the vaccine was administered beyond the manufacturer's expiration date.   This case was linked to MOD-2021-396137 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow-up received contains no new information. On 29-Nov-2021: Follow up received: Additional reporter added. Patient Information updated.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder, Thyroid hormones test
Clinical narrative: Thyroid is still high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID DISORDER (non-serious), outcome "not recovered", described as "Thyroid is still high". Relevant laboratory tests and procedures are available in the appropriate section.      Additional information: The patient had a severe reaction about that thing, her thyroid was still high now, she doesn't know what.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Somnolence
Clinical narrative: Woke up in the evening with severe headache, but felt better after hydration and meal.; Felt body aches; flu like symptoms; sleeping all day; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Jul2021 18:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 27Jul2021, outcome "recovered" (29Jul2021), described as "Woke up in the evening with severe headache, but felt better after hydration and meal."; PAIN (non-serious) with onset 27Jul2021, outcome "recovered" (27Jul2021), described as "Felt body aches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 27Jul2021, outcome "recovered" (27Jul2021), described as "flu like symptoms"; SOMNOLENCE (non-serious) with onset 27Jul2021, outcome "recovered" (27Jul2021), described as "sleeping all day".  Additional information: On 28Jul2021 resumed to his normal activities with a mild headache. Today 29Jul2021 presented with no symptoms of adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Movement disorder, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: she is 10 days out from her vaccination and she is still not ok and is feeling worse; Her pain is worse in her hands/ her right hand as being the absolute worse, to the point she cannot do anything with it; can hardly move my right hand/ not able to move my body properly; feeling "pins and needles" in her feet and fingers; stiffness; I have tingling in my fingers and toes; entire body was hurting; severe pain; Her pain is worse in her hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FF2588) at the age of 29 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 10Sep2021, outcome "not recovered", described as "can hardly move my right hand/ not able to move my body properly"; PARAESTHESIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "feeling "pins and needles" in her feet and fingers"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 10Sep2021, outcome "not recovered", described as "stiffness"; PARAESTHESIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "I have tingling in my fingers and toes"; PAIN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "entire body was hurting"; PAIN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "severe pain"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Her pain is worse in her hands and feet"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Her pain is worse in her hands/ her right hand as being the absolute worse, to the point she cannot do anything with it"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she is 10 days out from her vaccination and she is still not ok and is feeling worse".  Additional information: The patient was in severe pain for the past 9 days on 10 days. There was no investigation assessment done.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: she is 10 days out from her vaccination and she is still not ok and is feeling worse; Her pain is worse in her hands/ her right hand as being the absolute worse, to the point she cannot do anything with it; can hardly move my right hand/ not able to move my body properly; feeling "pins and needles" in her feet and fingers; stiffness; I have tingling in my fingers and toes; entire body was hurting; severe pain; Her pain is worse in her hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FF2588) at the age of 29 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 10Sep2021, outcome "not recovered", described as "can hardly move my right hand/ not able to move my body properly"; PARAESTHESIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "feeling "pins and needles" in her feet and fingers"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 10Sep2021, outcome "not recovered", described as "stiffness"; PARAESTHESIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "I have tingling in my fingers and toes"; PAIN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "entire body was hurting"; PAIN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "severe pain"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Her pain is worse in her hands and feet"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Her pain is worse in her hands/ her right hand as being the absolute worse, to the point she cannot do anything with it"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she is 10 days out from her vaccination and she is still not ok and is feeling worse".  Additional information: The patient was in severe pain for the past 9 days on 10 days. There was no investigation assessment done.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test interference, Potentiating drug interaction
Clinical narrative: After receiving shot #2 of the vaccine patients fast acting insulin (humalog) effective time was significantly increased from time of administration formerly 30 minutes went to 6 hours+/-.; After receiving shot #2 of the vaccine patients fast acting insulin (humalog) effective time was significantly increased from time of administration formerly 30 minutes went to 6 hours+/-.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 38 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "type 1 Diabetic" (unspecified if ongoing), notes: ?More than 25 years??. The patient's concomitant medications were not reported. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious), LABORATORY TEST INTERFERENCE (non-serious), outcome "recovered" and all described as "After receiving shot #2 of the vaccine patients fast acting insulin (humalog) effective time was significantly increased from time of administration formerly 30 minutes went to 6 hours+/-.".  Additional Information: It was reported that, the patient experienced after receiving shot #2 of the vaccine patients fast acting insulin (humalog) effective time was significantly increased from time of administration formerly 30 minutes went to 6 hours+/-. This persisted for approximately 6 months following the vaccine administration then subsequently returned to normal levels. This was not noticed following the first administration of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dyspnoea, Fatigue, Pulmonary pain
Clinical narrative: SOB; lung pain; chest pain; fevers; fatigue; The initial case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on (19Nov2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68-year-old female patient received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in arm, administration date 24Feb2021 (Lot number: EN6202) at the age of 68 years as dose 1, single and intramuscular, administered in arm, administration date 18Mar2021 (Lot number: ED7534) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (life threatening) with onset 2021, outcome "not recovered", described as "SOB"; PULMONARY PAIN (life threatening) with onset 2021, outcome "not recovered", described as "lung pain"; CHEST PAIN (life threatening) with onset 2021, outcome "not recovered", described as "chest pain"; PYREXIA (life threatening) with onset 2021, outcome "not recovered", described as "fevers"; FATIGUE (life threatening) with onset 2021, outcome "not recovered", described as "fatigue". The patient underwent the following laboratory tests and procedures: body temperature: (2021) fevers. Clinical course: Patient age at time of vaccination was 68 Years. SOB (Shortness of breath), lung pain, chest pain, fevers, Fatigues continues. Vaccine administered at  facility was No.  No follow-up attempts are needed. No further information is expected.