chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: I feel sick with a cold; I feel sick with a cold; 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 MALAISE (I feel sick with a cold) and NASOPHARYNGITIS (I feel sick with a cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 MALAISE (I feel sick with a cold) and NASOPHARYNGITIS (I feel sick with a cold). At the time of the report, MALAISE (I feel sick with a cold) and NASOPHARYNGITIS (I feel sick with a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like coming down with the flu) 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 01-Jun-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 INFLUENZA LIKE ILLNESS (Felt like coming down with the flu). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like coming down with the flu) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not provided. Treatment medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Feeling hot, Injection site pain, Myalgia
Clinical narrative: body aches; chills; fever; hotness; trembling; bone aches; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hotness), TREMOR (trembling), BONE PAIN (bone aches), INJECTION SITE PAIN (Injection site pain) and MYALGIA (body aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 01-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced FEELING HOT (hotness), TREMOR (trembling), BONE PAIN (bone aches), INJECTION SITE PAIN (Injection site pain), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, FEELING HOT (hotness), TREMOR (trembling), BONE PAIN (bone aches), INJECTION SITE PAIN (Injection site pain), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) had resolved.            No treatment medication was reported .   This case was linked to MOD-2021-271513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up information received: Outcome of the events updated and Event sore arm was captured from initial version from narrative.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: body aches; chills; fever; hotness; trembling; bone aches; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hotness), TREMOR (trembling), BONE PAIN (bone aches), INJECTION SITE PAIN (Injection site pain) and MYALGIA (body aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 01-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced FEELING HOT (hotness), TREMOR (trembling), BONE PAIN (bone aches), INJECTION SITE PAIN (Injection site pain), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, FEELING HOT (hotness), TREMOR (trembling), BONE PAIN (bone aches), INJECTION SITE PAIN (Injection site pain), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) had resolved.            No treatment medication was reported .   This case was linked to MOD-2021-271513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up information received: Outcome of the events updated and Event sore arm was captured from initial version from narrative.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Vaccination complication
Clinical narrative: their bodies are magnetized; can stick a fork, paper clip, quarters, rings, lighters and its magnetized to their arms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (their bodies are magnetized) and VACCINATION COMPLICATION (can stick a fork, paper clip, quarters, rings, lighters and its magnetized to their arms) 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 ADVERSE REACTION (their bodies are magnetized) and VACCINATION COMPLICATION (can stick a fork, paper clip, quarters, rings, lighters and its magnetized to their arms). At the time of the report, ADVERSE REACTION (their bodies are magnetized) and VACCINATION COMPLICATION (can stick a fork, paper clip, quarters, rings, lighters and its magnetized to their arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Headache; 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 CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching, Vaccination site pain, Vomiting projectile
Clinical narrative: Projectile vomiting; Dry heaves; Vaccine arm was a little sore; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING PROJECTILE (Projectile vomiting), RETCHING (Dry heaves), VACCINATION SITE PAIN (Vaccine arm was a little sore) and NAUSEA (Nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced VOMITING PROJECTILE (Projectile vomiting), RETCHING (Dry heaves), VACCINATION SITE PAIN (Vaccine arm was a little sore) and NAUSEA (Nausea). At the time of the report, VOMITING PROJECTILE (Projectile vomiting) and VACCINATION SITE PAIN (Vaccine arm was a little sore) outcome was unknown, RETCHING (Dry heaves) had resolved and NAUSEA (Nausea) had not resolved.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; 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 ARTHRALGIA (Joint pain) 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 ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Sinus congestion
Clinical narrative: Sinus congestion; Sinus pressure; 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 SINUS CONGESTION (Sinus congestion) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUS CONGESTION (Sinus congestion) and PARANASAL SINUS DISCOMFORT (Sinus pressure). At the time of the report, SINUS CONGESTION (Sinus congestion) and PARANASAL SINUS DISCOMFORT (Sinus pressure) outcome was unknown.            Relevant concomitant medications were not provided.  Treatment medications were OTC drugs, steroids and antibiotics.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Vaccination site swelling
Clinical narrative: Swelling at injection site; Flu symptoms; Terrible headaches; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Flu symptoms), HEADACHE (Terrible headaches) and VACCINATION SITE SWELLING (Swelling at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced INFLUENZA (Flu symptoms) and HEADACHE (Terrible headaches). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, INFLUENZA (Flu symptoms), HEADACHE (Terrible headaches) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: still having breathing issues; fever till last night; 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 DYSPNOEA (still having breathing issues) and PYREXIA (fever till last night) 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 31-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced DYSPNOEA (still having breathing issues) and PYREXIA (fever till last night). On 01-Jun-2021, PYREXIA (fever till last night) had resolved. At the time of the report, DYSPNOEA (still having breathing issues) outcome was unknown.            No concomitant medications was reported Treatment information was not provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: Sore arm for a day; Was not able to sleep; Cold last night; Shivering for 3 hours; Fever all night like 101.5 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a day), INSOMNIA (Was not able to sleep), NASOPHARYNGITIS (Cold last night), CHILLS (Shivering for 3 hours) and PYREXIA (Fever all night like 101.5 F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-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 PAIN IN EXTREMITY (Sore arm for a day), INSOMNIA (Was not able to sleep), NASOPHARYNGITIS (Cold last night), CHILLS (Shivering for 3 hours) and PYREXIA (Fever all night like 101.5 F). At the time of the report, PAIN IN EXTREMITY (Sore arm for a day), INSOMNIA (Was not able to sleep), NASOPHARYNGITIS (Cold last night), CHILLS (Shivering for 3 hours) and PYREXIA (Fever all night like 101.5 F) outcome was unknown.        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 provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Not too much arm pain) and PYREXIA (Next day felt like feverish) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included AMLODIPINE for an unknown indication. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Not too much arm pain) and PYREXIA (Next day felt like feverish). On 26-Apr-2021, PAIN IN EXTREMITY (Not too much arm pain) and PYREXIA (Next day felt like feverish) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: i was very sick on the first shot; 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 ILLNESS (i was very sick on the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (i was very sick on the first shot). At the time of the report, ILLNESS (i was very sick on the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided Treatment medication was not provided
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of blurry vision in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 023C21A) for COVID-19 immunization. No medical history reported. On May 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 3, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced blurry vision. At the time of the report, blurry vision: resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. Reporter stated the patient received his first dose of vaccine. After 2 hours he experienced blurry vision, which lasted for 2-3 weeks. The patient visited an optometrist who said there was nothing out of ordinary upon evaluating the patient's eyes. Patient's blurriness was 90% resolved. He had no medical conditions nor does he take any medications. No treatment information provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: terrible rash on back of his knees and on his back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (terrible rash on back of his knees and on his back) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (terrible rash on back of his knees and on his back). At the time of the report, RASH (terrible rash on back of his knees and on his back) had not resolved.        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 medications were provided by the reporter.   This case was linked to MOD-2021-200350 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Event onset date was updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Pain in extremity
Clinical narrative: pain in arm; 2nd dose was delayed due to not feeling well; pain in her arm/whole body starting aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed due to not feeling well) and MYALGIA (pain in her arm/whole body starting aching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-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 PAIN IN EXTREMITY (pain in arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed due to not feeling well) and MYALGIA (pain in her arm/whole body starting aching). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 800 mg. At the time of the report, PAIN IN EXTREMITY (pain in arm) and MYALGIA (pain in her arm/whole body starting aching) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed due to not feeling well) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. The patient was treated with heating pad. The patient stated that she was scheduled for a procedure on her left arm soon.   This case was linked to MOD-2021-200406 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: High fever; Body aches; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (High fever) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PYREXIA (High fever) and MYALGIA (Body aches). At the time of the report, PYREXIA (High fever) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: were sick from something they had ate; missed the second appointment; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (were sick from something they had ate) and PRODUCT DOSE OMISSION ISSUE (missed the second appointment) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (were sick from something they had ate) and PRODUCT DOSE OMISSION ISSUE (missed the second appointment). At the time of the report, ILLNESS (were sick from something they had ate) and PRODUCT DOSE OMISSION ISSUE (missed the second appointment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Having chest pain; 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 CHEST PAIN (Having chest pain) 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 CHEST PAIN (Having chest pain). At the time of the report, CHEST PAIN (Having chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of urticaria (hives), pain in extremity (arm soreness), chills and pyrexia (fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001B21A) for COVID-19 vaccination. No medical history reported. On Mar 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 14, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced pain in extremity (arm soreness). On May 31, 2021, patient experienced urticaria (hives), chills and pyrexia (fever). The patient treated with Tylenol (paracetamol) for pain in extremity, chills and fever; at an unspecified dose and frequency. On May 31, 2021, pain in extremity (arm soreness) resolved. At the time of the report, urticaria (hives), chills and pyrexia (fever) outcome: unknown. Concomitant medications not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product expiration date issue, Product label issue
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021), PRODUCT LABEL ISSUE (labeling error) and EXPIRED PRODUCT ADMINISTERED (2-3 people received the vaccine as the 1st dose after the 30 day expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2-3 people received the vaccine as the 1st dose after the 30 day expiry). On an unknown date, the patient experienced PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021) and PRODUCT LABEL ISSUE (labeling error). On 30-May-2021, EXPIRED PRODUCT ADMINISTERED (2-3 people received the vaccine as the 1st dose after the 30 day expiry) had resolved. At the time of the report, PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021) and PRODUCT LABEL ISSUE (labeling error) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up report received included information that all patients did fine with no problems.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip swelling, Peripheral swelling
Clinical narrative: swollen arm; swollen lips; difficulty breathing; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swollen arm), LIP SWELLING (swollen lips) and DYSPNOEA (difficulty breathing) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21a and 031A21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced LIP SWELLING (swollen lips) and DYSPNOEA (difficulty breathing). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm). The patient was treated with EPINEPHRINE at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (swollen arm), LIP SWELLING (swollen lips) and DYSPNOEA (difficulty breathing) outcome was unknown.            Concomitant product use was not provided. Treatment drugs include IV, Steroids.   This case was linked to MOD-2021-200440 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Mobility decreased, Pain in extremity, Pregnancy test
Clinical narrative: Sore arm after vaccination; Has a lot of tiredness/ Fatigue; Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt; Vaccine exposure during pregnancy; Doctor diagnosed her with vertigo / She only had vertigo feeling that same morning and one or two hours later.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN IN EXTREMITY (Sore arm after vaccination), VERTIGO (Doctor diagnosed her with vertigo / She only had vertigo feeling that same morning and one or two hours later.), MOBILITY DECREASED (Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt) and FATIGUE (Has a lot of tiredness/ Fatigue) in a 38-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02021A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo since 13-May-2021.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-May-2021, the patient experienced VERTIGO (Doctor diagnosed her with vertigo / She only had vertigo feeling that same morning and one or two hours later.). On 22-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 01-Jun-2021, the patient experienced MOBILITY DECREASED (Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after vaccination) and FATIGUE (Has a lot of tiredness/ Fatigue). On 13-May-2021, VERTIGO (Doctor diagnosed her with vertigo / She only had vertigo feeling that same morning and one or two hours later.) had resolved. On 22-May-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm after vaccination), MOBILITY DECREASED (Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt) and FATIGUE (Has a lot of tiredness/ Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Pregnancy test: positive (Positive) Positive.         This case was linked to MOD21-104749 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Sore arm after vaccination; Has a lot of tiredness/ Fatigue; Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt; Vaccine exposure during pregnancy; Doctor diagnosed her with vertigo / She only had vertigo feeling that same morning and one or two hours later.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN IN EXTREMITY (Sore arm after vaccination), VERTIGO (Doctor diagnosed her with vertigo / She only had vertigo feeling that same morning and one or two hours later.), MOBILITY DECREASED (Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt) and FATIGUE (Has a lot of tiredness/ Fatigue) in a 38-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02021A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo since 13-May-2021.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-May-2021, the patient experienced VERTIGO (Doctor diagnosed her with vertigo / She only had vertigo feeling that same morning and one or two hours later.). On 22-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 01-Jun-2021, the patient experienced MOBILITY DECREASED (Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after vaccination) and FATIGUE (Has a lot of tiredness/ Fatigue). On 13-May-2021, VERTIGO (Doctor diagnosed her with vertigo / She only had vertigo feeling that same morning and one or two hours later.) had resolved. On 22-May-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm after vaccination), MOBILITY DECREASED (Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt) and FATIGUE (Has a lot of tiredness/ Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Pregnancy test: positive (Positive) Positive.         This case was linked to MOD21-104749 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Peripheral swelling, Sleep disorder, Trigger finger
Clinical narrative: swelling in hands; warm feeling in his hand and knee joints,; right thumb locked open; has woken up twice from sleep; decreased strength in hands; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling in hands), FEELING HOT (warm feeling in his hand and knee joints,), TRIGGER FINGER (right thumb locked open), SLEEP DISORDER (has woken up twice from sleep) and ASTHENIA (decreased strength in hands) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included FISH OIL, EZETIMIBE, LISINOPRIL, IBUPROFEN and NAPROXEN for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PERIPHERAL SWELLING (swelling in hands), FEELING HOT (warm feeling in his hand and knee joints,), TRIGGER FINGER (right thumb locked open), SLEEP DISORDER (has woken up twice from sleep) and ASTHENIA (decreased strength in hands). At the time of the report, PERIPHERAL SWELLING (swelling in hands), FEELING HOT (warm feeling in his hand and knee joints,), TRIGGER FINGER (right thumb locked open), SLEEP DISORDER (has woken up twice from sleep) and ASTHENIA (decreased strength in hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported .
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feels malaise/has not felt well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels malaise/has not felt well) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (feels malaise/has not felt well). At the time of the report, MALAISE (feels malaise/has not felt well) outcome was unknown.            No concomitant medications was included. No treatment drug was mentioned.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Feeling abnormal, Muscle spasms, Restlessness
Clinical narrative: I felt bad,the fifth day I started feeling bad; woke up with cramps for 2 days/neck cramps/head cramps; I don't dream usually, but now I have dreams; take teas to sleep because I can't rest; I felt like chills,; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt bad,the fifth day I started feeling bad), MUSCLE SPASMS (woke up with cramps for 2 days/neck cramps/head cramps), ABNORMAL DREAMS (I don't dream usually, but now I have dreams), RESTLESSNESS (take teas to sleep because I can't rest) and CHILLS (I felt like chills,) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.    On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced FEELING ABNORMAL (I felt bad,the fifth day I started feeling bad) and CHILLS (I felt like chills,). 22-May-2021, the patient experienced MUSCLE SPASMS (woke up with cramps for 2 days/neck cramps/head cramps), ABNORMAL DREAMS (I don't dream usually, but now I have dreams) and RESTLESSNESS (take teas to sleep because I can't rest). The patient was treated with PARACETAMOL (TYLENOL) for Feeling bad, at a dose of UNK dosage form; IBUPROFEN at a dose of 1 dosage form and VICK VAPOUR-RUB for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (I felt bad,the fifth day I started feeling bad) and MUSCLE SPASMS (woke up with cramps for 2 days/neck cramps/head cramps) had resolved and ABNORMAL DREAMS (I don't dream usually, but now I have dreams), RESTLESSNESS (take teas to sleep because I can't rest) and CHILLS (I felt like chills,) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       After receiving the Dose-2 on 22-MAY-2021 patient had massaged on head and neck to felt better   This case was linked to MOD-2021-200445 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: New events added.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: COVID tongue\tip of tongue swollen in a "V" shape\ her tongue was swollen to the point it felt as though she had a big hunk of meat in her mouth; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (COVID tongue\tip of tongue swollen in a "V" shape\ her tongue was swollen to the point it felt as though she had a big hunk of meat in her mouth) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction NOS (teeth pulled and dental work). Concurrent medical conditions included Infection, Autoimmune hepatitis and Cirrhosis liver. Concomitant products included LEVOFLOXACIN (LEVAQUIN) for Infection.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (COVID tongue\tip of tongue swollen in a "V" shape\ her tongue was swollen to the point it felt as though she had a big hunk of meat in her mouth) and PYREXIA (Low grade fever). At the time of the report, SWOLLEN TONGUE (COVID tongue\tip of tongue swollen in a "V" shape\ her tongue was swollen to the point it felt as though she had a big hunk of meat in her mouth) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included immunosuppressants, chronic oral steroids. The patient reported her physician at the clinic suggested she should receive Johnson and Johnson instead of Moderna for her second COVID-19 Vaccine dose. No information regarding corrective treatment was reported by the patient.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments     Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient is on day 49 past first dose and wants to get second dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is on day 49 past first dose and wants to get second dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is on day 49 past first dose and wants to get second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is on day 49 past first dose and wants to get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Neck pain
Clinical narrative: My friend told me he was sick for 3 weeks after receiving the second dose of the Moderna COVID-19 vaccine; Neck pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (My friend told me he was sick for 3 weeks after receiving the second dose of the Moderna COVID-19 vaccine), NECK PAIN (Neck pain) and HEADACHE (Headache) in a 50-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (My friend told me he was sick for 3 weeks after receiving the second dose of the Moderna COVID-19 vaccine), NECK PAIN (Neck pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form and IBUPROFEN for Pain, at a dose of 1 UNK. At the time of the report, ILLNESS (My friend told me he was sick for 3 weeks after receiving the second dose of the Moderna COVID-19 vaccine) outcome was unknown and NECK PAIN (Neck pain) and HEADACHE (Headache) was resolving.            No concomitant medications were mentioned.   Patient did not consult  doctor  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR added. Additional information received on 10-JUN-2021 and it contained significant information. event outcomes and new events were updated.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Frequent bowel movements
Clinical narrative: hands are tingling; Hands cold; little bit of tightness in her chest; a lot of bowel movements; dizziness; short of breath; headaches; body aches; chills; fever (hot n cold); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (hands are tingling), PERIPHERAL COLDNESS (Hands cold), CHEST DISCOMFORT (little bit of tightness in her chest), FREQUENT BOWEL MOVEMENTS (a lot of bowel movements) and DIZZINESS (dizziness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced HEADACHE (headaches), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever (hot n cold)). On 28-May-2021, the patient experienced PARAESTHESIA (hands are tingling), PERIPHERAL COLDNESS (Hands cold), CHEST DISCOMFORT (little bit of tightness in her chest), FREQUENT BOWEL MOVEMENTS (a lot of bowel movements), DIZZINESS (dizziness) and DYSPNOEA (short of breath). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at a dose of 1 dosage form. On 24-May-2021, HEADACHE (headaches), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever (hot n cold)) had resolved. On 28-May-2021, CHEST DISCOMFORT (little bit of tightness in her chest) had resolved. At the time of the report, PARAESTHESIA (hands are tingling), PERIPHERAL COLDNESS (Hands cold), FREQUENT BOWEL MOVEMENTS (a lot of bowel movements), DIZZINESS (dizziness) and DYSPNOEA (short of breath) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Concomitant medication and treatment medications updated.