chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 025B21A and 022C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 05-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications include anti-rejection medication for dermatomyositis called Cellcept No treatment reported.   This case was linked to MOD-2021-310491, MOD-2021-310516 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose in Jan2021 and no 2nd dose; 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 PRODUCT DOSE OMISSION ISSUE (1st dose in Jan2021 and no 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose in Jan2021 and no 2nd dose). On 07-Sep-2021, PRODUCT DOSE OMISSION ISSUE (1st dose in Jan2021 and no 2nd dose) had resolved.            No concomitant product information was provided.  Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product quality issue, Vaccination complication
Clinical narrative: reaction; didn't feel well; The solution that was injected was red; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (reaction), MALAISE (didn't feel well) and PRODUCT QUALITY ISSUE (The solution that was injected was red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029K20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-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 VACCINATION COMPLICATION (reaction), MALAISE (didn't feel well) and PRODUCT QUALITY ISSUE (The solution that was injected was red). At the time of the report, VACCINATION COMPLICATION (reaction) outcome was unknown and MALAISE (didn't feel well) and PRODUCT QUALITY ISSUE (The solution that was injected was red) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up received on 13-SEP-2021 contains no new information .Reporter had stated that" This was an error on patient's part so please cancel or close case"
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right arm where the patient received the first dose was really sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm where the patient received the first dose was really sore) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (right arm where the patient received the first dose was really sore). At the time of the report, VACCINATION SITE PAIN (right arm where the patient received the first dose was really sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Treatment information included cold medicine that helped the patient to get sleep like nightquil. The patient drunk lot's of fluids.  Patient's date of birth was 1985.   This case was linked to MOD-2021-310671 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included METOPROLOL, APIXABAN (ELIQUIS), LISINOPRIL, LISINOPRIL (TENSOLISIN), ATORVASTATIN, AMLODIPINE, VITAMIN D [VITAMIN D NOS] and VITAMIN E NOS for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-310836, MOD-2021-310835 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Started spotting each day it has become heavier; it has become heavier until it was a real menstruation; Did not get periods anymore; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Did not get periods anymore), INTERMENSTRUAL BLEEDING (Started spotting each day it has become heavier) and HEAVY MENSTRUAL BLEEDING (it has become heavier until it was a real menstruation) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced AMENORRHOEA (Did not get periods anymore). On an unknown date, the patient experienced INTERMENSTRUAL BLEEDING (Started spotting each day it has become heavier) and HEAVY MENSTRUAL BLEEDING (it has become heavier until it was a real menstruation). At the time of the report, AMENORRHOEA (Did not get periods anymore), INTERMENSTRUAL BLEEDING (Started spotting each day it has become heavier) and HEAVY MENSTRUAL BLEEDING (it has become heavier until it was a real menstruation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant and treatment drugs were not provided
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the ears following a Moderna COVID-19 vaccine.; 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 TINNITUS (ringing in the ears following a Moderna COVID-19 vaccine.) 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced TINNITUS (ringing in the ears following a Moderna COVID-19 vaccine.). At the time of the report, TINNITUS (ringing in the ears following a Moderna COVID-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Heart rate increased, Insomnia
Clinical narrative: related to anxiety; Only slept about an hour; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), INSOMNIA (Only slept about an hour) and ANXIETY (related to anxiety) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety. Concurrent medical conditions included Hypertension.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Sep-2021, the patient experienced DIZZINESS (Light headed). On 06-Sep-2021, the patient experienced INSOMNIA (Only slept about an hour). On an unknown date, the patient experienced ANXIETY (related to anxiety). At the time of the report, DIZZINESS (Light headed), INSOMNIA (Only slept about an hour) and ANXIETY (related to anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Heart rate increased: 105 bpm (High) heart rate went up to 105 bpm. On 07-Sep-2021, Heart rate increased: 99bpm (High) heart rate goes up to 99bpm upon rising.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concurrent medication was reported by patient. patient reported treatment as Sits Back down, Deep breaths, Relaxes.  Patient reported that her rate would go back down when she would sit back down, take some deep breaths and relax. patient reported that this happened a little bit on the second day, but the third day after vaccination she was great.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash in her left arm; red bumps and itching over the area of size similar to a base ball; red bumps and itching over the area of size similar to a base ball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash in her left arm), VACCINATION SITE SWELLING (red bumps and itching over the area of size similar to a base ball) and VACCINATION SITE PRURITUS (red bumps and itching over the area of size similar to a base ball) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 78C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced VACCINATION SITE RASH (rash in her left arm), VACCINATION SITE SWELLING (red bumps and itching over the area of size similar to a base ball) and VACCINATION SITE PRURITUS (red bumps and itching over the area of size similar to a base ball). At the time of the report, VACCINATION SITE RASH (rash in her left arm) was resolving and VACCINATION SITE SWELLING (red bumps and itching over the area of size similar to a base ball) and VACCINATION SITE PRURITUS (red bumps and itching over the area of size similar to a base ball) outcome was unknown.            Reportedly, Consent for safety follow up by the patient was granted.  Patient had used Ice to treat the symptoms  Concomitant product use was not provided.  Treatment product information was not provided.   This case was linked to MOD-2021-310822 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Non-Significant F/U Case.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Application site erythema, Limb discomfort, Mobility decreased, Peripheral swelling, Sensory loss
Clinical narrative: Could not raise the arm for several days; swelled up, twice the size of a normal arm; It was so red from the top of the shoulder down to the elbow, wrapped all the way around; Had a bad reaction; she did not feel it when she was given the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not raise the arm for several days), PERIPHERAL SWELLING (swelled up, twice the size of a normal arm), APPLICATION SITE ERYTHEMA (It was so red from the top of the shoulder down to the elbow, wrapped all the way around), LIMB DISCOMFORT (Had a bad reaction) and SENSORY LOSS (she did not feel it when she was given the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical history details was provided.  Concomitant products included METOPROLOL, DOXYCYCLINE and DIAZEPAM for an unknown indication, NSAIDS.   On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced SENSORY LOSS (she did not feel it when she was given the vaccine). On an unknown date, the patient experienced MOBILITY DECREASED (Could not raise the arm for several days), PERIPHERAL SWELLING (swelled up, twice the size of a normal arm), APPLICATION SITE ERYTHEMA (It was so red from the top of the shoulder down to the elbow, wrapped all the way around) and LIMB DISCOMFORT (Had a bad reaction). On 02-Jul-2021, SENSORY LOSS (she did not feel it when she was given the vaccine) had resolved. At the time of the report, MOBILITY DECREASED (Could not raise the arm for several days), PERIPHERAL SWELLING (swelled up, twice the size of a normal arm), APPLICATION SITE ERYTHEMA (It was so red from the top of the shoulder down to the elbow, wrapped all the way around) and LIMB DISCOMFORT (Had a bad reaction) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   Patient was taken tiny amounts of the Moderna Covid-19 Vaccine at different intervals to check for an Anaphylactic reaction.  she had a bad reaction 7 days after receiving the first dose of the vaccine, she got COVID arm, it was unbelievable. She was questioning if she got any effectiveness from the vaccine. Also wanted to knowif Moderna has heard of someone that had a severe reaction to the first dose of the vaccine and no reaction with the second dose. She stated she was unknow if she was Vaccinated.   NSAIDs Concomitant product use was provided.   Treatment information was not  provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial of Moderna COVID19 Vaccine was opened at 5:24 PM on 01Sep2021,On Thursday 02Sep2021, 4 doses were administered at these times: 12:24 PM, 3:08 PM, 5:32 PM, and 6:18 PM.; Vial of Moderna COVID19 Vaccine was opened at 5:24 PM on 01Sep2021/ In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial of Moderna COVID19 Vaccine was opened at 5:24 PM on 01Sep2021,On Thursday 02Sep2021, 4 doses were administered at these times: 12:24 PM, 3:08 PM, 5:32 PM, and 6:18 PM.) and PRODUCT STORAGE ERROR (Vial of Moderna COVID19 Vaccine was opened at 5:24 PM on 01Sep2021/ In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021 at 6:16 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial of Moderna COVID19 Vaccine was opened at 5:24 PM on 01Sep2021,On Thursday 02Sep2021, 4 doses were administered at these times: 12:24 PM, 3:08 PM, 5:32 PM, and 6:18 PM.) and PRODUCT STORAGE ERROR (Vial of Moderna COVID19 Vaccine was opened at 5:24 PM on 01Sep2021/ In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vial of Moderna COVID19 Vaccine was opened at 5:24 PM on 01Sep2021,On Thursday 02Sep2021, 4 doses were administered at these times: 12:24 PM, 3:08 PM, 5:32 PM, and 6:18 PM.) and PRODUCT STORAGE ERROR (Vial of Moderna COVID19 Vaccine was opened at 5:24 PM on 01Sep2021/ In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were  provided by the reporter.   No treatment medications were reported. On 09/01/2021 a Moderna vial was opened at approximately 05:30 PM, at closing of the business day (7pm) the Moderna vial was not removed from the refrigerator and discarded. Subsequently the vial was used the next day on 09/02/2021 at 06:16 PM to vaccinate approximately 12 hours 45 minutes past its 12 hour refrigerated expiration. The Moderna vial was always kept refrigerated.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up document received contains non significant information. Vaccine administration site was updated. On 15-Sep-2021: Follow up Received and contain Non significant Info.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness) 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 MYALGIA (soreness). At the time of the report, MYALGIA (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain in extremity, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Slept for 12 hours straight 2 nights in a row; Large covid arm 3 inches across and 4 inches deep; Hot arm; Sore arm; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 12 hours straight 2 nights in a row), PERIPHERAL SWELLING (Large covid arm 3 inches across and 4 inches deep), FEELING HOT (Hot arm), MYALGIA (Sore arm) and FATIGUE (Very tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included HYDROCHLOROTHIAZIDE for Glaucoma, OMEPRAZOLE, LEVOTHYROXINE, PHENYTOIN (DILANTIN [PHENYTOIN]), SPIRONOLACTONE, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CITRATE;COLECALCIFEROL]), SIMVASTATIN, WARFARIN and METOPROLOL for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Slept for 12 hours straight 2 nights in a row), PERIPHERAL SWELLING (Large covid arm 3 inches across and 4 inches deep), FEELING HOT (Hot arm), MYALGIA (Sore arm) and FATIGUE (Very tired). At the time of the report, HYPERSOMNIA (Slept for 12 hours straight 2 nights in a row), PERIPHERAL SWELLING (Large covid arm 3 inches across and 4 inches deep), FEELING HOT (Hot arm), MYALGIA (Sore arm) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient took Tylenol for symptoms.   This case was linked to MOD-2021-311066 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: resting heart rate elevated; heart was pounding a little bit/ slight spluttering on the chest, a little bit, a mild case; This case was received via an unknown source, no reference has been entered for a health authority on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of resting heart rate elevated and PALPITATIONS in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced resting heart rate elevated and PALPITATIONS. On 26-Aug-2021, resting heart rate elevated and PALPITATIONS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No Concomitant medication was reported.  No treatment Drug was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection which started burning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (started burning) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (started burning). At the time of the report, VACCINATION SITE PAIN (started burning) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant drug was not reported. Treatment medication was not reported.  It was reported that the patient doesn't know what she was diagnosed with.   This case was linked to MOD-2021-310846 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 101 Fever; This spontaneous case was reported by a consumer and describes the occurrence of 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 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced Fever. At the time of the report, Fever outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high, 101 Fever.         Concomitant medications were not provided.  No Treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Opened at 5:24 PM on 01Sep2021, In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge.; The vial was put back into the refrigerator. The vial was also stored overnight in the fridge.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Opened at 5:24 PM on 01Sep2021, In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) and PRODUCT STORAGE ERROR (The vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 007D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021 at 3:08 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Opened at 5:24 PM on 01Sep2021, In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) and PRODUCT STORAGE ERROR (The vial was put back into the refrigerator. The vial was also stored overnight in the fridge.). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Opened at 5:24 PM on 01Sep2021, In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) and PRODUCT STORAGE ERROR (The vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No treatment medications were provided.   This case was linked to MOD-2021-311050, MOD-2021-311328, MOD-2021-311050, MOD-2021-311221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Significant follow up received : second dose details added On 15-Sep-2021: Follow up contains no new information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: dizziness; no energy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and ASTHENIA (no energy) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and ASTHENIA (no energy). At the time of the report, DIZZINESS (dizziness) and ASTHENIA (no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not provided. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Opened at 5:24 PM on 01Sep2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Opened at 5:24 PM on 01Sep2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Opened at 5:24 PM on 01Sep2021). On 02-Sep-2021, PRODUCT DOSE OMISSION ISSUE (Opened at 5:24 PM on 01Sep2021) 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 concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-311328, MOD-2021-311042, MOD-2021-311221, MOD-2021-311042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up received contains Added patient details. On 15-Sep-2021: FU Received on 15 Sep 2021,contain Non Significant Info.
Sex: U
Vaccine: COVID19
Symptoms: Aphonia, Nasopharyngitis
Clinical narrative: No voice; Felt like I was catching a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt like I was catching a cold) and APHONIA (No voice) 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 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced NASOPHARYNGITIS (Felt like I was catching a cold). On 07-Sep-2021, the patient experienced APHONIA (No voice). At the time of the report, NASOPHARYNGITIS (Felt like I was catching a cold) and APHONIA (No voice) outcome was unknown.            Concomitant medications were not provided.  Treatment medication was not provided.   Patient thought the third dose was booster and got vaccinated was told that third dose are for immunosuppressed.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vials were punctured 18 hours ago; 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 EXPIRED PRODUCT ADMINISTERED (The vials were punctured 18 hours ago) 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 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vials were punctured 18 hours ago). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (The vials were punctured 18 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Reporter was not sure how may patient was given with the vaccine.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Vaccination site pain
Clinical narrative: pain at the injection site; lethargic; tired for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site), LETHARGY (lethargic) and FATIGUE (tired for a day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site), LETHARGY (lethargic) and FATIGUE (tired for a day). At the time of the report, VACCINATION SITE PAIN (pain at the injection site), LETHARGY (lethargic) and FATIGUE (tired for a day) outcome was unknown.            Concomitant medications include inhalers for COPD.  No treatment medications provided.   This case was linked to MOD-2021-310917, MOD-2021-311064 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; more exhausted; This spontaneous case was reported by a consumer and describes the occurrence of fever and FATIGUE in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 088021A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-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 fever and FATIGUE. At the time of the report, fever and FATIGUE outcome was unknown.            Concomitant products included INHALERS for COPD.  No Treatment informations were reported.   This case was linked to MOD-2021-310917, MOD-2021-311057, MOD-2021-310917 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Gait disturbance, Hot flush, Rash
Clinical narrative: I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness; Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before; I got a rash over my torso neck and chest; I cant go on long walks, having brain fog; having brain fog/ I do not usually feel this way; second vaccine gave covid arm lasting 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness), HOT FLUSH (Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before), RASH (I got a rash over my torso neck and chest), GAIT DISTURBANCE (I cant go on long walks, having brain fog) and FEELING ABNORMAL (having brain fog/ I do not usually feel this way) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness), HOT FLUSH (Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before), RASH (I got a rash over my torso neck and chest), GAIT DISTURBANCE (I cant go on long walks, having brain fog), FEELING ABNORMAL (having brain fog/ I do not usually feel this way) and VACCINATION SITE REACTION (second vaccine gave covid arm lasting 2 weeks). At the time of the report, DIZZINESS (I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness), HOT FLUSH (Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before), RASH (I got a rash over my torso neck and chest), GAIT DISTURBANCE (I cant go on long walks, having brain fog), FEELING ABNORMAL (having brain fog/ I do not usually feel this way) and VACCINATION SITE REACTION (second vaccine gave covid arm lasting 2 weeks) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-311001 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness; Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before; I got a rash over my torso neck and chest; I cant go on long walks, having brain fog; having brain fog/ I do not usually feel this way; second vaccine gave covid arm lasting 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness), HOT FLUSH (Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before), RASH (I got a rash over my torso neck and chest), GAIT DISTURBANCE (I cant go on long walks, having brain fog) and FEELING ABNORMAL (having brain fog/ I do not usually feel this way) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness), HOT FLUSH (Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before), RASH (I got a rash over my torso neck and chest), GAIT DISTURBANCE (I cant go on long walks, having brain fog), FEELING ABNORMAL (having brain fog/ I do not usually feel this way) and VACCINATION SITE REACTION (second vaccine gave covid arm lasting 2 weeks). At the time of the report, DIZZINESS (I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness), HOT FLUSH (Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before), RASH (I got a rash over my torso neck and chest), GAIT DISTURBANCE (I cant go on long walks, having brain fog), FEELING ABNORMAL (having brain fog/ I do not usually feel this way) and VACCINATION SITE REACTION (second vaccine gave covid arm lasting 2 weeks) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-311001 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema
Clinical narrative: Moderna side effects after a week; Redness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION COMPLICATION (Moderna side effects after a week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 SITE ERYTHEMA (Redness on injection site) and VACCINATION COMPLICATION (Moderna side effects after a week). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION COMPLICATION (Moderna side effects after a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID (wait to take him to get his third vaccination); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID (wait to take him to get his third vaccination)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced COVID-19 (diagnosed with COVID (wait to take him to get his third vaccination)). At the time of the report, COVID-19 (diagnosed with COVID (wait to take him to get his third vaccination)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided. No treatment information was provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives which look like raised looking bug bites; Itchiness in her lower back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives which look like raised looking bug bites) and PRURITUS (Itchiness in her lower back) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced URTICARIA (Hives which look like raised looking bug bites) and PRURITUS (Itchiness in her lower back). At the time of the report, URTICARIA (Hives which look like raised looking bug bites) and PRURITUS (Itchiness in her lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Headache
Clinical narrative: chest pain; diarrhea; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), DIARRHOEA (diarrhea), CHILLS (chills) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), DIARRHOEA (diarrhea), CHILLS (chills) and HEADACHE (Headache). At the time of the report, CHEST PAIN (chest pain), DIARRHOEA (diarrhea), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.            Patient felts throwing up and hit by a truck after getting her third dose Concomitant product was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-311093 (Patient Link).   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Illness, Injected limb mobility decreased, Joint warmth
Clinical narrative: sickness; capsulitis; fever; tiredness; injection was "higher" than it should have been, was not in the deltoid; shoulder feels hot; jolt of pain into her shoulder; pain and hot burning at the injection site; lymph nodes in my arm are swollen; arm feels stiff; hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of JOINT WARMTH (shoulder feels hot), ILLNESS (sickness), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm) and PERIARTHRITIS (capsulitis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced JOINT WARMTH (shoulder feels hot), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm), VACCINATION SITE PAIN (pain and hot burning at the injection site), LYMPHADENOPATHY (lymph nodes in my arm are swollen) and ARTHRALGIA (jolt of pain into her shoulder). On an unknown date, the patient experienced ILLNESS (sickness), PERIARTHRITIS (capsulitis), PYREXIA (fever), FATIGUE (tiredness) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injection was "higher" than it should have been, was not in the deltoid). At the time of the report, JOINT WARMTH (shoulder feels hot), ILLNESS (sickness), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm), PERIARTHRITIS (capsulitis), VACCINATION SITE PAIN (pain and hot burning at the injection site), LYMPHADENOPATHY (lymph nodes in my arm are swollen), PYREXIA (fever), FATIGUE (tiredness), ARTHRALGIA (jolt of pain into her shoulder) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injection was "higher" than it should have been, was not in the deltoid) outcome was unknown.            The patient treatment medication included Tylenol and advil, also using ice for shoulder pain. Also prescribed steroid for 5 days but she had not taken yet.   This case was linked to MOD-2021-311116 (Patient Link).