chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.    This case was linked to MOD21-068788, MOD21-068786, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068785, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068784, MOD21-068717, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068783, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781, MOD21-068782 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-068788: MOD21-068786: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068785: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068784: MOD21-068717: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068783: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain in extremity; Achiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity) and VACCINATION SITE PAIN (Achiness at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient was taking blood pressure medication). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Blood pressure.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in extremity) and VACCINATION SITE PAIN (Achiness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, PAIN IN EXTREMITY (Pain in extremity) and VACCINATION SITE PAIN (Achiness at injection site) had resolved. Not Related          Concomitant medications included cholesterol medication, blood pressure medication.   Action taken with mRNA-1273 in response to the event was not applicable.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Pain in extremity, Pyrexia
Clinical narrative: Wires sensation on her chest; Fever; Headache; Body aches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Body aches), PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (Wires sensation on her chest), PYREXIA (Fever) and HEADACHE (Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and HEADACHE (Headache). On 03-Apr-2021, the patient experienced CHEST DISCOMFORT (Wires sensation on her chest). At the time of the report, PAIN IN EXTREMITY (Body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and HEADACHE (Headache) had resolved and CHEST DISCOMFORT (Wires sensation on her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 02-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided ; Sender's Comments:  MOD21-068797: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068796: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068795: MOD21-068717: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068794: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782: MOD21-068783: MOD21-068784: MOD21-068785: MOD21-068786: MOD21-068788: MOD21-068791: MOD21-068792: MOD21-068793:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Sore arm; Feeling weak; Black/blue spots; Dizzy; Could not eat; Itching; She could not lift her arm; Red egg circle shape; Nausea; Chills; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Feeling weak), VACCINATION SITE SCAR (Black/blue spots), DIZZINESS (Dizzy) and DECREASED APPETITE (Could not eat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Feeling weak), VACCINATION SITE SCAR (Black/blue spots), DIZZINESS (Dizzy), DECREASED APPETITE (Could not eat), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red egg circle shape), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Headache). 31-Mar-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (She could not lift her arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 02-Apr-2021, ASTHENIA (Feeling weak), VACCINATION SITE SCAR (Black/blue spots), DIZZINESS (Dizzy), DECREASED APPETITE (Could not eat), VACCINATION SITE ERYTHEMA (Red egg circle shape), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), PRURITUS (Itching) and INJECTED LIMB MOBILITY DECREASED (She could not lift her arm) outcome was unknown and HEADACHE (Headache) had resolved.            No relevant concomitant medications were reported.  Treatment medication includes Gatorade for the symptoms   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow-up information received: date of birth of the patient was updated On 20-Jul-2021: Follow up was received : Contain Non significant information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injected limb mobility decreased, Nausea, Pain in extremity, Pruritus
Clinical narrative: Sore arm; Feeling weak; Black/blue spots; Dizzy; Could not eat; Itching; She could not lift her arm; Red egg circle shape; Nausea; Chills; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Feeling weak), VACCINATION SITE SCAR (Black/blue spots), DIZZINESS (Dizzy) and DECREASED APPETITE (Could not eat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Feeling weak), VACCINATION SITE SCAR (Black/blue spots), DIZZINESS (Dizzy), DECREASED APPETITE (Could not eat), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red egg circle shape), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Headache). 31-Mar-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (She could not lift her arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 02-Apr-2021, ASTHENIA (Feeling weak), VACCINATION SITE SCAR (Black/blue spots), DIZZINESS (Dizzy), DECREASED APPETITE (Could not eat), VACCINATION SITE ERYTHEMA (Red egg circle shape), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), PRURITUS (Itching) and INJECTED LIMB MOBILITY DECREASED (She could not lift her arm) outcome was unknown and HEADACHE (Headache) had resolved.            No relevant concomitant medications were reported.  Treatment medication includes Gatorade for the symptoms   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow-up information received: date of birth of the patient was updated On 20-Jul-2021: Follow up was received : Contain Non significant information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site scar
Clinical narrative: Sore arm; Feeling weak; Black/blue spots; Dizzy; Could not eat; Itching; She could not lift her arm; Red egg circle shape; Nausea; Chills; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Feeling weak), VACCINATION SITE SCAR (Black/blue spots), DIZZINESS (Dizzy) and DECREASED APPETITE (Could not eat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Feeling weak), VACCINATION SITE SCAR (Black/blue spots), DIZZINESS (Dizzy), DECREASED APPETITE (Could not eat), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red egg circle shape), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Headache). 31-Mar-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (She could not lift her arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 02-Apr-2021, ASTHENIA (Feeling weak), VACCINATION SITE SCAR (Black/blue spots), DIZZINESS (Dizzy), DECREASED APPETITE (Could not eat), VACCINATION SITE ERYTHEMA (Red egg circle shape), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), PRURITUS (Itching) and INJECTED LIMB MOBILITY DECREASED (She could not lift her arm) outcome was unknown and HEADACHE (Headache) had resolved.            No relevant concomitant medications were reported.  Treatment medication includes Gatorade for the symptoms   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow-up information received: date of birth of the patient was updated On 20-Jul-2021: Follow up was received : Contain Non significant information
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Musculoskeletal stiffness
Clinical narrative: Started experiencing stiffness in her mouth, that lasted 25 minutes; Trouble breathing, that lasted 2 to 3 minutes; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Started experiencing stiffness in her mouth, that lasted 25 minutes) and DYSPNOEA (Trouble breathing, that lasted 2 to 3 minutes) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Started experiencing stiffness in her mouth, that lasted 25 minutes) and DYSPNOEA (Trouble breathing, that lasted 2 to 3 minutes). On 02-Apr-2021, MUSCULOSKELETAL STIFFNESS (Started experiencing stiffness in her mouth, that lasted 25 minutes) and DYSPNOEA (Trouble breathing, that lasted 2 to 3 minutes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Heart rate: 77 heart beats per minute (normal) 70-77 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Thyroid medication. Patient prescribed an Antihistaminic pill for events. On 02-Apr-2021, oxygen levels were fine.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Live follow up was received on 15-Jun-2021 and contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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) (Intramuscular) 1 dosage form(s). On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) outcome was unknown. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in freezer and refrigerator where temperature dropped to : Frozen Vaccine 47Minutes -13.79 C, Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses, Lot no 027B21A 100 doses, Lot no 030B21A 100 doses and Lot No 02B21A 140 doses. HCP stated that 63 doses were administered and she also received the dose.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Red, hard, and large swollen lump at injection site; Red, hard, and large swollen lump at injection site; Red, hard, and large swollen lump at injection site; Painful throbbing at injection site; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Red, hard, and large swollen lump at injection site), VACCINATION SITE ERYTHEMA (Red, hard, and large swollen lump at injection site), VACCINATION SITE SWELLING (Red, hard, and large swollen lump at injection site), VACCINATION SITE PAIN (Painful throbbing at injection site) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Penicillin allergy since an unknown date.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Painful throbbing at injection site), FATIGUE (Fatigue) and NAUSEA (Nausea). On 01-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Red, hard, and large swollen lump at injection site), VACCINATION SITE ERYTHEMA (Red, hard, and large swollen lump at injection site) and VACCINATION SITE SWELLING (Red, hard, and large swollen lump at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Mar-2021, NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE INDURATION (Red, hard, and large swollen lump at injection site), VACCINATION SITE ERYTHEMA (Red, hard, and large swollen lump at injection site), VACCINATION SITE SWELLING (Red, hard, and large swollen lump at injection site), VACCINATION SITE PAIN (Painful throbbing at injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Red, hard, and large swollen lump at injection site; Red, hard, and large swollen lump at injection site; Red, hard, and large swollen lump at injection site; Painful throbbing at injection site; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Red, hard, and large swollen lump at injection site), VACCINATION SITE ERYTHEMA (Red, hard, and large swollen lump at injection site), VACCINATION SITE SWELLING (Red, hard, and large swollen lump at injection site), VACCINATION SITE PAIN (Painful throbbing at injection site) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Penicillin allergy since an unknown date.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Painful throbbing at injection site), FATIGUE (Fatigue) and NAUSEA (Nausea). On 01-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Red, hard, and large swollen lump at injection site), VACCINATION SITE ERYTHEMA (Red, hard, and large swollen lump at injection site) and VACCINATION SITE SWELLING (Red, hard, and large swollen lump at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Mar-2021, NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE INDURATION (Red, hard, and large swollen lump at injection site), VACCINATION SITE ERYTHEMA (Red, hard, and large swollen lump at injection site), VACCINATION SITE SWELLING (Red, hard, and large swollen lump at injection site), VACCINATION SITE PAIN (Painful throbbing at injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site swelling, Vaccination site pain
Clinical narrative: red swelling under the injection site; hurts under the injection site; tired; injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), VACCINATION SITE PAIN (injection site hurt), INJECTION SITE SWELLING (red swelling under the injection site) and VACCINATION SITE PAIN (hurts under the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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 FATIGUE (tired) and VACCINATION SITE PAIN (injection site hurt). On 01-Apr-2021, the patient experienced INJECTION SITE SWELLING (red swelling under the injection site) and VACCINATION SITE PAIN (hurts under the injection site). On 24-Mar-2021, FATIGUE (tired) and VACCINATION SITE PAIN (injection site hurt) had resolved. At the time of the report, INJECTION SITE SWELLING (red swelling under the injection site) and VACCINATION SITE PAIN (hurts under the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history information was reported. No concomitant medication was reported. No treatment medication was reported.
Age: 55.0
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 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus, Rash
Clinical narrative: Arm sore and hot; rash; Itchy; Red; Arm sore and hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore and hot), RASH (rash), PRURITUS (Itchy), ERYTHEMA (Red) and FEELING HOT (Arm sore and hot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore and hot), RASH (rash), PRURITUS (Itchy), ERYTHEMA (Red) and FEELING HOT (Arm sore and hot). At the time of the report, PAIN IN EXTREMITY (Arm sore and hot), RASH (rash), PRURITUS (Itchy), ERYTHEMA (Red) and FEELING HOT (Arm sore and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007MZ0A and 0320Z0A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Dec-2020. Concurrent medical conditions included Heartbeats irregular (required no treatment change) since 2019. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN CALCIUM (CRESTOR) and VITAMIN C [ASCORBIC ACID] for Prophylactic, GLUCOSAMINE & CHONDORITIN, VITAMIN D3 and PROBIOTICS NOS for Prophylaxis.   On 22-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021 at 10:00 AM, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (adverse event). On 20-Feb-2021, ADVERSE EVENT FOLLOWING IMMUNISATION (adverse event) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  The patient did not specify what the adverse event was.  She did not seek medical attention for the event.  No treatment medication was provided.   This case was linked to MOD-2021-013433 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeding disorder, Gait inability, Headache
Clinical narrative: not been able to eat or drink anything since then; can barely get out of bed; don't have any energy; nauseous all day and all night; feel fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (not been able to eat or drink anything since then), GAIT INABILITY (can barely get out of bed), ASTHENIA (don't have any energy), NAUSEA (nauseous all day and all night) and FATIGUE (feel fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FEEDING DISORDER (not been able to eat or drink anything since then), GAIT INABILITY (can barely get out of bed), ASTHENIA (don't have any energy), NAUSEA (nauseous all day and all night), FATIGUE (feel fatigue) and HEADACHE (headache). The patient was treated with OMEPRAZOLE at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (not been able to eat or drink anything since then), GAIT INABILITY (can barely get out of bed), ASTHENIA (don't have any energy), NAUSEA (nauseous all day and all night), FATIGUE (feel fatigue) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: not been able to eat or drink anything since then; can barely get out of bed; don't have any energy; nauseous all day and all night; feel fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (not been able to eat or drink anything since then), GAIT INABILITY (can barely get out of bed), ASTHENIA (don't have any energy), NAUSEA (nauseous all day and all night) and FATIGUE (feel fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FEEDING DISORDER (not been able to eat or drink anything since then), GAIT INABILITY (can barely get out of bed), ASTHENIA (don't have any energy), NAUSEA (nauseous all day and all night), FATIGUE (feel fatigue) and HEADACHE (headache). The patient was treated with OMEPRAZOLE at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (not been able to eat or drink anything since then), GAIT INABILITY (can barely get out of bed), ASTHENIA (don't have any energy), NAUSEA (nauseous all day and all night), FATIGUE (feel fatigue) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: "felt weird for a day" patient could not describe the feeling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("felt weird for a day" patient could not describe the feeling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Root canal procedure (two).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING ABNORMAL ("felt weird for a day" patient could not describe the feeling). On 20-Mar-2021, FEELING ABNORMAL ("felt weird for a day" patient could not describe the feeling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided Patient was called to ask if there is any report of tooth side effects due to the vaccine because  he has to have two root canals
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Muscle fatigue, Myalgia, Swelling, Vaccination site pain
Clinical narrative: COVID arm; Tender,Painful; swelling on my left arm where the injection site is.It's 6 inches wide and 6 inch long,Bump on injection site; very painful; it became like a rock, very solid; very fatigued in my arm; Less strength in left hand; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (it became like a rock, very solid), MUSCLE FATIGUE (very fatigued in my arm), ASTHENIA (Less strength in left hand), VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE SWELLING (swelling on my left arm where the injection site is.It's 6 inches wide and 6 inch long,Bump on injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.     On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SWELLING (it became like a rock, very solid), MUSCLE FATIGUE (very fatigued in my arm), ASTHENIA (Less strength in left hand), VACCINATION SITE SWELLING (swelling on my left arm where the injection site is.It's 6 inches wide and 6 inch long,Bump on injection site) and MYALGIA (very painful). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE PAIN (Tender,Painful). At the time of the report, SWELLING (it became like a rock, very solid), MUSCLE FATIGUE (very fatigued in my arm), ASTHENIA (Less strength in left hand), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE SWELLING (swelling on my left arm where the injection site is.It's 6 inches wide and 6 inch long,Bump on injection site), MYALGIA (very painful) and VACCINATION SITE PAIN (Tender,Painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications were reported.  Patient reported that she applied a hot pad one time. Since then, she started using ice pack. She did not take any medication.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No specific follow-up information recorded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: COVID arm; Tender,Painful; swelling on my left arm where the injection site is.It's 6 inches wide and 6 inch long,Bump on injection site; very painful; it became like a rock, very solid; very fatigued in my arm; Less strength in left hand; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (it became like a rock, very solid), MUSCLE FATIGUE (very fatigued in my arm), ASTHENIA (Less strength in left hand), VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE SWELLING (swelling on my left arm where the injection site is.It's 6 inches wide and 6 inch long,Bump on injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.     On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SWELLING (it became like a rock, very solid), MUSCLE FATIGUE (very fatigued in my arm), ASTHENIA (Less strength in left hand), VACCINATION SITE SWELLING (swelling on my left arm where the injection site is.It's 6 inches wide and 6 inch long,Bump on injection site) and MYALGIA (very painful). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE PAIN (Tender,Painful). At the time of the report, SWELLING (it became like a rock, very solid), MUSCLE FATIGUE (very fatigued in my arm), ASTHENIA (Less strength in left hand), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE SWELLING (swelling on my left arm where the injection site is.It's 6 inches wide and 6 inch long,Bump on injection site), MYALGIA (very painful) and VACCINATION SITE PAIN (Tender,Painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications were reported.  Patient reported that she applied a hot pad one time. Since then, she started using ice pack. She did not take any medication.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No specific follow-up information recorded.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: minor child has taken the Moderna vaccine; This spontaneous case was reported by an other caregiver and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (minor child has taken the Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pre-existing disease (The mother of the patient reported that her daughter had pre-existing conditions and that's why she wanted her to have the shot).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (minor child has taken the Moderna vaccine). On 06-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (minor child has taken the Moderna vaccine) had resolved. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested + to covid between doses; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested + to covid between doses) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested + to covid between doses). At the time of the report, SARS-COV-2 TEST POSITIVE (tested + to covid between doses) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Fever; Body aches; Second vaccine given 93 days after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given 93 days after first vaccine), PYREXIA (Fever) and MYALGIA (Body aches) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 025L201A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given 93 days after first vaccine). On 03-Apr-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given 93 days after first vaccine) had resolved. On 03-Apr-2021, PYREXIA (Fever) had resolved. On 05-Apr-2021, MYALGIA (Body aches) had resolved.            No concomitant medications were reported.  No treatment information for the events was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Sinusitis, Sputum discoloured
Clinical narrative: sinus infection that has spread down to her chest; cough; coughing green phlegm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection that has spread down to her chest), COUGH (cough) and SPUTUM DISCOLOURED (coughing green phlegm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and Blood pressure high (Low grade blood pressure). Concomitant products included IBUPROFEN for Fibromyalgia, FLUOXETINE HYDROCHLORIDE (PROZAC) for Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SINUSITIS (sinus infection that has spread down to her chest), COUGH (cough) and SPUTUM DISCOLOURED (coughing green phlegm). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection that has spread down to her chest), COUGH (cough) and SPUTUM DISCOLOURED (coughing green phlegm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased, Tachycardia
Clinical narrative: symptoms of feeling warmth over the head and ears; heart beat started to beat very fast; quoted," bum ,bum, bum and almost like tachycardia"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (symptoms of feeling warmth over the head and ears), HEART RATE INCREASED (heart beat started to beat very fast) and TACHYCARDIA (quoted," bum ,bum, bum and almost like tachycardia") in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced FEELING HOT (symptoms of feeling warmth over the head and ears), HEART RATE INCREASED (heart beat started to beat very fast) and TACHYCARDIA (quoted," bum ,bum, bum and almost like tachycardia"). At the time of the report, FEELING HOT (symptoms of feeling warmth over the head and ears), HEART RATE INCREASED (heart beat started to beat very fast) and TACHYCARDIA (quoted," bum ,bum, bum and almost like tachycardia") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Chills, Dizziness
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Medium
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Hypoaesthesia, Insomnia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Medium
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Tremor, Visual impairment
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Medium
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Increase in the loudness of tinnitus.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Booster Given Too Early-
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram, Concussion, Dehydration, Dizziness
Clinical narrative: Dizziness, dehydration, nausea, severe back pain  after 2 more days diagnosed kidney stone removed surgically,  Then blackout, fall  and concussion.  Lingering brain fog and tinnitus increased
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Nausea, Nephrolithiasis
Clinical narrative: Dizziness, dehydration, nausea, severe back pain  after 2 more days diagnosed kidney stone removed surgically,  Then blackout, fall  and concussion.  Lingering brain fog and tinnitus increased
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Renal stone removal, Tinnitus
Clinical narrative: Dizziness, dehydration, nausea, severe back pain  after 2 more days diagnosed kidney stone removed surgically,  Then blackout, fall  and concussion.  Lingering brain fog and tinnitus increased
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Lactation disorder
Clinical narrative: Swelling and dilation of the breasts with inability to drain milk, after six months of uninterrupted breastfeeding.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to animal, Food allergy
Clinical narrative: Food allergies and animal touch.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis microscopic, Colonoscopy, Diarrhoea, Stool analysis
Clinical narrative: Chronic diarrhea with collagenous colitis diagnosis