chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLUC3
Symptoms: Diarrhoea, Fatigue, Hot flush, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph node; Felt flashed; Pain; Tired; Diarrhea; This spontaneous case was received on 29-Sep-2022 from nurse via Communications (reference number: SEQW22-03718) and concerned a 31-year-old, female patient.  The patient's medical history and concomitant medication were not reported.  On 28-Sep-2022, in the morning, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0,5 ml, route of administration: intramuscular, anatomical location: arm) for prevention of influenza disease. The batch number reported was 348378 and expiry date: 30-Jul-2023.  On the same day, at 23:00 p.m., after receiving Flucelvax Quadrivalent, the patient experienced swollen lymph node under the arm that the vaccine was administered, she felt flashed, tired and had diarrhoea. The patient was treated with Advil (mefenamic acid), for the pain.  On an unspecified date in Sep-2022, the patient recovered from events 'flush hot' 'tiredness', 'diarrhoea' and 'pain' as it was reported that the patient was feeling ok at the moment.  At the time of initial reporting on 29-Sep-2022, the patient was recovering from event of 'swollen lymph nodes' as the lymph node was going down.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 31-year-old female patient developed lymphadenopathy, hot flush, fatigue, pain and diarrhea on the same day after vaccination with Flucelvax Quadrivalent. Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.; Sender's Comments: A 31-year-old female patient developed lymphadenopathy, hot flush, fatigue, pain and diarrhea on the same day after vaccination with Flucelvax Quadrivalent. Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: The site is warm to the touch; Redness 2x2 inch below the inject site; The rash didn't get worst but it still there; This spontaneous case was received on 29-Sep-2022 from other healthcare professional (pharmacist student) via Communications (reference number: SEQW22- 03682) and concerned an 84-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included Eliquis (apixaban), lisinopril, cyanocobalamin, atorvastatin, metoprolol and levothyroxine sodium, all used for an unreported indication.  On 26-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 346346 and expiry date was 21-Apr-2023.  On 28-Sep-2022, two days after receiving Fluad Quadrivalent, the patient experienced redness 2x2 inch below the inject site. The site was warm to the touch. Also, the patient experienced rash. The patient did not received any treatment measures.   At the time of initial reporting on 29-Sep-2022, the patient had not recovered from the events. As reported, the rash did not get worse, but it was still there.   The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: An 84-year-old, female patient was vaccinated with Fluad Quadrivalent. Two days following vaccination, the patient developed vaccination site warmth, localised erythema and rash. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender's Comments: An 84-year-old, female patient was vaccinated with Fluad Quadrivalent. Two days following vaccination, the patient developed vaccination site warmth, localised erythema and rash. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: pretty sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (On an unknown date the patient received 1st dose of shingles vaccine refer case US2022AMR142039).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR142039   Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comments:  This case was received from Consumer via interactive digital media. The reporter stated that a shot was little bit of a rough shot, but way better than getting Shingles. The patient did not get covid or flu shots of course they would vary from person to person. The patient was pretty sick after both shots, but from he/she heard, getting shingles was considerable worse and recommended getting the shots. Additional supportive information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR142039:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Loss of personal independence in daily activities, Vertigo
Clinical narrative: feeling dizzy; vertigo/spinning; couldn't walk normally; couldn't do anything; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (feeling dizzy), VERTIGO (vertigo/spinning), GAIT DISTURBANCE (couldn't walk normally) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A (S or 5) 7164B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced DIZZINESS (feeling dizzy), VERTIGO (vertigo/spinning), GAIT DISTURBANCE (couldn't walk normally) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything). At the time of the report, DIZZINESS (feeling dizzy), VERTIGO (vertigo/spinning), GAIT DISTURBANCE (couldn't walk normally) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything) had resolved.            The patient had no concomitant medications.  It was reported that patient experienced the events 10 hours after receiving the bivalent booster dose and condition was worst when patient lay down.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received a bivalent booster dose as a first dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a bivalent booster dose as a first dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a bivalent booster dose as a first dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a bivalent booster dose as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a bivalent booster dose as a first dose).    No concomitant medications were reported. No treatment medications were reported.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Bivalent Booster was given to 5 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster was given to 5 years old) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster was given to 5 years old). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster was given to 5 years old) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster was given to 5 years old).    No concomitant medications were reported. Patient received vaccine around 1:00 PM. It was reported that no side effects were noted. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: 30% of vaccine leaked out while being injected; No adverse event; the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).), DEVICE CONNECTION ISSUE (30% of vaccine leaked out while being injected) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced UNDERDOSE (the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (30% of vaccine leaked out while being injected) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).), DEVICE CONNECTION ISSUE (30% of vaccine leaked out while being injected) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).) and DEVICE CONNECTION ISSUE (30% of vaccine leaked out while being injected).    No concomitant information was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received the Bivalent Booster instead of Moderna's 1st primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the Bivalent Booster instead of Moderna's 1st primary series dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received the Bivalent Booster instead of Moderna's 1st primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received the Bivalent Booster instead of Moderna's 1st primary series dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received the Bivalent Booster instead of Moderna's 1st primary series dose).    Concomitant product use was not provided by the reporter.  The patient was not having side effects.  Treatment information was not provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Influenza like illness, Pain in extremity, Rash
Clinical narrative: flu like symptoms; with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm; arm hurt awful for days; experienced chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug intolerance (Dilaudid) and Herbal allergy (herbal tea (rash)). Concomitant products included ROSUVASTATIN, IRBESARTAN and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm) and CHILLS (experienced chills) outcome was unknown and PAIN IN EXTREMITY (arm hurt awful for days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient never had COVID positive test or diagnosis. Patient reported that none of adverse events experienced after primary series concerned her that much as they were all expected reactions to the shots. No treatment drug was reported.   This case was linked to MOD-2022-657100, MOD-2022-657016 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Influenza like illness
Clinical narrative: flu like symptoms; with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm; arm hurt awful for days; experienced chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug intolerance (Dilaudid) and Herbal allergy (herbal tea (rash)). Concomitant products included ROSUVASTATIN, IRBESARTAN and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm) and CHILLS (experienced chills) outcome was unknown and PAIN IN EXTREMITY (arm hurt awful for days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient never had COVID positive test or diagnosis. Patient reported that none of adverse events experienced after primary series concerned her that much as they were all expected reactions to the shots. No treatment drug was reported.   This case was linked to MOD-2022-657100, MOD-2022-657016 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Claustrophobia, Dyspnoea, Feeling abnormal, Influenza like illness
Clinical narrative: flu like symptoms; with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm; arm hurt awful for days; experienced chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug intolerance (Dilaudid) and Herbal allergy (herbal tea (rash)). Concomitant products included ROSUVASTATIN, IRBESARTAN and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm) and CHILLS (experienced chills) outcome was unknown and PAIN IN EXTREMITY (arm hurt awful for days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient never had COVID positive test or diagnosis. Patient reported that none of adverse events experienced after primary series concerned her that much as they were all expected reactions to the shots. No treatment drug was reported.   This case was linked to MOD-2022-657100, MOD-2022-657016 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Malaise, Nasopharyngitis, Uterine hypotonus, Uterine spasm
Clinical narrative: flu like symptoms; with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm; arm hurt awful for days; experienced chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug intolerance (Dilaudid) and Herbal allergy (herbal tea (rash)). Concomitant products included ROSUVASTATIN, IRBESARTAN and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm) and CHILLS (experienced chills) outcome was unknown and PAIN IN EXTREMITY (arm hurt awful for days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient never had COVID positive test or diagnosis. Patient reported that none of adverse events experienced after primary series concerned her that much as they were all expected reactions to the shots. No treatment drug was reported.   This case was linked to MOD-2022-657100, MOD-2022-657016 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: flu like symptoms; with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm; arm hurt awful for days; experienced chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug intolerance (Dilaudid) and Herbal allergy (herbal tea (rash)). Concomitant products included ROSUVASTATIN, IRBESARTAN and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm) and CHILLS (experienced chills) outcome was unknown and PAIN IN EXTREMITY (arm hurt awful for days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient never had COVID positive test or diagnosis. Patient reported that none of adverse events experienced after primary series concerned her that much as they were all expected reactions to the shots. No treatment drug was reported.   This case was linked to MOD-2022-657100, MOD-2022-657016 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Caller said the crotch area is still very bad and itches like crazy; broke out in rash all over body/tried a lot of creams that eased it a little bit but other than that it's only cleared up stomach and back.; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Caller said the crotch area is still very bad and itches like crazy) and RASH (broke out in rash all over body/tried a lot of creams that eased it a little bit but other than that it's only cleared up stomach and back.) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus and Pulmonary stenosis (stenosis in lung). Concomitant products included PARACETAMOL (TYLENOL), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CLOBETASOL PROPIONATE (CLOBETASOL 0.05%), DICLOFENAC, DIPHENHYDRAMINE, EMPAGLIFLOZIN, HYDROCORTISONE, LIDOCAINE, METFORMIN, METHOCARBAMOL (ROBAXIN), SIMVASTATIN and TRIAMCINOLONE for an unknown indication.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRURITUS (Caller said the crotch area is still very bad and itches like crazy) and RASH (broke out in rash all over body/tried a lot of creams that eased it a little bit but other than that it's only cleared up stomach and back.). At the time of the report, PRURITUS (Caller said the crotch area is still very bad and itches like crazy) and RASH (broke out in rash all over body/tried a lot of creams that eased it a little bit but other than that it's only cleared up stomach and back.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also includes Camphor menthol topical and Colloidal oatmeal topical.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fever, missed 2 days of work; Chills, missed 2 days of work; missed 2 days of work; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills and activities of daily living impaired. On an unknown date, the outcome of the fever and chills were unknown and the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the fever, chills and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-OCT-2022 Reporters comment: This case was reported by a consumer via (interactive digital media  First vaccine was terrible. Fever, chills and missed 2 days of work. Almost afraid to get the second one.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: After 2nd dose, aches and pains; After 2nd dose, Fever; After 2nd dose,  the normal, headaches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pneumonia vaccine (Patient also had other reactions.), Flu vaccine (other reactions with Flu vaccine, had to take the low dose flu vaccine) and Shingles vaccine (Patient also had other reactions.). Past adverse reactions to the above products included Fever with Flu vaccine, Shingles vaccine and pneumonia vaccine. Concurrent medical conditions included Blood pressure high, Acid reflux (esophageal) and Drug allergy (Sulfa). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal), SPIRONOLACTONE, LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure high, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches) outcome was unknown.            Patient did not ever have COVID positive test or diagnosis. Patient did not give other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient took Tylenol 2 days after dose.   This case was linked to US-MODERNATX, INC.-MOD-2022-657178 (E2B Linked Report). This case was linked to MOD-2022-656985, MOD-2022-656992 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657178:same reporter
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bedridden, Chills, Malaise, Nausea, Pain
Clinical narrative: After 2nd dose, aches and pains; After 2nd dose, Fever; After 2nd dose,  the normal, headaches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pneumonia vaccine (Patient also had other reactions.), Flu vaccine (other reactions with Flu vaccine, had to take the low dose flu vaccine) and Shingles vaccine (Patient also had other reactions.). Past adverse reactions to the above products included Fever with Flu vaccine, Shingles vaccine and pneumonia vaccine. Concurrent medical conditions included Blood pressure high, Acid reflux (esophageal) and Drug allergy (Sulfa). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal), SPIRONOLACTONE, LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure high, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches) outcome was unknown.            Patient did not ever have COVID positive test or diagnosis. Patient did not give other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient took Tylenol 2 days after dose.   This case was linked to US-MODERNATX, INC.-MOD-2022-657178 (E2B Linked Report). This case was linked to MOD-2022-656985, MOD-2022-656992 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657178:same reporter
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: After 2nd dose, aches and pains; After 2nd dose, Fever; After 2nd dose,  the normal, headaches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pneumonia vaccine (Patient also had other reactions.), Flu vaccine (other reactions with Flu vaccine, had to take the low dose flu vaccine) and Shingles vaccine (Patient also had other reactions.). Past adverse reactions to the above products included Fever with Flu vaccine, Shingles vaccine and pneumonia vaccine. Concurrent medical conditions included Blood pressure high, Acid reflux (esophageal) and Drug allergy (Sulfa). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal), SPIRONOLACTONE, LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure high, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches) outcome was unknown.            Patient did not ever have COVID positive test or diagnosis. Patient did not give other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient took Tylenol 2 days after dose.   This case was linked to US-MODERNATX, INC.-MOD-2022-657178 (E2B Linked Report). This case was linked to MOD-2022-656985, MOD-2022-656992 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657178:same reporter
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Electrocardiogram, Heart rate, Palpitations, Ultrasound scan
Clinical narrative: After 2nd dose, aches and pains; After 2nd dose, Fever; After 2nd dose,  the normal, headaches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pneumonia vaccine (Patient also had other reactions.), Flu vaccine (other reactions with Flu vaccine, had to take the low dose flu vaccine) and Shingles vaccine (Patient also had other reactions.). Past adverse reactions to the above products included Fever with Flu vaccine, Shingles vaccine and pneumonia vaccine. Concurrent medical conditions included Blood pressure high, Acid reflux (esophageal) and Drug allergy (Sulfa). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal), SPIRONOLACTONE, LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure high, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (After 2nd dose, aches and pains), PYREXIA (After 2nd dose, Fever) and HEADACHE (After 2nd dose,  the normal, headaches) outcome was unknown.            Patient did not ever have COVID positive test or diagnosis. Patient did not give other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient took Tylenol 2 days after dose.   This case was linked to US-MODERNATX, INC.-MOD-2022-657178 (E2B Linked Report). This case was linked to MOD-2022-656985, MOD-2022-656992 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657178:same reporter
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 22-Dec-2020 and second dose on 27-Jan-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 025J20A) for COVID-19 prophylaxis.     It was reported that patient had no illness at the time of vaccination and up to one month before. It was also reported that patient had no chronic or long standing health conditions. It was unknown if the patient was on any Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.    On 22-Dec-2020 at 12:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jan-2021 at 8:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021).    No concomitant medication was reported.  No treatment medication was provided.   This case was linked to MOD-2022-657250, MOD-2022-655862 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow up received contains no new information.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: No adverse event; First dose on 22-Dec-2020 and second dose on 27-Jan-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 025J20A) for COVID-19 prophylaxis.     It was reported that patient had no illness at the time of vaccination and up to one month before. It was also reported that patient had no chronic or long standing health conditions. It was unknown if the patient was on any Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.    On 22-Dec-2020 at 12:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jan-2021 at 8:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021).    No concomitant medication was reported.  No treatment medication was provided.   This case was linked to MOD-2022-657250, MOD-2022-655862 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: On Sunday 09-Oct-2022 she took a home test which turned out positive and on 10-Oct-2022 she did a PCR test which was also positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (On Sunday 09-Oct-2022 she took a home test which turned out positive and on 10-Oct-2022 she did a PCR test which was also positive) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Oct-2022, the patient experienced COVID-19 (On Sunday 09-Oct-2022 she took a home test which turned out positive and on 10-Oct-2022 she did a PCR test which was also positive). At the time of the report, COVID-19 (On Sunday 09-Oct-2022 she took a home test which turned out positive and on 10-Oct-2022 she did a PCR test which was also positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2022, SARS-CoV-2 test: (Positive) Positive. On 10-Oct-2022, SARS-CoV-2 test: (Positive) Positive.         Relevant concomitant medications were not reported.  On 08-Oct-2022, the patient had cough and thought it was nervous cough. On Sunday 09-Oct-2022, she took a home test which turned out positive and on 10-Oct-2022, she did a PCR test which was also positive. Patient had mild symptoms. She would like to know if it was possible that her tests were false positive. She was afraid that she might have infected her friend.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: ADACEL was administered to a patient subcutaneously instead of intramuscularly,with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was administered to a patient subcutaneously instead of intramuscularly, with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation was unknown, lot number: U7453AA and expiry date: 29-Jun-2024) via subcutaneous route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of adacel was administered to a patient subcutaneously instead of intramuscularly, with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone high-dose quadrivalent being administered to a patient under 65 years of age (with no reported adverse event); Initial information was received on 06-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 60 years old female patient to whom fluzone high-dose quadrivalent being administered to a patient under 65 years of age (with no reported adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2022, the patient received 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot-UT7714AA and expiry 30-06-23) via intramuscular route in the left deltoid for immunization.  On 06-OCT-2022 the patient developed a non-serious fluzone high-dose quadrivalent being administered to a patient under 65 years of age (with no reported adverse event) (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken:not applicable.  At time of reporting, the outcome was Unknown for the event fluzone high-dose quadrivalent being administered to a patient under 65 years of age (with no reported adverse event).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Peripheral coldness, Pyrexia, Skin discolouration
Clinical narrative: Fingers and toes turning white and cold. Resolved after 3-4 hours. Fever and aches lasting 24+ hours.
Age: 45.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Tinnitus
Clinical narrative: Minor tinnitus in left ear. I received both vaccines at the same time, one in each shoulder. I am not sure which vaccine went into which shoulder and I think there is no way to tell if one vaccine or the other (or their interaction) caused the tinnitus.
Age: 31.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Right ear tinnitus, awoken from sleep at 2am, high pitch ring, constant, varying pitch, varying intensity low to medium-low.