chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection arm was warm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, FOLIC ACID, CALCIUM and MELOXICAM for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection arm was warm). At the time of the report, VACCINATION SITE WARMTH (Injection arm was warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown This case pertains to patient 1. Patient 1 calling to report their spouse (patient 2, reported in another crosslinked case) and themselves got three doses of the Moderna vaccine already. First dose was on 07Jan2021 (lot#039K20A, expiration date 20Jun2021), second dose was on 04Feb2021 (lot#029K20A, expiration date 31Dec2026) and the third dose was on 04Sep2021 (lot#037F21A) for both. Neither patient is immunocompromised, although patient 1 has diabetes and had their thyroid removed, and patient 2 has high blood pressure. Patient 1 reports that the next days, after their first and second dose, their injection arm was warm. After the second dose patient 1 also experienced a little discomfort and body ache. After the third dose, administered on the left arm, the next day patient 1 had to much swelling on their left arm, it was very hot, lasting 2-3 days, and they experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down. Patient 1 provides consent for Safety to follow up with them or their HCP. Patient 1 state that patient 2 had no reactions after getting the third dose. Patent mentions 3 other people got the third dose of the Moderna vaccine without any reactions. This will be reported in 3 different crosslinked cases   This case was linked to MOD-2021-318654, MOD-2021-318659 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Dizziness
Clinical narrative: Nasal congestion; Dizziness; Explosive diarrhea; Slight cough; weak from spending so many days in bed; Off label use; sore arm / muscle aches; Fever / continues to have fever 102.2; Chills; Headache; Fatigue / Exhausted; This spontaneous case was reported by a nurse and describes the occurrence of NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough) and ASTHENIA (weak from spending so many days in bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknwon) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney transplant in 1998 and Kidney transplant in 2019.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough), ASTHENIA (weak from spending so many days in bed), OFF LABEL USE (Off label use), MYALGIA (sore arm / muscle aches), PYREXIA (Fever / continues to have fever 102.2), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue / Exhausted). At the time of the report, NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough), ASTHENIA (weak from spending so many days in bed), MYALGIA (sore arm / muscle aches), PYREXIA (Fever / continues to have fever 102.2), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue / Exhausted) outcome was unknown and OFF LABEL USE (Off label use) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza A virus test: negative (Negative) negative for Flu A. On an unknown date, Influenza B virus test: negative (Negative) negative for Flu B. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The patient had test for Flu A and Flu B on unknown date ,whose result where Negative
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza A virus test, Influenza B virus test, Myalgia
Clinical narrative: Nasal congestion; Dizziness; Explosive diarrhea; Slight cough; weak from spending so many days in bed; Off label use; sore arm / muscle aches; Fever / continues to have fever 102.2; Chills; Headache; Fatigue / Exhausted; This spontaneous case was reported by a nurse and describes the occurrence of NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough) and ASTHENIA (weak from spending so many days in bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknwon) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney transplant in 1998 and Kidney transplant in 2019.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough), ASTHENIA (weak from spending so many days in bed), OFF LABEL USE (Off label use), MYALGIA (sore arm / muscle aches), PYREXIA (Fever / continues to have fever 102.2), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue / Exhausted). At the time of the report, NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough), ASTHENIA (weak from spending so many days in bed), MYALGIA (sore arm / muscle aches), PYREXIA (Fever / continues to have fever 102.2), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue / Exhausted) outcome was unknown and OFF LABEL USE (Off label use) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza A virus test: negative (Negative) negative for Flu A. On an unknown date, Influenza B virus test: negative (Negative) negative for Flu B. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The patient had test for Flu A and Flu B on unknown date ,whose result where Negative
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Off label use, Pyrexia, SARS-CoV-2 test
Clinical narrative: Nasal congestion; Dizziness; Explosive diarrhea; Slight cough; weak from spending so many days in bed; Off label use; sore arm / muscle aches; Fever / continues to have fever 102.2; Chills; Headache; Fatigue / Exhausted; This spontaneous case was reported by a nurse and describes the occurrence of NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough) and ASTHENIA (weak from spending so many days in bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknwon) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney transplant in 1998 and Kidney transplant in 2019.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough), ASTHENIA (weak from spending so many days in bed), OFF LABEL USE (Off label use), MYALGIA (sore arm / muscle aches), PYREXIA (Fever / continues to have fever 102.2), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue / Exhausted). At the time of the report, NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough), ASTHENIA (weak from spending so many days in bed), MYALGIA (sore arm / muscle aches), PYREXIA (Fever / continues to have fever 102.2), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue / Exhausted) outcome was unknown and OFF LABEL USE (Off label use) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza A virus test: negative (Negative) negative for Flu A. On an unknown date, Influenza B virus test: negative (Negative) negative for Flu B. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The patient had test for Flu A and Flu B on unknown date ,whose result where Negative
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Never got the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never got the second shot) 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 COVID-19.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never got the second shot). On 13-Sep-2021, PRODUCT DOSE OMISSION ISSUE (Never got the second shot) had resolved.            Concomitant product use was not provided.   Treatment information was not provided.    Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Influenza like illness
Clinical narrative: Helt like had flu; Diarrhea; sore right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Helt like had flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (sore right shoulder) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 017E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Helt like had flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (sore right shoulder). At the time of the report, INFLUENZA LIKE ILLNESS (Helt like had flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (sore right shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment informations were reported.   This case was linked to MOD-2021-320087 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Burning sensation, Feeling hot, Inflammation, Palmar erythema
Clinical narrative: Palms of both hands became inflamed; Itching; Felt like they were put on top of a hot stove; Intense burning; palms of both hands became inflamed red; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Palms of both hands became inflamed), PRURITUS (Itching), FEELING HOT (Felt like they were put on top of a hot stove), BURNING SENSATION (Intense burning) and PALMAR ERYTHEMA (palms of both hands became inflamed red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Palms of both hands became inflamed), PRURITUS (Itching), FEELING HOT (Felt like they were put on top of a hot stove), BURNING SENSATION (Intense burning), PALMAR ERYTHEMA (palms of both hands became inflamed red) and ALLERGY TO VACCINE (Allergic reaction). At the time of the report, INFLAMMATION (Palms of both hands became inflamed), PRURITUS (Itching), FEELING HOT (Felt like they were put on top of a hot stove), BURNING SENSATION (Intense burning), PALMAR ERYTHEMA (palms of both hands became inflamed red) and ALLERGY TO VACCINE (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It mentioned that the patient had other reactions but did not want to mention them and doctor told her to wait 3 months between vaccine.  No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Palms of both hands became inflamed; Itching; Felt like they were put on top of a hot stove; Intense burning; palms of both hands became inflamed red; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Palms of both hands became inflamed), PRURITUS (Itching), FEELING HOT (Felt like they were put on top of a hot stove), BURNING SENSATION (Intense burning) and PALMAR ERYTHEMA (palms of both hands became inflamed red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Palms of both hands became inflamed), PRURITUS (Itching), FEELING HOT (Felt like they were put on top of a hot stove), BURNING SENSATION (Intense burning), PALMAR ERYTHEMA (palms of both hands became inflamed red) and ALLERGY TO VACCINE (Allergic reaction). At the time of the report, INFLAMMATION (Palms of both hands became inflamed), PRURITUS (Itching), FEELING HOT (Felt like they were put on top of a hot stove), BURNING SENSATION (Intense burning), PALMAR ERYTHEMA (palms of both hands became inflamed red) and ALLERGY TO VACCINE (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It mentioned that the patient had other reactions but did not want to mention them and doctor told her to wait 3 months between vaccine.  No concomitant medications were reported.  No treatment medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness on Injection site after first vaccine; Sorenson Injection site after first vaccine; Tired at night after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on Injection site after first vaccine), VACCINATION SITE PAIN (Sorenson Injection site after first vaccine) and FATIGUE (Tired at night after first vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder (Autoimmune conditions) and Gastrointestinal surgery (Few years ago had to give her CPR post GI operation and her sternum was hurt.). Concomitant products included OMALIZUMAB (XOLAIR) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on Injection site after first vaccine), VACCINATION SITE PAIN (Sorenson Injection site after first vaccine) and FATIGUE (Tired at night after first vaccine). On 06-Mar-2021, VACCINATION SITE ERYTHEMA (Redness on Injection site after first vaccine), VACCINATION SITE PAIN (Sorenson Injection site after first vaccine) and FATIGUE (Tired at night after first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was mentioned as patient took Xolair for biologics. No treatment medication was given.  Company comment: This case concerns a 54-year-old female subject with medical history of autoimmune disorder and gastrointestinal surgery who experienced the events of vaccination site erythema, vaccination site pain, and fatigue. The events occurred approximately 1 day after the first dose of Spikevax. Rechallenge was positive (fatigue) after the second dose. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2021-320235 (Patient Link).; Sender's Comments: This case concerns a 54-year-old female subject with medical history of autoimmune disorder and gastrointestinal surgery who experienced the events of vaccination site erythema, vaccination site pain, and fatigue. The events occurred approximately 1 day after the first dose of Spikevax. Rechallenge was positive (fatigue) after the second dose. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Rhinorrhoea
Clinical narrative: Runny nose; Feel body aches; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), MYALGIA (Feel body aches) and HEADACHE (mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced RHINORRHOEA (Runny nose), MYALGIA (Feel body aches) and HEADACHE (mild headache). At the time of the report, RHINORRHOEA (Runny nose), MYALGIA (Feel body aches) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment or concomitant were reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant follow up-Events added and Contact information updated
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: i'm fully vax by mederna 4/5 and 5/4   3 weeks ago I was diagnosed positive with COVID Delta; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (i'm fully vax by mederna 4/5 and 5/4   3 weeks ago I was diagnosed positive with COVID Delta) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (i'm fully vax by mederna 4/5 and 5/4   3 weeks ago I was diagnosed positive with COVID Delta). At the time of the report, COVID-19 (i'm fully vax by mederna 4/5 and 5/4   3 weeks ago I was diagnosed positive with COVID Delta) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: sweating ( required her to change pajamas); dizziness; joints were locked; weak; all symptoms of the flu (cold and hot); fever; really tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating ( required her to change pajamas)), DIZZINESS (dizziness), JOINT LOCK (joints were locked), ASTHENIA (weak) and INFLUENZA LIKE ILLNESS (all symptoms of the flu (cold and hot)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included FLECAINIDE for Cardiac disorder, COLECALCIFEROL (VIT D3) for an unknown indication.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced HYPERHIDROSIS (sweating ( required her to change pajamas)), DIZZINESS (dizziness), JOINT LOCK (joints were locked), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (all symptoms of the flu (cold and hot)), PYREXIA (fever) and FATIGUE (really tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of taken 1 dosage form. On 18-Sep-2021, HYPERHIDROSIS (sweating ( required her to change pajamas)), DIZZINESS (dizziness), JOINT LOCK (joints were locked), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (all symptoms of the flu (cold and hot)), PYREXIA (fever) and FATIGUE (really tired) had resolved.            This case was linked to MOD-2021-324276 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up received. Contact information Updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Joint lock, Pyrexia
Clinical narrative: sweating ( required her to change pajamas); dizziness; joints were locked; weak; all symptoms of the flu (cold and hot); fever; really tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating ( required her to change pajamas)), DIZZINESS (dizziness), JOINT LOCK (joints were locked), ASTHENIA (weak) and INFLUENZA LIKE ILLNESS (all symptoms of the flu (cold and hot)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included FLECAINIDE for Cardiac disorder, COLECALCIFEROL (VIT D3) for an unknown indication.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced HYPERHIDROSIS (sweating ( required her to change pajamas)), DIZZINESS (dizziness), JOINT LOCK (joints were locked), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (all symptoms of the flu (cold and hot)), PYREXIA (fever) and FATIGUE (really tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of taken 1 dosage form. On 18-Sep-2021, HYPERHIDROSIS (sweating ( required her to change pajamas)), DIZZINESS (dizziness), JOINT LOCK (joints were locked), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (all symptoms of the flu (cold and hot)), PYREXIA (fever) and FATIGUE (really tired) had resolved.            This case was linked to MOD-2021-324276 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up received. Contact information Updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Rash macular, Urticaria
Clinical narrative: red marks on her upper chest and back spreading down her arm; spots looked like hives flat on the skin; Itching; 1st dose Aug 4th 2021 2nd dose Sep 13th 2021; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red marks on her upper chest and back spreading down her arm), URTICARIA (spots looked like hives flat on the skin), PRURITUS (Itching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Aug 4th 2021 2nd dose Sep 13th 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteraemia. Concomitant products included ALIROCUMAB (PRALUENT) for Hypercholesteremia, METOPROLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.    On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced RASH MACULAR (red marks on her upper chest and back spreading down her arm), URTICARIA (spots looked like hives flat on the skin), PRURITUS (Itching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Aug 4th 2021 2nd dose Sep 13th 2021). At the time of the report, RASH MACULAR (red marks on her upper chest and back spreading down her arm), URTICARIA (spots looked like hives flat on the skin) and PRURITUS (Itching) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Aug 4th 2021 2nd dose Sep 13th 2021) had resolved.            No treatment drugs were reported   This case was linked to MOD-2021-325429 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Left sore arm; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Left sore arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 12-Dec-2012. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Hypertension.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Left sore arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MYALGIA (Left sore arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications include blood pressure medications.   This case was linked to MOD-2021-325355 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received and medical history updated, concomitant medication updated.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer vaccine given as 2nd dose. Vaccine interchanged.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine given as 2nd dose. Vaccine interchanged.) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine given as 2nd dose. Vaccine interchanged.). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine given as 2nd dose. Vaccine interchanged.) 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 treatment medication information was provided. No concomitant medication information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ear haemorrhage, Feeling abnormal, Muscle spasticity, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Bleeding in her left ear after receiving the 1st dose/Fresh blood coming out of the left ear.; Right arm is hurting; Shoulder is cracking; Uncontrolled spasm in her right arm; Upset as hell because they used her as a guinea pig/So scared/Feels like she is going to die/She believes got screwed; This spontaneous case was reported by a consumer and describes the occurrence of EAR HAEMORRHAGE (Bleeding in her left ear after receiving the 1st dose/Fresh blood coming out of the left ear.), PAIN IN EXTREMITY (Right arm is hurting), MUSCULOSKELETAL DISCOMFORT (Shoulder is cracking), MUSCLE SPASTICITY (Uncontrolled spasm in her right arm) and FEELING ABNORMAL (Upset as hell because they used her as a guinea pig/So scared/Feels like she is going to die/She believes got screwed) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066021A) for COVID-19 vaccination.     Concurrent medical conditions included Mental disability and Physical disability.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR HAEMORRHAGE (Bleeding in her left ear after receiving the 1st dose/Fresh blood coming out of the left ear.), PAIN IN EXTREMITY (Right arm is hurting), MUSCULOSKELETAL DISCOMFORT (Shoulder is cracking), MUSCLE SPASTICITY (Uncontrolled spasm in her right arm) and FEELING ABNORMAL (Upset as hell because they used her as a guinea pig/So scared/Feels like she is going to die/She believes got screwed). At the time of the report, EAR HAEMORRHAGE (Bleeding in her left ear after receiving the 1st dose/Fresh blood coming out of the left ear.), PAIN IN EXTREMITY (Right arm is hurting), MUSCULOSKELETAL DISCOMFORT (Shoulder is cracking), MUSCLE SPASTICITY (Uncontrolled spasm in her right arm) and FEELING ABNORMAL (Upset as hell because they used her as a guinea pig/So scared/Feels like she is going to die/She believes got screwed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter has reported that patient went to ER No concomitant medication was given by reporter. No treatment medication was given by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Excursion/ Thawed 3 times/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours; Unknown number patients administered invalid dose/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Excursion/ Thawed 3 times/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Unknown number patients administered invalid dose/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Excursion/ Thawed 3 times/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Unknown number patients administered invalid dose/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours). At the time of the report, PRODUCT STORAGE ERROR (Excursion/ Thawed 3 times/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Unknown number patients administered invalid dose/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) had resolved.      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 medications were provided.  No treatment medications were provided.  Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Non-significant follow-up appended On 21-Sep-2021: Updated report's details and added Batch/Lot number. On 23-Sep-2021: The follow up document contains no new information. On 24-Sep-2021: Follow-up received contains additional non-significant information. On 25-Oct-2021: Non-significant follow-up due to reporter information updated.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Urticaria
Clinical narrative: HIVES ON EXTREMETIES AND BURING/POSSIBLE HIVES IN EAR CANAL ABOUT 60 MINUTES POST VACCINATION. PATIENT RESPONDED TO ORAL DIPHENHYDRAMINE AND WAS FEELING SYMPTOMATIC RELIEF 12 HOURS POST VACCINATION. WILL MONITOR FOR COMPLETE SYMPTOM RESOLUTION.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Immediate post-injection reaction, Incorrect route of product administration, Injection site reaction
Clinical narrative: Immediately I had a spasm in the muscle or site she injected into. I had a sharp pain shoot into my top shoulder area. She either injected it into the nerve or shoulder socket. I was unable to lift my arm for 3 days after injection and now 7 weeks later, I have constant pain in my shoulder that has now moved down into my arm. It interferes with my ability to raise my arm above my head and to lift things.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Immediately I had a spasm in the muscle or site she injected into. I had a sharp pain shoot into my top shoulder area. She either injected it into the nerve or shoulder socket. I was unable to lift my arm for 3 days after injection and now 7 weeks later, I have constant pain in my shoulder that has now moved down into my arm. It interferes with my ability to raise my arm above my head and to lift things.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Aphonia, Chest X-ray normal, Chills, Oropharyngeal pain, Painful respiration
Clinical narrative: 02/21/2022- Chills 02/22/2022 Congestion, sore throat, lost voice  02/23/2022 sore throat to a point painful to breath
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: 02/21/2022- Chills 02/22/2022 Congestion, sore throat, lost voice  02/23/2022 sore throat to a point painful to breath
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: all the symptoms of the flu; loss of appetite; headache; joint aches and pains; very tired; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (all the symptoms of the flu), DECREASED APPETITE (loss of appetite), HEADACHE (headache), ARTHRALGIA (joint aches and pains) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062B21A, 013L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII on 09-Sep-2021. Concurrent medical conditions included Asthma and Hashimoto's disease.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (all the symptoms of the flu), DECREASED APPETITE (loss of appetite), HEADACHE (headache), ARTHRALGIA (joint aches and pains) and FATIGUE (very tired). On 01-Oct-2021, CHILLS (chills) had resolved. On 02-Oct-2021, PYREXIA (fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (all the symptoms of the flu), DECREASED APPETITE (loss of appetite), HEADACHE (headache), ARTHRALGIA (joint aches and pains) and FATIGUE (very tired) outcome was unknown.            NO Concomitant medication was reported Patient did not take medication to treat symptoms. She had an elbow replacement in the right arm.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: all the symptoms of the flu; loss of appetite; headache; joint aches and pains; very tired; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (all the symptoms of the flu), DECREASED APPETITE (loss of appetite), HEADACHE (headache), ARTHRALGIA (joint aches and pains) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062B21A, 013L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII on 09-Sep-2021. Concurrent medical conditions included Asthma and Hashimoto's disease.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (all the symptoms of the flu), DECREASED APPETITE (loss of appetite), HEADACHE (headache), ARTHRALGIA (joint aches and pains) and FATIGUE (very tired). On 01-Oct-2021, CHILLS (chills) had resolved. On 02-Oct-2021, PYREXIA (fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (all the symptoms of the flu), DECREASED APPETITE (loss of appetite), HEADACHE (headache), ARTHRALGIA (joint aches and pains) and FATIGUE (very tired) outcome was unknown.            NO Concomitant medication was reported Patient did not take medication to treat symptoms. She had an elbow replacement in the right arm.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cognitive disorder, Computerised tomogram thorax, Confusional state, Dizziness
Clinical narrative: Extremely lightheaded. Vertigo. Confused. Dizzy. Cramps, Shortness of breath, Decreased cognitive function, Swollen lymph nodes,
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram ambulatory abnormal, Electromyogram, Lung disorder
Clinical narrative: Extremely lightheaded. Vertigo. Confused. Dizzy. Cramps, Shortness of breath, Decreased cognitive function, Swollen lymph nodes,
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscle spasms
Clinical narrative: Extremely lightheaded. Vertigo. Confused. Dizzy. Cramps, Shortness of breath, Decreased cognitive function, Swollen lymph nodes,
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Oesophagram, Pulmonary function test abnormal, Tachycardia, Urine analysis
Clinical narrative: Extremely lightheaded. Vertigo. Confused. Dizzy. Cramps, Shortness of breath, Decreased cognitive function, Swollen lymph nodes,
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Extremely lightheaded. Vertigo. Confused. Dizzy. Cramps, Shortness of breath, Decreased cognitive function, Swollen lymph nodes,
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: event occurred after 2nd vaccine; breakthrough case admission
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Neck pain, Pain
Clinical narrative: Local tenderness and localized swelling at time of injection. The injection site swelling gone in 12 hours. The localized pain remained and became worse. 16 days later, minimal pain (all the time), which increases substantially with movement. The pain moved up my arm into shoulder and neck. Reported to doctor on 2/23/2022 and to pharmacist on 2/26/2022. Doctor suggested heat. Pharmacist suggested ibuprofen. Neither seems to relieve the pain. I allow the pain to limit my activities. If the pain increases with a certain movement or activity, I stop what I'm doing.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Local tenderness and localized swelling at time of injection. The injection site swelling gone in 12 hours. The localized pain remained and became worse. 16 days later, minimal pain (all the time), which increases substantially with movement. The pain moved up my arm into shoulder and neck. Reported to doctor on 2/23/2022 and to pharmacist on 2/26/2022. Doctor suggested heat. Pharmacist suggested ibuprofen. Neither seems to relieve the pain. I allow the pain to limit my activities. If the pain increases with a certain movement or activity, I stop what I'm doing.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Diarrhoea
Clinical narrative: Severe severe, diarrhea, bed ridden, weakness for over a week.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Peripheral swelling
Clinical narrative: My left hand began to feel swollen several hours after receiving the shot, particularly when I made a fist. When I wake in the morning now, and make a fist with both hands, the left hand is very stiff and swollen compared to the right. The stiffness diminishes after a minute of opening and closing my hand, but that hand remains noticeably more swollen throughout the day than my right hand.  This was a booster shot, after a JJ initial shot. I have not sought medical treatment, as I don?t believe there is anything to be done about this.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration past beyond use date Exp 10/03/21; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration past beyond use date Exp 10/03/21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration past beyond use date Exp 10/03/21). On 02-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administration past beyond use date Exp 10/03/21) had resolved.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-348962 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Lethargy, Nausea
Clinical narrative: Fever 102, uncontrollable chills for 5 hours, incredibly severe headache, pain at injection site, nausea, sore throat, mild congestion, lethargy
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever 102, uncontrollable chills for 5 hours, incredibly severe headache, pain at injection site, nausea, sore throat, mild congestion, lethargy
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling cold, Injection site pain, Pain
Clinical narrative: Large red, warm/hot and swollen mark on my arm. Still there 3 days later. Still warm, red, swollen and sore to touch.   Along with uncontrollable shivering and body aches from the afternoon of day 1 throughout day 2.    By the beginning of day 3 with OTC excedrin the body aches had cleared.  The shivering and cold only lasted the whole of the first night.  The tenderness in the arm at the injection site continues currently.  The red swollen area is about 3?x2? on my upper arm.  We so sore the first day/night it was impossible to sleep on that side.   There were no side effects from the first shingrix shot.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Sleep disorder
Clinical narrative: Large red, warm/hot and swollen mark on my arm. Still there 3 days later. Still warm, red, swollen and sore to touch.   Along with uncontrollable shivering and body aches from the afternoon of day 1 throughout day 2.    By the beginning of day 3 with OTC excedrin the body aches had cleared.  The shivering and cold only lasted the whole of the first night.  The tenderness in the arm at the injection site continues currently.  The red swollen area is about 3?x2? on my upper arm.  We so sore the first day/night it was impossible to sleep on that side.   There were no side effects from the first shingrix shot.