chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pruritus, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Low grade fever 99.9; arm red; arm warm; arm tender; arm swollen; Itchy; Body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (Low grade fever 99.9), VACCINATION SITE ERYTHEMA (arm red), VACCINATION SITE WARMTH (arm warm), VACCINATION SITE PAIN (arm tender) and VACCINATION SITE SWELLING (arm swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021 at 1:02 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021 at 4:00 AM, the patient experienced PYREXIA (Low grade fever 99.9). 23-Jan-2021 at 4:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (arm red), VACCINATION SITE WARMTH (arm warm), VACCINATION SITE PAIN (arm tender), VACCINATION SITE SWELLING (arm swollen), PRURITUS (Itchy) and MYALGIA (Body aches). At the time of the report, PYREXIA (Low grade fever 99.9), VACCINATION SITE ERYTHEMA (arm red), VACCINATION SITE WARMTH (arm warm), VACCINATION SITE PAIN (arm tender), VACCINATION SITE SWELLING (arm swollen), PRURITUS (Itchy) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Low grade fever 99.9; arm red; arm warm; arm tender; arm swollen; Itchy; Body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (Low grade fever 99.9), VACCINATION SITE ERYTHEMA (arm red), VACCINATION SITE WARMTH (arm warm), VACCINATION SITE PAIN (arm tender) and VACCINATION SITE SWELLING (arm swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021 at 1:02 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021 at 4:00 AM, the patient experienced PYREXIA (Low grade fever 99.9). 23-Jan-2021 at 4:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (arm red), VACCINATION SITE WARMTH (arm warm), VACCINATION SITE PAIN (arm tender), VACCINATION SITE SWELLING (arm swollen), PRURITUS (Itchy) and MYALGIA (Body aches). At the time of the report, PYREXIA (Low grade fever 99.9), VACCINATION SITE ERYTHEMA (arm red), VACCINATION SITE WARMTH (arm warm), VACCINATION SITE PAIN (arm tender), VACCINATION SITE SWELLING (arm swollen), PRURITUS (Itchy) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: unsure if she is pregnant; one big circle; Injection site was a raised red patch; very itchy; swollen; Looks like hives; Covid arm; warm to the touch; A spontaneous report was received from a consumer concerning a 43-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm/hypersensitivity, injection site was a raised red patch/vaccination site erythema, warm to the touch/vaccination site warmth, very itchy/vaccination site pruritus, swollen, one big circle/vaccination site reaction, looks like hives/vaccination site urticaria, unsure if she is pregnant/pregnancy.  The patient's medical history include allergies to ivory soap, hypothyroidism. Concomitant medications reported were hypothyroidism for drug use for unknown indication.  On 31 Jan 2021, approximately 8 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) covid arm, injection site was a raised red patch, warm to the touch, very itchy, swollen. One big circle, looks like hives. On an unknown date, the patient experienced the event(s) unsure if she is pregnant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), covid arm, injection site was a raised red patch, warm to the touch, very itchy, swollen, one big circle, looks like hives, unsure if she is pregnant was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site warmth, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: unsure if she is pregnant; one big circle; Injection site was a raised red patch; very itchy; swollen; Looks like hives; Covid arm; warm to the touch; A spontaneous report was received from a consumer concerning a 43-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm/hypersensitivity, injection site was a raised red patch/vaccination site erythema, warm to the touch/vaccination site warmth, very itchy/vaccination site pruritus, swollen, one big circle/vaccination site reaction, looks like hives/vaccination site urticaria, unsure if she is pregnant/pregnancy.  The patient's medical history include allergies to ivory soap, hypothyroidism. Concomitant medications reported were hypothyroidism for drug use for unknown indication.  On 31 Jan 2021, approximately 8 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) covid arm, injection site was a raised red patch, warm to the touch, very itchy, swollen. One big circle, looks like hives. On an unknown date, the patient experienced the event(s) unsure if she is pregnant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), covid arm, injection site was a raised red patch, warm to the touch, very itchy, swollen, one big circle, looks like hives, unsure if she is pregnant was unknown.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: continuous diarrhea; A spontaneous report was received from a consumer concerning a 27 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events continuous diarrhea /diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) continuous diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), continuous diarrhea was unknown.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: continuous diarrhea; A spontaneous report was received from a consumer concerning a 27 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events continuous diarrhea /diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) continuous diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), continuous diarrhea was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: abdominal pain; diarrhea; vomiting; fever; chills; cheek swelled; hives on top of his head,forehead and chest; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (cheek swelled), URTICARIA (hives on top of his head,forehead and chest), ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING FACE (cheek swelled) and URTICARIA (hives on top of his head,forehead and chest). On 13-Mar-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills). At the time of the report, SWELLING FACE (cheek swelled), URTICARIA (hives on top of his head,forehead and chest), ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Pyrexia, Swelling face
Clinical narrative: abdominal pain; diarrhea; vomiting; fever; chills; cheek swelled; hives on top of his head,forehead and chest; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (cheek swelled), URTICARIA (hives on top of his head,forehead and chest), ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING FACE (cheek swelled) and URTICARIA (hives on top of his head,forehead and chest). On 13-Mar-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills). At the time of the report, SWELLING FACE (cheek swelled), URTICARIA (hives on top of his head,forehead and chest), ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: abdominal pain; diarrhea; vomiting; fever; chills; cheek swelled; hives on top of his head,forehead and chest; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (cheek swelled), URTICARIA (hives on top of his head,forehead and chest), ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING FACE (cheek swelled) and URTICARIA (hives on top of his head,forehead and chest). On 13-Mar-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills). At the time of the report, SWELLING FACE (cheek swelled), URTICARIA (hives on top of his head,forehead and chest), ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Injection site pain, Myalgia, Pain in extremity, Skin lesion
Clinical narrative: sharp, shooting pains into neck and head; sharp, shooting pains into neck and head; ugly, painful shingles like lesions; large and small shingles like lesions; elbow pain/ wrist pain/ shoulder pain; bad arm ache at injection site; sore arm; lightheadedness; disorientation; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), DISORIENTATION (disorientation), PAIN IN EXTREMITY (sore arm), HERPES ZOSTER (ugly, painful shingles like lesions) and HERPES ZOSTER (large and small shingles like lesions) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced DIZZINESS (lightheadedness) and DISORIENTATION (disorientation). On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Feb-2021, the patient experienced ARTHRALGIA (elbow pain/ wrist pain/ shoulder pain) and VACCINATION SITE PAIN (bad arm ache at injection site). On 28-Feb-2021, the patient experienced HERPES ZOSTER (ugly, painful shingles like lesions) and HERPES ZOSTER (large and small shingles like lesions). On 06-Mar-2021, the patient experienced NECK PAIN (sharp, shooting pains into neck and head) and HEADACHE (sharp, shooting pains into neck and head). At the time of the report, DIZZINESS (lightheadedness), DISORIENTATION (disorientation), PAIN IN EXTREMITY (sore arm), HERPES ZOSTER (ugly, painful shingles like lesions), HERPES ZOSTER (large and small shingles like lesions), NECK PAIN (sharp, shooting pains into neck and head), ARTHRALGIA (elbow pain/ wrist pain/ shoulder pain), VACCINATION SITE PAIN (bad arm ache at injection site) and HEADACHE (sharp, shooting pains into neck and head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Gabapentin and Tylenol for nerve pain and general pain.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: FU information included Email ID and address updated.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin reaction
Clinical narrative: sharp, shooting pains into neck and head; sharp, shooting pains into neck and head; ugly, painful shingles like lesions; large and small shingles like lesions; elbow pain/ wrist pain/ shoulder pain; bad arm ache at injection site; sore arm; lightheadedness; disorientation; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), DISORIENTATION (disorientation), PAIN IN EXTREMITY (sore arm), HERPES ZOSTER (ugly, painful shingles like lesions) and HERPES ZOSTER (large and small shingles like lesions) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced DIZZINESS (lightheadedness) and DISORIENTATION (disorientation). On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Feb-2021, the patient experienced ARTHRALGIA (elbow pain/ wrist pain/ shoulder pain) and VACCINATION SITE PAIN (bad arm ache at injection site). On 28-Feb-2021, the patient experienced HERPES ZOSTER (ugly, painful shingles like lesions) and HERPES ZOSTER (large and small shingles like lesions). On 06-Mar-2021, the patient experienced NECK PAIN (sharp, shooting pains into neck and head) and HEADACHE (sharp, shooting pains into neck and head). At the time of the report, DIZZINESS (lightheadedness), DISORIENTATION (disorientation), PAIN IN EXTREMITY (sore arm), HERPES ZOSTER (ugly, painful shingles like lesions), HERPES ZOSTER (large and small shingles like lesions), NECK PAIN (sharp, shooting pains into neck and head), ARTHRALGIA (elbow pain/ wrist pain/ shoulder pain), VACCINATION SITE PAIN (bad arm ache at injection site) and HEADACHE (sharp, shooting pains into neck and head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Gabapentin and Tylenol for nerve pain and general pain.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: FU information included Email ID and address updated.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Disorientation, Dizziness, Headache, Herpes zoster
Clinical narrative: sharp, shooting pains into neck and head; sharp, shooting pains into neck and head; ugly, painful shingles like lesions; large and small shingles like lesions; elbow pain/ wrist pain/ shoulder pain; bad arm ache at injection site; sore arm; lightheadedness; disorientation; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), DISORIENTATION (disorientation), PAIN IN EXTREMITY (sore arm), HERPES ZOSTER (ugly, painful shingles like lesions) and HERPES ZOSTER (large and small shingles like lesions) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced DIZZINESS (lightheadedness) and DISORIENTATION (disorientation). On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Feb-2021, the patient experienced ARTHRALGIA (elbow pain/ wrist pain/ shoulder pain) and VACCINATION SITE PAIN (bad arm ache at injection site). On 28-Feb-2021, the patient experienced HERPES ZOSTER (ugly, painful shingles like lesions) and HERPES ZOSTER (large and small shingles like lesions). On 06-Mar-2021, the patient experienced NECK PAIN (sharp, shooting pains into neck and head) and HEADACHE (sharp, shooting pains into neck and head). At the time of the report, DIZZINESS (lightheadedness), DISORIENTATION (disorientation), PAIN IN EXTREMITY (sore arm), HERPES ZOSTER (ugly, painful shingles like lesions), HERPES ZOSTER (large and small shingles like lesions), NECK PAIN (sharp, shooting pains into neck and head), ARTHRALGIA (elbow pain/ wrist pain/ shoulder pain), VACCINATION SITE PAIN (bad arm ache at injection site) and HEADACHE (sharp, shooting pains into neck and head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Gabapentin and Tylenol for nerve pain and general pain.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: FU information included Email ID and address updated.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: sharp, shooting pains into neck and head; sharp, shooting pains into neck and head; ugly, painful shingles like lesions; large and small shingles like lesions; elbow pain/ wrist pain/ shoulder pain; bad arm ache at injection site; sore arm; lightheadedness; disorientation; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), DISORIENTATION (disorientation), PAIN IN EXTREMITY (sore arm), HERPES ZOSTER (ugly, painful shingles like lesions) and HERPES ZOSTER (large and small shingles like lesions) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced DIZZINESS (lightheadedness) and DISORIENTATION (disorientation). On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Feb-2021, the patient experienced ARTHRALGIA (elbow pain/ wrist pain/ shoulder pain) and VACCINATION SITE PAIN (bad arm ache at injection site). On 28-Feb-2021, the patient experienced HERPES ZOSTER (ugly, painful shingles like lesions) and HERPES ZOSTER (large and small shingles like lesions). On 06-Mar-2021, the patient experienced NECK PAIN (sharp, shooting pains into neck and head) and HEADACHE (sharp, shooting pains into neck and head). At the time of the report, DIZZINESS (lightheadedness), DISORIENTATION (disorientation), PAIN IN EXTREMITY (sore arm), HERPES ZOSTER (ugly, painful shingles like lesions), HERPES ZOSTER (large and small shingles like lesions), NECK PAIN (sharp, shooting pains into neck and head), ARTHRALGIA (elbow pain/ wrist pain/ shoulder pain), VACCINATION SITE PAIN (bad arm ache at injection site) and HEADACHE (sharp, shooting pains into neck and head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Gabapentin and Tylenol for nerve pain and general pain.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: FU information included Email ID and address updated.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash papular
Clinical narrative: raised; red; covid arm; warm; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (raised), ERYTHEMA (red), VACCINATION SITE REACTION (covid arm), FEELING HOT (warm) and PRURITUS (Itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (MULTI-VIT) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH PAPULAR (raised), ERYTHEMA (red), VACCINATION SITE REACTION (covid arm), FEELING HOT (warm) and PRURITUS (Itchy). At the time of the report, RASH PAPULAR (raised), ERYTHEMA (red), VACCINATION SITE REACTION (covid arm), FEELING HOT (warm) and PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash papular, Vaccination site reaction
Clinical narrative: raised; red; covid arm; warm; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (raised), ERYTHEMA (red), VACCINATION SITE REACTION (covid arm), FEELING HOT (warm) and PRURITUS (Itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (MULTI-VIT) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH PAPULAR (raised), ERYTHEMA (red), VACCINATION SITE REACTION (covid arm), FEELING HOT (warm) and PRURITUS (Itchy). At the time of the report, RASH PAPULAR (raised), ERYTHEMA (red), VACCINATION SITE REACTION (covid arm), FEELING HOT (warm) and PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Hypoaesthesia, Menstruation delayed, Muscle tightness, Paraesthesia
Clinical narrative: HIGH BLOOD PRESSURE; OTHER HEART CONDITIONS; SORE ARM FROM THE NECK DOWN TO THE ELBOW; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced high blood pressure, other heart conditions, and sore arm from the neck down to the elbow. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine was not applicable. The outcome of the sore arm from the neck down to the elbow, high blood pressure and other heart conditions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: HIGH BLOOD PRESSURE; OTHER HEART CONDITIONS; SORE ARM FROM THE NECK DOWN TO THE ELBOW; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced high blood pressure, other heart conditions, and sore arm from the neck down to the elbow. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine was not applicable. The outcome of the sore arm from the neck down to the elbow, high blood pressure and other heart conditions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Cardiac disorder, Hypertension, Pain in extremity
Clinical narrative: HIGH BLOOD PRESSURE; OTHER HEART CONDITIONS; SORE ARM FROM THE NECK DOWN TO THE ELBOW; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced high blood pressure, other heart conditions, and sore arm from the neck down to the elbow. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine was not applicable. The outcome of the sore arm from the neck down to the elbow, high blood pressure and other heart conditions was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Syncope
Clinical narrative: Anaphylactic reaction killed him hours after the shot
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Autopsy, Death
Clinical narrative: Anaphylactic reaction killed him hours after the shot
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Agitation, Disorganised speech, Incoherent
Clinical narrative: Fever and confusion started around 10am on 4.26.21 with progressing to shortness of breath and tangential speaking and severe dehydration preceded loss of executive reasoning( occurred around 3 pm).  Combative demeanor and confusion resulted in transportation to ER.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aggression, Confusional state, Dehydration, Dyspnoea, Impaired reasoning
Clinical narrative: Fever and confusion started around 10am on 4.26.21 with progressing to shortness of breath and tangential speaking and severe dehydration preceded loss of executive reasoning( occurred around 3 pm).  Combative demeanor and confusion resulted in transportation to ER.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pyrexia, Tangentiality
Clinical narrative: Fever and confusion started around 10am on 4.26.21 with progressing to shortness of breath and tangential speaking and severe dehydration preceded loss of executive reasoning( occurred around 3 pm).  Combative demeanor and confusion resulted in transportation to ER.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Computerised tomogram, Deep vein thrombosis, Malaise, Platelet count decreased
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet factor 4, Pulmonary embolism, Pyrexia
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Headache, Hypertension, Laboratory test abnormal, Pain
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Pulmonary embolism, Tremor, Ultrasound Doppler abnormal
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Anxiety, Back pain, Blood pressure increased
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Condition aggravated, Echocardiogram, Headache
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Intensive care, Intestinal ischaemia, Laboratory test abnormal, Platelet count decreased, Pulmonary thrombosis
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative, Scan, Surgery
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia, Thrombosis, Tremor, Vomiting
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abnormal faeces, Antiphospholipid antibodies, Blood pressure increased, Blood pressure measurement, Body temperature
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings