chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Kinrix to a 9 month old male patient; administered Kinrix / instead of D-Tap & and Polio (3rd dose); This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported.  The  9 month old patient inadvertently administered with Kinrix instead of D-Tap & and Polio (3rd dose), which led to inappropriate age at vaccine administration and wrong vaccine administered. No further details provided. The reporter consent to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pruritus, Scar, Skin ulcer
Clinical narrative: Sores on his legs / have spread to his entire body /  like moon craters; The sores itch; Combination of scars and sores; First / vaccine in November, 2019 / Consumer just took the first dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of skin ulcer in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, between 1 and 2 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced skin ulcer, pruritus, scar and incomplete course of vaccination. The patient was treated with loratadine (Claritine). On 13th April 2021, the outcome of the skin ulcer was not recovered/not resolved. On an unknown date, the outcome of the pruritus, scar and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the skin ulcer, pruritus and scar to be related to Shingrix.  Additional details were provided as follows: The patient reported that he received 1st dose of Shingrix on November 2019. After one and one half to two week later he experienced sores on his legs the sores were itchy and were spread to entire body except the genitals. The patient describe them as looking like moon craters and they were a combination of scars and sores. The patient was taking Claritin for the sores, but it was becoming less effective. The patient was advised to see a physician. The patient did not received 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient who received a pediatric dose of Engerix-B; Adult patient who received a pediatric dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 65-year-old female patient who received HBV (Engerix B) (batch number LX4XP, expiry date 6th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 13th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a pediatric dose of Engerix-B which led to adult use of a child product and underdose. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ear swelling, Erythema, Feeling hot, Hypoaesthesia, Injection site pain
Clinical narrative: NUMB CHEEK; WARM LEFT EAR; RED LEFT EAR; SENSATION OF TINGLE ON LEFT SIDE OF THE FACE; LEFT EAR SWOLLEN; FACIAL MUSCLE SWOLLEN; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 220 pounds, and height was 187.96 centimeters. The patient's concurrent conditions included penicillin allergy, allergic reaction to bee stings, insect bites allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included none and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 13:42 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for acid reflux. On 06-MAR-2021, the subject experienced numb cheek. On 06-MAR-2021, the subject experienced warm left ear. On 06-MAR-2021, the subject experienced red left ear. On 06-MAR-2021, the subject experienced sensation of tingle on left side of the face. On 06-MAR-2021, the subject experienced left ear swollen. On 06-MAR-2021, the subject experienced facial muscle swollen. On 06-MAR-2021, the subject experienced pain at the injection site. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left ear swollen, and facial muscle swollen, and had not recovered from numb cheek, warm left ear, pain at the injection site, red left ear, and sensation of tingle on left side of the face. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face
Clinical narrative: NUMB CHEEK; WARM LEFT EAR; RED LEFT EAR; SENSATION OF TINGLE ON LEFT SIDE OF THE FACE; LEFT EAR SWOLLEN; FACIAL MUSCLE SWOLLEN; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 220 pounds, and height was 187.96 centimeters. The patient's concurrent conditions included penicillin allergy, allergic reaction to bee stings, insect bites allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included none and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 13:42 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for acid reflux. On 06-MAR-2021, the subject experienced numb cheek. On 06-MAR-2021, the subject experienced warm left ear. On 06-MAR-2021, the subject experienced red left ear. On 06-MAR-2021, the subject experienced sensation of tingle on left side of the face. On 06-MAR-2021, the subject experienced left ear swollen. On 06-MAR-2021, the subject experienced facial muscle swollen. On 06-MAR-2021, the subject experienced pain at the injection site. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left ear swollen, and facial muscle swollen, and had not recovered from numb cheek, warm left ear, pain at the injection site, red left ear, and sensation of tingle on left side of the face. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, Fatigue, Feeling hot, Headache
Clinical narrative: HOT; UPPER BACK PAIN; STUFFY NOSE; RECURRENT FEVER; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 110 pounds, and height was 62.4 inches. The patient's past medical history included anaphylactic reaction to penicillin, and anaphylactic reaction to sulfa drug, and concurrent conditions included non alocoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no history of drug abuse or drug illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced hot. On 10-MAR-2021, the subject experienced upper back pain. On 10-MAR-2021, the subject experienced stuffy nose. On 10-MAR-2021, the subject experienced recurrent fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) LOW TEMPERATURE not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from recurrent fever, nausea, and headache on 13-MAR-2021, and had not recovered from hot, upper back pain, fatigue, and stuffy nose. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Nausea, Pyrexia
Clinical narrative: HOT; UPPER BACK PAIN; STUFFY NOSE; RECURRENT FEVER; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 110 pounds, and height was 62.4 inches. The patient's past medical history included anaphylactic reaction to penicillin, and anaphylactic reaction to sulfa drug, and concurrent conditions included non alocoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no history of drug abuse or drug illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced hot. On 10-MAR-2021, the subject experienced upper back pain. On 10-MAR-2021, the subject experienced stuffy nose. On 10-MAR-2021, the subject experienced recurrent fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) LOW TEMPERATURE not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from recurrent fever, nausea, and headache on 13-MAR-2021, and had not recovered from hot, upper back pain, fatigue, and stuffy nose. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypoaesthesia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: HOT; UPPER BACK PAIN; STUFFY NOSE; RECURRENT FEVER; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 110 pounds, and height was 62.4 inches. The patient's past medical history included anaphylactic reaction to penicillin, and anaphylactic reaction to sulfa drug, and concurrent conditions included non alocoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no history of drug abuse or drug illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced hot. On 10-MAR-2021, the subject experienced upper back pain. On 10-MAR-2021, the subject experienced stuffy nose. On 10-MAR-2021, the subject experienced recurrent fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) LOW TEMPERATURE not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from recurrent fever, nausea, and headache on 13-MAR-2021, and had not recovered from hot, upper back pain, fatigue, and stuffy nose. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Ear pain, Fatigue
Clinical narrative: NECK WAS PAINFUL; EARS WERE PAINFUL; BAD CASE OF THE FLU; DIFFICULT TO SLEEP; FEELS AWFUL; BODY ACHE; LETHARGIC; SEVERE CHILLS; PAINFUL JOINTS; HEAD WAS PAINFUL; PAINFUL MUSCLE; NAUSEA; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 140 (pound), and height was 167.64 (centimeter). The patient's concurrent conditions included shellfish allergy, alcohlic, artheriosclerosis, cholesterol, non smoker, and contrast dye allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse. The patient experienced mild adverse events when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 10-MAR-2021 10:00 on right arm for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included rosuvastatin for cholesterol, ascorbic acid, colecalciferol, fish oil, magnesium, sambucus nigra, and zinc. On 10-MAR-2021, the subject experienced neck was painful. On 10-MAR-2021, the subject experienced ears were painful. On 10-MAR-2021, the subject experienced bad case of the flu. On 10-MAR-2021, the subject experienced difficult to sleep. On 10-MAR-2021, the subject experienced feels awful. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced severe chills. On 10-MAR-2021, the subject experienced painful joints. On 10-MAR-2021, the subject experienced head was painful. On 10-MAR-2021, the subject experienced painful muscle. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) low grade fever of 100. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears were painful, bad case of the flu, feels awful, body ache, head was painful, nausea, and low grade fever on 13-MAR-2021, and severe chills, and fatigue on MAR-2021, had not recovered from lethargic, and the outcome of neck was painful, painful joints, painful muscle and difficult to sleep was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Influenza, Insomnia, Lethargy
Clinical narrative: NECK WAS PAINFUL; EARS WERE PAINFUL; BAD CASE OF THE FLU; DIFFICULT TO SLEEP; FEELS AWFUL; BODY ACHE; LETHARGIC; SEVERE CHILLS; PAINFUL JOINTS; HEAD WAS PAINFUL; PAINFUL MUSCLE; NAUSEA; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 140 (pound), and height was 167.64 (centimeter). The patient's concurrent conditions included shellfish allergy, alcohlic, artheriosclerosis, cholesterol, non smoker, and contrast dye allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse. The patient experienced mild adverse events when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 10-MAR-2021 10:00 on right arm for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included rosuvastatin for cholesterol, ascorbic acid, colecalciferol, fish oil, magnesium, sambucus nigra, and zinc. On 10-MAR-2021, the subject experienced neck was painful. On 10-MAR-2021, the subject experienced ears were painful. On 10-MAR-2021, the subject experienced bad case of the flu. On 10-MAR-2021, the subject experienced difficult to sleep. On 10-MAR-2021, the subject experienced feels awful. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced severe chills. On 10-MAR-2021, the subject experienced painful joints. On 10-MAR-2021, the subject experienced head was painful. On 10-MAR-2021, the subject experienced painful muscle. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) low grade fever of 100. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears were painful, bad case of the flu, feels awful, body ache, head was painful, nausea, and low grade fever on 13-MAR-2021, and severe chills, and fatigue on MAR-2021, had not recovered from lethargic, and the outcome of neck was painful, painful joints, painful muscle and difficult to sleep was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: NECK WAS PAINFUL; EARS WERE PAINFUL; BAD CASE OF THE FLU; DIFFICULT TO SLEEP; FEELS AWFUL; BODY ACHE; LETHARGIC; SEVERE CHILLS; PAINFUL JOINTS; HEAD WAS PAINFUL; PAINFUL MUSCLE; NAUSEA; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 140 (pound), and height was 167.64 (centimeter). The patient's concurrent conditions included shellfish allergy, alcohlic, artheriosclerosis, cholesterol, non smoker, and contrast dye allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse. The patient experienced mild adverse events when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 10-MAR-2021 10:00 on right arm for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included rosuvastatin for cholesterol, ascorbic acid, colecalciferol, fish oil, magnesium, sambucus nigra, and zinc. On 10-MAR-2021, the subject experienced neck was painful. On 10-MAR-2021, the subject experienced ears were painful. On 10-MAR-2021, the subject experienced bad case of the flu. On 10-MAR-2021, the subject experienced difficult to sleep. On 10-MAR-2021, the subject experienced feels awful. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced severe chills. On 10-MAR-2021, the subject experienced painful joints. On 10-MAR-2021, the subject experienced head was painful. On 10-MAR-2021, the subject experienced painful muscle. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) low grade fever of 100. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears were painful, bad case of the flu, feels awful, body ache, head was painful, nausea, and low grade fever on 13-MAR-2021, and severe chills, and fatigue on MAR-2021, had not recovered from lethargic, and the outcome of neck was painful, painful joints, painful muscle and difficult to sleep was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: BITTER TASTE IN MOUTH; This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 132 (pound), and height was 5.3 inches. The patient's past medical history included urinary tract infection, and concurrent conditions included irritable bowel syndrome, sinus congestion, non alcohol user, non smoker, and pollen allergy, and other pre-existing medical conditions included the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021;12:45 to left arm for prophylactic vaccination. Concomitant medications included vitamins nos for drug use for unapproved indication. On 10-MAR-2021, the subject experienced bitter taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bitter taste in mouth. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: VOMITING; ARM SORENESS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced arm soreness. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, arm soreness, and fever on MAR-2021. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Influenza like illness, Lip swelling, Pharyngeal swelling
Clinical narrative: SWOLLEN LIPS; SWOLLEN THROAT; DIZZINESS; FLUSHED FACE; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was 194 (unit unspecified), and height was 71 inches. The patient's concurrent conditions included gout, alcohol use, non-smoker, cipro allergy, high cholesterol, and high blood pressure, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 08:00 in left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, febuxostat for drug used for unknown indication, losartan for drug used for unknown indication, pravastatin for drug used for unknown indication, probiotics nos for drug used for unknown indication, selenium for drug used for unknown indication, vitamin d nos for drug used for unknown indication, and calcium. On 08-MAR-2021, the subject experienced swollen lips. On 08-MAR-2021, the subject experienced swollen throat. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced flushed face. On 08-MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lips, swollen throat, dizziness, and flushed face on 08-MAR-2021, and flu-like symptoms on 10-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fall, Gait disturbance, Musculoskeletal stiffness
Clinical narrative: DIZZY; FALLS; SHAKING; NEUROLOGICAL DISORDER; DIFFICULTY IN WALKING; LEGS STIFFENING; LOWER BACK PAIN WORSE; BACK OF LEG AND BACK OF ARM PAIN; FEVER RUNNING CONSTANTLY; BODY ACHES/PAIN ALL OVER BODY; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included failed neck and back surgery, and car accident, and concurrent conditions included hashimoto's disease, high cholesterol, high blood pressure, type 2 diabetes, glaucoma, arthritis in back, herniated disc, bulging disc, upper back scoliosis, severe hearing loss, irritable bowel syndrome, sulfa and sulfate drugs allergy, upper/lower back pain, and neck pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrocodone for neck pain, and upper/lower back pain. On 16-MAR-2021, the subject experienced body aches/pain all over body. On 16-MAR-2021, the subject experienced legs stiffening. On 16-MAR-2021, the subject experienced lower back pain worse. On 16-MAR-2021, the subject experienced back of leg and back of arm pain. On 16-MAR-2021, the subject experienced fever running constantly. On 17-MAR-2021, the subject experienced difficulty in walking. On an unspecified date, the subject experienced dizzy, falls, shaking, and neurological disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty in walking, back of leg and back of arm pain, legs stiffening, and lower back pain worse, and the outcome of body aches/pain all over body, fever running constantly, dizzy, falls, neurological disorder and shaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: DIZZY; FALLS; SHAKING; NEUROLOGICAL DISORDER; DIFFICULTY IN WALKING; LEGS STIFFENING; LOWER BACK PAIN WORSE; BACK OF LEG AND BACK OF ARM PAIN; FEVER RUNNING CONSTANTLY; BODY ACHES/PAIN ALL OVER BODY; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included failed neck and back surgery, and car accident, and concurrent conditions included hashimoto's disease, high cholesterol, high blood pressure, type 2 diabetes, glaucoma, arthritis in back, herniated disc, bulging disc, upper back scoliosis, severe hearing loss, irritable bowel syndrome, sulfa and sulfate drugs allergy, upper/lower back pain, and neck pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrocodone for neck pain, and upper/lower back pain. On 16-MAR-2021, the subject experienced body aches/pain all over body. On 16-MAR-2021, the subject experienced legs stiffening. On 16-MAR-2021, the subject experienced lower back pain worse. On 16-MAR-2021, the subject experienced back of leg and back of arm pain. On 16-MAR-2021, the subject experienced fever running constantly. On 17-MAR-2021, the subject experienced difficulty in walking. On an unspecified date, the subject experienced dizzy, falls, shaking, and neurological disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty in walking, back of leg and back of arm pain, legs stiffening, and lower back pain worse, and the outcome of body aches/pain all over body, fever running constantly, dizzy, falls, neurological disorder and shaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Breath odour, Chest pain, Cough, Discharge
Clinical narrative: WET MUCUS IN MOUTH; MOUTH WITH FOUL ODOR; MOUTHFUL OF WHITE THICK FLUID; FEELING OVERALL SICK; FATIGUED; FEVER; COULD NOT CATCH BREATH; COUGH; CHEST PAIN; CONGESTION; TACHYCARDIA; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included head injury, and concurrent conditions included cannot read/see very well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805829, expiry: UNKNOWN) dose was not reported, administered to left deltoid on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 21-MAR-2021, the subject experienced congestion. On 21-MAR-2021, the subject experienced tachycardia. On 21-MAR-2021, the subject experienced chest pain. On 21-MAR-2021, the subject experienced cough. On 21-MAR-2021, the subject experienced could not catch breath. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99-100. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 28-MAR-2021, the subject experienced wet mucus in mouth. On 28-MAR-2021, the subject experienced mouth with foul odor. On 28-MAR-2021, the subject experienced mouthful of white thick fluid. On 28-MAR-2021, the subject experienced feeling overall sick. On 28-MAR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, chest pain, could not catch breath, and fever on 23-MAR-2021, and feeling overall sick, and fatigued on 31-MAR-2021, and had not recovered from congestion, mouth with foul odor, cough, wet mucus in mouth, and mouthful of white thick fluid. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Malaise, Nasal congestion, Pyrexia
Clinical narrative: WET MUCUS IN MOUTH; MOUTH WITH FOUL ODOR; MOUTHFUL OF WHITE THICK FLUID; FEELING OVERALL SICK; FATIGUED; FEVER; COULD NOT CATCH BREATH; COUGH; CHEST PAIN; CONGESTION; TACHYCARDIA; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included head injury, and concurrent conditions included cannot read/see very well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805829, expiry: UNKNOWN) dose was not reported, administered to left deltoid on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 21-MAR-2021, the subject experienced congestion. On 21-MAR-2021, the subject experienced tachycardia. On 21-MAR-2021, the subject experienced chest pain. On 21-MAR-2021, the subject experienced cough. On 21-MAR-2021, the subject experienced could not catch breath. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99-100. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 28-MAR-2021, the subject experienced wet mucus in mouth. On 28-MAR-2021, the subject experienced mouth with foul odor. On 28-MAR-2021, the subject experienced mouthful of white thick fluid. On 28-MAR-2021, the subject experienced feeling overall sick. On 28-MAR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, chest pain, could not catch breath, and fever on 23-MAR-2021, and feeling overall sick, and fatigued on 31-MAR-2021, and had not recovered from congestion, mouth with foul odor, cough, wet mucus in mouth, and mouthful of white thick fluid. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Secretion discharge, Tachycardia
Clinical narrative: WET MUCUS IN MOUTH; MOUTH WITH FOUL ODOR; MOUTHFUL OF WHITE THICK FLUID; FEELING OVERALL SICK; FATIGUED; FEVER; COULD NOT CATCH BREATH; COUGH; CHEST PAIN; CONGESTION; TACHYCARDIA; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included head injury, and concurrent conditions included cannot read/see very well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805829, expiry: UNKNOWN) dose was not reported, administered to left deltoid on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 21-MAR-2021, the subject experienced congestion. On 21-MAR-2021, the subject experienced tachycardia. On 21-MAR-2021, the subject experienced chest pain. On 21-MAR-2021, the subject experienced cough. On 21-MAR-2021, the subject experienced could not catch breath. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99-100. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 28-MAR-2021, the subject experienced wet mucus in mouth. On 28-MAR-2021, the subject experienced mouth with foul odor. On 28-MAR-2021, the subject experienced mouthful of white thick fluid. On 28-MAR-2021, the subject experienced feeling overall sick. On 28-MAR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, chest pain, could not catch breath, and fever on 23-MAR-2021, and feeling overall sick, and fatigued on 31-MAR-2021, and had not recovered from congestion, mouth with foul odor, cough, wet mucus in mouth, and mouthful of white thick fluid. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Myalgia
Clinical narrative: INFLAMMATION IN THE ABDOMINAL AREA; TIRED/FATIGUE; MUSCLE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry: not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced muscle pain. On an unspecified date, the subject experienced inflammation in the abdominal area, and tired/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, and the outcome of tired/fatigue and inflammation in the abdominal area was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic increased, Body temperature, Dizziness, Fatigue
Clinical narrative: FEVERISH; NAUSEA; BLOOD PRESSURE WAS 181/80; COLD HANDS AROUND 18:00; FAST HEART RATE; WOOZY; MORE TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced woozy. On MAR-2021, the subject experienced more tired. On 18-MAR-2021, the subject experienced blood pressure was 181/80. On 18-MAR-2021, the subject experienced cold hands around 18:00. On 18-MAR-2021, the subject experienced fast heart rate. On 18-MAR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) 181/80 (unit not provided), and Heart rate (NR: not provided) 135 (unit not provided). On 18-MAR-2021 21:00, the subject experienced feverish. Laboratory data included: Body temperature (NR: not provided) 102.1 (unit not provided). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure was 181/80, cold hands around 18:00, woozy, feverish, nausea, and more tired on 20-MAR-2021, and fast heart rate on 19-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nausea, Peripheral coldness, Pyrexia
Clinical narrative: FEVERISH; NAUSEA; BLOOD PRESSURE WAS 181/80; COLD HANDS AROUND 18:00; FAST HEART RATE; WOOZY; MORE TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced woozy. On MAR-2021, the subject experienced more tired. On 18-MAR-2021, the subject experienced blood pressure was 181/80. On 18-MAR-2021, the subject experienced cold hands around 18:00. On 18-MAR-2021, the subject experienced fast heart rate. On 18-MAR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) 181/80 (unit not provided), and Heart rate (NR: not provided) 135 (unit not provided). On 18-MAR-2021 21:00, the subject experienced feverish. Laboratory data included: Body temperature (NR: not provided) 102.1 (unit not provided). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure was 181/80, cold hands around 18:00, woozy, feverish, nausea, and more tired on 20-MAR-2021, and fast heart rate on 19-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eyelid boil, Eyelid rash, Paraesthesia, Pruritus
Clinical narrative: Broke out in itchy, swollen, red rash. Began as single spot on right eyelid withing 4 hours of receiving vaccine. Spread over first week, across temple and forehead and chin, later on belly (which spread to cover 1/4 torso below waist on front side), between legs on both sides at top of inner thighs, latter on outer thighs of both legs. Felt like needles pricking skin if fabric touched skin. Lasted three weeks. However, at three weeks I am sill not over the rash. I can now function normally, even though the skin is still red and slightly itchy.  Oddly, the rash was strong on the right side of my body with a fainter mirror image on the left side. I reported all this on the V-SAFE app.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Swelling
Clinical narrative: Broke out in itchy, swollen, red rash. Began as single spot on right eyelid withing 4 hours of receiving vaccine. Spread over first week, across temple and forehead and chin, later on belly (which spread to cover 1/4 torso below waist on front side), between legs on both sides at top of inner thighs, latter on outer thighs of both legs. Felt like needles pricking skin if fabric touched skin. Lasted three weeks. However, at three weeks I am sill not over the rash. I can now function normally, even though the skin is still red and slightly itchy.  Oddly, the rash was strong on the right side of my body with a fainter mirror image on the left side. I reported all this on the V-SAFE app.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Full blood count, Thrombocytopenia
Clinical narrative: I already have Thrombocytopenia, but platelets (which were averaging 90,000-95,000) dropped to 59,000
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER AND CHILLS
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Pyrexia
Clinical narrative: FEVER AND CHILLS
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: 5 hours after shot, fever, chills, body aches, nausea. Continued for 40 hours afterwards.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: High Fever,Extreme Fatigue and muscle aches over the course of a week
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Syncope
Clinical narrative: None stated.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Dysmenorrhoea, Heavy menstrual bleeding, Pyrexia
Clinical narrative: High fever for 3 days, lost of taste.  Stomach pains and heavy menstrual cramps and bleeding. Blood cloths while menstrual cycle.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: High fever for 3 days, lost of taste.  Stomach pains and heavy menstrual cramps and bleeding. Blood cloths while menstrual cycle.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Pain in extremity, Sleep disorder
Clinical narrative: When I woke up the day after receiving the vaccine my armpit on the left (side I received the vaccine) and the underside of my arm heading towards my elbow (but not all the way to the elbow) was in excruciating pain.  The pain kept me up til 5am the following day and this continued for 5 nights.  I treated it with frozen vegetable packs under my arm.  Very very painful.  I have had surgical procedures and take ZERO painkillers......have a high threshold for pain, and I'm telling you this was bad....very uncomfortable.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash/swelling in location where shot was administered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Wheezing
Clinical narrative: Covid 19 wheezing
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Fatigue, Influenza like illness, Malaise
Clinical narrative: Flu like symptoms - fatigue, chills, general malaise - 24 hours Heartburn - 48 hours
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Electrocardiogram, Exposure during pregnancy
Clinical narrative: First time mother, in her third trimester of pregnancy, diagnosed with Bells Palsy on April 11th, 2021, after receiving her first dose of the Pfizer brand COVID-19 vaccine on April 7th, 2021. Her son is due May 26th, 2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling face, Toothache
Clinical narrative: 2days after my teeth! My teeth are in so much pain only on the left side and now I have swollen glands in my neck left side! My face is getting puffy on the left side as well! I just want to know am I the only one!? I am now laying on a heating pad around that area! And taking tylenol because ibuprofen makes it worse! I would do this over again but want to know if it is normal and how long will it take for it to come out of my teeth!? Thank you!
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Disturbance in attention, Feeling abnormal
Clinical narrative: The second dose has caused me to lose a lot of my senses such as smell and taste.  I still feel like my head is swimming and it is hard to concentrate.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Very sore arm. Mild swelling. Very painful to move my arm. Especially painful moving upwards over my head.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased
Clinical narrative: Increased heart rate, heart rate elevated to 171 bpm during my work day. Heart rate episode lasted an hour before going back down. Intense chest pains and sharp pain while breathing.  I now have a heart rate monitor for the next two weeks to ensure nothing else happens and if it happens the doctors will be able to track everything.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Headache, Hypoaesthesia, Malaise, Vomiting
Clinical narrative: While conducting a mobile vaccination clinic for workers , patient came to the clinic for her 1st dose of the Moderna Vaccine. She received the vaccine at 15:10 hours and proceeded to the 15 minute waiting area where she was observed with no complaints and or reactions at that time. The patient then proceeded back to work in the cold storage area of the packing shed. at about 16:15 we received a call that there was female who was not feeling well. she was brought back to the vaccination area, where she stated that she had a severe headache, numbness to both arms and had emesis one time. patient vital signs were BP 124/78, pulse normal sinus rhythm at 73 beat per minute, oxygen saturation 99% at room air, glucometer reading of 101, respirations 16 non labored. Patient states that the headache is an 8 on a scale form 1-10 and denies having felt bad at all in the last week. patient was transport to ER.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Laboratory test normal, Seizure
Clinical narrative: Got shot on the 30th, on April 1st,  5th, 14th and 15th I have had mini seizures. No history of any either. They can't find out what has caused the seizures. But the vaccine is the only thing that has changed. All test have came back clear so far.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Started 48 hours after injection, and is still there 72+ hours later. Contacted medical professional through a telehealth visit, who recommended Benadryl as to not impact the vaccine's effectiveness, but suggested monitoring it incase it increased in severity.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Night sweats, Pain, Pyrexia
Clinical narrative: Chills Fever 103 Body aches Headaches Night sweats
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Post procedural haemorrhage
Clinical narrative: Postprocedural hemorrhage of a digestive system organ or structure following a digestive system procedure