chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Off label use, Product administered to patient of inappropriate age
Clinical narrative: DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; FLU LIKE SYMPTOMS; OFF LABEL USE; This spontaneous report received from a physician concerned a 16 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and  expiry: 21/JUN/2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced drug administered to subject of inappropriate age. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 04-APR-2021, and the outcome of drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache
Clinical narrative: HEADACHE; FEELS WARM; CHILLS; This spontaneous report received from a consumer concerned a 35 year old male.  The patient's weight was 160 pounds, and height was not reported. The patient's concurrent conditions included non-smoker, and alcohol use, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced feels warm. On 07-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feels warm, and chills on 07-APR-2021, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Product administration error, Product storage error
Clinical narrative: PUNCTURED VACCINE VIAL HAS BEEN IN THE FRIDGE FOR MORE THAN 6 HOURS; MEDICATION ERROR; VACCINE WAS  LEFT OVERNIGHT IN THE FRIDGE AND TODAY A DOSE OF THE VACCINE FROM THIS VIAL WAS ADMINISTERED; This spontaneous report received from a pharmacist 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced vaccine was left overnight in the fridge and today a dose of the vaccine from this vial was administered. On an unspecified date, the subject experienced punctured vaccine vial has been in the fridge for more than 6 hours, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vaccine vial has been in the fridge for more than 6 hours, medication error and vaccine was left overnight in the fridge and today a dose of the vaccine from this vial was administered was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Hypoaesthesia, Migraine
Clinical narrative: BRAIN FOG; MIGRAINE; TIRED; NAUSEA; TINGLING IN HANDS; NUMBNESS IN HANDS; ARM HURT; VERY SHARP STABBING PAIN IN RIGHT SHOULDER; FEVER >103; This spontaneous report received from a patient concerned a 41 year old female. 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced tingling in hands. On 25-MAR-2021, the subject experienced numbness in hands. On 25-MAR-2021, the subject experienced arm hurt. On 25-MAR-2021, the subject experienced very sharp stabbing pain in right shoulder. On 25-MAR-2021, the subject experienced fever >103. On 25-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced migraine. On 26-MAR-2021, the subject experienced brain fog. On 26-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and nausea on 25-MAR-2021, and fever >103 on 28-MAR-2021, and was recovering from numbness in hands, migraine, brain fog, tired, very sharp stabbing pain in right shoulder, and tingling in hands. This report was non-serious. This case is associated with PQC number: 90000175693.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: BRAIN FOG; MIGRAINE; TIRED; NAUSEA; TINGLING IN HANDS; NUMBNESS IN HANDS; ARM HURT; VERY SHARP STABBING PAIN IN RIGHT SHOULDER; FEVER >103; This spontaneous report received from a patient concerned a 41 year old female. 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced tingling in hands. On 25-MAR-2021, the subject experienced numbness in hands. On 25-MAR-2021, the subject experienced arm hurt. On 25-MAR-2021, the subject experienced very sharp stabbing pain in right shoulder. On 25-MAR-2021, the subject experienced fever >103. On 25-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced migraine. On 26-MAR-2021, the subject experienced brain fog. On 26-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and nausea on 25-MAR-2021, and fever >103 on 28-MAR-2021, and was recovering from numbness in hands, migraine, brain fog, tired, very sharp stabbing pain in right shoulder, and tingling in hands. This report was non-serious. This case is associated with PQC number: 90000175693.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Pyrexia, Vaginal lesion
Clinical narrative: MUCOSAL ULCERS ON VAGINA; CANKER SORES ON LABIA; MUCOSAL ULCER ON LABIA; FEVERISH; JOINT PAIN; ON AND OFF HEADACHE; FEELING BAD; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included headache, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient was previously treated with acetylsalicylic acid/caffeine/paracetamol for on and off headache.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced feeling bad. On APR-2021, the subject experienced on and off headache. On 04-APR-2021, the subject experienced joint pain. On 05-APR-2021, the subject experienced mucosal ulcers on vagina. On 05-APR-2021, the subject experienced canker sores on labia. On 05-APR-2021, the subject experienced mucosal ulcer on labia. On 05-APR-2021, the subject experienced feverish. On 07-APR-2021, treatment medications included: benzocaine. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, feeling bad, on and off headache, and feverish on APR-2021, and had not recovered from mucosal ulcers on vagina, canker sores on labia, and mucosal ulcer on labia. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal ulceration, Vulval ulceration
Clinical narrative: MUCOSAL ULCERS ON VAGINA; CANKER SORES ON LABIA; MUCOSAL ULCER ON LABIA; FEVERISH; JOINT PAIN; ON AND OFF HEADACHE; FEELING BAD; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included headache, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient was previously treated with acetylsalicylic acid/caffeine/paracetamol for on and off headache.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced feeling bad. On APR-2021, the subject experienced on and off headache. On 04-APR-2021, the subject experienced joint pain. On 05-APR-2021, the subject experienced mucosal ulcers on vagina. On 05-APR-2021, the subject experienced canker sores on labia. On 05-APR-2021, the subject experienced mucosal ulcer on labia. On 05-APR-2021, the subject experienced feverish. On 07-APR-2021, treatment medications included: benzocaine. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, feeling bad, on and off headache, and feverish on APR-2021, and had not recovered from mucosal ulcers on vagina, canker sores on labia, and mucosal ulcer on labia. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Insomnia, Nightmare
Clinical narrative: WEAKNESS; NIGHTMARE; UNABLE TO SLEEP; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to antibiotics, alcohol, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: paracetamol. On 07-APR-2021, the subject experienced nightmare. On 07-APR-2021, the subject experienced unable to sleep. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 8/10. On 08-APR-2021, the subject experienced weakness. Laboratory data included: Pain scale (NR: not provided) 2/10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and chills, had not recovered from weakness, and the outcome of nightmare and unable to sleep was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment
Clinical narrative: WEAKNESS; NIGHTMARE; UNABLE TO SLEEP; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to antibiotics, alcohol, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: paracetamol. On 07-APR-2021, the subject experienced nightmare. On 07-APR-2021, the subject experienced unable to sleep. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 8/10. On 08-APR-2021, the subject experienced weakness. Laboratory data included: Pain scale (NR: not provided) 2/10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and chills, had not recovered from weakness, and the outcome of nightmare and unable to sleep was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Back pain, Body temperature, Chills
Clinical narrative: THROWING UP; BACK PAIN; UPSET STOMACH; STOMACH PAIN; NECK PAIN; CHILLS; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 34 year old female. 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 07-APR-2021 for prophylactic vaccination. .The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol.  On 07-APR-2021, the subject experienced throwing up. On 07-APR-2021, the subject experienced back pain. On 07-APR-2021, the subject experienced upset stomach. On 07-APR-2021, the subject experienced stomach pain. On 07-APR-2021, the subject experienced neck pain. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103.7 (not reported), 102.9 not reported), 99-100 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain, neck pain, stomach pain, headache, fever, throwing up, fatigue, upset stomach, and chills. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Pyrexia, Vomiting
Clinical narrative: THROWING UP; BACK PAIN; UPSET STOMACH; STOMACH PAIN; NECK PAIN; CHILLS; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 34 year old female. 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 07-APR-2021 for prophylactic vaccination. .The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol.  On 07-APR-2021, the subject experienced throwing up. On 07-APR-2021, the subject experienced back pain. On 07-APR-2021, the subject experienced upset stomach. On 07-APR-2021, the subject experienced stomach pain. On 07-APR-2021, the subject experienced neck pain. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103.7 (not reported), 102.9 not reported), 99-100 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain, neck pain, stomach pain, headache, fever, throwing up, fatigue, upset stomach, and chills. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO INAPPROPRIATE AGE GROUP; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a 13 year old male. The patient's weight was 150 pounds, and height was 176.784 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: 09-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced vaccine administered to inappropriate age group. On 08-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to inappropriate age group and off label use was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysphemia, Feeling cold, Heart rate increased, Pyrexia
Clinical narrative: HEART RATE HIGH; STUTTERING; EXTREME COLD/CHILLING; SUPER HIGH FEVER; This spontaneous report received from a patient via a company representative 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced heart rate high, stuttering, extreme cold/chilling, and super high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from super high fever, heart rate high, stuttering, and extreme cold/chilling. 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle tightness
Clinical narrative: LOWER BACK PAIN; TIGHTNESS OF BACK; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 08-APR-2021 to right arm for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced lower back pain.  On 08-APR-2021, the subject experienced tightness of back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower back pain, and tightness of back. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: SORE ARM; ACHY; BRAIN FOG; HEADACHE; This spontaneous report received from a consumer . 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 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 pain in arm. On MAR-2021, the subject experienced ache. On MAR-2021, the subject experienced brain fog. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, ache, brain fog, and headache on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Tremor
Clinical narrative: FATIGUE; ARM PAIN; SHAKES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced shakes. On 19-MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes on 19-MAR-2021, and fatigue, and arm pain on 21-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210417720.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site mass
Clinical narrative: INJECTION SITE LUMP; INJECTION SITE BRUISING; 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced injection site lump, and injection site bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site lump, and injection site bruising. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Full blood count, Headache
Clinical narrative: NECK STIFFNESS; HEADACHE; INJECTION SITE TENDERNESS; INJECTION SITE REDNESS; CHILLS; FEVER; LUMP BY THE COLLARBONE ON THE LEFT SIDE (LEFT SIDE WAS INJECTION SIDE); This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included PCOS, stomach ulcer, and hashimoto, and concurrent conditions included sensitive to food numerous, non alcohol, and non smoker.  The patient was previously treated with ethinylestradiol/norethindrone for birth control, sucralfate for stomach ulcer, and levothyroxine for hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lump by the collarbone on the left side (left side was injection side). On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) BELOW 99 F. On 09-APR-2021 10:00, the subject experienced injection site tenderness. On 09-APR-2021 10:00, the subject experienced injection site redness. On an unspecified date, the subject experienced neck stiffness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, had not recovered from lump by the collarbone on the left side (left side was injection side), and the outcome of neck stiffness, headache, injection site tenderness and injection site redness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: NECK STIFFNESS; HEADACHE; INJECTION SITE TENDERNESS; INJECTION SITE REDNESS; CHILLS; FEVER; LUMP BY THE COLLARBONE ON THE LEFT SIDE (LEFT SIDE WAS INJECTION SIDE); This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included PCOS, stomach ulcer, and hashimoto, and concurrent conditions included sensitive to food numerous, non alcohol, and non smoker.  The patient was previously treated with ethinylestradiol/norethindrone for birth control, sucralfate for stomach ulcer, and levothyroxine for hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lump by the collarbone on the left side (left side was injection side). On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) BELOW 99 F. On 09-APR-2021 10:00, the subject experienced injection site tenderness. On 09-APR-2021 10:00, the subject experienced injection site redness. On an unspecified date, the subject experienced neck stiffness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, had not recovered from lump by the collarbone on the left side (left side was injection side), and the outcome of neck stiffness, headache, injection site tenderness and injection site redness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Feeling hot, Medication error, Off label use
Clinical narrative: MULTIPLE DOSE/RECEIVED INJECTION BOTH IN LEFT AND RIGHT ARM; LITTLE HOT; OFF-LABEL USE; MEDICATION ERROR; This spontaneous report received from a health care professional concerned a 53 year old female. 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: 205A21A, and expiry: UNKNOWN) 0.5 ml, administered on 09-APR-2021 10:00, and 0.5 ml, administered on 09-APR-2021 10:15 for prophylactic vaccination.  No concomitant medications were reported. On 09-APR-2021, the subject experienced multiple dose/received injection both in left and right arm. On 09-APR-2021, the subject experienced little hot. On 09-APR-2021, the subject experienced off-label use. On 09-APR-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little hot, and the outcome of multiple dose/received injection both in left and right arm, off-label use and medication error was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Myalgia, Tinnitus
Clinical narrative: SHORTNESS OF BREATH; TINNITUS; CHILLS; FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced shortness of breath.  On 09-APR-2021, the subject experienced tinnitus. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tinnitus on 09-APR-2021, and chills, and had not recovered from shortness of breath, fatigue, and muscle ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Neck pain
Clinical narrative: CHILLS/SHIVERING; PAIN IN THE NECK MUSCLES; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to antibiotics, and type 1 diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included insulin for type 1 diabetes mellitus.  On 09-APR-2021, the subject experienced chills.  On 09-APR-2021, the subject experienced pain in the neck muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and pain in the neck muscles. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: TROUBLE BREATHING; LIGHT HEADEDNESS/ DIZZINESS; HEADACHE; TIREDNESS/FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included asthma, allergies to pollen, allergy to penicillin, sulfur allergy, and she feels tired all the time. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for trouble breathing, and asthma. On 08-APR-2021, the subject experienced trouble breathing. On 08-APR-2021, the subject experienced light headedness/ dizziness. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness/fatigue. On 08-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headedness/ dizziness, headache, trouble breathing, tiredness/fatigue, and nausea. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 31 year old male. 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 and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersensitivity, Nausea, Pain, Pain in extremity
Clinical narrative: VOMITING; DIARRHEA; ACHY ALL OVER; BURNING PAIN IN LEGS; NAUSEA; ALLERGY SYMPTOMS; HIVES; This spontaneous report received from a parent 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergy symptoms. On APR-2021, the subject experienced hives. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced achy all over. On 08-APR-2021, the subject experienced burning pain in legs. On 08-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, nausea, diarrhea, burning pain in legs, achy all over, allergy symptoms and hives was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: VOMITING; DIARRHEA; ACHY ALL OVER; BURNING PAIN IN LEGS; NAUSEA; ALLERGY SYMPTOMS; HIVES; This spontaneous report received from a parent 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergy symptoms. On APR-2021, the subject experienced hives. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced achy all over. On 08-APR-2021, the subject experienced burning pain in legs. On 08-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, nausea, diarrhea, burning pain in legs, achy all over, allergy symptoms and hives was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Musculoskeletal stiffness
Clinical narrative: NECK TIGHT/SORE; HEADACHE; FEVER; ITCHY; SHAKING ALL OVER; CHILLS; WEAKNESS; MUSCLE ACHE; This spontaneous report received from a patient. 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: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 102 F. On 08-APR-2021 19:00, the subject experienced itchy. On 08-APR-2021 19:00, the subject experienced shaking all over. On 08-APR-2021 19:00, the subject experienced chills. On 08-APR-2021 19:00, the subject experienced weakness. On 08-APR-2021 20:30, the subject experienced fever. On 09-APR-2021, the subject experienced neck tight/sore. On 09-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy, and shaking all over on 09-APR-2021, was recovering from weakness, chills, and fever, and had not recovered from muscle ache, headache, and neck tight/sore. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Pyrexia, Tremor
Clinical narrative: NECK TIGHT/SORE; HEADACHE; FEVER; ITCHY; SHAKING ALL OVER; CHILLS; WEAKNESS; MUSCLE ACHE; This spontaneous report received from a patient. 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: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 102 F. On 08-APR-2021 19:00, the subject experienced itchy. On 08-APR-2021 19:00, the subject experienced shaking all over. On 08-APR-2021 19:00, the subject experienced chills. On 08-APR-2021 19:00, the subject experienced weakness. On 08-APR-2021 20:30, the subject experienced fever. On 09-APR-2021, the subject experienced neck tight/sore. On 09-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy, and shaking all over on 09-APR-2021, was recovering from weakness, chills, and fever, and had not recovered from muscle ache, headache, and neck tight/sore. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Cold sweat, Headache
Clinical narrative: TEETH  CHATTERING; NAUSEA; HEADACHE; SHAKY FEVER/FEVER GREATER THEN 104F; CLAMMY; FAST HEART RATE; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to hazelnut, allergy to latex, alcoholic (2 -3 glasses on weekend), and non smoker, and other pre-existing medical conditions included patient had no previous medical history and had no drug abuse/illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:22 for prophylactic vaccination. Concomitant medications included ibuprofen for fever, and paracetamol for fever. On 08-APR-2021, the subject experienced chest tightness. Laboratory data included: Body temperature (NR: not provided) Greater then 104 F. On 08-APR-2021 17:30, the subject experienced clammy. On 08-APR-2021 17:30, the subject experienced fast heart rate. On 08-APR-2021 17:30, the subject experienced teeth chattering. On 08-APR-2021 17:30, the subject experienced nausea. On 08-APR-2021 17:30, the subject experienced headache. On 08-APR-2021 17:30, the subject experienced shaky fever/fever greater then 104F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clammy, and fast heart rate, and chest tightness on 08-APR-2021, was recovering from shaky fever/fever greater then 104f, and teeth chattering, and had not recovered from nausea, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pyrexia
Clinical narrative: TEETH  CHATTERING; NAUSEA; HEADACHE; SHAKY FEVER/FEVER GREATER THEN 104F; CLAMMY; FAST HEART RATE; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to hazelnut, allergy to latex, alcoholic (2 -3 glasses on weekend), and non smoker, and other pre-existing medical conditions included patient had no previous medical history and had no drug abuse/illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:22 for prophylactic vaccination. Concomitant medications included ibuprofen for fever, and paracetamol for fever. On 08-APR-2021, the subject experienced chest tightness. Laboratory data included: Body temperature (NR: not provided) Greater then 104 F. On 08-APR-2021 17:30, the subject experienced clammy. On 08-APR-2021 17:30, the subject experienced fast heart rate. On 08-APR-2021 17:30, the subject experienced teeth chattering. On 08-APR-2021 17:30, the subject experienced nausea. On 08-APR-2021 17:30, the subject experienced headache. On 08-APR-2021 17:30, the subject experienced shaky fever/fever greater then 104F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clammy, and fast heart rate, and chest tightness on 08-APR-2021, was recovering from shaky fever/fever greater then 104f, and teeth chattering, and had not recovered from nausea, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nervousness, Pain
Clinical narrative: WRECKED ALL DAY; HORRIBLE ACHES OVER MY WHOLE BODY; MUSCLE PAIN; 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, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 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 an unspecified date, the subject experienced wrecked all day, horrible aches over my whole body, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrecked all day, horrible aches over my whole body and muscle pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain
Clinical narrative: ACHE; LIGHT HEADEDNESS; FATIGUE; This spontaneous report received from a physician 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced ache, light headedness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ache, fatigue and light headedness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; 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 09-APR-2021 for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms. This report was non-serious. This case, from the same reporter is linked to 20210428195.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 INFECTION; .This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and seasonal allergies, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced covid 19 infection. On 08-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chills, Dizziness, Headache
Clinical narrative: DROP IN BLOOD PRESSURE; DIZZYNESS; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse / illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced drop in blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, dizziness, headache, and drop in blood pressure. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: TINGLING AND BURNING SENSATION IN FEET; WEAK IN THE BODY; TIRED IN THE BODY; FEELING NUMB IN THE HANDS; This spontaneous report received from a patient concerned a 61 year old female. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feeling numb in the hands. On 05-APR-2021, the subject experienced tired in the body. On 08-APR-2021, the subject experienced tingling and burning sensation in feet. On 08-APR-2021, the subject experienced weak in the body. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired in the body, and feeling numb in the hands, and had not recovered from tingling and burning sensation in feet, and weak in the body. This report was non-serious.