chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: mild pain in the site of injection; This spontaneous report received from a consumer concerned a 35 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced mild pain in the site of injection. The action taken with covid-19 vaccine was not applicable. The outcome of mild pain in the site of injection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: BLOODLETTING TO GO WITH IT; PAINLESS VACCINATION HAD SOME PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 bloodletting to go with it, and painless vaccination had some pain. The action taken with covid-19 vaccine was not applicable. The outcome of the painless vaccination had some pain and bloodletting to go with it was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain
Clinical narrative: KNOCKED OUT THE NEXT DAY; WAS NOT IN A LOT OF PAIN; SOME CHILLS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 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 knocked out the next day, was not in a lot of pain, some chills, and fatigue. The action taken with covid-19 vaccine was not applicable. The outcome of the knocked out the next day, fatigue, some chills and was not in a lot of pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills
Clinical narrative: VERY SORE BACK/HOT PATCHES; SEVERE CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 29-MAY-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 very sore back/hot patches, and severe chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of the severe chills and very sore back/hot patches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: INCONSISTENT TIMING OF PERIODS; WORSENED MENSTRUAL CRAMPS; DRAGGING FOR AN ENTIRE WEEK; WORSENED HEADACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 inconsistent timing of periods, worsened menstrual cramps, dragging for an entire week, and worsened headaches. The action taken with covid-19 vaccine was not applicable. The outcome of the inconsistent timing of periods, worsened menstrual cramps, worsened headaches and dragging for an entire week was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nausea, Pyrexia, Vomiting
Clinical narrative: FEVER; NAUSEA; SICK ALL NIGHT; VOMITING; This spontaneous report received from a consumer concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no significant medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAY-2021, the subject experienced sick all night. On 30-MAY-2021, the subject experienced vomiting. On 30-MAY-2021, the subject experienced nausea. On 31-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, sick all night, nausea, and vomiting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Poor quality sleep
Clinical narrative: COLD FOR LIKE 20 HOURS; LOT OF BODY ACHES; SNOOZE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 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 number. No concomitant medications were reported.  On an unspecified date, the subject experienced cold for like 20 hours, lot of body aches, and snooze. The action taken with covid-19 vaccine was not applicable. The patient was recovering from cold for like 20 hours, and the outcome of lot of body aches and snooze was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) 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 number in this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pain
Clinical narrative: MISERABLE FEELING; WORST PAIN; Feeling sick; This spontaneous report received from a consumer via a company representative concerned a 3 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-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 MAY-2021, the subject experienced miserable feeling. On MAY-2021, the subject experienced worst pain. On MAY-2021, the subject experienced feeling sick. The action taken with covid-19 vaccine was not applicable. The outcome of the miserable feeling, worst pain and feeling sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Chills, Injection site pain, Malaise
Clinical narrative: FELT LIKE I WAS COMING DOWN WITH SOMETHING BUT IT NEVER PROGRESSED TO A FEVER; BODY MALAISE; CHILLS; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-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 MAY-2021, the subject experienced body malaise. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced soreness on the injection site. On MAY-2021, the subject experienced felt like I was coming down with something but it never progressed to a fever. The action taken with covid-19 vaccine was not applicable. The outcome of the body malaise, chills, soreness on the injection site and felt like coming down with something was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: BODY ACHE; SLEPT ALL DAY; FEVER; TIREDNESS; COLD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported. On 25-MAY-2021, the subject experienced cold. On 25-MAY-2021, the subject experienced tiredness. On 26-MAY-2021, the subject experienced body ache. On 26-MAY-2021, the subject experienced slept all day. On 26-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.9 (Unit not reported). The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache, and fever on MAY-2021, and slept all day on 27-MAY-2021, had not recovered from cold, and the outcome of tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: BODY ACHE; SLEPT ALL DAY; FEVER; TIREDNESS; COLD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported. On 25-MAY-2021, the subject experienced cold. On 25-MAY-2021, the subject experienced tiredness. On 26-MAY-2021, the subject experienced body ache. On 26-MAY-2021, the subject experienced slept all day. On 26-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.9 (Unit not reported). The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache, and fever on MAY-2021, and slept all day on 27-MAY-2021, had not recovered from cold, and the outcome of tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 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 number. No concomitant medications were reported.  On an unspecified date, the subject experienced fever symptoms. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever symptoms. This report was non-serious.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: DULL ACHE TO RIGHT ARM/ PAINFUL TO SLEEP ON THAT SIDE; INJECTION SITE PAIN- RIGHT ARM; This spontaneous report received from a consumer concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic lymphocytic leukemia, and sulfa allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced injection site pain- right arm. On 17-MAY-2021, the subject experienced dull ache to right arm/ painful to sleep on that side. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site pain- right arm on 04-MAY-2021, and had not recovered from dull ache to right arm/ painful to sleep on that side. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Burning sensation, Chills, Communication disorder, Dissociation
Clinical narrative: HIGH BLOOD PRESSURE; DISSOCIATION; FEEL LIKE ROOFIED; CAN'T FOCUS ON CONVERSATION; DIZZINESS; BURNING SENSATION IN BRAIN; CHILLS; FEVER; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 28-APR-2021, the subject experienced burning sensation in brain. On an unspecified date, the subject experienced high blood pressure, dissociation, feel like roofied, can't focus on conversation, and dizziness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) increased to 190/100. The action taken with covid-19 vaccine was not applicable. The patient recovered from high blood pressure, and body aches, chills, fever, and headache on APR-2021, and the outcome of burning sensation in brain, dizziness, dissociation, feel like roofied and can't focus on conversation was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypertension, Pain, Pyrexia
Clinical narrative: HIGH BLOOD PRESSURE; DISSOCIATION; FEEL LIKE ROOFIED; CAN'T FOCUS ON CONVERSATION; DIZZINESS; BURNING SENSATION IN BRAIN; CHILLS; FEVER; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 28-APR-2021, the subject experienced burning sensation in brain. On an unspecified date, the subject experienced high blood pressure, dissociation, feel like roofied, can't focus on conversation, and dizziness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) increased to 190/100. The action taken with covid-19 vaccine was not applicable. The patient recovered from high blood pressure, and body aches, chills, fever, and headache on APR-2021, and the outcome of burning sensation in brain, dizziness, dissociation, feel like roofied and can't focus on conversation was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: HIGH BLOOD PRESSURE; DISSOCIATION; FEEL LIKE ROOFIED; CAN'T FOCUS ON CONVERSATION; DIZZINESS; BURNING SENSATION IN BRAIN; CHILLS; FEVER; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 28-APR-2021, the subject experienced burning sensation in brain. On an unspecified date, the subject experienced high blood pressure, dissociation, feel like roofied, can't focus on conversation, and dizziness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) increased to 190/100. The action taken with covid-19 vaccine was not applicable. The patient recovered from high blood pressure, and body aches, chills, fever, and headache on APR-2021, and the outcome of burning sensation in brain, dizziness, dissociation, feel like roofied and can't focus on conversation was not reported. This report was non-serious.
Age: 16.0
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 pharmacist concerned a 16 year old male. 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 allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: 23-JUN-2021) .5 ml, administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced vaccine administered to inappropriate age group. On 31-MAY-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. This report was associated with product quality complaint: 90000181255.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Pain in extremity
Clinical narrative: BLOOD VESSEL BURST IN RIGHT EYE; PAIN IN ARM; This spontaneous report received from a patient concerned a 67 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: 205A21A expiry: unknown) frequency 1 total, dose was not reported, administered at left arm on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, Patient's arm was also sore after getting the vaccine and resolved within a few days. On 31-MAY-2021, the patient looked in the mirror and noticed one of the blood vessels in the right eye had burst. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm on MAY-2021, and the outcome of blood vessel burst in right eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210600178- covid-19 vaccine ad26.cov2.s- blood vessels burst in the right eye. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Hunger
Clinical narrative: LITTLE DIZZY; SHORT OF BREATH; FEELING HUNGRY; WEAKNESS; TIREDNESS; This spontaneous report received from a patient concerned a 39 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced little dizzy, short of breath, feeling hungry, weakness, and tiredness. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tiredness, and feeling hungry, and the outcome of little dizzy, short of breath and weakness was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: FATIGUE; LOOSER STOOL THAN NORMAL; SORE ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced looser stool than normal. On 25-MAY-2021, the subject experienced sore arm. On 27-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from fatigue on 28-MAY-2021, and had not recovered from looser stool than normal, and sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, 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 patient died due to unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210600235 -COVID-19 VACCINE AD26.COV2.S- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned an 87 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no illness at the time of vaccination. the patient had no past history of similar event. the patient had no adverse event after any previous vaccination. the patient had no history of allergy to vaccine, drug, or food. the patient had no pre-existing acute illness 30 days prior to vaccination. the patient had no history of hospitalization in last 30 days. the patient had no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine (suspension for injection, intramuscular, and batch number: 1805029 expiry: 25-MAY-2021) .5 ml, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced expired vaccine used. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case is a duplicate of 20210559435. This case, from the same reporter is linked to 20210549259 and 20210557958.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING ON THE FEET, ANKLES, ON THE BACK, HAND AND ARMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021, the subject experienced itching on the feet, ankles, on the back, hand and arms. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itching on the feet, ankles, on the back, hand and arms. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Flank pain, Headache, Initial insomnia, Nausea
Clinical narrative: FLANK PAIN; INABILITY TO FALL ASLEEP; HEADACHE; NAUSEA; INABILITY TO URINATE; CONSTIPATION; This spontaneous report received from a patient concerned a 31-year-old male. The patient's height, and weight were not reported. The patient's past medical history included back pain due to car accident a year ago, and dislocated disc in lower back and neck.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, RA10630, expiry: unknown) dose was not reported, 1 total administered on 19-MAY-2021 for prophylactic vaccination to left deltoid. No concomitant medications were reported.  On 19-MAY-2021, for the first week, patient could not sleep at all and had a headache and nausea for about 3-4 days. Then it got better. As per patient, it was easier to sleep at the time of reporting, but still a little harder to fall asleep. Patient reported that he was having constipation and urinations issues since getting the vaccine. It was not painful to go to the bathroom but it took a while. Consumer woke up on 31-MAY-2021, and had excruciating pain in the back, flank area. It was hurting when he tried to move anyway to the left and if he used to touch it. He felt like he wants to scream. Consumer did consult with his PHP regarding the inability to fall asleep and problems with constipation. He was given some sleep medications and advised to take cranberry juice. HCP (health care professional) was not aware of the flank pain that consumer had that day. He was advised to call PHP or go to urgent care to determine cause of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea on MAY-2021, was recovering from inability to fall asleep, and had not recovered from constipation, flank pain, and inability to urinate. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210557948-COVID-19 VACCINE AD26.COV2.S - inability to urinate. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary retention
Clinical narrative: FLANK PAIN; INABILITY TO FALL ASLEEP; HEADACHE; NAUSEA; INABILITY TO URINATE; CONSTIPATION; This spontaneous report received from a patient concerned a 31-year-old male. The patient's height, and weight were not reported. The patient's past medical history included back pain due to car accident a year ago, and dislocated disc in lower back and neck.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, RA10630, expiry: unknown) dose was not reported, 1 total administered on 19-MAY-2021 for prophylactic vaccination to left deltoid. No concomitant medications were reported.  On 19-MAY-2021, for the first week, patient could not sleep at all and had a headache and nausea for about 3-4 days. Then it got better. As per patient, it was easier to sleep at the time of reporting, but still a little harder to fall asleep. Patient reported that he was having constipation and urinations issues since getting the vaccine. It was not painful to go to the bathroom but it took a while. Consumer woke up on 31-MAY-2021, and had excruciating pain in the back, flank area. It was hurting when he tried to move anyway to the left and if he used to touch it. He felt like he wants to scream. Consumer did consult with his PHP regarding the inability to fall asleep and problems with constipation. He was given some sleep medications and advised to take cranberry juice. HCP (health care professional) was not aware of the flank pain that consumer had that day. He was advised to call PHP or go to urgent care to determine cause of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea on MAY-2021, was recovering from inability to fall asleep, and had not recovered from constipation, flank pain, and inability to urinate. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210557948-COVID-19 VACCINE AD26.COV2.S - inability to urinate. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal detachment
Clinical narrative: DISCONNECTED RETNA; This spontaneous report received from a patient concerned a 64-year-old male. The patient's height, and weight were not reported. 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: 201A21A expiry: unknown) dose was not reported, 1 total administered on 14-MAY-2021 for prophylactic vaccination to left arm. No concomitant medications were reported.  On 15-MAY-2021, the patient started to experience intermittent flashing lights on his right eye, followed by a black line that goes across his right eye when his eyes are closed. Patient also experienced a "black curtain" effect. After a week of symptoms, the patient visited his MD and was diagnosed with a 'Disconnected Retna'. The patient had surgery for his right eye as per diagnosis on Tuesday, 25-MAY-2021. Patient was doing well so far with slight discomfort but no pain. Patient was going to see his ophthalmologist on 01-JUN-2021 for his post-op follow-up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Disconnected Retna. This report was Serious (Other Medically Important Condition).; Sender's Comments: V0: 20210558759-covid-19 vaccine ad26.cov2.s-Disconnected Retna.. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 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 dizziness. The action taken with covid-19 vaccine was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: LITTLE NUMBNESS IN LEFT THIGH/NUMBNESS IN UPPER PART OF BACK; ARMS WHERE VACCINE WAS APPLIED TINGLING/HAND OF THE SAME ARM TINGLING WHEN LYING DOWN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number and expiry unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced little numbness in left thigh/numbness in upper part of back. On MAY-2021, the subject experienced arms where vaccine was applied tingling/hand of the same arm tingling when lying down. The action taken with covid-19 vaccine was not applicable. The outcome of the little numbness in left thigh/numbness in upper part of back and arms where vaccine was applied tingling/hand of the same arm tingling when lying down was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: ITCHY RED RAISED, SPLOTCHY RASH ON LOWER POSTERIOR REGION BACK SIDE  OF BOTH THIGHS, BUTTOCKS AND LOWER BACK; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine(suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAY-2021, the subject experienced itchy red raised, splotchy rash on lower posterior region back side of both thighs, buttocks and lower back. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchy red raised, splotchy rash on lower posterior region back side of both thighs, buttocks and lower back. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: RED ITCHY RASH ON KNEES, ELBOWS, BELLY, LEGS AND ARMS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 200 pounds, and height was not reported. The patient's pre-existing medical conditions included patient had no known history of allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced red itchy rash on knees, elbows, belly, legs and arms. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine was not applicable. The patient was recovering from red itchy rash on knees, elbows, belly, legs and arms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hyperventilation, Palpitations, Panic attack
Clinical narrative: heart racing; hyperventilation; shaking of arms and legs; panic attack; Faint after covid vaccine on awakeing,Vasovagal, Passed out; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to nuts (Allergy to peanuts and tree nuts).   On 27-Jan-2021 at 10:29 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) (seriousness criterion medically significant) and PANIC ATTACK (panic attack). On 27-Jan-2021 at 10:29 AM, the patient experienced HYPERVENTILATION (hyperventilation) and TREMOR (shaking of arms and legs). On 27-Jan-2021 at 10:40 AM, the patient experienced PALPITATIONS (heart racing). On 27-Jan-2021, SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) and PANIC ATTACK (panic attack) had resolved. At the time of the report, PALPITATIONS (heart racing), HYPERVENTILATION (hyperventilation) and TREMOR (shaking of arms and legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood pressure measurement: 148/88 mmHg (High) 148/88. On 27-Jan-2021, Heart rate: 100 (normal) 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitantly the patient was taking medications for birth control (unspecified).  The patient received treatment with oxygen via NRB @15L.  It was reported that patient approximately had 3 episodes. She reported no loss of consciousness and no loss of bladder or bowel control.  Patient used pulse oximeter  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up serious event updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor
Clinical narrative: heart racing; hyperventilation; shaking of arms and legs; panic attack; Faint after covid vaccine on awakeing,Vasovagal, Passed out; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to nuts (Allergy to peanuts and tree nuts).   On 27-Jan-2021 at 10:29 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) (seriousness criterion medically significant) and PANIC ATTACK (panic attack). On 27-Jan-2021 at 10:29 AM, the patient experienced HYPERVENTILATION (hyperventilation) and TREMOR (shaking of arms and legs). On 27-Jan-2021 at 10:40 AM, the patient experienced PALPITATIONS (heart racing). On 27-Jan-2021, SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) and PANIC ATTACK (panic attack) had resolved. At the time of the report, PALPITATIONS (heart racing), HYPERVENTILATION (hyperventilation) and TREMOR (shaking of arms and legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood pressure measurement: 148/88 mmHg (High) 148/88. On 27-Jan-2021, Heart rate: 100 (normal) 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitantly the patient was taking medications for birth control (unspecified).  The patient received treatment with oxygen via NRB @15L.  It was reported that patient approximately had 3 episodes. She reported no loss of consciousness and no loss of bladder or bowel control.  Patient used pulse oximeter  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up serious event updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: arm pain; shoulder pain, knee, hip pain; Polymyalgia rheumatica; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021. The most recent information was received on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Osteoarthritis since 2012, Eczema (Exacerbated since Mar 2021) and Polymyalgia rheumatica since 2020. Concomitant products included DUPILUMAB (DUPIXENT) for Eczema, IRBESARTAN for Hypertension, CELECOXIB (CELEBREX) for Osteoarthritis.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant). On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and ARTHRALGIA (shoulder pain, knee, hip pain). The patient was treated with METHYLPREDNISOLONE (oral) on 25-Feb-2021 for Polymyalgia rheumatica, at a dose of 4 milligram twice a day. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), PAIN IN EXTREMITY (arm pain) and ARTHRALGIA (shoulder pain, knee, hip pain) had not resolved.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Updated Event onset date of event - polymyalgia rheumatica. Updated  concomitant medication - Celebrex and onset date of treatment medication. Updated patient demographics.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.