chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 10/15/2019 / on 06/01/2021 for 2nd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 15th October 2019 having batch number BP57E and expiry date 7th December 2021).   On 1st June 2021, the patient received the 2nd dose of Shingrix. On 1st June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: Pharmacist reported that the patient back for 2nd dose of Shingrix more than recommended time after 1st dose which led to lengthening of vaccination schedule. The reporter consented to follow up. This case had been linked with US2021117121 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117121:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Past the 6 month time frame for the 2nd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix on unknown date, 6 months ago.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patients did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, the patients were past the 6-month time frame for 2nd dose of Shingrix. The reporter did not ask for additional details as decision to file adverse event was made after call was disconnected. The reporter did not consent to follow up. This case linked with US2021117114, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117114:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: BAD SKIN REACTION; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bad skin reaction. The action taken with covid-19 vaccine was not applicable. The outcome of bad skin reaction was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: PSORIATIC ARTHRITIS FLARE UP AFTER COVID-19 VACCINE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included ear infection with humira (adalimumab). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, 1 total administered on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in MAY-2021, the patient experienced psoriatic arthritis flare up after covid-19 vaccine. Treatment medications included adalimumab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from psoriatic arthritis flare up after covid-19 vaccine on 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210601327-covid-19 vaccine ad26.cov2.s- psoriatic arthritis flare up  after covid-19 vaccine. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Low density lipoprotein, Low density lipoprotein increased
Clinical narrative: OXIDIZED LOW DENSITY LIPOPROTEIN AROUND 1000; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included vegan. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN), dose was not reported, 1 total administered on an unspecified date in the first week of APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, 15 days after the vaccination, the patient had a wide blood test and a few days later the head doctor called via phone to the parent and told that he had not seen such results in his professional experience and advised to take the patient urgently to a cardiologist. On an unspecified date in 2021, the patient had the main extreme problem with the marker called oxidized low density lipoprotein around 1000 and its normal range is 10-170, where 200 would require medication and diet. The patient repeated the test again with another lab and laboratory data included: Oxidised low density lipoprotein (NR: not provided) results were about the same as before. The parent reported that the consequences of these results are bad and requested immediate help. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of oxidized low density lipoprotein around 1000 was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210601449 and 20210601462.; Sender's Comments: V0:20210601430 -JANSSEN COVID-19VACCINE .Ad26.COV2.S - . oxidized low density lipoprotein around 1000 - 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).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Low density lipoprotein, Low density lipoprotein increased
Clinical narrative: OXIDIZED LOW DENSITY LIPOPROTEIN ABOVE 2500; This spontaneous report received from a parent concerned a 19 year old male with unknown race and ethnicity. 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: Unknown expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date in the first week of APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, 15 days after the vaccination, the patient had a wide blood test and a few days later the head doctor called via phone to the parent and told that he hasn't seen such results in his professional experience and advised to take the patient urgently to a cardiologist. On an unspecified date in APR-2021, the patient had the main extreme problem with the marker called oxidized low density lipoprotein above 2,500 and its normal range is 10-170, where 200 would require medication and diet. The patient repeated the test again with another lab and laboratory data included: Oxidised low density lipoprotein (NR: not provided) results were about the same as before. The parent reported that the consequences of these results are bad and requested immediate help. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of oxidized oxidized low density lipoprotein above 2500 was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210601449 and 20210601430.; Sender's Comments: V0: 20210601462 -Covid-19 vaccine ad26.cov2.s -Oxidized low density lipoprotein above 2500. 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: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS AFTER VACCINE; 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tiredness after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness after vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: TWO BLOOD CLOTS; LEFT CALF PAIN FOR A COUPLE OF DAYS/FELT LIKE MUSCLE STRAIN; This spontaneous report received from a patient 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, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the patient experienced left calf pain for a couple of days which the patient believed that it was a muscle strain and was increasingly painful. On 28-MAY-2021, the patient was sent to the hospital to do an ultrasound and the HCP (health care professional) suggested for the patient to go to the emergency room visit because the patient had two blood clots. On 28-MAY-2021, the patient was hospitalized and was discharged on 28-MAY-2021. The patient was hospitalized for 1 day.  Laboratory data included: Diagnostic ultrasound (NR: not provided) 2 blood clots. On the day of reporting, it was informed that the patient was taking treatment medications (dates unspecified) which included: Eliquis (apixaban) for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from two blood clot, and the outcome of left calf pain for a couple of days/felt like muscle strain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210601553-covid-19 vaccine ad26.cov2.s - two blood clots in patient. 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: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Rhinorrhoea
Clinical narrative: ALLERGIES; NASAL SECRETIONS; 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 MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced allergies. On MAY-2021, the subject experienced nasal secretions. The action taken with covid-19 vaccine was not applicable. The outcome of the allergies and nasal secretions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Discomfort, Fear, Feeling abnormal, Feeling hot
Clinical narrative: MOOD SWINGS; BODY FROZE AND FELT LIKE STONE FROM WAIST DOWN; COULDN'T MOVE; PULLED MUSCLE OR A VEIN; VERY UNCOMFORTABLE; BODY HEAT UP; NIGHT SWEATS; DARK YELLOW URINE; SHARP PAIN ALL OVER BODY LIKE STOKE WITH A PIN; FELT LIKE KIDNEY DESTROYED; SLEEPING A LOT; FELT LIKE BODY DESTROYING LITTLE BY LITTLE; VERY VERY FRIGHTENED; MUSCLE TIGHTNESS; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included menopause, and mood swings. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt like kidney destroyed. On 2021, the subject experienced sleeping a lot. On 2021, the subject experienced sharp pain all over body like stoke with a pin. On 2021, the subject experienced felt like body destroying little by little. On 2021, the subject experienced very very frightened. On 2021, the subject experienced muscle tightness. On 2021, the subject experienced headaches. Treatment medications included: acetylsalicylic acid. On MAY-2021, the subject experienced night sweats. On MAY-2021, the subject experienced dark yellow urine. On MAY-2021, the subject experienced body heat up. On MAY-2021, the subject experienced very uncomfortable. On 16-MAY-2021, the subject experienced body froze and felt like stone from waist down. On 16-MAY-2021, the subject experienced couldn't move. On 16-MAY-2021, the subject experienced pulled muscle or a vein. On 19-MAY-2021, the subject experienced mood swings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, and the outcome of sleeping a lot, body froze and felt like stone from waist down, mood swings, night sweats, dark yellow urine, sharp pain all over body like stoke with a pin, body heat up, felt like kidney destroyed, felt like body destroying little by little, couldn't move, pulled muscle or a vein, very uncomfortable, very very frightened and muscle tightness 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: F
Vaccine: COVID19
Symptoms: Freezing phenomenon, Headache, Hypersomnia, Hypokinesia, Mood swings
Clinical narrative: MOOD SWINGS; BODY FROZE AND FELT LIKE STONE FROM WAIST DOWN; COULDN'T MOVE; PULLED MUSCLE OR A VEIN; VERY UNCOMFORTABLE; BODY HEAT UP; NIGHT SWEATS; DARK YELLOW URINE; SHARP PAIN ALL OVER BODY LIKE STOKE WITH A PIN; FELT LIKE KIDNEY DESTROYED; SLEEPING A LOT; FELT LIKE BODY DESTROYING LITTLE BY LITTLE; VERY VERY FRIGHTENED; MUSCLE TIGHTNESS; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included menopause, and mood swings. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt like kidney destroyed. On 2021, the subject experienced sleeping a lot. On 2021, the subject experienced sharp pain all over body like stoke with a pin. On 2021, the subject experienced felt like body destroying little by little. On 2021, the subject experienced very very frightened. On 2021, the subject experienced muscle tightness. On 2021, the subject experienced headaches. Treatment medications included: acetylsalicylic acid. On MAY-2021, the subject experienced night sweats. On MAY-2021, the subject experienced dark yellow urine. On MAY-2021, the subject experienced body heat up. On MAY-2021, the subject experienced very uncomfortable. On 16-MAY-2021, the subject experienced body froze and felt like stone from waist down. On 16-MAY-2021, the subject experienced couldn't move. On 16-MAY-2021, the subject experienced pulled muscle or a vein. On 19-MAY-2021, the subject experienced mood swings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, and the outcome of sleeping a lot, body froze and felt like stone from waist down, mood swings, night sweats, dark yellow urine, sharp pain all over body like stoke with a pin, body heat up, felt like kidney destroyed, felt like body destroying little by little, couldn't move, pulled muscle or a vein, very uncomfortable, very very frightened and muscle tightness 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: F
Vaccine: COVID19
Symptoms: Muscle strain, Muscle tightness, Night sweats, Pain, Renal disorder
Clinical narrative: MOOD SWINGS; BODY FROZE AND FELT LIKE STONE FROM WAIST DOWN; COULDN'T MOVE; PULLED MUSCLE OR A VEIN; VERY UNCOMFORTABLE; BODY HEAT UP; NIGHT SWEATS; DARK YELLOW URINE; SHARP PAIN ALL OVER BODY LIKE STOKE WITH A PIN; FELT LIKE KIDNEY DESTROYED; SLEEPING A LOT; FELT LIKE BODY DESTROYING LITTLE BY LITTLE; VERY VERY FRIGHTENED; MUSCLE TIGHTNESS; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included menopause, and mood swings. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt like kidney destroyed. On 2021, the subject experienced sleeping a lot. On 2021, the subject experienced sharp pain all over body like stoke with a pin. On 2021, the subject experienced felt like body destroying little by little. On 2021, the subject experienced very very frightened. On 2021, the subject experienced muscle tightness. On 2021, the subject experienced headaches. Treatment medications included: acetylsalicylic acid. On MAY-2021, the subject experienced night sweats. On MAY-2021, the subject experienced dark yellow urine. On MAY-2021, the subject experienced body heat up. On MAY-2021, the subject experienced very uncomfortable. On 16-MAY-2021, the subject experienced body froze and felt like stone from waist down. On 16-MAY-2021, the subject experienced couldn't move. On 16-MAY-2021, the subject experienced pulled muscle or a vein. On 19-MAY-2021, the subject experienced mood swings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, and the outcome of sleeping a lot, body froze and felt like stone from waist down, mood swings, night sweats, dark yellow urine, sharp pain all over body like stoke with a pin, body heat up, felt like kidney destroyed, felt like body destroying little by little, couldn't move, pulled muscle or a vein, very uncomfortable, very very frightened and muscle tightness 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
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Dyspnoea, Limb discomfort
Clinical narrative: LEGS FEEL LIKE LEAD; PAIN IN THE JOINTS; CHILLS; DIFFICULTY BREATHING; COLD LEGS; LACK OF APPETITE; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 04-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced difficulty breathing. On 29-MAY-2021, the subject experienced cold legs. On 29-MAY-2021, the subject experienced lack of appetite. On 29-MAY-2021, the subject experienced pain in the joints. On 29-MAY-2021, the subject experienced chills. On an unspecified date, the subject experienced legs feel like lead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the joints, cold legs, lack of appetite, difficulty breathing, chills and legs feel like lead 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: LEGS FEEL LIKE LEAD; PAIN IN THE JOINTS; CHILLS; DIFFICULTY BREATHING; COLD LEGS; LACK OF APPETITE; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 04-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced difficulty breathing. On 29-MAY-2021, the subject experienced cold legs. On 29-MAY-2021, the subject experienced lack of appetite. On 29-MAY-2021, the subject experienced pain in the joints. On 29-MAY-2021, the subject experienced chills. On an unspecified date, the subject experienced legs feel like lead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the joints, cold legs, lack of appetite, difficulty breathing, chills and legs feel like lead 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Pain in extremity, Vaccination site mass
Clinical narrative: LUMP UNDER THE SKIN CLOSE TO VACCINATION SITE; LUMP WAS GOING TO LOOK LIKE A BRUISE; SORE ARM; This spontaneous report received from a patient concerned a 45 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, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced lump under the skin close to vaccination site. On 20-MAY-2021, the subject experienced lump was going to look like a bruise. On 20-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from lump under the skin close to vaccination site, and the outcome of sore arm and lump was going to look like a bruise was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; This spontaneous report received from a consumer 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 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 urinary tract infection. The action taken with covid-19 vaccine was not applicable. The outcome of urinary tract infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605720.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; 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 was not reported, administered on 28-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 2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: WRONG VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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 was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced wrong vaccine administered. The action taken with covid-19 vaccine  was not applicable. The outcome of wrong vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604872.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Computerised tomogram, Dehydration, Discomfort
Clinical narrative: DIZZINESS; TIGHTNESS OF FACE; UNCOMFORTABLE FEELING; SEVERE MIGRAINE; DEHYDRATION; COLD CHILLS; WEAKNESS; DO NOT FEEL 100% OK; HEADACHE; NAUSEA; FEVER; CANNOT STAND UP; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced cannot stand up. Laboratory data included: CT scan (NR: not provided) NORMAL. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced tightness of face. On 14-APR-2021, the subject experienced uncomfortable feeling. On 14-APR-2021, the subject experienced severe migraine. On 14-APR-2021, the subject experienced dehydration. On 14-APR-2021, the subject experienced cold chills. On 14-APR-2021, the subject experienced weakness. On 14-APR-2021, the subject experienced do not feel 100% ok. On 14-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from cold chills, and fever on 2021, had not recovered from dizziness, weakness, headache, tightness of face, uncomfortable feeling, do not feel 100% ok, nausea, and severe migraine, and the outcome of dehydration and cannot stand up was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Headache, Malaise, Migraine
Clinical narrative: DIZZINESS; TIGHTNESS OF FACE; UNCOMFORTABLE FEELING; SEVERE MIGRAINE; DEHYDRATION; COLD CHILLS; WEAKNESS; DO NOT FEEL 100% OK; HEADACHE; NAUSEA; FEVER; CANNOT STAND UP; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced cannot stand up. Laboratory data included: CT scan (NR: not provided) NORMAL. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced tightness of face. On 14-APR-2021, the subject experienced uncomfortable feeling. On 14-APR-2021, the subject experienced severe migraine. On 14-APR-2021, the subject experienced dehydration. On 14-APR-2021, the subject experienced cold chills. On 14-APR-2021, the subject experienced weakness. On 14-APR-2021, the subject experienced do not feel 100% ok. On 14-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from cold chills, and fever on 2021, had not recovered from dizziness, weakness, headache, tightness of face, uncomfortable feeling, do not feel 100% ok, nausea, and severe migraine, and the outcome of dehydration and cannot stand up was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Skin tightness
Clinical narrative: DIZZINESS; TIGHTNESS OF FACE; UNCOMFORTABLE FEELING; SEVERE MIGRAINE; DEHYDRATION; COLD CHILLS; WEAKNESS; DO NOT FEEL 100% OK; HEADACHE; NAUSEA; FEVER; CANNOT STAND UP; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced cannot stand up. Laboratory data included: CT scan (NR: not provided) NORMAL. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced tightness of face. On 14-APR-2021, the subject experienced uncomfortable feeling. On 14-APR-2021, the subject experienced severe migraine. On 14-APR-2021, the subject experienced dehydration. On 14-APR-2021, the subject experienced cold chills. On 14-APR-2021, the subject experienced weakness. On 14-APR-2021, the subject experienced do not feel 100% ok. On 14-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from cold chills, and fever on 2021, had not recovered from dizziness, weakness, headache, tightness of face, uncomfortable feeling, do not feel 100% ok, nausea, and severe migraine, and the outcome of dehydration and cannot stand up was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: JOINTS HURTING MORE THAN NORMAL; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included joints hurting.The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 160 mg, frequency was not reported, from 11-MAY-2021 for hidradenitis suppurativa. 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 11-MAY-2021, the subject experienced joints hurting more than normal. The action taken with covid-19 vaccine was not applicable; and dose of adalimumab was not changed. The outcome of joints hurting more than normal was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Feeling abnormal, Feeling of relaxation
Clinical narrative: TIGHTNESS IN CHEST; Shortness of Breath; FEELS LIKE DRUGGED,FELT EXTREMELY WEIRD,FEELS LIKE A ROBOT SHUTTING DOWN; RANDOMLY FALLING ASLEEP; WAKING UP FEELING RESTED; EXTREMELY TIRED; This spontaneous report received from a patient concerned a 59-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, thyroid issues, irritable bowel syndrome, latex allergy, and penicillin allergy, and other pre-existing medical conditions included patient was allergies to anything you can think of in Kansas could not name them all. The patient experienced allergic reaction when treated with nitrofurantoin for urinary tract infection. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 03AZ1A, and 03A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 15:00 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced tightness in chest. On 24-MAY-2021, the subject experienced shortness of breath. On 24-MAY-2021, the subject experienced feels like drugged, felt extremely weird, feels like a robot shutting down. On 24-MAY-2021, the subject experienced randomly falling asleep. On 24-MAY-2021, the subject experienced waking up feeling rested. On 24-MAY-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tightness in chest, shortness of breath, and extremely tired, and the outcome of feels like drugged, felt extremely weird, feels like a robot shutting down, randomly falling asleep and waking up feeling rested was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: TIGHTNESS IN CHEST; Shortness of Breath; FEELS LIKE DRUGGED,FELT EXTREMELY WEIRD,FEELS LIKE A ROBOT SHUTTING DOWN; RANDOMLY FALLING ASLEEP; WAKING UP FEELING RESTED; EXTREMELY TIRED; This spontaneous report received from a patient concerned a 59-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, thyroid issues, irritable bowel syndrome, latex allergy, and penicillin allergy, and other pre-existing medical conditions included patient was allergies to anything you can think of in Kansas could not name them all. The patient experienced allergic reaction when treated with nitrofurantoin for urinary tract infection. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 03AZ1A, and 03A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 15:00 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced tightness in chest. On 24-MAY-2021, the subject experienced shortness of breath. On 24-MAY-2021, the subject experienced feels like drugged, felt extremely weird, feels like a robot shutting down. On 24-MAY-2021, the subject experienced randomly falling asleep. On 24-MAY-2021, the subject experienced waking up feeling rested. On 24-MAY-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tightness in chest, shortness of breath, and extremely tired, and the outcome of feels like drugged, felt extremely weird, feels like a robot shutting down, randomly falling asleep and waking up feeling rested was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthropathy, COVID-19, Illness, Joint swelling
Clinical narrative: ELBOW SWELLED LIKE GRAPEFRUIT; JOINTS WERE HUGE (KNEES AND ELBOWS WERE BIGGER THAN WHAT THEY SHOULD BE); SICKNESS; COVID-19; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. no relevant medical history. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. No concomitant medications were reported. On 24-DEC-2020, the subject experienced covid-19. On an unspecified date, the subject experienced elbow swelled like grapefruit, joints were huge (knees and elbows were bigger than what they should be), and sickness. The action taken with covid-19 vaccine  was not applicable. The outcome of the elbow swelled like grapefruit, joints were huge (knees and elbows were bigger than what they should be), sickness and covid-19 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eye inflammation, Injection site discolouration, Injection site erythema, Injection site nodule, Injection site papule
Clinical narrative: INFLAMMATION IN THE RIGHT EYE; BROWN SPOTS AT THE INJECTION SITE; ITCHINESS AT THE INJECTION SITE; BUMP AT THE INJECTION SITE; INJECTION SITE PAPULE; WEAKNESS IN BOTH LEGS; SWELLING AT THE INJECTION SITE; REDNESS AT THE INJECTION SITE; INJECTION SITE RASH; This spontaneous report received from a patient concerned an adult 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, intramuscular, 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate, posterior and panuveitis, and moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced inflammation in the right eye, brown spots at the injection site, itchiness at the injection site, bump at the injection site, injection site papule, weakness in both legs, swelling at the injection site, redness at the injection site, and injection site rash. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from brown spots at the injection site, redness at the injection site, swelling at the injection site, weakness in both legs, and injection site rash, and the outcome of inflammation in the right eye, itchiness at the injection site, bump at the injection site and injection site papule was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Muscular weakness
Clinical narrative: INFLAMMATION IN THE RIGHT EYE; BROWN SPOTS AT THE INJECTION SITE; ITCHINESS AT THE INJECTION SITE; BUMP AT THE INJECTION SITE; INJECTION SITE PAPULE; WEAKNESS IN BOTH LEGS; SWELLING AT THE INJECTION SITE; REDNESS AT THE INJECTION SITE; INJECTION SITE RASH; This spontaneous report received from a patient concerned an adult 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, intramuscular, 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate, posterior and panuveitis, and moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced inflammation in the right eye, brown spots at the injection site, itchiness at the injection site, bump at the injection site, injection site papule, weakness in both legs, swelling at the injection site, redness at the injection site, and injection site rash. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from brown spots at the injection site, redness at the injection site, swelling at the injection site, weakness in both legs, and injection site rash, and the outcome of inflammation in the right eye, itchiness at the injection site, bump at the injection site and injection site papule was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Skin mass
Clinical narrative: TWO BIG KNOTS ON SHOULDER; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 45 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  (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced injection site soreness. On 02-JUN-2021, the subject experienced two big knots on shoulder. The action taken with covid-19 vaccine  was not applicable. The patient recovered from injection site soreness on 01-JUN-2021, and had not recovered from two big knots on shoulder. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; 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 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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine was not applicable. The patient recovered from tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: FEELS ACHES AND PAINS; FEELING SICK TO STOMACH; FEELS LIKE GETTING A HEADACHE; 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 19:00 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced feels aches and pains. On 01-JUN-2021, the subject experienced feeling sick to stomach. On 01-JUN-2021, the subject experienced feels like getting a headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feeling sick to stomach, feels aches and pains, and feels like getting a headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POOR QUALITY PRODUCT ADMINISTERED; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a 46 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  (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced poor quality product administered. On 01-JUN-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine  was not applicable. The outcome of the poor quality product administered and incorrect storage of drug was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: ITCHING; BURNING; HIVES; This spontaneous report received from a patient 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  (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced itching. On 02-JUN-2021, the subject experienced burning. On 02-JUN-2021, the subject experienced hives. The action taken with covid-19 vaccine  was not applicable. The outcome of the hives, itching and burning was not reported. This report was non-serious.