chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Pain at the injection site; Rough flu like symptoms; Fever; Chills; Increased bowel movements; First 24 hours after brutal symptoms started, was in bed; Next 24 hours was still moping around; Was still barely eating; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 22nd October 2021, the patient received the 1st dose of Shingrix (intramuscular). In October 2021, 12 hrs after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fever, chills, frequent bowel movements, feels awful, asthenia and decreased appetite. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fever, chills, frequent bowel movements, feels awful, asthenia and decreased appetite were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fever, chills, frequent bowel movements, feels awful, asthenia and decreased appetite to be related to Shingrix.  Additional details were reported as follows: The pharmacist, who was also the patient reported that he received the first dose of Shingrix in his left deltoid.  Twelve hours after the injection the patient started experiencing pain at the injection site, rough flu like symptoms, fever, chills and increased bowel movements.  The first 24 hours after the symptoms started, the patient was in bed, the next 24 hours symptoms started improving but he was still moping around and barely eating. Symptoms started improving after the third 24 hours and disappeared the next day.  The symptoms were reported as brutal. The reporter consented to follow up. This case had been linked with case US2021239187, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021239187:Same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 9 years old received a Havrix adult dose; 9 years old received a Havrix adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 9-year-old patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The 9 years old had been administered with a Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: An extra non paired diluent of Menveo was found; Someone may have gotten a powder vial wrongly reconstituted; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that an extra non paired diluent of Menveo was found.The reporter was thinking someone might have gotten a powder vial reconstituted with a non approved diluent but the investigation was still in progress, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Bronchitis bacterial, Eye pain, Headache, Renal impairment
Clinical narrative: DETACHED POSTERIOR MEMBRANE IN EYE; KIDNEY FUNCTION WENT FROM NORMAL TO STAGE 3; ARTHRITIS FLARE; EYE ACHE; ACUTE BACTERIAL BRONCHITIS /MUCUS IN LUNGS; HEADACHE; This solicited report received from a patient via Agency: concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included arthropathic psoriasis. The patient was treated with product Stelara (ustekinumab) (solution for injection in pre-filled syringe, subcutaneous, batch number: Unknown and expiry: Unknown) 90 mg, frequency was not reported, from AUG-2001 for arthropathic psoriasis.  The patient received the covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Z-pak (azithromycin) for drug used for unknown indication.  On 05-OCT-2021, the patient experienced detached posterior membrane in eye, headache and eye ache, then mucus in lungs, the had arthritis flare and returned to urgent care acute bacterial bronchitis. The patient's kidney function went from normal to stage 3. Further waited for more blood work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The patient was recovering from arthritis flare, eye ache, acute bacterial bronchitis /mucus in lungs, detached posterior membrane in eye, kidney function went from normal to stage 3, and headache. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and detached posterior membrane in eye, kidney function went from normal to stage 3, acute bacterial bronchitis /mucus in lungs, arthritis flare, eye ache, and headache was related; and between ustekinumab, and detached posterior membrane in eye, kidney function went from normal to stage 3, arthritis flare, eye ache, acute bacterial bronchitis /mucus in lungs, and headache was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211131851-covid-19 vaccine ad26.cov2.s-detached posterior membrane in eye, kidney function went from normal to stage 3. This event(s) is considered related. 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).  20211131851-stellera-detached posterior membrane in eye, kidney function went from normal to stage 3. This event(s) is considered related. 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, UNK
Symptoms: Vitreous detachment
Clinical narrative: DETACHED POSTERIOR MEMBRANE IN EYE; KIDNEY FUNCTION WENT FROM NORMAL TO STAGE 3; ARTHRITIS FLARE; EYE ACHE; ACUTE BACTERIAL BRONCHITIS /MUCUS IN LUNGS; HEADACHE; This solicited report received from a patient via Agency: concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included arthropathic psoriasis. The patient was treated with product Stelara (ustekinumab) (solution for injection in pre-filled syringe, subcutaneous, batch number: Unknown and expiry: Unknown) 90 mg, frequency was not reported, from AUG-2001 for arthropathic psoriasis.  The patient received the covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Z-pak (azithromycin) for drug used for unknown indication.  On 05-OCT-2021, the patient experienced detached posterior membrane in eye, headache and eye ache, then mucus in lungs, the had arthritis flare and returned to urgent care acute bacterial bronchitis. The patient's kidney function went from normal to stage 3. Further waited for more blood work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The patient was recovering from arthritis flare, eye ache, acute bacterial bronchitis /mucus in lungs, detached posterior membrane in eye, kidney function went from normal to stage 3, and headache. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and detached posterior membrane in eye, kidney function went from normal to stage 3, acute bacterial bronchitis /mucus in lungs, arthritis flare, eye ache, and headache was related; and between ustekinumab, and detached posterior membrane in eye, kidney function went from normal to stage 3, arthritis flare, eye ache, acute bacterial bronchitis /mucus in lungs, and headache was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211131851-covid-19 vaccine ad26.cov2.s-detached posterior membrane in eye, kidney function went from normal to stage 3. This event(s) is considered related. 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).  20211131851-stellera-detached posterior membrane in eye, kidney function went from normal to stage 3. This event(s) is considered related. 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: Brain injury, Cardiac arrest, Coma, Intracardiac thrombus, Malaise
Clinical narrative: CARDIAC ARREST AND WAS WITHOUT A HEARTBEAT, AND EFFECTIVELY DEAD FOR 18 MINUTES; 2 MASSIVE BLOOD CLOTS TO THE HEART; COMA; EXTENSIVE BRAIN DAMAGE THAT OCCURRED WHEN BRAIN WAS WITHOUT OXYGEN; FEELING REALLY UNWELL; This spontaneous report received from a consumer via a company representative via social media concerned a 51 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: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total, administered 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 JUL-2021, the patient experienced feeling really unwell and for which patient went to the emergency room. On an unspecified date, the patient experienced 2 massive blood clots to the heart. Due to a number of events, patient went into cardiac arrest and was without a heartbeat, and effectively dead for 18 minutes and was hospitalized (for unspecified duration). Followed two weeks in a coma, the patient faced many months of intensive therapy seven days a week to heal and strengthen patient brain to combat the extensive brain damage that occurred when patient brain was without oxygen. In addition to the daily physical, occupational, and speech therapy the patient would be getting hyperbaric oxygen therapy to accelerate patient brain function and healing. The patient was working so hard every day at improving physical and mental abilities and for which patient already had made amazing progress. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coma, was recovering from extensive brain damage that occurred when brain was without oxygen, and the outcome of 2 massive blood clots to the heart, feeling really unwell and cardiac arrest and was without a heartbeat, and effectively dead for 18 minutes was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211139814-covid-19 vaccine ad26.cov2.s-cardiac arrest and was without a heartbeat, and effectively dead for 18 minutes;  2 massive blood clots to the heart;  Coma;  extensive brain damage that occurred when brain was without oxygen. This event(s) is considered unassessable. 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).  20211139814-covid-19 vaccine ad26.cov2.s-feeling really unwell. This event(s) is labeled per RA and is therefore considered potentially related
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Dependence on respirator, Ill-defined disorder, SARS-CoV-2 test
Clinical narrative: DEATH; PATIENT PLACED ON VENTILATOR; COVID-19 INFECTION; ILLNESS; This spontaneous report received from a consumer concerned a 61 year old male male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was super healthy before. 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 12-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in AUG-2021, few days after receiving vaccine, the patient started getting sick. On 12-Aug-2021, as soon as received vaccine patient got deathly ill. On an unspecified date, patient tested positive for covid -19. It was reported that the patient was anti vaxer. On an unspecified date, the patient was hospitalized for unspecified number of days and on ventilator at time in hospital. The reporter thought that getting the vaccine and having Covid complicated patient illness. On 01-SEP-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 01-SEP-2021, and the outcome of covid-19 infection, patient placed on ventilator and illness was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: 20211143152-covid-19 vaccine ad26.cov2.s-Death, Patient placed on ventilator, covid-19 infection, Illness. 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Menstrual disorder
Clinical narrative: MENSTRUAL CYCLE MID CYCLE (IN DAY 20 OF CYCLE); CHILLS; FEVER; FATIGUE; HEADACHE; PAIN IN ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: Patient had never been on hormonal birth control, nor any hormonal therapy. Patient's cycle was very clockwork within a day prior or a day after the expected start date. Patient had never been on any fertility drugs, nor had any issues with getting pregnant. Patient did not have any changes in diet, exercise and lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-NOV-2021 15:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-NOV-2021, the patient experienced chills. On 16-NOV-2021, the patient experienced fever. On 16-NOV-2021, the patient experienced fatigue. On 16-NOV-2021, the patient experienced headache. On 16-NOV-2021, the patient experienced pain in arm at injection site. On 22-NOV-2021, the patient experienced menstrual cycle mid cycle (in day 20 of cycle). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on NOV-2021, and the outcome of fatigue, headache, pain in arm at injection site and menstrual cycle mid cycle (in day 20 of cycle) was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MENSTRUAL CYCLE MID CYCLE (IN DAY 20 OF CYCLE); CHILLS; FEVER; FATIGUE; HEADACHE; PAIN IN ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: Patient had never been on hormonal birth control, nor any hormonal therapy. Patient's cycle was very clockwork within a day prior or a day after the expected start date. Patient had never been on any fertility drugs, nor had any issues with getting pregnant. Patient did not have any changes in diet, exercise and lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-NOV-2021 15:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-NOV-2021, the patient experienced chills. On 16-NOV-2021, the patient experienced fever. On 16-NOV-2021, the patient experienced fatigue. On 16-NOV-2021, the patient experienced headache. On 16-NOV-2021, the patient experienced pain in arm at injection site. On 22-NOV-2021, the patient experienced menstrual cycle mid cycle (in day 20 of cycle). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on NOV-2021, and the outcome of fatigue, headache, pain in arm at injection site and menstrual cycle mid cycle (in day 20 of cycle) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Cough, Myalgia, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: COUGH; FEVER; MUSCLE ACHES; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INCREASED DREAMS; This spontaneous report received from a physician concerned a 34 year old of unknown 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 and expiry: Unknown) 1 total, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUN-2021 (This started a day or two after receipt of the vaccine), the patient experienced increased dreams and and physician was wondering if this was related to lack of antibodies. On 22-NOV-2021, the patient underwent though antibodies test with a  made home-antibody test (confirmed immunological vaccine failure). exact type of antibody test not reported. It was also reported that physician does not know if the made test was reliable and the antibody test results were found to be negative for IgG and IgM. the patient received vaccine at a trailer (that moves all over) along with this patient had increased dreams (non-specific) after receiving the Janssen Covid-19 vaccine. On an unspecified date, the patient experienced cough, fever, and muscle aches and it's unclear if he had Covid-19. It was also stated that it could be something else (like a cold or Flu), as the patient has not received a flu-shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased dreams on 01-NOV-2021, and the outcome of confirmed immunological vaccine failure, fever, cough and muscle aches was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority:90000203429.; Sender's Comments: V0; 20211149757-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: COUGH; FEVER; MUSCLE ACHES; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INCREASED DREAMS; This spontaneous report received from a physician concerned a 34 year old of unknown 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 and expiry: Unknown) 1 total, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUN-2021 (This started a day or two after receipt of the vaccine), the patient experienced increased dreams and and physician was wondering if this was related to lack of antibodies. On 22-NOV-2021, the patient underwent though antibodies test with a  made home-antibody test (confirmed immunological vaccine failure). exact type of antibody test not reported. It was also reported that physician does not know if the made test was reliable and the antibody test results were found to be negative for IgG and IgM. the patient received vaccine at a trailer (that moves all over) along with this patient had increased dreams (non-specific) after receiving the Janssen Covid-19 vaccine. On an unspecified date, the patient experienced cough, fever, and muscle aches and it's unclear if he had Covid-19. It was also stated that it could be something else (like a cold or Flu), as the patient has not received a flu-shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased dreams on 01-NOV-2021, and the outcome of confirmed immunological vaccine failure, fever, cough and muscle aches was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority:90000203429.; Sender's Comments: V0; 20211149757-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE WITH A DOSE THAT WAS FROZEN TWICE; This spontaneous report received from a health care professional concerned a 74 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of vaccine with a dose that was frozen twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine with a dose that was frozen twice was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Renal pain
Clinical narrative: SEVERE FLU LIKE SYMPTOMS LIKE (3 TO 4 TIMES TO NORMAL); VERY PAINFUL KIDNEY SPASMS THE SAME PAIN RANGE AS KIDNEY STONES; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: impaired kidney function. The patient experienced drug allergy when treated with prochlorperazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe flu like symptoms like (3 to 4 times to normal), and very painful kidney spasms the same pain range as kidney stones. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe flu like symptoms like (3 to 4 times to normal), and very painful kidney spasms the same pain range as kidney stones. This report was non-serious. This case, from the same reporter is linked to 20211039771.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: THE INDIVIDUAL RECEIVED VACCINE THAT WAS FROZEN  TWICE; THE PHARMACIST AND THE STAFF KEPT THE VACCINE  IN THE FREEZER; This spontaneous report received from a health care professional concerned a 31 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: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced the pharmacist and the staff kept the vaccine in the freezer. On 18-NOV-2021, the patient experienced the individual received vaccine that was frozen twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received vaccine that was frozen twice and the pharmacist and the staff kept the vaccine in the freezer was not reported. This report was non-serious. This case, from the same reporter is linked to 20211150068.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: DIZZINESS; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 36 year old male. 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 had no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 19-NOV-2021 11:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-NOV-2021, the patient experienced headache. On 19-NOV-2021, the patient experienced fatigue. On 19-NOV-2021, the patient experienced nausea. On 21-NOV-2021, the patient experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, fatigue, and nausea on 20-NOV-2021, and had not recovered from dizziness. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hypersomnia, Hypokinesia, Injection site erythema
Clinical narrative: FEVER; FATIGUE; SLEPT THE WHOLE DAY; ARM LOOKS LIKE IT WAS INFECTED; CAN NOT MOVE ARM; ARM SORE; SWOLLEN AT SITE OF INJECTION (LEFT ARM); RED AT INJECTION SITE (LEFT ARM); HOT AT THE SITE OF INJECTION (LEFT ARM); ITCHY AT SITE OF INJECTION (LEFT ARM); RAISED AT INJECTION SITE (LEFT ARM); HARD AT INJECTION SITE (LEFT ARM); This spontaneous report received from a patient concerned a 26 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A21A, expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced itchy at site of injection (left arm). On NOV-2021, the patient experienced raised at injection site (left arm). On NOV-2021, the patient experienced hard at injection site (left arm). On NOV-2021, the patient experienced arm looks like it was infected. On NOV-2021, the patient experienced can not move arm. On NOV-2021, the patient experienced arm sore. On NOV-2021, the patient experienced swollen at site of injection (left arm). On NOV-2021, the patient experienced red at injection site (left arm). On NOV-2021, the patient experienced hot at the site of injection (left arm). On 18-NOV-2021, the patient experienced slept the whole day. On 18-NOV-2021, the patient experienced fever. On 18-NOV-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-NOV-2021, had not recovered from arm sore, and the outcome of fatigue, swollen at site of injection (left arm), itchy at site of injection (left arm), red at injection site (left arm), raised at injection site (left arm), hard at injection site (left arm), slept the whole day, can not move arm, arm looks like it was infected and hot at the site of injection (left arm) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211149605.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: FEVER; FATIGUE; SLEPT THE WHOLE DAY; ARM LOOKS LIKE IT WAS INFECTED; CAN NOT MOVE ARM; ARM SORE; SWOLLEN AT SITE OF INJECTION (LEFT ARM); RED AT INJECTION SITE (LEFT ARM); HOT AT THE SITE OF INJECTION (LEFT ARM); ITCHY AT SITE OF INJECTION (LEFT ARM); RAISED AT INJECTION SITE (LEFT ARM); HARD AT INJECTION SITE (LEFT ARM); This spontaneous report received from a patient concerned a 26 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A21A, expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced itchy at site of injection (left arm). On NOV-2021, the patient experienced raised at injection site (left arm). On NOV-2021, the patient experienced hard at injection site (left arm). On NOV-2021, the patient experienced arm looks like it was infected. On NOV-2021, the patient experienced can not move arm. On NOV-2021, the patient experienced arm sore. On NOV-2021, the patient experienced swollen at site of injection (left arm). On NOV-2021, the patient experienced red at injection site (left arm). On NOV-2021, the patient experienced hot at the site of injection (left arm). On 18-NOV-2021, the patient experienced slept the whole day. On 18-NOV-2021, the patient experienced fever. On 18-NOV-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-NOV-2021, had not recovered from arm sore, and the outcome of fatigue, swollen at site of injection (left arm), itchy at site of injection (left arm), red at injection site (left arm), raised at injection site (left arm), hard at injection site (left arm), slept the whole day, can not move arm, arm looks like it was infected and hot at the site of injection (left arm) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211149605.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Pain in extremity, Pyrexia
Clinical narrative: FEVER; FATIGUE; SLEPT THE WHOLE DAY; ARM LOOKS LIKE IT WAS INFECTED; CAN NOT MOVE ARM; ARM SORE; SWOLLEN AT SITE OF INJECTION (LEFT ARM); RED AT INJECTION SITE (LEFT ARM); HOT AT THE SITE OF INJECTION (LEFT ARM); ITCHY AT SITE OF INJECTION (LEFT ARM); RAISED AT INJECTION SITE (LEFT ARM); HARD AT INJECTION SITE (LEFT ARM); This spontaneous report received from a patient concerned a 26 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A21A, expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced itchy at site of injection (left arm). On NOV-2021, the patient experienced raised at injection site (left arm). On NOV-2021, the patient experienced hard at injection site (left arm). On NOV-2021, the patient experienced arm looks like it was infected. On NOV-2021, the patient experienced can not move arm. On NOV-2021, the patient experienced arm sore. On NOV-2021, the patient experienced swollen at site of injection (left arm). On NOV-2021, the patient experienced red at injection site (left arm). On NOV-2021, the patient experienced hot at the site of injection (left arm). On 18-NOV-2021, the patient experienced slept the whole day. On 18-NOV-2021, the patient experienced fever. On 18-NOV-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-NOV-2021, had not recovered from arm sore, and the outcome of fatigue, swollen at site of injection (left arm), itchy at site of injection (left arm), red at injection site (left arm), raised at injection site (left arm), hard at injection site (left arm), slept the whole day, can not move arm, arm looks like it was infected and hot at the site of injection (left arm) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211149605.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Injection site reaction, Injection site urticaria, Pain in extremity
Clinical narrative: RED,SWOLLEN AND ITCHY INJECTION SITE; INJECTION SITE REACTION OF A RED, HOT, HARD CIRCLE LIKE A GIANT HIVE, BIG WELT, THAT CONTINUES TO GROW; FLU LIKE SYMPTOMS; ARM WAS SORE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: seasonal emu oil allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822309, and expiry: UNKNOWN) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol for seasonal emu oil allergy, and loratadine for seasonal emu oil allergy.  On 18-NOV-2021, the patient experienced arm was sore. Treatment medications included: ibuprofen. On 19-NOV-2021, the patient experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 99 F, 101.3 F. On 20-NOV-2021, the patient experienced red, swollen and itchy injection site. On 20-NOV-2021, the patient experienced injection site reaction of a red, hot, hard circle like a giant hive, big welt, that continues to grow. Laboratory data included: Body temperature (NR: not provided) 99 F. On 21-NOV-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 20-NOV-2021, and had not recovered from injection site reaction of a red, hot, hard circle like a giant hive, big welt, that continues to grow, red, swollen and itchy injection site, and arm was sore. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE STORED OUTSIDE RECOMMENDED CONDITIONS; This spontaneous report received from a physician concerned multiple patients. 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 patient experienced administration of vaccine stored outside recommended conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine stored outside recommended conditions was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: FREEZED VIAL, THAWED AND INJECTED; THE PHARMACIST AND THE STAFF KEPT THE VACCINE  IN THE FREEZER; This spontaneous report received from a health care professional concerned a 60 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: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced the pharmacist and the staff kept the vaccine in the freezer. On 18-NOV-2021, the patient experienced freezed vial, thawed and injected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the freezed vial, thawed and injected and the pharmacist and the staff kept the vaccine in the freezer was not reported. This report was non-serious. This case, from the same reporter is linked to 20211149908 and 20211149780.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE WITH A DOSE THAT WAS FROZEN TWICE; This spontaneous report received from a health care professional concerned a 68 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: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-NOV-2021, the patient experienced administration of vaccine with a dose that was frozen twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine with a dose that was frozen twice was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN ARM; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: FLARE UP OF SYMPTOMS WHICH REQUIRED RESTART OF STELLARA THERAPY; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ustekinumab for drug used for unknown indication. On an unspecified date, the patient experienced flare up of symptoms which required restart of stellara therapy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flare up of symptoms which required restart of stellara therapy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Night sweats, Pain in extremity
Clinical narrative: SWEATING MORE AT NIGHT; A BIT OF PAIN ON MY ARM; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-NOV-2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 23-NOV-2021, the patient experienced sweating more at night. On 23-NOV-2021, the patient experienced a bit of pain on my arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a bit of pain on my arm and sweating more at night was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous report received from a pharmacist concerned a 53 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: 042A21A and expiry: 19-SEP-2021) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000203761. This case, from the same reporter is linked to 20211151967.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: GONNA DIE; HURTING AT VACCINATION 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 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 02-APR-2021, the patient experienced hurting at vaccination site. On an unspecified date, the patient experienced gonna die. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hurting at vaccination site and gonna die was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Very bad rash from booster; Warm at injection site; Very swollen, arm all red; Itching near injection site/Itchy; Red at injection site; Swelling near injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Very bad rash from booster), VACCINATION SITE WARMTH (Warm at injection site), PERIPHERAL SWELLING (Very swollen, arm all red), VACCINATION SITE PRURITUS (Itching near injection site/Itchy) and VACCINATION SITE ERYTHEMA (Red at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (Allergic to latex).   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced RASH (Very bad rash from booster), VACCINATION SITE WARMTH (Warm at injection site), PERIPHERAL SWELLING (Very swollen, arm all red), VACCINATION SITE PRURITUS (Itching near injection site/Itchy), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling near injection site). In November 2021, PERIPHERAL SWELLING (Very swollen, arm all red) had resolved. At the time of the report, RASH (Very bad rash from booster), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE PRURITUS (Itching near injection site/Itchy), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling near injection site) was resolving.            No concomitant medications were reported. The patient states the tape that was used to put over injection site may be the cause or contained latex, the itching had got better after removing the tape but still ongoing. Patient taken some medication for allergies (Pills) and the itching subsidized for a little while. It was very swollen before, and arm was all red. Patient said It was horrible itching. At the time of report,she said that it is itching a little, but not too much Patient mentioned that she had the previous 2 doses of the vaccines, and did not feel anything   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Patient demographics and new events were added