chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Thrombosis, Ultrasound Doppler, Ultrasound scan
Clinical narrative: THREE BLOOD CLOTS ON LEG; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included occasional alcohol use, and non-smoker. The patient had no known drug allergies. The patient was healthy and regularly active. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported,1 total administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. The patient experienced pain in his leg since mid November and went to urgent care on 27-NOV-2021. They sent him to emergency room where he was diagnosed with three blood clots on his leg on the same day but was not hospitalized. They did a real time grayscale and duplex ultrasound of his right lower extremity and the results came out to be occlusive and non occlusive thrombosis in the peroneal vein of the calf and a non-occlusive thrombosis in the posterior tibial vein of the calf. Laboratory test also included bloodwork and the results seemed to be normal. The patient was put on blood thinners, Elaquis 5mg 2 tabs twice daily for 1 week then dropping down to take 1 tab twice daily for the next 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from three blood clots on leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211163804-covid-19 vaccine ad26.cov2.s- three blood clots on leg. 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: Facial paralysis
Clinical narrative: FACE PARALYZED; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, 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 date: Unknown) dose, start therapy date were not reported (dose number in series 1),1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot number. No concomitant medications were reported.  On an unspecified date, the reporter stated that "your vaccine paralyzed my brothers face". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of face paralyzed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211163834-COVID-19 VACCINE AD26.COV2.S- Face paralyzed. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PAIN ESPECIALLY WHEN ARM RAISE; ARMS HAVE NOT BEEN THE SAME (PAIN WHERE VACCINE GOT IT); This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pain especially when arm raise, and arms have not been the same (pain where vaccine got it). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain especially when arm raise and arms have not been the same (pain where vaccine got it) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211163953.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Headache
Clinical narrative: COUGH; RUNNY NOSE; BODY ACHE; LOSS OF TASTE; LOSS OF SMELL; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient is otherwise healthy and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced cough. On NOV-2021, the patient experienced runny nose. On NOV-2021, the patient experienced body ache. On NOV-2021, the patient experienced loss of taste. On NOV-2021, the patient experienced loss of smell. On NOV-2021, the patient experienced chills. On NOV-2021, the patient experienced headache. Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, cough, runny nose, chills, body ache, loss of taste, and loss of smell. This report was non-serious. This report was associated with product quality complaint.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: COUGH; RUNNY NOSE; BODY ACHE; LOSS OF TASTE; LOSS OF SMELL; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient is otherwise healthy and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced cough. On NOV-2021, the patient experienced runny nose. On NOV-2021, the patient experienced body ache. On NOV-2021, the patient experienced loss of taste. On NOV-2021, the patient experienced loss of smell. On NOV-2021, the patient experienced chills. On NOV-2021, the patient experienced headache. Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, cough, runny nose, chills, body ache, loss of taste, and loss of smell. This report was non-serious. This report was associated with product quality complaint.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT SICK; This spontaneous report received from a health care professional concerned multiple patients.  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 got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ARMS HAVE NOT BEEN THE SAME AND PAIN WHERE WE GOT IT AND ESPECIALLY IF RAISE 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 APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced arms have not been the same and pain where we got it and especially if raise arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arms have not been the same and pain where we got it and especially if raise arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211163843.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CURRENTLY SUFFERING WITH COVID; 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 AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced currently suffering with covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of currently suffering with covid was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test
Clinical narrative: COVID-19 HOME INSTANT TEST  POSITIVE; FEELING A LITTLE BIT OFF; 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: Unknown) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On NOV-2021, the patient experienced feeling a little bit off. On 28-NOV-2021, the patient experienced covid-19 home instant test positive. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. On 29-NOV-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 home instant test positive and feeling a little bit off was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: ON AND OFF SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced on and off shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on and off shortness of breath was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: JNJ KNOCKED ME OUT FOR A WHOLE DAY; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced JNJ knocked me out for a whole day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of JNJ knocked me out for a whole day was not reported. This report was non-serious. This case, involving the same patient is linked to 20211116367.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: NORMAL FEELING LIKE TRASH FOR 24 HOURS; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-MAR-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 normal feeling like trash for 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from normal feeling like trash for 24 hours. This report was non-serious. This case, involving the same patient is linked to 20211116405.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 6 decade old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. Dose number series was 1. The batch number was not reported and has been requested. No concomitant medications were reported.  After few days on an unspecified date in NOV-2021, patient was diagnosed with Covid-19 and had mild symptoms for a couple of days (suspected clinical vaccination failure and suspected covid-19). Patient was in good health. On 06-NOV-2021 patient 8 year old daughter who was exposed at school, got sick and was diagnosed with covid-19 and had flu like symptoms for about 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on NOV-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000204609.; Sender's Comments: V0: 20211164394-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination 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
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Influenza like illness, Pain, Pyrexia
Clinical narrative: SWEATS; SORENESS; FLU-LIKE; TIREDNESS/FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 6 decade 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: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sweats, soreness, flu-like, tiredness/fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sweats, soreness, tiredness/fatigue and flu-like was not reported. This report was non-serious. This case, from the same reporter is linked to 20211164631.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: SLIGHT MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced slight muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight muscle pain. This report was non-serious. This case, involving the same patient is linked to 20211127326.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS ADMINISTERED AFTER 6 HOURS AND 20 MINUTES AFTER VIAL WAS OPENED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist 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: 1855191, expiry: UNKNOWN) dose was not reported, administered on 29-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced incorrect product storage. On 29-NOV-2021, the patient experienced vaccine was administered after 6 hours and 20 minutes after vial was opened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and vaccine was administered after 6 hours and 20 minutes after vial was opened was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR STARTED SHEDDING/ DRAMATIC HAIR LOSS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced hair started shedding/ dramatic hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair started shedding/ dramatic hair loss. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: WILL BE ON HEART MEDS THE REST OF LIFE; This spontaneous report received from a parent concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in an organization so was healthy till the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 29-NOV-2021, the patient experienced will be on heart meds the rest of life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of will be on heart meds the rest of life was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Mental disorder, Tinnitus
Clinical narrative: PSYCHOLOGICAL EFFECTS; DEBILITATING 24/7 TINNITUS; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced psychological effects, and debilitating 24/7 tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the debilitating 24/7 tinnitus and psychological effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Suspected COVID-19
Clinical narrative: 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 was not reported, administered on 28-MAY-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 suspected covid-19, and sleeping all the time.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from suspected covid-19, and the outcome of sleeping all the time was not reported.This report was non-serious.This case, from the same reporter is linked to 20211152159.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; Based on the current case data, this case has been classified as invalid. This literature-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    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, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (anaphylaxis) to be possibly related.    Treatment and concomitant medications not reported.  Patient desensitized and no adverse events occurred after second dose.  Patient developed hives, flushing, shortness of breath, and feeling of impending doom within 30 minutes.  Company Comment: This literature non-study case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced the expected serious (medically significant) event of Anaphylactic reaction after mRNA- 1273 Moderna vaccine. The event occurred within 30 minutes after the first dose of mRNA- 1273 vaccine. Clinical manifestations included hives, flushing, shortness of breath, and feeling of impending doom. Information regarding treatment is not available. The rechallenge was negative, since patient desensitized and no adverse events occurred after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   This case was linked to MOD-2021-396936, MOD-2021-396937, MOD-2021-396938, MOD-2021-396939, MOD-2021-396940 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received by safety on 25-Nov-2021 included an Email team and contains significant information.; Sender's Comments: This literature non-study case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced the expected serious (medically significant) event of Anaphylactic reaction after mRNA- 1273 Moderna vaccine. The event occurred within 30 minutes after the first dose of mRNA- 1273 vaccine. Clinical manifestations included hives, flushing, shortness of breath, and feeling of impending doom. Information regarding treatment is not available. The rechallenge was negative, since patient desensitized and no adverse events occurred after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Felt fine for first 2 days, woke up with strange brain fog/confusion and it lasted 4 days; Felt fine for first 2 days, woke up with strange brain fog/confusion and it lasted 4 days; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CONFUSIONAL STATE (Felt fine for first 2 days, woke up with strange brain fog/confusion and it lasted 4 days) and the second episode of CONFUSIONAL STATE (Felt fine for first 2 days, woke up with strange brain fog/confusion and it lasted 4 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced the first episode of CONFUSIONAL STATE (Felt fine for first 2 days, woke up with strange brain fog/confusion and it lasted 4 days) and the second episode of CONFUSIONAL STATE (Felt fine for first 2 days, woke up with strange brain fog/confusion and it lasted 4 days). At the time of the report, last episode of CONFUSIONAL STATE (Felt fine for last 2 days, woke up with strange brain fog/confusion and it lasted 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications includes Supplements Patient did not take any treatment medication   This case was linked to MOD-2021-395927, MOD-2021-395928 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she had Pfizer for her 1st and 2nd dose), FEELING HOT (very warm), VACCINATION SITE SWELLING (arm got swollen, grown in diameter within the last couple of hours), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE INDURATION (hard) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0341C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (for 1st and 2nd dose).Past adverse reactions to the above products included Asthmatic with Pfizer COVID-19 vaccine.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she had Pfizer for her 1st and 2nd dose), FEELING HOT (very warm), VACCINATION SITE SWELLING (arm got swollen, grown in diameter within the last couple of hours), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (bright red). On 19-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she had Pfizer for her 1st and 2nd dose) had resolved. At the time of the report, FEELING HOT (very warm), VACCINATION SITE SWELLING (arm got swollen, grown in diameter within the last couple of hours), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (bright red) had not resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was reported.Patient experienced swollen and hard and itchy and very warm and bright red also mentioned that it had grown in diameter on arm. No treatment done yet, but patient is planning to take Benadryl.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she had Pfizer for her 1st and 2nd dose), FEELING HOT (very warm), VACCINATION SITE SWELLING (arm got swollen, grown in diameter within the last couple of hours), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE INDURATION (hard) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0341C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (for 1st and 2nd dose).Past adverse reactions to the above products included Asthmatic with Pfizer COVID-19 vaccine.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she had Pfizer for her 1st and 2nd dose), FEELING HOT (very warm), VACCINATION SITE SWELLING (arm got swollen, grown in diameter within the last couple of hours), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (bright red). On 19-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she had Pfizer for her 1st and 2nd dose) had resolved. At the time of the report, FEELING HOT (very warm), VACCINATION SITE SWELLING (arm got swollen, grown in diameter within the last couple of hours), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (bright red) had not resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was reported.Patient experienced swollen and hard and itchy and very warm and bright red also mentioned that it had grown in diameter on arm. No treatment done yet, but patient is planning to take Benadryl.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: fever; chills; headache; underarm started to swell/ arm was so swollen that I couldn't put it down to my side; arm is sore. I had it in my left arm/ really sore, hurts; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (underarm started to swell/ arm was so swollen that I couldn't put it down to my side), PAIN IN EXTREMITY (arm is sore. I had it in my left arm/ really sore, hurts), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 003A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced PERIPHERAL SWELLING (underarm started to swell/ arm was so swollen that I couldn't put it down to my side) and PAIN IN EXTREMITY (arm is sore. I had it in my left arm/ really sore, hurts). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PERIPHERAL SWELLING (underarm started to swell/ arm was so swollen that I couldn't put it down to my side), PAIN IN EXTREMITY (arm is sore. I had it in my left arm/ really sore, hurts), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she doesn't know whether if it was lymph nodes or just swollen. Patient stated that on 22-Nov-2021, it was not hurting like it was and it was different from the first two injections that she got.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This case concerns a 50 year-old, female patient with no relevant medical history, who experienced the unexpected events of peripheral swelling and pain in extremity and expected events of pyrexia chills and headache. The events occurred after the third dose of mRNA-1273.  The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was reported.No treatment medication use was reported. Non-serious case.This case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the expected event of Myalgia. The event occurred on an unknown date after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: Non-serious case.This case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the expected event of Myalgia. The event occurred on an unknown date after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: felt bad; she had fever; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt bad) and PYREXIA (she had fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad) and PYREXIA (she had fever). At the time of the report, FEELING ABNORMAL (felt bad) and PYREXIA (she had fever) outcome was unknown.            Patient stated that she was healthy and did not take any medications.  Treatment information was not provided by the reporter.  This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious event of feeling abnormal and the expected, non-serious event of pyrexia after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-396434, MOD-2021-395617, MOD-2021-395805, MOD-2021-395824 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious event of feeling abnormal and the expected, non-serious event of pyrexia after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pain, Pain, Stomatitis
Clinical narrative: Cracks and sores in the mouth; Cracks and sores in the mouth; Extreme pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 17:00 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN; ACETAMINOPHEN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE Lot Number: UNKNOWN, Anatomical location: Left armAdministration time: 17:00), administration date: Aug2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: STOMATITIS (non-serious), ORAL PAIN (non-serious) all with onset 01Sep2021 13:00, outcome "not recovered" and all described as "Cracks and sores in the mouth"; PAIN (non-serious) with onset 01Sep2021 13:00, outcome "not recovered", described as "Extreme pain". Therapeutic measures were taken as a result of stomatitis, oral pain, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Investigation
Clinical narrative: daily episodes of fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 17 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "daily episodes of fatigue". The event "daily episodes of fatigue" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient was healthy. He received the vaccine 6 weeks ago. He was seen last week in the office and physical exam and lab work was unremarkable as to a reason for the fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Complicated appendicitis, Computerised tomogram, Diarrhoea
Clinical narrative: gangrenous appendicitis; vomiting; diarrhea; Abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: EM9809) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Appendicitis", start date: 20Sep2021 (unspecified if ongoing), notes: was admitted to ER and had appendectomy. Patient did not have allergies. Concomitant medication(s) included: TRI LO MARZIA. Vaccination history included: Bnt162b2 (lot number: EL3247, dose number: 1, vaccine location: Left arm), administration date: 25Jan2021, when the patient was 43 years old, for covid 19 immunization. The following information was reported: COMPLICATED APPENDICITIS (hospitalization, medically significant), outcome "unknown", described as "gangrenous appendicitis"; ABDOMINAL PAIN (hospitalization, medically significant) with onset 19Sep2021 10:00, outcome "unknown", described as "Abdominal pain"; CONDITION AGGRAVATED (hospitalization, medically significant) with onset 19Sep2021 01:30, outcome "unknown", described as "became worse"; Abdominal pain started around 10:00 Am on Sunday, 19Sep2021. Persisted through the day and became worse around 1:30 AM Monday, 20Sep2021. VOMITING (hospitalization, medically significant) with onset 20Sep2021, outcome "unknown", described as "vomiting"; DIARRHOEA (hospitalization, medically significant) with onset 20Sep2021, outcome "unknown", described as "diarrhea". The events "gangrenous appendicitis", "abdominal pain", "became worse", "vomiting" and "diarrhea" were evaluated at the emergency room visit. Vomiting and diarrhea began at that time as well. Around 9:00 AM patient went, after an examination, they sent to hospital where patient was then admitted. The patient underwent the following laboratory tests and procedures: blood test: (20Sep2021) 20-sep-2021, notes: unknown; computerised tomogram: (20Sep2021) confirmed appendicitis; sars-cov-2 test, Nasal Swab: (20Sep2021) negative. Patient did not have covid prior vaccination and tested for covid post vaccination. A CT scan and bloodwork was performed to confirm an appendicitis. The appendix had not yet ruptured but needed to be removed immediately. After the appendectomy, patient was told she had a gangrenous appendicitis. Since this surgery, she have heard of seven more acquaintances who had an appendectomy and the only common factor was that we all had the Pfizer vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: gangrenous appendicitis; vomiting; diarrhea; Abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: EM9809) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Appendicitis", start date: 20Sep2021 (unspecified if ongoing), notes: was admitted to ER and had appendectomy. Patient did not have allergies. Concomitant medication(s) included: TRI LO MARZIA. Vaccination history included: Bnt162b2 (lot number: EL3247, dose number: 1, vaccine location: Left arm), administration date: 25Jan2021, when the patient was 43 years old, for covid 19 immunization. The following information was reported: COMPLICATED APPENDICITIS (hospitalization, medically significant), outcome "unknown", described as "gangrenous appendicitis"; ABDOMINAL PAIN (hospitalization, medically significant) with onset 19Sep2021 10:00, outcome "unknown", described as "Abdominal pain"; CONDITION AGGRAVATED (hospitalization, medically significant) with onset 19Sep2021 01:30, outcome "unknown", described as "became worse"; Abdominal pain started around 10:00 Am on Sunday, 19Sep2021. Persisted through the day and became worse around 1:30 AM Monday, 20Sep2021. VOMITING (hospitalization, medically significant) with onset 20Sep2021, outcome "unknown", described as "vomiting"; DIARRHOEA (hospitalization, medically significant) with onset 20Sep2021, outcome "unknown", described as "diarrhea". The events "gangrenous appendicitis", "abdominal pain", "became worse", "vomiting" and "diarrhea" were evaluated at the emergency room visit. Vomiting and diarrhea began at that time as well. Around 9:00 AM patient went, after an examination, they sent to hospital where patient was then admitted. The patient underwent the following laboratory tests and procedures: blood test: (20Sep2021) 20-sep-2021, notes: unknown; computerised tomogram: (20Sep2021) confirmed appendicitis; sars-cov-2 test, Nasal Swab: (20Sep2021) negative. Patient did not have covid prior vaccination and tested for covid post vaccination. A CT scan and bloodwork was performed to confirm an appendicitis. The appendix had not yet ruptured but needed to be removed immediately. After the appendectomy, patient was told she had a gangrenous appendicitis. Since this surgery, she have heard of seven more acquaintances who had an appendectomy and the only common factor was that we all had the Pfizer vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Sleep disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101440587 (Pfizer). A 43 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA (ongoing); CELEXA (ongoing); SYNTHROID (ongoing); BUSPIRONE (ongoing); ZYRTEC ALLERGY (ongoing). Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "she had pain under the arm pits/experienced a significant pain under her armpit"; SLEEP DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "persisted Saturday night and kept her up that night". It was unknown if therapeutic measures were taken as a result of axillary pain.Additional Information: Follow up attempts are completed, No further information is expected.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.