chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's sibling. The age at vaccination was not reported. The reporter had the shingles twice and that was horrible and so he/she had not received the vaccine yet. The reporter was sort of worried about getting the vaccine because it made the patient really sick. The reporter guesses the vaccine would still be better than getting them (shingles) again. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Eye pain, Eye swelling, Feeling cold, Feeling hot
Clinical narrative: Swollen arm at injection site, size of tennis ball; Pain at the injection site; felt very sick; chills/ shivering; felt freezing cold; felt hot; Fever; Pain under eyes; Eyes swollen; Swollen face: lips, tongue, eyes, cheeks; couldn't see well with peripheral vision; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. In October 2021, 2 days after receiving Shingrix, the patient experienced eye pain, eye swelling, facial swelling and peripheral vision defective. On 21st October 2021, the patient experienced injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot and fever. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site swelling, injection site pain, sickness, chills, eye pain, eye swelling, facial swelling and peripheral vision defective were not recovered/not resolved and the outcome of the feeling cold, feeling hot and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot, fever, eye pain, eye swelling, facial swelling and peripheral vision defective to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. Patient reported that 1 day after after receiving the first dose of Shingrix experienced serval adverse reactions such as  felt very sick, shivering, felt freezing cold and hot, fever, pain under eyes, huge injection site reaction the size of a tennis ball. The patient 2 days after receiving the dose had pain under eyes, right eye swollen and could not see well with peripheral vision, lips, cheeks and whole face are swollen and had shills, The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Injection site pain, Injection site swelling, Lip swelling, Pyrexia
Clinical narrative: Swollen arm at injection site, size of tennis ball; Pain at the injection site; felt very sick; chills/ shivering; felt freezing cold; felt hot; Fever; Pain under eyes; Eyes swollen; Swollen face: lips, tongue, eyes, cheeks; couldn't see well with peripheral vision; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. In October 2021, 2 days after receiving Shingrix, the patient experienced eye pain, eye swelling, facial swelling and peripheral vision defective. On 21st October 2021, the patient experienced injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot and fever. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site swelling, injection site pain, sickness, chills, eye pain, eye swelling, facial swelling and peripheral vision defective were not recovered/not resolved and the outcome of the feeling cold, feeling hot and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot, fever, eye pain, eye swelling, facial swelling and peripheral vision defective to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. Patient reported that 1 day after after receiving the first dose of Shingrix experienced serval adverse reactions such as  felt very sick, shivering, felt freezing cold and hot, fever, pain under eyes, huge injection site reaction the size of a tennis ball. The patient 2 days after receiving the dose had pain under eyes, right eye swollen and could not see well with peripheral vision, lips, cheeks and whole face are swollen and had shills, The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face, Visual field defect
Clinical narrative: Swollen arm at injection site, size of tennis ball; Pain at the injection site; felt very sick; chills/ shivering; felt freezing cold; felt hot; Fever; Pain under eyes; Eyes swollen; Swollen face: lips, tongue, eyes, cheeks; couldn't see well with peripheral vision; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. In October 2021, 2 days after receiving Shingrix, the patient experienced eye pain, eye swelling, facial swelling and peripheral vision defective. On 21st October 2021, the patient experienced injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot and fever. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site swelling, injection site pain, sickness, chills, eye pain, eye swelling, facial swelling and peripheral vision defective were not recovered/not resolved and the outcome of the feeling cold, feeling hot and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot, fever, eye pain, eye swelling, facial swelling and peripheral vision defective to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. Patient reported that 1 day after after receiving the first dose of Shingrix experienced serval adverse reactions such as  felt very sick, shivering, felt freezing cold and hot, fever, pain under eyes, huge injection site reaction the size of a tennis ball. The patient 2 days after receiving the dose had pain under eyes, right eye swollen and could not see well with peripheral vision, lips, cheeks and whole face are swollen and had shills, The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Eye swelling, Feeling hot, Injection site mass
Clinical narrative: Swollen arm at injection site, size of tennis ball; Pain at the injection site; felt very sick; chills/ shivering; felt freezing cold; felt hot; Fever; Pain under eyes; Eyes swollen; Swollen face: lips, tongue, eyes, cheeks; couldn't see well with peripheral vision; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. In October 2021, 2 days after receiving Shingrix, the patient experienced eye pain, eye swelling, facial swelling and peripheral vision defective. On 21st October 2021, the patient experienced injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot and fever. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site swelling, injection site pain, sickness, chills, eye pain, eye swelling, facial swelling and peripheral vision defective were not recovered/not resolved and the outcome of the feeling cold, feeling hot and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot, fever, eye pain, eye swelling, facial swelling and peripheral vision defective to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. Patient reported that 1 day after after receiving the first dose of Shingrix experienced serval adverse reactions such as  felt very sick, shivering, felt freezing cold and hot, fever, pain under eyes, huge injection site reaction the size of a tennis ball. The patient 2 days after receiving the dose had pain under eyes, right eye swollen and could not see well with peripheral vision, lips, cheeks and whole face are swollen and had shills, The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling, Pyrexia, Swelling face, Tremor
Clinical narrative: Swollen arm at injection site, size of tennis ball; Pain at the injection site; felt very sick; chills/ shivering; felt freezing cold; felt hot; Fever; Pain under eyes; Eyes swollen; Swollen face: lips, tongue, eyes, cheeks; couldn't see well with peripheral vision; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. In October 2021, 2 days after receiving Shingrix, the patient experienced eye pain, eye swelling, facial swelling and peripheral vision defective. On 21st October 2021, the patient experienced injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot and fever. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site swelling, injection site pain, sickness, chills, eye pain, eye swelling, facial swelling and peripheral vision defective were not recovered/not resolved and the outcome of the feeling cold, feeling hot and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot, fever, eye pain, eye swelling, facial swelling and peripheral vision defective to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. Patient reported that 1 day after after receiving the first dose of Shingrix experienced serval adverse reactions such as  felt very sick, shivering, felt freezing cold and hot, fever, pain under eyes, huge injection site reaction the size of a tennis ball. The patient 2 days after receiving the dose had pain under eyes, right eye swollen and could not see well with peripheral vision, lips, cheeks and whole face are swollen and had shills, The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Necrosis, Skin discolouration, Skin warm
Clinical narrative: area turned purple and looked necrotic; Red arm below injection site; arm thick below injection site; Warm arm below injection site; area turned purple; looks like sunburn across bicep and tricep; This case was reported by a nurse via call center representative and described the occurrence of necrosis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced necrosis (serious criteria GSK medically significant), erythema of extremities, induration, skin warm, skin discoloration and sunburn. On an unknown date, the outcome of the necrosis, erythema of extremities, induration, skin warm and skin discoloration were recovered/resolved and the outcome of the sunburn was not recovered/not resolved.   It was unknown if the reporter considered the necrosis, erythema of extremities, induration, skin warm, skin discoloration and sunburn to be related to Shingrix.  Additional details were provided as follows: The patient was a nurse and reported for herself.  The patient received Shingrix in an unknown arm. On day 2 or 3, after receiving Shingrix, the patient's arm was red, thick and warm below the injection site. This lasted a while but resolved. She reported that, later the area turned purple and looked necrotic but had resolved at the time of reporting, it was unsure when this occurred and how long it lasted and when the event resolved.  At the time of reporting, it had been 8 weeks since the patient received the Shingrix and she reported that, the area looked like a band of sunburn across her bicep and triceps, unknown date when this started.  The patient inquired if this had been reported and wanted further information beyond the information given from the PI (Package insert).  She also inquired about the ingredients in the Shingrix vaccine.  The reporter consented to follow-up. The patient reported that, the pharmacist who administered the vaccine, his father experienced the same adverse events but did not have patient identifiers, refer linked case US2021AMR223501.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR223501:Same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Sunburn
Clinical narrative: area turned purple and looked necrotic; Red arm below injection site; arm thick below injection site; Warm arm below injection site; area turned purple; looks like sunburn across bicep and tricep; This case was reported by a nurse via call center representative and described the occurrence of necrosis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced necrosis (serious criteria GSK medically significant), erythema of extremities, induration, skin warm, skin discoloration and sunburn. On an unknown date, the outcome of the necrosis, erythema of extremities, induration, skin warm and skin discoloration were recovered/resolved and the outcome of the sunburn was not recovered/not resolved.   It was unknown if the reporter considered the necrosis, erythema of extremities, induration, skin warm, skin discoloration and sunburn to be related to Shingrix.  Additional details were provided as follows: The patient was a nurse and reported for herself.  The patient received Shingrix in an unknown arm. On day 2 or 3, after receiving Shingrix, the patient's arm was red, thick and warm below the injection site. This lasted a while but resolved. She reported that, later the area turned purple and looked necrotic but had resolved at the time of reporting, it was unsure when this occurred and how long it lasted and when the event resolved.  At the time of reporting, it had been 8 weeks since the patient received the Shingrix and she reported that, the area looked like a band of sunburn across her bicep and triceps, unknown date when this started.  The patient inquired if this had been reported and wanted further information beyond the information given from the PI (Package insert).  She also inquired about the ingredients in the Shingrix vaccine.  The reporter consented to follow-up. The patient reported that, the pharmacist who administered the vaccine, his father experienced the same adverse events but did not have patient identifiers, refer linked case US2021AMR223501.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR223501:Same reporter
Age: 0.67
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Half dose administered.; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 8-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 5277A, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received the 1st dose of Fluarix Quadrivalent 2021-2022 season .25 ml and Fluarix Tetra Pre-Filled Syringe Device. On 11th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose was 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 reporter was a clinical supervisor. The reporter stated that, half dose (0.25 ml) was administered to infant patient, which led to underdose. The reporter consented to follow up. Note: Event outcome date was reported as 26th October 2021 however was not captured considering the nature of event (medication error).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222783:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: DRY COUGH; RUNNY NOSE; CONGESTION IN NOSE; SORE THROAT; HEADACHE; BLOOD CLOTS COMING OUT OF MY NOSE; SORE LEFT ARM; MUSCLES FELT SORE; This spontaneous report received from a patient concerned a 45-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: High blood pressure controlled, alcohol user, and nonsmoker. The patient had no known allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204B21A expiry: UNKNOWN) dose was not reported, 1 in total administered to left arm on 30-SEP-2021 for prophylactic vaccination. Concomitant medications included amlodipine 5mg once daily for high blood pressure.  On 30-SEP-2021 (on the same day of vaccination), the patient had blood clots coming out of his nose, sore left arm, muscles felt sore. The patient stated that after receiving vaccine, he felt his left arm was sore for one day and muscles were sore the same way he feels muscle pain after a workout and it lasted one day (as per the report), also had blood clots coming out of his nose every time, he blew his nose for 2 to 3 days then cleared on its own. On 26-OCT-2021, the patient experienced sore throat, headache. On the same day (26-OCT-2021), laboratory data included: COVID-19 virus test made by Abbott and the result was negative. On 27-OCT-2021, the patient experienced runny nose, congestion in nose. On 28-OCT-2021 (date of report), the patient experienced dry cough, and headache. However patient had no fever and no loss of taste or smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots coming out of my nose on 04-OCT-2021, sore throat on 27-OCT-2021, runny nose, congestion in nose, and headache on 28-OCT-2021, and sore left arm, and muscles felt sore on 01-OCT-2021, and had not recovered from dry cough. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211058458-COVID-19 VACCINE AD26.COV2.S-Blood clots coming out of my nose. 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: Pain in extremity, Rhinorrhoea, SARS-CoV-2 test, Thrombosis
Clinical narrative: DRY COUGH; RUNNY NOSE; CONGESTION IN NOSE; SORE THROAT; HEADACHE; BLOOD CLOTS COMING OUT OF MY NOSE; SORE LEFT ARM; MUSCLES FELT SORE; This spontaneous report received from a patient concerned a 45-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: High blood pressure controlled, alcohol user, and nonsmoker. The patient had no known allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204B21A expiry: UNKNOWN) dose was not reported, 1 in total administered to left arm on 30-SEP-2021 for prophylactic vaccination. Concomitant medications included amlodipine 5mg once daily for high blood pressure.  On 30-SEP-2021 (on the same day of vaccination), the patient had blood clots coming out of his nose, sore left arm, muscles felt sore. The patient stated that after receiving vaccine, he felt his left arm was sore for one day and muscles were sore the same way he feels muscle pain after a workout and it lasted one day (as per the report), also had blood clots coming out of his nose every time, he blew his nose for 2 to 3 days then cleared on its own. On 26-OCT-2021, the patient experienced sore throat, headache. On the same day (26-OCT-2021), laboratory data included: COVID-19 virus test made by Abbott and the result was negative. On 27-OCT-2021, the patient experienced runny nose, congestion in nose. On 28-OCT-2021 (date of report), the patient experienced dry cough, and headache. However patient had no fever and no loss of taste or smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots coming out of my nose on 04-OCT-2021, sore throat on 27-OCT-2021, runny nose, congestion in nose, and headache on 28-OCT-2021, and sore left arm, and muscles felt sore on 01-OCT-2021, and had not recovered from dry cough. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211058458-COVID-19 VACCINE AD26.COV2.S-Blood clots coming out of my nose. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Ageusia, Anosmia, Bedridden, Bowel movement irregularity
Clinical narrative: CANNOT URINATE; LOSS OF SENSE OF TASTE; BREATHING ISSUES; EPISODES OF CONSTIPATION (NOT GONE TO THE BATHROOM IN 5 DAYS); PAIN IN THE ABDOMEN; COLD SWEATS; BOWEL MOVEMENT ISSUES; LOSS OF APPETITE; LOST 20 TO 30 POUNDS; CANNOT GO TO WORK; CANNOT GET OUT OF BED; LOSS OF SENSE OF SMELL; CHILLS/SHIVERING; FEVER; DIARRHEA; VOMITING; TIRED; This spontaneous report received from a patient concerned a 60-year-old male. The patient's height, and weight were not reported. The patient's past medical history included: broken ribs, bacterial pneumonia, and hematoma, and concurrent conditions included: non-alcohol user, and smoker, and the patient had no known drug allergies and was healthy overall before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 17-AUG-2021 at right arm for prophylactic vaccination into. No concomitant medications were reported. On an unspecified date (for couple of days), the patient experienced fever, chills, diarrhea, could not urinate and pain in the abdomen. The patient stated that since then patient has been tired and sometimes cannot get out of bed and cannot go to work. Patient lost sense of taste and smell and patient also had breathing issues. The patient had symptoms started getting better but 2 weeks ago, woke up with fever and was shivering. Patient vomited and had episodes of constipation and diarrhea, lost taste and smell again and also patient had cold sweats. Patient had issue with bowel movement and lost appetite. The patient was constipated and has not gone to the bathroom in 5 days. The patient lost 20-30 pounds, Patient took acetylsalicylic acid and ibuprofen few times a day which seems to help a little bit but then wane off. The patient was concerned that patient was not tested at the facility before getting the shot and what if patient had COVID-19 before and did not know because patient was never tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cannot urinate, tired, cannot get out of bed, and cannot go to work, had not recovered from episodes of constipation (not gone to the bathroom in 5 days), and the outcome of fever, chills/shivering, loss of sense of taste, breathing issues, diarrhea, vomiting, pain in the abdomen, cold sweats, bowel movement issues, loss of appetite, lost 20 to 30 pounds and loss of sense of smell was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211059177-covid-19 vaccine ad26.cov2.s- Can not urinate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Constipation, Decreased appetite, Diarrhoea
Clinical narrative: CANNOT URINATE; LOSS OF SENSE OF TASTE; BREATHING ISSUES; EPISODES OF CONSTIPATION (NOT GONE TO THE BATHROOM IN 5 DAYS); PAIN IN THE ABDOMEN; COLD SWEATS; BOWEL MOVEMENT ISSUES; LOSS OF APPETITE; LOST 20 TO 30 POUNDS; CANNOT GO TO WORK; CANNOT GET OUT OF BED; LOSS OF SENSE OF SMELL; CHILLS/SHIVERING; FEVER; DIARRHEA; VOMITING; TIRED; This spontaneous report received from a patient concerned a 60-year-old male. The patient's height, and weight were not reported. The patient's past medical history included: broken ribs, bacterial pneumonia, and hematoma, and concurrent conditions included: non-alcohol user, and smoker, and the patient had no known drug allergies and was healthy overall before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 17-AUG-2021 at right arm for prophylactic vaccination into. No concomitant medications were reported. On an unspecified date (for couple of days), the patient experienced fever, chills, diarrhea, could not urinate and pain in the abdomen. The patient stated that since then patient has been tired and sometimes cannot get out of bed and cannot go to work. Patient lost sense of taste and smell and patient also had breathing issues. The patient had symptoms started getting better but 2 weeks ago, woke up with fever and was shivering. Patient vomited and had episodes of constipation and diarrhea, lost taste and smell again and also patient had cold sweats. Patient had issue with bowel movement and lost appetite. The patient was constipated and has not gone to the bathroom in 5 days. The patient lost 20-30 pounds, Patient took acetylsalicylic acid and ibuprofen few times a day which seems to help a little bit but then wane off. The patient was concerned that patient was not tested at the facility before getting the shot and what if patient had COVID-19 before and did not know because patient was never tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cannot urinate, tired, cannot get out of bed, and cannot go to work, had not recovered from episodes of constipation (not gone to the bathroom in 5 days), and the outcome of fever, chills/shivering, loss of sense of taste, breathing issues, diarrhea, vomiting, pain in the abdomen, cold sweats, bowel movement issues, loss of appetite, lost 20 to 30 pounds and loss of sense of smell was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211059177-covid-19 vaccine ad26.cov2.s- Can not urinate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Impaired work ability, Pyrexia, Urinary retention
Clinical narrative: CANNOT URINATE; LOSS OF SENSE OF TASTE; BREATHING ISSUES; EPISODES OF CONSTIPATION (NOT GONE TO THE BATHROOM IN 5 DAYS); PAIN IN THE ABDOMEN; COLD SWEATS; BOWEL MOVEMENT ISSUES; LOSS OF APPETITE; LOST 20 TO 30 POUNDS; CANNOT GO TO WORK; CANNOT GET OUT OF BED; LOSS OF SENSE OF SMELL; CHILLS/SHIVERING; FEVER; DIARRHEA; VOMITING; TIRED; This spontaneous report received from a patient concerned a 60-year-old male. The patient's height, and weight were not reported. The patient's past medical history included: broken ribs, bacterial pneumonia, and hematoma, and concurrent conditions included: non-alcohol user, and smoker, and the patient had no known drug allergies and was healthy overall before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 17-AUG-2021 at right arm for prophylactic vaccination into. No concomitant medications were reported. On an unspecified date (for couple of days), the patient experienced fever, chills, diarrhea, could not urinate and pain in the abdomen. The patient stated that since then patient has been tired and sometimes cannot get out of bed and cannot go to work. Patient lost sense of taste and smell and patient also had breathing issues. The patient had symptoms started getting better but 2 weeks ago, woke up with fever and was shivering. Patient vomited and had episodes of constipation and diarrhea, lost taste and smell again and also patient had cold sweats. Patient had issue with bowel movement and lost appetite. The patient was constipated and has not gone to the bathroom in 5 days. The patient lost 20-30 pounds, Patient took acetylsalicylic acid and ibuprofen few times a day which seems to help a little bit but then wane off. The patient was concerned that patient was not tested at the facility before getting the shot and what if patient had COVID-19 before and did not know because patient was never tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cannot urinate, tired, cannot get out of bed, and cannot go to work, had not recovered from episodes of constipation (not gone to the bathroom in 5 days), and the outcome of fever, chills/shivering, loss of sense of taste, breathing issues, diarrhea, vomiting, pain in the abdomen, cold sweats, bowel movement issues, loss of appetite, lost 20 to 30 pounds and loss of sense of smell was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211059177-covid-19 vaccine ad26.cov2.s- Can not urinate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting, Weight, Weight decreased
Clinical narrative: CANNOT URINATE; LOSS OF SENSE OF TASTE; BREATHING ISSUES; EPISODES OF CONSTIPATION (NOT GONE TO THE BATHROOM IN 5 DAYS); PAIN IN THE ABDOMEN; COLD SWEATS; BOWEL MOVEMENT ISSUES; LOSS OF APPETITE; LOST 20 TO 30 POUNDS; CANNOT GO TO WORK; CANNOT GET OUT OF BED; LOSS OF SENSE OF SMELL; CHILLS/SHIVERING; FEVER; DIARRHEA; VOMITING; TIRED; This spontaneous report received from a patient concerned a 60-year-old male. The patient's height, and weight were not reported. The patient's past medical history included: broken ribs, bacterial pneumonia, and hematoma, and concurrent conditions included: non-alcohol user, and smoker, and the patient had no known drug allergies and was healthy overall before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 17-AUG-2021 at right arm for prophylactic vaccination into. No concomitant medications were reported. On an unspecified date (for couple of days), the patient experienced fever, chills, diarrhea, could not urinate and pain in the abdomen. The patient stated that since then patient has been tired and sometimes cannot get out of bed and cannot go to work. Patient lost sense of taste and smell and patient also had breathing issues. The patient had symptoms started getting better but 2 weeks ago, woke up with fever and was shivering. Patient vomited and had episodes of constipation and diarrhea, lost taste and smell again and also patient had cold sweats. Patient had issue with bowel movement and lost appetite. The patient was constipated and has not gone to the bathroom in 5 days. The patient lost 20-30 pounds, Patient took acetylsalicylic acid and ibuprofen few times a day which seems to help a little bit but then wane off. The patient was concerned that patient was not tested at the facility before getting the shot and what if patient had COVID-19 before and did not know because patient was never tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cannot urinate, tired, cannot get out of bed, and cannot go to work, had not recovered from episodes of constipation (not gone to the bathroom in 5 days), and the outcome of fever, chills/shivering, loss of sense of taste, breathing issues, diarrhea, vomiting, pain in the abdomen, cold sweats, bowel movement issues, loss of appetite, lost 20 to 30 pounds and loss of sense of smell was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211059177-covid-19 vaccine ad26.cov2.s- Can not urinate. 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: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-OCT-2021, the patient experienced sars-cov-2 test positive. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine  was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000199942.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: HEADACHE; NAUSEA; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, the patient experienced headache. On 28-OCT-2021, the patient experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Sensory disturbance
Clinical narrative: FELT LIKE HIT BY A MACK TRUCK; CHILLS; COULD NOT GET WARM; This spontaneous report received from a patient via a company representative 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 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 APR-2021, the patient experienced felt like hit by a mack truck. On APR-2021, the patient experienced chills. On APR-2021, the patient experienced could not get warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like hit by a mack truck, chills, and could not get warm. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Feeling abnormal
Clinical narrative: feels really bad; sick to the stomach; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels really bad), ABDOMINAL DISCOMFORT (sick to the stomach), CHILLS (chills) and FATIGUE (fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21C, 010M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, 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 experienced FEELING ABNORMAL (feels really bad), ABDOMINAL DISCOMFORT (sick to the stomach), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feels really bad), ABDOMINAL DISCOMFORT (sick to the stomach), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications present, yet not disclosed.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Fast heart beat/can not get their heart beat down from 90/I can't get my pulse down below 90. When I go to bed it goes low when I'm up around it goes 93. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beat/can not get their heart beat down from 90/I can't get my pulse down below 90. When I go to bed it goes low when I'm up around it goes 93.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0317F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM, IBUPROFEN (ADVIL [IBUPROFEN]), DOXYCYCLINE and VITAMIN D3 for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Fast heart beat/can not get their heart beat down from 90/I can't get my pulse down below 90. When I go to bed it goes low when I'm up around it goes 93.). At the time of the report, HEART RATE INCREASED (Fast heart beat/can not get their heart beat down from 90/I can't get my pulse down below 90. When I go to bed it goes low when I'm up around it goes 93.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Heart rate: 90 (abnormal) Patient heartbeat was 90..         First dose of COVID-19 batch lot number was rusph .  Concomitant medications includes blood pressure medicine  Patient did not took anything to treat the side effect.   This case was linked to MOD-2021-362847 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2021: Follow up appended includes vaccine dose date update and concomitant medication added
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: completed primary vaccination with Johnson and Johnson.; notice that the vial had expired on the 28 sept 2021/manufactured on the 28Feb2021; has a tiny bit of a sore shoulder were the needle went in but not even; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (completed primary vaccination with Johnson and Johnson.), EXPIRED PRODUCT ADMINISTERED (notice that the vial had expired on the 28 sept 2021/manufactured on the 28Feb2021) and VACCINATION SITE PAIN (has a tiny bit of a sore shoulder were the needle went in but not even) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036b21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson. (Johnson and Johnson.).    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (completed primary vaccination with Johnson and Johnson.), EXPIRED PRODUCT ADMINISTERED (notice that the vial had expired on the 28 sept 2021/manufactured on the 28Feb2021) and VACCINATION SITE PAIN (has a tiny bit of a sore shoulder were the needle went in but not even). On 22-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (completed primary vaccination with Johnson and Johnson.) and EXPIRED PRODUCT ADMINISTERED (notice that the vial had expired on the 28 sept 2021/manufactured on the 28Feb2021) had resolved. At the time of the report, VACCINATION SITE PAIN (has a tiny bit of a sore shoulder were the needle went in but not even) outcome was unknown.            No concomitant medication was provided by the reporter. No treatment information was provided by the reporter. It was reported that patient had completed primary vaccination with Johnson and Johnson.   Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2021: Non significant follow up
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Dyspnoea
Clinical narrative: difficulty of breathing; tightness of chest; 4-5 pumps a day for his spray (asthma); This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty of breathing), CHEST DISCOMFORT (tightness of chest) and ASTHMA (4-5 pumps a day for his spray (asthma)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (difficulty of breathing), CHEST DISCOMFORT (tightness of chest) and ASTHMA (4-5 pumps a day for his spray (asthma)). At the time of the report, DYSPNOEA (difficulty of breathing), CHEST DISCOMFORT (tightness of chest) and ASTHMA (4-5 pumps a day for his spray (asthma)) had not resolved.            Concomitant medication included using 1-2 pumps daily for Asthma.  Patient reported that now he takes 4-5 pumps of this spray daily, for the same.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dysgeusia, Extra dose administered, Illness
Clinical narrative: Possible administered a 3rd full dose; Back hurt; Felt like he swallowed a bowl of nickle after vaccine; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back hurt), DYSGEUSIA (Felt like he swallowed a bowl of nickle after vaccine), ILLNESS (Very sick) and EXTRA DOSE ADMINISTERED (Possible administered a 3rd full dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 028A21A and 007M20A) for COVID-19 vaccination.     No Medical history information was reported.  Concomitant products included APIXABAN (ELIQUIS), CLOPIDOGREL BISULFATE (PLAVIX), ATORVASTATIN CALCIUM (LIPITOR) and AMLODIPINE for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced BACK PAIN (Back hurt), DYSGEUSIA (Felt like he swallowed a bowl of nickle after vaccine) and ILLNESS (Very sick). On 23-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Possible administered a 3rd full dose). On 23-Oct-2021, EXTRA DOSE ADMINISTERED (Possible administered a 3rd full dose) had resolved. At the time of the report, BACK PAIN (Back hurt) and DYSGEUSIA (Felt like he swallowed a bowl of nickle after vaccine) had not resolved and ILLNESS (Very sick) outcome was unknown.            No treatment information was reported. The patient had stated that he was taking another blood pressure medication before he had the vaccination.   This case was linked to MOD-2021-362185 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2021: Follow-up received include no new information.