chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tongue eruption
Clinical narrative: First / vaccine in / November 2020 or November 2019 / second / on 6-14-2021; Pain / at injection site; Redness at injection site; Nausea; Chills; Slight fever; Noticed spots all over her tongue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose  in November 2020).   On 14th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 14th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In June 2021, the patient experienced injection site pain, injection site erythema, nausea, chills, fever and tongue pigmentation. On 16th June 2021, the outcome of the nausea, chills and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and tongue pigmentation were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the injection site pain and injection site erythema to be related to Shingrix. It was unknown if the reporter considered the nausea, chills, fever and tongue pigmentation to be related to Shingrix.  Additional details were provided as follows: 12 hours after receiving 2nddose of Shingrix, patient experienced injection site pain, injection site redness, chills, fever, nausea and 21 hours after receiving Shingrix, patient experienced spots on tongue. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The reporter mentioned that, fever, nausea, chills resolved after about 12 hours. The reporter also mentioned that, injection site pain, injection site redness and spots on tongue were not resolved. No other information was given on spots on tongue. The reporter did not consent to follow up  Note- As start date for 1st dose was not clearly specified, November 2020 was being captured conservatively
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Limb discomfort
Clinical narrative: Shoulder pain / left shoulder as the area of concern; Had sever problems with her left arm; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shoulder pain and arm discomfort. On an unknown date, the outcome of the shoulder pain and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and arm discomfort to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter was the patients husband. The reporter reported that his wife had severe problems with her left arm after receiving the Shingrix vaccine about three months ago. The patient went to a chiropractor, then to a shoulder specialist, and was now in physical therapy. The reporter did not consent to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got dose1 / 3 yrs ago, got 2nd dose today on 6/16/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 52B24, expiry date 23rd August 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago, batch number-T24P9, expiry date-23rd August 2021).   On 16th June 2021, the patient received the 2nd dose of Shingrix. On 16th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose longer than the recommended interval, which led to lengthening of vaccination schedule. The pharmacist inquired that they had to restart the series or give another dose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose / in August of 2020 and has not yet received the second dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was patient's mother. Age at vaccination was not applicable for this report. Till the time of reporting patient did not received 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose 1 on Jan 2020. Any guidance on 2nd dose?; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist inquired that if patient received 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No other details were provided. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose on September 8th 2020 and had not yet received the third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (2nd dose received on 8th September 2020).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 reported as follows: The age at vaccination was not reported. The patient had received 2nd dose of Twinrix and till the time of reporting patient did not received 3rd dose of twinrix, which led to incomplete course of vaccination. No further events were reported. HCP (Healthcare professional ) did not consent to follow up.
Age: 48.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on February 2nd 2021 and the second dose June 16th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 48-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix with an associated reaction of no adverse event (1st dose received on 2nd February 2021).   On 16th June 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th June 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   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 reported as follows: The pharmacist reported that, the patient received 2nd dose of Twinrix longer than recommended interval, which led to lengthening of vaccination schedule. No further events were reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on November 6th 2019 / second dose / not / administered yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Malaise, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; MALAISE; FEVER; This spontaneous report was received from a 75-year-old female patient via a physician. The patient's height, and weight were not reported. The patient's concurrent conditions included pulmonary arterial hypertension and sinus infection due to seasonal allergies. The patient received macitentan (OPSUMIT) (tablet, form of administration:10 mg, oral, batch number was not reported) 10 mg, daily, from 23-JAN-2020, frequency was not reported for pulmonary arterial hypertension.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the patient experienced fever which was treated with Tylenol (paracetamol). On 12-APR-2021, her fever returned and was accompanied by shortness of breath and malaise, following which she was hospitalized in the afternoon. It was reported that the patient had a possible reaction to the vaccine. At the time of report, the hospitalization status was provided as 'current'/'not resolved'. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the malaise, shortness of breath and fever was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210440876-covid-19 vaccine ad26.cov2.s -SHORTNESS OF BREATH. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210440876-covid-19 vaccine ad26.cov2.s -MALAISE, FEVER. This event(s) are labeled per RSI and is therefore considered potentially related. 20210440876-OPSUMIT-SHORTNESS OF BREATH,MALAISE,FEVER. This event(s) are 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: CONMEDS-OTHER SUSPECT DRUGS
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Fluid overload, Malaise, Oxygen saturation, SARS-CoV-2 test positive
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; FLUID OVERLOAD; NOT FELT WELL; This spontaneous report received from a health care professional concerned a 57 year old adult male, ethnicity not reported. The patient's weight was 110.9 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient received Uptravi (selexipag) (tablet, oral, batch number: 031541502 expiry: 31-JUL-2022) 1000 ug, 2 times every 1 day, therapy dates were not reported for primary pulmonary hypertension. Concomitant medications included amlodipine, Opsumit (macitentan), and Adempas (riociguat). On an unspecified date, patient received covid-19 vaccine and had not felt well since then. He was diagnosed with covid-19 infection and was advised by primary care physician to go to the emergency room for worsening shortness of breath and decreased oxygen levels. The patient went to emergency room and fluid overload has also been determined. The patient had suspected clinical vaccination failure.  Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Not reported, and Oxygen saturation (NR: not provided) Decreased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The patient had not recovered from covid-19 infection, not felt well, and fluid overload, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint number 90000182758.  Additional information received from Product Quality Vigilance on 14-JUN-2021.   .; Sender's Comments: V0 20210624724-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. V0 20210624724-UPTRAVI-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.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; FLUID OVERLOAD; NOT FELT WELL; This spontaneous report received from a health care professional concerned a 57 year old adult male, ethnicity not reported. The patient's weight was 110.9 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient received Uptravi (selexipag) (tablet, oral, batch number: 031541502 expiry: 31-JUL-2022) 1000 ug, 2 times every 1 day, therapy dates were not reported for primary pulmonary hypertension. Concomitant medications included amlodipine, Opsumit (macitentan), and Adempas (riociguat). On an unspecified date, patient received covid-19 vaccine and had not felt well since then. He was diagnosed with covid-19 infection and was advised by primary care physician to go to the emergency room for worsening shortness of breath and decreased oxygen levels. The patient went to emergency room and fluid overload has also been determined. The patient had suspected clinical vaccination failure.  Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Not reported, and Oxygen saturation (NR: not provided) Decreased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The patient had not recovered from covid-19 infection, not felt well, and fluid overload, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint number 90000182758.  Additional information received from Product Quality Vigilance on 14-JUN-2021.   .; Sender's Comments: V0 20210624724-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. V0 20210624724-UPTRAVI-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.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a 58 year old male. The patient's height, and weight were not reported. The patient had no known allergies and no significant medical history on file.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: 04-AUG-2021) 0.5 ml, 1 total administered on 02-APR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 21-MAY-2021, seven weeks after covid-19 vaccination, the patient had SARS-COV2 Antibody IGg Spike Quantitative Test performed, which came back negative (less than 1 and cut off for positive was more than 1) (confirmed immunological vaccine failure). The physician wanted to know the incidence of this happening post vaccination and what was needed to be done and also stated that the patient was freaking out and wanted to know what to do The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210626621-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This spontaneous report received from a consumer via social media via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced suffering with joint pain. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering with joint pain was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyskinesia, Headache, Pain, Pain in jaw
Clinical narrative: WOKE UP IN THE MIDDLE OF THE NIGHT HURTING ALL OVER (BODY PAIN); MORE TOTAL BODY JERKING; SORE JAW (PAINFUL TO OPEN MOUTH); TREMOR; JOINT PAINS FROM ARTHRITIS WORSENED; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and back surgery, and concurrent conditions included osteoarthritis of all major joints, and benign essential tremor.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 23A21A, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for pain. On 11-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced woke up in the middle of the night hurting all over (body pain). On 12-JUN-2021, the subject experienced more total body jerking. On 12-JUN-2021, the subject experienced sore jaw (painful to open mouth). On 12-JUN-2021, the subject experienced tremor. On 12-JUN-2021, the subject experienced joint pains from arthritis worsened. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woke up in the middle of the night hurting all over (body pain), sore jaw (painful to open mouth), headache, joint pains from arthritis worsened, more total body jerking, and tremor. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: WOKE UP IN THE MIDDLE OF THE NIGHT HURTING ALL OVER (BODY PAIN); MORE TOTAL BODY JERKING; SORE JAW (PAINFUL TO OPEN MOUTH); TREMOR; JOINT PAINS FROM ARTHRITIS WORSENED; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and back surgery, and concurrent conditions included osteoarthritis of all major joints, and benign essential tremor.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 23A21A, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for pain. On 11-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced woke up in the middle of the night hurting all over (body pain). On 12-JUN-2021, the subject experienced more total body jerking. On 12-JUN-2021, the subject experienced sore jaw (painful to open mouth). On 12-JUN-2021, the subject experienced tremor. On 12-JUN-2021, the subject experienced joint pains from arthritis worsened. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woke up in the middle of the night hurting all over (body pain), sore jaw (painful to open mouth), headache, joint pains from arthritis worsened, more total body jerking, and tremor. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient via social media 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had blood clot and died.The cause of death is blood clot. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210627090.; Sender's Comments: V0: 20210627096-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
Sex: M
Vaccine: COVID19
Symptoms: Myositis, SARS-CoV-2 test
Clinical narrative: UNSPECIFIED INFLAMMATION IN ALL MUSCLES LIKE ALL OF A SUDDEN MUSCLES DID NOT MOVE; This spontaneous report received from a consumer concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 13-MAY-2021, the subject experienced unspecified inflammation from all of the muscles and muscles did not move all of a sudden. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified inflammation from all of the muscles and muscles did not move all of a sudden. This report was non-serious. This report was associated with product quality complaint: 90000182565 The suspected product quality complaint has been confirmed to be void: y (did not meet pqc criteria) based on the PQC evaluation/investigation performed.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Eating disorder, Pain, Pyrexia
Clinical narrative: BODY ACHE; NOT EATEN ANYTHING OR DRINK ANYTHING; CHILLS; FEELING VERY WEAK; FEVER; This spontaneous report received from a pharmacist concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-JUN-2021, the subject experienced body ache. On 13-JUN-2021, the subject experienced not eaten anything or drink anything. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced feeling very weak. On 13-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body ache, feeling very weak and not eaten anything or drink anything was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR FALLING (HAIR LOSS); This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid with pneumonia, and intensive care unit.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced hair falling (hair loss). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair falling (hair loss). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Feeling drunk, Influenza like illness, Mood swings
Clinical narrative: FLU-LIKE SYMPTOMS; SORENESS AND ACHES; REFUSING TO GET OUT OF BED; WILLINGNESS TO BE UP AND ABOUT VARIES; LIGHT FEVER; FATIGUE; ALMOST LIKE DRUNKENNESS; 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) dose, start therapy date were not reported 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 subject experienced flu-like symptoms, soreness and aches, refusing to get out of bed, willingness to be up and about varies, light fever, fatigue, and almost like drunkenness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, light fever, soreness and aches, fatigue, refusing to get out of bed, willingness to be up and about varies and almost like drunkenness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; SORENESS AND ACHES; REFUSING TO GET OUT OF BED; WILLINGNESS TO BE UP AND ABOUT VARIES; LIGHT FEVER; FATIGUE; ALMOST LIKE DRUNKENNESS; 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) dose, start therapy date were not reported 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 subject experienced flu-like symptoms, soreness and aches, refusing to get out of bed, willingness to be up and about varies, light fever, fatigue, and almost like drunkenness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, light fever, soreness and aches, fatigue, refusing to get out of bed, willingness to be up and about varies and almost like drunkenness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: THROWING UP; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight was 94 pounds, and height was 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced throwing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throwing up. This report was non-serious. This case, from the same reporter is linked to 20210627698.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RAN A LITTLE TEMPERATURE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced ran a little temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ran a little temperature was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included she's a dialysis patient. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and low grade fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Chills, Dizziness, Eye pain, Headache
Clinical narrative: DIZZINESS; EYE PAIN; MEMORY FAILURE; CHILLS; HEADACHE; 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. The patient's pre-existing medical conditions included the patient never had health problems. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, eye pain, memory failure, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, eye pain, chills, memory failure and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FELT A LITTLE FLUISH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt a little fluish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little fluish. This report was non-serious. This case, from the same reporter is linked to 20210327861.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Therapeutic response unexpected
Clinical narrative: BLOOD SUGAR HASN'T GONE OVER  250; This spontaneous report received from a consumer concerned a 75 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes .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 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included insulin aspart for high blood sugar, insulin degludec for high blood sugar, liraglutide for high blood sugar, and metformin for high blood sugar. On an unspecified date, the subject experienced blood sugar hasn't gone over 250. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 250, 400. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood sugar hasn't gone over 250 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHY; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-JUN-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 13-JUN-2021, the subject experienced achy. On 13-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and achy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210630179.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin reaction
Clinical narrative: ITCHINESS AROUND ARM AND ABOVE WRIST ON SAME SIDE AS AFFECTED LEG; SKIN REACTION ON ARM; RASH ABOUT 4 INCHES AROUND ANKLE AND BELOW LEG ON ONE LEG; BRIGHT RED SKIN REACTION ABOUT 4 INCHES AROUND ANKLE AND BELOW LEG ON ONE LEG; This spontaneous report received from a pharmacist concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bright red skin reaction about 4 inches around ankle and below leg on one leg. On APR-2021, the subject experienced skin reaction on arm. On APR-2021, the subject experienced rash about 4 inches around ankle and below leg on one leg. On JUN-2021, the subject experienced itchiness around arm and above wrist on same side as affected leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash about 4 inches around ankle and below leg on one leg, bright red skin reaction about 4 inches around ankle and below leg on one leg, itchiness around arm and above wrist on same side as affected leg, and skin reaction on arm. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Magnetic resonance imaging, Pain in extremity, Pulmonary embolism, X-ray
Clinical narrative: RIGHT LEG DEEP VEIN THROMBOSIS; RIGHT ARM PAIN; PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol user, non smoker, tree allergy, onion allergy, topical iodine cleanser allergy, and weeds allergy, and patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: UNKNOWN) dose was not reported, 1 total administered on 19-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, cetirizine, fluticasone, levothyroxine and omeprazole used for unknown indication.  On 05-APR-2021, the patient experienced chest pain, shortness of breath, extreme shortness on upper back, right arm pain, right rib cage pain. On 19-APR-2011 patient was travelling, took a bus, when patient arrived, symptoms were so severe that patient could not pick up the luggage. Patient arrived around 5:30pm to his destination and was taken to the ER (emergency room). Patient had x-rays and an MRI done, and was admitted to hospital. Patient was discharged on 24-APR-2021 (hospitalized for 5 days) with diagnosis of acute pulmonary embolism, Shortness of breath, right leg deep vein thrombosis, pain in chest, elevated troponins. Patient was prescribed Eliquis during this admission and patient was currently taking it.  On 11-JUN-2021 Patient went to the hospital out of town and was admitted. Patient had chest pain and right arm pain, and right side rib pain. Patient was discharged on 12-JUN-2021 and diagnosed with pulmonary embolism. Patient stated that the chest has improved since starting to take Eliquis, but still feels pressure on the right side of rib cage and felt has not fully recovered yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right arm pain, and had not recovered from pulmonary embolism, and right leg deep vein thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210629366-COVID-19 VACCINE AD26.COV2.S- Pulmonary embolism, right leg deep vein thrombosis, right arm pain. 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. 20210629366-COVID-19 VACCINE AD26.COV2.S- right arm pain. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN LEG; This spontaneous report received from a parent 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) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included unspecified oral contraceptives.  On an unspecified date (10 days after vaccination), the patient had blood clots in leg and was treated with unspecified blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in leg was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210629309.; Sender's Comments: V0:20210629530-COVID-19 VACCINE AD26.COV2.S-Blood clots in leg. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Rash pruritic
Clinical narrative: ACHINESS; FEVER; TIREDNESS; ITCHY RASH ON FACE/NECK/RIGHT BELOW/NECK LINE AREA/ AROUND SHOULDERS /CHEST AREA.; This spontaneous report received from a patient via a company representative concerned a 43 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205AZIA and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced itchy rash on face/neck/right below/neck line area/ around shoulders/chest area. On an unspecified date, the subject experienced achiness, fever, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, fever, and tiredness, and itchy rash on face/neck/right below/neck line area/ around shoulders/chest area. on 06-JUN-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: NUMBNESS IN THREE FINGERS OF RIGHT HAND; PAIN IN HAND OR FINGERS; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced numbness in three fingers of right hand, and pain in hand or fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness in three fingers of right hand, and the outcome of pain in hand or fingers was not reported. This report was non-serious.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chest X-ray, Fatigue, Feeling cold
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; FEELING COLD; FEELING SICK; NO ENERGY; FEELING TIRED; This spontaneous report received from a patient concerned a 92 year old female. The patient's height, and weight were not reported. The patient's past medical history included dropped bladder, and concurrent conditions included non-alcohol user, non-smoker, penicillin allergy, hard time hearing, and hard time understanding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 28-JUL-2021) 1 total, dose was not reported, administered on left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  After vaccination, the patient had no side effects. On unspecified date in MAY-2021, the patient was sick and had cold (put a sweater while was 90 F). She felt tired and had no energy. The patient had stated that she was usually energetic. The patient had blood work done on 03-JUN-2021 and chest X-ray on 07-JUN-2021 for which results were not reported. The patient's physician informed that her test results showed that she did not get the COVID-19 vaccine. It was reported that, the patient had covid-19 antibody test which came back negative (suspected immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure, feeling cold, feeling tired, feeling sick and no energy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630052-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.