chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: in march 23rd 2021/ they gave a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 05th August 2019) and Shingrix (received second dose of Shingrix on 21st October 2019).   On 23rd March 2021, the patient received the 3rd dose of Shingrix. On 23rd March 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter informed as per the records, the patient was given third dose and was discovered later that patient had 2 doses already but patient said it was false and requested another dose which led to extra dose administered. The patient did not receive any 4th dose of Shingrix. The reporter consented to follow up. This case has been linked with case ID US2021111558 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111558:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: more than 6 months since his first 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 more than 6 months from reporting date.).   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: This case was reported by patient himself. The age at vaccination was not applicable for 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 wanted to know if it was still ok to get his 2nd dose. The reporter did not consent to follow up. No further information was reported.
Sex: U
Vaccine: FLU4, HEPA
Symptoms: Injection site discolouration, Injection site mass, Injection site pruritus
Clinical narrative: itching/at injection site.; Lump/at injection site.; discoloration (bruise)/at injection site.; This case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date unknown) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 94J24, expiry date unknown) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2019, the patient received FluLaval Tetra 2019-2020 season, Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, less than 2 years after receiving FluLaval Tetra 2019-2020 season, Havrix and Havrix Pre-Filled Syringe Device, the patient experienced injection site itching, injection site lump and injection site discoloration. On an unknown date, the outcome of the injection site itching, injection site lump and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site itching, injection site lump and injection site discoloration to be related to FluLaval Tetra 2019-2020 season, Havrix and Havrix Pre-Filled Syringe Device.  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 received Flulaval and Havrix and experienced discoloration (brulse), itching and lump instead of numbness at the injection site. There were no more information. The reporter consented to follow up via an email.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: received first dose of Shingrix 2 years ago (2019) and would like the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years before the reporting date in the year 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 reporter was a pharmacy student. The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose till the time of reporting which led to incomplete course of vaccination. The reporter asked if the patient could get the second dose of Shingrix.  The patient would like to receive the second dose of Shingrix.  The reporter was unable to provide the vaccine details.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix 18 months ago and has not received a second dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date 18 months prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that the patient did not received 1st dose at this pharmacy but may receive 2nd dose there. The reporter consented to follow up via email.
Age: 0.5
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: Overdose
Clinical narrative: during the day male patient received Infanrix and a the same time Pentacel (DTaP-IPV-Hib).; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL for prophylaxis.   On 24th May 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device and PENTACEL. On 24th May 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 nurse stated that during the day the patient received Infanrix and at the same time Pentacel (DTaP-IPV-Hib), which led to overdose. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received Havrix and a second dose one month after that; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Concomitant products included HAV (Havrix).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix and an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details provided were as follows: The patient received 2nd dose of Havrix, 1 month after the 1st dose, which led to shortening of vaccination schedule. The reporter did not consented to follow-up. No further details provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test
Clinical narrative: ALLERGY SYMPTOMS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 13-APR-2021, the subject experienced allergy symptoms. Treatment medications (dates unspecified) included: dequalinium chloride. The action taken with covid-19 vaccine  was not applicable. The outcome of allergy symptoms was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be while a positive covid-19 test result was received after vaccination, insufficient time had elapsed for immunity to develop. approval to void this record due to no pqc identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: SLIGHT LEFT SIDE CHEST PAIN BELOW NIPPLE; SORE ARM; 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, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced slight left side chest pain below nipple. On 19-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from slight left side chest pain below nipple, and sore arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Lethargy, Menstruation delayed
Clinical narrative: LETHARGIC (FATIGUED,VERY TIRED,UNABLE TO GET OUT OF BED); WINDED FROM WALKING AND RUNNING; PERIOD DELAYED BY 2 WEEKS; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 130 pounds, and height was 66 inches. The patient's concurrent conditions included social drinker, non smoker, and copper iud, and other pre-existing medical conditions included the patient had no known allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced period delayed by 2 weeks. On 26-APR-2021, the subject experienced lethargic (fatigued, very tired, unable to get out of bed). On 26-APR-2021, the subject experienced winded from walking and running. The action taken with covid-19 vaccine  was not applicable. The patient recovered from period delayed by 2 weeks, had not recovered from lethargic (fatigued,very tired,unable to get out of bed), and the outcome of winded from walking and running was not reported. This report was non-serious. This case, from the same reporter is linked to 20210537334.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MILD FEVER; 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 (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported.  On an unspecified date, the subject experienced mild fever. The action taken with covid-19 vaccine was not applicable. The outcome of mild fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210539009 and 20210545499.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Consciousness fluctuating
Clinical narrative: PASSING IN AND OUT OF CONSCIOUSNESS; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex and ethnicity. 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, Expiry Date: 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 was laying in bed with the chills passing in and out of consciousness. Patient was fine 48 hours later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from consciousness fluctuating and chills. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210541935-covid-19 vaccine ad26.cov2.s -passing in and out of consciousness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTRATION; THE PREFILLED SYRINGE WAS OUT OF THE 2 HOUR FRAME BY 15 MINUTES; This spontaneous report received from a health care professional concerned a 49 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced expired vaccine administration. On 21-MAY-2021, the subject experienced the prefilled syringe was out of the 2 hour frame by 15 minutes. The action taken with covid-19 vaccine was not applicable. The outcome of the expired vaccine administration and the prefilled syringe was out of the 2 hour frame by 15 minutes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Chills, Ear pain
Clinical narrative: NECK PAIN; BODY ACHES; EARS HURT; BACK PAIN; THROAT KIND OF STINGS; CHILLS; NO STRENGTH; HEAD ACHE; ACHE IN ARM; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced ache in arm. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced head ache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 22-MAY-2021, the subject experienced neck pain. On 22-MAY-2021, the subject experienced body aches. On 22-MAY-2021, the subject experienced ears hurt. On 22-MAY-2021, the subject experienced back pain. On 22-MAY-2021, the subject experienced throat kind of stings. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced no strength. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, ache in arm, head ache, neck pain, throat kind of stings, ears hurt, chills, body aches, no strength, and back pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: NECK PAIN; BODY ACHES; EARS HURT; BACK PAIN; THROAT KIND OF STINGS; CHILLS; NO STRENGTH; HEAD ACHE; ACHE IN ARM; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced ache in arm. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced head ache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 22-MAY-2021, the subject experienced neck pain. On 22-MAY-2021, the subject experienced body aches. On 22-MAY-2021, the subject experienced ears hurt. On 22-MAY-2021, the subject experienced back pain. On 22-MAY-2021, the subject experienced throat kind of stings. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced no strength. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, ache in arm, head ache, neck pain, throat kind of stings, ears hurt, chills, body aches, no strength, and back pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NECK PAIN; BODY ACHES; EARS HURT; BACK PAIN; THROAT KIND OF STINGS; CHILLS; NO STRENGTH; HEAD ACHE; ACHE IN ARM; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced ache in arm. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced head ache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 22-MAY-2021, the subject experienced neck pain. On 22-MAY-2021, the subject experienced body aches. On 22-MAY-2021, the subject experienced ears hurt. On 22-MAY-2021, the subject experienced back pain. On 22-MAY-2021, the subject experienced throat kind of stings. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced no strength. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, ache in arm, head ache, neck pain, throat kind of stings, ears hurt, chills, body aches, no strength, and back pain. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Laboratory test, Malaise, Rhinorrhoea, Vertigo
Clinical narrative: VERTIGO; RUNNY NOSE; FEELING SICK; This spontaneous report received from a patient concerned a 61 year old not Hispanic or Latino, African American female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, cholesterol, depression, and non smoker, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) frequency 1 total, dose was not reported, administered on 31-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included blood pressure pill, cholesterol pill and anti-depressant.  One week after vaccination, on 07-APR-2021, the patient was feeling sick and dizzy. She said that the ambulance picked her up that day she felt really dizzy and took her to the hospital. There they performed tests on her and kept her overnight. Doctor of Medicine (MD) diagnosed her with vertigo and told her to take some over the counter medications for it. She reported that her runny nose and sick feeling went away after about a day. One to two weeks after that emergency room (ER) visit, she again went to the ER. This occurred at around 1-2:30 AM she went to the ER and MD said she had vertigo but she just stayed until the morning. MD prescribed her medicine for the vertigo, but the vertigo had not gone away. The MD there, did tests for blood clots but did not find anything but told her to take Aspirin (acetylsalicylic acid). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and feeling sick on 08-APR-2021, and had not recovered from vertigo. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210544583-covid-19 vaccine ad26.cov2-Vertigo, Runny 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). V0:20210544583-covid-19 vaccine ad26.cov2-Feeling sick. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient refused to give details regarding allergies, drug abuse or illicit drug usage, alcohol consumption, smoking and lab details. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The outcome of fever was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Blood pressure measurement, Body mass index, Body temperature
Clinical narrative: URINE WAS COKE LOOKING; MUSCLE WEAKNESS ON BOTH LOWER EXTREMITIES; INTENSE WEAKNESS; NAUSEA; TEMPERATURE 101.2 TO 102; LOST 9 POUNDS; TACHYCARDIA; LOW BACK PAIN; NECK PAIN; VACCINE FOR COVID WORKED AS ASTHMA CONTROLLER AND FOR WEIGHT LOSS; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, exposed to TB, and high weight, and other pre-existing medical conditions included patient did not took other medications including no Tylenol or NSAIDs not even for a cold and had no reactions until 3 hours after vaccination. patient had no vomiting, appetite, malaise feelings, headaches for the last 30 years. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fluticasone propionate for drug used for unknown indication, salbutamol for drug used for unknown indication, and bupropion hydrochloride for weight loss.  On MAY-2021, the subject experienced vaccine for COVID worked as asthma controller and for weight loss. Laboratory data included: Body mass index (NR: not provided) 29. On 19-MAY-2021, the subject experienced tachycardia. On 19-MAY-2021, the subject experienced low back pain. On 19-MAY-2021, the subject experienced neck pain. On 19-MAY-2021, the subject experienced lost 9 pounds. On 19-MAY-2021, the subject experienced intense weakness. On 19-MAY-2021, the subject experienced nausea. On 19-MAY-2021, the subject experienced temperature 101.2 to 102. Laboratory data included: Blood pressure (NR: not provided) 80-110, Body temperature (NR: not provided) 101.2 to 102, and Heart rate (NR: not provided) 110. On 21-MAY-2021, the subject experienced urine was coke looking. On 21-MAY-2021, the subject experienced muscle weakness on both lower extremities. The action taken with covid-19 vaccine  was not applicable. The outcome of the tachycardia, intense weakness, low back pain, neck pain, nausea, urine was coke looking, muscle weakness on both lower extremities, temperature 101.2 to 102, lost 9 pounds and vaccine for COVID worked as asthma controller and for weight loss was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Chromaturia, Heart rate, Muscular weakness, Nausea, Neck pain
Clinical narrative: URINE WAS COKE LOOKING; MUSCLE WEAKNESS ON BOTH LOWER EXTREMITIES; INTENSE WEAKNESS; NAUSEA; TEMPERATURE 101.2 TO 102; LOST 9 POUNDS; TACHYCARDIA; LOW BACK PAIN; NECK PAIN; VACCINE FOR COVID WORKED AS ASTHMA CONTROLLER AND FOR WEIGHT LOSS; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, exposed to TB, and high weight, and other pre-existing medical conditions included patient did not took other medications including no Tylenol or NSAIDs not even for a cold and had no reactions until 3 hours after vaccination. patient had no vomiting, appetite, malaise feelings, headaches for the last 30 years. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fluticasone propionate for drug used for unknown indication, salbutamol for drug used for unknown indication, and bupropion hydrochloride for weight loss.  On MAY-2021, the subject experienced vaccine for COVID worked as asthma controller and for weight loss. Laboratory data included: Body mass index (NR: not provided) 29. On 19-MAY-2021, the subject experienced tachycardia. On 19-MAY-2021, the subject experienced low back pain. On 19-MAY-2021, the subject experienced neck pain. On 19-MAY-2021, the subject experienced lost 9 pounds. On 19-MAY-2021, the subject experienced intense weakness. On 19-MAY-2021, the subject experienced nausea. On 19-MAY-2021, the subject experienced temperature 101.2 to 102. Laboratory data included: Blood pressure (NR: not provided) 80-110, Body temperature (NR: not provided) 101.2 to 102, and Heart rate (NR: not provided) 110. On 21-MAY-2021, the subject experienced urine was coke looking. On 21-MAY-2021, the subject experienced muscle weakness on both lower extremities. The action taken with covid-19 vaccine  was not applicable. The outcome of the tachycardia, intense weakness, low back pain, neck pain, nausea, urine was coke looking, muscle weakness on both lower extremities, temperature 101.2 to 102, lost 9 pounds and vaccine for COVID worked as asthma controller and for weight loss was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Therapeutic response unexpected, Weight decreased
Clinical narrative: URINE WAS COKE LOOKING; MUSCLE WEAKNESS ON BOTH LOWER EXTREMITIES; INTENSE WEAKNESS; NAUSEA; TEMPERATURE 101.2 TO 102; LOST 9 POUNDS; TACHYCARDIA; LOW BACK PAIN; NECK PAIN; VACCINE FOR COVID WORKED AS ASTHMA CONTROLLER AND FOR WEIGHT LOSS; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, exposed to TB, and high weight, and other pre-existing medical conditions included patient did not took other medications including no Tylenol or NSAIDs not even for a cold and had no reactions until 3 hours after vaccination. patient had no vomiting, appetite, malaise feelings, headaches for the last 30 years. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fluticasone propionate for drug used for unknown indication, salbutamol for drug used for unknown indication, and bupropion hydrochloride for weight loss.  On MAY-2021, the subject experienced vaccine for COVID worked as asthma controller and for weight loss. Laboratory data included: Body mass index (NR: not provided) 29. On 19-MAY-2021, the subject experienced tachycardia. On 19-MAY-2021, the subject experienced low back pain. On 19-MAY-2021, the subject experienced neck pain. On 19-MAY-2021, the subject experienced lost 9 pounds. On 19-MAY-2021, the subject experienced intense weakness. On 19-MAY-2021, the subject experienced nausea. On 19-MAY-2021, the subject experienced temperature 101.2 to 102. Laboratory data included: Blood pressure (NR: not provided) 80-110, Body temperature (NR: not provided) 101.2 to 102, and Heart rate (NR: not provided) 110. On 21-MAY-2021, the subject experienced urine was coke looking. On 21-MAY-2021, the subject experienced muscle weakness on both lower extremities. The action taken with covid-19 vaccine  was not applicable. The outcome of the tachycardia, intense weakness, low back pain, neck pain, nausea, urine was coke looking, muscle weakness on both lower extremities, temperature 101.2 to 102, lost 9 pounds and vaccine for COVID worked as asthma controller and for weight loss was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Flushing, Headache
Clinical narrative: RESTLESS LEGS; SPINE PAIN; BACK PAIN; HIP AND KNEE PAIN; FEVER; BODY ACHES; HEADACHE; CHILLS; FLUSHING; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced flushing. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced restless legs. On 21-MAY-2021, the subject experienced spine pain. On 21-MAY-2021, the subject experienced back pain. On 21-MAY-2021, the subject experienced hip and knee pain. On 21-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from restless legs on 21-MAY-2021, and chills on 14-MAY-2021, and had not recovered from body aches, hip and knee pain, headache, flushing, spine pain, back pain, and fever. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Restless legs syndrome, Spinal pain
Clinical narrative: RESTLESS LEGS; SPINE PAIN; BACK PAIN; HIP AND KNEE PAIN; FEVER; BODY ACHES; HEADACHE; CHILLS; FLUSHING; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced flushing. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced restless legs. On 21-MAY-2021, the subject experienced spine pain. On 21-MAY-2021, the subject experienced back pain. On 21-MAY-2021, the subject experienced hip and knee pain. On 21-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from restless legs on 21-MAY-2021, and chills on 14-MAY-2021, and had not recovered from body aches, hip and knee pain, headache, flushing, spine pain, back pain, and fever. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Paraesthesia
Clinical narrative: FLU LIKE SYMPTOMS (BAD CHILLS, FEVER, FATIGUE, BODY ACHES AND CONSTANT HEADACHE); TINGLING FEELING THROUGH THE BACK ON THE SPINE AND ON THE STOMACH; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 023A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced flu like symptoms (bad chills, fever, fatigue, body aches and constant headache). On 20-MAY-2021, the subject experienced tingling feeling through the back on the spine and on the stomach. The action taken with covid-19 vaccine  was not applicable. The patient recovered from flu like symptoms (bad chills, fever, fatigue, body aches and constant headache) on 22-MAY-2021, and had not recovered from tingling feeling through the back on the spine and on the stomach. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Gastrooesophageal reflux disease, Haematochezia, Illness
Clinical narrative: BLOOD IN STOOL; SORENESS; DIARRHEA; VOMITING; PRICKLING IN CHEST; ACID REFLUX; SICK; FEVER; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After vaccination patient felt fine for the first few days. On an unspecified date, the patient had soreness and fever. Patient stated would estimate it was low grade fever and indicated that had a fever now. Patient had prickling in chest and stated could not eat and hold food down, it came out both ways. Patient reported vomiting for 2 days along with pooting, which patient implied as excessive bowel movements, potentially diarrhea. Patient indicated that now had bleeding when pooting. Patient also had acid reflux. Patient was concerned about the blood which was seen. The caller informed patient to seek medical attention from HCP, urgent care or ER (especially if symptoms are worsening). The caller then stated that patient was starting to get sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, fever, blood in stool, diarrhea, vomiting, prickling in chest, acid reflux, and the outcome of sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210544936-Covid-19 vaccine ad26.cov2.s-Blood in stool. 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: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: BLOOD IN STOOL; SORENESS; DIARRHEA; VOMITING; PRICKLING IN CHEST; ACID REFLUX; SICK; FEVER; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After vaccination patient felt fine for the first few days. On an unspecified date, the patient had soreness and fever. Patient stated would estimate it was low grade fever and indicated that had a fever now. Patient had prickling in chest and stated could not eat and hold food down, it came out both ways. Patient reported vomiting for 2 days along with pooting, which patient implied as excessive bowel movements, potentially diarrhea. Patient indicated that now had bleeding when pooting. Patient also had acid reflux. Patient was concerned about the blood which was seen. The caller informed patient to seek medical attention from HCP, urgent care or ER (especially if symptoms are worsening). The caller then stated that patient was starting to get sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, fever, blood in stool, diarrhea, vomiting, prickling in chest, acid reflux, and the outcome of sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210544936-Covid-19 vaccine ad26.cov2.s-Blood in stool. 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN IN LEFT ARM AT AND AROUND INJECTION SITE AND MUSCLE PAIN AT INJECTION SITE EXTENDS INTO SHOULDER AND BACK; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced pain in left arm at and around injection site and muscle pain at injection site extends into shoulder and back. The action taken with covid-19 vaccine was not applicable. The patient was recovering from pain in left arm at and around injection site and muscle pain at injection site extends into shoulder and back. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a male 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, expiry: unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient did not receive any concomitant medications.  It was reported that the physician was providing antibody test 4 to 6 weeks after receiving the JANSSEN COVID-19 VACCINE on all office staff and immunosuppressed patients. The antibody test was named. The patient received antibody test 7 weeks after receiving the JANSSEN COVID-19 VACCINE. On an unspecified date, he experienced confirmed immunological vaccine failure and the laboratory data (dates unspecified) included: antibody test (NR: not provided) with result as 0 antibodies (negative). The MD (Doctor of Medicine) was telling all the patients to function as if they never had received the vaccine at all. The physician knew that the vaccine did not had to go in the freezer, but it can only be out of the fridge for 2 hours and suspects that these people received vaccine that were in prefilled syringes and kept out of the refrigerator for more than 2 hours, thus rendered them useless. The physician wanted for his patients to be able to get a booster of Pfizer or Moderna and would like a medical director from JnJ (Johnson and Johnson) to directly call him to discuss regarding these tests. The physician already called the CDC (Centers for Disease Control and Prevention). It was reported that the patients who received Pfizer and Moderna produced strong results. It was reported that the patient was a healthy individual. 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). This case, from the same reporter is linked to.; Sender's Comments: -COVID-19 VACCINE -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
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 antibody test, Somnolence, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL  VACCINE FAILURE; FELT LITTLE SLEEPY; FATIGUE; This spontaneous report received from a consumer concerned a 50 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: 204A21A, expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 03-MAY-2021 vaccination at left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the patient felt little sleepy the day after the vaccine and experienced fatigue. On 17-MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative (Coded suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and the outcome of suspected immunological vaccine failure and felt little sleepy was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000180552. The suspected product quality complaint has been confirmed to be voided, this did not meet the defined definition for lack of effect on a vaccine product. based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210545203-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. 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: SPECIAL SITUATIONS
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Myalgia, Ocular hyperaemia, Pyrexia
Clinical narrative: MUSCLE PAIN; FEVER; HEADACHE; EYES HURT; RED EYES; This spontaneous report received from a parent concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced eyes hurt. On MAY-2021, the subject experienced red eyes. On 22-MAY-2021, the subject experienced muscle pain. On 22-MAY-2021, the subject experienced fever. On 22-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, headache, and muscle pain, and the outcome of eyes hurt and red eyes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545645.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Headache
Clinical narrative: TRANSPARENT URINE; MILD HEADACHE; This spontaneous report received from a consumer concerned a 47 year old male. The patient's concurrent conditions included weight loss, and high blood pressure. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. Concomitant medications included amlodipine/telmisartan for high blood pressure, and empagliflozin/metformin hydrochloride for weight loss. On MAY-2021, the subject experienced mild headache. On 22-MAY-2021, the subject experienced transparent urine. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from transparent urine, and the outcome of mild headache was not reported. This report was non-serious. This case, from the same reporter is linked.