chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersensitivity, Inappropriate schedule of product administration, Musculoskeletal stiffness
Clinical narrative: Thought it was allegic reaction; Experience a lot of tiredness; Experience / a sore / throat / she thought / was an allergic reaction; Experience / itchy throat / she thought / was an allergic reaction; Experience a stiff arm; Headache; First Shingrix dose in Sep-2020 / Second dose / on 6-Apr-2021; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient stated that she had shingles 35 years ago.). Previously administered products included Shingrix (1st of dose Shingrix received in September 2021, no problems.).   On 6th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 6th April 2021, 12 hrs after receiving Shingrix, the patient experienced allergic reaction, tiredness, sore throat, itchy throat, limbs stiffness, headache and drug dose administration interval too long. On an unknown date, the outcome of the allergic reaction and drug dose administration interval too long were unknown and the outcome of the tiredness, sore throat, itchy throat, limbs stiffness and headache were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, tiredness, sore throat, itchy throat, limbs stiffness and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient was late for 2nd dose because she was in another state for three months which led to drug dose administration interval too long. In the morning or afternoon time, the patient received 2nd dose in the left deltoid. The patient stated that she was not feeling well and was pretty sick. The patient further described this by describing the symptoms she had. Twelve hours after vaccination, she started to experience a lot of tiredness and a sore and itchy throat that same day in the middle of the night.  The patient stated that she thought the sore and itchy throat was an allergic reaction to the Shingrix vaccine she had just received.  She started to experience a stiff arm and a headache that same day after she received the Shingrix. She stated that nothing she took helps her headache. She stated that this tired feeling, stiff arm, headache, as well as the sore and itchy throat was still present. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Throat irritation
Clinical narrative: Thought it was allegic reaction; Experience a lot of tiredness; Experience / a sore / throat / she thought / was an allergic reaction; Experience / itchy throat / she thought / was an allergic reaction; Experience a stiff arm; Headache; First Shingrix dose in Sep-2020 / Second dose / on 6-Apr-2021; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient stated that she had shingles 35 years ago.). Previously administered products included Shingrix (1st of dose Shingrix received in September 2021, no problems.).   On 6th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 6th April 2021, 12 hrs after receiving Shingrix, the patient experienced allergic reaction, tiredness, sore throat, itchy throat, limbs stiffness, headache and drug dose administration interval too long. On an unknown date, the outcome of the allergic reaction and drug dose administration interval too long were unknown and the outcome of the tiredness, sore throat, itchy throat, limbs stiffness and headache were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, tiredness, sore throat, itchy throat, limbs stiffness and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient was late for 2nd dose because she was in another state for three months which led to drug dose administration interval too long. In the morning or afternoon time, the patient received 2nd dose in the left deltoid. The patient stated that she was not feeling well and was pretty sick. The patient further described this by describing the symptoms she had. Twelve hours after vaccination, she started to experience a lot of tiredness and a sore and itchy throat that same day in the middle of the night.  The patient stated that she thought the sore and itchy throat was an allergic reaction to the Shingrix vaccine she had just received.  She started to experience a stiff arm and a headache that same day after she received the Shingrix. She stated that nothing she took helps her headache. She stated that this tired feeling, stiff arm, headache, as well as the sore and itchy throat was still present. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late second dose / First dose was given on 31Aug2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 31st 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 reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. No further information was reported. The reporter did not consent to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: rash was present when they vaccinated the patient; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 2A3Z9, expiry date 14th October 2022) and (batch number MM59F, expiry date 14th October 2022) for prophylaxis.   Concurrent medical conditions included shingles (had shingles 2 weeks ago) and rash.   On 8th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 8th April 2021, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The reporter stated that, had a patient that received the shingrix vaccine on the day of reporting and was diagnosed with shingles 2 weeks ago. The reporter asked should they expect any adverse events and should they get the 2 vaccine. It was confirmed with health care professional, that the patient still had an active rash. The reporter stated that, it was known by the health care professional, that rash was present when they vaccinated the patient, which led to off label use. The reporter consented to follow up. The batch number of Shingrix was updated from 2A329 to 2A3Z9, as per sales data sheet.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: adult dose of havrix was given to an 11 year old; adult dose of havrix was given to an 11 year old; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received HAV (Havrix adult) (batch number J95H7, expiry date 31st May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the child patient received dose of Havrix adult which led to overdose and adult product administered to child. The nurse was wondering what adverse events or side effects they should be on the lookout for. The reporter consented to follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, In vitro fertilisation, Progesterone decreased
Clinical narrative: LOWER PROGESTERONE LEVELS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prevention of covid-19. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced lower progesterone levels. Laboratory data (dates unspecified) included: In vitro fertilization (NR: not provided) UNKNOWN. Treatment medications (dates unspecified) included: progesterone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 11-MAR-2021, and had not recovered from lower progesterone levels. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Headache, Nausea
Clinical narrative: HAIR LOSS/HAIR FALLING OUT/ LOST TREMENDOUS AMOUNT OF HAIR; HEADACHE; NAUSEA; This spontaneous report received from a consumer 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: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced nausea. On 18-MAR-2021, the subject experienced hair loss/hair falling out/ lost tremendous amount of hair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and had not recovered from headache, and hair loss/hair falling out/ lost tremendous amount of hair. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Hypersensitivity, Oropharyngeal pain, Pyrexia
Clinical narrative: VOMITING; SORE THROAT; COUGH; CONGESTION; RUNNY NOSE; CHILLS; FEVER; SINUS INFECTION; SEVERE  ALLERGY SYMPTOMS; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and coughing for four months, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. 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 11-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sinus infection. On MAR-2021, the subject experienced severe allergy symptoms. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced congestion. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced vomiting. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, cough, congestion, runny nose, and sore throat, and the outcome of vomiting, sinus infection and severe allergy symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Sinus congestion, Sinusitis, Vomiting
Clinical narrative: VOMITING; SORE THROAT; COUGH; CONGESTION; RUNNY NOSE; CHILLS; FEVER; SINUS INFECTION; SEVERE  ALLERGY SYMPTOMS; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and coughing for four months, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. 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 11-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sinus infection. On MAR-2021, the subject experienced severe allergy symptoms. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced congestion. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced vomiting. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, cough, congestion, runny nose, and sore throat, and the outcome of vomiting, sinus infection and severe allergy symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nonspecific reaction, Pyrexia
Clinical narrative: MILD REACTION; CHILLS; ON AND OFF FEVER; TIREDNESS; 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 was not reported, 1 total, administered on 10-MAR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On 11-MAR-2021 03:30, the subject experienced chills. On 11-MAR-2021 03:30, the subject experienced on and off fever. On an unspecified date, the subject experienced mild reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and on and off fever on 11-MAR-2021, and tiredness on MAR-2021, and the outcome of mild reaction was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Condition aggravated, Headache, Rotator cuff syndrome, Sigmoidoscopy
Clinical narrative: TORN ROTATOR CUFF; JOINT PAIN; HEADACHE; CONDITION AGGRAVATED; This spontaneous report received from a consumer concerned a 59 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis, and moderate to severe adult crohn's disease. No concomitant medications were reported. On MAR-2021, the subject experienced condition aggravated. Laboratory data included: Flexible sigmoidoscopy (NR: not provided) not reported. On an unspecified date, the subject experienced torn rotator cuff, joint pain, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was increased. The patient recovered from condition aggravated on MAR-2021, and headache, and had not recovered from joint pain, and torn rotator cuff. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysgeusia, Feeling cold, Hallucination
Clinical narrative: FEVER OF 102-107F; SHAKINESS; VOMITING; SENSATION OF COLD; CHILLS AND SHIVERING; HALLUCINATIONS; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, acid reflux, and heat burn. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021  around 1-1:20 pm to the left arm for prophylactic vaccination. Concomitant medications include blood thinners, medication for heart burn and acid reflux. Patient did not take his medicines on the day of his vaccination and few days after the vaccination. On 01-APR-2021 23:00, the patient experienced chills and shivering, fever of 102-107F, sensation of cold, vomiting and shakiness. Patient had not contacted his MD and had not taken any medications to manage those symptoms. At the time of calling (on the day of reporting), patient was feeling better but was having weird taste in mouth. On the same night of the vaccination (01-APR-2021), patient started experiencing hallucinations. The person who took this report on call recommended patient seeing his doctor regarding hallucinations. There were no hallucinations at the time of reporting. Laboratory data included: Body temperature (NR: not provided) 102-107 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, shakiness, sensation of cold, chills and shivering, and fever of 102-107f on APR-2021, had not recovered from weird taste in mouth, and the outcome of vomiting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210406953-COVID-19 VACCINE AD26.COV2.S-hallucination. 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. 2021040695300-COVID-19 VACCINE AD26.COV2.S-fever. This event is labeled per RSI and is therefore considered potentially related.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: FEVER OF 102-107F; SHAKINESS; VOMITING; SENSATION OF COLD; CHILLS AND SHIVERING; HALLUCINATIONS; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, acid reflux, and heat burn. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021  around 1-1:20 pm to the left arm for prophylactic vaccination. Concomitant medications include blood thinners, medication for heart burn and acid reflux. Patient did not take his medicines on the day of his vaccination and few days after the vaccination. On 01-APR-2021 23:00, the patient experienced chills and shivering, fever of 102-107F, sensation of cold, vomiting and shakiness. Patient had not contacted his MD and had not taken any medications to manage those symptoms. At the time of calling (on the day of reporting), patient was feeling better but was having weird taste in mouth. On the same night of the vaccination (01-APR-2021), patient started experiencing hallucinations. The person who took this report on call recommended patient seeing his doctor regarding hallucinations. There were no hallucinations at the time of reporting. Laboratory data included: Body temperature (NR: not provided) 102-107 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, shakiness, sensation of cold, chills and shivering, and fever of 102-107f on APR-2021, had not recovered from weird taste in mouth, and the outcome of vomiting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210406953-COVID-19 VACCINE AD26.COV2.S-hallucination. 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. 2021040695300-COVID-19 VACCINE AD26.COV2.S-fever. This event is labeled per RSI and is therefore considered potentially related.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Malaise, Pain
Clinical narrative: The patient's weight was 135 kilograms, and height was 70 inches. The patient's past medical history included reported to only take "ADHD" medication at school" when needed, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on 13:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced not feeling well. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced feel off. On 02-APR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, was recovering from achy, tired, and feverish, had not recovered from feel off, and the outcome of not feeling well was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: The patient's weight was 135 kilograms, and height was 70 inches. The patient's past medical history included reported to only take "ADHD" medication at school" when needed, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on 13:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced not feeling well. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced feel off. On 02-APR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, was recovering from achy, tired, and feverish, had not recovered from feel off, and the outcome of not feeling well was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: RED MARK ON ARM NEXT TO INJECTION SITE; SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced red mark on arm next to injection site. On 02-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from red mark on arm next to injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Pain, Pyrexia
Clinical narrative: LOST OF SMELL; LOST OF TASTE; CONGESTION; BODY ACHES; LOW GRADE FEVER; COUGH; This spontaneous report received from a patient 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) dose was not reported, administered on 01-APR-2021 09:00 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced congestion. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced low grade fever. On 01-APR-2021, the subject experienced low cough. On 03-APR-2021, the subject experienced lost of smell. On 03-APR-2021, the subject experienced lost of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, low grade fever, congestion, lost of taste, and low cough, and the outcome of lost of smell 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.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: LOST OF SMELL; LOST OF TASTE; CONGESTION; BODY ACHES; LOW GRADE FEVER; COUGH; This spontaneous report received from a patient 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) dose was not reported, administered on 01-APR-2021 09:00 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced congestion. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced low grade fever. On 01-APR-2021, the subject experienced low cough. On 03-APR-2021, the subject experienced lost of smell. On 03-APR-2021, the subject experienced lost of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, low grade fever, congestion, lost of taste, and low cough, and the outcome of lost of smell 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: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Suspected COVID-19
Clinical narrative: SWEATING; POSSIBLE COVID 19; This spontaneous report received from a patient concerned a 20 year old male. 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sweating, and possible COVID 19. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating and possible COVID 19 was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Dizziness, Dry skin, Erythema
Clinical narrative: CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE; FACE FLUSH/ FACE WAS RED AND BUMPY; TOO HOT OR COLD/ INTERMITTENT FEELING EXTRA COLD(HEAD FEELS HOT AND REST OF BODY FEELS COLD); TINGLY FINGER; FELT LOUSY; BLOOD PRESSURE FLUCTUATION; This spontaneous report received from a patient concerned a 61 year old female. 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced blood pressure fluctuation. On 12-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/84 mmHg. On 15-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 125/85 mmHg. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/91 mmHg, 156/90 mmHg, 142/92 mmHg. On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/88 mmHg, 140/92 mmHg. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 143/89 mmHg. On 23-MAR-2021, the subject experienced felt lousy. On 24-MAR-2021, the subject experienced tingly finger. On 27-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 156/96 mmHg. On an unspecified date, the subject experienced chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, headache, face flush/ face was red and bumpy, and too hot or cold/ intermittent feeling extra cold (head feels hot and rest of body feels cold). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure fluctuation, and the outcome of headache, chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, face flush/ face was red and bumpy, too hot or cold/ intermittent feeling extra cold(head feels hot and rest of body feels cold), felt lousy and tingly finger was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408073.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeling abnormal, Feeling of body temperature change, Flushing, Headache
Clinical narrative: CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE; FACE FLUSH/ FACE WAS RED AND BUMPY; TOO HOT OR COLD/ INTERMITTENT FEELING EXTRA COLD(HEAD FEELS HOT AND REST OF BODY FEELS COLD); TINGLY FINGER; FELT LOUSY; BLOOD PRESSURE FLUCTUATION; This spontaneous report received from a patient concerned a 61 year old female. 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced blood pressure fluctuation. On 12-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/84 mmHg. On 15-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 125/85 mmHg. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/91 mmHg, 156/90 mmHg, 142/92 mmHg. On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/88 mmHg, 140/92 mmHg. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 143/89 mmHg. On 23-MAR-2021, the subject experienced felt lousy. On 24-MAR-2021, the subject experienced tingly finger. On 27-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 156/96 mmHg. On an unspecified date, the subject experienced chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, headache, face flush/ face was red and bumpy, and too hot or cold/ intermittent feeling extra cold (head feels hot and rest of body feels cold). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure fluctuation, and the outcome of headache, chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, face flush/ face was red and bumpy, too hot or cold/ intermittent feeling extra cold(head feels hot and rest of body feels cold), felt lousy and tingly finger was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408073.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Paraesthesia, Rash pruritic, Thirst
Clinical narrative: CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE; FACE FLUSH/ FACE WAS RED AND BUMPY; TOO HOT OR COLD/ INTERMITTENT FEELING EXTRA COLD(HEAD FEELS HOT AND REST OF BODY FEELS COLD); TINGLY FINGER; FELT LOUSY; BLOOD PRESSURE FLUCTUATION; This spontaneous report received from a patient concerned a 61 year old female. 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced blood pressure fluctuation. On 12-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/84 mmHg. On 15-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 125/85 mmHg. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/91 mmHg, 156/90 mmHg, 142/92 mmHg. On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/88 mmHg, 140/92 mmHg. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 143/89 mmHg. On 23-MAR-2021, the subject experienced felt lousy. On 24-MAR-2021, the subject experienced tingly finger. On 27-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 156/96 mmHg. On an unspecified date, the subject experienced chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, headache, face flush/ face was red and bumpy, and too hot or cold/ intermittent feeling extra cold (head feels hot and rest of body feels cold). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure fluctuation, and the outcome of headache, chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, face flush/ face was red and bumpy, too hot or cold/ intermittent feeling extra cold(head feels hot and rest of body feels cold), felt lousy and tingly finger was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408073.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Blister, Body temperature, Feeling hot
Clinical narrative: FEVER; EXCRUCIATINGLY PAINFUL HEADACHE; INJECTION SITE REDNESS; INJECTION SITE SWELLING; TENDERNESS AT INJECTION SITE; MUSCLE PAIN; BODY ACHE; FEELING HOT AT INJECTION SITE; BLISTERS ON COVID ARM; JOINT PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 16:30 to right deltoid, for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced feeling hot at injection site. On APR-2021, the subject experienced blisters on covid arm. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced tenderness at injection site. On APR-2021, the subject experienced muscle pain. On 02-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced injection site swelling. Laboratory data included: Body temperature (NR: not provided) 101.5. On 02-APR-2021 11:00, the subject experienced excruciatingly painful headache. On 02-APR-2021 12:30, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) I antibodies found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciatingly painful headache, and fever on 04-APR-2021, was recovering from body ache, had not recovered from injection site redness, feeling hot at injection site, blisters on covid arm, and tenderness at injection site, and the outcome of joint pain, injection site swelling and muscle pain was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: FEVER; EXCRUCIATINGLY PAINFUL HEADACHE; INJECTION SITE REDNESS; INJECTION SITE SWELLING; TENDERNESS AT INJECTION SITE; MUSCLE PAIN; BODY ACHE; FEELING HOT AT INJECTION SITE; BLISTERS ON COVID ARM; JOINT PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 16:30 to right deltoid, for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced feeling hot at injection site. On APR-2021, the subject experienced blisters on covid arm. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced tenderness at injection site. On APR-2021, the subject experienced muscle pain. On 02-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced injection site swelling. Laboratory data included: Body temperature (NR: not provided) 101.5. On 02-APR-2021 11:00, the subject experienced excruciatingly painful headache. On 02-APR-2021 12:30, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) I antibodies found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciatingly painful headache, and fever on 04-APR-2021, was recovering from body ache, had not recovered from injection site redness, feeling hot at injection site, blisters on covid arm, and tenderness at injection site, and the outcome of joint pain, injection site swelling and muscle pain was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; EXCRUCIATINGLY PAINFUL HEADACHE; INJECTION SITE REDNESS; INJECTION SITE SWELLING; TENDERNESS AT INJECTION SITE; MUSCLE PAIN; BODY ACHE; FEELING HOT AT INJECTION SITE; BLISTERS ON COVID ARM; JOINT PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 16:30 to right deltoid, for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced feeling hot at injection site. On APR-2021, the subject experienced blisters on covid arm. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced tenderness at injection site. On APR-2021, the subject experienced muscle pain. On 02-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced injection site swelling. Laboratory data included: Body temperature (NR: not provided) 101.5. On 02-APR-2021 11:00, the subject experienced excruciatingly painful headache. On 02-APR-2021 12:30, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) I antibodies found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciatingly painful headache, and fever on 04-APR-2021, was recovering from body ache, had not recovered from injection site redness, feeling hot at injection site, blisters on covid arm, and tenderness at injection site, and the outcome of joint pain, injection site swelling and muscle pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: COVID-19 TEST POSITIVE; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 72 year old male. Initial information was processed with additional information received on 06-APR-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, reflux, high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no medical history of immunosuppressive disease processes. Patient had no known allergies. Patient had no drug abuse or illicit drug usage. The patient was previously treated with atorvastatin calcium, lisinopril, amlodipine, anti-reflux medications and ranolazine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: unknown) dose was not reported, frequency once total, administered on 06-MAR-2021 at left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for prophylaxis.  On 23-MAR-2021, the patient had normally scheduled blood work performed including an antibody test for COVID-19 vaccine response. The results of the blood work showed a non-responsive result to vaccination (coded as suspected immunological vaccine failure) and the patient also had a positive COVID-19 test. All other results were normal. At the time of the report, the patient was scheduled for a second antibody test on 07-APR-2021 and he is scheduled for another Covid-19 vaccination of an unknown manufacturer on 12-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected immunological vaccine failure, and the outcome of covid-19 test positive was not reported. This report was serious (Other Medically Important Condition). This report is associated with Product quality complaint Number: 90000175289. The suspected product quality complaint has been confirmed to be void. confirmed no PQC was identified within the reported complaint reported based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210408983- JANSSEN 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Head discomfort, Staphylococcal infection, Staphylococcus test, Tinnitus
Clinical narrative: PRESSURE BUILDING ON THE RIGHT SIDE OF THE HEAD (FELT  LIKE SOMEONE TRIED TO STICK A REALLY HOT FINGER THROUGH THE EAR); NOSE BLEEDING WHEN BLOWING THE NOSE; RINGING IN BOTH EARS; Staphylococcal infection; This spontaneous report received from a parent concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and high cholesterol, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-MAR-2021, the patient experienced staphylococcal infection. On an unspecified date, the patient experienced pressure building on the right side of the head (felt like someone tried to stick a really hot finger through the ear), nose bleeding when blowing the nose (dark colored blood), and ringing in both ears. Patient's mother was not sure when these symptoms started. All the symptoms have not been resolved. The mother was really concerned that the patient was not getting proper treatment and would like the company to ask for the medical facility to be provided. On MAR-2021, Laboratory data included:Staphylococcus test (NR: not provided) Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from staphylococcal infection, pressure building on the right side of the head (felt like someone tried to stick a really hot finger through the ear), nose bleeding when blowing the nose, and ringing in both ears. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409259-Covid-19 vaccine ad26.cov2.s-Staphylococcal infection. 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).