chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Off label use, Photophobia, Vaccination error
Clinical narrative: WORSENING OF BRUISES ON TOP OF HER ANKLES AND DOWN TOWARDS THE TOES AND SPORADIC; LIGHT SENSITIVITY IN HER EYES; ADMINISTERED JANSSEN VACCINE AS A SUBSTITUTE 2ND DOSE VACCINE AFTER MODERNA VACCINE; OFF LABEL USE; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have history of drug abuse/illicit drug use. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On AUG-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Normal, Haemoglobin (NR: not provided) Normal, Lymphocyte count (NR: not provided) Normal, Monocyte count (NR: not provided) Normal, and White blood cell count (NR: not provided) Normal. On 27-AUG-2021, the patient experienced light sensitivity in her eyes. On 27-AUG-2021, the patient experienced administered janssen vaccine as a substitute 2nd dose vaccine after moderna vaccine. On 27-AUG-2021, the patient experienced off label use. On 27-AUG-2021, the patient experienced tiredness. On 29-AUG-2021, the patient experienced worsening of bruises on top of her ankles and down towards the toes and sporadic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light sensitivity in her eyes on AUG-2021, and tiredness on 29-AUG-2021, had not recovered from worsening of bruises on top of her ankles and down towards the toes and sporadic, and the outcome of off label use and administered janssen vaccine as a substitute 2nd dose vaccine after moderna vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Amnesia, Asthenia, Haemoglobin, Haemolytic anaemia
Clinical narrative: LOSS OF TASTE; WARM HEMOLYTIC ANEMIA; MEMORY LOSS; EYE SIGHT ISSUES; NO ENERGY; This spontaneous report received from a patient concerned a 74 year old male with unspecified race and ethnicity. The patient's weight was 165 pounds, and height was 71 inches. The patient's past medical history included alcohol use (1 beer or wine 3 times a month), and concurrent conditions included, hay fever, non smoker, allergy, non-alcoholic and prostrate cancer (since 2012). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) 1 total was administered to right arm on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021 the patient experienced memory loss, eye sight issue, and felt tired with no energy. On MAY-2021 or JUN-2021, the patient diagnosed with warm hemolytic anemia. On an unspecified date, the patient experienced loss of taste. The patient was treated with steroids (prednisone) for 8 weeks, and On 18-AUG-2021, treatment medications included: Rituximab infusion (has had 4 infusions a week apart). Last infusion was on last Wednesday to the date of reporting (08-SEP-2021). Laboratory data (dates unspecified) included: Hemoglobin (NR: not provided) 7.8, 8.9 (units unspecified). The patient was still under physician care (oncologist and hematologist). The patient's autoimmune system had kicked in and is causing the adverse events, and his doctor cannot ruled out the vaccine as a causative agent.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from warm hemolytic anemia, and the outcome of memory loss, eye sight issues, loss of taste and no energy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210924336-Covid-19 vaccine ad26.cov2.s- Warm hemolytic anemia. 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: LOSS OF TASTE; WARM HEMOLYTIC ANEMIA; MEMORY LOSS; EYE SIGHT ISSUES; NO ENERGY; This spontaneous report received from a patient concerned a 74 year old male with unspecified race and ethnicity. The patient's weight was 165 pounds, and height was 71 inches. The patient's past medical history included alcohol use (1 beer or wine 3 times a month), and concurrent conditions included, hay fever, non smoker, allergy, non-alcoholic and prostrate cancer (since 2012). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) 1 total was administered to right arm on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021 the patient experienced memory loss, eye sight issue, and felt tired with no energy. On MAY-2021 or JUN-2021, the patient diagnosed with warm hemolytic anemia. On an unspecified date, the patient experienced loss of taste. The patient was treated with steroids (prednisone) for 8 weeks, and On 18-AUG-2021, treatment medications included: Rituximab infusion (has had 4 infusions a week apart). Last infusion was on last Wednesday to the date of reporting (08-SEP-2021). Laboratory data (dates unspecified) included: Hemoglobin (NR: not provided) 7.8, 8.9 (units unspecified). The patient was still under physician care (oncologist and hematologist). The patient's autoimmune system had kicked in and is causing the adverse events, and his doctor cannot ruled out the vaccine as a causative agent.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from warm hemolytic anemia, and the outcome of memory loss, eye sight issues, loss of taste and no energy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210924336-Covid-19 vaccine ad26.cov2.s- Warm hemolytic anemia. 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 in extremity
Clinical narrative: VERY SORE ARM WITH EXCRUCIATING PAIN FOR ALMOST 4 MONTHS; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced very sore arm with excruciating pain for almost 4 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sore arm with excruciating pain for almost 4 months. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old male of unknown race and ethnicity. The patient's weight was 197 pounds, and height was 64 inches. Patient had no known allergies. Patient had no medical history and no daily medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-SEP-2021, patient was tested positive for rapid test (suspected covid-19 infection and suspected clinical vaccination failure). Patient was shocked as he had no symptoms. Again on 08-SEP-2021 patient was tested positive for rapid test. Patient mentioned that he had maybe a little bit of cough and slight head ache in the morning. He stated that the symptoms come and go but he did not felt sick to think they indicate anything. He only noticed after he was tested positive. He was able to do all normal activities. Patient stated that he was exposed to his mom. She tested positive on 01-SEP-2021 and the last exposure to her was on 29-AUG-2021. His mother spent the day with him and his family. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20210924403- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Headache
Clinical narrative: SEVERE REACTION; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe reaction, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe reaction, headache and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis psoriasiform
Clinical narrative: RASH THAT LOOKS LIKE PSORIASIS; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced rash that looks like psoriasis. Treatment medications (dates unspecified) included: triamcinolone. The action taken with covid-19 vaccine was not applicable. The patient was recovering from rash that looks like psoriasis. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Haemorrhage, Laboratory test
Clinical narrative: DEATH; HEMORRHAGING AND BLEEDING; FELT BAD; BACK PAIN; This spontaneous report received from a patient via a company representative concerned a 37 year old female of an unspecified race and ethnic origin. 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 and expiry date: Unknown) dose was not reported, 1 total administered on 02-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-SEP-2021 (Saturday), the patient experienced back pain and felt bad and went to the emergency room. She had tests run and was then sent home. On 05-Sep-2021, she developed hemorrhaging and bleeding and ambulance returned for her. On 07-Sep-2021, she died due to unknown cause. It was not reported, if the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 07-SEP-2021, and the outcome of feeling bad, back pain and hemorrhaging and bleeding was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210924439-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  Death, Hemorrhaging and bleeding. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Rash pruritic, Skin test
Clinical narrative: TERRIBLE RASH ON UPPER THIGH, 12-14 INCHES IN THE UPPER BODY, DEEP RED RASH WITH LITTLE SPOTS BY THE BREAST BONE, AREA UP AND AROUND NECK WAS ITCHY AND PRESENTED WITH RASH AND SEVERE ITCHINESS; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cll(chronic lymphocytic leukemia) with no complications presently, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAR-2021, the patient experienced terrible rash on upper thigh, 12-14 inches in the upper body, deep red rash with little spots by the breast bone, area up and around neck was itchy and presented with rash and severe itchiness. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) something may have touched the skin, and Skin patch test (NR: not provided) skin had a reaction to an ingredient in a topical product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible rash on upper thigh, 12-14 inches in the upper body, deep red rash with little spots by the breast bone, area up and around neck was itchy and presented with rash and severe itchiness on 01-SEP-2021. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient had no known allergies. 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Oedema, Weight, Weight increased
Clinical narrative: GAINED 9KG (ABOUT 18 POUNDS. EVERY DAY SHE GETS ON THE SCALE AND SHE SEES 2.2 KG MORE NON STOP. IT INCREASES EVERY DAY); WHOLE BODY SWOLLEN; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-SEP-2021 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, Laboratory data included: Lab test (NR: not provided) numbers are good. On 10-SEP-2021, the patient experienced gained 9kg (about 18 pounds. every day she gets on the scale and she sees 2.2 kg more non stop. it increases every day). On 10-SEP-2021, the patient experienced whole body swollen. Laboratory data included: Weight (NR: not provided) 9 kg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gained 9kg (about 18 pounds. every day she gets on the scale and she sees 2.2 kg more non stop. it increases every day), and whole body swollen. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: SEVERE BODY ACHES; MUSCLE ACHES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: 21-SEP-2021) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced severe body aches, muscle aches, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, muscle aches, headache, and fever. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: FATIGUE; HEADACHE; MUSCLE SORENESS ALL OVER; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and no drug abuse or illicit drug usage . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, expiry: 21-OCT-2021) dose was not reported, administered on 11-SEP-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced fatigue. On 12-SEP-2021, the patient experienced headache. On 12-SEP-2021, the patient experienced muscle soreness all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, headache, and muscle soreness all over on 13-SEP-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis psoriasiform
Clinical narrative: BROKE OUT WITH A RASH SIMILAR TO PSORIASIS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced broke out with a rash similar to psoriasis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out with a rash similar to psoriasis was not reported. This report was non-serious. This case, from the same reporter is linked to 20210924422.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: THROWING UP; 103 FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 13-SEP-2021, the patient experienced throwing up. On 13-SEP-2021, the patient experienced 103 fever. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of the throwing up and 103 fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hallucination, visual, Headache, Pyrexia, Sleep disorder
Clinical narrative: KEEP SEEING WIERD THINGS; DISTURBED SLEEP; BAD HEADACHE; CHILLS; MILD FEVER; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, after receiving the vaccine the patient experienced mild fever and chills after about 7 hours of feeling fine. Then it went away. On an unspecified date the patient had disturbed sleep with a bad headache. The patient thought that those were the right symptoms for body building an immunity. The patient also stated that he keep seeing weird things from mRNA. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mild fever on APR-2021, and the outcome of disturbed sleep, bad headache and keep seeing weird things was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210926109.; Sender's Comments: V0: 20210925695-Covid-19 vaccine ad26.cov2.s-Keep seeing weird things . 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, COVID19
Symptoms: Adverse event, Breast pain, Laboratory test, Lymphadenopathy, Neck mass
Clinical narrative: OTHER THINGS (UNSPECIFIED); PAIN IN LEFT BREAST; LYMPH NODE ISSUES; TWO LUMPS ON MY NECK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: homeless. 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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced two lumps on my neck. On an unspecified date, the patient experienced other things (unspecified), pain in left breast, and lymph node issues. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Lymph node issues, and Mammogram (NR: not provided) Found something (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two lumps on my neck, pain in left breast, and other things (unspecified), and the outcome of lymph node issues was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Choking, Condition aggravated, Dyspnoea, Mammogram, Salivary gland mass
Clinical narrative: OTHER THINGS (UNSPECIFIED); PAIN IN LEFT BREAST; LYMPH NODE ISSUES; TWO LUMPS ON MY NECK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: homeless. 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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced two lumps on my neck. On an unspecified date, the patient experienced other things (unspecified), pain in left breast, and lymph node issues. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Lymph node issues, and Mammogram (NR: not provided) Found something (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two lumps on my neck, pain in left breast, and other things (unspecified), and the outcome of lymph node issues was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tenderness, Ultrasound scan
Clinical narrative: OTHER THINGS (UNSPECIFIED); PAIN IN LEFT BREAST; LYMPH NODE ISSUES; TWO LUMPS ON MY NECK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: homeless. 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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced two lumps on my neck. On an unspecified date, the patient experienced other things (unspecified), pain in left breast, and lymph node issues. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Lymph node issues, and Mammogram (NR: not provided) Found something (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two lumps on my neck, pain in left breast, and other things (unspecified), and the outcome of lymph node issues was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood grouping, Cough, Fatigue, Laziness, Muscle contracture
Clinical narrative: TEETH PAIN; JAW CLENCHING; FEELING LAZY; FATIGUE; COUGH WORSENED; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: thyroid cancer, and thyroidectomy, and concurrent conditions included: environmental allergies, seasonal allergies, current respiratory infection (suspected rsv), seasonal mold allergy, shellfish allergy, cough, dust mites allergy, dog dander allergy, eggplant and wheat germ allergy and dust allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient had allergy to Goldenrod. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced cough worsened. On 13-APR-2021, the patient experienced feeling lazy. On 13-APR-2021, the patient experienced fatigue. On 15-APR-2021, the patient experienced teeth pain. On 15-APR-2021, the patient experienced jaw clenching. On 08-SEP-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood grouping (NR: not provided) O +ve. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth pain, and jaw clenching on 17-APR-2021, and feeling lazy, and fatigue on 15-APR-2021, and had not recovered from cough worsened. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: TEETH PAIN; JAW CLENCHING; FEELING LAZY; FATIGUE; COUGH WORSENED; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: thyroid cancer, and thyroidectomy, and concurrent conditions included: environmental allergies, seasonal allergies, current respiratory infection (suspected rsv), seasonal mold allergy, shellfish allergy, cough, dust mites allergy, dog dander allergy, eggplant and wheat germ allergy and dust allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient had allergy to Goldenrod. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced cough worsened. On 13-APR-2021, the patient experienced feeling lazy. On 13-APR-2021, the patient experienced fatigue. On 15-APR-2021, the patient experienced teeth pain. On 15-APR-2021, the patient experienced jaw clenching. On 08-SEP-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood grouping (NR: not provided) O +ve. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth pain, and jaw clenching on 17-APR-2021, and feeling lazy, and fatigue on 15-APR-2021, and had not recovered from cough worsened. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In AUG-2021, the patient had COVID-19 antibody test which showed no antibodies (confirmed immunological vaccine failure).  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 report was associated with product quality complaint: 90000193282.; Sender's Comments: V0: 20210925740-Covid-19 vaccine ad26.cov2.s- Confirmed 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
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: RECEIVED A DOSE OF THE JANSSEN COVID-19  VACCINE 6 HOURS AND 52 MINUTES AFTER FIRST PUNCTURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced received a dose of the janssen covid-19 vaccine 6 hours and 52 minutes after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received a dose of the janssen covid-19 vaccine 6 hours and 52 minutes after first puncture was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site reaction, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; A SMALL DOT AT INJECTION SITE; This spontaneous report received from a parent concerned a 21 year old male. The patient's weight was 190 pounds, and height was 73 inches. The patient's concurrent conditions included: hay fever, and other pre-existing medical conditions included: The patient did not have past medical history and was not on medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: Unknown) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced a small dot at injection site. On 09-SEP-2021, the patient experienced sore arm. On 09-SEP-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache on 10-SEP-2021, and had not recovered from a small dot at injection site. This report was non-serious. This case, from the same reporter is linked to 20210926070.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Migraine, Rash
Clinical narrative: RASH OVER ANKLES WRISTS AND BACK OF KNEES; FLU LIKE SYMPTOMS/BODY ACHES; MIGRAINE; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and eosinophilic esophagitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. he batch number was not reported and has been requested. No concomitant medications were reported. On 09-SEP-2021, the patient experienced flu like symptoms/body aches. On 09-SEP-2021, the patient experienced migraine. On 14-SEP-2021, the patient experienced rash over ankles wrists and back of knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms/body aches, and migraine on SEP-2021, and the outcome of rash over ankles wrists and back of knees was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gastrectomy, Pain in extremity
Clinical narrative: SLEEVE SURGERY; HIP PAIN; LEG PAIN THAT TRAVELS FROM  KNEE TO THIGH TO HIP; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: open heart surgery, and concurrent conditions included: baker cyst, and hypertrophic cardiomyopathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included duloxetine hydrochloride.  On 04-APR-2021, the patient experienced leg pain that travels from knee to thigh to hip. On MAY-2021, the patient experienced hip pain. On an unspecified date, the patient experienced sleeve surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain that travels from knee to thigh to hip, and hip pain, and the outcome of sleeve surgery was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Hypoaesthesia, Pain, Pain assessment
Clinical narrative: FEVER (102.4 DEGREES FAHRENHEIT (F)); TINGLING DOWN THE ARMS, HANDS AND FEET; SEVERE UPPER BACK PAIN (SCALE 9/10); ACHING; NUMBNESS DOWN THE ARMS, HANDS AND FEET; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: The patient was not breastfeeding at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: 30-OCT-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for to prevent of blood clot.  On 08-SEP-2021, the patient experienced severe upper back pain (scale 9/10). On 08-SEP-2021, the patient experienced aching. On 08-SEP-2021, the patient experienced numbness down the arms, hands and feet. On 08-SEP-2021, the patient experienced tingling down the arms, hands and feet. Laboratory data included: Pain scale (NR: not provided) scale 9/10. On 09-SEP-2021, the patient experienced fever (102.4 degrees fahrenheit (f) ). Laboratory data included: Body temperature (NR: not provided) 102.4 degrees fahrenheit (F). Treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness down the arms, hands and feet, fever (102.4 degrees fahrenheit (f)), and tingling down the arms, hands and feet on 10-SEP-2021, and had not recovered from severe upper back pain (scale 9/10), and aching. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: FEVER (102.4 DEGREES FAHRENHEIT (F)); TINGLING DOWN THE ARMS, HANDS AND FEET; SEVERE UPPER BACK PAIN (SCALE 9/10); ACHING; NUMBNESS DOWN THE ARMS, HANDS AND FEET; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: The patient was not breastfeeding at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: 30-OCT-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for to prevent of blood clot.  On 08-SEP-2021, the patient experienced severe upper back pain (scale 9/10). On 08-SEP-2021, the patient experienced aching. On 08-SEP-2021, the patient experienced numbness down the arms, hands and feet. On 08-SEP-2021, the patient experienced tingling down the arms, hands and feet. Laboratory data included: Pain scale (NR: not provided) scale 9/10. On 09-SEP-2021, the patient experienced fever (102.4 degrees fahrenheit (f) ). Laboratory data included: Body temperature (NR: not provided) 102.4 degrees fahrenheit (F). Treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness down the arms, hands and feet, fever (102.4 degrees fahrenheit (f)), and tingling down the arms, hands and feet on 10-SEP-2021, and had not recovered from severe upper back pain (scale 9/10), and aching. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: KNEE PAIN; INJECTION SITE PAIN; GENERAL TIREDNESS; This spontaneous report received from a patient concerned a 28 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: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 13-SEP-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On 13-SEP-2021, the patient experienced injection site pain. On 13-SEP-2021, the patient experienced general tiredness. On 14-SEP-2021, the patient experienced knee pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 14-SEP-2021, and had not recovered from knee pain, and general tiredness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN LEFT LEG AND NOW THE PAIN WAS AFFECTING HIS RIGHT LEG; This spontaneous report received from a patient concerned an 89 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: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced pain in left leg and now the pain was affecting his right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left leg and now the pain was affecting his right leg. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A BIT OF SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 experienced a bit of sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a bit of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925834.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A BIT OF A SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced a bit of a sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a bit of a sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925820.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Migraine, Myalgia
Clinical narrative: NAUSEA; MUSCLE SORENESS  (NECK, SHOULDERS AND BACK); FEVER; HEADACHE TURNED INTO A MIGRAINE; DIZZY; SENSITIVE SKIN; FEEL TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 13-SEP-2021, the patient experienced headache turned into a migraine. On 13-SEP-2021, the patient experienced dizzy. On 13-SEP-2021, the patient experienced sensitive skin. On 13-SEP-2021, the patient experienced feel tired/fatigue. On 14-SEP-2021, the patient experienced nausea. On 14-SEP-2021, the patient experienced muscle soreness (neck, shoulders and back). On 14-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.32 F, 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feel tired/fatigue, dizzy, headache turned into a migraine, sensitive skin, nausea, muscle soreness (neck, shoulders and back), and fever. This report was non-serious.