chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Swollen tongue
Clinical narrative: BURNING IN MOUTH; SWOLLEN TONGUE; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced burning in mouth, and swollen tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning in mouth and swollen tongue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534846.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Contusion, Platelet count decreased
Clinical narrative: LOW PLATLET COUNT; BLACK AND BLUES; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 194 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included blood work clean in september 2020,no drug allergies. The patient did not had any illness at the time of vaccination, no similar event in the past. He never had any adverse event in past for vaccination. The patient did not had family history of any disease or allergy. The patient did not had medical history of blood clots, heart disease. 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 12-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included doxycycline for drug used for unknown indication. On APR-2021,he noticed black and blues appearing randomly all over his body for no reason whatsoever. They continued to worsen until he went to primacy doctor who did blood work on 29-APR-2021. On 1-MAY-2021 doctor called about blood work to said that he had dangerously low platelet count and to make sure he did not fall and hurt himself. He was instructed to go to the emergency room where they were waiting for him. He was admitted that day. He was treated with steroids for two days with no response, 2 day plasma treatment with minimal response. On May 7-MAY-2021 he was discharged from hospital and was told to continue Doxycycline 2 weeks treatment course. He later had more blood work and the levels have radically dropped again. He had an appointment with a Hematologist/Oncologist specialist on Friday 12-MAY-2021., Laboratory data included: Blood test (NR: not provided) low platelet count. Laboratory data (dates unspecified) included: Blood test (NR: not provided) levels dropped. Treatment medications (dates unspecified) included: plasma, Steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelet count, and black and blues. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210536558.; Sender's Comments: V0: 20210535373-covid-19 vaccine ad26.cov2.s-low platelet count. 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: Computerised tomogram, Epistaxis, Headache, Rash erythematous, Rash pruritic
Clinical narrative: BLOODY NOSE; RED RASH ON LEGS; HEADACHE; ITCHY RASH; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient reported that she usually did not get headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 in total administered on 11-APR-2021 for prophylactic vaccination on Left Arm. No concomitant medications were reported.  On 07-MAY-2021, the patient experienced red rash on legs and headache. The patient reported that the rash was little pin point red round dots from above ankles to about the knees and a few small spots on hands as well. The patient further added that the rash was itchy and looked like an allergic reaction. On an unknown date the rash was starting to go away. On the fifth day of headache, on 12-MAY-2021, the patient experienced bloody nose and was hospitalized for 4 days till 15-MAY-2021. During her hospital stay patient underwent CT (Computerized Tomography) Scan and other test which were normal. The patient stated that her headache resolved while she was in hospital. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAY-2021, was recovering from itchy rash and red rash on legs, and had not recovered from bloody nose. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210535420 - Covid-19 vaccine ad26.cov2.s-Bloody nose.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.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: DOSE GIVEN OUTSIDE OF THE 2 HOUR WINDOW (VIAL WAS PUNCTURED AT 10 AM AND THE DOSE WAS GIVEN TO THE PATIENT AT 1 PM); This spontaneous report received from a pharmacist concerned a 44 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, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced dose given outside of the 2 hour window (vial was punctured at 10 am and the dose was given to the subject at 1 pm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given outside of the 2 hour window (vial was punctured at 10 am and the dose was given to the patient at 1 pm) was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pain, Pyrexia
Clinical narrative: CHEST PAIN; GENERALISED ACHING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight was 132 pounds, and height was 177 centimeters. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse. The patient was not on any medication at the time of event. The patient had no illness at the time of vaccination, no past history of similar event, no adverse event after any previous vaccination, no history of allergy to vaccine, drug, or pre-existing acute illness 30 days prior to vaccination. The patient had no history of hospitalization in last 30 days and no family history of any disease (relevant to vaccination) or allergy. The patient was not breastfeeding at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included calcium for maintain normal calcium levels.  On 10-APR-2021, the subject experienced chest pain. On 10-APR-2021, the subject experienced generalised aching. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, generalised aching, fever, and headache on 12-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative 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: Unknown) 1 total dose, start date of therapy was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced suspected covid-19 infection and the patient experienced suspected clinical vaccination failure. 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).; Sender's Comments: V0:20210535990-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
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 69 year old white, Not Hispanic or Latino 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: 1805022, and expiry: 25-MAY-2021) dose was 0.5 ml, one total administered on 09-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that physician had tested patient 4-6 weeks after receiving the vaccine and tested for immunity levels. Patient received vaccine on 9-MAR-2021. On 26-APR-2021 Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative (no antibodies present, no immunity, and no protection against COVID). The range goes from less than 1 to greater than 20, noting that less than 1 was negative for antibodies. On an unspecified date, the patient had 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: 90000179999 The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Based on the PQC evaluation/investigation performed.  This case, from the same reporter is linked to 20210534629, 20210535317 and 20210536071.  Additional information was received from a consumer on 19-MAY-2021 and from on 20-MAY-2021.; Sender's Comments: V0:20210536064-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned an 18 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: 1808980, and expiry: 20-JUN-2021) dose was 0.5 ml, once total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that, the patient received her vaccine on 09-APR-2021 at an elementary school. Patient was tested on 12-MAY-2021 for antibody and had confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative (1.49) unspecified unit. The range goes from 20, noting that less than 1 was negative for antibodies. Reporter noted that healthy patient of that ages results should be greater than 20. 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). The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210535317, 20210534629 and 20210536064. This report was associated with a product quality complaint 90000180000.  Additional information was received from a consumer on 19-MAY-2021 and on 20-MAY-2021.; Sender's Comments: V0: 20210536071-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: POSSIBLE ADVERSE EVENT; 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, batch number: Unknown and expiry: 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 possible adverse event. It was reported that the patient called to call center with a question that whether it is safe to take Ibuprofen or Tylenol because of vaccine and clotting. The patient was referred to vaccine facility or HCP for medical advice. It was reported that clarification was not obtained as to what the Ibuprofen or Tylenol was for before ending the call. Call center attempted to call back but number leads to cancer institute. Additional information was received from the patient that the patient had fact sheet from Janssen website but the patient did not see anything that talks about medication for side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible adverse event 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: General physical health deterioration
Clinical narrative: CRITICAL CONDITION; This spontaneous report received from a consumer concerned an adult 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was in critical condition and hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of critical condition was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210530468.; Sender's Comments: V0:20210536620-COVID-19 VACCINE AD26.COV2.S-Critical condition. 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: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported.  On an unspecified date, the subject experienced blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210537368-covid-19 vaccine ad26.cov2.s -Blood clot-his event is considered Un assessable. 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.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; 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 past medical history included unknown.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the patient underwent antibody test and the test result was 4.12, but according to patient's physician it should have been 9.9. The patient had confirmed immunological vaccine failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210537468-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
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Pain
Clinical narrative: This spontaneous report received from a patient concerned a 55 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: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced bruise as the size of the palm of the hand, dark, blueish-green, a little red in the middle. On 12-MAY-2021, the subject experienced bruising hurt while laying on right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise as the size of the palm of the hand, dark, blueish-green, a little red in the middle, and bruising hurt while laying on right side. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising
Clinical narrative: This spontaneous report received from a patient concerned a 55 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: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced bruise as the size of the palm of the hand, dark, blueish-green, a little red in the middle. On 12-MAY-2021, the subject experienced bruising hurt while laying on right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise as the size of the palm of the hand, dark, blueish-green, a little red in the middle, and bruising hurt while laying on right side. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Drug exposure before pregnancy, Pregnancy test
Clinical narrative: DRUG EXPOSURE PRIOR TO PREGNANCY; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included infertility, and concurrent conditions included penicillin allergy.  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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced drug exposure prior to pregnancy. Laboratory data included: Pregnancy test (NR: not provided) Positive. On 05-MAY-2021, Laboratory data included: Blood test (NR: not provided) pregnancy confirmed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure prior to pregnancy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Rhabdomyolysis
Clinical narrative: RHABDOMYOLYSIS; This spontaneous report received from a physician 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  Laboratory data (dates unspecified) included: Creatine kinase (NR: not provided) greater than 500, 000. No concomitant medications were reported. On an unspecified date, the patient experienced rhabdomyolysis, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rhabdomyolysis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210537566-COVID-19 VACCINE AD26.COV2.S-RHABDOMYOLYSIS. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: PHLEGM; 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: 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 subject experienced phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of phlegm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: EXPIRED VACCINE RECEIVED; PRODUCT TEMPERATURE EXCURSION ISSUE (PUNCTURED VIAL LEFT OUT BEYOND 6 HOURS ADMINISTERED); This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAY-2021, the subject experienced expired vaccine received. On 19-MAY-2021, the subject experienced product temperature excursion issue (punctured vial left out beyond 6 hours administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine received and product temperature excursion issue (punctured vial left out beyond 6 hours administered) was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided: yes. no pqc criteria has been identified. based on the PQC evaluation/investigation performed. This report was associated with product quality complaint: 90000180101.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: NIGHT SWEATS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 19-MAY-2021, the subject experienced night sweats. On 19-MAY-2021, the subject experienced fever. On 19-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, fever, and fatigue on 19-MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: CHILLS; LOW OXYGEN LEVEL; CHEST DISCOMFORT; This spontaneous report received from a patient of unspecified age, sex, 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) dose was not reported, 1 total administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the patient experienced chills. On an unspecified date in APR-2021 the patient experienced low oxygen levels and chest discomfort in the evenings for the next few days. On 09-APR-2021, after advising with doctor of oxygen levels in the low 80s, the patient was admitted to hospital for nearly a week where the patient was given oxygen and albuterol treatments. They were unable to find a reason for her symptoms. The patient's oxygen levels returned to normal . On an unspecified date in APR-2021, the patient was released. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low oxygen level on APR-2021, and the outcome of chills and chest discomfort was not reported.  This report was serious (Hospitalization Caused / Prolonged). This spontaneous report received from a patient concerned a patient of unspecified age and sex.; Sender's Comments: V0: 20210537756-Covid-19 vaccine ad26.cov2.s-Low oxygen level, Chest discomfort. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0: 20210537756-Covid-19 vaccine ad26.cov2.s-Chills. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Injection site erythema, Injection site mass
Clinical narrative: SINUS INFECTION; JOINT ACHING ON BOTH  FEET AND ANKLES; LUMP ON INJECTION SITE; SORE INJECTION ARM; REDNESS AT INJECTION SITE; REALLY ROUGH LOWER BACK PAIN; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has no known allergies and also has no covid in past and not tested positive for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced really rough lower back pain. On 17-MAY-2021, the subject experienced lump on injection site. On 17-MAY-2021, the subject experienced sore injection arm. On 17-MAY-2021, the subject experienced redness at injection site. On 18-MAY-2021, the subject experienced joint aching on both feet and ankles. On an unspecified date, the subject experienced sinus infection. Treatment medications (dates unspecified) included: amoxicillin trihydrate/clavulanate potassium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really rough lower back pain on 16-MAY-2021, and was recovering from sore injection arm, lump on injection site, redness at injection site, joint aching on both feet and ankles, headache, and sinus infection. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Sinusitis
Clinical narrative: SINUS INFECTION; JOINT ACHING ON BOTH  FEET AND ANKLES; LUMP ON INJECTION SITE; SORE INJECTION ARM; REDNESS AT INJECTION SITE; REALLY ROUGH LOWER BACK PAIN; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has no known allergies and also has no covid in past and not tested positive for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced really rough lower back pain. On 17-MAY-2021, the subject experienced lump on injection site. On 17-MAY-2021, the subject experienced sore injection arm. On 17-MAY-2021, the subject experienced redness at injection site. On 18-MAY-2021, the subject experienced joint aching on both feet and ankles. On an unspecified date, the subject experienced sinus infection. Treatment medications (dates unspecified) included: amoxicillin trihydrate/clavulanate potassium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really rough lower back pain on 16-MAY-2021, and was recovering from sore injection arm, lump on injection site, redness at injection site, joint aching on both feet and ankles, headache, and sinus infection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Peripheral swelling, Skin warm
Clinical narrative: KNOT IN ARM; ARM SWELLING; ARM WARM TO TOUCH; 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 asthma, and the patient had no known allergies.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced knot in arm. On 10-MAY-2021, the subject experienced arm swelling. On 10-MAY-2021, the subject experienced arm warm to touch. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from knot in arm, arm swelling, and arm warm to touch. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer via a company representative, concerned a female patient of unspecified age, 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 administration was not reported, batch number: unknown and expiry: unknown) dose and therapy start date were not reported, 1 total, administered 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, in 2021 (11 hours post vaccination), the patient died due to heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was fatal. This report was serious (Death).; Sender's Comments: V0 20210538222-covid-19 vaccine ad26.cov2.s-Myocardial infarction. 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: HEART ATTACK
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gait disturbance
Clinical narrative: BARELY WALK; This spontaneous report received from a patient concerned a 71 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, 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 2021, the subject experienced barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from barely walk on 2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. 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: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210535199.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: STRANGE STUFF; This spontaneous report received from a patient via a company representative 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 31-MAR-2021, the subject experienced strange stuff. The action taken with covid-19 vaccine  was not applicable. The outcome of strange stuff was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: SUPER EXHAUSTED; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced super exhausted. The action taken with covid-19 vaccine was not applicable. The outcome of super exhausted was not reported. This report was non-serious. This case, from the same reporter is linked to 20210539039 and 20210539060.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: DON'T FEEL RIGHT; ACHE; CHILLS; FEVER; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the subject experienced don't feel right, ache, chills, and fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever, and had not recovered from don't feel right, chills, and ache. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Immediately following vaccination left foot went numb & both hands became numb. About 6 hours following vaccination legs felt heavy for 2 weeks following. Vaccination arm was sore & swollen for 3 weeks following vaccination, and is still having intermittent swelling in various places like deltoid, forearm, wrist, hand, & most recently the labrum. Swelling & pain come and go.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Heart rate irregular
Clinical narrative: Heart region pain, thick heart beats, pain in chest after physical movement, irregular heartbeat
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Body temperature, Influenza like illness, Nausea, Pyrexia
Clinical narrative: DRY HEAVING; NAUSEA; HIGH FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 68 year old male. 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 the patient had no known allergies and had no history of 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced flu like symptoms. On 19-MAY-2021, the subject experienced high fever. Laboratory data included: Blood glucose (NR: not provided) Not Reported, and Body temperature (NR: not provided) up to 101.9. Treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced dry heaving. On 20-MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) up to 102.9. Treatment medications included: prochlorperazine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, dry heaving, and nausea, and had not recovered from high fever. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: DRY HEAVING; NAUSEA; HIGH FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 68 year old male. 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 the patient had no known allergies and had no history of 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced flu like symptoms. On 19-MAY-2021, the subject experienced high fever. Laboratory data included: Blood glucose (NR: not provided) Not Reported, and Body temperature (NR: not provided) up to 101.9. Treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced dry heaving. On 20-MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) up to 102.9. Treatment medications included: prochlorperazine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, dry heaving, and nausea, and had not recovered from high fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sweat gland disorder
Clinical narrative: LOST ABILITY TO SWEAT; This spontaneous report received from a patient via a company representative 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: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On  2021, the subject experienced lost ability to sweat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost ability to sweat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: SORE FEELING; FEVER; EXHAUSTED FEELING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore feeling, fever, and exhausted feeling. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, exhausted feeling and sore feeling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Limb injury, Nausea
Clinical narrative: ARM HIT WITH BAT; DROP DEAD FATIGUE; NAUSEA; 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  (suspension for injection, route of admin not reported, batch unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On an unspecified date, the subject experienced arm hit with bat, drop dead fatigue, and nausea. The action taken with covid-19 vaccine was not applicable. The outcome of the drop dead fatigue, nausea and arm hit with bat was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: SORE THROAT; BODY ACHES; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sore throat, body aches, headache, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache, fever, body aches and sore throat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE SIDE EFFECTS; 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  (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced severe side effects. The action taken with covid-19 vaccine  was not applicable. The outcome of severe side effects 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.