chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Syncope
Clinical narrative: abdominal cramps; fainted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 at 14:00 as dose 2, single (Lot number: EL9242) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Melanoma", start date: 2004, stop date: 2004, notes: Pertinent details: removed+ resection; "Hashimoto's", start date: 1986 (ongoing), notes: Hashimoto's, Pertinent details: Meds; "Bladder cancer", start date: 2019, stop date: 2019, notes: Pertinent details: ureter + Kidney removed- chemo; "IBS", start date: 1977 (ongoing), notes: IBS, Pertinent details: Meds. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, time: 14:00, Anatomical Site of injection: left arm, Anatomical location: Intramuscular, Batch/Lot number: EH9899), administration date: 06Jan2021, when the patient was 66-year-old, for Covid-19 Immunization. The following information was reported: SYNCOPE (medically significant) with onset Jan2021, outcome "recovered" (2021), described as "fainted"; ABDOMINAL PAIN (non-serious) with onset 27Jan2021 at 12:30, outcome "recovered", described as "abdominal cramps". Therapeutic measures were not taken as a result of syncope, abdominal pain.  Clinical course: Had vaccination went to sleep at 10:30 pm took about 12:00 am abdominal cramps- very severe. Had bowel movement, flushed stood up and fainted Hit the floor then stood up again- fainted again- her husband caught her before she hit her head on the tile floor she was sleeping the whole next day. She was fine after next day.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. An 86-year-old female patient received BNT162B2, on 10Mar2021 as dose 1, single (Lot number: EN6208, Expiration Date: 30Jun2021) and on 07Apr2021 as dose 2, single (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 85 years for covid-19 immunization. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: Patient had diabetes for 20 years or more; "heart attack", start date: 2008 (unspecified if ongoing); "anemic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022, outcome "unknown" and all described as "Received 2 doses of the Pfizer COVID-19 vaccine, tested positive for COVID 21Jun2022.". The event "received 2 doses of the Pfizer covid-19 vaccine, tested positive for covid 21jun2022." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given as treatment medication for covid-19. Patient height: 4 feet and 9 inches, maybe 4 feet and 9.5 inches. No follow-up attempts are required. No further information is expected
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell abnormality, Renal injury
Clinical narrative: Injured my kidneys; Effected red blood cells; This spontaneous case was reported by a patient and describes the occurrence of RENAL INJURY (Injured my kidneys) in a 78-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL INJURY (Injured my kidneys) (seriousness criterion medically significant) and RED BLOOD CELL ABNORMALITY (Effected red blood cells). At the time of the report, RENAL INJURY (Injured my kidneys) and RED BLOOD CELL ABNORMALITY (Effected red blood cells) was resolving.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was provided.  Company comment: This spontaneous case concerns a 78 year old female, with no reported medical history, who experienced the unexpected, serious (medically significant) event of Renal injury which occurred at an unspecified date after receiving a dose of mRNA1273. Red blood cell abnormality was also reported as an additional event in the case which may be in association with renal injury. Further details regarding the clinical course, diagnostic test done on the patient and treatment were not provided in the case. The patient's advanced age may be considered as a risk factor for Renal injury. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 78 year old female, with no reported medical history, who experienced the unexpected, serious (medically significant) event of Renal injury which occurred at an unspecified date after receiving a dose of mRNA1273. Red blood cell abnormality was also reported as an additional event in the case which may be in association with renal injury. Further details regarding the clinical course, diagnostic test done on the patient and treatment were not provided in the case. The patient's advanced age may be considered as a risk factor for Renal injury. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm had increased Swelling; Left arm was set on fired; Left arm  had increased pain; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Left arm had increased Swelling), BURNING SENSATION (Left arm was set on fired) and PAIN IN EXTREMITY (Left arm  had increased pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 013M20A) for COVID-19 prophylaxis.     Patient had no known drug allergies. Patient had no alcohol use and drug use as past medical history. Patient had no pertinent family history. No other vaccines given on the same day or within one month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Ex-smoker (Tobacco Use, Former smoker), Cataract extraction, Gallbladder operation NOS, Hernia repair and Colonoscopy (Colonoscopy Screening) in May 2019. Concurrent medical conditions included Heart disease, unspecified, Hypertension, Hypothyroidism and Adhesive capsulitis of shoulder (Adhesive capsulitis of left shoulder (M75 02)). Concomitant products included METHYLPREDNISOLONE, TRAMADOL HCL, LEVOTHYROXINE SODIUM (EUTHYROX), ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), OLMESARTAN MEDOXOMIL and ATENOLOL for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Left arm had increased Swelling), BURNING SENSATION (Left arm was set on fired) and PAIN IN EXTREMITY (Left arm  had increased pain). At the time of the report, PERIPHERAL SWELLING (Left arm had increased Swelling), BURNING SENSATION (Left arm was set on fired) and PAIN IN EXTREMITY (Left arm  had increased pain) outcome was unknown.            Patient received the booster dose.  Concomitant medications also included Pdeudoeph-Bromphen-DM (30-2-10MG/5 Ml Syrup Oral).  Patient was encouraged to take the booster dose after getting COVID on 03-Aug-2021 since patient has cardiovascular disease.  On 02-Sep-2021, patient took the Flu vaccine.  No treatment medications were provided.   This case was linked to MOD-2021-286668 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: experienced a fever after her second dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 25-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE:1 , Manufacturer unknown), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "experienced a fever after her second dose of the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: EN5318) and on 19Apr2021 as dose 2, single (Lot number: EN5318) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 26Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 26Jun2022, outcome "not recovered" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient had full 2 dose series and tested positive for covid. Symptoms are fever, chills, sinus congestion, tired, achy. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no know known allergies.  Facility where the most recent COVID-19 vaccine was administered: Workplace clinic,  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure, Chest pain, Expired product administered
Clinical narrative: heart failure; had mistakenly given me an expired dose that was in the throw away batch; severe chest pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 04Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure"; EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "had mistakenly given me an expired dose that was in the throw away batch"; CHEST PAIN (non-serious), outcome "unknown", described as "severe chest pains".  Clinical course: Hello, I was given a COVID booster shot on 04Nov2021. The pharmacist called me a couple of hours later to inform me the nurse had mistakenly given me an expired dose that was in the throw away batch. Twenty four hours later I started having severe chest pains. I have been under the doctors care since then and (8 months later) was recently diagnosed with heart failure. I was told by the company at fault to contact Pfizer because you all were at fault due to my adverse reaction.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID on Saturday 25Jun2022. Had symptoms starting on Thursday 23Jun2022. Symptoms include post nasal drip/sore throat, fatigue, sneezing, fever, body aches.; Tested positive for COVID on Saturday 25Jun2022. Had symptoms starting on Thursday 23Jun2022. Symptoms include post nasal drip/sore throat, fatigue, sneezing, fever, body aches.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EJ3247), in left arm, on 28Mar2021 as dose 2, single (Lot number: ER8734), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 48 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEGA-3 FATTY ACIDS; VIT D; ADVIL; BIOTIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "not recovered" and all described as "Tested positive for COVID on Saturday 25Jun2022. Had symptoms starting on Thursday 23Jun2022. Symptoms include post nasal drip/sore throat, fatigue, sneezing, fever, body aches.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Positive; (24Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination were vitamins (Omega 3, vit D, biotin) advil. It was reported that, the patient tested positive for COVID on Saturday 25Jun2022. Had symptoms starting on Thursday 23Jun2022. Symptoms include postnasal drip/sore throat, fatigue, sneezing, fever, body aches. Adverse events start date was reported as, 22Jun2022. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. Awareness Date was reported as, 24Jun2022. The was reported as, non-serious.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: she has been diagnosed with COVID-19 again even after receiving her vaccinations; she has been diagnosed with COVID-19 again even after receiving her vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 05May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid 19" (unspecified if ongoing); "lose her taste" (unspecified if ongoing), notes: lose her taste for 4 months. The patient's concomitant medications were not reported. Past drug history included: Flu vaccine for immunization, reaction(s): "vomiting", notes: last time when patient received the flu vaccine she experienced a terrible reaction about 3 weeks later which included vomiting all night and recounts that one night she had to message her son downstairs to help her because she threw up 6 times in one episode 3 weeks after receiving "a flu vaccine". The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she has been diagnosed with COVID-19 again even after receiving her vaccinations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she did get diagnosed with COVID-19 prior to receiving her vaccinations; Positive, notes: she has been diagnosed with COVID-19 again even after receiving her vaccinations but did not provide a date. clinical information:She had not received any booster or subsequent doses. she did get diagnosed with COVID-19 prior to receiving her vaccinations which caused her to lose her taste for 4 months and then after she received her second dose of the Pfizer COVID-19 vaccine she suddenly regained her sense of taste. She also states that she had been diagnosed with COVID-19 again even after receiving her vaccinations but did not provide a date.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC, RVX
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: HAEMATOCHEZIA; OCCULT BLOOD POSITIVE; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2011217-1. The original narrative from the sender is as below:  Developed hematochezia 24 hours after first dose of Rotavirus.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC, RVX
Symptoms: Haematochezia
Clinical narrative: HAEMATOCHEZIA; OCCULT BLOOD POSITIVE; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2011217-1. The original narrative from the sender is as below:  Developed hematochezia 24 hours after first dose of Rotavirus.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Red, swollen lump at injection site, 3cm in diameter; Injection site erythema; Red, swollen lump at injection site, 3cm in diameter; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2062020-1. The original narrative from the sender is as below:  Red, swollen lump at injection site, 3cm in diameter. Redness and swelling lasted approximately 3 weeks. Lump palpable 2 months post-vaccine  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Injection site mass, Injection site erythema and Injection site swelling".   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13, DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Agitation, Cellulitis, Erythema, Exophthalmos, Eye movement disorder
Clinical narrative: Became stiff; Agitation; 'cellulitis' to right calf area; Very faint pinkness noted to right calf; her eyes buldged; EYE MOVEMENT DISORDER; very fussy and inconsolable; Some swelling to the R thigh; pt had a low grade fever; Eyes fluttered a little (she described this as a seizure).; This non-serious case was received from a parent and a nurse via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2134584-1. The original narrative from the sender is available:  "Mother reported that pt had a low grade fever, very fussy and inconsolable, her eyes bulged and became stiff, then her eyes fluttered a little (she described this as a seizure). Some swelling to the R thigh.". In addition:  "Seen in ER. Pt put on Amoxicillin for 'cellulitis' to right calf area. Pt was visualized by this reporting nurse on 02.23.2022. Very faint pinkness noted to right calf. There was ink markings noted below knee from where medical staff outlined redness at time seen in ER."
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13, DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Peripheral swelling, Pyrexia, Seizure
Clinical narrative: Became stiff; Agitation; 'cellulitis' to right calf area; Very faint pinkness noted to right calf; her eyes buldged; EYE MOVEMENT DISORDER; very fussy and inconsolable; Some swelling to the R thigh; pt had a low grade fever; Eyes fluttered a little (she described this as a seizure).; This non-serious case was received from a parent and a nurse via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2134584-1. The original narrative from the sender is available:  "Mother reported that pt had a low grade fever, very fussy and inconsolable, her eyes bulged and became stiff, then her eyes fluttered a little (she described this as a seizure). Some swelling to the R thigh.". In addition:  "Seen in ER. Pt put on Amoxicillin for 'cellulitis' to right calf area. Pt was visualized by this reporting nurse on 02.23.2022. Very faint pinkness noted to right calf. There was ink markings noted below knee from where medical staff outlined redness at time seen in ER."
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13, DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Agitation, Exophthalmos, Eye movement disorder, Injection site cellulitis, Injection site erythema
Clinical narrative: Became stiff; Agitation; 'cellulitis' to right calf area; Very faint pinkness noted to right calf; her eyes buldged; EYE MOVEMENT DISORDER; very fussy and inconsolable; Some swelling to the R thigh; pt had a low grade fever; Eyes fluttered a little (she described this as a seizure).; This non-serious case was received from a parent and a nurse via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2134584-1. The original narrative from the sender is available:  "Mother reported that pt had a low grade fever, very fussy and inconsolable, her eyes bulged and became stiff, then her eyes fluttered a little (she described this as a seizure). Some swelling to the R thigh.". In addition:  "Seen in ER. Pt put on Amoxicillin for 'cellulitis' to right calf area. Pt was visualized by this reporting nurse on 02.23.2022. Very faint pinkness noted to right calf. There was ink markings noted below knee from where medical staff outlined redness at time seen in ER."
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13, DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Became stiff; Agitation; 'cellulitis' to right calf area; Very faint pinkness noted to right calf; her eyes buldged; EYE MOVEMENT DISORDER; very fussy and inconsolable; Some swelling to the R thigh; pt had a low grade fever; Eyes fluttered a little (she described this as a seizure).; This non-serious case was received from a parent and a nurse via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2134584-1. The original narrative from the sender is available:  "Mother reported that pt had a low grade fever, very fussy and inconsolable, her eyes bulged and became stiff, then her eyes fluttered a little (she described this as a seizure). Some swelling to the R thigh.". In addition:  "Seen in ER. Pt put on Amoxicillin for 'cellulitis' to right calf area. Pt was visualized by this reporting nurse on 02.23.2022. Very faint pinkness noted to right calf. There was ink markings noted below knee from where medical staff outlined redness at time seen in ER."
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st + 2nd shots - got sore arm - after 1 week ok; passed away 12May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year old female patient received BNT162b2 (BNT162B2), on 08Feb2021 at 13:00 as dose 2, single (Lot number: EL9265) at the age of 70 years intramuscular, in left arm for covid-19 immunisation.The patient's relevant medical history included: "Bronchithisis (COPD)" (ongoing), notes: Pertinent details: in care of a pulmonary Dr.; "Asthma" (ongoing); "High cholesterol" (ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM taken for hypersensitivity, asthma (ongoing); ERGOCALCIFEROL (ongoing); ALENDRONATE SODIUM taken for osteoporosis (ongoing). Vaccination history included: BNT162b2 (Dose : 01 , Date:18Jan2021, Time:11:00 AM , Route of administration: intramuscular , Anatomical site of injection: upper left arm , Batch/lot number:Pfizer biotech lot # EL2347), administration date: 18Jan2021, for covid 19 immunization. The following information was reported: DEATH (death, medically significant) with onset 12May2022, outcome "fatal", described as "passed away 12May2022"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "1st + 2nd shots - got sore arm - after 1 week ok". The patient date of death was 12May2022. Reported cause of death: "passed away 12May2022". It was not reported if an autopsy was performed. Clinical course: reported that Over 65 years old with COPD and patient taking Montelukast sodium taking daily many years ago. Ergocalcife weekly 2 years ago. Alendronate sodium bi-weekly 3 months ago and Many vitamins Ongoing. Follow-up (27Jun2022): This is a follow-up spontaneous report from a contactable consumer. updated New event added Cause of death and Autopsy result updated. (Name) passed away 12May2022. She could not answer this questionnaire.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: passed away 12May2022
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Pain in extremity
Clinical narrative: 1st + 2nd shots - got sore arm - after 1 week ok; passed away 12May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year old female patient received BNT162b2 (BNT162B2), on 08Feb2021 at 13:00 as dose 2, single (Lot number: EL9265) at the age of 70 years intramuscular, in left arm for covid-19 immunisation.The patient's relevant medical history included: "Bronchithisis (COPD)" (ongoing), notes: Pertinent details: in care of a pulmonary Dr.; "Asthma" (ongoing); "High cholesterol" (ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM taken for hypersensitivity, asthma (ongoing); ERGOCALCIFEROL (ongoing); ALENDRONATE SODIUM taken for osteoporosis (ongoing). Vaccination history included: BNT162b2 (Dose : 01 , Date:18Jan2021, Time:11:00 AM , Route of administration: intramuscular , Anatomical site of injection: upper left arm , Batch/lot number:Pfizer biotech lot # EL2347), administration date: 18Jan2021, for covid 19 immunization. The following information was reported: DEATH (death, medically significant) with onset 12May2022, outcome "fatal", described as "passed away 12May2022"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "1st + 2nd shots - got sore arm - after 1 week ok". The patient date of death was 12May2022. Reported cause of death: "passed away 12May2022". It was not reported if an autopsy was performed. Clinical course: reported that Over 65 years old with COPD and patient taking Montelukast sodium taking daily many years ago. Ergocalcife weekly 2 years ago. Alendronate sodium bi-weekly 3 months ago and Many vitamins Ongoing. Follow-up (27Jun2022): This is a follow-up spontaneous report from a contactable consumer. updated New event added Cause of death and Autopsy result updated. (Name) passed away 12May2022. She could not answer this questionnaire.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: passed away 12May2022
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE EVENT; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This case was retrieved during the monitoring on the Vaccine Adverse Event Reporting System (VAERS) on 11-Apr-2022 with the following reference number: 2178210-1. The original narrative from the sender is as follows:  Dose of Vaxelis given to an 11 year patient (out of recommended age range). This was not noted until approx 6 weeks later. Pt had no adverse events or symptoms reported.
Sex: U
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022; This non-serious case was received from a Health Care Professional via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2178992 and databased on 13-APR-2022. The original narrative from the sender is the following:  "No additional AE reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported. On 10 FEB-2022, the patient was vaccinated with both improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (lot # 1741817, expiration date: 30-JUL-2022, strength and dose were unknown) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (V419) (lot # U7124AA, expiration date: 13-JUL-2024, strength, dose and route were unknown) for prophylaxis (product storage error). The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022 as confirmed by reporter. There was no previous excursion. No additional adverse event was reported."  Due to the nature of the reported event, the causality between Vaxelis and the events "Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS, and The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022" was not applicable.   No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022; This non-serious case was received from a Health Care Professional via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2178992 and databased on 13-APR-2022. The original narrative from the sender is the following:  "No additional AE reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported. On 10 FEB-2022, the patient was vaccinated with both improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (lot # 1741817, expiration date: 30-JUL-2022, strength and dose were unknown) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (V419) (lot # U7124AA, expiration date: 13-JUL-2024, strength, dose and route were unknown) for prophylaxis (product storage error). The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022 as confirmed by reporter. There was no previous excursion. No additional adverse event was reported."  Due to the nature of the reported event, the causality between Vaxelis and the events "Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS, and The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022" was not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC, RVX
Symptoms: Haematochezia, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Haematochezia; Intussusception; Ultrasound abdomen abnormal; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2179935. The original narrative from the sender is as below:  Intussusception 5-6 days after vaccines. Seen in ER with bloody stools, intussusception seen on ultrasound, successfully reduced with air enema.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC, RVX
Symptoms: Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Haematochezia; Intussusception; Ultrasound abdomen abnormal; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2179935. The original narrative from the sender is as below:  Intussusception 5-6 days after vaccines. Seen in ER with bloody stools, intussusception seen on ultrasound, successfully reduced with air enema.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Breast discomfort, Breast pain, Discomfort, Neuralgia
Clinical narrative: Carditis type symptoms; Muscle aches; Shingle like nerve damage around my chest; Now experiencing chest discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 12Dec2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Type II Diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: NORVASC; METFORMIN; LOPRESSOR; ZOCOR; PLAVIX; LISI. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 21Mar2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN0151, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 11Apr2021, when the patient was 65-year-old, for Covid-19 Immunization. The following information was reported: CARDITIS (medically significant) with onset 14Apr2022, outcome "not recovered", described as "Carditis type symptoms"; MYALGIA (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Muscle aches"; CHEST DISCOMFORT (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Now experiencing chest discomfort"; NERVE INJURY (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Shingle like nerve damage around my chest". The events "carditis type symptoms", "muscle aches", "shingle like nerve damage around my chest" and "now experiencing chest discomfort" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of carditis, myalgia, nerve injury, chest discomfort.  Clinical course: Thee  patient did not receive other medication in four weeks. Patient going for a stress test next week. AE patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.Prior to coccid vaccination and post vaccination patient was not tested covid.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nipple pain, Pain, Pruritus
Clinical narrative: Carditis type symptoms; Muscle aches; Shingle like nerve damage around my chest; Now experiencing chest discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 12Dec2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Type II Diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: NORVASC; METFORMIN; LOPRESSOR; ZOCOR; PLAVIX; LISI. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 21Mar2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN0151, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 11Apr2021, when the patient was 65-year-old, for Covid-19 Immunization. The following information was reported: CARDITIS (medically significant) with onset 14Apr2022, outcome "not recovered", described as "Carditis type symptoms"; MYALGIA (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Muscle aches"; CHEST DISCOMFORT (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Now experiencing chest discomfort"; NERVE INJURY (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Shingle like nerve damage around my chest". The events "carditis type symptoms", "muscle aches", "shingle like nerve damage around my chest" and "now experiencing chest discomfort" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of carditis, myalgia, nerve injury, chest discomfort.  Clinical course: Thee  patient did not receive other medication in four weeks. Patient going for a stress test next week. AE patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.Prior to coccid vaccination and post vaccination patient was not tested covid.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carditis, Chest discomfort, Myalgia, Nerve injury
Clinical narrative: Carditis type symptoms; Muscle aches; Shingle like nerve damage around my chest; Now experiencing chest discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 12Dec2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Type II Diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: NORVASC; METFORMIN; LOPRESSOR; ZOCOR; PLAVIX; LISI. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 21Mar2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN0151, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 11Apr2021, when the patient was 65-year-old, for Covid-19 Immunization. The following information was reported: CARDITIS (medically significant) with onset 14Apr2022, outcome "not recovered", described as "Carditis type symptoms"; MYALGIA (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Muscle aches"; CHEST DISCOMFORT (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Now experiencing chest discomfort"; NERVE INJURY (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Shingle like nerve damage around my chest". The events "carditis type symptoms", "muscle aches", "shingle like nerve damage around my chest" and "now experiencing chest discomfort" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of carditis, myalgia, nerve injury, chest discomfort.  Clinical course: Thee  patient did not receive other medication in four weeks. Patient going for a stress test next week. AE patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.Prior to coccid vaccination and post vaccination patient was not tested covid.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (COMIRNATY), in Nov2021 as dose 1, single (Batch/Lot number: unknown) and in Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: No underlying health conditions or medications. 2 doses of Comirnaty administered Nov2021. He has not yet gotten a booster dose. Event took place after use of product. Patient tested positive for COVID - experiencing mild symptoms - headache, sore throat, runny nose.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (COMIRNATY), in Nov2021 as dose 1, single (Batch/Lot number: unknown) and in Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: No underlying health conditions or medications. 2 doses of Comirnaty administered Nov2021. He has not yet gotten a booster dose. Event took place after use of product. Patient tested positive for COVID - experiencing mild symptoms - headache, sore throat, runny nose.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Large amount of redness going from the pts hip to his knee; Large amount of redness going from the pts hip to his knee along with swelling; Crying; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2182077-1. The original narrative from the sender is as below:  "Large amount of redness going from the pts hip to his knee along with swelling, and inconsolable. Mom was advised to administer tylenol and gave a warm bath. ""Left leg"""  History of  Hydronephrosis.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Crying, Erythema, Peripheral swelling
Clinical narrative: Large amount of redness going from the pts hip to his knee; Large amount of redness going from the pts hip to his knee along with swelling; Crying; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2182077-1. The original narrative from the sender is as below:  "Large amount of redness going from the pts hip to his knee along with swelling, and inconsolable. Mom was advised to administer tylenol and gave a warm bath. ""Left leg"""  History of  Hydronephrosis.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Cyanosis, Pyrexia
Clinical narrative: Lips turned blue; Temp at that time was 97, then with in ten minutes, temp was 103; This non-serious spontaneous case was received from a non-Health Care Professional via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2184373-1. The original narrative from the sender is available and included in the source document:  "Mom states that she thought he had a fever so she put him in a warm bath, his lips turned blue temp at that time was 97, then with in ten minutes his temp was 103".  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events: Lips turned blue, and Temp at that time was 97, then with in ten minutes, temp was 103.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: Redness; Hard lump; Painful; Swelling; This non-serious spontaneous case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2198947-1. The original narrative from the sender is not available.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events: Swelling, Redness, Hard lump, and Painful.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Erythema, Induration, Mass, Pain, Swelling
Clinical narrative: Redness; Hard lump; Painful; Swelling; This non-serious spontaneous case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2198947-1. The original narrative from the sender is not available.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events: Swelling, Redness, Hard lump, and Painful.   No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Fatigue, Nausea, Oropharyngeal pain, Palpitations
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 13:00 as dose 1, single (Lot number: EN6200), in right arm, on 16Mar2021 at 13:00 as dose 2, single (Lot number: EN6206), in right arm and on 25Jan2022 at 18:00 as dose 3 (booster), single (Lot number: FJ5682) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (20Jun2022) Negative; (21Jun2022) Negative; (22Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.