chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Hypoaesthesia, Lymph node pain, Pain in extremity
Clinical narrative: allergies; hard of breathing/lung problems; heart is racing; Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers; nerve is numb; pains in my lymphnode on my arm; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (allergies), DYSPNOEA (hard of breathing/lung problems), PALPITATIONS (heart is racing), PAIN IN EXTREMITY (Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers) and HYPOAESTHESIA (nerve is numb) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) in March 2021, JANSSEN COVID-19 VACCINE (1st booster dose) on 15-Dec-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and no record). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 09-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ALLERGY TO VACCINE (allergies), DYSPNOEA (hard of breathing/lung problems), PALPITATIONS (heart is racing), PAIN IN EXTREMITY (Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers), HYPOAESTHESIA (nerve is numb) and LYMPH NODE PAIN (pains in my lymphnode on my arm). At the time of the report, ALLERGY TO VACCINE (allergies), DYSPNOEA (hard of breathing/lung problems), PALPITATIONS (heart is racing), HYPOAESTHESIA (nerve is numb) and LYMPH NODE PAIN (pains in my lymphnode on my arm) had not resolved and PAIN IN EXTREMITY (Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers) outcome was unknown.            No concomitant medication information provided.  Patient had second booster dose.  It was stated that they did not had problems after getting the Pfizer and J and J and There was something with the Moderna vaccine because 4 out of 5 people are affected when they got it.  It was reported that they thought they were going to get pneumonia and they were given antibiotic for it.  They already consulted with their doctor and the nurse they see had advised putting cold pad but they are putting heat pad on the affected side.  Treatment medications reported was antibiotics and heat pads.   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2022: Follow up contains Non-significant information: ID added
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: allergies; hard of breathing/lung problems; heart is racing; Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers; nerve is numb; pains in my lymphnode on my arm; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (allergies), DYSPNOEA (hard of breathing/lung problems), PALPITATIONS (heart is racing), PAIN IN EXTREMITY (Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers) and HYPOAESTHESIA (nerve is numb) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) in March 2021, JANSSEN COVID-19 VACCINE (1st booster dose) on 15-Dec-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and no record). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 09-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ALLERGY TO VACCINE (allergies), DYSPNOEA (hard of breathing/lung problems), PALPITATIONS (heart is racing), PAIN IN EXTREMITY (Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers), HYPOAESTHESIA (nerve is numb) and LYMPH NODE PAIN (pains in my lymphnode on my arm). At the time of the report, ALLERGY TO VACCINE (allergies), DYSPNOEA (hard of breathing/lung problems), PALPITATIONS (heart is racing), HYPOAESTHESIA (nerve is numb) and LYMPH NODE PAIN (pains in my lymphnode on my arm) had not resolved and PAIN IN EXTREMITY (Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers) outcome was unknown.            No concomitant medication information provided.  Patient had second booster dose.  It was stated that they did not had problems after getting the Pfizer and J and J and There was something with the Moderna vaccine because 4 out of 5 people are affected when they got it.  It was reported that they thought they were going to get pneumonia and they were given antibiotic for it.  They already consulted with their doctor and the nurse they see had advised putting cold pad but they are putting heat pad on the affected side.  Treatment medications reported was antibiotics and heat pads.   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2022: Follow up contains Non-significant information: ID added
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Panic attack, SARS-CoV-2 test, SARS-CoV-2 test false positive, Stress
Clinical narrative: This false positive test caused me to have anxiety; This false positive test caused me to have a panic attack; This false positive test caused me to have stress; When they tested me for COVID, the test came back positive for Covid-19. It was a false positive!; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (This false positive test caused me to have anxiety), PANIC ATTACK (This false positive test caused me to have a panic attack), STRESS (This false positive test caused me to have stress) and SARS-COV-2 TEST FALSE POSITIVE (When they tested me for COVID, the test came back positive for Covid-19. It was a false positive!) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     The patient had severe medical conditions.  The patient's past medical history included COVID-19.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Nov-2022, the patient experienced SARS-COV-2 TEST FALSE POSITIVE (When they tested me for COVID, the test came back positive for Covid-19. It was a false positive!). On 22-Nov-2022, the patient experienced ANXIETY (This false positive test caused me to have anxiety), PANIC ATTACK (This false positive test caused me to have a panic attack) and STRESS (This false positive test caused me to have stress). At the time of the report, ANXIETY (This false positive test caused me to have anxiety), PANIC ATTACK (This false positive test caused me to have a panic attack), STRESS (This false positive test caused me to have stress) and SARS-COV-2 TEST FALSE POSITIVE (When they tested me for COVID, the test came back positive for Covid-19. It was a false positive!) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2022, SARS-CoV-2 test: false positive. On 22-Nov-2022, SARS-CoV-2 test: Negative.         No concomitant medications were reported.  On 21-Nov-2022, the patient was admitted to the hospital for a procedure with a medical device. When they tested patient for COVID, the test came back positive for COVID-19. It was a false positive. False positive tests had happened 3-10 days after the shot.  No treatment medications were reported.   This case was linked to MOD-2022-676669 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 09Feb2021 as dose 2, single (Lot number: EL8982), in left arm, on 15Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: 33036BD), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic myeloid leukaemia" (unspecified if ongoing); "Known allergies: Gadalinium" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; VIT D [VITAMIN D NOS]; METOPROLOL; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Nov2022) Negative; (Nov2022) Negative; (Nov2022) Negative; (Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as DOSE 5 (BOOSTER), SINGLE (lot number: GH9694) at the age of 79 years, administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 13Apr2022 as DOSE 4 (BOOSTER), SINGLE (lot number: FJ4989), administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (batch/lot number: unknown), as DOSE 2, SINGLE (batch/lot number: unknown) and as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "triple bypass 3 years ago" (unspecified if ongoing). Patient had no known allergy. Concomitant medications included: ATORVASTATIN; ASPIRIN 81; LOSARTAN POTASSIUM; METOPROLOL; TAMSULOSIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GJ6739) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 at 09:00 as dose 1, single (Lot number: EL3246), on 03Feb2021 at 09:00 as dose 2, single (Lot number: EL9265), in left arm and on 21Jan2022 at 15:00 as dose 3 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "allergic to contrast dye when getting MRI" (unspecified if ongoing). There were no concomitant medications. The patient started feeling ill on Saturday, 05Nov2020. She had chills, sore throat, body aches, fatigue, and fever of 102.3 (fever was normal when taking Tylenol) then tested positive for Covid-19 on Monday, 07Nov2022. The patient took Paxlovid that evening. She took every dose as prescribed and tested negative on Friday, 11Nov2022. The patient took the last dose of Paxlovid on Saturday, 12Nov2022 and got a new sore throat, runny nose, congestion, fatigue on Saturday, 18Nov2022. The patient tested positive for Covid again on Monday, 21Nov2022. Outcome of the events was unknown.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 , BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), o the Vaccination failure and covid 19 cannot be ruled out.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Seizure, Somnolence, Upper limb fracture
Clinical narrative: Later on I felt sleepy went to bed; Woke up having seizures; it felt like my arm was broken; Flu vaccine given on 16Nov2022; Flu vaccine given on 16Nov2022; received bivalent vaccine as dose 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 10:30 as dose 2, single (Lot number: Gh9703) at the age of 57 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 16Nov2022 at 10:30 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Several Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01; Manufacturer unknown, Lot number: unknown), for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  The following information was reported: SOMNOLENCE (hospitalization) with onset Nov2022, outcome "recovered" (21Nov2022), described as "Later on I felt sleepy went to bed"; SEIZURE (hospitalization) with onset Nov2022, outcome "recovered" (21Nov2022), described as "Woke up having seizures"; UPPER LIMB FRACTURE (hospitalization) with onset Nov2022, outcome "recovered" (21Nov2022), described as "it felt like my arm was broken"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 16Nov2022 at 10:30, outcome "unknown" and all described as "Flu vaccine given on 16Nov2022"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 16Nov2022 at 10:30, outcome "unknown", described as "received bivalent vaccine as dose 2". The events "later on i felt sleepy went to bed", "woke up having seizures" and "it felt like my arm was broken" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of somnolence, seizure, upper limb fracture. Clinical course: Patient stated that he took both his covid and flu shot. Later on, he felt sleepy went to bed. Woke up having seizures and it felt like his arm was broken. Called ambulance and went to the hospital. They were so severe he did not know what happened in the hospital. Only being kicked out and told to go home while he was still having seizures. But they are over now 21Nov2022. Onset date and time of events were also reported as 16Nov2022 10:30 (possible discrepant; pending clarification)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Later on I felt sleepy went to bed; Woke up having seizures; it felt like my arm was broken; Flu vaccine given on 16Nov2022; Flu vaccine given on 16Nov2022; received bivalent vaccine as dose 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 10:30 as dose 2, single (Lot number: Gh9703) at the age of 57 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 16Nov2022 at 10:30 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Several Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01; Manufacturer unknown, Lot number: unknown), for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  The following information was reported: SOMNOLENCE (hospitalization) with onset Nov2022, outcome "recovered" (21Nov2022), described as "Later on I felt sleepy went to bed"; SEIZURE (hospitalization) with onset Nov2022, outcome "recovered" (21Nov2022), described as "Woke up having seizures"; UPPER LIMB FRACTURE (hospitalization) with onset Nov2022, outcome "recovered" (21Nov2022), described as "it felt like my arm was broken"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 16Nov2022 at 10:30, outcome "unknown" and all described as "Flu vaccine given on 16Nov2022"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 16Nov2022 at 10:30, outcome "unknown", described as "received bivalent vaccine as dose 2". The events "later on i felt sleepy went to bed", "woke up having seizures" and "it felt like my arm was broken" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of somnolence, seizure, upper limb fracture. Clinical course: Patient stated that he took both his covid and flu shot. Later on, he felt sleepy went to bed. Woke up having seizures and it felt like his arm was broken. Called ambulance and went to the hospital. They were so severe he did not know what happened in the hospital. Only being kicked out and told to go home while he was still having seizures. But they are over now 21Nov2022. Onset date and time of events were also reported as 16Nov2022 10:30 (possible discrepant; pending clarification)
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm with vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore arm with vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318614 same product, different patient/event;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait inability, Investigation
Clinical narrative: After the initial vaccination she could not walk; She had extreme inflammation/she blew up from the knee down to her ankles.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Lot number: EW0196) at the age of 68 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: GAIT INABILITY (non-serious) with onset Jun2021, outcome "recovered" (2021), described as "After the initial vaccination she could not walk"; ARTHRITIS (non-serious) with onset Jun2021, outcome "recovered", described as "She had extreme inflammation/she blew up from the knee down to her ankles.". The events "after the initial vaccination she could not walk" and "she had extreme inflammation/she blew up from the knee down to her ankles." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that before getting the vaccine she was healthy with no issues and took no medicines at all. The patient received the first injection in right upper arm, exact time unknown; sometime in early afternoon. After the initial vaccination she could not walk. She had extreme inflammation. This occurred within two weeks of getting the first injection. The event extreme inflammation as clarified, she mentioned she blew up from the knee down to her ankles. Confirmed she no longer had it. It went away when she got covid. It eliminated the inflammation. Attempted to clarify if she recovered completely or with lasting effects, and stated she overcame it. The event could not walk confirmed no longer had this issue, it improved a year ago. The patient had testing done to determine why she was having inflammation. However, reporter did not know any dates or additional information to provide. Stated that was in the hospital computer and not something she would have. There were no prior vaccinations (within 4 weeks). She had several doctors. She was seeing one in a state and had one in a state. There were a few, but had no additional details to provide.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318002 same patient/drug, different dose/event;US-PFIZER INC-202201318929 same patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she has 19 friends who lost their life because of the vaccine; This spontaneous report from a non-contactable reporter(s) (Consumer or other non HCP) Program ID reporting same event under the same suspect product for 19 patients. This is one of 19 reports.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "she has 19 friends who lost their life because of the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200107580 Same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: she has 19 friends who lost their life because of the vaccine
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Asplenia" (unspecified if ongoing), notes: other medical history: Asplenia; "Depression" (unspecified if ongoing), notes: other medical history: Depression; "Left Nephrectomy" (unspecified if ongoing), notes: other medical history: Left Nephrectomy; "known allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "Known allergies: Adhesive tape" (unspecified if ongoing), notes: known allergies: Adhesive tape. Concomitant medication(s) included: NEURONTIN; CYMBALTA; WELLBUTRIN; PRAZOSIN; TRAZODONE. Past drug history included: Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex; Clindamycin, reaction(s): "known allergies: Clindamycin", notes: known allergies: Clindamycin; Oxycodone, reaction(s): "known allergies: Oxycodone", notes: known allergies: Oxycodone; Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was received other medication in 2 weeks. Patient received Treatment of COVID-19 as Paxlovid from 18Nov2022 (lot number: 2692438).; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for covid initially on 10Nov; Tested positive for covid initially on 10Nov; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 22May2021 at 08:00 as dose 1, single (Lot number: EW00183), in left arm and on 12Jun2021 at 08:00 as dose 2, single (Lot number: EW0186) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "known allergies: Seasonal" (unspecified if ongoing), notes: known allergies: Seasonal; "Know allergies: Oysters" (unspecified if ongoing), notes: Know allergies: Oysters; "Moderate persistent asthma" (unspecified if ongoing), notes: Other medical history: Moderate persistent asthma; "Obesity" (unspecified if ongoing); "Hypertriglyceridemia" (unspecified if ongoing); "migraine" (unspecified if ongoing); "varicose veins" (unspecified if ongoing); "strabismic amblyopia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "HLD" (unspecified if ongoing), notes: Other medical history: HLD. Concomitant medication(s) included: ALYACEN; FENOFIBRATE; OMEPRAZOLE; VITAMIN D NOS. Past drug history included: Erythromycin, reaction(s): "Know allergies: Erythromycin", notes: Know allergies: Erythromycin; Tetracycline, reaction(s): "Know allergies: Tetracycline", notes: Know allergies: Tetracycline; Bactrim, reaction(s): "Know allergies: Bactrim", notes: Know allergies: Bactrim; Wellbutrin, reaction(s): "Know allergies: Wellbutrin", notes: Know allergies: Wellbutrin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Nov2022, outcome "not recovered" and all described as "Tested positive for covid initially on 10Nov". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Nov2022) Positive, notes: Tested positive for covid initially on 10Nov; (18Nov2022) Negative, notes: Tested negative on 18Nov; (22Nov2022) Positive, notes: Tested positive again on 22Nov. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; 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.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Mar2021 as dose 1, single (Lot number: 001B21A), in left arm, on 18Apr2021 as dose 2, single (Lot number: 041B21A), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 037C21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION HCL. Past drug history included: Augmentin, reaction(s): "Drug allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09May2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: potential allergic reaction to bivalent Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "no reaction"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "no reaction"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 33130BA.), administration date: Dec2021, for COVID-19 Immunization, reaction(s): "no reaction". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "potential allergic reaction to bivalent Pfizer booster".  Additional information: It was reported that patient took three Pfizer shots before with no issue. Through some research, it was found that tromethamine replaced PBS as the buffer in the Pfizer formulation sometime around Oct2021. Tromethamine was approved in Oct2021 and she received her third shot in Dec2021.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder discomfort, Burning sensation
Clinical narrative: I felt as if my bladder was hit by a truck plus burning; I felt as if my bladder was hit by a truck plus burning; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), BLADDER DISCOMFORT (non-serious) all with onset 16Nov2021, outcome "not recovered" and all described as "I felt as if my bladder was hit by a truck plus burning". The event "i felt as if my bladder was hit by a truck plus burning" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of burning sensation, bladder discomfort.  Additional information: The patient did not have any other vaccine in four weeks. The patient did not have Covid prior to vaccination. Within 24 hours of receiving first vaccine, she felt as if her bladder was hit by a truck plus burning. She saw her doctor and long story short she attributed this incident to the vaccine, being that there was no infection present.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: I also felt dizziness in June 2021 without any noticeable reasons; 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 male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: ER8727) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 66-year-old, for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset Jun2021, 1 day after the suspect product(s) administration, outcome "unknown", described as "I also felt dizziness in June 2021 without any noticeable reasons". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient also felt dizziness in Jun2021 without any noticeable reasons. Patient believe this was the start-up of Pfizer vaccine side effects.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Every time, it itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Every time, it itches".  Additional information: Caller had no dates or Lot numbers available for any of her previous doses of the COVID vaccines. Caller did not recall how many COVID vaccines she had over time. Mentioned that every time, it itches. Caller mentioned having her second dose of the COVID vaccine, she thought, on 06Jul2021. Caller denied any concomitant medications, medical conditions relevant to report, any lab testing or treatments to report. The patient's other condition and investigations were reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201322830 same reporter/patient/event, different drug dose;US-PFIZER INC-202201322508 same reporter/patient, different drug dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Illness
Clinical narrative: Sickness; He had joint pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004151.  A male patient received BNT162b2 (BNT162B2), as dose 3 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Joint pain". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sickness"; ARTHRALGIA (non-serious), outcome "not recovered", described as "He had joint pains".  Additional information: It was reported the patient experienced six months of joint pain after the second dose. He experienced adverse reactions again after the Pfizer booster dose. He had joint pains, sickness and it reportedly lasted for a long time. At the time of reporting, the patient still had those joint pains.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200109361 Same patient/drug, different AE, different dose of vaccine;
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing), notes: Patient had it for about a year or two. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose), administration date: 08Feb2022, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: DEATH (death) with onset 24Apr2022, outcome "fatal". The patient date of death was 24Apr2022. The reported cause of death was unknown. No autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201322762 Same reporter/ drug/ AE, different patients;; Reported Cause(s) of Death: Death
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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 Unknown Manufacturer), for COVID-19 immunization. The following information was reported: DEATH (death), outcome "fatal". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201322761 Same reporter/ drug/ AE, different patients;; Reported Cause(s) of Death: Unknown cause of death
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Every time, it itches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 06Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE.), for Covid-19 Immunisation, reaction(s): "every time, it itches". The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Every time, it itches". Additional information: Other Conditions, Investigations and other product was No. States she is using an unspecified itch cream. Reporter has no dates or Lot Numbers available for any of her previous doses of the COVID Vaccines. Reporter does not recall how many COVID Vaccines she has had over time. Mentions that every time, it itches. Caller mentions having her second dose of the COVID Vaccine, she thinks, on 06Jul2021. Reporter denies any concomitant medications. Reporter then states that she had some unspecified pill the doctor gave her and then said it is bad for the caller's brain. No further information provided related to this unspecified pill. Reporter denies any medical conditions relevant to report. History and Investigations, Reporter denies any labs, testing, or treatments to report relevant to these events.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201322724 same reporter/patient/event, diffrent drug dose;US-PFIZER INC-202201322508 same reporter/patient, diffrent drug dose/event.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna Vaccine dose 5, BNT162B2 dose 1,2,3,4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 75 years, on 20Oct2021 as dose 3 (booster), single (Lot number: 30155BA), on 09Feb2021 as dose 2, single (Lot number: EL3247), on 19Jan2021 as dose 1, single (Lot number: EK9231) and (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Sep2022 at 15:45 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; vitamin d3 (VITAMIN D3), since Jan2000 (Batch/Lot number: unknown). The patient's relevant medical history included: "mild emphysema" (unspecified if ongoing), notes: mild emphysema; "mild glaucoma" (unspecified if ongoing), notes: mild glaucoma; "osteopenia" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Sep2022, outcome "unknown", described as "Moderna Vaccine dose 5, BNT162B2 dose 1,2,3,4"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient stated that Rebound, I guess and had felt great after 5 days of Paxlovid. Felt a little worse 2 days later, did home antigen test, was positive. She also Continued to feel worse each day for several more days. Today it has been a week since finishing Paxlovid and finally I'm starting to feel better, though I'm still testing positive on home antigen tests.It's been all the typical COVID symptoms, enough to make me want to stay home and sleep a lot but not serious enough to seek medical care.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she has 19 friends who lost their life because of the vaccine; This spontaneous report from a non-contactable reporter(s) (Consumer or other non HCP) Program ID: (Unknown) reporting same event under the same suspect product for 19 patients. This is one of 19 reports.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "she has 19 friends who lost their life because of the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200107580 Same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: she has 19 friends who lost their life because of the vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she has 19 friends who lost their life because of the vaccine; This spontaneous report from a non-contactable reporter(s) (Consumer or other non HCP) Program ID: (Unknown) reporting same event under the same suspect product for 19 patients. This is one of 19 reports.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "she has 19 friends who lost their life because of the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201319230 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325359 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325360 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325361 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325362 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325363 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325364 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325365 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325366 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325367 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325368 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325369 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325370 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325371 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325372 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325373 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325374 Same reporter/vaccine/event, different patients;US-PFIZER INC-202201325375 Same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: she has 19 friends who lost their life because of the vaccine