chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bipolar I disorder, Chronic obstructive pulmonary disease, Cough
Clinical narrative: Does have a mental illness problem, bipolar manic depression.; COPD; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-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: Bnt162b2 (Dose 1, Every COVID-19 vaccine she ever got caused her to cough but she has COPD.), for COVID-19 Immunization, reaction(s): "COPD", "Cough". The following information was reported: BIPOLAR I DISORDER (medically significant), outcome "unknown", described as "Does have a mental illness problem, bipolar manic depression."; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "recovered", described as "COPD"; COUGH (non-serious), outcome "recovered".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Pain at the injection site & tiredness; Pain at the injection site & tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GH9694) at the age of 34 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: VACCINATION SITE PAIN (non-serious), FATIGUE (non-serious) all with onset 22Sep2022, outcome "recovering" and all described as "Pain at the injection site & tiredness". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional Information: It was also reported as Dose 1, administration time 06:15PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Dizziness, Headache, Hypotension
Clinical narrative: Hypotension; light-headedness; mild headache; unsteadiness; dose number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "CKD" (unspecified if ongoing); "OA" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 29Aug2022 as dose number unknown, single; LIPITOR; BENICAR; SYNTHROID; GLUCOPHAGE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL1283, Anatomical Location : Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: EL9265, Anatomical Location : Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FC3184, Anatomical Location : Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot Number: FP4554, Anatomical Location : Left Arm), for Covid-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 22Sep2022 at 09:30, outcome "unknown", described as "dose number: 5"; HYPOTENSION (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered"; DIZZINESS (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered", described as "light-headedness"; HEADACHE (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered", described as "mild headache"; BALANCE DISORDER (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered", described as "unsteadiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypotension, dizziness, headache, balance disorder.  Additional information: The patient had no known allergies. Prior to vaccination, the patient had not have COVID. Post vaccination, the patient had not been tested for COVID.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Hypotension; light-headedness; mild headache; unsteadiness; dose number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "CKD" (unspecified if ongoing); "OA" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 29Aug2022 as dose number unknown, single; LIPITOR; BENICAR; SYNTHROID; GLUCOPHAGE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL1283, Anatomical Location : Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: EL9265, Anatomical Location : Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FC3184, Anatomical Location : Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot Number: FP4554, Anatomical Location : Left Arm), for Covid-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 22Sep2022 at 09:30, outcome "unknown", described as "dose number: 5"; HYPOTENSION (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered"; DIZZINESS (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered", described as "light-headedness"; HEADACHE (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered", described as "mild headache"; BALANCE DISORDER (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered", described as "unsteadiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypotension, dizziness, headache, balance disorder.  Additional information: The patient had no known allergies. Prior to vaccination, the patient had not have COVID. Post vaccination, the patient had not been tested for COVID.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose 3 (booster), single (Lot number: 301358) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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. Clinical course: There was no other medication in 2weeks. Antiviral details: Product: Paxlovid, Treatment start date: 10Sep2022, stop date: 14Sep2022, Indication: Treatment of COVID-19. Rebound 5 days after finishing paxlovid course. Adverse event start date: 18Sep2022. If patient recovered: Recovering. If treatment ae: No. Known allergies: No.
Age: 48.0
Sex: F
Vaccine: 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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 48 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Mar2021 as dose 1, single (Lot number: 038A21A), on 11Apr2021 as dose 2, single (Lot number: 036B21A) and on 22Sep2021 as dose 3 (booster), single (Lot number: 939902) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: 01Jun2016; SULFASALAZINE, start date: 01Nov2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 49.0
Sex: F
Vaccine: 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 a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that she received other medications in 2 weeks. Known allergies reported as yes. She started antiviral treatment for COVID-19 on 12Sep2022 and stopped on 16Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Age: 53.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Aug2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Arthritis/ pre diabetic/ obesity; "Pre diabetic" (unspecified if ongoing), notes: Arthritis/ pre diabetic/ obesity; "Obesity" (unspecified if ongoing), notes: Arthritis/ pre diabetic/ obesity. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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) Positive, notes: Treatment of COVID-19; (21Sep2022) Positive, notes: Covid symptoms with positive home test returned on 21Sep2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Prescribed Paxlovid as a treatment to a patient from 13Sep2022 to 18Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Positron emission tomogram, Recall phenomenon
Clinical narrative: radiation recall phenomenon; Flared up after vaccination; This is a literature report.  A 67-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing); "edema of the laryngeal mucosa" (unspecified if ongoing); "radiation therapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ramucirumab, reaction(s): "induced RRP", notes: flared up after vaccination. Vaccination history included: Covid-19 vaccine (Unknown manufacture, DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: RECALL PHENOMENON (medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "radiation recall phenomenon"; CONDITION AGGRAVATED (medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "Flared up after vaccination". The patient underwent the following laboratory tests and procedures: Positron emission tomogram: Unknown result.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events RECALL PHENOMENON , CONDITION AGGRAVATED  and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac operation, Dyspnoea, Pain, Pericarditis, Pleural effusion
Clinical narrative: Pericarditis; Heart surgery; Experienced shortness of breath which turned out to be fluid around the lining of her heart/I was almost died and it was hard for me to breath; Experienced shortness of breath which turned out to be fluid around the lining of her heart/fluid around her heart which was pericarditis and did have heart surgery; I did get extreme pain and fever; I did get extreme pain and fever; 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 10Apr2022 as dose 3 (booster), single (Lot number: 33025BD) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension. Vaccination history included: pfizer coviD-19 vaccine (Dose: 02, Lot no.: ER8733), administration date: 29Mar2021, when the patient was 64-year-old, for COVID-19 immunization; pfizer coviD-19 vaccine (Dose: 01, Lot no.: EN6205), administration date: 04Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown"; CARDIAC OPERATION (medically significant), outcome "unknown", described as "Heart surgery"; DYSPNOEA (non-serious), outcome "unknown", described as "Experienced shortness of breath which turned out to be fluid around the lining of her heart/I was almost died and it was hard for me to breath"; PLEURAL EFFUSION (non-serious), outcome "unknown", described as "Experienced shortness of breath which turned out to be fluid around the lining of her heart/fluid around her heart which was pericarditis and did have heart surgery"; PYREXIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "I did get extreme pain and fever". The events "pericarditis", "experienced shortness of breath which turned out to be fluid around the lining of her heart/i was almost died and it was hard for me to breath" and "experienced shortness of breath which turned out to be fluid around the lining of her heart/fluid around her heart which was pericarditis and did have heart surgery" required emergency room visit. Therapeutic measures were taken as a result of pericarditis, cardiac operation, dyspnoea.  Clinical course: The patient reported that when she took the vaccine she did get extreme pain and fever and then after some time she felt shortness of breath, and pericarditis. She do not know what was wrong with her when she was having shortness of breath she went to the hospital and they keep telling her they do not know. They gave her asthma medicine and then she went to emergency in the month of January. She was almost died and then they did test and said there was fluid in her heart that was pericarditis. She did not know what was wrong. What she knew she was having shortness of breath and it was hard for her to breath.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pericarditis; Heart surgery; Experienced shortness of breath which turned out to be fluid around the lining of her heart/I was almost died and it was hard for me to breath; Experienced shortness of breath which turned out to be fluid around the lining of her heart/fluid around her heart which was pericarditis and did have heart surgery; I did get extreme pain and fever; I did get extreme pain and fever; 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 10Apr2022 as dose 3 (booster), single (Lot number: 33025BD) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension. Vaccination history included: pfizer coviD-19 vaccine (Dose: 02, Lot no.: ER8733), administration date: 29Mar2021, when the patient was 64-year-old, for COVID-19 immunization; pfizer coviD-19 vaccine (Dose: 01, Lot no.: EN6205), administration date: 04Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown"; CARDIAC OPERATION (medically significant), outcome "unknown", described as "Heart surgery"; DYSPNOEA (non-serious), outcome "unknown", described as "Experienced shortness of breath which turned out to be fluid around the lining of her heart/I was almost died and it was hard for me to breath"; PLEURAL EFFUSION (non-serious), outcome "unknown", described as "Experienced shortness of breath which turned out to be fluid around the lining of her heart/fluid around her heart which was pericarditis and did have heart surgery"; PYREXIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "I did get extreme pain and fever". The events "pericarditis", "experienced shortness of breath which turned out to be fluid around the lining of her heart/i was almost died and it was hard for me to breath" and "experienced shortness of breath which turned out to be fluid around the lining of her heart/fluid around her heart which was pericarditis and did have heart surgery" required emergency room visit. Therapeutic measures were taken as a result of pericarditis, cardiac operation, dyspnoea.  Clinical course: The patient reported that when she took the vaccine she did get extreme pain and fever and then after some time she felt shortness of breath, and pericarditis. She do not know what was wrong with her when she was having shortness of breath she went to the hospital and they keep telling her they do not know. They gave her asthma medicine and then she went to emergency in the month of January. She was almost died and then they did test and said there was fluid in her heart that was pericarditis. She did not know what was wrong. What she knew she was having shortness of breath and it was hard for her to breath.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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), on 12Mar2020 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Treatment with Paxloid from 18Sep2022 to 22Sep2022.  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: Fatigue, Lymphadenopathy, Myalgia, Nasal congestion
Clinical narrative: Swollen lymph nodes under left arm; generalized muscle aches; nasal congestion; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 11:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing), notes: Diabetes Type 2. Concomitant medication(s) included: METFORMIN; VICTOZA. Past drug history included: Tramadol, reaction(s): "known allergies: Tramadol"; Nexium, reaction(s): "known allergies: Nexium". Vaccination history included: Covid-19 vaccine (Dose Number: 01, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 02, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 03, MANUFACTURER: UNKNOWN), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Sep2022 at 22:15, outcome "not recovered", described as "Swollen lymph nodes under left arm"; FATIGUE (non-serious) with onset 23Sep2022 at 22:15, outcome "not recovered"; MYALGIA (non-serious) with onset 23Sep2022 at 22:15, outcome "not recovered", described as "generalized muscle aches"; NASAL CONGESTION (non-serious) with onset 23Sep2022 at 22:15, outcome "not recovered". Therapeutic measures were not taken as a result of lymphadenopathy, myalgia, nasal congestion, fatigue.  Additional information: The patient did not received any other vaccine in four weeks. Other medications in two weeks were Metformin, Victoza. The patient was not tested COVID post vaccination and no COVID prior vaccination.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm within 12 hours, followed by sore muscles in left armpit and left upper side the next 2 days (as if the soreness migrated from left deltoid to armpit to upper side); Sore arm within 12 hours, followed by sore muscles in left armpit and left upper side the next 2 days (as if the soreness migrated from left deltoid to armpit to upper side); This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if COVID prior vaccination: Yes" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EL3247), for COVID-19 Immunization; Bnt162b2 (Dose: 2, Lot: EL3247), for COVID-19 Immunization; Bnt162b2 (Dose: 3, Lot: FF8839), for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset 23Sep2022 at 05:00, outcome "recovering" and all described as "Sore arm within 12 hours, followed by sore muscles in left armpit and left upper side the next 2 days (as if the soreness migrated from left deltoid to armpit to upper side)". Therapeutic measures were not taken as a result of pain in extremity, myalgia.  Additional information: Dose received More than 3. Patient did not had other vaccine in four weeks. Patient did not had other medications in two weeks. Patient had not tested COVID post vaccination. No Known allergies. Other medical history was none. The case reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dyskinesia, Feeling cold, Pain
Clinical narrative: after I received the 2nd booster: Very cold, severe body jerks, sharp pains throughout my body; After I received the 2nd booster: Very cold, severe body jerks, sharp pains throughout my body; After I received the 2nd booster: Very cold, severe body jerks, sharp pains throughout my body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 18:15 as dose 4 (booster), single (Lot number: GJ2524) at the age of 65 years, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), on 22Sep2022 as dose 1, single (Lot number: UJ924AB), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRIAMTERENE HCTZ. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (1st Booster), for COVID-19 Immunization. The following information was reported: DYSKINESIA (non-serious), PAIN (non-serious) all with onset 22Sep2022 at 17:30, outcome "recovering" and all described as "After I received the 2nd booster: Very cold, severe body jerks, sharp pains throughout my body"; FEELING COLD (non-serious) with onset 22Sep2022 at 17:30, outcome "recovering", described as "after I received the 2nd booster: Very cold, severe body jerks, sharp pains throughout my body". Therapeutic measures were not taken as a result of feeling cold, dyskinesia, pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. These effects occurred Thursday, 22Sep2022, at 5:30 pm, the day after patient received the 2nd booster: Very cold, severe body jerks, sharp pains throughout my body.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID-19 Infection; Breakthrough COVID-19 Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), on 12Apr2021 as dose 2, single (Lot number: EP6955), on 12Dec2021 as dose 3 (booster), single (Lot number: 33130BA) and on 28May2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 59 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "High Cholesterol" (unspecified if ongoing); "Pre-Diabetes" (unspecified if ongoing); "Rosacea" (unspecified if ongoing); "tree nut allergy" (unspecified if ongoing), notes: tree nut allergy. Concomitant medication(s) included: LEVOTHYROXINE; ROSUVASTATIN; FARXIGA; ORACEA [DOXYCYCLINE]; OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Sep2022, outcome "recovering" and all described as "Breakthrough COVID-19 Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical course: No other vaccine in four weeks. No covid prior vaccination.  No follow up attempts possible. No further information is required.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: I had fever, oral temp 100; severe body aches; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Lot number: Gh9702) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history included: "Mitral Valve prolapse" (unspecified if ongoing); "Nodular gastritis" (unspecified if ongoing), notes: Nodular gastritis; "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose Number: 2, Batch/Lot No: B2021092934, Manufacturer: Sinopharm), administration date: 18Nov2021, when the patient was 26-year-old, for COVID-19 immunization; coviD-19 vaccine (Dose Number: 1, Batch/Lot No: B2021093198, Manufacturer: Sinopharm), administration date: 21Oct2021, when the patient was 26-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 20Sep2022, outcome "recovered" (Sep2022), described as "I had fever, oral temp 100"; HEADACHE (non-serious) with onset 20Sep2022, outcome "not recovered", described as "headaches"; PAIN (non-serious) with onset 20Sep2022, outcome "not recovered", described as "severe body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, headache. Additional information: There was no known allergies. About 12 hours after receiving the vaccine the patient had fever, oral temp 100, severe Body aches and most notably severe adverse event Body aches and most notably severe Headaches. Fortunately, fever stopped almost 36 hours after vaccination. But unfortunately, the patient was still having headache even though he took vaccine five days. At first the headache was severe but at the moment it was mild to moderate but he still had It.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Blood pressure dropped to 90/65 with a heart rate of 90; Blood pressure dropped to 90/65 with a heart rate of 90; Dose Number: 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 14:00 as dose 1, single (Lot number: Gh9694) at the age of 74 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Bad back" (unspecified if ongoing), notes: Other medical history :  Bad back; "heart murmur" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 24Sep2022 at 14:00, outcome "unknown", described as "Dose Number: 1"; BLOOD PRESSURE DECREASED (non-serious), HEART RATE INCREASED (non-serious) all with onset 25Sep2022 at 08:00, outcome "not recovered" and all described as "Blood pressure dropped to 90/65 with a heart rate of 90". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure decreased, heart rate increased.  Additional information: Blood pressure dropped to 90/65 with a heart rate of 90. My normal blood pressure is about 135/75 with a heart rate of about 63  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Blood pressure dropped to 90/65 with a heart rate of 90; Blood pressure dropped to 90/65 with a heart rate of 90; Dose Number: 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 14:00 as dose 1, single (Lot number: Gh9694) at the age of 74 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Bad back" (unspecified if ongoing), notes: Other medical history :  Bad back; "heart murmur" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 24Sep2022 at 14:00, outcome "unknown", described as "Dose Number: 1"; BLOOD PRESSURE DECREASED (non-serious), HEART RATE INCREASED (non-serious) all with onset 25Sep2022 at 08:00, outcome "not recovered" and all described as "Blood pressure dropped to 90/65 with a heart rate of 90". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure decreased, heart rate increased.  Additional information: Blood pressure dropped to 90/65 with a heart rate of 90. My normal blood pressure is about 135/75 with a heart rate of about 63  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Disease recurrence, Guillain-Barre syndrome
Clinical narrative: Guillen Barre; Guillen Barre; Sep2022 diagnosed with CIDP chronic form of Guillen Barre; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There was no known allergies. Concomitant medication(s) included: OZEMPIC. Vaccination history included: BNT162b2 (Dose 2, single, Batch/Lot No: EL9267, location of injection: Arm Left), administration date: 03Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Guillen Barre"; BNT162b2 (Dose 1, single, Batch/Lot No: EL8982,  location of injection: Arm Left), administration date: 22Jan2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (caused and prolonged hospitalization, disability, life threatening), DISEASE RECURRENCE (caused and prolonged hospitalization, disability, life threatening) all with onset Jun2022, outcome "not recovered" and all described as "Guillen Barre"; CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (caused and prolonged hospitalization, disability, life threatening) with onset 2022, outcome "not recovered", described as "Sep2022 diagnosed with CIDP chronic form of Guillen Barre". The patient was hospitalized and prolonged hospitalization for guillain-barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, disease recurrence (start date: Aug2022). The events "guillen barre" and "sep2022 diagnosed with cidp chronic form of guillen barre" required emergency room visit.  Therapeutic measures were taken as a result of guillain-barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, disease recurrence. The patient was hospitalized for Guillen Barre in Aug2022, and was hospitalized again for Guillen Barre in Sep2022 diagnosed with CIDP (Chronic inflammatory demyelinating polyneuropathy) form of Guillen Barre. It was also reported vaccine received during existing hospitalization. The patient received treatment intravenous immunoglobulin for the events.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: High fever; pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 4-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2022 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 4 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 23Sep2022 at 10:00, outcome "not recovered", described as "High fever"; PAIN (non-serious) with onset 23Sep2022 at 10:00, outcome "not recovered", described as "pains". The events "high fever" and "pains" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain.  Addition information: Other vaccine in four weeks was none. Covid prior vaccination was yes and Covid tested post vaccination was none. Known allergy was none. Other medical history was none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 22Sep2022, outcome "recovering", described as "Body aches"; COUGH (non-serious) with onset 22Sep2022, outcome "recovering"; PYREXIA (non-serious) with onset 22Sep2022, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 22Sep2022, outcome "recovering". Therapeutic measures were taken as a result of pyrexia, pain, headache, cough. Additional Information: It was reported that the case was Non-Serious. Anti viral details: product COVID-19 Treatment. Case narrative: She took the booster on 22Sep2022, she has been experiencing fever, body aches, headache and a cough. Adverse events start date was 22Sep2022 12:00 AM. Outcome of the events was Recovering. AE treatment Took Advil as advised by pharmacy. No known allergies. other medical history was None. 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.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sore and achy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient 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: PAIN (non-serious), outcome "unknown", described as "Sore and achy".  Additional Context: Consumer refused to provide any information would like to know the inactive ingredients of the bivalent vaccine mentioned that she had the J&J for her primary series and booster dose for the second booster dose she got the Pfizer vaccine. She has lymph node problems from the vaccine. Had high dose flu shot yesterday. Not a very healthy person. Has migraines and fibromyalgia as well. While providing information about herself, caller provided the following details: Nephew was sore and achy after getting the Pfizer COVID-19 vaccine, but so be it if its better than getting the illness. She had so much information stolen in the past and she doesn't want to give out any information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: 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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: En6207), in left arm and on 03May2021 as dose 2, single (Lot number: Ew0171) at the age of 35 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Nov2021 as dose 3 (booster), single (Lot number: 071F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Alopecia Areata" (unspecified if ongoing); "Androgenic Alopecia" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 15Jul2019, stop date: 24Sep2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. The patient used Paxlovid from 16Sep2022 to 21Sep2022 for anti viral (Treatment of COVID-19).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 65 years, in right arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breast cancer survivor" (unspecified if ongoing), notes: breast cancer survivor; "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "interstitial cystitis" (unspecified if ongoing), notes: interstitial cystitis; "acid reflux" (unspecified if ongoing), notes: acid reflux; "sulphas" (unspecified if ongoing), notes: sulphas, seasonal allergies; "seasonal allergies" (unspecified if ongoing), notes: sulphas, seasonal allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2022) Negative; (24Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The reported COVID-19 positive after BNT162b2 COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: 6M9810), in left arm, on 05Mar2021 as dose 2, single (Lot number: EN6502), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "stroke" (unspecified if ongoing); "pneumothorax" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative twice 48 hours apart; (unspecified date) Negative, notes: tested negative twice 48 hours apart; (Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Rebound of COVID-19 symptoms and testing positive again, after symptoms went away and tested negative twice, 48 hours apart. Known allergies was no.