chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19-2
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) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: Gj53uz) at the age of 54 years, in left 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), 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: "Other medication in 2weeks product: Anti depressant" (unspecified if ongoing), notes: Other medication in 2weeks product: Anti depressant. Concomitant medication(s) included: DULOXETINE; ADDERALL; TAMSULOSIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" (Dec2022) 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: The patient had no Known allergies and Other medical history. The patient received other medications included Anti depressant, Duloxetine, Adderal and Tamsulosin within 2 weeks of vaccination. The patient received Paxlovid as treatment of COVID-19 from 30Nov2022 to 04Dec2022.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID: (054550). The reporter is the patient.  A 52-year-old female 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: MIGRAINE (non-serious), outcome "not recovered", described as "migraines".  Additional information: It was reported that the patient had migraines that started after a covid-19 vaccine dose. She didn't specify how long she had migraines. The adverse event was non-serious and the reporter considered the event was not caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE(medically significant), COVID-19 (medically significant), outcome "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, notes: Testing positive since on now 15 day from original; (02Dec2022) Negative, notes: On 6th day, 2 antigen tests both negative; (02Dec2022) Negative, notes: On 6th day, 2 antigen tests both negative; (06Dec2022) Positive, notes: tested positive on the 10th day after initial test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years 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 included: "Type 1 D" (unspecified if ongoing), notes: Type 1 D. Concomitant medication(s) included: STATIN [NYSTATIN], stop date: 11Dec2022. Past drug history included: Ceclore, reaction(s): "Known allergies: ceclore"; Penicillin, reaction(s): "Known allergies: Penicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medications in two weeks. Paxlovid started on 11Dec2022 for Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: Soreness in arm/Tender, can lift but if touches and pushes then arm still hurts; Dose 1, Dose 2 comirnaty and Dose 3 JANSSEN; 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 received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 30Aug2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 30Sep2021, when the patient was 52-year-old, for COVID-19 immunization; coviD-19 vaccine janssen (DOSE 3 (BOOSTER), SINGLE), administration date: 14Mar2022, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10Dec2022, outcome "unknown", described as "Dose 1, Dose 2 comirnaty and Dose 3 JANSSEN"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2022, outcome "not recovered", described as "Soreness in arm/Tender, can lift but if touches and pushes then arm still hurts".  Additional Information: The patient had booster shot on saturday evening and had soreness in arm. Right after the vaccination,, the patient experienced the events. Patient had first dose got in the states, then went back to a country, not sure at time of call which doses caller got where for the prior doses.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201372568 same reporter/drug, different patient/event;
Age: 36.0
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 non-contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: ER8730) and in Nov2021 as dose 2, single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history: Depression. Concomitant medication(s) included: WELLBUTRIN XL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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: Paxlovid.  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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, SARS-CoV-2 test
Clinical narrative: Spongiotic Dermatitis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: EP6955) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6199; Location of injection: Arm Right), administration date: 02Mar2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: ECZEMA (non-serious) with onset 01Apr2021, outcome "recovering", described as "Spongiotic Dermatitis". The event "spongiotic dermatitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  Additional information: Patient also received dose 3 (lit number: 33030BD) on 02Dec2021 in right arm.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). There were no 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: (unspecified date) Positive; (11Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No Known allergies, No other medication received in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Sore arm; lump in lymph node under arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: FE3590), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years, ago,; "SVT" (unspecified if ongoing); "mastectomy" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years, ago,. Concomitant medication(s) included: LETROZOLE; ATORVASTATIN; METOPROLOL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9269; Anatomical location: Arm Right), administration date: 13Feb2021, for COVID-19 Immunization, reaction(s): "Sore arm", "lump in lymph node under arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6204; Anatomical location: Arm Right), administration date: 06Mar2021, for COVID-19 Immunization, reaction(s): "Sore arm", "lump in lymph node under arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lump in lymph node under arm". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: Adverse events lasted a couple days. AEs did not result in physician office visit or Emergency room visit. The patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201373781 Same Reporter/Patient AE; Different Vaccine Dose;US-PFIZER INC-202201373782 Same Reporter/Patient AE; Different Vaccine Dose;
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Sore arm; lump in lymph node under arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 13:15 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "mastectomy", start date: 2015, stop date: 2015, notes: Breast cancer resulting in mastectomy 7 years ago; "SVT" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE; ATORVASTATIN; METOPROLOL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot No: EL9269; Anatomical location: Arm Right), administration date: 13Feb2021, for COVID-19 immunization, reaction(s): "Sore arm", "lump in lymph node under arm"; BNT162b2 (DOSE 2, SINGLE; Lot No: EN6204; Anatomical location: Arm Right), administration date: 06Mar2021, for COVID-19 immunization, reaction(s): "Sore arm", "lump in lymph node under arm"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot No: FE3590; Anatomical location: Arm Right), administration date: 09Oct2021, for COVID-19 immunization, reaction(s): "Sore arm", "lump in lymph node under arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lump in lymph node under arm". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: Adverse events lasted for a couple of days. The patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201373782 Same Reporter/Patient, Different AE/Vaccine Dose;US-PFIZER INC-202201373767 Same Reporter/Patient AE; Different Vaccine Dose;
Age: 35.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left 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), 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); "bronchitis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: carrots" (unspecified if ongoing), notes: Known allergies: carrots; "Known allergies: soy" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE]. 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, notes: Testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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 included: "Thyroid cancer" (unspecified if ongoing). Concomitant medication(s) included: CYTOMEL, start date: 09Mar2010, stop date: 14Dec2022; SYNTHYROID, start date: 09Mar2010, stop date: 14Dec2022; CYMBALTA, start date: 09Mar2010, stop date: 14Dec2022; BUSPAR, start date: 09Mar2010, stop date: 14Dec2022; KLONOPIN, start date: 09Mar2010, stop date: 14Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies noted as no. Patient received vaccine. Paxlovid was noted as COVID 19 treatment. Treatment start date was noted as 04Dec2022 and treatment stop date was noted as 11Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller states she is fully vaccinated against Covid-19 and received the first two doses of Pfizer's Covid-19 vaccine, but now she has Covid-19; Caller states she is fully vaccinated against Covid-19 and received the first two doses of Pfizer's Covid-19 vaccine, but now she has Covid-19; 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 female patient received BNT162b2 (BNT162B2), 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 included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller states she is fully vaccinated against Covid-19 and received the first two doses of Pfizer's Covid-19 vaccine, but now she has Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Caller stated she was fully vaccinated against Covid-19 and received the first two doses of Pfizer's Covid-19 vaccine, but now she had Covid-19 and had been prescribed Paxlovid. Caller stated she was breastfeeding and also took nifedipine for high blood pressure. Caller asking if Paxlovid interacts with nifedipine. Caller denied having started taking Paxlovid. Caller asking if she can take Paxlovid while breastfeeding.  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-202201374878 mother/baby case;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of right arm after each injection 1-4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 at 11:00 as dose 1, single (Lot number: EN6199) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HUMIRA taken for colitis, start date: Nov2020 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Soreness of right arm after each injection 1-4".  Additional information: Humira was Started about 2 years ago this last November. Dosage text: 40mg/0.4ml Injection twice monthly, every 2 weeks given in leg. Other Conditions were reported as no. They did not want Moderna, so all of them were Pfizer. Vaccination Facility Type was 1st two were at a site that the (facility withheld) set up. Prior Vaccinations (within 4 weeks) was none. Family Medical History Relevant to Adverse Events (AEs) were none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369165 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neoplasm malignant
Clinical narrative: her lymph nodes swelled in her arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "her lymph nodes swelled in her arm pit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient wants to report about her son's Pfizer Covid-19 Vaccine second dose. She wanted to report what happened to her son. Her son received a heart transplant after his second dose. He was healthy 24-year-old. It happened on 16May2022. While reporting on her son, the caller mentioned that she has cancer. She stated that she also had the same Pfizer Covid-19 Vaccine. Her cancer was diagnosed after her Pfizer doses, and she believes that the vaccine showed them that she had cancer. She thinks the vaccine sped up her cancer. After her first vaccination, her lymph nodes swelled in her arm pit. She did not want to get a second dose but was getting a new job and did not want to lie on the application, so she got fully vaccinated. She was diagnosed with a very aggressive breast cancer in Sep2022.  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-202201372253 Same product, patient, different AEs, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: His grandma got one and two weeks later had the onset of dementia.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: DEMENTIA (medically significant), outcome "unknown", described as "His grandma got one and two weeks later had the onset of dementia".  Clinical course: The PRIVATE owns Moderna. His grandparents know they messed up in getting the vaccines. They know they messed up. His grandma got one and two weeks later had the onset of dementia. It doesn't matter to file an adverse event report. His grandfather had one on VAERS, vetted and called the (hospital name withheld) and (hospital name withheld) doctor and not attributed to the (hospital name withheld), so it was reviewed and deemed not attributed to the vaccine so it was removed. He has the screen shots of the before and after. He knows others who have had their VAERS reports deleted.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity
Clinical narrative: I have I inflammation and pain in that arm; I have I inflammation and pain in that arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2022 as dose 3 (booster), single (Lot number: FJ1614) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine brand: Pfizer/BioNTech, Vaccine administration date: 20Apr2021, Vaccine lot number: EW0170, Vaccine dose number: 1, Vaccine location: Left arm), administration date: 20Apr2021, when the patient was 44-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Treatment start date: 12May2021, Lot number: EW0167), administration date: 12May2021, when the patient was 44-year-old, for COVID-19 Immunization, reaction(s): "Extreme pain in left breast and left arm", "Extreme pain in left breast and left arm", "I had Inflammation". The following information was reported: PAIN IN EXTREMITY (disability), INFLAMMATION (disability), outcome "not recovered" and all described as "I have inflammation and pain in that arm". Therapeutic measures were taken as a result of pain in extremity, inflammation. Additional information: No Other medication in 2weeks. Ae treatment included Steroid shot. The reporter reported that she had Extreme pain in left breast and left arm. Went to Dr. and they confirmed she had Inflammation. She got the booster in right arm and now she has inflammation and pain in that arm. This was over a year and still in extreme pain. No known allergies. No Other medical history.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201374946 Same reporter/patient, same drug/different dose, same AEs;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of left arm after each injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 11:00 as dose 1, single (Lot number: EN6199) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "recovering", described as "Soreness of left arm after each injection". Therapeutic measures were not taken as a result of pain in extremity.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: soreness at injection site; sore body; chills/sweats; chills/sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 43 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), HYPERHIDROSIS (non-serious) all with onset 13Dec2022 at 21:00, outcome "unknown" and all described as "chills/sweats"; MYALGIA (non-serious) with onset 13Dec2022 at 21:00, outcome "unknown", described as "sore body"; INJECTION SITE PAIN (non-serious) with onset 13Dec2022 at 21:00, outcome "unknown", described as "soreness at injection site". Therapeutic measures were not taken as a result of injection site pain, myalgia, chills, hyperhidrosis.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of left arm after each injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 at 17:00 as dose 5 (booster), single (Lot number: GJ3275) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot EN6199, expiration unknown, injected in left arm), administration date: 06Mar2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "Soreness of left arm after each injection"; BNT162b2 (Dose: 2, Lot EP6955, expiration unknown, injected in left arm), administration date: 27Mar2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "Soreness of left arm after each injection"; BNT162b2 (Dose: 3 , Lot 301558A, expiration unknown, injected in left arm), administration date: 20Oct2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "Soreness of left arm after each injection"; BNT162b2 (Dose: 4 , Lot FJ4989 ,expiration unknown, injected in left arm), administration date: 14Apr2022, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "Soreness of left arm after each injection". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Dec2022, outcome "recovered" (10Dec2022), described as "Soreness of left arm after each injection". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: This report is to capture his  information. He said they both had arm soreness after each injection, not just the 3rd dose. He did not have any other issues other than arm soreness. Soreness in left arm after each vaccine. Sore arm for about 3 days. Started the same day but was more noticeable the next day. All improved and had no issues and no medical treatment required. He did not have any spot or indentation. All of his dates and vaccine lots are all the same. All soreness started the evening of the injection, and really noticed it the next day. Eventually in a couple or 3 days, the soreness was gone. They did not want Moderna, so all of them were Pfizer. He does not take any medications. Both of them received their vaccines on the same dates, times, locations, with the exact same lot numbers for all. Prior Vaccinations (within 4 weeks) was none. Family Medical History Relevant to Adverse Events (AEs) was none. No medical treatment required. He wanted to find out what Pfizer had to say first and then may  make an appointment to see the doctor. here was no other Conditions, Investigations, Other Products.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Drug ineffective, Suspected COVID-19
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3249) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "TBI" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obese" (unspecified if ongoing); "known allergies: Penecillians" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, start date: 30Jul2015; GABAPENTIN, start date: 10Jun2015; OMEPRAZOLE, start date: 01Aug2007. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Lethargy
Clinical narrative: on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2; It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.; It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000004355.  A 56-year-old female patient received BNT162b2 (BNT162B2), in 2021 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, SINGLE), administration date: 2021, for COVID-19 immunisation, reaction(s): "the patient was tired the next day and lethargic after the 1st dose", "the patient was tired the next day and lethargic after the 1st dose". The following information was reported: LETHARGY (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2".  Additional information: On 28Nov2022, it was reported that a patient started treatment on an unspecified date in early 2021 with Pfizer COVID-19 Vaccine dose 1, on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2, on an unspecified date in Sep2021 with Pfizer COVID-19 Vaccine dose 3 (reported as 1st booster) and on an unspecified date in Apr2022 with dose 4 (reported as 2nd booster) for COVID-19 immunization. It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster. After the 2nd booster, the patient started to get really sick, had high fever, chills, could not be still and was in bed all the next day and described it "like having a bad flu".   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) : PV202200124812 same patient different dose number/ event;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: patient was tired the next day and lethargic after the booster; patient was tired the next day and lethargic after the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004355.  A 56-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 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), administration date: 2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Patient was tired", "Lethargic"; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): "Patient was tired", "Pfizer COVID-19 Vaccine dose 1, on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2", "Lethargic". The following information was reported: LETHARGY (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "patient was tired the next day and lethargic after the booster".  Additional information: it was reported that a patient started treatment on an unspecified date in early 2021 with Pfizer COVID-19 Vaccine dose 1, on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2, on an unspecified date in Sep2021 with Pfizer COVID-19 Vaccine dose 3 (reported as 1st booster) and on an unspecified date in Apr2022 with dose 4 (reported as 2nd booster) for COVID-19 immunisation. It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.  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-PV202200124812 same patient /event different dose number;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Illness, Influenza like illness, Pyrexia
Clinical narrative: get really sick; like having a bad flu; high fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 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, Lot number: unknown), administration date: 2021, for COVID-19 Immunization, reaction(s): "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.", "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster."; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), administration date: 2021, for COVID-19 Immunization, reaction(s): "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.", "Inappropriate schedule of vaccine administered", "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster."; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: unknown), administration date: Sep2021, for COVID-19 Immunization, reaction(s): "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.", "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.". The following information was reported: CHILLS (non-serious) with onset 2022, outcome "unknown"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "get really sick"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "high fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "like having a bad flu". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the 2nd booster, the patient started to get really sick, had high fever, chills, could not be still and was in bed all the next day and described it "like having a bad flu".    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-PV202200124812 same patient different dose number/ event;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: First two shots, I fell and had hard time getting up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EL9264) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FALL (non-serious), outcome "unknown", described as "First two shots, I fell and had hard time getting up". Therapeutic measures were not taken as a result of fall.  Additional information: Consumer stated, first two shots, he fell and had hard time getting up. He had taken blood pressure medicine at that time, and he found out later on, he should not take it as it can drop your blood pressure. And then on the other ones, afterwards, couple of hours later, he got sick to his stomach and was throwing up and those were not given as any of the side effects. Sender's Comments: Linked Report(s) : PFIZER INC-202201375626 same patient/reporter, different vaccine dose; PFIZER INC-202201375627 same patient/reporter, different vaccine dose; PFIZER INC-202201375625 same patient/reporter, different vaccine dose; PFIZER INC-202201375628 same reporter/patient, different vaccine dose;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: First two shots, I fell and had hard time getting up; 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 male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 2, single (Lot number: EW0171) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "taken blood pressure medicine" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9264), administration date: 01Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Fell". The following information was reported: FALL (non-serious) with onset 2021, outcome "unknown", described as "First two shots, I fell and had hard time getting up". Therapeutic measures were not taken as a result of fall.  Patient had an adverse reaction to the first two Pfizer Covid-19 vaccine shots. First two shots, patient fell and had hard time getting up. Patient had taken blood pressure medicine at that time and found out later on, you should not take it as it can drop your blood pressure. No investigations were conducted. Patient had blood pressure medication that patient stopped taking before he got the shot, booster shot. Because with the blood pressure medication getting the shot, the blood pressure dropped, according to patient's doctor. So, patient didn't take his blood pressure. That was week a later. Patient did not take regular medications, had no lab work, no treatment, and no prior vaccinations. There was a product complaint to report.; Sender's Comments: Linked Report(s) :PFIZER INC-202201375592 Same patient/reporter, different vaccine dose;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Nausea, Vomiting
Clinical narrative: I got sick to my stomach; I was throwing up; I got sick to my stomach; I was throwing up; I just found I have Asthma; 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 male patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: 0308D) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9264), administration date: 01Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "First two shots, I fell and had hard time getting up Fall"; BNT162b2 (DOSE 2, SINGLE; Lot number EW0171), administration date: 29Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "First two shots, I fell and had hard time getting up Fall". The following information was reported: NAUSEA (non-serious), VOMITING (non-serious) all with onset 2021, outcome "unknown" and all described as "I got sick to my stomach; I was throwing up"; ASTHMA (non-serious) with onset 2021, outcome "unknown", described as "I just found I have Asthma". Therapeutic measures were not taken as a result of nausea, vomiting, asthma.  Additional information: The consumer stated that first two shots, he fell and had hard time getting up. He had taken blood pressure medicine at that time and he found out later on, you shouldn't take it as it can drop your blood pressure. And then on the other ones, afterwards, couple of hours later, he got sick to his stomach and was throwing up and those were not given as any of the side effects. The patient had blood pressure medication that he stopped taking before he got the shot, booster shot. Because with the blood pressure medication getting the shot, the blood pressure drops, according to his doctor. So, he didn't take blood pressure. That was week a later. The consumer stated, he did not have ii (blood pressure medication) handy. He didn't take it for the last three shots, when he found it, he just found he had Asthma. There were no lab work. There were no treatment. There were no prior vaccinations; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375592 same patient/reporter, different vaccine dose;