chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012S21E) for COVID-19 prophylaxis.     Patient do not have any relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.).    The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Patient was still looking for to get the second dose.  No treatment medications was reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     The patient had no known conditions.     On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.).    No concomitant medications were reported.     The patient had not reported any adverse events (AEs).  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other Moderna; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Dec2021 as dose 3, single (Batch/Lot number: unknown), in left arm and on 22Apr2022 as dose 4, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Oct2022, outcome "unknown", described as "vaccine brand other Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". 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 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Back disorder, Blood test, Malaise
Clinical narrative: Feeling sick; it was my back bothering me; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years intramuscular, in arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot (Any prior vaccination: Consumer stated, "I got a Flu shot a couple of years ago."), for Immunization. The following information was reported: MALAISE (non-serious) with onset 31Mar2023, outcome "unknown", described as "Feeling sick"; BACK DISORDER (non-serious) with onset 31Mar2023, outcome "unknown", described as "it was my back bothering me". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, back disorder. Additional information included: the patient reported that last she received Prevnar 20 this Thursday 30Mar and the next day she began feeling so sick, really sick. The patient just notice that it was her back bothering her then the day after that morning she looked up, she had been just pick up the dog, she was good. He did all blood work for her. Lab test on of 30Mar2023. Lab details were not available. The patient did Ibuprofen, she took Ibuprofen 200 milligrams and she took two of them. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "Allergy to NSAIDs" (unspecified if ongoing), notes: Known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300144177 Same patient, different product, different event;
Age: 74.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 74 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: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Keflex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Apr2023 at 01:00, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Paxlovid from 26Mar2023 to 30Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300144428 same reporter/patient, different product/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old male 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; elasomeran (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There were no other medication in 2weeks. No Known allergies. The patient was treated with Paxlovid on 01Apr2023.  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 vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300144513 Same patient, different drug, different event;
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; 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 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "previous cancer patient (10 years ago)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient had no known allergies. Patient was treated with Paxlovid (from 24Mar2023 to 27Mar2023) for COVID-19.  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-202300144614 Same patient, different product and event;
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16May2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Nov2022 at 12:45 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2022 at 12:45, outcome "unknown"; 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: The patient was treated with Paxlovid from 23Mar2023 to 27Mar2023. The patient did not received any other medication in last two weeks at the time of reporting. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300144562 same reporter/patient, different product/AE;
Age: 52.0
Sex: F
Vaccine: COVID19, 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) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing), notes: take medication for depression; "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: (29Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The treatment start date was 25Mar2023 and stop date reported as 29Mar2023 for the treatment of COVID-19.  Investigation result conclusion for lot number GJ2524: The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GJ2524. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 65.0
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 03Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: tests had faint positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment with Paxlovid from 23Mar2023 till 28Mar2023. Patient had not allergies.   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-202300144811 same reporter/patient, different product/AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 67-year-old female patient received BNT162b2 (BNT162B2 NOS), on 24Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known drug allergies. Patient was not given other medication in 2 weeks. The Paxlovid used as treatment for covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Electroencephalogram, Hypoaesthesia, Illness
Clinical narrative: mild residual tingling numbness; mild residual tingling numbness; felt sick; body aches; fever; chills; nausea; This is a spontaneous report received from contactable reporter(s) (Physician).  A 25-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2023 as dose 2, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: prior Hx of possible Multiple Sclerosis with Brain MRI showes abnormal imaging 5 yrs ago but stable.; "abnormal EEG" (unspecified if ongoing), notes: Also has Hx of prior abnormal EEG.; "acid reflux" (unspecified if ongoing), notes: His only current medication is Omeprazole for acid reflux. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (Dose 1, single), administration date: 07Mar2023, when the patient was 25-year-old, for COVID-19 Immunization, reaction(s): "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "felt sick", "Fever", "body aches", "chills". The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "not recovered" and all described as "mild residual tingling numbness"; ILLNESS (non-serious), outcome "recovered", described as "felt sick"; PAIN (non-serious), outcome "recovered", described as "body aches"; PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered"; NAUSEA (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: A 25-year-old male patient received his first COVID-19 vaccine on 07Mar2023 and 13 days later developed severe numbness of bilateral distal arms and legs (forearms/hands & shins/feet) which dramatically improved after 10 days when he received his 2nd COVID-19 vaccination on 30Mar2023. He now only has very mild residual tingling numbness. Did have side effects and felt sick from both shots with fever, body aches, and chills lasting 24 hrs along with some nausea with 2nd vaccination. No imaging or other tests have been done yet, but plans to see his Neurologist in follow up. Optional Information included, Patient has prior Hx of possible Multiple Sclerosis with Brain MRI showing some abnormal imaging 5 yrs ago but has been stable since. Also has Hx of prior abnormal EEG. His only current medication is Omeprazole for acid reflux. Event took place after use of product.  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-PV202300063057 same patient/SD, different AE/dose;
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: mild residual tingling numbness; mild residual tingling numbness; felt sick; body aches; fever; chills; nausea; This is a spontaneous report received from contactable reporter(s) (Physician).  A 25-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2023 as dose 2, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: prior Hx of possible Multiple Sclerosis with Brain MRI showes abnormal imaging 5 yrs ago but stable.; "abnormal EEG" (unspecified if ongoing), notes: Also has Hx of prior abnormal EEG.; "acid reflux" (unspecified if ongoing), notes: His only current medication is Omeprazole for acid reflux. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (Dose 1, single), administration date: 07Mar2023, when the patient was 25-year-old, for COVID-19 Immunization, reaction(s): "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "felt sick", "Fever", "body aches", "chills". The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "not recovered" and all described as "mild residual tingling numbness"; ILLNESS (non-serious), outcome "recovered", described as "felt sick"; PAIN (non-serious), outcome "recovered", described as "body aches"; PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered"; NAUSEA (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: A 25-year-old male patient received his first COVID-19 vaccine on 07Mar2023 and 13 days later developed severe numbness of bilateral distal arms and legs (forearms/hands & shins/feet) which dramatically improved after 10 days when he received his 2nd COVID-19 vaccination on 30Mar2023. He now only has very mild residual tingling numbness. Did have side effects and felt sick from both shots with fever, body aches, and chills lasting 24 hrs along with some nausea with 2nd vaccination. No imaging or other tests have been done yet, but plans to see his Neurologist in follow up. Optional Information included, Patient has prior Hx of possible Multiple Sclerosis with Brain MRI showing some abnormal imaging 5 yrs ago but has been stable since. Also has Hx of prior abnormal EEG. His only current medication is Omeprazole for acid reflux. Event took place after use of product.  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-PV202300063057 same patient/SD, different AE/dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the guy I work with passed covid to every single person and I brought it home; the guy I work with passed covid to every single person and I brought it home; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the guy I work with passed covid to every single person and I brought it home". 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.  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 information in the case , the causal relationship between reported events  Drug ineffective and COVID-19 cannot be excluded as there is no conclusive evidence to deny the causality.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pericardial effusion
Clinical narrative: Pericardial effusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: PERICARDIAL EFFUSION (medically significant), outcome "unknown".  Clinical course: Reporter stated, "My mom got the Bivalent COVID Vaccine (Pfizer COVID-19 Vaccine), the last one, the fifth shot that she was supposed to get. At the same time as the high dose Flu shot. She is having Pericardial effusion. I was calling to see if you have any reports of pericardial effusion?" Reporter stated, "I do not know what the Flu shot (Hence suspect captured as Unspecified Flu shot) whatever the high dose Flu shot they give, the pharmacy. I think they were a few days apart but for instances and purposes they were almost."      No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 included PF-07321332, RITONAVIR (PAXLOVID) from 29Mar2023 to 03Apr2023.  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EK5730), on 22Jan2021 as dose 2, single (Lot number: EL0142) and on 26Oct2021 as dose 3 (booster), single (Lot number: 3D155BA) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". The clinical course was reported as follows: The patient tested negative on 02Apr2023 after treatment with PF-07321332, ritonavir (PAXLOVID). The patient started experiencing symptoms on 05Apr2023 and tested positive again for COVID-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2023) negative; (05Apr2023) positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included PF-07321332,  ritonavir (PAXLOVID) from 25Mar2023 to 29Mar2023 and fluticasone propionate (FLONASE) from an unspecified date to 25Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145983 Same reporter/patient, same drug/different dose, different AE;
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Mouth ulceration
Clinical narrative: started to get ulcers in mouth. It was some kind of sore and taste changed, it was not oozing. It was inside of lower lip and into the corner of mouth. It was very painful. Tongue burns; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (1st Booster, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (2nd Booster, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: MOUTH ULCERATION (non-serious), 4 days after the suspect product(s) administration, outcome "unknown", described as "started to get ulcers in mouth. It was some kind of sore and taste changed, it was not oozing. It was inside of lower lip and into the corner of mouth. It was very painful. Tongue burns". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient enquired for information regarding a potential adverse effect she was experiencing. She referred that 4 days after getting her third booster, the adult Pfizer BioNTech COVID-19 bivalent vaccine, she started to get ulcers in her mouth. It was some kind of sore and her taste changed, it was not oozing. It was inside of her lower lip and into the corner of her mouth. It was very painful. Her tongue burns. Some days it goes away and some days it comes back. The patient have not gotten COVID-19 so she discarded that, and all her bloodwork came back normal. Her dentist said she saw other patients coming with the same issue. She was not the only one. She also saw online some people complaining about the same issue. She havent changed her diet, she take the same 5 pills that she have been taking for 15 years so she thought she could call Pfizer to get some information, but she see that it has been a waste of time.  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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear infection, Myalgia, Sinusitis
Clinical narrative: 8 major sinus/ear infections; 8 major sinus/ear infections; Constant pains in both arm from shoulder to elbow in my muscles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: asthma, controlled (as reported). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ADVAIR. Vaccination history included: coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown), administration date: 17Feb2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown), administration date: 17Mar2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "I have only had one prior to this sinus/ear infections", "I have only had one prior to this sinus/ear infections". The following information was reported: SINUSITIS (non-serious), EAR INFECTION (non-serious) all with onset 26Oct2021, outcome "not recovered" and all described as "8 major sinus/ear infections"; MYALGIA (non-serious) with onset 26Oct2021, outcome "not recovered", described as "Constant pains in both arm from shoulder to elbow in my muscles". The events "8 major sinus/ear infections" and "constant pains in both arm from shoulder to elbow in my muscles" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of sinusitis, ear infection, myalgia.  Additional Information: The patient had not taken other vaccines in four weeks. The patient has had 8 major sinus/ ear infections since taking the vaccine and has only had one prior to that. The patient is having another one right then and needs it to stop. The patient also had constant pains in both arm from shoulder to elbow in the muscles. The treatment taken for Adverse events were reported as antibiotics every time. The patient has not been tested for COVID prior to vaccination. The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146277 Same patient, same reporter, same vaccine, different dose, different events;US-PFIZER INC-202300146276 Same patient, same reporter, same vaccine, different dose, different events;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 8 major sinus/ear infections; 8 major sinus/ear infections; Constant pains in both arm from shoulder to elbow in my muscles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: asthma, controlled (as reported). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ADVAIR. Vaccination history included: coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown), administration date: 17Feb2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown), administration date: 17Mar2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "I have only had one prior to this sinus/ear infections", "I have only had one prior to this sinus/ear infections". The following information was reported: SINUSITIS (non-serious), EAR INFECTION (non-serious) all with onset 26Oct2021, outcome "not recovered" and all described as "8 major sinus/ear infections"; MYALGIA (non-serious) with onset 26Oct2021, outcome "not recovered", described as "Constant pains in both arm from shoulder to elbow in my muscles". The events "8 major sinus/ear infections" and "constant pains in both arm from shoulder to elbow in my muscles" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of sinusitis, ear infection, myalgia.  Additional Information: The patient had not taken other vaccines in four weeks. The patient has had 8 major sinus/ ear infections since taking the vaccine and has only had one prior to that. The patient is having another one right then and needs it to stop. The patient also had constant pains in both arm from shoulder to elbow in the muscles. The treatment taken for Adverse events were reported as antibiotics every time. The patient has not been tested for COVID prior to vaccination. The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146277 Same patient, same reporter, same vaccine, different dose, different events;US-PFIZER INC-202300146276 Same patient, same reporter, same vaccine, different dose, different events;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear infection, Myalgia, Sinusitis
Clinical narrative: COVID test result: Positive; COVID test result: Positive; This is a spontaneous report received from 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 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Oct2021 at 12:00 as dose 3 (booster), single (Lot number: ff8841) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma, controlled" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Sep2022, outcome "unknown" and all described as "COVID test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive.  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-202300146065 Same patient, same reporter, same vaccine, different dose, different events;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID test result: Positive; COVID test result: Positive; This is a spontaneous report received from 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 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Oct2021 at 12:00 as dose 3 (booster), single (Lot number: ff8841) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma, controlled" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Sep2022, outcome "unknown" and all described as "COVID test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive.  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-202300146065 Same patient, same reporter, same vaccine, different dose, different events;
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmic migraine
Clinical narrative: ocular migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Apr2021 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: OPHTHALMIC MIGRAINE (non-serious), outcome "not recovered", described as "ocular migraines". Additional information: Patient has been suffering from ocular migraines for almost two years. He took his first Pfizer COVID-19 mRNA immunization in Apr2021, and things haven't been the same since. Strangely, some doctors find the ocular adverse events reported on vaccine have less "test book presentation".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID: (Unknown).  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALBUTEROL SULFATE HFA; FAMOTIDINE; PAROXETINE HCL; HYDROXYZINE HCL; VITAMIN D3; VITAMIN B-6. Past drug history included: Arava, reaction(s): "Allergies", notes: 10 mg tablet; Cefprozil, reaction(s): "Allergies", notes: 250 mg tablet; Cipro, reaction(s): "Allergies", notes: 250 mg tablet; Sulfamethoxazole-trimethoprim, reaction(s): "Allergies". The following information was reported: COVID-19 (medically significant) with onset 14Feb2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 14Feb2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2023) Positive.  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 information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2.,Linked Report(s) : US-PFIZER INC-202101082022 same patient, different drug/event;
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Swelling
Clinical narrative: I have been swelling, abnormal swelling; Feeling abnormal (Something is blowing, something is wrong); I am having problems with the right side of my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: SWELLING (non-serious), outcome "unknown", described as "I have been swelling, abnormal swelling"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling abnormal (Something is blowing, something is wrong)"; DISCOMFORT (non-serious), outcome "unknown", described as "I am having problems with the right side of my body".  Additional Information: The patient is not really sure of what all the side effects were from the Pfizer Covid shot (Clarified as Pfizer Covid-19 vaccine) because it is concerning because patient was not overeating, and had swelling, abnormal swelling. The patient do not know what kind of reaction. The patient stated something is wrong and just wanted to know. The patient does not had information about this vaccination. The patient looks like about 4 or 500 pounds. The patient is hurt and victimized and is in harm's way. The patient had problems with the right side of body, the patient tries to think that he/she had shot on which side of shoulder, and the patient is not sure of which side.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
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) (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), as dose 5 (booster), single (Batch/Lot number: unknown), 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), 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 and concomitant medications were not reported. Patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received paxlovid treatment from 5Mar2023 to 29Mar2023.  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.