chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Magnetic resonance imaging, X-ray
Clinical narrative: joint pain from the arm were the vaccine was received , to the elbow, knee, butt, hand; patient can't walk/ not able to move; This spontaneous case was reported by a non-health professional and describes the occurrence of ARTHRALGIA (joint pain from the arm were the vaccine was received , to the elbow, knee, butt, hand) and GAIT INABILITY (patient can't walk/ not able to move) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes (has diabetes). Concomitant products included METFORMIN for an unknown indication.    On 22-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2022, the patient experienced ARTHRALGIA (joint pain from the arm were the vaccine was received , to the elbow, knee, butt, hand) and GAIT INABILITY (patient can't walk/ not able to move). At the time of the report, ARTHRALGIA (joint pain from the arm were the vaccine was received , to the elbow, knee, butt, hand) and GAIT INABILITY (patient can't walk/ not able to move) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: X-RAYS, MRIs still going to a specialist in and out the hospital. On an unknown date, X-ray: X-RAYS, MRIs still going to a specialist in and out the hospital.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient called vaccination 4 days after receiving the vaccine started to experience joint pain from the arm were the vaccine was received, to the elbow, knee, butt, hand, patient can't walk. Symptoms are getting worse Without medication cannot move Caller has diabetes TREATMENT X-RAYS, MRIs still going to a specialist in and out the hospital and she is on steroids.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Off label use
Clinical narrative: Died of a heart attack; A 3rd grader [just died of a heart attack after taking the booster]; On 16-DEC-2022, this serious, initial spontaneous safety report was received by Novavax from a consumer via social media monitoring.  A child of an unspecified race, age and sex was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 3 (reported as booster) on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the 3rd grader died of a heart attack after taking the booster (PT: Off label use) (PT: Myocardial infarction) (Serious: Death and Medically Significant).  At the time of reporting, the event outcome of Myocardial infarction was fatal and Off label use was recovered/resolved.  Lot number was not provided in the report.  ; Sender's Comments: This individual of an unspecified age and sex experienced: Myocardial infarction and Off label use after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Myocardial infarction was assessed as serious. The event Off label use was assessed as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.; Reported Cause(s) of Death: Heart attack
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; The initial version of the case was processed as Invalid due to Unidentifiable reporter, but now upon the follow-up the case contains all the necessary information required for the case to be valid.  This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID:   A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "unknown". The event "pericarditis" required emergency room visit.  Clinical course: Ended up in the emergency room on Wednesday night diagnosed with Pericarditis after taking the 2nd Pfizer shot. The Doctor said this is now common after the Pfizer shot. Especially with teenage boys and young males.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: I started my period and it was very very heavy/After 2sec booster 15Nov2022 I started my period 07Dec and again it's very very heavy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 46-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 03:45 as dose 4 (booster), single (Lot number: GH9697) at the age of 46 years, in left arm and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: I was covid +. Concomitant medication(s) included: CETIRIZINE; ATORVASTATIN. Vaccination history included: moderna (DOSE 3 (BOOSTER), SINGLE; Lot number: 027H21B, Vaccine location: Left arm), administration date: 30Dec2021, when the patient was 45-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EJ1685, Vaccine location: Left arm), administration date: 21Jan2021, when the patient was 44-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1 SINGLE; Lot number: EJ1685, Vaccine location: Left arm), administration date: 31Dec2020, for Covid-19 immunization, reaction(s): "Menstrual flow excessive". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 07Dec2022, outcome "not recovered", described as "I started my period and it was very very heavy/After 2sec booster 15Nov2022 I started my period 07Dec and again it's very very heavy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient got vaccine dose 1 of primary series while she was covid positive without knowing. Few days later, she started her period and it was very heavy. Next period was heavy but not as much then it went back to normal. After second booster on 15Nov2022, she started her period on 07Dec and again it was very heavy. She never had her periods be this heavy in her life. Changing super abs tampons every 30mins same as in Dec2020. She had read case reports of heavy menstrual cycles post COVID infections and from vaccine.  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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications and no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (08Dec2022) Negative, notes: Negative and no symptoms on 08Dec2022; (11Dec2022) Positive, notes: Symptoms and positive test on 11Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 03Dec2022 to 07Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood cholesterol, Blood pressure measurement, Investigation, Myalgia, Pain
Clinical narrative: ache and pain in left thumb pad/Pain radiated up to left deltoid muscle; ache and pain in left thumb pad; Pain radiated up to left deltoid muscle; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 14:15 as dose 4 (booster), single (Lot number: GJ2524) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP (controlled)" (unspecified if ongoing); "high cholesterol (moderate)" (unspecified if ongoing); "increased eye pressure" (unspecified if ongoing); "hx migraines" (unspecified if ongoing); "sciatica" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LISINOPRIL; ROCKLATAN; VITAMIN D3. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization.  The following information was reported: MYALGIA (non-serious) with onset 20Oct2022, outcome "not recovered", described as "Pain radiated up to left deltoid muscle"; PAIN IN EXTREMITY (non-serious) with onset 20Oct2022, outcome "not recovered", described as "ache and pain in left thumb pad"; PAIN (non-serious) with onset 20Oct2022, outcome "not recovered", described as "ache and pain in left thumb pad/Pain radiated up to left deltoid muscle". The events "ache and pain in left thumb pad/pain radiated up to left deltoid muscle", "ache and pain in left thumb pad" and "pain radiated up to left deltoid muscle" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, pain in extremity, myalgia.  Additional information: In late Oct2022 the patient began experiencing ache and pain in left thumb pad; more severe at night and occasionally during the day. Severe pain when pressed left thumb pad using right thumb and index fingers to press. Pain radiated up to left deltoid muscle. The patient had Chiropractor ordered an x-ray of left thumb, arm. No covid prior vaccination and the patient had tested covid post vaccination. The patient received Anti-viral product for COVID 19 Treatment start date: 01Dec2022 and stop date: 06Dec2022. No other vaccine in four weeks. No known allergies.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, SARS-CoV-2 test, X-ray
Clinical narrative: ache and pain in left thumb pad/Pain radiated up to left deltoid muscle; ache and pain in left thumb pad; Pain radiated up to left deltoid muscle; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 14:15 as dose 4 (booster), single (Lot number: GJ2524) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP (controlled)" (unspecified if ongoing); "high cholesterol (moderate)" (unspecified if ongoing); "increased eye pressure" (unspecified if ongoing); "hx migraines" (unspecified if ongoing); "sciatica" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LISINOPRIL; ROCKLATAN; VITAMIN D3. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization.  The following information was reported: MYALGIA (non-serious) with onset 20Oct2022, outcome "not recovered", described as "Pain radiated up to left deltoid muscle"; PAIN IN EXTREMITY (non-serious) with onset 20Oct2022, outcome "not recovered", described as "ache and pain in left thumb pad"; PAIN (non-serious) with onset 20Oct2022, outcome "not recovered", described as "ache and pain in left thumb pad/Pain radiated up to left deltoid muscle". The events "ache and pain in left thumb pad/pain radiated up to left deltoid muscle", "ache and pain in left thumb pad" and "pain radiated up to left deltoid muscle" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, pain in extremity, myalgia.  Additional information: In late Oct2022 the patient began experiencing ache and pain in left thumb pad; more severe at night and occasionally during the day. Severe pain when pressed left thumb pad using right thumb and index fingers to press. Pain radiated up to left deltoid muscle. The patient had Chiropractor ordered an x-ray of left thumb, arm. No covid prior vaccination and the patient had tested covid post vaccination. The patient received Anti-viral product for COVID 19 Treatment start date: 01Dec2022 and stop date: 06Dec2022. No other vaccine in four weeks. No known allergies.
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Pulmonary HTN" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: contrast media" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Statins, reaction(s): "known allergies: Statins". 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: 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.
Age: 54.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 17Aug2022 at 12:00 as dose number 3 (booster), single (Batch/Lot number: unknown) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Paxlovid Treatment received for COVID 19 from 28Nov2022 to 02Dec2022. No Known allergies. No other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 at 12:00 as dose 2, single (Lot number: el9265), in right arm, on 09Oct2021 at 12:00 as dose 3 (booster), single (Lot number: ff8841), in right arm and on 20Apr2022 at 12:00 as dose 4 (booster), single (Lot number: fk9896), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
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). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 11:00 as dose number unknown (booster), single (Lot number: gh9694), 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: "Overweight" (unspecified if ongoing); "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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive; (08Dec2022) Positive; (09Dec2022) Positive; (10Dec2022) Positive; (11Dec2022) Positive; (12Dec2022) Positive; (13Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine and Other medication in 2 weeks. Other medication details: Other medication in 2 weeks product: Alka Seltzer Plus Cold Medicine. Other medication in 2 weeks brand: Alka Seltzer, Other medication in 2 weeks start date: 01Dec2022, Other medication in 2 weeks stop date: 10Dec2022. Covid symptoms of cough, runny nose, sore throat, fever and congestion returned 07Dec and tested positive. Covid symptoms and positive test results continued through 13Dec.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, SARS-CoV-2 test
Clinical narrative: inability to hear / very hard of hearing; 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 75-year-old female patient received BNT162b2 (BNT162B2), on 10Aug2022 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), for Covid-19 Immunization; Bnt162b2 (DOSE 2), for Covid-19 Immunization; Bnt162b2 (DOSE 3), for Covid-19 Immunization.  The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "inability to hear / very hard of hearing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient had very hard of hearing, is calling to see when she can get the booster dose of the Pfizer BioNTech Covid vaccine. She has had four previous boosters of the Pfizer Covid vaccines, the last being administered on 10Aug2022. She developed a mild case of Covid on 09Sep2022, and tested positive 13Sep2022. Patient was struggling with inability to hear while on call, did not clarify if that developed or had worsened after vaccinations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lymphadenopathy, Musculoskeletal stiffness, Neck pain, Nodule
Clinical narrative: stiff neck; a swelling that is pressing her neck, collarbone and shoulder.; swollen lymph node; The nodule feeling is thickening; nodules by neck; bad pain, hurting in neck region between neck and shoulder and collar bone; sore arm/soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose 3 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 13 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Dec2022, outcome "unknown", described as "sore arm/soreness in arm"; NECK PAIN (non-serious) with onset 12Dec2022, outcome "unknown", described as "bad pain, hurting in neck region between neck and shoulder and collar bone"; NODULE (non-serious) with onset 12Dec2022, outcome "unknown", described as "nodules by neck"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiff neck"; SWELLING (non-serious), outcome "unknown", described as "a swelling that is pressing her neck, collarbone and shoulder."; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "The nodule feeling is thickening.  Additional information: Patient received the Bivalent booster dose for 12 years and up last Saturday on the evening. At the beginning she had a sore arm, however, she woke up with a stiff neck. with a swelling that is pressing her neck, collarbone and shoulder. She mentioned this is a swelling that goes beyond the stiff neck. They thought she might had slept in a bad position, but then they noticed about this swollen lymph node. Patient has soreness in arm. This was patient's 3rd one and yesterday patient getting nodules by neck, bad pain, was hurting in neck region between neck and shoulder and collar bone. Thought patient had pulled a muscle because patient was trying to not sleep on arm. The nodule feeling is thickening  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: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: stiff neck; a swelling that is pressing her neck, collarbone and shoulder.; swollen lymph node; The nodule feeling is thickening; nodules by neck; bad pain, hurting in neck region between neck and shoulder and collar bone; sore arm/soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose 3 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 13 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Dec2022, outcome "unknown", described as "sore arm/soreness in arm"; NECK PAIN (non-serious) with onset 12Dec2022, outcome "unknown", described as "bad pain, hurting in neck region between neck and shoulder and collar bone"; NODULE (non-serious) with onset 12Dec2022, outcome "unknown", described as "nodules by neck"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiff neck"; SWELLING (non-serious), outcome "unknown", described as "a swelling that is pressing her neck, collarbone and shoulder."; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "The nodule feeling is thickening.  Additional information: Patient received the Bivalent booster dose for 12 years and up last Saturday on the evening. At the beginning she had a sore arm, however, she woke up with a stiff neck. with a swelling that is pressing her neck, collarbone and shoulder. She mentioned this is a swelling that goes beyond the stiff neck. They thought she might had slept in a bad position, but then they noticed about this swollen lymph node. Patient has soreness in arm. This was patient's 3rd one and yesterday patient getting nodules by neck, bad pain, was hurting in neck region between neck and shoulder and collar bone. Thought patient had pulled a muscle because patient was trying to not sleep on arm. The nodule feeling is thickening  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: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Leukaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Imatinib, reaction(s): "Known allergies: Imatinib"; Epinephrine, reaction(s): "Known allergies: epinephrine"; Codeine, reaction(s): "Known allergies: Codeine"; Sulfur, reaction(s): "Known allergies: Sulfur". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks: Unknown. Paxlovid: Treatment start date= 04Dec2022, treatment stop date= 09Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 2, single (Lot number: FE3592), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing). There were no concomitant medications. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FE3592 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FE3592, fill lot FF2553, and the bulk formulated drug product lot FA9141. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Clinical Course: Received covid treatment.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: had Covid "likely" omnicron; had Covid "likely" omnicron; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Dec2021 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), SUSPECTED COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "had Covid "likely" omnicron". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2022) Unknown Results, notes: had Covid "likely" omnicron, caller confirmed this is how reporter spelled omnicron, Mar2022 and again in Nov2022, likely subvariant; (Nov2022) Unknown Results, notes: had Covid "likely" omnicron, caller confirmed this is how reporter spelled omnicron, Mar2022 and again in Nov2022, likely subvariant. Clinical Course: Reporter was triple vaccinated "Pfizer", last dose Dec2021, had Covid "likely" omnicron, caller confirmed this was how reporter spelled omnicron, Mar2022 and again in Nov2022, likely subvariant.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Inflammation, Pain in extremity
Clinical narrative: Extreme pain in left breast and left arm; I had inflammation.; Extreme pain in left breast and left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2021 as dose 2, single (Lot number: EW0167) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Vaccine lot number: EW0170, Vaccine location: Left arm), administration date: 20Apr2021, when the patient was 44-year-old, for COVID-19 Immunization. The following information was reported: BREAST PAIN (disability, medically significant), PAIN IN EXTREMITY (disability, medically significant) all with onset 22May2021, outcome "not recovered" and all described as "Extreme pain in left breast and left arm"; INFLAMMATION (disability, medically significant) with onset 22May2021, outcome "not recovered", described as "I had inflammation.". The events "extreme pain in left breast and left arm" and "i had inflammation." required physician office visit. Therapeutic measures were taken as a result of breast pain, inflammation, pain in extremity. Clinical course: Other medication in 2weeks: No. Extreme pain in left breast and left arm. Went to Dr. and they confirmed Inflammation. Treatment mediation included steroid shot. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375113 Same reporter/patient, same drug/different dose, same AEs;
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESTRADIOL.  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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received other medication in 2weeks. No known allergies. The patient received anti viral product from 28Nov2022 to 02Dec2022 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain
Clinical narrative: Terrible pain; between my belly and vagina on my pelvic floor has been bruised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "lump of inflammation under skin on low back for unknown causes (appeared after being exposed to Covid but did not test positive)" (unspecified if ongoing), notes: lump of inflammation under skin on low back for unknown causes (exposed to Covid test Negative). Concomitant medication(s) included: LETROZOLE; NORETHISTERONE; HYDROXYZINE. Vaccination history included: Bnt162b2 (Previous dose product: COVID 19,, Previous dose brand: Pfizer,, Previous dose brand unknown: False,, Previous dose lot unknown: True,, Previous dose number: 1), for Covid-19 Immunization; Bnt162b2 (Previous dose details, Previous dose product: COVID 19,, Previous dose brand: Pfizer,, Previous dose brand unknown: False,, Previous dose lot unknown: True,, Previous dose number: 2,), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 22Apr2022, outcome "not recovered", described as "Terrible pain"; CONTUSION (non-serious) with onset 22Apr2022, outcome "not recovered", described as "between my belly and vagina on my pelvic floor has been bruised". The events "terrible pain" and "between my belly and vagina on my pelvic floor has been bruised" required physician office visit.  Additional Information: Patient was in Terrible pain starting the day after for a week. Then, the space in between my belly and vagina on my pelvic floor has been bruised since a week after my booster.  The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Decreased appetite, Headache, Pain, Pain in extremity
Clinical narrative: left armpit swollen; soreness in left arm; chills; headache; body aches; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 at 08:00 as dose 5 (booster), single (Lot number: GJ6742) at the age of 48 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; FISH OIL [EICOSAPENTAENOIC ACID]; VITAMIN D3; CINNAMON [CINNAMOMUM CASSIA]. Vaccination history included: Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering"; HEADACHE (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering"; SWELLING (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering", described as "left armpit swollen"; DECREASED APPETITE (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering", described as "soreness in left arm". Therapeutic measures were not taken as a result of swelling, pain in extremity, chills, headache, pain, decreased appetite.  Additional information: The patient did not receive any other vaccine in four weeks prior to suspect vaccination. The patient did not had COVID prior vaccination and was not tested for COVID post vaccination. The patient had no known allergies.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling
Clinical narrative: left armpit swollen; soreness in left arm; chills; headache; body aches; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 at 08:00 as dose 5 (booster), single (Lot number: GJ6742) at the age of 48 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; FISH OIL [EICOSAPENTAENOIC ACID]; VITAMIN D3; CINNAMON [CINNAMOMUM CASSIA]. Vaccination history included: Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering"; HEADACHE (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering"; SWELLING (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering", described as "left armpit swollen"; DECREASED APPETITE (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious) with onset 14Dec2022 at 12:15, outcome "recovering", described as "soreness in left arm". Therapeutic measures were not taken as a result of swelling, pain in extremity, chills, headache, pain, decreased appetite.  Additional information: The patient did not receive any other vaccine in four weeks prior to suspect vaccination. The patient did not had COVID prior vaccination and was not tested for COVID post vaccination. The patient had no known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: experiencing joint pain; inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), in Feb2021 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: ARTHRALGIA (non-serious) with onset Feb2021, 2 days after the suspect product(s) administration, outcome "not recovered", described as "experiencing joint pain"; INFLAMMATION (non-serious) with onset Feb2021, 2 days after the suspect product(s) administration, outcome "not recovered". The events "experiencing joint pain" and "inflammation" required physician office visit.  Additional information: After patient received the Pfizer-BioNTech COVID-19 Vaccine, Monovalent (gray cap), in Feb2021, he had been experiencing joint pain and inflammation, and it was getting worse. The symptoms started the day after receiving the vaccine. The had consulted the case with doctors. They had investigated for rheumatoid arthritis and auto immune diseases but found nothing. Reporter wanted to know if it had been reported before. Patient's symptoms were getting worse. The case was reported as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: pain in my left arm at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2021 at 15:00 as dose 2, single (Lot number: Ew0185) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AVIANE. Past drug history included: Ranitidine, reaction(s): "Known allergies: Ranitidine"; Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin". Vaccination history included: BNT162b2 (DOSE1, SINGLE; Lot number: Ew0171; Administration time: 03:00 PM; Anatomical location: Left arm), administration date: 01May2021, when the patient was 30-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Jul2022, outcome "not recovered", described as "pain in my left arm at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient had allergies to Ranitidine, Ciprofloxacin. There was no treatment received. Patient did not have covid prior vaccination. Patient was tested for covid post vaccination. On 07Oct2022 and 02Nov2022, patient underwent Covid test type post vaccination: Nasal Swab; Covid test name post vaccination Rapid PCR Test, RT-PCR test and the result was negative. On 06Nov2022, patient underwent Covid test type post vaccination: Nasal Swab; Covid test name post vaccination: SARS-COV-2 RNA, RT-PCR  and the result was negative.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "If covid prior vaccination Yes" (unspecified if ongoing), notes: If covid prior vaccination Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Dec2022 at 05:15, outcome "recovering", described as "Sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The patient did not receive any medications within two weeks of vaccination. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 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.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, 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). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney cancer" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "high BP" (unspecified if ongoing); "Diabetes Type 2" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN, start date: 02Nov2019; NOVOLOG, start date: 02Nov2019; TRETIVA, start date: 02Nov2019. 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: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications were received in 2weeks. Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date was 04Dec2022, treatment stop date was 09Dec2022, indication was Treatment of COVID-19. Other medications in 2 weeks include Levothyroxin, Novolog, Trexiva, Heat meds, start date 02Nov2019. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.