chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain, Vaccination site warmth
Clinical narrative: Having pain at the injection site; Being warm to the touch; He developed a "bump" or a lymph node under his armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 31 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Jan2022 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Von Willebrand Syndrome" (unspecified if ongoing); "Platelet Aggregation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Having pain at the injection site"; VACCINATION SITE WARMTH (non-serious) with onset 2022, outcome "unknown", described as "Being warm to the touch"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "He developed a "bump" or a lymph node under his armpit".  Additional information :He received gray cap booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pityriasis rosea
Clinical narrative: Outbreak of Pityriasis Rosea / still spreading today. Spread over torso, thighs, back, arms, legs, neck; BOOSTER; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 (Lot number: FH8028) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EW0169, prev dose lot unknown: False, prev dose administration date: 16Apr2021, prev dose number: 2, prev dose vaccine location: Left arm), administration date: 16Apr2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Pityriasis Rosea"; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: ER8732, prev dose lot unknown: False, prev dose administration date: 26Mar2021, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 26Mar2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "BOOSTER"; PITYRIASIS ROSEA (non-serious), outcome "unknown", described as "Outbreak of Pityriasis Rosea / still spreading today. Spread over torso, thighs, back, arms, legs, neck".  Additional information: The reporter was reported administered in facility type vaccine: Doctor's office/urgent care visited. The patient was in facility country: private.  The patient did not had  other vaccine in four weeks and  received other medications in two weeks. The adverse event was described in   Outbreak of Pityriasis Rosea after 2nd shot, waned slightly before 3rd shot, still spreading today. Spread over torso, thighs, back, arms, legs, neck. The details for Dose 2 in Linked case 202200143794 adverse event start date 23Apr2021. The AE resulted was  Doctor or other healthcare professional office/clinic visit and no treatment and patient Not recovered. The patient did not covid prior vaccination and no tested post vaccination and no known allergies. There was no other medical history for significant.  Follow-up (02Feb2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blister, SARS-CoV-2 test
Clinical narrative: Large blisters on the forearms, legs, back and particularly scalp / suffer with skin and scalp blisters/ small vesicles appeared on soles; Thining hair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 13:15 (Lot number: 30135ba) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "seasonal (spring) hay fever" (unspecified if ongoing), notes: I have a history of seasonal (spring) hay fever that was cured by hypersensitization.; "Known allergy-grass pollen" (unspecified if ongoing), notes: Grass pollen. Concomitant medication(s) included: FLUZONE HIGH DOSE QUADRIVALENT taken for immunisation, administration date 08Sep2021; SYNTHROID; SIMVASTATIN; FISH OIL; CALCIUM; TURMERIC CURCUMIN [CURCUMA LONGA]. Vaccination history included: Bnt162b2 (Dose 2, lot number: EN6204, Vaccine location: Left arm), administration date: 21Mar2021, when the patient was 66 years old, for COVID-19 immunization, reaction(s): "I got hives shaped rash on calves and forearms"; Bnt162b2 (Dose 1, Lot number: EN6205, vaccine location: Left arm), administration date: 28Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "No side effects"; Bnt162b2 (Dose 2, lot number: EN6204, Vaccine location: Left arm), administration date: 21Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "I got hives shaped rash on calves and forearms", "itching", "two pea-sized blisters appeared above the heel and on the shoulder".  The following information was reported: BLISTER (non-serious) with onset 05Oct2021, outcome "recovering", described as "Large blisters on the forearms, legs, back and particularly scalp / suffer with skin and scalp blisters/ small vesicles appeared on soles"; ALOPECIA (non-serious) with onset 05Oct2021, outcome "recovering", described as "Thining hair". The events "large blisters on the forearms, legs, back and particularly scalp / suffer with skin and scalp blisters/ small vesicles appeared on soles" and "thining hair" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blister, alopecia.  Additional information: No covid prior vaccination. No covid tested post vaccination. Ae treatment was Prednisone tablets, Clobetasol cream and solution.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen under left arm pit area and pec. Roughly 48hrs after booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Jan2022 12:00 (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, single , Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunisation; Bnt162b2 (Dose 1, single , Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 24Jan2022 12:00, outcome "recovering", described as "Swollen under left arm pit area and pec. Roughly 48hrs after booster". It was unknown if therapeutic measures were taken as a result of lymphadenopathy.  Additional information: The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks prior COVID vaccination. Facility type vaccine was unknown. Covid prior vaccination and covid tested post vaccination reported as no. known allergies reported as unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm is a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer unknown), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm is a little sore".  Additional information: Patient reported about receiving booster shot yesterday. Patients arm was little sore. Patient reported to had good days and bad days while on Xeljanz. Patient was prescribed Xeljanz XR 11 mg tablets.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: normal fever; Fatigue; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number Unknown, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "normal fever"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain".  Additional information: They received the Pfizer covid booster. Her son had the normal fever, fatigue, muscle pain the day after and so did her other half, her partner. She declined to complete a report on her son, stating he experienced the expected or normal symptoms. Stated her and her son had nothing, no arm pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lymphadenopathy
Clinical narrative: Swollen lymph node in neck; swollen right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A 29-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, Swollen lymph node in neck, Manufacturer unknown), for COVID-19 immunization, reaction(s): "Swollen lymph node in neck"; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph node in neck"; EYE SWELLING (non-serious), outcome "unknown", described as "swollen right eye".  Additional Information: It was reported that patient had swollen lymph node in neck occurred after dose 2 in primary series as well. This was reported as well. The event took place after use of product.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation, Urticaria
Clinical narrative: irritation and hives on the body; irritation and hives on the body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SKIN IRRITATION (non-serious), URTICARIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "irritation and hives on the body". The event "irritation and hives on the body" and "irritation and hives on the body" was evaluated at the physician office visit.  Additional information: She visited her doctor and he indicated that it could have been a reaction to the vaccine but that it would only last a month. She continues experiencing the reaction.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: coughing; wiped out; sore throat; nasal congestion; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient in his 30's received bnt162b2 (BNT162B2), administration date 24Jan2022 (Batch/Lot number: unknown) at the age of 4 decade as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 24Jan2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 25Jan2022, outcome "recovering", described as "wiped out"; OROPHARYNGEAL PAIN (non-serious) with onset 25Jan2022, outcome "not recovered", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 25Jan2022, outcome "not recovered", described as "nasal congestion"; COUGH (non-serious) with onset 27Jan2022, outcome "not recovered", described as "coughing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, reporter just spoke with a male, mid-30's, at approximately 08:30 AM today (Friday, 28Jan). He reported that he received his 3rd Pfizer COVID-19 vaccine late afternoon on Monday, 24Jan. Later that evening he may have had some fever. On Tuesday morning he felt "wiped out", but that improved over the day. He also started to develop a sore throat and then some nasal congestion and coughing which was continuing through Thursday night (his time) when reporter spoke with him.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: coughing; wiped out; sore throat; nasal congestion; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient in his 30's received bnt162b2 (BNT162B2), administration date 24Jan2022 (Batch/Lot number: unknown) at the age of 4 decade as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 24Jan2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 25Jan2022, outcome "recovering", described as "wiped out"; OROPHARYNGEAL PAIN (non-serious) with onset 25Jan2022, outcome "not recovered", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 25Jan2022, outcome "not recovered", described as "nasal congestion"; COUGH (non-serious) with onset 27Jan2022, outcome "not recovered", described as "coughing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, reporter just spoke with a male, mid-30's, at approximately 08:30 AM today (Friday, 28Jan). He reported that he received his 3rd Pfizer COVID-19 vaccine late afternoon on Monday, 24Jan. Later that evening he may have had some fever. On Tuesday morning he felt "wiped out", but that improved over the day. He also started to develop a sore throat and then some nasal congestion and coughing which was continuing through Thursday night (his time) when reporter spoke with him.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Chest pain, Investigation, Pain in extremity
Clinical narrative: Swelling under both of his armpits; "Strange twinges" in his left armpit area, arm, and across his chest; "Strange twinges" in his left armpit area, arm, and across his chest; "Strange twinges" in his left armpit area, arm, and across his chest; 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 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Lot number: FF2593, Expiration Date: 31Dec2021) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Keep hair from falling out" (unspecified if ongoing), notes: Keep hair from falling out; "He is 5 feet 10 inches to 5 feet 11 inches, and that he probably shrunk" (unspecified if ongoing), notes: he is 5 feet 10 inches to 5 feet 11 inches, and that he probably shrunk. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased, start date: Dec2010; ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder, start date: 2000; FINASTERIDE taken for alopecia. Vaccination history included: Covid-19 vaccine (Dose: 1, Lot: EN6202), administration date: 08Mar2021, when the patient was 61 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Lot: ER2613, Received his 2nd dose of the vaccine on his left arm), administration date: 29Mar2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "Swelling under his left armpit". The following information was reported: SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "Swelling under both of his armpits"; PAIN IN EXTREMITY (non-serious), CHEST PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as ""Strange twinges" in his left armpit area, arm, and across his chest". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that his doctor mentioned that the swelling would go down but it persisted for a couple of weeks. Bloodwork, urine test, and other test have been done to him as per his report. It is stated by the patient that this began after the second shot, left him wondering if others report that their glands were swelling for months on end, like if this is something a certain percentage of people who get the vaccines experience.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Ultrasound scan, Urine analysis
Clinical narrative: Swelling under both of his armpits; "Strange twinges" in his left armpit area, arm, and across his chest; "Strange twinges" in his left armpit area, arm, and across his chest; "Strange twinges" in his left armpit area, arm, and across his chest; 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 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Lot number: FF2593, Expiration Date: 31Dec2021) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Keep hair from falling out" (unspecified if ongoing), notes: Keep hair from falling out; "He is 5 feet 10 inches to 5 feet 11 inches, and that he probably shrunk" (unspecified if ongoing), notes: he is 5 feet 10 inches to 5 feet 11 inches, and that he probably shrunk. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased, start date: Dec2010; ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder, start date: 2000; FINASTERIDE taken for alopecia. Vaccination history included: Covid-19 vaccine (Dose: 1, Lot: EN6202), administration date: 08Mar2021, when the patient was 61 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Lot: ER2613, Received his 2nd dose of the vaccine on his left arm), administration date: 29Mar2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "Swelling under his left armpit". The following information was reported: SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "Swelling under both of his armpits"; PAIN IN EXTREMITY (non-serious), CHEST PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as ""Strange twinges" in his left armpit area, arm, and across his chest". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that his doctor mentioned that the swelling would go down but it persisted for a couple of weeks. Bloodwork, urine test, and other test have been done to him as per his report. It is stated by the patient that this began after the second shot, left him wondering if others report that their glands were swelling for months on end, like if this is something a certain percentage of people who get the vaccines experience.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Nausea
Clinical narrative: experienced heart area/chest pain, sometime dull sometimes sharp pain; experienced heart area/chest pain, sometime dull sometimes sharp pain and discomfort; nausea; 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), administered in arm left, administration date 17Mar2021 11:00 (Lot number: EN6208) at the age of 53 years as dose 1, single and administered in arm left, administration date 12Apr2021 11:00 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies: sulfite" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing); "Known allergies: Aspirin" (unspecified if ongoing). Concomitant medication(s) included: PROAIR [SALBUTAMOL SULFATE]; PULMICORT. The following information was reported: CHEST PAIN (non-serious) with onset 2021, outcome "recovered with sequelae", described as "experienced heart area/chest pain, sometime dull sometimes sharp pain"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "recovered with sequelae", described as "experienced heart area/chest pain, sometime dull sometimes sharp pain and discomfort"; NAUSEA (non-serious) with onset 2021, outcome "recovered with sequelae", described as "nausea". Therapeutic measures were not taken as a result of chest pain, chest discomfort, nausea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received ProAir Inhaler sometimes, Pulmicort 180mcg often within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Heavy menstrual bleeding, Inflammation, Intermenstrual bleeding, SARS-CoV-2 test
Clinical narrative: Severe menstral bleeding, breakthrough bleeding; Severe menstral bleeding, breakthrough bleeding; inflammation; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 14:30 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NUVARING. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 14:30, Manufacturer unknown), administration date: 30Mar2021, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: INTERMENSTRUAL BLEEDING (medically significant), HEAVY MENSTRUAL BLEEDING (medically significant) all with onset 10May2021, outcome "not recovered" and all described as "Severe menstral bleeding, breakthrough bleeding"; INFLAMMATION (non-serious) with onset 10May2021, outcome "not recovered", described as "inflammation"; ARTHRALGIA (non-serious) with onset 10May2021, outcome "not recovered", described as "joint pain". The events "severe menstral bleeding, breakthrough bleeding", "severe menstral bleeding, breakthrough bleeding", "inflammation" and "joint pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of intermenstrual bleeding, heavy menstrual bleeding, inflammation, arthralgia with ablation and tubal ligation, medication used was NSAID . The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she got the vaccines and booster dose and was sick last year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS taken for anticoagulant therapy. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got the vaccines and booster dose and was sick last year".  Additional information: Patient is taking Eliquis for her blood thinner. Reporter stated that in December she's missing 2 for the Eliquis and from January she's missing 8 of them. Caller mentioned that it should be 60 pcs of tablets per bottle for the Eliquis. Reporter mentioned that she got the vaccines and booster dose and was sick last year.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: CSF lymphocyte count, CSF white blood cell count, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram pelvis
Clinical narrative: Herpes zoster meningitis; This is a literature report for the following literature source(s):  A 54 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER MENINGITIS (hospitalization, medically significant), outcome "recovered", described as "Herpes zoster meningitis". The event "herpes zoster meningitis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram abdomen: negative for lymphadenopathy or neoplasm; computerised tomogram head: negative; computerised tomogram pelvis: negative for lymphadenopathy or neoplasm; computerised tomogram thorax: negative for lymphadenopathy or neoplasm; csf lymphocyte count: 89 %; csf white blood cell count: 750 /mm3, notes: with lymphocytic predominance; 200 /mm3; herpes virus test: positive, notes: (in the CSF); negative, notes: (study); lumbar puncture: csf analysis revealed 750, notes: white blood cells per mm3 with lymphocytic predominance; magnetic resonance imaging head: negative; negative; revealed multiple small enhancing leptomeningeal, notes: nodules throughout the dorsal cervical and thoracic spinal cord, along with abnormal enhancement involving the cauda equina nerve roots; magnetic resonance imaging spinal: revealed multiple small enhancing leptomeningeal, notes: nodules throughout the dorsal cervical and thoracic spinal cord, along with abnormal enhancement involving the cauda equina nerve roots; showed dramatic resolution of the leptomeningeal, notes: nodules; 25 days later. Therapeutic measures were taken as a result of herpes zoster meningitis.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments:  Based on the information in the case report, a possible causal relationship between reported events herpes zoster meningitis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200206631 Same article/drug/event; different patient;US-PFIZER INC-202200206630 Same article/drug/event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Herpes virus test, Herpes zoster meningitis, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: Herpes zoster meningitis; This is a literature report for the following literature source(s):  A 54 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER MENINGITIS (hospitalization, medically significant), outcome "recovered", described as "Herpes zoster meningitis". The event "herpes zoster meningitis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram abdomen: negative for lymphadenopathy or neoplasm; computerised tomogram head: negative; computerised tomogram pelvis: negative for lymphadenopathy or neoplasm; computerised tomogram thorax: negative for lymphadenopathy or neoplasm; csf lymphocyte count: 89 %; csf white blood cell count: 750 /mm3, notes: with lymphocytic predominance; 200 /mm3; herpes virus test: positive, notes: (in the CSF); negative, notes: (study); lumbar puncture: csf analysis revealed 750, notes: white blood cells per mm3 with lymphocytic predominance; magnetic resonance imaging head: negative; negative; revealed multiple small enhancing leptomeningeal, notes: nodules throughout the dorsal cervical and thoracic spinal cord, along with abnormal enhancement involving the cauda equina nerve roots; magnetic resonance imaging spinal: revealed multiple small enhancing leptomeningeal, notes: nodules throughout the dorsal cervical and thoracic spinal cord, along with abnormal enhancement involving the cauda equina nerve roots; showed dramatic resolution of the leptomeningeal, notes: nodules; 25 days later. Therapeutic measures were taken as a result of herpes zoster meningitis.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments:  Based on the information in the case report, a possible causal relationship between reported events herpes zoster meningitis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200206631 Same article/drug/event; different patient;US-PFIZER INC-202200206630 Same article/drug/event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal
Clinical narrative: Herpes zoster meningitis; This is a literature report for the following literature source(s):  A 54 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER MENINGITIS (hospitalization, medically significant), outcome "recovered", described as "Herpes zoster meningitis". The event "herpes zoster meningitis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram abdomen: negative for lymphadenopathy or neoplasm; computerised tomogram head: negative; computerised tomogram pelvis: negative for lymphadenopathy or neoplasm; computerised tomogram thorax: negative for lymphadenopathy or neoplasm; csf lymphocyte count: 89 %; csf white blood cell count: 750 /mm3, notes: with lymphocytic predominance; 200 /mm3; herpes virus test: positive, notes: (in the CSF); negative, notes: (study); lumbar puncture: csf analysis revealed 750, notes: white blood cells per mm3 with lymphocytic predominance; magnetic resonance imaging head: negative; negative; revealed multiple small enhancing leptomeningeal, notes: nodules throughout the dorsal cervical and thoracic spinal cord, along with abnormal enhancement involving the cauda equina nerve roots; magnetic resonance imaging spinal: revealed multiple small enhancing leptomeningeal, notes: nodules throughout the dorsal cervical and thoracic spinal cord, along with abnormal enhancement involving the cauda equina nerve roots; showed dramatic resolution of the leptomeningeal, notes: nodules; 25 days later. Therapeutic measures were taken as a result of herpes zoster meningitis.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments:  Based on the information in the case report, a possible causal relationship between reported events herpes zoster meningitis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200206631 Same article/drug/event; different patient;US-PFIZER INC-202200206630 Same article/drug/event; different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: drug ineffective; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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), outcome "unknown", described as "drug ineffective"; COVID-19 (medically significant), outcome "unknown", described as "covid".  Clinical information: The patient reaching out to you to get help with eliquis 5 mg patient insurance would not pay for it but patient need the medicine and patient did take their shot but patient still got the covid , patient was suffering with blood clots in lungs and need the eliquis medicine to help so patient asked how to receive a discount or free samples of this medicine, patient would leave there name and phone number they look forward to hearing from phone number .  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Laboratory test
Clinical narrative: Patient had the delta variant; Patient had the delta variant; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ulcerative colitis" (ongoing), notes: since 10 years. Concomitant medication(s) included: ENTYVIO taken for colitis ulcerative (ongoing). Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), administration date: Feb2021, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "Patient had the delta variant". The patient underwent the following laboratory tests and procedures: laboratory test: (Nov2021) delta variant. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received 3rd dose in end of Aug. The patient was wondering if they should consider a 4th dose of the Pfizer Covid vaccine in March 5 months after the August vaccine. Caller said that she was looking for data whether this patient should or should not consider a 4th dose in March prior to travelling. Caller mentioned that she found data on 3rd doses, not necessarily on 4th doses. Caller also mentioned that the patient should wait for 90 days after the monoclonal antibody infusion before getting a vaccine. The reporter wanted to know how much the 4th dose would increase efficacy over the 3rd dose and what potential side effects it could have. The reporter stated that that she was looking for data and recommendation that insist would be more robust for Pfizer than any cross-over study.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Interchange of vaccine products
Clinical narrative: Got Pfizer as her first dose on 29Jan2021, had an allergic reaction to it.; Then got Moderna COVID-19 vaccine as her second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administration date 29Jan2021 (Batch/Lot number: unknown) at the age of 74 years as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm left, administration date 03Nov2021 (Lot number: 071F21A) as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 03Nov2021, outcome "unknown", described as "Then got Moderna COVID-19 vaccine as her second dose"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Got Pfizer as her first dose on 29Jan2021, had an allergic reaction to it.".  Clinical information: Patients stated that she got pfizer as her 1st dose on 29Jan2021 had an allergic reaction to it. The got the Moderna Covid-19 Vaccine as her 2nd dose (lot # 071F21A) on 03Nov2021 in her left arm she said that she just got a pain in her left arm after the 2nd dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on rapid antigen test; tested positive on rapid antigen test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Jun2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild asthma" (unspecified if ongoing), notes: mild asthma; "peanut allergy" (unspecified if ongoing), notes: peanut allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 31Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 30Jan2022, outcome "unknown" and all described as "tested positive on rapid antigen test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive, notes: Rapid antigen. Clinical course: It was reported that, patient received his second dose of Comirnaty on 17Jun2021, began experiencing a headache and nausea and sore throat on 30Jan2022.He tested positive on rapid antigen test on 31Jan2022. Patient also has mild asthma and peanut allergy. Event took place after use of product.  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, Headache, Malaise, Pain
Clinical narrative: Had Covid viruses after two doses of vaccine; Had Covid viruses after two doses of vaccine; Achy; Headache; Felt bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3  (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single 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 "Had Covid viruses after two doses of vaccine"; PAIN (non-serious), outcome "unknown", described as "Achy"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MALAISE (non-serious), outcome "unknown", described as "Felt bad". The patient underwent the following laboratory tests and procedures: covid-19: positive, notes: Delta Covid virus variant. The reporter stated that her daughter had two doses of the Moderna Covid vaccine, and got the Delta Covid virus variant. The reporter stated her daughter was achy, had a headache and felt bad after her booster. The reporter stated that the entire facility at her part time job was positive for Covid and they were all vaccinated. The reporter stated her daughter said that if she did not have the vaccine, she would have been much sicker.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Paraesthesia, Peripheral swelling, Swelling
Clinical narrative: Right armpit lymph nodes swollen; Right thumb, pointer finger, tingling and swollen, swelling inside forearm.; Soreness, right arm; Right thumb, pointer finger, tingling and swollen, swelling inside forearm.; Right thumb, pointer finger, tingling and swollen, swelling inside forearm.; the swelling is ongoing on the thumb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2022 18:00 (Lot number: FJ6396) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Covid vaccine: 17Mar2021, Lot Number / Expiry Date: EN6208, Route, Anatomical Location: left arm), administration date: 17Mar2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Second Covid vaccine, Lot Number / Expiry Date: EW0150, Route, Anatomical Location: left arm , No. of Previous Doses: one, Date: 07Apr2021), administration date: 07Apr2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Jan2022, outcome "unknown", described as "Right armpit lymph nodes swollen"; SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 28Jan2022, outcome "recovering" and all described as "Right thumb, pointer finger, tingling and swollen, swelling inside forearm."; PAIN IN EXTREMITY (non-serious) with onset 28Jan2022, outcome "recovered" (28Jan2022), described as "Soreness, right arm"; PARAESTHESIA (non-serious) with onset 28Jan2022, outcome "recovered" (30Jan2022), THUMB SUCKING (non-serious) with onset Jan2022, outcome "not recovered" and all described as "the swelling is ongoing on the thumb".  Additional Information: Vaccine Administered at Military Facility: No. Any AE(s) require a visit to Emergency Room: No and Physician Office: No. No prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations. No relevant tests were performed.  No follow-up attempts are possible. No further information is expected.