chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Weight
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): UNT-2022-004274 (Regulatory Authority). A 75 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for Covid-19 immunisation; influenza vaccine (FLU), administration date Feb2022 (Batch/Lot number: unknown) as unknown, single for antiviral prophylaxis; Treprostinil sodium (TYVASO), first regimen since 29Jan2022 (Batch/Lot number: unknown) at 36 ug 4x/day, second regimen since Feb2022 (Batch/Lot number: unknown) at 18 ug 4x/day and third regimen (ongoing) (Batch/Lot number: unknown) at 36 ug 4x/day for pulmonary arterial hypertension. Relevant medical history included: "Pulmonary arterial hypertension", start date: Feb2022 (ongoing). 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: COUGH (non-serious) with onset Feb2022, outcome "not recovered", described as "Continued baseline cough associated with IH TYVASO treatments"; THROAT IRRITATION (non-serious) with onset Feb2022, outcome "unknown", described as "Throat irritation"; OEDEMA (non-serious) with onset Feb2022, outcome "unknown", described as "Edema"; DIZZINESS (non-serious) with onset Feb2022, outcome "unknown", described as "Was not moving around well and was getting dizzy". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for Treprostinil sodium was dosage not changed. Additional information: The male patient began therapy with IH TYVASO (Treprostinil sodium, concentration of 0.6 mg/ml) delivered by TYVASO Inhalation Device (TD-300/A), on an unspecified date in Feb2022 for pulmonary arterial hypertension. The current dose was reported as 18 µg (3 breaths) four times a day (QID), via inhalation (IH) route. On an unspecified date in Feb 2022 (late last week), the patient got her third Covid vaccination and flu shot. Her blood pressure and weight remained stable. She was overall feeling better after that day with the vaccination. It was unknown if the physician was aware. The reporter's causality for the event cough with IH TYVASO was considered to be possibly related. The reporter did not provide causality for the events of throat irritation and oedema. The reporter did not provide causality for the event of dizziness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Peripheral swelling
Clinical narrative: red swollen lump on her arm; insomnia; anxiety; 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 56 year-old female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Batch/Lot number: unknown) at the age of 55 years 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "red swollen lump on her arm"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia"; ANXIETY (non-serious), outcome "unknown", described as "anxiety".  Additional information: Caller stated that she got the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 18Aug2021 and immediately after that she started experiencing insomnia and anxiety. Aside from that, she also has a red swollen lump on her arm. She was told to wait 3-6 months to get the second dose, but the symptoms have not receded.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Laryngitis, SARS-CoV-2 test
Clinical narrative: Loss of voice within 2 days of getting the booster; Laryngitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm right, administration date 21Jan2022 (Lot number: F55683) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines (one and off)" (unspecified if ongoing), notes: Migraines (one and off); "COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Right), administration date: 27Feb2021, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Since the vaccination, the patient has been tested for COVID-19", "Since the vaccination, the patient has been tested for COVID-19"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Right), administration date: 01Feb2021, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Since the vaccination, the patient has been tested for COVID-19", "Since the vaccination, the patient has been tested for COVID-19". The following information was reported: APHONIA (non-serious) with onset 23Jan2022, outcome "not recovered", described as "Loss of voice within 2 days of getting the booster"; LARYNGITIS (non-serious) with onset 23Jan2022, outcome "not recovered", described as "Laryngitis". The events "loss of voice within 2 days of getting the booster" and "laryngitis" 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 aphonia, laryngitis.  Additional information: This case was reported as non serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The patient received (doctor believed cause at the time was laryngitis) treatment for the adverse event Prednisone.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female 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: Bnt162b2 (Dose 1), administration date: Dec2021, for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: Dec2021, for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "Flu". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis Rosea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2022 16:45 (Lot number: FK9896) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose number=2, product=COVID 19, brand=Pfizer, lot number=FF2589, administration date=05Oct2021 , administration time=12:00 PM, vaccine location=Left arm), administration date: 05Oct2021, when the patient was 26 years old, for COVID-19 immunization; Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer, lot number=FF2588, administration date=17Sep2021, administration time=12:00 PM, vaccine location=Left arm), administration date: 17Sep2021, when the patient was 26 years old, for COVID-19 immunization. It was reported that patient was not suffered with Covid 19 prior to vaccination. Patient was not tested Covid positive post vaccination.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Feb2022 16:45, outcome "unknown", described as "Dose number=3; administration date=25Feb2022/ dose number=2; administration date=05Oct2021"; PITYRIASIS ROSEA (non-serious) with onset 06Mar2022 12:00, outcome "not recovered", described as "Pityriasis Rosea". The event "pityriasis rosea" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pityriasis rosea.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Immune system disorder
Clinical narrative: after the patients got their shot, their immune system was off track; get sick all the time; the patients got off track and get sick all the time.; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown, solution for injection) 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: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "after the patients got their shot, their immune system was off track; get sick all the time"; ILLNESS (non-serious), outcome "unknown", described as "the patients got off track and get sick all the time.". Additional information: The doctor mentioned the COVID vaccine and said she had three patients who had a bad immune system, she finally got the patients on track and states after the patients got their shot, their immune system was off track. The caller asked the doctor if she reported this in VAERS or with Pfizer if it's Pfizer's vaccine, and the doctor didn't respond. The caller asked the doctor which of the three manufacturers she was referring to and the doctor didn't clarify between the three manufacturers. The doctor only said the patients got off track and get sick all the time. Caller confirmed the reporter was a physician. Details of the patient: Unknown. The caller mentions the patients did have comorbidities, but the caller did not ask for any patient details. She believes that was a violation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200402607 Same product and event, different patient;US-PFIZER INC-202200402705 Same product and event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Illness, Immune system disorder
Clinical narrative: after the patients got their shot, their immune system was off track; get sick all the time; after the patients got their shot, their immune system was off track; get sick all the time; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (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: IMMUNE SYSTEM DISORDER (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "after the patients got their shot, their immune system was off track; get sick all the time".  Additional information: The doctor mentioned the COVID vaccine and said she had three patients who had a bad immune system, she finally got the patients on track and states after the patients got their shot, their immune system was off track. The caller mentions the patients did have comorbidities, but the caller did not ask for any patient details. She believes that is a violation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200402607 Same product and event, different patient; US-PFIZER INC-202200402704 Same product and event, different patient
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Maternal exposure before pregnancy, Myositis
Clinical narrative: Is pregnant: Yes; last menstrual date 23Dec2020; Chest pain; Tingling down arm; Feels like pinched nerve; Feels like pinched nerve and muscle inflammation on left side of chest and around sholder; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FC3180) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seizure history" (unspecified if ongoing), notes: Seizure history; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Date of last menstrual period: 23Dec2020. The patient was 34 weeks pregnant at the time of exposure to bnt162b2. The patient was 45 weeks pregnant at the event onset. The patient is expected to deliver a baby(s). Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Past drug history included: Cephalex for Known allergies: Cephalex, notes: Known allergies: Cephalex. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left), administration date: 30Jul2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes; last menstrual date 23Dec2020"; CHEST PAIN (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Chest pain"; PARAESTHESIA (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Tingling down arm"; NERVE COMPRESSION (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Feels like pinched nerve"; MYOSITIS (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Feels like pinched nerve and muscle inflammation on left side of chest and around sholder". The events "chest pain", "tingling down arm", "feels like pinched nerve" and "feels like pinched nerve and muscle inflammation on left side of chest and around sholder" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest pain, paraesthesia, nerve compression, myositis.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve compression, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Is pregnant: Yes; last menstrual date 23Dec2020; Chest pain; Tingling down arm; Feels like pinched nerve; Feels like pinched nerve and muscle inflammation on left side of chest and around sholder; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FC3180) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seizure history" (unspecified if ongoing), notes: Seizure history; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Date of last menstrual period: 23Dec2020. The patient was 34 weeks pregnant at the time of exposure to bnt162b2. The patient was 45 weeks pregnant at the event onset. The patient is expected to deliver a baby(s). Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Past drug history included: Cephalex for Known allergies: Cephalex, notes: Known allergies: Cephalex. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left), administration date: 30Jul2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes; last menstrual date 23Dec2020"; CHEST PAIN (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Chest pain"; PARAESTHESIA (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Tingling down arm"; NERVE COMPRESSION (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Feels like pinched nerve"; MYOSITIS (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Feels like pinched nerve and muscle inflammation on left side of chest and around sholder". The events "chest pain", "tingling down arm", "feels like pinched nerve" and "feels like pinched nerve and muscle inflammation on left side of chest and around sholder" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest pain, paraesthesia, nerve compression, myositis.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Peripheral swelling, Swelling
Clinical narrative: In the arm or the shoulder that I got the shot I had severe swelling and I have pain on the opposite side also, in the other shoulder too; severely swollen shoulder at the top; In the arm or the shoulder that I got the shot I had severe swelling and I have pain on the opposite side also, in the other shoulder too; severely swollen shoulder at the top; This morning my armpit underneath is swollen/swelling; I have pain on the opposite side also, in the other shoulder too."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Mar2022 09:00 (Batch/Lot number: unknown) at the age of 53 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: 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: PERIPHERAL SWELLING (non-serious), PAIN (non-serious) all with onset Mar2022, outcome "not recovered" and all described as "In the arm or the shoulder that I got the shot I had severe swelling and I have pain on the opposite side also, in the other shoulder too; severely swollen shoulder at the top"; SWELLING (non-serious) with onset Mar2022, outcome "not recovered", described as "This morning my armpit underneath is swollen/swelling"; ARTHRALGIA (non-serious) with onset Mar2022, outcome "not recovered", described as "I have pain on the opposite side also, in the other shoulder too."". Therapeutic measures were not taken as a result of peripheral swelling, pain, swelling, arthralgia.  Additional information: Patient reported vitamins as concomitant product. She had prior vaccination of first shot and the second shot. She received the booster vaccine on Wednesday.Consumer stated height was "5 feet" (When clarified reported as 5 feet 2 inches, consumer confirmed the same).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: sore arm for a day or two; 1st dose. Date: 10May2021/2nd dose. Date: 29Jun2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDCA22-00635 (Moderna).  A male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS. Vaccination history included: Bnt162b2 (1st dose, Route: Intramuscular injection left arm), administration date: 10May2021, for COVID-19 Immunization, reaction(s): "Sore arm for a day ". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm for a day or two"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Jun2021, outcome "unknown", described as "1st dose. Date: 10May2021/2nd dose. Date: 29Jun2021".  Additional information: Concomitant/regular medication: Ocrevus once every 6 months. Last dose received in Oct. Wait 5 months. Next infusion is next month. Allergies (medications, food and other products). No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pain in extremity
Clinical narrative: First vaccine: headache; First Dose: pain in her arm; had shingles by that time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 (Lot number: EL9266) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart surgery she had three bypasses" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "Arthritis" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "Diabetes" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "thyroid" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "Blood cholesterol" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "for her heart" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder; METFORMIN taken for diabetes mellitus; ATORVASTATIN taken for blood cholesterol abnormal; GLIPIZIDE XL taken for diabetes mellitus; GABAPENTIN taken for arthritis. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "First vaccine: headache"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "First Dose: pain in her arm"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "had shingles by that time".  Additional information: No investigation assessment was done. The caller got the first vaccine and she had a headache and pain in her arm and it was fine because it then went away. The caller got the first shot of the Pfizer COVID 19 vaccine on 23Feb2021 clinic. When the caller got the first one she had a headache. The caller felt like her head was going to explode because she just had shingles by that time. The caller got her vaccines at (Hospital withheld). The caller provides informatiom from her vaccination card. Everyone was saying that senior people have to get the vaccine and there were a lot of announcements. It was a law and 4 of the caller's brothers died of COVID. The caller took the same medications that she took for many years. The caller also takes another medication but she did not know the name of it. The caller did not have allergies to medications and has no records for allergies. The caller's doctor has this information. The caller wanted treatment.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US057269_NS.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 70 years 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: RASH (non-serious), outcome "unknown", described as "rash on body".  Additional information: It was stated that, patient had no reaction at first then had a Covid shot in Nov2021- got a rash on body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blue toe syndrome
Clinical narrative: I developed ''covid toes'' (blue toe syndrome) on all occasions of getting the vaccine. Right now, I still have scabs healing. It has been 10 weeks since my booster shot. I am healthy otherwise.; lost my sense of smell and taste somehow.; lost my sense of smell and taste somehow.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jan2022 15:00 (Lot number: fl3197) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: wood dust" (unspecified if ongoing), notes: Known allergies: Cipro, wood dust, seasonal pollen; "Known allergies: seasonal pollen" (unspecified if ongoing), notes: Known allergies: Cipro, wood dust, seasonal pollen. The patient's concomitant medications were not reported. Past drug history included: Cipro for Known allergies: Cipro, notes: Known allergies: Cipro, wood dust, seasonal pollen. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0187, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 22May2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 01May2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: BLUE TOE SYNDROME (non-serious) with onset 04Jan2022, outcome "not recovered", described as "I developed ''covid toes'' (blue toe syndrome) on all occasions of getting the vaccine. Right now, I still have scabs healing. It has been 10 weeks since my booster shot. I am healthy otherwise."; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 04Jan2022, outcome "not recovered" and all described as "lost my sense of smell and taste somehow.". Therapeutic measures were not taken as a result of blue toe syndrome, anosmia, ageusia.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Patient had never been tested for Covid19. No COVID prior vaccination. No COVID tested post vaccination. 'Thin veins' run in the family.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: her periods has been much worse; cramps has been very difficult to manage; her periods has been much worse; cramps has been very difficult to manage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single and administration date 12Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "her periods has been much worse; cramps has been very difficult to manage". Therapeutic measures were taken as a result of dysmenorrhoea. Additional information: Reporter was calling to report about the adverse reaction for daughter. She has the 'fungus' (voice not clear). She had the Pfizer vaccine in Sep when she was 14, she was 15 now but she was 14 and her periods has been much worse and reporter have heard that the people have that side effect (general statement, further clarifications unknown hence split not made). And the cramps have been very difficult to manage. First or the second shot were only a couple of weeks apart, so reporter don't know she had both. LOT#: Pfizer 10121 (Not clarified hence not captured) and that was on (12Aug2021). The date was 12Aug2021 with the first one. The second was LOT#8448 and that was given on 03Sep2021. Patient did not receive Any prior vaccinations. For the cramp patient have been using the heating pad and Midol.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 (Lot number: EL3302) at the age of 75 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that, patient called because she has question about the Covid vaccine and she has experienced adverse events. She has a question about long term side effects, she had the first and second dose of the Covid Vaccine. First dose on 28Jan2021, Second dose on 25Feb2021, and she also had booster on 01Nov2021. She had a sore arm after first two doses and after booster shot, after a month she experienced joint pain, shoulder and knee joint pain. Caller wants to know if this delayed reaction are from the vaccine. No any prior Vaccinations (within 4 weeks), no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; 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 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 (Lot number: EL3242) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, date: 28Jan2021, Lot: EL3302), administration date: 28Jan2021, when the patient was 75 years old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm".  Additional information: Consumer (name-withheld) calling, unknown telephone number. Called because she has question about the Covid vaccine and she has experienced adverse events. She has a question about long term side effects, she had the first and second dose of the Covid Vaccine. First dose on 28Jan2021, second dose on 25Feb2021, and she also had booster on 01Nov2021. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines.  No follow-up attempts are possible. No further information is expected.
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).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Dizziness/felt dizzy; can not balance herself; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (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 (Primary Immunization series complete, unknown manufacturer, Dose number unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "Dizziness/felt dizzy"; BALANCE DISORDER (non-serious), outcome "unknown", described as "can not balance herself". Additional information: Patient after receiving the booster dose of pfizer BioNtech vaccine on 03Dec2021, has been experiencing Dizziness and would like to know if this was a side effect from the vaccine or it might be her iron level. She still felt dizzy up to date and cannot balance herself.  Follow-up attempts completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Hypoaesthesia, Pain in extremity
Clinical narrative: I almost fainted immediately after the first dose/Felt faint for a few days; my arm and fingers on the left side went numb; Severe chills; fever over 100F; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2022 17:00 (Lot number: Fk9895) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Past drug history included: Morphine, reaction(s): "Known Allergies: Morphine". The following information was reported: DIZZINESS (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "I almost fainted immediately after the first dose/Felt faint for a few days"; HYPOAESTHESIA (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "my arm and fingers on the left side went numb"; CHILLS (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "Severe chills"; PYREXIA (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "fever over 100F"; PAIN IN EXTREMITY (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, hypoaesthesia, chills, pyrexia, pain in extremity. Clinical course: The patient almost fainted immediately after the first dose and my arm and fingers on the left side went numb. Severe chills for a few days. Felt faint for a few days, fever over 100F. Sore arm.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I almost fainted immediately after the first dose/Felt faint for a few days; my arm and fingers on the left side went numb; Severe chills; fever over 100F; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2022 17:00 (Lot number: Fk9895) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Past drug history included: Morphine, reaction(s): "Known Allergies: Morphine". The following information was reported: DIZZINESS (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "I almost fainted immediately after the first dose/Felt faint for a few days"; HYPOAESTHESIA (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "my arm and fingers on the left side went numb"; CHILLS (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "Severe chills"; PYREXIA (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "fever over 100F"; PAIN IN EXTREMITY (non-serious) with onset 19Feb2022 18:00, outcome "recovering", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, hypoaesthesia, chills, pyrexia, pain in extremity. Clinical course: The patient almost fainted immediately after the first dose and my arm and fingers on the left side went numb. Severe chills for a few days. Felt faint for a few days, fever over 100F. Sore arm.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses; 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 male patient received bnt162b2 (COMIRNATY) (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 and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses".  Additional Details: He called to receive his third dose of Pfizer COVID-19 vaccine, he received his second dose on 14Sep, he also calls on behalf of his wife who also wanted to received the third dose of the vaccine. During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses. Agency: e-transmitting probable AE noticed during documentation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received bnt162b2 (COMIRNATY), administration date 14Sep2021 (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 and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses". Additional information: When he will be called to receive his third dose of Pfizer COVID-19 vaccine, he received his second dose on 14Sep, he also calls on behalf of his wife: who also wants to receive the third dose of the vaccine. During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Onset of unilateral (right) chronic facial pain eventually diagnosed as trigeminal neuralgia/ pain associated with trigeminal neuralgia diagnosis; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received the third dose of bnt162b2 (BNT162B2) via an unspecified route of administration, administered in the left arm, on an unspecified date (batch/lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Relevant medical history included: "Childhood Guillain-Barre" (unspecified if ongoing), notes: early infancy, 4MO, believed to be triggered by routine childhood vaccinations; "Routine childhood vaccinations" (not ongoing); "Known allergies: Tomatoes" (unspecified if ongoing). Patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, via an unspecified route of administration, administered in the left arm (batch/lot number: EN5318) as DOSE 1, SINGLE) for COVID-19 immunization; Bnt162b2 (second dose, via an unspecified route of administration, administered in the left arm (batch/lot number: EL3249) as DOSE 2, SINGLE), for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The following information was reported: TRIGEMINAL NEURALGIA (medically significant) with onset 10Dec2021, outcome "not recovered" described as "Onset of unilateral (right) chronic facial pain eventually diagnosed as trigeminal neuralgia/ pain associated with trigeminal neuralgia diagnosis." The event was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of trigeminal neuralgia which included Gabapentin, Prednisone, antibiotics (as reported). The clinical course was reported as follows: Onset of unilateral (right) chronic facial pain (eventually diagnosed as trigeminal neuralgia) shortly after receiving third dose of vaccination. Pain associated with trigeminal neuralgia diagnosis persists though lessened by prescription of 300mg Gabapentin 3 times per day. Patient was not tested for COVID-19 post vaccination.  The batch/lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: got hives all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (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: URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "got hives all over my body". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient got the first dose of the Pfizer COVID 19 vaccine last year and had a reaction to it. patient got hives all over her body and had to be on steroids for 1 week. patient asked should I get the 2nd dose? her PCP said it's her choice.  Follow-up attempts completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Haemolytic anaemia, Immunisation, Off label use
Clinical narrative: Hemolytic anemia; vaccine dose number=4; vaccine dose number=4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2022 12:00 (Lot number: FL3198) at the age of 70 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Kidney transplant patient" (unspecified if ongoing). No known allergies. Concomitant medication(s) received within 2 weeks included: METOPROLOL; MYCOPHENOLATE; TACROLIMUS. Vaccination history included: Bnt162b2 (vaccine brand=Pfizer / BioNTech,, vaccine administration date=03Mar2022, vaccine lot number=EN6205,, vaccine dose number=1,, vaccine location=Left arm.), administration date: 03Mar2021, when the patient was 69 years old, for COVID-19 immunisation; Bnt162b2 (vaccine brand=Pfizer / BioNTech,, vaccine administration date=25Mar2021, vaccine lot number=ER2613,, vaccine dose number=2,, vaccine location=Left arm.), administration date: 25Mar2021, when the patient was 69 years old, for covid- 19 immunisation; Bnt162b2 (vaccine brand=Pfizer / BioNTech,, vaccine administration date=14Aug2021,, vaccine administration time=12:00AM, vaccine lot number=FA7484,, vaccine dose number=3,, vaccine location=Left arm.), administration date: 14Aug2021, when the patient was 69 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 03Feb2022 12:00 and all described as "vaccine dose number=4"; HAEMOLYTIC ANAEMIA (medically significant) with onset 06Feb2022 05:00, described as "Hemolytic anemia". Therapeutic measures were not taken as a result of haemolytic anaemia.  No follow-up attempts are possible. No further information is expected.