chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, X-ray
Clinical narrative: feet were swollen up/legs were swollen up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PERIPHERAL SWELLING (medically significant), outcome "unknown", described as "feet were swollen up/legs were swollen up". The event "feet were swollen up/legs were swollen up" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; coagulation time: unknown results; echocardiogram: unknown results; x-ray: unknown results. Clinical course: Call in January went in for a wellness check. Caller told doctor it had been more than 10 years and her doctor told her she had to get the pneumonia shot. A couple of days after the pneumonia shot caller's feet were swollen up, within 4 days her legs were swollen up.  She went back to doctor, sent for a blood clots in the leg test for both legs because both legs are swollen up. Can't get shoes on. Tests: Caller has had an echocardiogram, x-rays, orthopedic surgeons, more blood tests and no one can help, doctors can't help. Caller has spoken to people and no one can help. She has been up and down since January and no one can help. Caller is 80 years old, pissed, frustrated, could be dead.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hyperacusis, Photophobia
Clinical narrative: lights and sounds mildly affected me/After that dose, lights as well as sound started to get worse for me; lights and sounds mildly affected me/After that dose, lights as well as sound started to get worse for me; lights and sounds mildly affected me/After that dose, lights as well as sound started to get worse for me; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 10:30 (Lot number: FE3594) at the age of 29 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "Covid-19", start date: Sep2021 (unspecified if ongoing); "Since then lights and sounds mildly affected me" (unspecified if ongoing), notes: but not enough to hinder my day to day routine. The patient had no known allergies. Concomitant medication included: DILANTIN [PHENYTOIN]. The following information was reported: PHOTOPHOBIA (disability), HYPERACUSIS (disability), CONDITION AGGRAVATED (disability), outcome "unknown" and all described as "lights and sounds mildly affected me/After that dose, lights as well as sound started to get worse for me". Patient reported that, "I was positive for COVID-19 in the end of Sep2021. Since then lights and sounds mildly affected me but not enough to hinder my day to day routine. I received my first dose of Pfizer in Jan2022. After that dose, lights as well as sound started to get worse for me however I was still able to work out and go to work as usual." The patient was not tested for COVID, post vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease
Clinical narrative: Graves disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: EP6955) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Metal substances, aluminum, nickel, cobalt" (unspecified if ongoing), notes: Known allergies: Metal substances, aluminum, nickel, cobalt; "Degenerative disc disease" (unspecified if ongoing); "Degenerative disc disease, lumbar and cervical" (unspecified if ongoing); "Degenerative disc disease, lumbar and cervical" (unspecified if ongoing); "small bowel obstructions" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left), administration date: 06Mar2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: BASEDOW'S DISEASE (disability) with onset 01Apr2021, outcome "not recovered", described as "Graves disease". The event "graves disease" was evaluated at the physician office visit. Therapeutic measures were taken as a result of basedow's disease. The patient did not have COIVD prior vaccination and was not COVID tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Myasthenia gravis
Clinical narrative: myasthenia gravesites; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-6-month-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Goats milk allergy" (unspecified if ongoing), notes: Goats milk. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown., Location of injection: Arm Right), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), for COVID-19 Immunization. The patient had no family history of myasthenia gravesites. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: MYASTHENIA GRAVIS (hospitalization, disability, medically significant) with onset 24Feb2022, outcome "recovered with sequelae", described as "myasthenia gravesites". The patient was hospitalized for myasthenia gravis (hospitalization duration: 6 day(s)). The event "myasthenia gravesites" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram of chest: no thymus involved. Therapeutic measures were taken as a result of myasthenia gravis, IV (intravenous) IEGg 5 doses steroids. Since the vaccination, the patient hadn't been tested for COVID-19. Lot unknown reason was misplaced/discarded.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test: Covid-19, Result: Positive; Test: Covid-19, Result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 14:45 (Batch/Lot number: unknown) at the age of 21 years as dose 2, single and administered in arm left, administration date 07Apr2021 14:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history: Depression; "anxiety" (unspecified if ongoing), notes: other medical history: anxiety; "IUD" (unspecified if ongoing), notes: other medical history: IUD; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "known allergies: any cillins" (unspecified if ongoing), notes: known allergies: any cillins. Concomitant medication(s) included: PAXIL [PAROXETINE HYDROCHLORIDE]; BUSPAR; ACETAMINOPHEN; TYLENOL. Past drug history included: Amoxicillin, reaction(s): "Allergy: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "unknown" and all described as "Test: Covid-19, Result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: Nasal Swab. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient has been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bursitis, Gait disturbance, Illness, Inflammation
Clinical narrative: Diagnosed with Lupus; fingers are so swollen; I can't even write. So, all I can do is I can use the telephone. I can't text; gotten really sick; Bursitis; Arthritis; major inflammation all over my body; not being able to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 (Lot number: FC3182) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Batch/lot number: FC3182; Anatomical site of administration: Left arm), administration date: 17Aug2021, when the patient was 55 years old, for Covid-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 25Mar2022, outcome "unknown", described as "Diagnosed with Lupus"; ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "gotten really sick"; BURSITIS (non-serious) with onset Sep2021, outcome "unknown", described as "Bursitis"; ARTHRITIS (non-serious) with onset Sep2021, outcome "unknown", described as "Arthritis"; INFLAMMATION (non-serious) with onset Sep2021, outcome "not recovered", described as "major inflammation all over my body"; GAIT DISTURBANCE (non-serious) with onset Sep2021, outcome "unknown", described as "not being able to walk"; PERIPHERAL SWELLING (non-serious) with onset Mar2022, outcome "unknown", described as "fingers are so swollen"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Mar2022, outcome "unknown", described as "I can't even write. So, all I can do is I can use the telephone. I can't text". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (26Mar2022) unknown results. Therapeutic measures were not taken as a result of systemic lupus erythematosus, illness, bursitis, arthritis, inflammation, gait disturbance, peripheral swelling, loss of personal independence in daily activities. Clinical course: Patient was reportedly very healthy prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging, Peripheral swelling, Systemic lupus erythematosus
Clinical narrative: Diagnosed with Lupus; fingers are so swollen; I can't even write. So, all I can do is I can use the telephone. I can't text; gotten really sick; Bursitis; Arthritis; major inflammation all over my body; not being able to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 (Lot number: FC3182) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Batch/lot number: FC3182; Anatomical site of administration: Left arm), administration date: 17Aug2021, when the patient was 55 years old, for Covid-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 25Mar2022, outcome "unknown", described as "Diagnosed with Lupus"; ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "gotten really sick"; BURSITIS (non-serious) with onset Sep2021, outcome "unknown", described as "Bursitis"; ARTHRITIS (non-serious) with onset Sep2021, outcome "unknown", described as "Arthritis"; INFLAMMATION (non-serious) with onset Sep2021, outcome "not recovered", described as "major inflammation all over my body"; GAIT DISTURBANCE (non-serious) with onset Sep2021, outcome "unknown", described as "not being able to walk"; PERIPHERAL SWELLING (non-serious) with onset Mar2022, outcome "unknown", described as "fingers are so swollen"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Mar2022, outcome "unknown", described as "I can't even write. So, all I can do is I can use the telephone. I can't text". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (26Mar2022) unknown results. Therapeutic measures were not taken as a result of systemic lupus erythematosus, illness, bursitis, arthritis, inflammation, gait disturbance, peripheral swelling, loss of personal independence in daily activities. Clinical course: Patient was reportedly very healthy prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: experienced a breakthrough COVID infection; experienced a breakthrough COVID infection; 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 parent.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 11 years 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "experienced a breakthrough COVID infection".  Clinical course includes that, Verbatim and Event Description: During an interview with a consumer, he stated that his daughter was fully vaccinated (received both doses), with the Pfizer COVID-19 vaccine, but still experienced a breakthrough COVID infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: My daughter cannot feel her arms, hands and feet/she lost feeling on the left side of her hip; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 30Mar2022, this case now contains all required information to be considered valid.  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 (005570). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Anatomical Location:Left Arm), for Covid-19 Immunization, reaction(s): "she lost sensitivity in her fingers". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "My daughter cannot feel her arms, hands and feet/she lost feeling on the left side of her hip". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller clarified that he was asking for treatment recommendations for his daughter. After the first shot, 2-3 hours later, she lost sensitivity in her fingers. The next morning, it went away.Two weeks later or something like 28 days after, immediately after the second shot, she lost feeling in her hand then her arm. After a couple days she could not feel her right arm and hands. Subsequently, she lost feeling on the left side of her hip. Eventually, couple of months later, she lost feeling in her feet.They had MRIs which were clean.They had EMG in which needles were poked through the muscles in her daughter's arm, in which her daughter couldn't feel the needles going in. The test was normal. They have went to neurologists and to a chiropractor in which nothing worked. The psychologist thinks it was in her head. Caller believes it didn't a psychological issue. He firmly believes it was from the shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; 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. The reporter is the patient.  A 84 year-old 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), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain". Therapeutic measures were taken as a result of pain.  Additional information: Patient states she is disappointed in Pfizer's answer in regards to how long someone should wait after taking Advil, before taking the Pfizer Covid Booster vaccine. Caller states she took 2 Advil on Tuesday morning because she had pain from a recent surgery. She is scheduled to have her 2nd Booster shot Thursday afternoon. Caller is asking if taking the Advil will interfere with her booster shot. Patient confirms above information and adds she was wondering if it will lessen the effect of the Pfizer booster. She knows that we are not supposed to take it close to each other and they are close together but asks if that was too close. States she didn't know when she took the Advil that she was to going to get the shot. It now has her worried and wondering if she should change the date she was to get the booster shot if this was going to be causing so many issues. She wants it to be effective. This was important to her she is 84 years old and can't afford to be fooling around and there was no second chance. She doesn't want medical advice she just wants to know if she needs to wait more than 48 hours.  Caller confirms this will be her 2nd booster and she already received the other three series from Pfizer.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: EW0169) at the age of 46 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Bell's palsy" (unspecified if ongoing); "Trigeminal neuralgia" (unspecified if ongoing). Concomitant medication(s) included: LYRICA. Vaccination history included: Bnt162b2 (Dose: 01, Lot: ER8733), administration date: 30Jan2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: DIABETES MELLITUS (hospitalization, medically significant) with onset Jan2022, outcome "unknown", described as "Diagnosed with diabetes"; BELL'S PALSY (hospitalization, medically significant), outcome "not recovered", described as "She also has bell's palsy"; HEADACHE (hospitalization) with onset Apr2021, outcome "unknown", described as "Head was pounding"; PYREXIA (hospitalization) with onset Apr2021, outcome "unknown", described as "High fever"; ASTHENIA (hospitalization) with onset Apr2021, outcome "unknown", described as "No energy at all"; BALANCE DISORDER (hospitalization) with onset Apr2021, outcome "unknown", described as "Felt off balance, kind of like her equilibrium was off"; BLOOD LACTIC ACID INCREASED (hospitalization), outcome "unknown", described as "Lactic acid was elevated"; SWELLING FACE (hospitalization), outcome "unknown", described as "Facial swelling"; TRIGEMINAL NEURALGIA (hospitalization), outcome "recovered", described as "She has trigeminal neuralgia behind her left eye"; CONDITION AGGRAVATED (hospitalization), outcome "unknown", described as "Clarifies that the flare up started before she received the vaccine but got worse after the second dose and she could not bear the pain anymore."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "head was real foggy". The patient was hospitalized for headache, pyrexia (start date: 21Apr2021, discharge date: 24Apr2021, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: blood culture: (unspecified date) negative, notes: Her doctor thought she was severely sepsis, but her results were negative; blood glucose abnormal: (unspecified date) high; blood lactic acid: (unspecified date) elevated; body temperature: (Apr2021) high, notes: High fever; glycosylated haemoglobin: (unspecified date) diabetes, notes: She asked to check her A1C and she was then diagnosed with diabetes. Therapeutic measures were taken as a result of trigeminal neuralgia. Clinical course: Symptoms after 2nd dose of Pfizer Vaccine: Head was pounding, high fever, no energy at all, felt off balance and what she means by that is her head was real foggy, kind of like her equilibrium was off. All started 6-8 hours after the 2nd dose was given. Symptoms after 3rd dose: 104.3 Fever, headache, loss of appetite, aches. only lasted 24 hours and then she bounced right back.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to chemicals, Interchange of vaccine products, Off label use
Clinical narrative: Off-Label use; Interchange of vaccine products; usually has sensitive reactions to the chemicals added to the gray cap; 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) (Batch/Lot number: unknown) as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "having reactions to a Pneumonia vaccine in the past" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen vaccine (first she got the Janssen vaccine), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off-Label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine products"; ALLERGY TO CHEMICALS (non-serious), outcome "unknown", described as "usually has sensitive reactions to the chemicals added to the gray cap".  Additional Information: It was reported that patient was going to get her 3rd shot of the Pfizer COVID-19 Vaccine yesterday but she usually has sensitive reactions to the chemicals added to the Gray cap, that the Purple cap did not had. She stated having reactions to a Pneumonia vaccine in the past. Caller stated to be looking for data on new shot, specifically if there were any reports on different AEs reported between the purple and gray cap. Caller mentioned that first she got the Janssen vaccine and not developing antibodies and that that's when her doctor suggested she get the Pfizer COVID-19 Vaccine. She also said that when she got the first dose she was monitored for over an hour and she did not get any side effects, but now she has worried the gray could cause her a reaction. Caller wanted to know where could she find any specific pharmacy that still had the purple cap, caller wanted to know if we were still manufacturing the purple cap. Caller wanted to know if we in Pfizer were the ones making Comirnaty. She stated being very afraid of going to the hospital for not being able to find the purple cap.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Condition aggravated, Cyanosis, Gait disturbance
Clinical narrative: I have alot of trouble walking; I have no balance at all; my lower legs and feet are turning blue and purple; have alot of trouble walking and it is progressively getting alot worse; 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 COVID-19 Vaccine - Manufacturer Unknown, administration date Jun2021 (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) with onset 2021, outcome "not recovered", described as "I have a lot of trouble walking"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I have no balance at all"; CYANOSIS (non-serious) with onset 2021, outcome "unknown", described as "my lower legs and feet are turning blue and purple"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "have a lot of trouble walking and it is progressively getting a lot worse".  Additional information: Ever since the patient has received 1st covid vaccine at the end of Jun2021. The patient have a lot of trouble walking and it was progressively getting a lot worse. The patient had to hold on to things just to walk or to stay in a standing position. Now the patient had no balance at all. This all began 2 days after the vaccine. Now lower legs and feet are turning blue and purple.  The lot number for vaccine [Manufacture unknown] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral venous disease
Clinical narrative: she reported to have venous insufficiency in her hands, describing that the blood comes into the hands but doesn't go back up; and that it is related to de vaccine. This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (COMIRNATY) (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: PERIPHERAL VENOUS DISEASE (non-serious), outcome "unknown", described as "she reported to have venous insufficiency in her hands, describing that the blood comes into the hands but doesn't go back up; and that it is related to de vaccine.".  Additional information: Caller was a dentist reached as a consumer in order to report an AE regarding Pfizer COVID-19 Vaccine. She reported to have venous insufficiency in her hands, described that the blood comes into the hands but doesn't go back up, and that it was related to the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I developed tinnitus after the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team 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: TINNITUS (non-serious), outcome "unknown", described as "I developed tinnitus after the vaccine". Additional information: The patient developed tinnitus after the vaccine and doctor said it's hearsay and would not treat. The patient was concerned what to do and asked for ideas to help.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Other Health Professional) from product quality group. The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech COVID-19), administered in arm left, administration date 03Jan2022 (Lot number: FL3197) at the age of 62 years as dose 3 (booster), single, administered in arm left, administration date 03Jul2021 (Lot number: EW0180) as dose 2, single and administered in arm left, administration date 12Jun2021 (Lot number: EW0182) as dose 1, single for covid-19 immunisation. Relevant medical history included: "parathyroid disease (removal of diseased parathyroid 2015)" (unspecified if ongoing); "Bicuspid Aortic Valve" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "removal of diseased parathyroid", start date: 2015 (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 05Feb2021; CHELATED MAGNESIUM [MAGNESIUM CHELATE]; QUERCETIN; OMEGA-3 FATTY ACIDS; ESTER-C [ASCORBIC ACID]; DIM DETOX; COQ10 [UBIDECARENONE]; SAW PALMETTO [SERENOA REPENS]; METHYL B COMPLEX; DHEA; VIT D3; PREGNENOLONE; BERGAMOT BPF; Pure Genomics Multivitamin; Stamets 7. No known allergies The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. Treatment with PAXLOVID(Treatment start date: Mar2022, Lot number: FX2740); Sender's Comments: Based on limited information in the case , a possible causal association between  the reported  events Vaccination failure, covid 19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dyspnoea, Epistaxis, Hypersensitivity, Peripheral swelling
Clinical narrative: she developed histamine issues or reactions; swelling of her stomach lower area (abdomen); swelling in her arm pit, close to the lymph node and the interior of her arm.; she stated to have shortness of breath and recently; nose bleeding; 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) (Batch/Lot number: unknown) as dose 2, 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, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "she developed histamine issues or reactions"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "swelling of her stomach lower area (abdomen)"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in her arm pit, close to the lymph node and the interior of her arm."; DYSPNOEA (non-serious), outcome "unknown", described as "she stated to have shortness of breath and recently"; EPISTAXIS (non-serious), outcome "unknown", described as "nose bleeding".  Additional information: Caller was a consumer who wanted to report side effects after receiving the second dose Pfizer-BioNTech COVID-19 Vaccine. Caller stated that 3-4 months after receiving the vaccine, she developed histamine issues or reactions. She stated to experience swelling of her stomach lower area (abdomen) that looks like pregnancy, and this causes problems to wear her usual clothes. Also, she reported to experience swelling in her arm pit, close to the lymph node and the interior of her arm. Finally she stated to have shortness of breath and recently, nose bleeding, which had never had in her life. Caller wanted to know if these side effects have been reported before.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No other vaccine in four weeks. No covid prior vaccination. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: CHEST PAIN (disability) with onset Dec2021, outcome "not recovered", described as "Chest pain". The event "chest pain" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: chest x-ray: unknown results; echocardiogram: unknown results; electrocardiogram: unknown results. Therapeutic measures were taken as a result of chest pain. No covid tested post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Oligomenorrhoea, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: suppose to start my menstruation cycle on 14Mar2022 but I have not started my cycle; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2022 10:00 (Lot number: FM0698) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known Allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: FEMARA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch: EW0217, Location: Arm Left, Time: 12:00 PM, Route: Intramuscular), administration date: 02Sep2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch: EW0181, Location: Arm Right, Time: 10:00 AM, Route: Intramuscular), administration date: 09Aug2021, when the patient was 33 years old, for Covid-19 Immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 01Mar2022 11:00, outcome "recovering", described as "suppose to start my menstruation cycle on 14Mar2022 but I have not started my cycle". The event "suppose to start my menstruation cycle on 14mar2022 but i have not started my cycle" was 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 menstruation delayed.  Additional information: Patient was prescribed Provera to induce her period. She had her cycle regular for 20 years. She never been late. Until the covid booster vaccine. She do not had any cysts as that was checked today too. Also her doctor said a "Bunch" of girls was called their clinic and told they was late and had received there booster or finished the series for the vaccine this month. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination: covid test type post vaccination, nasal swab, covid test name post vaccination pcr.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; 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 (COMIRNATY), administration date 28Mar2022 (Batch/Lot number: unknown) at the age of 56 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: PRURITUS (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Itching". Therapeutic measures were taken as a result of pruritus.  Additional information: The patient took a Benadryl just a few minutes ago at the reporting time, and was waiting for it to take effect to see if that helps.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Inappropriate schedule of product administration
Clinical narrative: loss of taste; loss of smell; Inappropriate schedule of vaccine administered; 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.  A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Aug2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Pfizer Covid vaccine), administration date: 21Jun2021, when the patient was 65 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; AGEUSIA (non-serious), outcome "unknown", described as "loss of taste"; ANOSMIA (non-serious), outcome "unknown", described as "loss of smell".  Additional information: Caller reported side effect of loss of taste and smell after getting the 2nd dose. Caller was asking if there is anything they can do about the side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Weight
Clinical narrative: she has feeling pain in the arm where she received the vaccine./caller's arm is extremely painful, not getting better at all.; Caller is tired today; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200506924 (Pfizer).  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 16:00 (Lot number: FH8030) at the age of 80 years as dose 3 (booster), 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, Lot number: EN6203 Expiration, date: 30Jun2021 Sees on vaccination card expires 6, hours. Dose and route: 0.3ml, syringe in arm), administration date: 04Mar2021, when the patient was 79 years old, for COVID-19 immunization; Bnt162b2 (DOSE: 2, Lot number: EN6207 Expiration, date: 31Jul2021 Sees on vaccination card, 30mcg / .3ml IM, vial diluted 30Mar at 1400 hours.), administration date: 30Mar2021, when the patient was 80 years old, for Covid-19 immunization, reaction(s): "Headache/After one of the first COVID-19 vaccine shots caller had a headache for 6 weeks or longer. Headache is gone now, took a long time. Caller clarifies this was after the 2nd dose.". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Jan2022, outcome "not recovered", described as "she has feeling pain in the arm where she received the vaccine./caller's arm is extremely painful, not getting better at all."; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Caller is tired today". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (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), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "pain in her left arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Agent stated caller was a consumer who received the Pfizer COVID vaccine primary series and the booster dose. Agent stated the caller stated she received the booster dose on 02Dec2021 and starting late Dec she began having noticeable pain in her left arm.  Agent stated caller has sought no treatment. Agent stated caller would like to know how long the pain will last.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspepsia
Clinical narrative: Metallic taste in her mouth; Heart burns; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2022 (Batch/Lot number: unknown) as dose 4 (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), for Covid-19 immunization; Bnt162b2 (1st booster dose of Pfizer Covid 19 vaccine.), for Covid-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset Mar2022, outcome "unknown", described as "Metallic taste in her mouth"; DYSPEPSIA (non-serious) with onset Mar2022, outcome "unknown", described as "Heart burns".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiomegaly, Computerised tomogram, Electrocardiogram
Clinical narrative: enlarged heart; 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 53 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2022 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Johnson and johnson (Dose: 01), administration date: Sep2021, for Covid-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 24Mar2022, outcome "unknown", described as "enlarged heart". The event "enlarged heart" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was put on a heart monitor on Tuesday that she just got off of today. They did tons and tons and tons of test, CT scans, bloodwork, EKGs, 14 tests that had came back and she doesn't know how many were done. She went in on Tuesday and had no idea of those results from Tuesday. She was perfectly healthy. She worked in food prep in the healthcare industry and she was told it was time to get a booster. After a second shot side effects after the second shot might be more intense than the ones experienced after the first shot. These side effects were normal signs that the body was building protection and should go away within a few days. If received a booster shot so far, reactions reported after getting a booster shot were similar to those after the two dose or single dose primary series. Fever, headache, fatigue and pain at the injection site were the most commonly reported side effects, and overall, most side effects were mild to moderate. However, as with the two-dose or single-dose primary series, serious side effects are rare, but may occur.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: tested positive for Covid after getting three vaccines; tested positive for Covid after getting three vaccines; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 15Aug2021 (Lot number: EW0198) at the age of 73 years as dose 3 (booster), single, administration date 01Mar2021 (Lot number: EN6203) as dose 2, single and administration date 06Feb2021 (Lot number: EM98001) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Diabetes, diagnosed about 30 years ago. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Mar2022, outcome "unknown" and all described as "tested positive for Covid after getting three vaccines". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Mar2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The clinical course was reported as follows: He has had three shots, 2 shots and a booster, last booster was 5-6 months ago. He tested positive for Covid last Thursday, 24Mar2022, states he started the Paxlovid the same day, finished the Paxlovid on Monday this week, 28Mar2022.