chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: A rash developed on arms, chest and next within a week of the second vaccine and got much worse after the booster shot (3rd).  Took predisone oral steroids in Mar2022 but it still will not go away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EW0164) at the age of 45 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 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: ER8737, prev dose lot unknown: False, prev dose administration date: 31Mar2021 , prev dose number: 1, prev dose vaccine location: Left arm), administration date: 31Mar2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "A rash developed on arms, chest and next within a week of the second vaccine and got much worse after the booster shot (3rd).  Took predisone oral steroids in Mar2022 but it still will not go away.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks: none. Adverse event treatment: Oral Steriods and steroid crème. No covid prior vaccination. Patient was covid tested post vaccination. Covid test type post vaccination was nasal swab. Covid test date: Sep2021. Covid test result: Negative. Known allergies: none. Other medical history: none.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EW0164) at the age of 45 years as dose 2, single and administered in arm left, administration date 23Nov2021 (Lot number: FH8030) as dose 3 (booster), single for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, single; lot number: ER8737; site: left arm), administration date: 31Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: RASH (medically significant) with onset 2021, outcome "not recovered", described as "Rash developed on arms, chest and next within a week of the second vaccine and got much worse after the booster shot". The event "rash developed on arms, chest and next within a week of the second vaccine and got much worse after the booster shot" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2021) negative. Therapeutic measures were taken as a result of rash. Additional information: The patient had no COVID-19 prior to vaccination. The patient has no known allergies. Clinical course: A rash developed on arms, chest and next within a week of the second vaccine and got much worse after the booster shot (3rd). Took prednisone oral steroids in Mar2022 but it still will not go away. The patient also took steroid creme.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Extreme pain in shoulders and hips.  This is causing loss of sleep, as well as severely impacting daily routines such as dressing.  It''s very painful to dress.  It's painful to remove items from cabin; Extreme pain in shoulders and hips.  This is causing loss of sleep, as well as severely impacting daily routines such as dressing.  It's very painful to dress.  It's painful to remove items from cabin; Extreme pain in shoulders and hips.  This is causing loss of sleep, as well as severely impacting daily routines such as dressing.  It's very painful to dress.  It's painful to remove items from cabin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 10:30 (Lot number: FJ8762) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE; TRAZODONE. Vaccination history included: Bnt162b2 (Previous dose details: prev dose product: COVID 19,, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: FL3209, Prev dose lot unknown: False, Prev dose administration date: 21Dec2021, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 21Dec2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (disability) with onset 20Jan2022, outcome "not recovered", described as "Extreme pain in shoulders and hips.  This is causing loss of sleep, as well as severely impacting daily routines such as dressing.  It''s very painful to dress.  It's painful to remove items from cabin"; INSOMNIA (disability), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) all with onset 20Jan2022, outcome "not recovered" and all described as "Extreme pain in shoulders and hips.  This is causing loss of sleep, as well as severely impacting daily routines such as dressing.  It's very painful to dress.  It's painful to remove items from cabin". The events "extreme pain in shoulders and hips.  this is causing loss of sleep, as well as severely impacting daily routines such as dressing.  it''s very painful to dress.  it's painful to remove items from cabin" were evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia, insomnia, loss of personal independence in daily activities: Prednisone, 20mg.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US037321_NC (Novartis).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: afib; 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 77 year-old patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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 completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "afib". Therapeutic measures were taken as a result of atrial fibrillation which included apixaban (Eliquis).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: I had the 1st injection with minimal soreness in R arm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 08:45 (Lot number: EN5318) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "known allergies : Fungus" (unspecified if ongoing); "known allergies : Mold" (unspecified if ongoing); "known allergies : Egg plant" (unspecified if ongoing); "known allergies : Wheat" (unspecified if ongoing); "known allergies : String" (unspecified if ongoing); "known allergies : Bean Chocolate" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTH; ALLEGRA; BENZONATATE. Past drug history included: Azithromax, reaction(s): "known allergies: Azithromax". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "I had the 1st injection with minimal soreness in R arm". Relevant laboratory tests and procedures are available in the appropriate section.Additional information: Concomitant medication(s) included: LOSARTAN (Dose: 50); HYDROCHLOROTH(Dose: 12.5); ALLEGRA; BENZONATATE(Dose:100). No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure measurement, Hypertension, Palpitations
Clinical narrative: atrial fib; palpitaions; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 82 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Jan2022 12:00 (Lot number: FD7218) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, brand unknown=False,, lot number: EL9262,, lot unknown=False,, administration time: 01:00 PM , number=1, vaccine location=Left arm), administration date: 25Jan2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False,, lot number: EN6201,, lot unknown: False, dose administration time: 02:00 PM, dose number=2, dose vaccine location=Left arm), administration date: 11Feb2021, when the patient was 81 years old, for Covid-19 immunization, reaction(s): "atrial fib", "high blood pressure", "Palpitations". The following information was reported: ATRIAL FIBRILLATION (disability) with onset 23Jan2022 16:00, outcome "recovered with sequelae", described as "atrial fib"; PALPITATIONS (disability) with onset 23Jan2022 16:00, outcome "recovered with sequelae", described as "palpitaions"; HYPERTENSION (disability) with onset 23Jan2022 16:00, outcome "recovered with sequelae", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Jan2022) high. Therapeutic measures were not taken as a result of atrial fibrillation, palpitations, hypertension.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Patient keep getting large red welts, similar to bug bites, sporadically since getting the second dose of the Covid vaccine; Patient keep getting large red welts, similar to bug bites, sporadically since getting the second dose of the Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 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: VACCINATION SITE URTICARIA (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Patient keep getting large red welts, similar to bug bites, sporadically since getting the second dose of the Covid vaccine".  Clinical Course: Patient keep getting large red welts, similar to bug bites, sporadically since getting the second dose of the Covid vaccine. They are not like a typical rash and are not from bugs or any environmental changes. he was wondering if there was any other reports of this. Forwarded as an Adverse Event by the team on 14Mar2022 Reporter provided verification of contact address on 13Mar2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Spinal X-ray
Clinical narrative: flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 (Lot number: EX931, Expiration Date: 30Apr2021) at the age of 82 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: Diagnosed probably before the year 2000; "Hypotension" (unspecified if ongoing), notes: Diagnosed about 3 years ago, borderline, sometimes he has hypertension too.; "Neuropathy" (unspecified if ongoing), notes: About 10 years ago; "one functioning lung" (unspecified if ongoing), notes: about two weeks after the surgery to remove the tumor.; "Tumor C2- C5", start date: 11Sep2001 (unspecified if ongoing), notes: Found out about the tumor 11Sep2001. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot Number:  EL0140 , Dose: 0.3ml, thinks it was the left arm., Expiration: 31Mar2021), administration date: 06Jan2021, when the patient was 82 years old, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No additional vaccines administered on same date of the Pfizer Suspect. Family Medical History Relevant to AE(s) were none. It was reported that patient got the 4th dose or booster dose and it was bit red. Patient had somewhat of a side effect from the second shot, he had flu like symptoms and went to bed and was fine the next day. This time he got the shot and the next day, he started getting achiness in his joints and went to bed early the achiness had somewhat there but improved but it was weird, he bent over to pick something up off of the floor and lost all balance, his legs went wobbly, whammed down and broke his coccyx bone. Later in the day, the muscular strength returned. It was like some short circuited his muscles, no electricity or anything, he lost control of his muscles. Patient lung doesn't function because of the frenetic nerve was nicked during surgery, he is getting old, two weeks after surgery his lung failed and he lost that lung. He has been going to a pulmonologist for a long time. In the emergency room, they took a fair amount of blood, and then put him into a machine, he thinks it was a CAT scan and then they took x-rays of his head, and down, they took x-rays of his lower spine and that is when they found the break of the coccyx bone.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pyrexia
Clinical narrative: Lymph nodes were aching so bad; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 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 completed, MANUFACTURER UNKNOWN, DOSE NUMBER UNKNOWN), for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; LYMPH NODE PAIN (non-serious), outcome "unknown", described as "Lymph nodes were aching so bad".  Additional information: Reporter stated that, patient received the booster shot of the vaccine with her husband. She said that she had a fever for 2 days and her lymph nodes were aching so bad.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ear canal erythema, Ear swelling, Erythema, Polychondritis
Clinical narrative: Relapsing Polychondritis; Severe external ear redness and swelling of it, plus the canal; Severe external ear redness and swelling of it, plus the canal; Severe external ear redness and swelling of it, plus the canal; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Autoimmune patient" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: POLYCHONDRITIS (medically significant) with onset 2021, outcome "unknown", described as "Relapsing Polychondritis"; ERYTHEMA (medically significant), EAR SWELLING (medically significant), EAR CANAL ERYTHEMA (medically significant) all with onset 2021, outcome "unknown" and all described as "Severe external ear redness and swelling of it, plus the canal". The events "relapsing polychondritis" and "severe external ear redness and swelling of it, plus the canal" were evaluated at the physician office visit. Therapeutic measures were taken as a result of polychondritis, erythema, ear swelling, ear canal erythema. Clinical course details: It was reported that patient is autoimmune, and fully vaccinated, plus booster, as of early Nov2021. Within two weeks of receiving the booster, patient developed a severe external ear redness and swelling of it, plus the canal. After three rounds of antibiotics, steroids, ENT, Internal Medicine doctors, and Rheumatologist, it has been determined that patient very likely have Relapsing Polychondritis, a debilitating disease. Patient reported it appears probable that this a result of the booster. More cases were discovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient in his 70's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, DOSE NUMBER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm aches".  Additional Information: It was reported that (Name withheld) called in regarding the invasion and she mentioned that they had already received the booster shot of the vaccine with her husband. She said that she had a fever for 2 days and her lymph nodes were aching so bad. She also mentioned that her husband had arm aches.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Respiratory disorder
Clinical narrative: Has had respiratory complications that have caused him to miss weeks of work; Has had respiratory complications that have caused him to miss weeks of work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional) from a sales representative. The reporter is the patient. A male patient 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: RESPIRATORY DISORDER (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown" and all described as "has had respiratory complications that have caused him to miss weeks of work".  Additional information: Description of Event: (Name withheld) reported stated that after receiving the Pfizer BioNTech vaccine he had respiratory complications that have caused him to miss weeks of work. He did not go into great detail , but did tell that he has been working with his doctor to recover from the complications. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing my hair; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (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: ALOPECIA (non-serious), outcome "unknown", described as "losing my hair".  Additional information: The patient has taken the Pfizer shots starting last February. For a year patient has been losing hair since taking all the required shots. It just falls out. It even like reporters hair was prior to the shots. Now another shot? Really? Reporter cannot justify taking another shot just lose more hair. Reporter truly believes that there was something wrong with the shots. And reporter was not the only person. Reporter would like comments from you because this issue needs to be corrected. Reporter still have hair falling out each day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia pneumococcal
Clinical narrative: Got the shot; got PP anyway.; Got the shot; got PP anyway.; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the patient.  A 70-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (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: DRUG INEFFECTIVE (hospitalization, medically significant) and PNEUMONIA PNEUMOCOCCAL (hospitalization, medically significant), outcome "unknown" and all described as "Got the shot; got PP anyway." The patient was hospitalized for drug ineffective and pneumonia pneumococcal (hospitalization duration: 9 days). Clinical course: The patient reported that he got the shot in May but got the PP (as reported) anyway. He was hospitalized in August for 9 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient had similar post covid symptoms as first and second doses; patient had similar post covid symptoms as first and second doses; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Feb2022 13:58 (Lot number: FK9896) at the age of 49 years as dose 3 (booster), single, intramuscular, administration date 28Apr2021 14:00 (Lot number: EW0172) as dose 2, single and intramuscular, administration date 07Apr2021 (Lot number: EW0153) 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 FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient had similar post covid symptoms as first and second doses". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: patient had similar post covid symptoms as first &, notes: No clinical consequences to patient. Patient had similar post covid symptoms as first & second doses.  Additional information: Prior vaccination within four weeks was none. Specific relevant test for thromboembolic events with thrombocytopenia was None. Patient(s) medical history was None. Relevant tests was None.  No follow-up attempts are required. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I'm afraid I'm not going to be able to do this, as I'm dealing with a severe health challenge; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "I'm afraid I'm not going to be able to do this, as I'm dealing with a severe health challenge".  Additional information: I'm afraid I'm not going to be able to do this, as I'm dealing with a severe health challenge that has appeared this year (not unrelated, I believe, to the mRNA vaccines, as it happens).   The lot number for bnt162b2 was not provided and will be requested during follow up
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: had a mild case of myocarditis after her 2nd dose of PBCV; 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 72 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Lot number: EW0150) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose:1, Lot: EN6207, Manufacturer Unknown), administration date: 24Mar2021, when the patient was 72 years old, for COVID-19 Immunization. The following information was reported: MYOCARDITIS (medically significant) with onset Apr2021, outcome "recovered" (2021), described as "had a mild case of myocarditis after her 2nd dose of PBCV".  Clinical course: She stated she had a mild case of myocarditis after her 2nd dose of PBCV and was asking how it will effect her eligibility for a booster dose. It was advice to go ahead and get the booster dose because they know how to treat the myocarditis.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: still having problems with severe muscle spams and cramps all over her body, eyes, under her tongue muscle, chin, arm and mainly legs; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 25Feb2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: H1n1 influenza virus for Immunization, reaction(s): "anaphylaxis". The following information was reported: MUSCLE SPASMS (non-serious) with onset 2022, outcome "not recovered", described as "still having problems with severe muscle spams and cramps all over her body, eyes, under her tongue muscle, chin, arm and mainly legs". Therapeutic measures were taken as a result of muscle spasms.  Additional information: Caller had her first dose of the Pfizer BioNTech COVID-19 vaccine last 25Feb2022. Caller stated that she "is still having problems with severe muscle spams and cramps all over her body, eyes, under her tongue muscle, chin, arm and mainly legs". Caller also stated that her side effects "have not subsided and she was given Magnesium". Caller also mentioned that she "had problems with vaccines as she had anaphylaxis with H1N1 vaccine". Since she had a previous side effect, caller is worried in getting the second dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Investigation, Nephrolithiasis
Clinical narrative: she had planned procedure and her kidney stone; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4321702-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single and intramuscular, administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. Relevant medical history included: "stage 3 colon cancer", start date: 2009 (unspecified if ongoing); "kidney stone" (unspecified if ongoing), notes: her kidney stone was removed which was three cm in size. The patient's concomitant medications were not reported. The following information was reported: NEPHROLITHIASIS (medically significant), outcome "recovered", described as "she had planned procedure and her kidney stone"; HEADACHE (non-serious), outcome "recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: investigation: (2009) stage 3 colon cancer. The action taken for adalimumab was unknown. Clinical Course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) kidney stone and headache was not provided. Agencies opinion is that there is no reasonable possibility that the events of kidney stone and headache are related to Humira (Adalimumab).  Causality for Pfizer BioNTech covid-19 vaccine: The reporter's causality for the event kidney stone was not reported and reporter's causality for the event headache was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possibility of high recurrence rate, the event of present episode of kidney stone could be more likely be related to patient's underlying relevant medical history of kidney stone, hence considered unrelated to BNT162B2 as per company assessment. Based on known drug safety profile, the event Headache assessed as related to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 (from the first dose) and re-infection of COVID-19 after second dose/ diagnosed covid again on 03Feb2022; COVID-19 (from the first dose) and re-infection of COVID-19 after second dose/ diagnosed covid again on 03Feb2022; This is a spontaneous report received from a contactable reporter (Other HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "CHF" (unspecified if ongoing); "PAH" (unspecified if ongoing); "DM2" (unspecified if ongoing); "CKD stage 3" (unspecified if ongoing); "non - smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Feb2022, outcome "unknown" and all described as "COVID-19 (from the first dose) and re-infection of COVID-19 after second dose/ diagnosed covid again on 03Feb2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Feb2022) diagnosed covid. Clinical course: She got her first dose in Jun2021. Diagnosed covid the day she was supposed to get second dose 23Aug2021. Got monoclonial antibiodies. Received 2nd dose 01Dec2021. Diagnosed covid again 03Feb2022. Had CHF, PAH, DM2, CKD stage 3. 62 year old non - smoker, female. Maybe info could help with studies. The patient could not get booster until Jun2022. Patient was a retired nurse and keep a mask on in public and wash her hands and most of the time she wear gloves. Follow safety protocols.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202200218630 same reporter, patient, product and event; different dose
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did get Omicron after being vaccinated; did get Omicron after being vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415; 176414). The reporter is the patient.  A 58 year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did get Omicron after being vaccinated".  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-202200458084 same patient/drug, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Drug ineffective, Psoriasis, Suspected COVID-19
Clinical narrative: COVID; COVID; Crohns disease flare up; Psoriasis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. 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 "recovered" and all described as "COVID"; CROHN'S DISEASE (medically significant), outcome "recovered", described as "Crohns disease flare up"; PSORIASIS (non-serious), outcome "recovered", described as "Psoriasis". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the DRUG INEFFECTIVE, COVID-19, CROHN'S DISEASE, PSORIASIS  with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira (Adalimumab)  The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of psoriasis and crohns disease flare up was not provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: (Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and CROHN'S DISEASE, PSORIASIS. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Psoriatic arthropathy
Clinical narrative: psoriatic arthritis flare up; pain in rib cage; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4317437-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis flare up"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "pain in rib cage". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of psoriatic arthritis flare up and pain in bib cage was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) :The reporter's causality for the event(s) of psoriatic arthritis flare up and pain in bib cage was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events psoriatic arthropathy and musculoskeletal chest pain cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Joint injury
Clinical narrative: Knee surgery; Ulcerative Colitis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4317616-00.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (cf) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 2021, outcome "recovering", described as "Ulcerative Colitis"; JOINT INJURY (medically significant) with onset 2022, outcome "recovered" (2022), described as "Knee surgery". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of joint injury.  Clinical course was reported as, Patient experienced events of Knee surgery and COVID shot triggered the symptoms of Ulcerative Colitis. Patient reported she did not know that she had Ulcerative Colitis until she had the COVID shot. It triggered the symptoms. In 2022, patient had surgery on knee. She needed a knee replacement and instead they put gel under her knee cap, but since she started the Humira her knee felt brand new now. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for (Adalimumab) HUMIRA: The reporter's causality for the event(s) of Knee surgery and COVID shot triggered the symptoms of Ulcerative Colitis with Humira (Adalimumab) was a reasonable possibility.  Causality for BNT162B2: The reporter considered "ulcerative colitis" related to bnt162b2 (reported as Probable), The reporters assessment of the causal relationship of the event Knee surgery NOS (Knee operation) with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment..  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event (AE)/ product quality complaints (PQC) reported.; The vaccine was administered after the excursion; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 19-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter, lot # U017140 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 28-NOV-2022; strength and route were not reported) after temperature excursions (product storage error) with sterile diluent for prophylaxis. The administered dose experienced temperature excursions of 6 Fahrenheit (F) up to 14 F for 4 hours and 14 F up to 46 F for 4 hours 45 minutes. No previous excursion was reported. No additional adverse event was reported.  A phone call was received from the reporter on 17-MAR-2022. It was reported the reporter did not have any patient information at the reporting. It was confirmed this was one of ten reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-2203USA001850: US-009507513-2203USA001841: US-009507513-2203USA001578: US-009507513-2203USA001612: US-009507513-2203USA001617: US-009507513-2203USA001688: US-009507513-2203USA001728: US-009507513-2203USA001890: US-009507513-2203USA007379:
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Eye inflammation, Eye swelling, Rash
Clinical narrative: Anaphylactic reaction; Inflammation in eye/ eye swelling; Rash; This case was reported by a physician via other manufacturer and described the occurrence of anaphylactic reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included abaloparatide (Tymlos) for senile osteoporosis.   Concurrent medical conditions included senile osteoporosis.   On an unknown date, the patient received the 1st dose of Shingrix. On 30th November 2021, the patient started Tymlos (subcutaneous) 80 ug once daily (80 ug daily). On 28th December 2021, unknown after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), eye swelling and rash. Tymlos was continued with no change. On an unknown date, the outcome of the anaphylactic reaction, eye swelling and rash were unknown.   It was unknown if the reporter considered the anaphylactic reaction, eye swelling and rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient's medical history was not provided.  Relevant surgical, social, or substance-usage history was not provided.  The patient received 1st dose of Shingrix vaccine and experienced eye swelling, rash, and an anaphylactic reaction. The patient was on Tymlos for the treatment of age-related osteoporosis. The patient's eye doctor advised that the eye Inflammation could be due to Shingrix but was unsure if related to Tymlos.  Treatments for the events was not reported. No relevant lab or diagnostic tests were reported. The action taken with Tymlos was did not changed. The outcomes of eye swelling, rash, and an anaphylactic reaction were not reported. It was unknown if the reporter considered the anaphylactic reaction, eye swelling and rash to be related to Tymlos.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had both shots, shingles/suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case. The age at vaccination was not reported. The patient had both Shingle shots and had shingles at the time of reporting.  The patient stated they were very painful. The patient reported that shots were only 90 percent effective. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.