chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Immunisation
Clinical narrative: Extremely painful menstruation. Large clots.; Extremely painful menstruation; Severe cramping; Left arm pain; This is a spontaneous report from a contactable consumer (patient).   A 40-year-old female patient received the third dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in the left arm  on 30Sep2021 19:00 (Batch/Lot Number: FF2589) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), ascorbic acid (VIT C), and multivitamins, taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in the left arm  on 21Dec2020  (Batch/Lot Number: EK5731) as DOSE 1, SINGLE; the second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in the left arm  on 11Jan2021  (Batch/Lot Number: EL3249) as DOSE 2, SINGLE and experienced left arm pain with the second shot; both given  for COVID-19 immunization. The patient was not pregnant at time of vaccination. Facility where vaccine was administered was a pharmacy or dug store. There were no other medications received in two weeks. The patient did not have COVID-19 prior to vaccination. On 01Oct2021, the patient  experienced extremely painful menstruation. large clots, severe cramping, and left arm pain. The patient underwent lab tests and procedures which included COVID test nasal swab: negative  on 01Oct2021 Nasal Swab per test weekly. The events did not require treatment. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Immunisation, Off label use
Clinical narrative: Bleeding from the side of his foot close to the ankle bone; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 301358A), via an unspecified route of administration, administered in left arm on 30Sep2021 10:30 (at 75 years old) as dose 3 (booster), single for COVID-19 immunization. Medical history included possible Penicillin allergy from an unknown date. The patient had no history of COVID prior to vaccination. The patient has not been Covid tested post vaccination. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (lot number EW6199), on 05Mar2021, on left arm; then second dose of BNT162B2 (lot number ER8733), on 26Mar2021, on left arm, both for COVID-19 immunization. On 30Sep2021 16:30, the patient began bleeding from the side of his foot close to the ankle bone. It continued for 15 minutes and stopped while applying direct pressure. Estimated blood loss onto floor and into rags: one-half cup measure. The outcome of the event "bleeding from the side of his foot close to the ankle bone" was recovered on 30Sep2021 16:45.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy on right side of my face; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 56-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 01Apr2021 14:30 (at the age of 56-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had known allergies to Penicillin. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. On 07Apr2021, the patient experienced bell's palsy on right side of my face. The patient visited to physician office for the adverse event. The patient received unspecified steroids as treatment for adverse event. The patient received her second dose of vaccine on 22Apr2021. The outcome of the event was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Autism spectrum disorder, Dizziness
Clinical narrative: Autism; Dizzy spells at night; A bit anxious; This is a solicited report from a non-contactable consumer (patient).  A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 (at an unspecified age) as dose number unknown, single for COVID-19 immunisation; treprostinil diolamin (ORENITRAM), oral from 19Nov2014 (Batch/Lot number was not reported), at 5 mg (every 8 hours), oral from 19Nov2014 (Lot Number: 2101811; Expiration Date: 31Jan2023) and ongoing, at 5 mg (every 8 hours) for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication included ambrisentan. On an unreported date, the patient experienced event of autism (medically significant) and the patient was a bit anxious. On an unreported date in 2021, the patient experienced event of dizzy spells at night. Clinical details: This case is a solicited report received on 23Sep2021, from a consumer from a patient support program. This 28-year-old, 200-lbs, male patient began therapy with Orenitram (treprostinil diethanolamine), on 14Nov2014 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 5 mg and the current dose was reported as 5mg, oral (PO), every 8 hours (q8h). Co-suspect medication included: COVID-19 vaccine. It was reported that, the patient had been getting some dizzy spells at night. The patient thought it was started back when he got a COVID vaccine at work in mid Feb 2021. The patient was a bit anxious during the call and mentioned autism. He was concerned that everyone was on same page with his medication. The action taken in response to the events for treprostinil diolamin was unknown. The outcome of the events was unknown.  The reporter's assessment of the causal relationship of the events 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.  Sender's Comment: The company has assessed the serious adverse event of autism spectrum disorder as not related to oral treprostinil. The cause of autism spectrum disorder is generally considered to be unknown although it has a higher frequency in some families indicating a possible hereditary link; it is commonly diagnosed in childhood, but can be identified in young adults as in this 28-year-old patient.  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 information currently available and currently known drug safety profile, the reported events spectrum disorder, dizziness and autism more likely represented intercurrent illness hence, unrelated to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy especially in hands; This is a spontaneous report from a contactable other health care professional. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose number unknown, single for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) for rheumatoid arthritis. It was reported that after receiving COVID-19 vaccine, the patient experienced neuropathy, especially in hands. The patient stated that she was unsure if Xeljanz was making a difference at that time due to having neuropathy. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Neuropathy Peripheral and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tested positive for Covid-19 after experiencing mild symptoms; Tested positive for Covid-19 after experiencing mild symptoms; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 01Mar2021 (at the age of 46 years old) (Batch/Lot Number: EN6203) as a single dose and dose 2 via an unspecified route of administration, administered in the left arm on 24Mar2021 (at the age of 46 years old) (Batch/Lot Number: EN6203) as a single dose, for covid-19 immunisation at workplace clinic. The patient had no medical history and no known allergies. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient tested for COVID-19. On 01Oct2021, the patient tested positive for Covid-19 after experiencing mild symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Oct2021 (Nasal Swab). The patient received no treatment for the event. The outcome of Covid-19 was recovering.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Deep vein thrombosis, Thrombosis, Ultrasound scan
Clinical narrative: Deep Vein Thrombosis; second blood clot on lower right leg; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (Pfizer COVID 19) via an unspecified route of administration on the right arm on 07Sep2021 at 10:30 AM (Lot Number: FD8448) as single dose for COVID-19 immunization. Medical history included melanoma (x3), hiatal hernia, bone tumor (left talus), asthmatic bronchitis (COPD) and childhood bacterial immunity deficiencies. The patient didn't received other vaccine in four weeks. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was none. Concomitant medication included ergocalciferol (VIT D [ERGOCALCIFEROL]) and multivitamin/VitD Gummies. The patient received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 28Sep2021 at 10:30 AM (Lot Number: 30130824) as single dose for COVID-19 immunization. On 21Sep2021 at 18:30, the patient experienced deep vein thrombosis and second blood clot on lower right leg. Presented 8 hours after shot. Admitted to hospital 32 hours after shot. The patient performed catscan and ultrasound. The events resulted in emergency room/department or urgent care and hospitalization. Treatment was received included eliquis (ultrasound/CATSCAN/bloodwork). The outcome of events was recovering.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, SARS-CoV-2 test
Clinical narrative: I have recently been diagnosed with multiple sclerosis with no family history of it; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 06May2021 (Batch/Lot Number: FW0153) (at the age of 19-years-old) as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EW0171), administered in the right arm on 15Apr2021 (at the age of 19-years-old) for COVID-19 immunisation. On 02Jul2021, the patient reported that she was recently been diagnosed with multiple sclerosis with no family history of it. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient was hospitalized for 4 days on an unspecified date due to the event. The patient was given steroids as treatment for the event. The patient underwent lab tests and procedures which included nasal swab post vaccination: negative on an unspecified date. Outcome of event was recovered with sequel in 2021.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, Tinnitus
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Ringing in left ear 14 days after first vaccine dose on August(Tinnitus); This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 06Aug2021 15:45 (Batch/Lot number was reported as FA7485 or F117485, pending clarification) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypersensitivity. The patient's concomitant medications were not reported. The patient experienced positive covid-19 test with symptoms on 26Aug2021 and ringing in left ear 14 days after first vaccine dose on august (tinnitus) on 21Aug2021 at 12:00. The patient underwent lab tests and procedures which included sars-cov-2 antibody test positive on 26Aug2021 Nasal Swab. The outcome of the event positive covid-19 test with symptoms was unknown. Outcome of ringing in left ear 14 days after first vaccine dose on august (tinnitus) was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Varicella zoster virus infection
Clinical narrative: Varicella Zoster (shingles) activation on Neck and Face days after Pfizer booster; The patient received third dose/Pfizer booster; The patient received third dose/Pfizer booster; This is a spontaneous report from a contactable physician (patient). A 45-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0183) via an unspecified route of administration, administered in arm left on 27Sep2021 14:15 (age at vaccination 45-year-old and non-pregnant at the time of vaccination) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient's medical history allergy. Concomitant medication was not reported. Historical vaccine included second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3246) via an unspecified route of administration, administered in arm left on 07Jan2021 11:00 AM as DOSE 2, SINGLE for COVID-19 immunisation and the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EK5730) via an unspecified route of administration, administered in arm left on 17Dec2021 02:00 PM as DOSE 1, SINGLE for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. On 27Sep2021 14:15, the patient received third dose/Pfizer booster. On 30Sep2021 16:00, the patient had varicella zoster (shingles) activation on neck and face 4 days after Pfizer booster. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Valaciclovir and Gabapentin for the event varicella zoster (shingles) activation on neck and face 4 days after Pfizer booster. The outcome of the event varicella zoster (shingles) activation on neck and face 4 days after Pfizer booster was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pyrexia
Clinical narrative: I ran a fever; sick; I was very nauseated and ran a fever; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 01Oct2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 02Oct2021 the patient ran a fever and was very nauseated patient would need but patient was fine today and just wanted to know if she can be around people if there's any danger. The outcome of the events was recovered on 03Oct2021.     The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Heavy menstrual bleeding, Infertility, SARS-CoV-2 test, Uterine leiomyoma
Clinical narrative: fibroids; won't be able to have kids; Periods lasting over 20+ days.; Severe vaginal bleeding; anemia; This is a spontaneous report received from a contactable consumer or other hcp. A 32-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK9231) via an unspecified route of administration in Arm Right on 08Jan2021 (age at vaccination 32years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks prior to the COVID vaccine reported as none. The patient medical history and concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK5730) via an unspecified route of administration in Arm Right on 18Dec2020 (age at vaccination 32years old) as single dose for covid-19 immunisation and trazodone and experienced drug hypersensitivity on unspecified date. The patient experienced severe vaginal bleeding, anaemia, won't be able to have kids, periods lasting over 20+ days on 01May2021, and fibroids on Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 01Oct2021, uterine leiomyoma: discovered fibroids on Sep2021 Discovered fibroids. The patient received treatment high dose birth control, Endometrial ablation for the adverse events. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of severe vaginal bleeding, anaemia, fibroids, won't be able to have kids, periods lasting over 20+ days.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: fibroids; won't be able to have kids; Periods lasting over 20+ days.; Severe vaginal bleeding; anemia; This is a spontaneous report received from a contactable consumer or other hcp. A 32-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK9231) via an unspecified route of administration in Arm Right on 08Jan2021 (age at vaccination 32years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks prior to the COVID vaccine reported as none. The patient medical history and concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK5730) via an unspecified route of administration in Arm Right on 18Dec2020 (age at vaccination 32years old) as single dose for covid-19 immunisation and trazodone and experienced drug hypersensitivity on unspecified date. The patient experienced severe vaginal bleeding, anaemia, won't be able to have kids, periods lasting over 20+ days on 01May2021, and fibroids on Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 01Oct2021, uterine leiomyoma: discovered fibroids on Sep2021 Discovered fibroids. The patient received treatment high dose birth control, Endometrial ablation for the adverse events. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of severe vaginal bleeding, anaemia, fibroids, won't be able to have kids, periods lasting over 20+ days.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pericardial effusion, SARS-CoV-2 test
Clinical narrative: Fluid buildup around the heart and rapid fluid retention; administration date=20Aug2021,dose number=2;prev dose administration date=03Aug2021, prev dose dose number=1; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 20Aug2021 (Lot Number: FC3181) as single for COVID-19 immunization (age at vaccination 42-year-old). Medical history included high cholesterol and obesity from an unknown date and unknown if ongoing. Concomitant medications included gabapentin; amitriptyline; lovastatin; tizanidine; and fluoxetine hydrochloride (PROZAC) all taken for an unspecified indication, start and stop date were not reported. The patient previously received (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Aug2021 (Lot Number: FC3180) as single for COVID-19 immunisation (age at vaccination 42-year-old). The patient did not receive other vaccine in four weeks. The patient experienced fluid buildup around the heart and rapid fluid retention on 02Sep2021 with outcome of unknown. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event). The patient experienced inappropriate schedule of product administration on 20Aug2021. The patient underwent lab tests and procedures which included Sars-CoV-2 test (Covid test type post vaccination=Nasal Swab): negative on 01Oct2021. Therapeutic measures were taken as a result of fluid buildup around the heart and rapid fluid retention includes pericardial window. The patient was not diagnosed with covid prior vaccination.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriatic arthropathy, Pyrexia
Clinical narrative: Psoriatic arthritis aggravated/flair up of psoriatic arthritis; Pyrexia; This is a solicited report based on information received by Pfizer (manufacturer Control number: 21K-163-4094162-00). A contactable consumer (patient) reported that a 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for psoriatic arthritis. The patient medical history and concomitant medications were not reported. The patient experienced psoriatic arthritis aggravated on an unspecified date with outcome of recovering, pyrexia on an unspecified date with outcome of recovered. On unknown dates, the patient experienced flare up of psoriatic arthritis and second dose of vaccine had a minor temperature. On an unknown date, second dose of vaccine had a minor temperature resolved. Pfizer BioNtech COVID-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The reporter's causality for the event of flair up of psoriatic arthritis and second dose of vaccine had a minor temperature was not provided for adalimumab. The reporter's causality for the event of flair up of psoriatic arthritis was not provided and for the event fever was possible for BNT162B2.  The reporter's assessment of the causal relationship of the event psoriatic arthritis aggravated 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.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pyrexia and the suspect drug BNT162B2. As there is limited information in the case provided, the causal association between the event psoriatic arthritis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Prostate cancer
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority support received from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, both doses for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced prostate cancer on an unspecified date. The reporter would like to know when he would be able to get booster shot. As the therapeutic measure degarelix acetate (FIRMAGON) injection. The outcome was unknown for the reported events.  The information about lot/batch number gas been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Relative's husband caught Covid-19 after returning from a vacation.; Relative's husband caught Covid-19 after returning from a vacation.; This is a spontaneous report from a contactable consumer or other non hcp. A adult male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE and dose 1 of bnt162b2 (COMIRNATY, formulation: solution for injection,Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced relative's husband caught covid-19 after returning from a vacation .The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. The outcome of event were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sibling reported that friend caught Covid-19 even though they were vaccinated; Sibling reported that friend caught Covid-19 even though they were vaccinated; This is a spontaneous report from a contactable consumer and a non-contactable consumer (Sibling), these consumers reported for an adult patient. An adult patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2 and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, Sibling reported that friend caught Covid-19 even though they were vaccinated. Patient tested positive for covid post vaccination. The patient underwent lab tests and procedures, which included Covid test: positive on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness, SARS-CoV-2 test
Clinical narrative: drug ineffective; covid 19; flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as dose 1, single; the second dose of via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced drug ineffective (medically significant), covid-19 (medically significant). She was fully vaccinated and now with flu like symptoms. Event took place after use of product. The patient underwent lab tests and procedures which included COVID: positive. Outcome of the events was unknown.   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-202101302276 Same reporter/drug, different patients
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient's husband now has covid 18 also and was also fully vaccinated; Patient's husband now has covid 18 also and was also fully vaccinated; This is a spontaneous report from a non-contactable consumer (patient's wife) via a sales representative. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient now has "COVID 18" also and was also fully vaccinated. The patient underwent lab tests and procedures which included COVID: positive. Outcome of the events was unknown.  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-202101302275 Same reporter/drug, different patients
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Illness, Psoriasis, Pyrexia, Rash
Clinical narrative: Sickness; Rash both legs; Streptococcal infection; Ear infection; Fever; Erythropapular rash/red bumps; Psoriasis; Respiratory infection; This is a solicited report from a marketing program facilitated collect received from a non-contactable consumer (patient) based on information received by Pfizer from (manufacturer control number: 21K-163-4078279-00). A 58-year-old female patient received bnt162b2 (BNT162B2) dose 3 intramuscular on 08Sep2021 (at the age of 58 years old, Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneous from an unspecified date (Batch/Lot number was not reported) at CF for psoriatic arthritis. Medical history included psoriatic arthropathy. The patient's concomitant medications were not reported. The patient previously received dose 1 (01Jan2021) and 2 (01Feb2021) of BNT162B2 for covid-19 immunisation and experienced rash on legs, strep infection, respiratory infection, ear infection, fever and red bumps that would had psoriasis on both shins in front and cracked tooth. On unknown dates in 2021, the patient experienced rash on both legs, strep infection, respiratory infection, ear infection, fever and Erythropapular rash/red bumps that would had psoriasis on both shins in front. In Sep2021, the patient experienced sick. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of event sickness was recovering and other events was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the events of sick, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for adalimumab was not provided. The reporters causality for the event of rash on legs with adalimumab was no reasonable possibility. The reporters causality for the events of sick, rash on legs, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for BNT162B2 was probable.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events respiratory tract infection and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Respiratory tract infection, Streptococcal infection
Clinical narrative: Sickness; Rash both legs; Streptococcal infection; Ear infection; Fever; Erythropapular rash/red bumps; Psoriasis; Respiratory infection; This is a solicited report from a marketing program facilitated collect received from a non-contactable consumer (patient) based on information received by Pfizer from (manufacturer control number: 21K-163-4078279-00). A 58-year-old female patient received bnt162b2 (BNT162B2) dose 3 intramuscular on 08Sep2021 (at the age of 58 years old, Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneous from an unspecified date (Batch/Lot number was not reported) at CF for psoriatic arthritis. Medical history included psoriatic arthropathy. The patient's concomitant medications were not reported. The patient previously received dose 1 (01Jan2021) and 2 (01Feb2021) of BNT162B2 for covid-19 immunisation and experienced rash on legs, strep infection, respiratory infection, ear infection, fever and red bumps that would had psoriasis on both shins in front and cracked tooth. On unknown dates in 2021, the patient experienced rash on both legs, strep infection, respiratory infection, ear infection, fever and Erythropapular rash/red bumps that would had psoriasis on both shins in front. In Sep2021, the patient experienced sick. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of event sickness was recovering and other events was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the events of sick, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for adalimumab was not provided. The reporters causality for the event of rash on legs with adalimumab was no reasonable possibility. The reporters causality for the events of sick, rash on legs, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for BNT162B2 was probable.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events respiratory tract infection and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthma, Immunisation, Nasal congestion, Off label use, Oropharyngeal pain
Clinical narrative: received 3rd dose covid-19 Vaccine; received 3rd dose covid-19 Vaccine; Rheumatoid arthritis flare up; Sore throat; Asthma; Nasal stuffiness; Stress; Fever; Aches; This is a solicited report from a Non-Interventional Study  based on information received by Pfizer from Company (manufacturer control number: 21K-163-4090390-00.   A contactable consumer (patient) reported that a 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Apr2021 (Batch/Lot number was not reported)(at the age of 57-year-old) as dose 1, single, on 20May2021 (Batch/Lot number was not reported)(at the age of 57-year-old) as dose 2, single and on 20Aug2021 (at the age of 58-year-old)(Batch/Lot number was not reported) as dose 3 (BOOSTER), single; all intramuscularly for COVID-19 immunization and upadacitinib (RINVOQ) orally from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. It was reported that the patient received the 3rd dose of COVID-19 vaccine on 20Aug2021. On an unspecified date in 2021, patient experienced rheumatoid arthritis flare up, sore throat, asthma, nasal stuffiness, stress, fever and aches. Outcome of event rheumatoid arthritis flare up was not recovered while the outcome of all other events was unknown. Action taken in response to the events for upadacitinib was dose not changed.  The reporter's causality assessment for the events Sore throat, Asthma, Nasal stuffiness and the drug RINVOQ(UPADACITINIB) was no reasonable possibility; Rheumatoid arthritis flare up and the drug RINVOQ(UPADACITINIB) was reasonable possibility; Stress and the drug RINVOQ(UPADACITINIB) was not reported. The reporter's causality assessment for the events Sore throat, Asthma, Nasal stuffiness and the PFIZER BIONTECH COVID-19 VACCINE was probable; events Rheumatoid arthritis flare up and Stress for the PFIZER BIONTECH COVID-19 VACCINE was not reported.  The reporter's assessment of the causal relationship of the events fever and aches with the suspect product PFIZER BIONTECH COVID-19 VACCINE 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.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, The casual association between the reported events with suspected vaccine BNT162B2 cannot be completely 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.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pyrexia, Rheumatoid arthritis, Stress
Clinical narrative: received 3rd dose covid-19 Vaccine; received 3rd dose covid-19 Vaccine; Rheumatoid arthritis flare up; Sore throat; Asthma; Nasal stuffiness; Stress; Fever; Aches; This is a solicited report from a Non-Interventional Study  based on information received by Pfizer from Company (manufacturer control number: 21K-163-4090390-00.   A contactable consumer (patient) reported that a 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Apr2021 (Batch/Lot number was not reported)(at the age of 57-year-old) as dose 1, single, on 20May2021 (Batch/Lot number was not reported)(at the age of 57-year-old) as dose 2, single and on 20Aug2021 (at the age of 58-year-old)(Batch/Lot number was not reported) as dose 3 (BOOSTER), single; all intramuscularly for COVID-19 immunization and upadacitinib (RINVOQ) orally from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. It was reported that the patient received the 3rd dose of COVID-19 vaccine on 20Aug2021. On an unspecified date in 2021, patient experienced rheumatoid arthritis flare up, sore throat, asthma, nasal stuffiness, stress, fever and aches. Outcome of event rheumatoid arthritis flare up was not recovered while the outcome of all other events was unknown. Action taken in response to the events for upadacitinib was dose not changed.  The reporter's causality assessment for the events Sore throat, Asthma, Nasal stuffiness and the drug RINVOQ(UPADACITINIB) was no reasonable possibility; Rheumatoid arthritis flare up and the drug RINVOQ(UPADACITINIB) was reasonable possibility; Stress and the drug RINVOQ(UPADACITINIB) was not reported. The reporter's causality assessment for the events Sore throat, Asthma, Nasal stuffiness and the PFIZER BIONTECH COVID-19 VACCINE was probable; events Rheumatoid arthritis flare up and Stress for the PFIZER BIONTECH COVID-19 VACCINE was not reported.  The reporter's assessment of the causal relationship of the events fever and aches with the suspect product PFIZER BIONTECH COVID-19 VACCINE 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.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, The casual association between the reported events with suspected vaccine BNT162B2 cannot be completely 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; fever; severe headache; This is a spontaneous report from a contactable consumer. This 60-year-old-year female consumer(patient) reported for herself that:  A 60-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (at the age of 60-year-old) (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced chills (non-serious) on an unspecified date with outcome of unknown, fever (non-serious) on an unspecified date with outcome of recovered in 2021, severe headache (non-serious) on an unspecified date with outcome of not recovered.  The clinical course of events was as follows: Chills, fever along with a severe headache on the day of third dose. Fever subsided next day but headache remained for several days.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Skin discolouration
Clinical narrative: feel just a little pain in my forearm/a little bit of pain; My index finger got purple, looked black blue mark, massaged it and purple; itching; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. A 71-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in the right arm on 01Oct2021 (at the age of 71-year-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Patient stated, that she received the booster shot at 6 o'clock. She came home, she ate, she took a shower and then in the shower, the arm she got her booster shot started to feel just a little pain. Patient described it as it 'tinged' something in her forearm and then she got out of the shower and her index finger on a same side, the right side where she got the shot, her inside hand at the base of the index finger got purple. She thought well maybe she hit it because she don't remember hitting it. It looked like a black blue mark so what she did was she started massaging it. The purple went away and the pain went away because there was itching and it turned purple and a little bit of pain. So she massaged it and it went away. So she was worried if that was a blood clot, and If so she mean it disappeared after she massaged it. No treatment were given for the events. The patient recovered from pain in forearm and index finger got purple, looked black blue mark on 01Oct2021, while outcome of itching was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.