chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Condition aggravated, Diarrhoea
Clinical narrative: It had burst and bled in my abdomen; I had a good sized ovarian cyst in my right ovary rupture; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19May2021 (Lot number: Er8735) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Possible iodine allergy" (unspecified if ongoing), notes: Verbatim: Possible iodine allergy; "Seasonal allergies" (unspecified if ongoing), notes: Verbatim: Seasonal allergies; "Chronic pain" (unspecified if ongoing); "PVC's" (unspecified if ongoing), notes: Verbatim: PVC's; "PTSD" (unspecified if ongoing), notes: Verbatim: PTSD. The patient's concomitant medications were not reported. Past drug history included: Epinephrine for Numbing Medicine, reaction(s): "Known allergy: Reaction to numbing medicine with epinephrine", notes: Verbatim: Known allergy: Reaction to numbing medicine with epinephrine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 28Apr2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: INTERNAL HAEMORRHAGE (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "It had burst and bled in my abdomen"; OVARIAN CYST (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "I had a good sized ovarian cyst in my right ovary rupture". The events "it had burst and bled in my abdomen" and "i had a good sized ovarian cyst in my right ovary rupture" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: ultrasound scan vagina: (20May2021) it had burst and bled in my abdomen. Therapeutic measures were taken as a result of internal haemorrhage, ovarian cyst.  Additional information: patient reported that A Day after her second covid 19 shot, she had a good sized ovarian cyst in my right ovary rupture that she had no idea she has. She had to go to the ER and get an ultrasound transvaginal. It had burst and bled in her abdomen. She was fine now but have another cyst and just got her 3rd Pfizer covid-19 vaccine. No covid prior vaccination. No covid tested post vaccination.Therapeutic measured included check ups and  observations with pain meds and rest.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Faeces discoloured, Fatigue, Gastrointestinal pain, Headache, Myalgia
Clinical narrative: It had burst and bled in my abdomen; I had a good sized ovarian cyst in my right ovary rupture; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19May2021 (Lot number: Er8735) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Possible iodine allergy" (unspecified if ongoing), notes: Verbatim: Possible iodine allergy; "Seasonal allergies" (unspecified if ongoing), notes: Verbatim: Seasonal allergies; "Chronic pain" (unspecified if ongoing); "PVC's" (unspecified if ongoing), notes: Verbatim: PVC's; "PTSD" (unspecified if ongoing), notes: Verbatim: PTSD. The patient's concomitant medications were not reported. Past drug history included: Epinephrine for Numbing Medicine, reaction(s): "Known allergy: Reaction to numbing medicine with epinephrine", notes: Verbatim: Known allergy: Reaction to numbing medicine with epinephrine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 28Apr2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: INTERNAL HAEMORRHAGE (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "It had burst and bled in my abdomen"; OVARIAN CYST (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "I had a good sized ovarian cyst in my right ovary rupture". The events "it had burst and bled in my abdomen" and "i had a good sized ovarian cyst in my right ovary rupture" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: ultrasound scan vagina: (20May2021) it had burst and bled in my abdomen. Therapeutic measures were taken as a result of internal haemorrhage, ovarian cyst.  Additional information: patient reported that A Day after her second covid 19 shot, she had a good sized ovarian cyst in my right ovary rupture that she had no idea she has. She had to go to the ER and get an ultrasound transvaginal. It had burst and bled in her abdomen. She was fine now but have another cyst and just got her 3rd Pfizer covid-19 vaccine. No covid prior vaccination. No covid tested post vaccination.Therapeutic measured included check ups and  observations with pain meds and rest.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ovarian cyst ruptured, Pain, Spinal pain, Swelling, Tendon pain
Clinical narrative: It had burst and bled in my abdomen; I had a good sized ovarian cyst in my right ovary rupture; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19May2021 (Lot number: Er8735) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Possible iodine allergy" (unspecified if ongoing), notes: Verbatim: Possible iodine allergy; "Seasonal allergies" (unspecified if ongoing), notes: Verbatim: Seasonal allergies; "Chronic pain" (unspecified if ongoing); "PVC's" (unspecified if ongoing), notes: Verbatim: PVC's; "PTSD" (unspecified if ongoing), notes: Verbatim: PTSD. The patient's concomitant medications were not reported. Past drug history included: Epinephrine for Numbing Medicine, reaction(s): "Known allergy: Reaction to numbing medicine with epinephrine", notes: Verbatim: Known allergy: Reaction to numbing medicine with epinephrine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 28Apr2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: INTERNAL HAEMORRHAGE (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "It had burst and bled in my abdomen"; OVARIAN CYST (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "I had a good sized ovarian cyst in my right ovary rupture". The events "it had burst and bled in my abdomen" and "i had a good sized ovarian cyst in my right ovary rupture" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: ultrasound scan vagina: (20May2021) it had burst and bled in my abdomen. Therapeutic measures were taken as a result of internal haemorrhage, ovarian cyst.  Additional information: patient reported that A Day after her second covid 19 shot, she had a good sized ovarian cyst in my right ovary rupture that she had no idea she has. She had to go to the ER and get an ultrasound transvaginal. It had burst and bled in her abdomen. She was fine now but have another cyst and just got her 3rd Pfizer covid-19 vaccine. No covid prior vaccination. No covid tested post vaccination.Therapeutic measured included check ups and  observations with pain meds and rest.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram, Herpes zoster, Hypokinesia, Magnetic resonance imaging, Pathology test
Clinical narrative: developed shingles in his right upper extremity and face; profound loss of function in the shoulder/lost the ability to raise his right arm; This is a literature report.  A 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "right anatomic shoulder arthroplasty", start date: Sep2018 (not ongoing); "lymphoma" (ongoing); "postoperative chemotherapy" (unspecified if ongoing); "glenohumeral osteoarthritis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1 Unknown manufacture), for covid-19 vaccination. The following information was reported: HERPES ZOSTER (medically significant), outcome "recovered", described as "developed shingles in his right upper extremity and face"; HYPOKINESIA (medically significant), outcome "recovering", described as "profound loss of function in the shoulder/lost the ability to raise his right arm". The patient underwent the following laboratory tests and procedures: electromyogram: the results showed mild median, ulnar, and radial, notes: nerve neuropathy, while the axillary nerve showed normal function.was done 3 days prior to his clinic visit, within 6 weeks of the onset of his symptoms; magnetic resonance imaging: showed mild atrophy and fatty infiltration of the, notes: subscapularis and supraspinatus. The deltoid was difficult to assess due to signal artifact from the prosthesis; pathology test: diagnosed with lymphoma; physical examination: he had 90 to 100 degrees of active forward, notes: elevation and his pain was well controlled. in December 2018; active forward flexion was 0, notes: significant deltoid atrophy; passive forward flexion to 120 degree, notes: significant deltoid atrophy. Therapeutic measures were taken as a result of herpes zoster, hypokinesia.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug 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 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.,Linked Report(s) : US-PFIZER INC-202200159961 Same article/ drug and different patient/event
Sex: M
Vaccine: COVID19
Symptoms: Physical examination
Clinical narrative: developed shingles in his right upper extremity and face; profound loss of function in the shoulder/lost the ability to raise his right arm; This is a literature report.  A 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "right anatomic shoulder arthroplasty", start date: Sep2018 (not ongoing); "lymphoma" (ongoing); "postoperative chemotherapy" (unspecified if ongoing); "glenohumeral osteoarthritis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1 Unknown manufacture), for covid-19 vaccination. The following information was reported: HERPES ZOSTER (medically significant), outcome "recovered", described as "developed shingles in his right upper extremity and face"; HYPOKINESIA (medically significant), outcome "recovering", described as "profound loss of function in the shoulder/lost the ability to raise his right arm". The patient underwent the following laboratory tests and procedures: electromyogram: the results showed mild median, ulnar, and radial, notes: nerve neuropathy, while the axillary nerve showed normal function.was done 3 days prior to his clinic visit, within 6 weeks of the onset of his symptoms; magnetic resonance imaging: showed mild atrophy and fatty infiltration of the, notes: subscapularis and supraspinatus. The deltoid was difficult to assess due to signal artifact from the prosthesis; pathology test: diagnosed with lymphoma; physical examination: he had 90 to 100 degrees of active forward, notes: elevation and his pain was well controlled. in December 2018; active forward flexion was 0, notes: significant deltoid atrophy; passive forward flexion to 120 degree, notes: significant deltoid atrophy. Therapeutic measures were taken as a result of herpes zoster, hypokinesia.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug 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 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.,Linked Report(s) : US-PFIZER INC-202200159961 Same article/ drug and different patient/event
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID test after vaccination; Positive COVID test after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult patient received bnt162b2 (BNT162B2) (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 "Positive COVID test after vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Loss of greater than 50 percent of hearing loss in right ear; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2021 12:00 (Lot number: E13248) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies : Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EK4231, Route: Intramuscular, Dose administration time: 12:00 PM at left arm), administration date: 14Jan2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 22Mar2021, outcome "not recovered", described as "Loss of greater than 50 percent of hearing loss in right ear". The event "loss of greater than 50 percent of hearing loss in right ear" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of deafness unilateral.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient was not tested for COVID-19, Since the vaccination. Device Date: 21Feb2022
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast inflammation, Breast mass, Breast pain, Pain
Clinical narrative: when i touched I felt a strong stinging sensation on my breast.; inflammation of the breast; Nodules in the breast/hard nodule/lump; it gave me a strong pain next to the breast.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Jun2021 (Lot number: EW0181) at the age of 49 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 (lot no: EW0168, Route of administration: Left arm, Dose no: 1, NDC: Unknown , Expiration: Unknown), administration date: 12May2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "COVID-19 immunization". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "when i touched I felt a strong stinging sensation on my breast."; BREAST INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "inflammation of the breast"; BREAST MASS (non-serious) with onset 2021, outcome "unknown", described as "Nodules in the breast/hard nodule/lump"; BREAST PAIN (non-serious) with onset 2021, outcome "unknown", described as "it gave me a strong pain next to the breast.".  Additional information: Patient (49 year, female)received the Pfizer COVID-19 Pfizer vaccine and after the 2nd and 3rd doses presented pain, inflammation and the presence of nodules (lumps) on left breast after 2nd dose patient noticed a hard nodule/lump, it gave me a strong pain next to the breast. Patient didn't realize when they appeared when she touched she felt a strong stinging sensation on breast.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Fatigue, Pain, Pyrexia
Clinical narrative: Felt achy; tired; fever; asthma symptom; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 55-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknow, single for covid-19 immunization. Relevant medical history included: "Severe asthma" (unspecified if ongoing), notes: Severe asthma; "bipolar disorder" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "back pain" (unspecified if ongoing); "Barrett's Esophagitis" (unspecified if ongoing); "benign bladder tumor" (unspecified if ongoing), notes: benign bladder tumor. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Felt achy"; FATIGUE (non-serious), outcome "unknown", described as "tired"; PYREXIA (non-serious), outcome "unknown", described as "fever"; ASTHMA (non-serious), outcome "unknown", described as "asthma symptom".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Herpes zoster, Lymphadenopathy, Nausea, Pain
Clinical narrative: fever; chills; body aches/ sore; nausea; sore swollen glands; sore arm; I got shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Codeine, reaction(s): "Known allergies: Codeine based medication makes me nauseous". Vaccination history included: Bnt162b2 (lot number=EN6207 , dose number=2, location=Left arm), administration date: 31Jul2021, when the patient was 62 years old, for Covid-19 Immunization, reaction(s): "sore arm"; Bnt162b2 (lot number=EN6202, dose number=1), administration date: 06Feb2021, when the patient was 62 years old, for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious) with onset 26Jan2022, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 26Jan2022, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 26Jan2022, outcome "not recovered", described as "body aches/ sore"; NAUSEA (non-serious) with onset 26Jan2022, outcome "not recovered", described as "nausea"; LYMPHADENOPATHY (non-serious) with onset 26Jan2022, outcome "not recovered", described as "sore swollen glands"; PAIN IN EXTREMITY (non-serious) with onset 26Jan2022, outcome "not recovered", described as "sore arm"; HERPES ZOSTER (non-serious) with onset 26Jan2022, outcome "not recovered", described as "I got shingles". The events "fever", "chills", "body aches/ sore", "nausea", "sore swollen glands", "sore arm" and "i got shingles" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pyrexia, chills, pain, nausea, lymphadenopathy, pain in extremity, herpes zoster.  Additional information: The patient got her first two shots with no problems other than a sore arm. When she gets her booster, she got a fever; chills; body aches; nausea; sore, swollen glands; and a sore arm. She was not alarmed but figured it was an immune response. However, within the month she got shingles. She believed that had she not gotten this booster, she would not have gotten shingles. The patient did not received any other vaccine in four weeks and other medications in two weeks. Treatment received as Valacyclovir, Gabapentin, and Lyrica.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; chills; body aches/ sore; nausea; sore swollen glands; sore arm; I got shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Codeine, reaction(s): "Known allergies: Codeine based medication makes me nauseous". Vaccination history included: Bnt162b2 (lot number=EN6207 , dose number=2, location=Left arm), administration date: 31Jul2021, when the patient was 62 years old, for Covid-19 Immunization, reaction(s): "sore arm"; Bnt162b2 (lot number=EN6202, dose number=1), administration date: 06Feb2021, when the patient was 62 years old, for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious) with onset 26Jan2022, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 26Jan2022, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 26Jan2022, outcome "not recovered", described as "body aches/ sore"; NAUSEA (non-serious) with onset 26Jan2022, outcome "not recovered", described as "nausea"; LYMPHADENOPATHY (non-serious) with onset 26Jan2022, outcome "not recovered", described as "sore swollen glands"; PAIN IN EXTREMITY (non-serious) with onset 26Jan2022, outcome "not recovered", described as "sore arm"; HERPES ZOSTER (non-serious) with onset 26Jan2022, outcome "not recovered", described as "I got shingles". The events "fever", "chills", "body aches/ sore", "nausea", "sore swollen glands", "sore arm" and "i got shingles" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pyrexia, chills, pain, nausea, lymphadenopathy, pain in extremity, herpes zoster.  Additional information: The patient got her first two shots with no problems other than a sore arm. When she gets her booster, she got a fever; chills; body aches; nausea; sore, swollen glands; and a sore arm. She was not alarmed but figured it was an immune response. However, within the month she got shingles. She believed that had she not gotten this booster, she would not have gotten shingles. The patient did not received any other vaccine in four weeks and other medications in two weeks. Treatment received as Valacyclovir, Gabapentin, and Lyrica.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depressed mood, Petechiae
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Aug 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. The patient experienced petechiae (it looks like petechiae, these little red dots all over my skin), depressed mood (she is very upset about everything) and anxiety (she is anxious), onset 2021, with outcome of unknown. Additional information: The dermatologist doesn't know, the doctor, no one knows. It happened six days after the second, the booster (third shot), and it was late Aug within six days developed. It looks like petechiae, these little red dots all over skin. Product details (expiration date, NDC# and UPC #), purchase details and other details unknown and limited information was available. There was no product complaint to report. During call back, reporter stated he was a companion to the patient. The patient was "having issues since the vaccine shot." Patient had red spots all over arms, which disappeared and came back. Upon further research by patient, she found out it may be an indication of possible serious problems. Patient was seen by the dermatologist, family doctor and a nurse; but they have no idea what the patient had. They wanted to know what should they do about it. The lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Loss of consciousness
Clinical narrative: has been passing out after she received the the third dose; has a brain bleed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 85 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing), notes: Verbatim: Autoimmune disorder. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization; Bnt162b2 (Dose 2, single), for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "has been passing out after she received the the third dose"; CEREBRAL HAEMORRHAGE (medically significant), outcome "unknown", described as "has a brain bleed". Clinical course: The patient has an autoimmune disorder and has been passing out after receiving the third dose. The patient found out that has a brain bleed and needs more testing but never has had anything like this before. The patient stays at home and passes out a lot. The patient has been at home and will not leave her house now because she has passed out in a parking lot. The patient needs to report this since it hasn't happened before she got the vaccine. The investigation assessment was not provided. The patient taken all the three doses and information about dose was not provided. The reporter declined phone number, address, and email.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: infected with COVID; infected with COVID; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (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 "infected with COVID".  Clinical course:He never received his booster and ended up becoming infected with COVID. He had symptoms for a week. His symptoms were high fever, mild dry cough, chills, and loss of taste. Symptoms resolved after a week.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Pulmonary thrombosis
Clinical narrative: A blood clot in my left lung; Chronic asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "A blood clot in my left lung"; ASTHMA (non-serious), outcome "unknown", described as "Chronic asthma".  Clinical information: After getting COVID vaccine, patient developed chronic asthma and a blood clot in left lung now patient on blood thinner, Eliquis, but patient couldn't afford it because patient a senior and insurance does not cover meds since patient have to take the blood thinner due to vaccine.  The lot number for 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: Tested covid-19 positive 2 months after second dose.; Tested covid-19 positive 2 months after second dose.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old 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 "Tested covid-19 positive 2 months after second dose.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: Experienced headache and flu symptoms  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: mild fatigue ST; cough; HOME AG:Positive; HOME AG:Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Lot number: FF2589) at the age of 37 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Feb2022, outcome "unknown" and all described as "HOME AG:Positive"; FATIGUE (non-serious) with onset 19Feb2022, outcome "unknown", described as "mild fatigue ST"; COUGH (non-serious) with onset 19Feb2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Feb2022) positive, notes: Home AG. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, fatigue, cough. Clinical course included "Household member with positive  COVID, 2 children then he had symptoms on 18Feb2022 and positive COVID 19Feb2022 mild fatigue ST and cough"  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: sx and + home Ag test 20Feb test result: Positive; sx and + home Ag test 20Feb test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 41 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 02Nov2021 (Lot number: FF2589) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 25Feb2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 04Feb2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 20Feb2022, outcome "unknown" and all described as "sx and + home Ag test 20Feb test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Feb2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, sars-cov-2 test positive. Facility type vaccine received at workplace clinic. It was unknown If patient received any other vaccine in four weeks. COVID prior to vaccination was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: Tested covid-19 positive 2 months after second dose; Tested covid-19 positive 2 months after second dose; pain in his legs during 2 days; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), 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 "Tested covid-19 positive 2 months after second dose"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in his legs during 2 days"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: positive, notes: Tested covid-19 positive.  Clinical course: Tested covid-19 positive 2 months after second dose. Experience fatigue and pain in his legs during 2 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Feeling abnormal, Influenza like illness, Rhinorrhoea, Suspected COVID-19
Clinical narrative: flu like symptoms; had a slight runny nose; she got Covid in Jan2022; she got Covid in Jan2022; a lot of brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 15:00 (Lot number: ER8735, Expiration Date: 31Jul2021) at the age of 53 years as dose 2, single and administered in arm left, administration date 06Apr2021 15:00 (Lot number: ER8737, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "has some pressure in her eyes" (unspecified if ongoing), notes: Verbatim: has some pressure in her eyes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she got Covid in Jan2022"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "a lot of brain fog"; INFLUENZA LIKE ILLNESS (non-serious) with onset 01Jan2022, outcome "unknown", described as "flu like symptoms"; RHINORRHOEA (non-serious) with onset Jan2022, outcome "unknown", described as "had a slight runny nose". The events "she got covid in jan2022", "she got covid in jan2022", "a lot of brain fog", "flu like symptoms" and "had a slight runny nose" were evaluated at the emergency room visit.  Clinical course: It was stated around 01Jan2022, that first week in Jan she started having not typical symptoms like flu like symptoms. Caller states she had a slight runny nose and a lot of brain fog. States her daughter is in college and was home and she tested positive that week. States what happened was she started feeling fogginess and out of sorts and on 07Jan2022 she went and got the Pfizer booster. It was clarified that she went to the ER and because she did not have typical symptoms she was not tested for Covid but she had been in the house with her daughter that was positive and she had all the symptoms.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Suspected COVID-19, Tinnitus
Clinical narrative: got real sick with COVID; got real sick with COVID; got real sick with COVID; she wished she could get rid of the ringing in her ears/it is ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200326768 (Pfizer).  A female patient in her 50's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), ILLNESS (non-serious), outcome "unknown" and all described as "got real sick with COVID"; TINNITUS (non-serious), outcome "unknown", described as "she wished she could get rid of the ringing in her ears/it is ringing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle injury, Muscle spasms, Muscle twitching, Paraesthesia, Skin burning sensation
Clinical narrative: burning skin; 2 days after Booster muscle spasms; twitches/nerve twitches; pins and needles hands; feet calves hamstrings; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Oct2021 08:00 (Lot number: FE3592) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Reflux IBS" (unspecified if ongoing); "Known allergies: iodine contrast" (unspecified if ongoing); "Known allergies: Wheat" (unspecified if ongoing); "known allergies: gluten" (unspecified if ongoing); "known allergies: milk" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: shrimp" (unspecified if ongoing). Concomitant medication(s) included: DIVIGEL; PROGESTERONE; ARMOUR THYROID. Past drug history included: Cephalosporins for known allergies: Cephalosporins. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6202, Vaccine Administration Time: 10:00 AM), administration date: 03Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El9265, Vaccine Administration Time: 10:00 AM), administration date: 10Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: SKIN BURNING SENSATION (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "burning skin"; MUSCLE SPASMS (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "2 days after Booster muscle spasms"; MUSCLE TWITCHING (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "twitches/nerve twitches"; PARAESTHESIA (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "pins and needles hands"; MUSCLE INJURY (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "feet calves hamstrings". The events "burning skin", "2 days after booster muscle spasms", "twitches/nerve twitches", "pins and needles hands" and "feet calves hamstrings" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin burning sensation, muscle spasms, muscle twitching, paraesthesia, muscle injury.  Additional information:Steroid dosepak was taken as treatment for adverse events.The patient didn't taken Covid prior vaccination. Patient was not tested Covid post vaccination.Patient didn't taken other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected. .
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: he tested 21Feb2022 + positive home AG; he tested 21Feb2022 + positive home AG; then sx Sunday 20Feb2022 of mild congestion; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Feb2022, outcome "unknown" and all described as "he tested 21Feb2022 + positive home AG"; NASAL CONGESTION (non-serious) with onset 20Feb2022, outcome "unknown", described as "then sx Sunday 20Feb2022 of mild congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (21Feb2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, nasal congestion. Clinical information: It was unknown if the patient was tested for covid prior to vaccination and patient was tested Covid post vaccination. It was unknown if other vaccine were taken in four weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, C1 esterase inhibitor test, Full blood count, Hepatitis B virus test, Hepatitis C virus test
Clinical narrative: Urticarial vasculitis; This is a literature report.  A 86 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIAL VASCULITIS (medically significant), outcome "recovered", described as "Urticarial vasculitis". The patient underwent the following laboratory tests and procedures: biopsy skin: revealing superficial perivascular inflammation, notes: with rare eosinophils and leukocytoclastic debris, raising suspicion for prior vascular injury; c1 esterase inhibitor test: within normal limits; full blood count: acceptable limits; hepatitis b virus test: negative; hepatitis c virus test: negative; immune complex assay: within normal limits; investigation: within normal limits; within normal limits; within normal limits; within normal limits; laboratory test: showed results; metabolic function test: acceptable limits. Therapeutic measures were taken as a result of urticarial vasculitis.  Clinical course: The patient was treated with oral prednisone 40 mg daily for 5 days,topical triamcinolone ointment, oral fexofenadine, and oral diphenhydramine as needed for itch. She reported progressive improvement with resolution within 2 weeks of treatment initiation.; Sender's Comments: Based on information provided and temporal association, causal relationship between the reported event urticarial vasculitis and the suspect BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200312449 Same article/drug and different patient/event