chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Neuralgia, Neuropathy peripheral, Pain in extremity, Radiculopathy
Clinical narrative: Diagnosed radial nerve inflammation in the left arm.; radiating pain throughout the lower left arm; some loss of sensation is also present in the index finger of the left arm; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 54 years, via an unspecified route of administration, administered in Arm Left on 10Feb2021 08:00 (Batch/Lot Number: EL9265; Expiration Date: May2021) as a single dose for covid-19 immunization. The patient's medical history included fibromyalgia like symptoms localized just to the right side of  body. Concomitant medication included levocetirizine (LEVOCETIRIZINE) taken for an unspecified indication, start and stop date were not reported.  The patient has no known allergies. The patient experienced diagnosed radial nerve inflammation in the left arm, radiating pain throughout the lower left arm, some loss of sensation is also present in the index finger of the left arm on 01Mar2021. It was further reported that the patient was diagnosed with radial nerve inflammation in the left arm. Pain occurred two weeks after vaccination and continues up to today despite multiple medications (steroids and anti-inflammatory) tried over the last two months. In addition to radiating pain throughout the lower left arm, some loss of sensation was also present in the index finger of the left arm. The patient underwent lab tests and procedures which included nasal Swab on 24Mar2021 and 06Apr2021 which were both negative. Therapeutic measures were taken as a result of the events included Prednisone, Zorvolex and Tizanidine and Dexamethason. The outcome of the event was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable consumer reported for himself. A 73-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# EW0162) on 09Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a headache last night (09Apr2021) and he still had it today, and inquired if it was safe to take extra strength tylenol or ibuprofen. The outcome of event was not recovered at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Fully vaccinated patient tested Covid-19 postive with full blown symptoms; Fully vaccinated patient tested Covid-19 postive with full blown symptoms; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EL9262) as a single dose; and dose 2 via an unspecified route of administration in the left arm on 09Feb2021 08:00 (Lot Number: EL1283) as a single dose for covid-19 immunisation. The medical history and concomitant medications of the patient were none. The patient was not diagnosed with covid-19 prior to vaccination. The patient has no known allergies. The patient did not have other vaccine in four weeks and did not have other medications in two weeks. The patient received the vaccine in a hospital. The patient reported that he was fully vaccinated on 09Feb2021. On Monday (05Apr2021), the patient mentioned that his two stepsons tested positive contracted it from their father that they saw on 01Apr2021. He further stated that his stepsons "interacted it house last week and they were tested positive Monday and Tuesday this week, this past week."He got tested on 09Apr2021 because he wanted to be safe for his restaurant employees and as a first responder. He was told he was positive. He mentioned that he had full blown symptoms and they said it's unheard of they said I should report it. He got fever, congestion and cough. He further added that he had systems coughing, stuffy nose and a fever of 104 last night (09Apr2021) and shortness of breathe. The doctor's office told him to reach out. This was very unusual. He inquired what do he do now, was he contagious, does he need 10-day quarantine even with the vaccine. The patient was Covid tested post vaccination with nasal swab rapid on 09Apr2021 with result of positive. It was reported that the treatment was unknown. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Malaise, SARS-CoV-2 test
Clinical narrative: tested positive for COVID infection; tested positive for COVID infection; headache; felt sick/ did not feel well; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program. A 16-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 16Mar2021 at single dose for COVID-19 immunisation. Medical history included being exposed to a person with COVID. The patient's concomitant medications were not reported. On 17Mar2021, the day after vaccination, the patient experienced headache and did not feel well, he felt sick. He was exposed to a person with COVID and later on, tested positive for COVID infection on 30Mar2021. The patient already recovered from COVID and wanted to know if he can get the second dose on their scheduled appointment on 15Apr2021. The outcome of the event "tested positive for COVID infection" was recovered on an unspecified date in 2021 and unknown for all other events. The events were reported as non-serious.   Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Influenza, Pyrexia
Clinical narrative: Flu; fever; chills; diarrhea; headache; major dizziness and nausea inner ear problems, diagnosed as UVH. Can't walk without walker, can't drive; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 24Mar2021 at 18:00 (lot number: EN6199 and expiration date: Jun2021) as single dose for covid-19 immunisation. Medical history included high blood pressure, previous stroke, spinal stenosis, and heartbeat issue. The patient is not pregnant at the time of report and at the time of vaccination. The patient has not had COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications included metoprolol; rosuvastatin; montelukast sodium (MONTELUCAST); and fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient did not receive other vaccine in four weeks. The patient experienced flu with fever, chills, diarrhea, and headache on 06Apr2021 at 19:00. Within 2 weeks (Apr2021), major dizziness and nausea inner ear problems, diagnosed as UVH (Unilateral Vestibular Hypofunction). Can't walk without walker, can't drive. The patient did not receive treatment for the events. Outcome of the events was not recovered. The events resulted in visit at emergency room/department or urgent care, and hospitalization for 2 days.
Sex: F
Vaccine: COVID19
Symptoms: Vestibular disorder
Clinical narrative: Flu; fever; chills; diarrhea; headache; major dizziness and nausea inner ear problems, diagnosed as UVH. Can't walk without walker, can't drive; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 24Mar2021 at 18:00 (lot number: EN6199 and expiration date: Jun2021) as single dose for covid-19 immunisation. Medical history included high blood pressure, previous stroke, spinal stenosis, and heartbeat issue. The patient is not pregnant at the time of report and at the time of vaccination. The patient has not had COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications included metoprolol; rosuvastatin; montelukast sodium (MONTELUCAST); and fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient did not receive other vaccine in four weeks. The patient experienced flu with fever, chills, diarrhea, and headache on 06Apr2021 at 19:00. Within 2 weeks (Apr2021), major dizziness and nausea inner ear problems, diagnosed as UVH (Unilateral Vestibular Hypofunction). Can't walk without walker, can't drive. The patient did not receive treatment for the events. Outcome of the events was not recovered. The events resulted in visit at emergency room/department or urgent care, and hospitalization for 2 days.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Vaccination site swelling
Clinical narrative: Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness; Anaphylaxis-swelling of eyes, tongue, and injection site.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 05Apr2021 16:00 as single dose for COVID-19 immunization.  Medical history included known allergies: yes and hypertension. The patient was not pregnant. Concomitant medications included metoprolol succinate (TOPROL XL), lisinopril dihydrate (LISINOPRIL), and cetirizine hydrochloride (ZYRTEC). The patient had no other vaccine in 4 weeks. On 05Apr2021 16:15, the patient experienced anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness. The events resulted in emergency room/ department or urgent care. Therapy for the events included prednisone, antihistamine, and intravenous (IV) fluid. The patient did not have covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering. Information about lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Mobility decreased, Pain assessment, Pain in extremity
Clinical narrative: severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones in my leg/comes on instantly with various movements; severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones in my leg/comes on instantly with various movements; severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones in my leg/comes on instantly with various movements; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 04Apr2021 15:00 (Lot Number: ER8730) as a single dose for covid-19 immunisation. Medical history included major depressive disorder and (CVID) common variable immunodeficiency. The patient has no known allergies. The patient was not diagnosed with Covid-19 prior to vaccinationThe patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) on 14Mar2021 at 15:00 (lot number: EN6202) in the left arm at vaccination age 46-year-old for covid-19 immunization. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), valacyclovir [valaciclovir] (VALACYCLOVIR), cyanocobalamin (B-12), and gam; all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient received the vaccine in a pharmacy or drug store. It was reported that 6 days later (05Apr2021 10:30 AM), she had severe pain in her right leg from mid-thigh to lower ankle. She feels like someone is crushing the bones in her leg (comes on instantly with various movements), has 9-10 on a pain scale of 0-10 and 98% of time can no longer bend her leg when sitting on ground or pain is unbearable. The adverse event resulted in emergency room/department or urgent care for the disability or permanent damage. The events received treatment which included wrapped knee and was referred to an orthopedic doctor. The patient has not been tested post vaccination. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on arms, Back, Stomach and legs; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL 3247) via an unspecified route of administration at left arm on 10Mar2021 13:00 as single dose for COVID-19 immunization. Medical history included allergy to tide laundry de-tergent. Patient concomitant medications were not reported. On an unspecified date the patient ex-perienced rash on arms, back, stomach and legs. Patient received prednisone as therapeutic measure for the event. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: anaphylactic shock and was transported to hospital ER/swollen lips and throat; This is a spontaneous report from a contactable consumer. An adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at a clinic. Medical history included allergic to penicillin and history of previous anaphylaxis reactions. The patient has no covid prior to vaccination. The patient's concomitant medications were not reported. The patient previously took IV iron and experienced allergy. The patient received the vaccine at clinic and within 10 minutes, the patient experienced swollen lips and throat like anaphylactic shock and was transported to hospital ER. The patient received IV benadryl and Pepcid as treatment. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Dizziness, Malaise, Nausea, Parosmia
Clinical narrative: diverticulitis; Dizziness; nausea; general unwell; affected my sense of taste; After losing part of her sense of smell since Mar2020, it came back really strong; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 31Mar2021 16:00 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included diverticulitis, abscess in back at the moment of the vaccination, and losing part of her sense of smell from Mar2020. There were no concomitant medications, and vaccines in four weeks. The patient experienced dizziness, nausea and generally unwell. Two days after receiving the vaccine, on 02Apr2021 15:00, patient was in the ER with diverticulitis. She had to take Ciprofloxacin and metronidazole. After losing part of her sense of smell since Mar2020, it came back really strong. It affected her sense of taste and all food taste bad now. It was like pregnancy sickness. Her sense of smell came in an estrange manner. The events were experienced on 02Apr2021 15:00. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: diverticulitis; Dizziness; nausea; general unwell; affected my sense of taste; After losing part of her sense of smell since Mar2020, it came back really strong; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 31Mar2021 16:00 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included diverticulitis, abscess in back at the moment of the vaccination, and losing part of her sense of smell from Mar2020. There were no concomitant medications, and vaccines in four weeks. The patient experienced dizziness, nausea and generally unwell. Two days after receiving the vaccine, on 02Apr2021 15:00, patient was in the ER with diverticulitis. She had to take Ciprofloxacin and metronidazole. After losing part of her sense of smell since Mar2020, it came back really strong. It affected her sense of taste and all food taste bad now. It was like pregnancy sickness. Her sense of smell came in an estrange manner. The events were experienced on 02Apr2021 15:00. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: Sudden hearing loss; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Apr2021 at 18:00 (6:00 PM) (at the age of 32 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included spironolactone and atomoxetine. The patient experienced sudden hearing loss on 06Apr2021. The patient did not receive treatment for the event. It was unknown if the patient has COVID prior to vaccination and was not tested for COVID post vaccination.  The patient did not receive other vaccine in four weeks. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Epistaxis, Full blood count, Infection, Thrombosis
Clinical narrative: infection; Abnormal nose bleed with blood cloths the first day; Abnormal nose bleed with blood cloths the first day/6 more nose bleed that it was taking me to control up to 30 min; This is a spontaneous report from a contactable other HCP (patient). A 75-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), via an unspecified route of administration on 15Mar2021 10:45 (at 75 years old, not pregnant), single dose for covid-19 immunisation. Medical history included Type II diabetes, Hypertension, GERD and hypercholesterilymia, sulfa allergy, all from an unknown date. Concomitant medications included verapamil; rosuvastatin calcium (CRESTOR); metformin; omeprazole, unspecified blood thinners. The patient previously took tetracycline for known allergies: Tethracycline. Patient experienced abnormal nose bleed with blood cloths the first day (reported as 30Mar2021 0130). Five days later in two days had 6 more nose bleed that it was taking me to control up to 30 min. She went to ER in the morning and had a CBC having results normal with normal levels of platelets. She was referred to PCP. She saw a NP next day and gave me referral to ENT specialist. Using an scope could not find anything and ordered to have CT Scan. Results show negative for polips, tumors and show only a shadow by eye socket which MD believe it was an infection that was leading to the bleed. Prescribe a very small amount of Amoxicilline 125 mg, twice a day for 7 days plus a saline gel. Patient had the last nose bleed at midnight. For 3 days did not have any bleeding until today, at 10:15 am, with heavy bleeding which took me 15 min. to control. She has no history of nose bleed, taking blood thinners, no head traumas either. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the event infection was unknown, other events was not recovered.; Sender's Comments: Information provided was so limited to prevent a meaningful and definite medical assessment for the events. A causal relationship cannot be completely excluded for BNT162B2 injection and development of Thrombosis and Epistaxis, only based on a plausible chronological sequence. 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Syncope
Clinical narrative: vasovagal syncope; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old male patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EP6955), intramuscular, administered in Arm Right on 10Apr2021 11:00 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a clinic. It was unknown if patient received any other vaccines within four weeks prior to receiving bnt162b2. Medical history included always gets nervous. Concomitant medications were not reported.  The patient had no known allergies and denied having other medical history. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EP6955), intramuscular, administered in Arm Right on 20Mar2021 (received at 65-years-old)  as SINGLE DOSE for COVID-19 immunization. On 10Apr2021 11:00 AM, 1-2 (unspecified) after receiving vaccine #2, the patient became pale and diaphoretic and then lost consciousness. He was taken out of car and medics evaluated person and family stated he had not eaten or drank anything and glucose stick was 130. When patient became conscious, he stated he had a similar episode when he was a child and received a vaccine. States he was very anxious receiving both vaccines and always gets nervous. The reported adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was evaluated in emergency and diagnosed with vasovagal syncope. Therapeutic measures were taken as a result of the event. Outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Breast disorder, Erythema multiforme, Fatigue, Haemorrhage
Clinical narrative: hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX).  On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab,  covid Test name post vaccination=Pi  xel by lab,  covid test date=31Mar2021, covid test result=Negative.  The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation delayed, Menstruation irregular, Nausea, Pain
Clinical narrative: hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX).  On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab,  covid Test name post vaccination=Pi  xel by lab,  covid test date=31Mar2021, covid test result=Negative.  The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX).  On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab,  covid Test name post vaccination=Pi  xel by lab,  covid test date=31Mar2021, covid test result=Negative.  The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: full body rash; hives servers; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 29Mar2021 at single dose for COVID-19 immunization. The patient's medical history included 11 years post kidney transplant remission, Non hodgkins lymphoma. The patient's concomitant medications included sodium bicarbonate, gabapentin, morniflumate (FLOMAX), and clarithromycin (CLARITIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), administered in right arm on 08Mar2021 12:30 PM for COVID-19 immunization. The facility type vaccine was Public Health Department. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was tested for COVID post vaccination. On 01Apr2021 at 12:00 (4 days after the second shot), the patient broke out in full body rash and hives servers. All over getting worse. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization. The patient was hospitalized due to the events for 5 days. The patient underwent lab tests and procedures which included nasal swab: negative on 08Apr2021. Therapeutic measures were taken as a result of the events and included treatment with steroid IV therapy and benedryl, topical creams. The outcome of the events were not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Muscle spasms, Weight
Clinical narrative: neurological ticks like back spasm; This is a spontaneous report from a contactable consumer (the patient who is a private citizen and had a pretty good knowledge of how virus works since she worked with wildlife and rehab them. She is familiar with domestic wildlife virus. She is basically a naturalist and catches wild animals). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613) via an unspecified route of administration in right arm on 19Mar2021 14:00 at age of 71-year-old at single dose for COVID-19 immunisation. Medical history included old injuries sustained years and years ago on her C2, T7, T8, L4, and L5, got COVID on 22Dec2020 and when she took the dog to Pharmacy she got another test 06Jan2021 that came back negative. Caller stated because when she had COVID and had a headache that lasted 10 days and she did not want to get the International version. The patient's concomitant medications were not reported. Past drug information was as follows: Caller stated after Prednisone she was at 139 and before was down to 126 and she wanted to be back down to 110, she stated she is quiet chunky. Unknown drug code, lot number, expiry for the prednisone. Caller stated the only thing she sees is the ER. Caller also stated she gained a bunch of weight when she had COVID prior to the shot and got it two days before on 22Dec2020 from neighbor but she was wearing a paper mask like a surgical mask. No prior vaccinations within 4 weeks. No family medical history relevant to AE. Caller stated after the vaccine she is experiencing neurological ticks like back spasm stuff like that from injuries in the past and she has never had this problem. Caller asked if it was a symptom of the vaccine. She got the vaccine on 19Mar2021 and this symptom started on 03Apr2021.The event require a visit to physician office. Caller stated she wanted to try a vitamin B12 shot and she did not want to go to the neurologist or orthopedic because they would say oh we can do surgery. Caller stated she wanted to try a Vitamin B12 and was going for acupuncture to see if that would help because the muscle relaxants did not. Caller also stated she had taken muscle relaxants which did not help. She was unsure of the name, drug code, expiry date as she borrowed them from her neighbor on Sunday. Treatment for the event included Vitamin B12 yesterday to see if it would help, acupuncture, and 3 muscle relaxants she got from her neighbor. The outcome of the event neurological ticks like back spasm was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Arm was sore; Chills; This is a spontaneous report from Pfizer sponsored program from a contactable consumer reported for a patient (reporter's husband). This is the 2nd of 2 reports, for the 2nd dose.   A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 16Mar2021 (Lot Number: EN6206) at single dose for covid-19 immunisation.  The patient medical history was not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9266) on 16Feb2021 at single dose for covid-19 immunisation and experienced just a little soreness. Concomitant drugs were not reported. His arm was sore and he kind of had chills for a couple hours after the second shot. That was his reaction. With the second shot everything happened the same day and was over by the next day, it was even 16Mar2021 that same day he was okay. His soreness recovered completely, it was gone. Events was recovered on 16Mar2021. Causality is N/A.                    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021393005 same patient, different drug(dose)/event.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Eye haemorrhage, Nausea, Pharyngeal haemorrhage, Vascular rupture
Clinical narrative: causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; Nausea; repeated vomiting; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 10:15 (Batch/Lot Number: ER 8737) as single dose for COVID-19 immunization. Medical history included drug amoxillin allergy. Concomitant medication included ibuprofen, simeticone (GAS X), cimetidine (TAGAMET [CIMETIDINE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On 07Apr2021 at 23:00, the patient experienced causing burst blood vessels in face, eyes, nose and throat, nausea and repeated vomiting. The outcome of the events was recovering. The patient did not had COVID prior to vaccination and did not tested positive post vaccination.  No follow-up attempts are possible. No information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; Nausea; repeated vomiting; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 10:15 (Batch/Lot Number: ER 8737) as single dose for COVID-19 immunization. Medical history included drug amoxillin allergy. Concomitant medication included ibuprofen, simeticone (GAS X), cimetidine (TAGAMET [CIMETIDINE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On 07Apr2021 at 23:00, the patient experienced causing burst blood vessels in face, eyes, nose and throat, nausea and repeated vomiting. The outcome of the events was recovering. The patient did not had COVID prior to vaccination and did not tested positive post vaccination.  No follow-up attempts are possible. No information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in lessor saphenous vein left leg; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 15:15 (lot number EN6207) as single dose for covid-19 immunization, administered at the hospital. The patient received the first dose on 24Feb2021 at 15:15 in the right arm (lot number EN6198) for covid-19 immunisation. The patient did not receive other vaccines in four weeks. Medical history included type 2 diabetes, deep vein thrombosis (DVT), and pulmonary embolism (PE). The patient has not had COVID prior to vaccination and not tested for COVID post vaccination. The patient's concomitant medications were not reported. The patient experienced blood clot in lessor saphenous vein left leg on 27Mar2021 at 18:00 with outcome of recovering. The patient's hematologist put the patient on Eliquis 5mg 2 BID and at the time of report, this medicine has started to dissolve the clot.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: on antibiotics for a sinus infection; This is a follow up report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number/ Expiry Date: Not Provided), via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced on antibiotics for a sinus infection. The caller stated that he is enquiring if he can still get the second dose of the vaccine as he is scheduled for his second dose on Friday, which will be 22 days since first. He is on antibiotic therapy for sinus infection, he has a 12-day prescription, he started it 9 days ago, last dose is supposed to be Saturday the day after the vaccine and wants to know if it is okay to get the second dose. He added that he got the first dose of the vaccine last 18Mar2021 and his second dose is scheduled on 09Apr2021. Upon checking, his second dose is scheduled more than 21 days after the first dose. Therapeutic measures were taken as a result of on antibiotics for a sinus infection. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Magnetic resonance imaging, Ultrasound Doppler
Clinical narrative: I had cob webs across my left eye, which turned out to be an occipital stroke; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot E19264), via an unspecified route of administration, administered in left arm on 15Mar2021 as single dose for COVID-19 immunisation. Medical history included diabetes, arthritis, high blood pressure (BP), and known allergies to adhesive. The patient was not pregnant. Concomitant medications included tolterodine l-tartrate (DETROL), propranolol hydrochloride (INDERAL), metformin, celecoxib (CELEBREX), and valsartan (DIOVAN). On 28Mar2021, the patient experienced cob webs across her left eye, which turned out to be an occipital stroke. She reported that she had good control of her BP so the cause of it was unknown at this time. Therapy of the event included Paxil and underwent doppler test and MRI. The event resulted in doctor or other healthcare professional office/clinic visit, and disability or permanent damage. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of event was recovered with sequel in Mar2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Neuropathy peripheral
Clinical narrative: the intensity of the CIPN increased exponentially; the intensity of the CIPN increased exponentially; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 57-year-old, via an unspecified route of administration, administered in left arm on 20Mar2021 13:30 as single dose for COVID-19 immunisation. Medical history included metastatic breast CA, known allergies to oak tree and pollen, and residual bilateral CIPN in the balls and toes and feet. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination and has not been tested post vaccination. Concomitant medications included olaparib, durvalumab, and levothyroxine sodium (SYNTHROID). On 22Mar2021 07:30 (also reported as two days after receiving the first dose), the intensity of the CIPN increased exponentially. This lasted about 5 days when it slowly started to return to normal levels at 2.5 weeks after the first dose. No treatment was received for the events. The outcome of the events was recovered on Apr2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2  to the reported "intensity of the CIPN increased exponentially" cannot be totally excluded.  Case will be reassessed if additional information is received.  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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Headache, Herpes zoster, Muscle spasms, Tourette's disorder
Clinical narrative: severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touch; severe pain in her head, it hurt to touch and had shocks and her whole body would cramp up; her whole body would cramp up; Tourette's; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198, expiration date: 30Jun2021) at the age of 71-years-old, via an unspecified route of administration in right shoulder on 05Mar2021 at 10:30 at single dose for COVID-19 immunization. Medical history included neuropathy in feet caused Tamoxifen (chemotherapy), anal cancer stage IV, breast cancer, double mastectomy, chemotherapy, and lymph node in left arm. Concomitant medications included gabapentin, meloxicam, and vitamins. There were no additional vaccines administered on the same date with the COVID-19 vaccine as well as within 4 weeks. The patient previously took tamoxifen as chemotherapy and experienced neuropathy in feet. The patient received her first COVID-19 vaccine on 05Mar2021 and on 13Mar2021, she experienced severe pain across the front of her stomach. On 19Mar2021, she said she has something, and it was a rash. She went to care facility on 20Mar2021 and was told she has shingles. The patient stated that the doctor just looked at her and said she has shingles, no testing was done. They told her it was ok for her to get the second shot, but she was worried about that. She experienced shingles since 13Mar2021, she still has it. She was supposed to have the shingles vaccine 4 years ago, but it was expensive. Her son heard on the radio that the shot may cause shingles, it may or may not be related but she wanted to let Pfizer know. The rash was starting to go away, and the pain was not, but the pain was far better. She ended up going to the doctor on 24Mar2021 with severe pain in her head since Mar2021, and she didn't know why. It hurt to touch and had shocks and her whole body would cramp up. Her daughter told her she looked like she had Tourette's, it was happening every 2-5 minutes. The doctor couldn't do anything and told her what she could take. It was an additional thing and the doctor said it was probably from shingles but she did not have a rash there. It was completely gone now. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiration date: 31Jul2021), via an unspecified route of administration in right shoulder on 26Mar2021 at noon and stated that it was getting better then, and by 27Mar2021 it was gone completely. She was petrified this was going to happen while she was there to get the second vaccine and they would say she couldn't do it. The outcome of the event shingles was recovering and recovered on 27Mar2021 for all other events.