chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: I got constipation on both time; This is a spontaneous report received from a contactable consumer (Patient). A 60-year-old patient of an unspecified gender received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation, dose 1 (Lot Number: EV6955) in left arm, dose 2 (Lot Number: ER8735). The patient medical history was none. Concomitant medications included levothyroxine. When the patient got both shots, the patient got constipation on both time on an unspecified date. No treatment was given for event. The outcome of event was recovered.               Patient History: No  Investigation Assessment: No   Email Address: Consumer stated, "I don't even read my email, so I will not give you."  LOT#: Consumer stated, "For first shot it's EV6955."      When probed for if consumer still experiencing issue, consumer stated, "No, it's went away."  Treatment: Consumer stated, "No."  QR Comment:  Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed. No further information is expected. This is a spontaneous report from a contactable consumer or other non hcp.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: injection site swelling; This a spontaneous report a Pfizer Sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2, dose 1, via an unspecified route of administration on 13Apr2021 (Lot Number: EW0153) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced injection site swelling on 13Apr2021. The patient just received first dose of Pfizer COVID vaccine and noticed injection site immediately swelled. The patient was wondering if this is ok or does it mean that the medication was inserted at the wrong location, underneath muscle or subcutaneously? The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: test result came back positive; test result came back positive; not feeling good after got the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer Covid Vaccine), dose 1 via an unspecified route of administration on 12Apr2021 (Lot Number: EN6202) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had been sick ever since, went to get test yesterday and result came back positive on an unspecified date, the patient was not feeling good after got the vaccine. The patient underwent lab tests and procedures which included SARS-CoV-2 test negative on 31Mar2021, SARS-CoV-2 test positive on unknown date. The outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Pain in extremity, Upper limb fracture
Clinical narrative: Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe; Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe; sore left arm; This is a spontaneous report from a contactable consumer (patient's husband). A 79-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 79-years-old, via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Lot Number: EP6955) as single dose for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. No Additional vaccines administered on same date. No Prior vaccinations within 4 weeks. Repoeter stating that he and his wife had shot number one, 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm on 27Mar2021. Sore left arm, same arm as shot. Arm was sore for the day. Treatment was none. Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe. Was prescribed pain medicine for a week but did not take because it makes her feel funny. Is one of those powerful medications, can't remember the name. No AEs require a visit to Emergency Room or Physician's office. Event outcome of sore arm was recovered on 27Mar2021, of broken right arm was recovering, of the remaining was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Peripheral artery thrombosis
Clinical narrative: DVTs in both legs; Femoral artery clotted from my thigh to my ankle; This is a spontaneous report from a Pfizer-sponsored program, PFIZER RXPATHWAYS. A contactable consumer (patient) reported that a male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included apixaban (ELIQUIS). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient had deep vein thrombosis (DVTs) in both legs; and femoral artery had clotted from the thigh to the ankle. The events were assessed as serious (medically significant). The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Accident, Fall, Rib fracture
Clinical narrative: Had the first dose; Had an accident and she fell and broke her ribs; Had the first dose; Had an accident and she fell and broke her ribs; Had the first dose; Had an accident and she fell and broke her ribs; This is a spontaneous report received from a contactable consumer(patient). A female patient of an unspecified age received the first dose of BNT162B2 (lot number EN6206), via an unspecified route of administration in left arm, on 25Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose on 25Mar2021 and she was scheduled today to get her second dose. However, the patient had an accident and she fell and broke her ribs on an unknown date and she wanted to reschedule her second dose on next Wednesday, that will be on 21Apr2021. The outcome of the events was unknown.  No follow up attempt possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Cellulitis, Feeling abnormal, Malaise, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 22Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had some concern because he/she had some side effects from Pfizer shot and wanted to know if have they all heard about any of these side effects. The patient was having side effects from the Pfizer shot and wanted to talk to somebody about the side effects. Asked if anybody have reported the side effects yet. (Vaccine name not clarified, hence suspect captured as Unspecified Shot and is this a Pfizer product tab left checked-Yes). On Monday, the patient was supposed to get that second shot but couldn't get it because he/she have got cellulitis in the arm from the shot (vaccination site location unspecified). The patient had been having anxiety effects from the shot. The patient stated 'I have been having' (word not clear). The patient had been feeling like he/she was about to die. 'I feel like' (voice not clear)." Patient further stated, "I am having shakes, I am having anxiety. 'I feel like not talking' (not clear). How long people have been reported, do people have reported side effects after two weeks of the shot. My body is having reaction to your shot and I am trying to figure out what should I do?", she stated. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Gait disturbance, Somnolence
Clinical narrative: I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours; have to go to bed and sleep for about 3 hours; Feeling weaker; Fatigue; This is a spontaneous report from two contactable consumer (patient's partner and patient). A 76-year-old-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982) via an unspecified route of administration on 04Jan2021 (76-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history included sick. Other products were reported as no. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269) via an unspecified route of administration on 04Feb2021 (77-year-old at vaccination) at a single dose for COVID-19 immunization. Consumer stated, "I hope you can, what's happening is I had my COVID shot on my last one on 04Feb2021 (further clarification unknown) and before that even I was sick ( Intent: medical history) and then now it's been 4 months later. This happen to start when I felt before I had the shot. I was like feeling weaker and weaker, there was no strength and then now I am totally fatigue (the start date of the feeling of weakness and fatigue was stated as "That's going to be hard, it's probably, it was in January. I want to look at this. January, probably, in the beginning of January maybe you can say 5th or something like that"), I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours. So, I am looking to you for some help or what can I do." No treatment received. The report was reported as non-serious. The patient was still feeling weak, he was little bit better but he was still very worried about it. The outcome of event feeling weak was resolving, and of other events was unknown.   No Follow-up attempts are needed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hot flush, Hypotension, Pyrexia
Clinical narrative: Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 12Apr2021 10:30 am (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included anxiety attack. The patient's concomitant medications were not reported. The same day that she received the Covid 19 vaccine on 12Apr2021, she had a little bit of fever but the next day the fever was gone. On the 13Apr2021 she had a headache, she took some Tylenol and the headache went away that same day. Her arm was also sore on the first and second day. Patient reported she did have a headache but she thought it was related to the weather because the weather affected her sometimes. She did not think her headache today was related to the vaccine. On 13Apr2021, she started getting hot flashes little by little. She is doing fine now. She has had hot flashes for the last 2 days. She also had low blood pressure. She reported she had taken her blood pressure and gotten the following results. 94/60mmHg, 99/63mmHg, 87/46mmHg. This morning (unspecified) her blood pressure was 99/63mmHg and now it's 107/65mmHg. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No emergency room and physician office required. No prior vaccinations within 4 weeks. The event outcome for low blood pressure (87/46mmHg) was recovered on unspecified date, for hot flashes little by little was recovered on 15Apr2021, for fever and headache was recovered on 13Apr2021, for arm was also sore was unknown.; Sender's Comments: A contributory role of BNT162B2 to the event headache cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 12Apr2021 10:30 am (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included anxiety attack. The patient's concomitant medications were not reported. The same day that she received the Covid 19 vaccine on 12Apr2021, she had a little bit of fever but the next day the fever was gone. On the 13Apr2021 she had a headache, she took some Tylenol and the headache went away that same day. Her arm was also sore on the first and second day. Patient reported she did have a headache but she thought it was related to the weather because the weather affected her sometimes. She did not think her headache today was related to the vaccine. On 13Apr2021, she started getting hot flashes little by little. She is doing fine now. She has had hot flashes for the last 2 days. She also had low blood pressure. She reported she had taken her blood pressure and gotten the following results. 94/60mmHg, 99/63mmHg, 87/46mmHg. This morning (unspecified) her blood pressure was 99/63mmHg and now it's 107/65mmHg. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No emergency room and physician office required. No prior vaccinations within 4 weeks. The event outcome for low blood pressure (87/46mmHg) was recovered on unspecified date, for hot flashes little by little was recovered on 15Apr2021, for fever and headache was recovered on 13Apr2021, for arm was also sore was unknown.; Sender's Comments: A contributory role of BNT162B2 to the event headache cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue for 48 hours; This is a spontaneous report from a non contactable consumer (patient). A 52-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:30 (Batch/Lot number was not reported) at age of 52-year-old, as single dose for covid-19 immunisation. Medical history was none. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical Vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) taken at age of 52-year-old, via an unspecified route of administration, administered in arm left on 22Mar2021 10:30 (Batch/Lot number was not reported), as single dose for covid-19 immunisation. The patient experienced fatigue for 48 hours on 12Apr2021 16:00. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hot flush, Hyperhidrosis, Intermenstrual bleeding
Clinical narrative: breakthrough bleeding; sweats without fever; bad headache,migraine did not respond to benadryl; Cramping; hot flash; Body aches; chills; it feels like I am about to have a period.; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 11:00 AM (Batch/Lot Number: ER8727) (at the age of 48-years-old) as single dose for covid-19 immunisation. Medical history included eczema, beef allergy, allergies: Sulfa, on birth control pills from an unknown date. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 23Mar2021 10:30 AM (Batch/Lot Number: EW0151) (at the age of 48-years-old) for covid-19 immunisation and experienced first shot just a sore arm like tetanus shot. The patient did not receive other vaccine in four weeks. The patient did not get Covid prior vaccination and did not receive Covid tested post vaccination. The patient stated after second shot, bad headache starting about 12 hours after shot on 13Apr2021 23:00. On 13Apr2021 10:00 PM, body aches, chills/sweats without fever. Similar to having flu on 13Apr2021 10:00 PM. Migraine did not respond to benadryl (usually benadryl or phenergan helps). Headache took about 36 hours to go away. Cramping and breakthrough bleeding the day after shot on 13Apr2021 10:00 PM and continuing today, two days after. She was on birth control pills (for hormones) and was on active row of pills. It's like she forgot to take a pill - hot flash, bleeding, even headache were all things that happen if she was missing progesterone. Headache and most aches gone except it felt like she was about to have a period. Treatment received for event Migraine included Benadryl and no treatment received for the other events. The outcome of the events breakthrough bleeding and Cramping was not resolved, of the event headache was resolved in Apr2021, of the event it feels like I am about to have a period was unknown and of the other events was resolving.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle spasms, Pain
Clinical narrative: breakthrough bleeding; sweats without fever; bad headache,migraine did not respond to benadryl; Cramping; hot flash; Body aches; chills; it feels like I am about to have a period.; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 11:00 AM (Batch/Lot Number: ER8727) (at the age of 48-years-old) as single dose for covid-19 immunisation. Medical history included eczema, beef allergy, allergies: Sulfa, on birth control pills from an unknown date. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 23Mar2021 10:30 AM (Batch/Lot Number: EW0151) (at the age of 48-years-old) for covid-19 immunisation and experienced first shot just a sore arm like tetanus shot. The patient did not receive other vaccine in four weeks. The patient did not get Covid prior vaccination and did not receive Covid tested post vaccination. The patient stated after second shot, bad headache starting about 12 hours after shot on 13Apr2021 23:00. On 13Apr2021 10:00 PM, body aches, chills/sweats without fever. Similar to having flu on 13Apr2021 10:00 PM. Migraine did not respond to benadryl (usually benadryl or phenergan helps). Headache took about 36 hours to go away. Cramping and breakthrough bleeding the day after shot on 13Apr2021 10:00 PM and continuing today, two days after. She was on birth control pills (for hormones) and was on active row of pills. It's like she forgot to take a pill - hot flash, bleeding, even headache were all things that happen if she was missing progesterone. Headache and most aches gone except it felt like she was about to have a period. Treatment received for event Migraine included Benadryl and no treatment received for the other events. The outcome of the events breakthrough bleeding and Cramping was not resolved, of the event headache was resolved in Apr2021, of the event it feels like I am about to have a period was unknown and of the other events was resolving.
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Eyelid pain, Ocular discomfort, Soft tissue swelling
Clinical narrative: eye pain/tremendous amount of pain in my right eye; Little bit of swelling I guess from the ocular nerve she called it soft tissue swelling; lot of pressure behind the eye/my eye was going to explode out of my head; Very painful especially eye lid; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer(patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had eye pain, behind the eye after getting the dose and he want to know he should still get the 2nd vaccine or not. The patient was due to get 2nd dose on 19th and he was just really nervous because everyone said that side effect can be more severe and he said that at one point his eye was going to explode out of his head, he mean it was not red but lot of pressure behind the eye. So finally 5 days later he went to ophthalmologist and she dilated his eye and so she could see the more, little bit of swelling he guess from the ocular nerve she called it soft tissue swelling. But it continued to get better every day, he still have it just little bit some part left, to the right but basically it almost gone, that morning he got up he got the vaccine by 2 o'clock he woke at 7:30 with tremendous amount of pain in his right eye so yeah that's his question did you have any reports like this at all. When further paraphrased, consumer stated, very painful especially eye lid. The outcome of the evens was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: received their First dose of the pfizer covid vaccine on 3/24/21; a week and half later they were tested positive for covid.; This is a spontaneous report from a Pfizer sponsored program COVAX support reported by a contactable nurse (Reporter Subtype: Pharmacist). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was tested positive for covid a week and half later after vaccination. The reporter reported that there was no PQC. The reporter needed the information about the second dose, when the patient should get it. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021432741 Same reporter/drug/AE, different patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Itch; redness and swelling around the injection site; redness and swelling around the injection site; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (Lot Number: EW0153) via an unspecified route of administration, administered in right arm (right deltoid) on 10Apr2021 as single dose for covid-19 immunisation. Medical history included asthma, hypertension. Concomitant medications included amlodipine, amlodipine besilate (NORVASC) taken for hypertension, fluticasone propionate/ salmeterol xinafoate (ADVAIR) taken for asthma. The patient reported she had the second dose of vaccine on 10Apr2021, on 12Apr2021, when patient woke up, she had redness and swelling around the injection site, on her right arm. It is probably around the size of an apple. On 14Apr2021 (Today), the redness and swelling were about the size of a grapefruit. It itched and it was swollen and it was red. It is like a big circle and its extending from the injection site which was in her deltoid muscle and it is extending over her bicep muscle. The patient stated it had actually gotten a little bit bigger. She would not say it was improved, it was getting a little bit bigger. She had not been to the doctor over this. The patient had not had any kind of treatment for this on her arm. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Heparin-induced thrombocytopenia test, Metabolic function test, Platelet count, Platelet count decreased
Clinical narrative: Thrombocytopenia; He had clot in the legs and in the lungs; He had clot in the legs and in the lungs; Low platelet count; This is a spontaneous report from a contactable Other-HCP. A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 67 years). Medical history included diabetes. Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]); colecalciferol (VITAMIN D [COLECALCIFEROL]); lisinopril; insulin taken for diabetes mellitus. The patient experienced thrombocytopenia, he had clot in the legs and in the lungs and have a low platelet count on an unspecified date. The patient was hospitalized for the events on an unspecified date. The patient underwent lab tests and procedures which included CBC: unknown result on 08Apr2021, Heparin associate antibody: unknown result, comprehensive metabolic panel (CMP): unknown result and platelet count: low on an unspecified date. Therapeutic measures were taken as a result of thrombosis included Heparin drip and Argatroban. Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: The reported events are considered unrelated to BNT162B2 vaccine, being rather intercurrent occurrences. Clots in the legs and in the lungs were likely favored by the mentioned diabetes and by a possible hyperlipidemia (the patient was taking  atorvastatin) in a setting of possible arterial hypertension (the patient was taking lisinopril).  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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombocytopenia, Thrombosis
Clinical narrative: Thrombocytopenia; He had clot in the legs and in the lungs; He had clot in the legs and in the lungs; Low platelet count; This is a spontaneous report from a contactable Other-HCP. A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 67 years). Medical history included diabetes. Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]); colecalciferol (VITAMIN D [COLECALCIFEROL]); lisinopril; insulin taken for diabetes mellitus. The patient experienced thrombocytopenia, he had clot in the legs and in the lungs and have a low platelet count on an unspecified date. The patient was hospitalized for the events on an unspecified date. The patient underwent lab tests and procedures which included CBC: unknown result on 08Apr2021, Heparin associate antibody: unknown result, comprehensive metabolic panel (CMP): unknown result and platelet count: low on an unspecified date. Therapeutic measures were taken as a result of thrombosis included Heparin drip and Argatroban. Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: The reported events are considered unrelated to BNT162B2 vaccine, being rather intercurrent occurrences. Clots in the legs and in the lungs were likely favored by the mentioned diabetes and by a possible hyperlipidemia (the patient was taking  atorvastatin) in a setting of possible arterial hypertension (the patient was taking lisinopril).  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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Hyperhidrosis, Musculoskeletal discomfort
Clinical narrative: rash that keeps pooping/red rash, itching; Itching; Chills; Tiredness; little bit of sweat; did have problem with back of my neck;  but it got worse since I got the vaccine; did have problem with back of my neck;  but it got worse since I got the vaccine; This is the spontaneous report received from contactable consumer (patient).   A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: ER8730) (at the age of 63 years old) as single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing, problem with back of neck (unknown if it's part of breast cancer) from an unknown date and ongoing (it got worse since she got the vaccine). The patient had received the first dose of BNT162B2 on 10Mar2021 (Lot # EN6203) for COVID-19 Immunization. Concomitant medications included anastrozole (ANASTROZOLE) taken for breast cancer, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRINE) taken for an unspecified indication, start and stop date were not reported; brimonidine tartrate/timolol maleate (COMBIGAN) taken for glaucoma, start and stop date were not reported; brinzolamide (AZOPT) taken for glaucoma, start and stop date were not reported; levetiracetam (LEVETIRACETAM) taken for headache, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; and multivitamins (unspecified).  The patient developed rash that keeps pooping on since 12Apr2021 on her back. She had red rash, itching. She had it for less than a couple of nights and it was constantly itching. She also had little bit of chills on 31Mar2021, little bit of sweat (unspecified date in 2021) and little bit tired (unspecified date in 2021) and they all went away. The patient previously had problem with back of her neck (not sure if it was a part of her breast cancer) and it got worse since she got the vaccine, and she had to see a spine and back specialist. She did not receive treatment for the events. She called her dermatologist to get some relief from the itching but she couldn't get in until the end of May. She wanted to get some advice, something to put on her back for itching. The events chills, sweat and tiredness were resolved on an unspecified date in 2021. The rash/red rash, itching were not resolved. The outcome of the problem with back of her neck was unknown.  No Follow-up attempts are needed; no further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: rash that keeps pooping/red rash, itching; Itching; Chills; Tiredness; little bit of sweat; did have problem with back of my neck;  but it got worse since I got the vaccine; did have problem with back of my neck;  but it got worse since I got the vaccine; This is the spontaneous report received from contactable consumer (patient).   A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: ER8730) (at the age of 63 years old) as single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing, problem with back of neck (unknown if it's part of breast cancer) from an unknown date and ongoing (it got worse since she got the vaccine). The patient had received the first dose of BNT162B2 on 10Mar2021 (Lot # EN6203) for COVID-19 Immunization. Concomitant medications included anastrozole (ANASTROZOLE) taken for breast cancer, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRINE) taken for an unspecified indication, start and stop date were not reported; brimonidine tartrate/timolol maleate (COMBIGAN) taken for glaucoma, start and stop date were not reported; brinzolamide (AZOPT) taken for glaucoma, start and stop date were not reported; levetiracetam (LEVETIRACETAM) taken for headache, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; and multivitamins (unspecified).  The patient developed rash that keeps pooping on since 12Apr2021 on her back. She had red rash, itching. She had it for less than a couple of nights and it was constantly itching. She also had little bit of chills on 31Mar2021, little bit of sweat (unspecified date in 2021) and little bit tired (unspecified date in 2021) and they all went away. The patient previously had problem with back of her neck (not sure if it was a part of her breast cancer) and it got worse since she got the vaccine, and she had to see a spine and back specialist. She did not receive treatment for the events. She called her dermatologist to get some relief from the itching but she couldn't get in until the end of May. She wanted to get some advice, something to put on her back for itching. The events chills, sweat and tiredness were resolved on an unspecified date in 2021. The rash/red rash, itching were not resolved. The outcome of the problem with back of her neck was unknown.  No Follow-up attempts are needed; no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: A patient was suppose to receive the second dose of the covid vaccine, but yesterday she tested positive for covid.; A patient was suppose to receive the second dose of the covid vaccine, but yesterday she tested positive for covid; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was supposed to receive the second dose of the COVID vaccine, but yesterday (14Apr2021) she tested positive for COVID.The pharmacist was asking if the patient would need to restart the COVID vaccine. If so, then pharmacist was asking when the patient could restart the COVID vaccines. Pharmacist was asking if the patient could just receive the second dose a couple of weeks later. The outcome of the event was unknown. The events were assessed as serious-medically significant.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event drug ineffective and COVID-19 and the suspect drug BNT162B2.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Neuropathy peripheral
Clinical narrative: Experiencing neuropathy in both feet/legs/hands; intense cramping in both calves; nausea; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 19Mar2021 17:30 (Batch/Lot Number: ep75534) as single dose for covid-19 immunization. Medical history included cancer survivor from an unknown date and unknown if ongoing , chemotherapy from 2017 to an unknown date, known allergies: penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced experiencing neuropathy in both feet/legs/hands, intense cramping in both calves and nausea for past 4 weeks on 20Mar2021. No treatment was received for the events. The patient did not recover from the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after her first dose; tested positive after her first dose; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 28Mar2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. In2021, the patient tested positive after her first dose (drug ineffective).The caller was scheduled for the second dose on 18Apr2021.Caller wants to reschedule her second dose 19Apr2021.The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The clinical outcome of the event was unknown.   Follow-up (18Apr2021): This follow up report contains no new safety information.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive after her first dose; tested positive after her first dose; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 28Mar2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. In2021, the patient tested positive after her first dose (drug ineffective).The caller was scheduled for the second dose on 18Apr2021.Caller wants to reschedule her second dose 19Apr2021.The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The clinical outcome of the event was unknown.   Follow-up (18Apr2021): This follow up report contains no new safety information.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was tested positive of Covid-19; was tested positive of Covid-19; This is a spontaneous report from a consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 27Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of vaccine on 27Mar2021, and she was tested positive for Covid-19 on an unspecified date. The patient was about to finish her quarantine on Saturday 17Apr2021. She is due to take her 2nd dose on 20Apr2021. she wanted to know if she can still get her 2nd shot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expuiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient had no known underlying conditions. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient felt very tired after receiving the second dose of Pfizer COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Nausea, Rhinorrhoea
Clinical narrative: Nauseous; Stomach ache; Runny nose; Tired; I did not feel good; This is a spontaneous report from a Pfizer-Sponsored program, received from a contactable nurse  A 75 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization and oral palbociclib (IBRANCE) from 02Apr2021 at 125 mg daily cyclic for 21days for an unspecified indication. Relevant medical history and concomitant medications were not reported. It was reported that patient received second dose of vaccination and she did not feel good, was nauseous  had a stomach ache, runny nose and tired. At the time of the reporting event outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Oropharyngeal discomfort, Vomiting, Weight decreased
Clinical narrative: throwing up; he says his throat is bothering him; He is weak; losing weight; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 18Apr2021, the patient experienced throwing up, oropharyngeal discomfort, weak and losing weight. The daughter stated that after he received first dose he was doing well as far as she knows, but on Sunday, April 18, he started throwing up and has not been able to keep anything down. He was weak from not eating and losing weight and he says his throat is bothering him and cannot get out of bed. She wanted to know can this be side effects of the vaccine even two weeks later. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report received from a contactable consumer (patient) via Medical information team. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 01Apr2021 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 dizziness. The patient went to family doctor to see if this was a side effect of the vaccine, but the doctor told him that it was not. However, the caller felt like it was a side effect and wondered could this be from the vaccine as a possible allergic reaction or something else. The patient scheduled to take second dose on 22Apr2021. The 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: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: caller got Pfizer covid vaccine first dose on 28Mar, caller tested positive for covid on past Sunday,; caller got Pfizer covid vaccine first dose on 28Mar, caller tested positive for covid on past Sunday,; This is a spontaneous report from a contactable consumer (the patient) via Pfizer-sponsored program.   A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 28Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in April 2021, caller tested positive for covid on past sunday. The second covax was due on 16Apr2021 but she couldn't go she was positive for COVID. Outcome of the events was unknown.   Information on the lot/ batch number has been requested.