chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Injection site extravasation, Vaccination site haemorrhage
Clinical narrative: Clear liquid that leaked from the site of injection; some bleeding from the site; This is a spontaneous report from a contactable nurse. A  male patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer -BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient noticed some bleeding from the site as well as clear liquid that leaked from the site of injection. Outcome was unknown.  The information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight tenderness at injection site; This is a spontaneous report from a contactable consumer (patient) and a contactable other health professional.  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at arm left on 11Jan2021 at 11:15 for COVID-19 immunization. The patient medical history included known allergies to adhesive from an unknown date and unknown if ongoing. The patient concomitant medication included metronidazole (METROGEL), vitamin c, cholecalciferol (VITAMIN D), krill oil (MEGARED OMEGA 3 KRILL OIL), cyanocobalamin (B12). On an unspecified date, the patient previously took triple antibiotic ointment and experienced allergy.  The patient experienced slight tenderness at injection site on 11Jan2021 at 17:00. The patient outcome of the event was recovering.  The information on the batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle tightness, Musculoskeletal stiffness, Nausea
Clinical narrative: tightness of shoulders and neck; tightness of shoulders and neck; started having severe nausea in the last hour; Has a slight headache; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 08:00 in left arm at single dose for covid-19 immunization.  Medical history included ongoing diabetes (she had it for 20 years), ongoing asthma (she had it for 25 years), ongoing cirrhosis of the liver non alcoholi diagnosed two years ago, ongoing hypertension diagnosed in the last three months, ongoing fatty liver diagnosed two years ago. There were no concomitant medications. Patient had Covid vaccine this morning at 8 am (12Jan2021) that was fine after 15 minutes, but patient started having severe nausea in the last hour and was unresolved by her nausea medicine. Patient had a slight headache. Patient stated that the headache which was mild, tightness of shoulders and neck started at 13:30. Patient stated that she took acetaminophen 1000 units and used a heating pad for the shoulder. Outcome of nausea was not recovered, and outcome of events were recovered on 12Jan2021.   Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Penile haemorrhage
Clinical narrative: bleeding from the penis; This is a spontaneous report from a contactable Nurse.  A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0142, via an unspecified route of administration in left arm on 05Jan2021 at single dose for covid-19 immunisation.  Medical history included fracture displacement on 23Dec2020, atrial fibrillation, non-hodgkin's lymphoma, post surgical ortho care, semen bleeding, from an unknown date and unknown if ongoing, Covid positive on 06Nov2020 (he was Covid positive before and didn't want to get it again and give it to his wife). There were no concomitant medications.  The patient underwent lab tests and procedures which included Covid test positive on 06Nov2020. The patient experienced bleeding from the penis on an unspecified date with outcome of unknown.  Nurse wanted to know if there is information about interactions between blood thinners and the vaccine.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event penile haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. Of note, semen bleeding was reported as medical history and no concomitant medications were reported; hence, the role of other possible medical conditions or medications cannot be ruled out. This case will be reassessed once additional information becomes available. 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: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Wrong product administered
Clinical narrative: Patient received casirivimab instead of intended COVID vaccine. At follow up Jan 4, patient reported having shortness of breath and fast heart rate (has pacemaker). Will see provider this week. Not yet scheduled to receive COVID 19 vaccine
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Cough, Rash, SARS-CoV-2 test positive
Clinical narrative: rash; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old male patient received the 1st does of bnt162b2 (BNT162B2) at single dose left upper arm on 23Dec2020 for Covid-19 immunisation, administered at hospital.  Medical history included ongoing hypertension that began maybe 10 years before and still ongoing, controlled with medication. No family medical history relevant to the events. The concomitant medications included paracetamol (TYLENOL). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the suspect. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. He has not had reactions to any other vaccines. On 30Dec2020 he tested positive for Covid. His symptoms of covid started 27Dec2020 in the evening sometime probably around 7pm. He experienced cough in Dec2020. No visit to physician office was required. On the 06Jan2021 he went to the emergency room but that was because he was concerned about rash he developed. He thought it was due to the Tylenol he was taking. Relevant tests performed in Ja2021 included: blood work and chest X-ray did when he went in for the rash and they were was fine. He was treated with steroid injection for the rash. The rash cleared up in the next couple days. As of 12Jan2021 the only thing he has cough but he coughs anyway. He still had a cough but it was not atypical for him to have a cough. He was scheduled to receive his second dose on 13Jan2021. He no longer had any Covid symptoms and wanted to know if he could still get the second dose as scheduled. The outcome of event tested positive for the virus and not recovered was unknown, of coughs was not recovered. A Product Complaint was filed.  Information on lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report from a contactable physician reporting for himself. A 47-years-old male patient received the second dose of  bnt162b2 (BNT162B2; Lot # EJ1686) vaccine  , intramuscular in the left deltoid on 07Jan2021 11:00 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  Previously on 17Dec2020 the patient received the first dose of BNT162B2 vaccine. The patient experienced nausea and vomiting  on 10Jan2021 23:59 with outcome of recovered , mild headache on 07Jan2021 20:30 with outcome of recovered , arm was hurting/left arm soreness  on 07Jan2021 20:30 with outcome of recovered.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative   on 20Nov2020. Nausea and vomiting were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events nausea and vomiting  cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontaneous report from a contactable nurse (patient).  A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration at left arm on 08Jan2021 at 09:30 at single dose for COVID-19 immunization. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing and COVID-19 from Oct2020 (as reported: "I had been diagnosed with COVID-19 on 21Oct2020 with symptoms onset on 15Oct2020") to an unknown date.  The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY), aspirin, calcium/cholecalciferol (CALCIUM + D3), docusate.  The patient previously took COMPAZINE and BACTRIM DS and experienced allergies.  The patient reported that on 08Jan2021 at 21:00 developed chills, fatigue, deep muscle aching in both arms and fever ranged between 100- 101 F.  On 09Jan2021 at 09:00 he felt fine, until approximately 17:00 and again developed chills, muscle aching and fatigue. On 10Jan2021 at 08:30 all symptoms were gone and never returned.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 21Oct2020. The patient outcome of the events was recovered on 10Jan2021 at 08:30.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontaneous report from a contactable nurse (patient).  A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration at left arm on 08Jan2021 at 09:30 at single dose for COVID-19 immunization. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing and COVID-19 from Oct2020 (as reported: "I had been diagnosed with COVID-19 on 21Oct2020 with symptoms onset on 15Oct2020") to an unknown date.  The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY), aspirin, calcium/cholecalciferol (CALCIUM + D3), docusate.  The patient previously took COMPAZINE and BACTRIM DS and experienced allergies.  The patient reported that on 08Jan2021 at 21:00 developed chills, fatigue, deep muscle aching in both arms and fever ranged between 100- 101 F.  On 09Jan2021 at 09:00 he felt fine, until approximately 17:00 and again developed chills, muscle aching and fatigue. On 10Jan2021 at 08:30 all symptoms were gone and never returned.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 21Oct2020. The patient outcome of the events was recovered on 10Jan2021 at 08:30.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Livedo reticularis, Pruritus, Rash
Clinical narrative: Really bad headache; Really itchy/itching in her upper body and in legs, like a  rash; Rash/itching in her upper body and in legs, like a  rash; Mottled skin; This is a spontaneous report from a contactable  nurse reporting for herself  A 41-years-old female patient  received bnt162b2 (BNT162B2; Lot #EL3249) vaccine , in the left arm  on 11Jan2021 13:00 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced really bad headache  on 12Jan2021 with outcome of unknown , really itchy/itching in her upper body and in legs, like a  rash  on 12Jan2021 with outcome of unknown , mottled skin on 12Jan2021 with outcome of unknown.  Unknown treatment was given for really bad headache  The reported events were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events headache, pruritus, rash and livedo reticularis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: fever; chills; shaking; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the second of seventeen reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. Consumer reported that multiple friends had the "regular side effects" of soreness in the arm but another one of her friends, which was the patient, also had COVID prior to getting the vaccine and had a similar reaction to the reporter of fever, chills and shaking on an unspecified date. Outcome of the events was unknown. Reporter asked if having COVID prior to getting vaccinated could cause worsen symptoms  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/ drug/ events, different patient
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive after 1st dose; tested positive after 1st dose; This is a spontaneous report from a contactable Nurse. This nurse reported similar events for 2 patients. This is the second of two reports.   This Nurse reported for a 65-year-old female patient (Mother) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose for covid-19 immunization. There was no medical history and no concomitant medications. Mother received 1st dose on 22Dec2020, tested positive for covid-19 infection after 1st dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19 virus test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021015122 same reporter/drug/AE, different patient.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Myalgia, Nausea
Clinical narrative: Fatigue; Nausea; Vomiting; Myalgia; Headache; Dose Number: 1 on 12Dec2020, Dose Number: 2 on 09Jan2021; This is a spontaneous report from a non-contactable other HCP. A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose on left arm for covid-19 immunisation. Medical history included none. No COVID prior vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 12Dec2020 02:00 PM on right arm and experienced fatigue and a headache for 2 days. The patient experienced fatigue, nausea, vomiting, myalgia, headache on 09Jan2021. No treatment received for the events. Outcome of events was recovering. No COVID tested post vaccination.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fatigue; Nausea; Vomiting; Myalgia; Headache; Dose Number: 1 on 12Dec2020, Dose Number: 2 on 09Jan2021; This is a spontaneous report from a non-contactable other HCP. A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose on left arm for covid-19 immunisation. Medical history included none. No COVID prior vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 12Dec2020 02:00 PM on right arm and experienced fatigue and a headache for 2 days. The patient experienced fatigue, nausea, vomiting, myalgia, headache on 09Jan2021. No treatment received for the events. Outcome of events was recovering. No COVID tested post vaccination.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I received a Shingrix (Zoster) 50 mcg vaccination the afternoon of 2021-01-16. The usual sore arm was expected, however, I also developed a +4 deg fever with 24 hours. The elevated temperature began to subside about 10 hours after onset.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Myalgia, Nausea, Vomiting
Clinical narrative: Loss of consciousness; Muscle aches; Headache; Nausea; Vomiting; Dose1 26Dec2020, dose 2 12Jan2021; Dose1 26Dec2020, dose 2 12Jan2021; This is a spontaneous report from a contactable nurse. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm second dose on 12Jan2021 12:15 at a single dose (lot number: EK4176) and intramuscular on the right arm first dose on 26Dec2020 10:15 at a single dose (lot number: EL1284) for COVID-19 immunisation. Medical history included asthma. Concomitant medication included Women's multivitamin within two weeks of vaccination. The patient had no allergies to medications, food, or other products; was not diagnosed with COVID-19 prior to vaccination, did not receive any other vaccines within four weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered at a hospital facility. On 13Jan2021 03:30, the patient experienced muscle aches, headache, nausea, vomiting and loss of consciousness. Treatment was not received for the events. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Hypoaesthesia, Palpitations, Paraesthesia oral, Vaccination site paraesthesia
Clinical narrative: left arm started tingling; roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger; heart palpitations; lower half of my face went numb; Right eye also felt weird like vibrating; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 23Dec2020 15:30 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing prior to vaccination of BNT162B2. Concomitant medication included ibuprofen (ADVIL), ibuprofen and escitalopram oxalate (LEXAPRO). The patient stated, "my left arm started tingling and it was very strong by my finger tips" on 23Dec2020 03:45 PM. The patient stated, "then the roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger. Then I got heart palpitations. The mouth tingling went away in ten minutes but then 15 minutes later the lower half of my face went numb and that lasted about 10 minutes. Right eye also felt weird like vibrating" on 23Dec2020. No treatment received for the adverse events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was recovered on unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: The patient that contracted COVID, 19 days after the first dose; The patient that contracted COVID, 19 days after the first dose; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reporter for himself. A male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient that contracted COVID 19 days after the first dose and want to know what guidance offer for that situation. The outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19  and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: a little nauseous; chills; headache; feeling like he is getting the flu; body aches; This is a spontaneous report from a non-contactable consumer (Patient wife). A 78 years old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 at unspecified age at single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient began with side effects last night on 12Jan2021. He was feeling a little nauseous, chills, headache. The patient was feeling like he was getting the flu. She didn't think he was running a fever and didn't feel like he was burning up or anything, just body aches. The caller wonder whether the side effects related to the vaccine or should he get tested, since the side effects were 5 days after the first dose and she didn't see any timeline for these reactions. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Patient had an allergic reaction.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Diarrhoea, Malaise, Nervousness
Clinical narrative: bad dreams; tightness around my head like there was a band around my head/Pressure like a band was around his head; was going to the bathroom a lot and had a lot of loose stools/digestive track issues with 6 loose stools; felt shaky all day long; woke up feeling lousy/Woke up early and did not feel good; Shivering; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age (Age: 75) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #EJ1685 (or possibly S instead of a 5)) on unknown date in Jan2021 at single dose for COVID-19 immunisation. Medical history included he did have high blood pressure most of the time and it is under control with medications. The patient's concomitant medications were not reported.  He received the first one on Saturday where he is a volunteer worker. He received it at noon on last Saturday and did not have any effects he could tell. They watched him for a while and dismissed after half an hour and was the fine rest of that day. He was fine on Sunday and Monday, but on Tuesday, he woke up early at 4am and just did not feel good. He was having a bad dream, could not get back to sleep. He had a tightness around his head like there was a band around his head. His head felt pressure like a band was around his head. It was not really a headache. He does have high blood pressure most of the time and it is under control with medications. However, yesterday, along with the pressure in his head, he also had digestive track issues which he described as 6 loose stools in the day. He was going to the bathroom a lot and had a lot of loose stools. He was not running fever and it was colder in the night and day but he was dressed appropriately. He felt shaky all day long. He was shivering all day long, but had no fever. He woke up feeling lousy. He went to bed early and slept really well and was better. He would like to know if this sounds like a delayed reaction. The outcome was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nightmare, Tension headache
Clinical narrative: bad dreams; tightness around my head like there was a band around my head/Pressure like a band was around his head; was going to the bathroom a lot and had a lot of loose stools/digestive track issues with 6 loose stools; felt shaky all day long; woke up feeling lousy/Woke up early and did not feel good; Shivering; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age (Age: 75) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #EJ1685 (or possibly S instead of a 5)) on unknown date in Jan2021 at single dose for COVID-19 immunisation. Medical history included he did have high blood pressure most of the time and it is under control with medications. The patient's concomitant medications were not reported.  He received the first one on Saturday where he is a volunteer worker. He received it at noon on last Saturday and did not have any effects he could tell. They watched him for a while and dismissed after half an hour and was the fine rest of that day. He was fine on Sunday and Monday, but on Tuesday, he woke up early at 4am and just did not feel good. He was having a bad dream, could not get back to sleep. He had a tightness around his head like there was a band around his head. His head felt pressure like a band was around his head. It was not really a headache. He does have high blood pressure most of the time and it is under control with medications. However, yesterday, along with the pressure in his head, he also had digestive track issues which he described as 6 loose stools in the day. He was going to the bathroom a lot and had a lot of loose stools. He was not running fever and it was colder in the night and day but he was dressed appropriately. He felt shaky all day long. He was shivering all day long, but had no fever. He woke up feeling lousy. He went to bed early and slept really well and was better. He would like to know if this sounds like a delayed reaction. The outcome was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received her first dose this afternoon on 13Jan2021, but has developed a headache, the patient wanted to know if she can take some ibuprofen. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Eye swelling, Hypersensitivity, Joint swelling, Peripheral swelling
Clinical narrative: allergy; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; my Tongue started swelling; both hands started swelling; Foot swelling including the ankle; Foot swelling including the ankle; This is a spontaneous report from a contactable other hcp reported for himself. A 56-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: bh9899), intramuscular on 31Dec2020 13:30 in left arm at single dose (first dose) for COVID-19 immunization. There were no concomitant medications and medical history. After a day of the vaccine which was giving on Thursday 31Dec2020, patient started experiencing sided effects of his foot swelling including the ankle. On Sunday (03Jan2021), both hands started swelling, Monday (04Jan2021) morning his tongue started swelling and went to his doctor. He administered a steroid and prescribed an Epinephrine pen just in case it got worse and was also prescribed additional medicines for his allergy. Since he had had additional swelling around his upper body including his right eye and right upper quadrant, right ribs. AE treatment including steroid injection, hydroxyzine HCL 25 mg, Methylprednisolone 4 mg. AE resulted in doctor or other healthcare professional office/clinic visit. No other vaccine in four weeks and no other medications in two weeks. There was no COVID tested post vaccination and COVID prior vaccination. The outcomes of events were resolved with sequel.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: allergy; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; my Tongue started swelling; both hands started swelling; Foot swelling including the ankle; Foot swelling including the ankle; This is a spontaneous report from a contactable other hcp reported for himself. A 56-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: bh9899), intramuscular on 31Dec2020 13:30 in left arm at single dose (first dose) for COVID-19 immunization. There were no concomitant medications and medical history. After a day of the vaccine which was giving on Thursday 31Dec2020, patient started experiencing sided effects of his foot swelling including the ankle. On Sunday (03Jan2021), both hands started swelling, Monday (04Jan2021) morning his tongue started swelling and went to his doctor. He administered a steroid and prescribed an Epinephrine pen just in case it got worse and was also prescribed additional medicines for his allergy. Since he had had additional swelling around his upper body including his right eye and right upper quadrant, right ribs. AE treatment including steroid injection, hydroxyzine HCL 25 mg, Methylprednisolone 4 mg. AE resulted in doctor or other healthcare professional office/clinic visit. No other vaccine in four weeks and no other medications in two weeks. There was no COVID tested post vaccination and COVID prior vaccination. The outcomes of events were resolved with sequel.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives; I used the Pfizer vaccine and had allergic reaction; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: 21Dec2020) via an unspecified route of administration, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no concomitant medications. The patient stated that she received the Pfizer vaccine and she had an allergic reaction on an unspecified date in Dec2020. She was told by infectious disease to report it. She also reported that she got hives 3 days later. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient and the physician (whom she consulted) both considered a causal relationship between the events and the suspect drug.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm and fatigue in Jan2021 lasting 24 hours with outcome of recovered.  No follow-up attempts are possible. Information about Lot or Batch Number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: three weeks of intense fatigue; This is a spontaneous report from a contactable Other-HCP (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported three weeks of intense fatigue following first dose of Pfizer COVID vaccine administration. Outcome of the event fatigue was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Pain
Clinical narrative: achy/sore; clammy; This is a spontaneous report from non-contactable physician (patient) via Pfizer Sales Representative. This male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. The patient felt achy, clammy and sore in Jan2021.  Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Throat tightness
Clinical narrative: throat tightness; chills; fever; This is a spontaneous report from a contactable pharmacist (patient) via Pfizer sales representative. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation. Within 5-10 minutes, she noted throat tightness which she successfully treated with diphenhydramine. Within 1-2 hours she noted chills and fever which partially resolved with ibuprofen. Clinical outcome of throat tightness was unknown while for the other events was recovering.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: now she has a cold; This is a spontaneous report from a contactable nurse, reporting for herself. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2, via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization and experienced head cold, nose running, stuffy and sneezing. It was reported that the patient got the second dose of vaccine and was fine and now she has a cold on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hyperventilation, Rash, Rash macular
Clinical narrative: shortness of breath (SOB) with hyperventilation; shortness of breath (SOB) with hyperventilation; Lightheaded; red blotching on face and neck; appeared shaky; This is a spontaneous report from a contactable pharmacist. An adult female patient (pregnant unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 for first dose at single dose (lot number: EL1283) for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded, shortness of breath (SOB) with hyperventilation on 08Jan2021. She was laying on the floor and appeared shaky with red blotching on face and neck on 08Jan2021. Medical response called. Anaphylaxis medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to emergency room (ER). Patient also received Diphenhydramine and Famotidine. The events resulted in emergency room/department or urgent care. It was unknown if covid prior vaccination and if covid tested post vaccination. The outcome of the events was recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162b2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shortness of breath (SOB) with hyperventilation; shortness of breath (SOB) with hyperventilation; Lightheaded; red blotching on face and neck; appeared shaky; This is a spontaneous report from a contactable pharmacist. An adult female patient (pregnant unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 for first dose at single dose (lot number: EL1283) for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded, shortness of breath (SOB) with hyperventilation on 08Jan2021. She was laying on the floor and appeared shaky with red blotching on face and neck on 08Jan2021. Medical response called. Anaphylaxis medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to emergency room (ER). Patient also received Diphenhydramine and Famotidine. The events resulted in emergency room/department or urgent care. It was unknown if covid prior vaccination and if covid tested post vaccination. The outcome of the events was recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162b2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: soreness in her left arm; headache; tired; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ0140, expiry date: unknown), intramuscular in upper left arm, on 20Dec2020 at 14:45-15:00 (as reported), at single dose, for preventive/COVID-19 immunization, in an education center that was turned into a hub for vaccine. Medical history included thyroid, cholesterol and blood pressure. Concomitant medications include medications (unspecified) for thyroid, cholesterol and blood pressure. The patient did not receive prior vaccinations within 4 weeks. The patient experienced a little headache and was tired on 20Dec2020. The patient took Advil and on 21Dec2020, her headache was gone, and she was tired. On 22Dec2020, the second day after receiving the first dose, she recovered completely. It was also reported that the patient experienced soreness in her left arm on an unspecified date. The patient recovered from headache on 21Dec2020 and from fatigue on 22Dec2020. The outcome of vaccination site pain was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Sleep disorder
Clinical narrative: She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the right arm on 09Jan2021 at single dose for COVID-19 immunization.  The patient had no medical history and there were no concomitant medications. The patient took the first dose of the Covid-19 vaccine and was fine. The lot for the first dose of the vaccine was EH9899. She received it on 19Dec2020 (at the age of 51 years). She took the second dose on Saturday (09Jan2021). She experienced nausea and had a sore arm on 10Jan2021. It was not death defying. She was also really tired on 10Jan2021. She was advised by her employer to report this information. She took some Tylenol and relaxed. She was no longer nauseated or tired. Her arm was not sore only tender. She woke up thinking she didn't sleep on an unspecified date. The patient added that her boss said she might have to be tested. The patient asked if that was something that she needs to do. The outcome of the events nausea and tired was recovered on 11Jan2021. The outcome of the event sore arm was recovering. And the outcome of the event "She woke up thinking she didn't sleep" was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Malaise, Nasal congestion, Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: Sore throat; Congestion; Dry cough; Feeling unwell; Upper resp infection; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration from 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  but the agent is unsure what type. Patient received his first dose of the COVID 19 vaccine in Dec2020. The second dose is due tomorrow with the expected 21 day interval. He felt congestion and a stuffy nose with sore throat and a dry cough and was feeling unwell 10Jan2021. Patient thought he has a upper resp infection on an unspecified date in Jan2021. He didn't have fever or chills. Outcome of the events was unknown.  Information on the lot/batch number has been requested.