chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Atrial fibrillation, Dyspnoea, Pleural effusion
Clinical narrative: Suddenly developed AFib; difficulty breathing; large buildup of fluid in my lungs; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Lot number: UNKNOWN) as single dose for COVID-19 immunisation; metoprolol tartrate, via an unspecified route of administration from an unspecified date to an unspecified date, at 50 mg, 2x/day for an unspecified indication; apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date, 2x/day for an unspecified indication. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced suddenly developed afib, difficulty breathing, large buildup of fluid in my lungs. The patient reported the course of the events as follows: Within 6 weeks after receiving the 2nd Pfizer C19 shot I suddenly developed AFib. I've never had heart problems and all of a sudden I had difficulty breathing. Dr prescribed large doses of Furosemide because of large buildup of fluid in my lungs. I am still on Eliquis 2x a day and 50 mg of Metoprolol 2 x a day. The patient inquired Have there been other patients develop AFib after receiving 2nd shot of Pfizer C19.The action taken in response to the events for metoprolol tartrate and apixaban was unknown. Therapeutic measures were taken as a result of large buildup of fluid in my lungs. The clinical outcome of the events was unknown.  Pfizer is a marketing authorization holder of [Metoprolol Tartrate] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Metoprolol Tartrate] has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Arthralgia, Axillary mass, Body temperature, Chills
Clinical narrative: preeclampsia level migraines; soreness at shot site; joint pain; chills; 104.0 fever/103 fever; I was itchy all over for a few nights; weird lump in my armpit by my breast; 3rd time CMV has reactivated; 3rd time CMV has reactivated; Anafalactic shock; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0158), via an unspecified route of administration in left arm on 26Apr2021 14:45 (at the age of 36-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a hospital. The patient received first dose of bnt162b2 (Lot no: ER8729) on 05Apr2021 at 14:45 in left arm for COVID-19 immunisation and experienced cytomegalovirus (CMV). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included CMV; HELLP syndrome and preeclampsia, all when she delivered her son 3 weeks early and pregnant. Concomitant medications included ferrous sulfate; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and unspecified prenatal vitamins. The patient reported 3 rd time CMV has reactivated in 2021. After 2nd vaccine dose (on 26Apr2021), soreness at shot site and joint pain. Late that night, chills, 104.0 fever. Next day (on 27Apr2021), 103 fever took paracetamol (TYLENOL) 4-6 hrs. Third day after (on 29Apr2021), 103 fever, still joint pain, & preeclampsia level migraines. Still had Rx migraine meds but couldn't mix with fever reducer. So took leftover oxycodone from having a baby at midnight and 05:00. Next day/4th post shot day (30Apr2021), severe migraine, fever staying around 100.something. So the patient took migraine medicine, melatonin (3 mg a few times that night). The melatonin was kinda helpful. In 2021, the patient was itchy all over for a few nights (been in anafalactic shock 3x prior so the patient knew it wasn't that) joint pain, now she have a weird lump in her armpit by her breast that hasn't gone away. Almost woke her husband to go to hospital because of migraine. The case was considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the event axillary mass was not recovered while for the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509886 baby case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cytomegalovirus infection reactivation, Disease recurrence, Migraine, Pruritus, Pyrexia
Clinical narrative: preeclampsia level migraines; soreness at shot site; joint pain; chills; 104.0 fever/103 fever; I was itchy all over for a few nights; weird lump in my armpit by my breast; 3rd time CMV has reactivated; 3rd time CMV has reactivated; Anafalactic shock; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0158), via an unspecified route of administration in left arm on 26Apr2021 14:45 (at the age of 36-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a hospital. The patient received first dose of bnt162b2 (Lot no: ER8729) on 05Apr2021 at 14:45 in left arm for COVID-19 immunisation and experienced cytomegalovirus (CMV). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included CMV; HELLP syndrome and preeclampsia, all when she delivered her son 3 weeks early and pregnant. Concomitant medications included ferrous sulfate; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and unspecified prenatal vitamins. The patient reported 3 rd time CMV has reactivated in 2021. After 2nd vaccine dose (on 26Apr2021), soreness at shot site and joint pain. Late that night, chills, 104.0 fever. Next day (on 27Apr2021), 103 fever took paracetamol (TYLENOL) 4-6 hrs. Third day after (on 29Apr2021), 103 fever, still joint pain, & preeclampsia level migraines. Still had Rx migraine meds but couldn't mix with fever reducer. So took leftover oxycodone from having a baby at midnight and 05:00. Next day/4th post shot day (30Apr2021), severe migraine, fever staying around 100.something. So the patient took migraine medicine, melatonin (3 mg a few times that night). The melatonin was kinda helpful. In 2021, the patient was itchy all over for a few nights (been in anafalactic shock 3x prior so the patient knew it wasn't that) joint pain, now she have a weird lump in her armpit by her breast that hasn't gone away. Almost woke her husband to go to hospital because of migraine. The case was considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the event axillary mass was not recovered while for the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509886 baby case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: preeclampsia level migraines; soreness at shot site; joint pain; chills; 104.0 fever/103 fever; I was itchy all over for a few nights; weird lump in my armpit by my breast; 3rd time CMV has reactivated; 3rd time CMV has reactivated; Anafalactic shock; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0158), via an unspecified route of administration in left arm on 26Apr2021 14:45 (at the age of 36-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a hospital. The patient received first dose of bnt162b2 (Lot no: ER8729) on 05Apr2021 at 14:45 in left arm for COVID-19 immunisation and experienced cytomegalovirus (CMV). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included CMV; HELLP syndrome and preeclampsia, all when she delivered her son 3 weeks early and pregnant. Concomitant medications included ferrous sulfate; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and unspecified prenatal vitamins. The patient reported 3 rd time CMV has reactivated in 2021. After 2nd vaccine dose (on 26Apr2021), soreness at shot site and joint pain. Late that night, chills, 104.0 fever. Next day (on 27Apr2021), 103 fever took paracetamol (TYLENOL) 4-6 hrs. Third day after (on 29Apr2021), 103 fever, still joint pain, & preeclampsia level migraines. Still had Rx migraine meds but couldn't mix with fever reducer. So took leftover oxycodone from having a baby at midnight and 05:00. Next day/4th post shot day (30Apr2021), severe migraine, fever staying around 100.something. So the patient took migraine medicine, melatonin (3 mg a few times that night). The melatonin was kinda helpful. In 2021, the patient was itchy all over for a few nights (been in anafalactic shock 3x prior so the patient knew it wasn't that) joint pain, now she have a weird lump in her armpit by her breast that hasn't gone away. Almost woke her husband to go to hospital because of migraine. The case was considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the event axillary mass was not recovered while for the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509886 baby case
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Fatigue, Headache, Memory impairment, Nausea
Clinical narrative: Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 12:45 PM at the age of 65-years-old (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included Herniated discs L4,L5,S1,C4,C5C6C7, type 2 diabetes from an unknown date. Concomitant medications included apixaban (ELIQUIS); dipyridamole (METROPOLYN) and bupropion, all taken for an unspecified indication, start and stop date were not reported.  The patient previously took lidocaine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 29Apr2021 01:15 PM, the patient experienced Fainting, pain, itching, fatigue, headache, nausea, Lost of smell, short term memory off and on. It was unknown if treatment received. The outcome of the events was resolving.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Syncope
Clinical narrative: Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 12:45 PM at the age of 65-years-old (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included Herniated discs L4,L5,S1,C4,C5C6C7, type 2 diabetes from an unknown date. Concomitant medications included apixaban (ELIQUIS); dipyridamole (METROPOLYN) and bupropion, all taken for an unspecified indication, start and stop date were not reported.  The patient previously took lidocaine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 29Apr2021 01:15 PM, the patient experienced Fainting, pain, itching, fatigue, headache, nausea, Lost of smell, short term memory off and on. It was unknown if treatment received. The outcome of the events was resolving.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dysgeusia, Hypoaesthesia oral
Clinical narrative: Bell's palsy; metallic, numb sensation on end of tongue; metallic, numb sensation on end of tongue; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Apr2021 at 09:45 AM (at the age of 50 years old) (Lot Number: ew0162, unknown expiration) as 1st dose, single for COVID-19 immunization.  Medical history included chronic atopic dermatitis, mild asthma, sulfa allergies, latex allergies, allergies of peanuts and almond, banana peel allergies, allergy to tomatoes, sesame allergy, and shrimp allergy. Concomitant medications included dupilumab (DUPIXENT); hydroxyzine hcl; and ibuprofen. The patient experienced metallic, numb sensation on end of tongue and Bell's palsy on 23Apr2021. The events resulted in emergency room/department or urgent care visit. The patient received prednisone and valacyclovir as treatment for the events. No other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: really really big allergy attack; Impairing his breathing; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 08Apr2021, as 1st dose, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that he received the first dose of BNT162B2 on 08Apr2021 and was scheduled to receive his second dose on 03May2021. However, on an unspecified date, he experienced a "really really big allergy attack" which was impairing his breathing. He stated that the events were not related to the vaccine. He wanted to reschedule his second dose appointment and wanted to know if it was okay to take the second dose more than 21 days after the first dose. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: The events are hypersensitivity and dyspnea are likely intercurrent and are unrelated to suspect product BNT162B2.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Lacrimation increased
Clinical narrative: Palsey on left side.  Watering left eye.  Numbness on left side around mouth and cheek.; Palsey on left side.  Watering left eye.  Numbness on left side around mouth and cheek.; Palsey on left side.  Watering left eye.  Numbness on left side around mouth and cheek.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 29Mar2021 10:00 (Batch/Lot number was not reported) at the age of 51 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included mitral valve prolapse. Concomitant medication included warfarin taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline hydrochloride (DOXYCYCLIN) and experienced allergy. The patient previously received first dose of bnt162b2 on 09Mar2021 09:00 AM at the age of 51 years old for COVID-19 immunization (vaccine location: right arm). No other vaccines received within 4 weeks prior to COVID vaccine. On 05Apr2021 07:00, the patient experienced Palsy (palsey) on left side, watering of left eye and numbness on left side around mouth and cheek. No treatment was received for the adverse events. The patient recovered from all the events on unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: blood in my feces; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included asthma, hay fever, and allergies. The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient stated that he had his second shot on Tuesday, 22Apr. The patient was okay on Wednesday, Thursday and Friday. On 25Apr2021, the patient had a bowel movement and had a quite a bit of blood in his feces. The patient stated that he has not had blood coming out of his rectum ever. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Then a sudden spike in my blood sugar. It was almost 600; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:00 (Batch/Lot Number: Er8727) (at 48 years old) as unknown, single for covid-19 immunisation. Medical history included Type 2 diabetes for about 10 years. But always well maintained. Concomitant medication included metformin. No problem the first 5-7 days. Then a sudden spike in patient's blood sugar. It was almost 600 on 07Apr2021 12:00. Treatment Received was IV and insulin. Patient visited Doctor and was brought to Emergency room/department or urgent care. Patient was hospitalized for 1 day. The outcome of the event was unknown. Prior to vaccination,the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Radial nerve injury
Clinical narrative: Radial nerve damage to left arm and hand; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0158), via an unspecified route of administration in left arm, on an unspecified date, as second dose, single, for COVID-19 immunization. The patient's medical history included diabetes, irritable bowel syndrome (IBS), high cholesterol, and allergies to sulfur or sulfa. The patient had unspecified concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EN6208) in Mar2021 (reported as 22Mar2021; pending clarification) at the age of 48 years for COVID-19 immunization (left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a public health clinic or Veterans administration facility. On 08Apr2021, the patient experienced radial nerve damage to left arm and hand and was hospitalized in 2021 for 3 days; event caused disability. The adverse event resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.; Sender's Comments: Based on limited information and temporal association a contributory role of  BNT162B2  to the reported radial nerve damage  cannot be totally  excluded.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Blood test, Computerised tomogram, Hemiparesis, Magnetic resonance imaging
Clinical narrative: Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 20Apr2021 10:30 1st dose, single for COVID-19 immunisation. Medical history included COVID (prior to vaccination), pre-diabetic, anxiety, chest tubes and chest pain. The patient's concomitant medications were not reported. On 29Apr2021 22:00, the patient had a Mini Stroke. Also have weakness on left side and memory loss. The events resulted in Emergency room/department or urgent care visit/hospitalization. The patient was hospitalized for 2 days. Treatment was received for the events which included bloodwork, MRI, CT scan. Since the vaccination, the patient has not been tested for COVID-19. The facility where the vaccine was administered was in a pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 20Apr2021 10:30 1st dose, single for COVID-19 immunisation. Medical history included COVID (prior to vaccination), pre-diabetic, anxiety, chest tubes and chest pain. The patient's concomitant medications were not reported. On 29Apr2021 22:00, the patient had a Mini Stroke. Also have weakness on left side and memory loss. The events resulted in Emergency room/department or urgent care visit/hospitalization. The patient was hospitalized for 2 days. Treatment was received for the events which included bloodwork, MRI, CT scan. Since the vaccination, the patient has not been tested for COVID-19. The facility where the vaccine was administered was in a pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Syncope
Clinical narrative: Fainting 14 hours after shot; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 29Apr2021 at 08:30 (batch/lot number: EW0173) as 2nd dose, single for COVID-19 immunization. Medical history included known allergies to penicillin. The patient was not pregnant. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 1st dose on 08Apr2021 at 09:30 (lot number: EW0158) administered in the right arm for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was public health clinic/veterans administration facility. No other vaccine in four weeks and no other medications in two weeks. The patient experienced fainting 14 hours after shot on 29Apr2021 at 23:15. No treatment was received for the adverse event. No Covid prior to vaccination. The patient was Covid tested post vaccination which included Covid test type nasal swab with unknown result on an unspecified date. The outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been received. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hypersensitivity, Pyrexia, Vomiting
Clinical narrative: had reactions to things I'm not allergic to; Vomit; issues with breathing; high fever; Chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 29Apr2021 10:00 (Batch/Lot Number: Ep7534) as 2nd dose, single for COVID-19 immunization. Medical history included egg allergy and anaphylactic reactions from an unknown date and unknown if ongoing. The patient previously took dose 1 of BNT162B2 in the left arm lot number: Er8732 on 09Apr2021 10:00 AM for COVID-19 immunization. Concomitant medications included amoxicillin taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021, at 2AM, the patient had high fever and chills lasted most of night. The patient stated that on 30Apr2021 12:00, "I have an egg allergy and occasionally have anaphylactic reactions when I have it. Strangely anytime I ate or drank anything for the day after my shot I had reactions to things I'm not allergic to. This manifested itself in needing to vomit then later it triggered issues with breathing and was quite concerning." The events resulted in doctor or healthcare professional office/clinic visit. The patient was treated with Prednisone. The outcome of the event was recovered on unspecified date. The events were serious per hospitalization on 30Apr2021 reported from health authority.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Thrombosis
Clinical narrative: Heavy bleeding including passing a blood clot with my first cycle after my second dose.; Heavy bleeding including passing a blood clot with my first cycle after my second dose.; This is a spontaneous report from a contactable consumer (reporting for herself). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 at 13:00 (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included etonogestrel (NEXPLANON); levothyroxine sodium (LEVOTHYROXIN); cetirizine hydrochloride (ZYRTEC ALLERGY); fluticasone propionate (FLONASE ALLERGY RELIEF), all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Left Arm on 04Mar2021 at 13:00 (Batch/Lot number: EN6206) for COVID-19 immunization. On 28Apr2021 at 14:30, the patient experienced heavy bleeding including passing a blood clot with her first cycle after my second dose. The have NEVER bleed like this except for when she was having a miscarriage or postpartum after giving birth to her daughters. She usually can go all day with the same pad and soaked through a pad and her underwear was completely bloody in 3 hours (it was so bad I discarded the underwear). When she got on the toilet it kept gushing out and that was when she passed a clot. After that the bleeding slowed down. The outcome of the events was unknown. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: I know someone that just had a miscarriage from it (Covid Vaccine); This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age 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.  The patient medical history and concomitant medications were not reported.  The reporter said: " I know someone that just had a miscarriage from it (Covid Vaccine)". The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Viral infection
Clinical narrative: Three weeks after my second shot, I developed Bells palsy, and virus attacked right side of my face; virus attacked right side of my face; This is a spontaneous report received from a contactable consumer (patient).  A 60-years-old male patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 15:15 (Batch/Lot number was not reported) at single dose for COVID-19 immunization.  Medical history included meniere's disease from Oct2020 to an unknown date. There was no known allergy. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on 13Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization and experienced vertigo. Three weeks after his second shot, the patient developed Bells palsy, and virus attacked right side of his face at 27Apr2021 07:30 AM. These events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. This event did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. Treatment for the events included Zaltrex - antivirus, Prednisone. The patient did not have covid prior vaccination. The patient was covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Vitreous detachment
Clinical narrative: Posterior vitreous detachment; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in right arm on 27Apr2021 09:45 (Lot Number: ER2613) as single for COVID-19 immunization. The patient has no medical history. The patient's concomitant medications were not reported. The patient experienced posterior vitreous detachment on 30Apr2021 09:45 with outcome of not recovered. Event reported as non-serious. Therapeutic measures were taken as a result of event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient had doctor visit with many exams (unknown results). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: She got admitted to the hospital for stroke like symptoms. The doctors diagnosed her with Bells Palsy. The doctors told her that the Bells Palsy was probably from the covid vaccine.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 34-year-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 between 9:00-10:00  (Lot Number: EP7534) as single dose for covid-19 immunisation at the age of 34-year-old.  No additional vaccines administered on the same date. There is no medical history of patient and family and no concomitant medications. The patient got admitted to the hospital for stroke like symptoms. The doctors diagnosed her with bells palsy. The doctors told her that the bells palsy was probably from the covid vaccine. The event started on 13Apr2021 with outcome of recovering. The patient went to the emergency room and physician office for the event and was hospitalized for the event from 13Apr2021 to 15Apr2021. Everyone in the hospital did not know if she should get the second dose of the covid vaccine. She sucked it up and got the second dose of the covid vaccine on 17Apr2021(Lot number: ER8737) at about 10:30 in left arm..  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; This is a spontaneous report from a contactable consumer (patient daughter).  A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after. The patient was due for their second doses, tomorrow (on 30Apr2021), but her quarantine will not be over by her. Event outcome was unknown.    Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Gait disturbance, Headache, Myalgia
Clinical narrative: Pain in heart area; Can't walk or get out of bed; Headache; Fingers hurt; Occasional tight band around chest; Severe muscle pain throughout the body; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 29Apr2021 (at the age of 74 years old) (Lot Number: EN727, unknown expiration) as 1st dose, single for COVID-19 immunization.  Medical history included penicillin allergy and diagnosed with COVID-19 (prior to vaccination, was the patient diagnosed with COVID-19: Yes).  The patient's concomitant medications were not reported.  The patient previously took codeine and experienced codeine allergy.  The patient experienced can't walk or get out of bed, headache, fingers hurt, severe muscle pain throughout the body, occasional tight band around chest, and sometimes pain in heart area on 30Apr2021. The patient did not received treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient had not yet recovered from the events.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in heart area; Can't walk or get out of bed; Headache; Fingers hurt; Occasional tight band around chest; Severe muscle pain throughout the body; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 29Apr2021 (at the age of 74 years old) (Lot Number: EN727, unknown expiration) as 1st dose, single for COVID-19 immunization.  Medical history included penicillin allergy and diagnosed with COVID-19 (prior to vaccination, was the patient diagnosed with COVID-19: Yes).  The patient's concomitant medications were not reported.  The patient previously took codeine and experienced codeine allergy.  The patient experienced can't walk or get out of bed, headache, fingers hurt, severe muscle pain throughout the body, occasional tight band around chest, and sometimes pain in heart area on 30Apr2021. The patient did not received treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient had not yet recovered from the events.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the worst was behind my eyes deep in sockets; Sharp pain both arms 1 min.; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Apr2021 at 11:15 (at the age of 40-years-old) as 1st dose, single for COVID-19 immunisation. Medical history was reported as yes but not specified. The patient's concomitant medications were not reported. On 30Apr2021 at 11:15, the patient experienced sharp pain both arms for 1 minute then itch was mild for 1 hour. Started itching all over the worst was behind her eyes deep in sockets that lasted 2 days, had to take diphenhydramine (BENADRYL). Left arm was swollen that night and lasted 2 days. On day 3, she was still itching but not as bad. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.         No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Myelitis transverse, Paraesthesia
Clinical narrative: Transverse Myelitis; had no feeling in his feet or left leg; Severe back pain; This is a spontaneous report from contactable consumers. A 33-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously healthy and athletic. Three days after receiving the vaccine the patient reported severe back pain, and 2 days after the back pain started he had no feeling in his feet or left leg. The staff at the hospital believe his condition is transverse myelitis, and told the family there are no reported cases of this being caused by the Pfizer covid vaccine, but the family would like more information from Pfizer. The patient was hospitalized for the event transverse myelitis on unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Skin discolouration
Clinical narrative: passed out; sweating; turned blue; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0173, expiry date not reported) via an unspecified route of administration, administered in left arm on 01May2021 18:00 (at the age of 24 years old) as first dose, single for covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. On 01May2021 18:00, patient immediately started sweating after getting the shot then passed out within a couple minutes. Pharmacist told the patient that she turned blue and they injected her with Epipen. Patient woke up after and felt fine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious medically significant. Since the vaccination, the patient was not tested for COVID-19. The patient recovered from the events reported on an unspecified date in May2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events loss of consciousness, hyperhidrosis and skin discolouration 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness postural, Fatigue, Headache
Clinical narrative: extreme dizziness to passing out stage when standing; numbness in arms; sweats; chills; fever; severe headache; extreme dizziness to passing out stage when standing; loose stools; joint pain in the arm where she received the shot; Mild fatigue for 2 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on the left arm, on 16Apr2021 10:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation. Medical history included cortical basal degeneration and allergies. Patient was not pregnant. No other vaccines were received in four weeks. Unspecified concomitant medications were received in two weeks. 15 days after injection on 01May2021 08:00, patient had numbness in arms, sweats, chills, fever, severe headache, body pain, extreme dizziness to passing out stage when standing and loose stools. The eve of injection on 16Apr2021, patient had joint pain in the arm where she received the shot, but no other issues other than mild fatigue for 2 days. No treatment was received for the events. Outcome of the event of fatigue was recovered on 18Apr2021 while for the remaining events was not recovered. Patient was diagnosed with covid prior to vaccination and had not been tested post-vaccination. The reporter considered the events non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Pyrexia, Syncope, Vaccination site joint pain
Clinical narrative: extreme dizziness to passing out stage when standing; numbness in arms; sweats; chills; fever; severe headache; extreme dizziness to passing out stage when standing; loose stools; joint pain in the arm where she received the shot; Mild fatigue for 2 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on the left arm, on 16Apr2021 10:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation. Medical history included cortical basal degeneration and allergies. Patient was not pregnant. No other vaccines were received in four weeks. Unspecified concomitant medications were received in two weeks. 15 days after injection on 01May2021 08:00, patient had numbness in arms, sweats, chills, fever, severe headache, body pain, extreme dizziness to passing out stage when standing and loose stools. The eve of injection on 16Apr2021, patient had joint pain in the arm where she received the shot, but no other issues other than mild fatigue for 2 days. No treatment was received for the events. Outcome of the event of fatigue was recovered on 18Apr2021 while for the remaining events was not recovered. Patient was diagnosed with covid prior to vaccination and had not been tested post-vaccination. The reporter considered the events non-serious.  No follow-up attempts are needed. No further information is expected.