chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema; A spontaneous report was received from a physician concerning a 71-years-old, female patient who received Moderna's COVID-19 Vaccine and who experienced angioedema of lip, mostly upper, part of lower, and into cheeks.   The patient's medical history included angioedema. Concomitant product use was not provided by the reporter.  On 13 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient woke up with angioedema of the lip, mostly upper, part of lower, and it went into cheeks. Patient reported the same thing happened to her a fewyears ago with no known cause.   Treatment for the event included a shot of prednisone and oral prednisone.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event angioedema of lip, mostly upper, part of lower and into cheeks was unknown.; Reporter's Comments: This case concerns a 71-year-old female patient with a significant medical history of angioedema, who experienced a serious unexpected event of angioedema. The event occurred approximately 6 days after first dose of mRNA-1273, lot # 039K20A. Treatment for the event included a shot of prednisone and oral prednisone. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's prior medical history of angioedema may have been contributory.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose 1 week before due date; A spontaneous report was received from a nurse concerning a 34 year old, female patient who received Moderna's COVID-19 vaccine and the patient received the second dose 1 week before due date (21 days after first dosage).     The patient's medical history was not provided.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 031K20A) on 14-Jan-2021 intramuscularly for prophylaxis of COVID-19 infection.   The patient received their second dose of mRNA-1273 (Batch number: 042L20A) on 04-Feb-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient received the second dose 1 week before due date (21 days after first dosage).     Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not unknown.  The outcome for the event Patient received the second dose 1 week before due date was considered resolved on 04-Feb-2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 042L20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: Needle was loose; vaccine drip on arm; vaccine drip on arm; A spontaneous report was received from a health care provider concerning a 30 year old, female patient who received less than 2nd dose of Moderna Vaccine on (03Feb2021) because syringe leaked a few drops. This HCP did not administer the doses.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 06/Jan/2021.  On 03Feb2021, approximately one month later, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. Nurse stated that needle was loose and full dose was not given because she noticed part of the vaccine that dripped out onto patients arm.   Treatment information was not provided.     The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event, Needle was loose and vaccine drip on arm was considered resolved on an unreported date.; Reporter's Comments: This case concerns a 30 year old female patient who received second dose of the vaccine and experienced vaccine drip on arm due to needle being loose. There were no reported adverse events in this case of syringe issue and exposure via skin contact.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gait inability, Inappropriate schedule of product administration, Paralysis, Urinary incontinence
Clinical narrative: Lost control of bladder; Could not walk; Paralyzed from the waist down for about 24 hours; Received the 2nd dose on 22Jan; Diarrhea; Vomiting; A spontaneous report was received from a consumer, concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralyzed from the waist down for about 24 hours/PT: Paralysis, received the 2nd dose on 22 Jan 2021/PT: inappropriate schedule of product administration,  lost control of bladder/PT: urinary incontinence, could not walk/PT: gait inability, diarrhea/PT: diarrhoea, and vomiting/PT: vomiting.  The patient's medical history was not provided.  Concomitant medications included omeprazole, fluoxetine hydrochloride, propranolol, colestipol, acetylsalicylic acid, and calcium.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) on 28 Dec 2020. On 22 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, following the second vaccination, the patient experienced vomiting and diarrhea. On 23 Jan 2021, the patient could not walk, was paralyzed from the waist down for about 24 hours, and lost control of her bladder.  Treatment information for the events was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the event, paralyzed from the waist down, was considered recovered/resolved on 24 Jan 2021. The outcome of the event, received second dose on 22 Jan 2021, was considered resolved on 22 Jan 2021. The outcome of the events, vomiting, diarrhea, could not walk, and lost control of bladder, was unknown.; Reporter's Comments: This case concerns a 67 year old female subject, who experienced a serious unexpected event of paralysis after second dose of mRNA1273 (Lot# 032L20A). Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Lost control of bladder; Could not walk; Paralyzed from the waist down for about 24 hours; Received the 2nd dose on 22Jan; Diarrhea; Vomiting; A spontaneous report was received from a consumer, concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralyzed from the waist down for about 24 hours/PT: Paralysis, received the 2nd dose on 22 Jan 2021/PT: inappropriate schedule of product administration,  lost control of bladder/PT: urinary incontinence, could not walk/PT: gait inability, diarrhea/PT: diarrhoea, and vomiting/PT: vomiting.  The patient's medical history was not provided.  Concomitant medications included omeprazole, fluoxetine hydrochloride, propranolol, colestipol, acetylsalicylic acid, and calcium.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) on 28 Dec 2020. On 22 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, following the second vaccination, the patient experienced vomiting and diarrhea. On 23 Jan 2021, the patient could not walk, was paralyzed from the waist down for about 24 hours, and lost control of her bladder.  Treatment information for the events was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the event, paralyzed from the waist down, was considered recovered/resolved on 24 Jan 2021. The outcome of the event, received second dose on 22 Jan 2021, was considered resolved on 22 Jan 2021. The outcome of the events, vomiting, diarrhea, could not walk, and lost control of bladder, was unknown.; Reporter's Comments: This case concerns a 67 year old female subject, who experienced a serious unexpected event of paralysis after second dose of mRNA1273 (Lot# 032L20A). Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Face was paralyzed; A spontaneous report was received from a consumer concerning a 42-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis.  The patient's medical history was not reported.  Concomitant medication history was not provided.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number:  029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient woke up to find that his face was paralyzed.  The patient went to the urgent care center and they referred him to the emergency department at the hospital.  After numerous tests they diagnosed him with Bell's Palsy.    Treatment for this event included prednisone and doxycycline.  Action taken with mRNA-1273 in response to this event was not reported.  The outcome for the event, facial paralysis, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism
Clinical narrative: Showing signs of hyperthyroidism; A spontaneous report was received from a consumer concerning a 68-year-old, female patient who received Moderna's COVID-19 vaccine and developed signs of hyperthyroidism.  The patient's medical history was hypothyroidism. No relevant concomitant medications were reported.  On 06 Jan 2021, patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) injection for the prophylaxis of COVID-19 infection.  On 02 Feb 2021, within 28 days of receiving vaccine, patient had a six-month checkup that showed signs of hyperthyroidism when patient has history of hypothyroidism. The patient's healthcare professional consent was obtained. Treatment for the event was not provided.  Action taken with the event was not reported.  The outcome of the event, signs of hyperthyroidism, was considered ongoing.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.  However, the patient's history of hypothyroidism may confound causality assessment. Further information has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Anaphylactic reaction, Dyspnoea, Obstructive airways disorder, Rales
Clinical narrative: Anaphylactic reaction; Burning sensation in eyeballs; Wheezing; Rales; Airways were closing; Can't breathe; A spontaneous report was received from a consumer concerning a 22-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction, burning sensation in eyeballs/abnormal sensation in eye, wheezing, rales, airways were closing/obstructive airways disorder, and can't breathe/dyspnoea.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Feb 2021, within 5 minutes prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Feb 2021, within 5 minutes after receiving her second dose of vaccine, the patient reported a burning sensation in her eyeballs, followed by wheezing and rales in her lungs.  She was given epinephrine and taken to the emergency room via an ambulance.  She was given a second dose of epinephrine. Her airways were closing and she could not breathe. She was given a steroid, diphenhydramine, H2 antagonist and albuterol. Consent given for follow up calls.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, anaphylactic reaction, burning sensation in eyeballs, wheezing, rales, airways were closing, and can't breathe, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Anaphylactic reaction; Burning sensation in eyeballs; Wheezing; Rales; Airways were closing; Can't breathe; A spontaneous report was received from a consumer concerning a 22-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction, burning sensation in eyeballs/abnormal sensation in eye, wheezing, rales, airways were closing/obstructive airways disorder, and can't breathe/dyspnoea.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Feb 2021, within 5 minutes prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Feb 2021, within 5 minutes after receiving her second dose of vaccine, the patient reported a burning sensation in her eyeballs, followed by wheezing and rales in her lungs.  She was given epinephrine and taken to the emergency room via an ambulance.  She was given a second dose of epinephrine. Her airways were closing and she could not breathe. She was given a steroid, diphenhydramine, H2 antagonist and albuterol. Consent given for follow up calls.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, anaphylactic reaction, burning sensation in eyeballs, wheezing, rales, airways were closing, and can't breathe, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: three 16 year old patients received their first dose of the Moderna vaccine; A spontaneous report  was received from a pharmacist concerning three 16 year old patients who were administered a COVID vaccine at an inappropriate age.    The patient's medical histories were not provided.  Concomitant medication details were not provided  On an unreported date, the patients received their first of two planned doses of mRNA-1273 (Batch numbers: 039K20A, 011L20A, 013L20A) some time between 11/Jan/2021 and 21/Jan/2021 intramuscularly for prophylaxis of COVID-19 infection.   On an unreported date,  three 16 year old patients were administered a COVID vaccine at an inappropriate age. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The event was considered resolved on an unreported date.; Reporter's Comments: This report refers to a case series of three (3) individual 16-year-old patients who each experienced the nonserious unexpected event of 'PT Product administered to patient of inappropriate age' for the first dose of mRNA-1273 (mRNA-1273 lots # 039K20A, 011L20A, 013L20A), with no associated adverse events in any patient. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: arm pain; sleepless night; This is a spontaneous report from a non-contactable adult female consumer reported for herself that: A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced arm pain and sleepless night. The patient received no treatment. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot: unknown, brand: Pfizer), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Pfizer product) at single dose for COVID-19 immunisation. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination or not. It was unknown whether the patient been tested for COVID-19 since the vaccination or not. It was reported that this was the second shot. The patient described muscle aches and a fever the night of the shot (on an unspecified date in Jan2021) and into the next day. It was unknown whether the patient received treatment for the adverse event or not. No seriousness criteria were reported for events. The outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 26Jan2021 (at an unspecified age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. In Jan2021, after the vaccination, the patient experienced a UTI (urinary tract infection). Treatment for the event UTI included sulfamethoxazole/trimethoprim (BACTRIM). The outcome of the event UTI was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received on the left arm BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on the left arm on 01Feb2021 09:30 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL [IBUPROFEN]) and pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]). On 02Feb2021 02:00 AM, the night following the vaccination patient had headache and sore arm. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a workplace clinic. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the events was recovered on an unspecified date.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness and tenderness near injection site; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 15:00 at single dose for COVID-19 immunization. The patient was vaccinated at a workplace clinic. Medical history was not reported. Concomitant medications included diphenhydramine hydrochloride (UNISOM), and diphenhydramine hydrochloride, ibuprofen (ADVIL PM). The patient was not pregnant at the time of vaccination. The patient experienced soreness and tenderness near injection site on 02Feb2021 20:00. No treatment was received for the adverse event. Clinical outcome of the event was not recovered.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: Chills; sweating; headache; body aches; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL3248; expiry date: unknown) via an unspecified route of administration, in the right arm, on 02Feb2021 at 06:45, at a single dose, for COVID-19 immunization. The patient had no relevant medical history. The patient has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248) on an unspecified date at 13:30, in the right arm. for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 02Feb2021, at 22:00, the patient experienced chills, sweating, headache and body aches. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Blood creatine phosphokinase, Chest scan, Myositis
Clinical narrative: This is a spontaneous report from a contactable physician. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (deltoid injection) on 22Jan2021 09:30 at SINGLE DOSE for covid-19 immunization.  Medical history included HBP (high blood pressure).  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 hasn't been tested for COVID-19. Concomitant medication included amlodipine, furosemide, lovastatin, losartan and niacin. On 24Jan2021 08:00, the patient experienced severe ipsilateral back pain extending to mid axillary line. Negative evaluation for renal stone, rib fracture. CPK pending. Symptoms started within 48 hrs of deltoid injection and have lasted for 13 days and have been severely activity restricting. Tentative diagnosis of myositis (CPK results pending). The patient underwent lab tests and procedures which included blood creatine phosphokinase: unknown   on   Tentative dx of myositis(CPK results  pending) , chest scan: negative   on   Negative evaluation for renal stone, rib fracture , renal function test: negative   on   Negative evaluation for renal stone, rib fracture.  The outcome of events was reported as 'recovering'. The patient did not receive treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Renal function test
Clinical narrative: This is a spontaneous report from a contactable physician. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (deltoid injection) on 22Jan2021 09:30 at SINGLE DOSE for covid-19 immunization.  Medical history included HBP (high blood pressure).  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 hasn't been tested for COVID-19. Concomitant medication included amlodipine, furosemide, lovastatin, losartan and niacin. On 24Jan2021 08:00, the patient experienced severe ipsilateral back pain extending to mid axillary line. Negative evaluation for renal stone, rib fracture. CPK pending. Symptoms started within 48 hrs of deltoid injection and have lasted for 13 days and have been severely activity restricting. Tentative diagnosis of myositis (CPK results pending). The patient underwent lab tests and procedures which included blood creatine phosphokinase: unknown   on   Tentative dx of myositis(CPK results  pending) , chest scan: negative   on   Negative evaluation for renal stone, rib fracture , renal function test: negative   on   Negative evaluation for renal stone, rib fracture.  The outcome of events was reported as 'recovering'. The patient did not receive treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial spasm, Sensation of blood flow, Tinnitus
Clinical narrative: hemifacial spasms on the right side of face; weird sound in the ear; pulsating in the neck; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 29-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the left arm on 30Dec2020 10:00 (lot number and expiry date unknown) at single dose for Covid-19 immunization in a workplace clinic. Medical history included hidradenitis suppurativa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified other medication. The patient received first dose of hepatitis vaccine in the left arm on 15Dec2020 (29 years old) for immunization which was within 4 weeks prior to the COVID vaccine. On 07Jan2021 07:15, the patient experienced hemifacial spasms on the right side of face. The right side of face tightens to the point her eye closes, mouth pulls up and cheeks pulls up as well along with a weird sound in the ear and pulsating in the neck. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included CT scan: unknown results in Jan2021. The patient has not been tested for COVID-19 since the vaccination. The patient received treatment of muscle relaxer, medrol dose pack. The outcome of the events was not recovered. The reporter considered the events serious as disabling/incapacitating but did not results in death, not life threatening, did not cause/prolong hospitalization, no congenital anomaly/birth defect.  Follow-up activities are possible, information on the 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 hemifacial spasms and other reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics including results of Head CT scan, EMG and chemistry panel, 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: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 47-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 03Feb2021, at a single dose on the arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not reported. The patient experienced arm injection site pain on an unspecified date in Feb2021. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if treatment was received for the adverse event. Outcome of the event was unknown. The reporter assessed the event as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer. A 44-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9269) on her left arm, via an unspecified route of administration on 03Feb2021 12:30 at a single dose for covid-19 immunization. Medical history included PCN allergies. The patient's concomitant medications were not reported. It was reported that the patient's left arm and the left side of her left hand has felt weak since having her shot yesterday. She can close her hand, but it feels weak. Took place at 03Feb2021 01:15PM. No treatment was received for the event. The outcome of the event was not recovered.
Sex: F
Vaccine: PNC13
Symptoms: Adverse drug reaction, Arthralgia, Gait disturbance, Myalgia
Clinical narrative: it took her 6-8 months to recover and walk again; she had pneumonia shot and experienced muscle and joint pain and all  kind of side effects.; she had pneumonia shot and experienced muscle and joint pain and all  kind of side effects.; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient (age: 80, unit: unknown) of an unspecified age started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that it took her 6-8 months to recover and walk again and she had pneumonia shot and experienced muscle and joint pain and all  kind of side effects. Outcome of the event Walking difficulty was recovered on an unspecified date while outcome of the remaining events was unknown.   Information on the lot/batch number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Groin pain, Investigation, X-ray
Clinical narrative: groin started to hurt; tired; This is a spontaneous report from a contactable consumer. A 85-years-old male patient (reporter's grandfather) received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Batch/lot number: EL9262, via an unspecified route of administration in right arm, on 01Feb2021 (at 85 years of age) at single dose for COVID-19 immunization. Medical history included diabetes from an unknown date. There were no concomitant medications. On 01Feb2021 the patient felt great; on 02Feb2021 he felt ok but was tired; on 03Feb2021 his groin started to hurt, it hurt even to touch it, his leg started to bother him from his groin down and then was unable to be touched; the reporter asked if that could be swollen lymph nodes from the vaccine. At 3 o'clock the patient rushed to the hospital and, on 04Feb2021, he was admitted to hospital due to pain in groin. They thought he had broken something but that was ruled out. The patient underwent an X-ray of his leg and labs. He does not have any infection. At the time of the report the patient was still in hospital and the events "groin started to hurt" had not resolved yet and outcome of the event "tired" was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Arthralgia, Crying, Discomfort, Dizziness
Clinical narrative: smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Feeling abnormal, Hallucination, Hypersensitivity, Insomnia
Clinical narrative: smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pain in extremity, Parosmia, X-ray
Clinical narrative: smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Dysarthria, Feeling abnormal
Clinical narrative: feeling flushed and faint; her blood pressure went up as well as her heart rate; her blood pressure went up as well as her heart rate; brain fog; slurring her words; lethargy/ lethargic for 2-3 hours; hands were so cold it was like they were stuck in a snow bank and wasn't able to get them warm; feeling flushed and faint; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on unspecified date as a SINGLE DOSE for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported. The consumer reported her daughter had a bad reaction and is concerned about getting the second dose since it is said people could have more severe reactions. The patient's heart rate was up, blood pressure was up, feeling flushed and faint. Since her daughter works at the hospital and was next to the emergency room they kept an eye on her and everything. When she was okay to go back to her department she had brain fog, lethargy/ lethargic for 2-3 hours, and slurring of her words and that lasted 2-3 more hours. A few days later her hands were so cold it was like they were stuck in a snow bank and she wasn't able to get them warm. Not sure if that was a late reaction since it has never happened before. The patient underwent lab tests and procedures which included blood pressure: blood pressure was up on unknown date, heart rate: heart rate was up on unknown date.   Outcome of the feeling flushed and faint, her blood pressure went up as well as her heart rate, brain fog, slurring her words, lethargy/ lethargic for 2-3 hours were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Heart rate increased, Lethargy, Peripheral coldness
Clinical narrative: feeling flushed and faint; her blood pressure went up as well as her heart rate; her blood pressure went up as well as her heart rate; brain fog; slurring her words; lethargy/ lethargic for 2-3 hours; hands were so cold it was like they were stuck in a snow bank and wasn't able to get them warm; feeling flushed and faint; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on unspecified date as a SINGLE DOSE for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported. The consumer reported her daughter had a bad reaction and is concerned about getting the second dose since it is said people could have more severe reactions. The patient's heart rate was up, blood pressure was up, feeling flushed and faint. Since her daughter works at the hospital and was next to the emergency room they kept an eye on her and everything. When she was okay to go back to her department she had brain fog, lethargy/ lethargic for 2-3 hours, and slurring of her words and that lasted 2-3 more hours. A few days later her hands were so cold it was like they were stuck in a snow bank and she wasn't able to get them warm. Not sure if that was a late reaction since it has never happened before. The patient underwent lab tests and procedures which included blood pressure: blood pressure was up on unknown date, heart rate: heart rate was up on unknown date.   Outcome of the feeling flushed and faint, her blood pressure went up as well as her heart rate, brain fog, slurring her words, lethargy/ lethargic for 2-3 hours were unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pain, Pyrexia
Clinical narrative: lethargy; Fever; chills; body aches; This is a spontaneous report from a non-contactable consumer. A 36-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his left arm, via an unspecified route of administration on 27Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, chills, body aches, lethargy; all on 28Dec2020. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Immunodeficiency, No adverse event, SARS-CoV-2 antibody test negative
Clinical narrative: negative COVID Spike IgG antibodies protein/failed to achieve immunity/patient had no response to the vaccine/vaccine did not work for her; relationship between Ocrevus and lack of response to the vaccine; This is a spontaneous report from a contactable physician (rheumatologist) reporting for his wife and a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1284/expiration date: 30Apr2021), via intramuscular route of administration, on 16Jan2021 12:00 (at the age of 62 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number:EH9899/expiration date: 30Mar2021), via intramuscular route of administration, on 26Dec2020 (at the age of 62 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Co-suspect medication included ocrelizumab (OCREVUS) from an unknown date with her last dose on 11Jun2020, (7 months prior to first dose of vaccination) via intravenous route of administration for multiple sclerosis. Relevant medical history included multiple sclerosis, sulfa allergy. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021, the patient had a COVID Spike IgG antibodies protein drawn to assess response. The results were negative on two occasions, even after sending the test to a different lab. The patient seems to have failed to achieve immunity. The patient reported that she had no response to the vaccine, as she had no antibody so the vaccine did not work for her. Action taken in response to the event with ocrelizumab was unknown. Treatment was not received for the event. The outcome of the event negative COVID Spike IgG antibodies protein/failed to achieve immunity/patient had no response to the vaccine/vaccine did not work for her was unknown. Since the vaccination, the patient had not been tested for COVID-19. The physician reported that he thinks there is a relationship between Ocrevus and lack of response to the vaccine.