chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Foot operation, Product dose omission issue
Clinical narrative: Had foot surgery and was in the hospital and now she is past the 42 day limit; Past the 42 day limit interval between the first and second vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FOOT OPERATION (Had foot surgery and was in the hospital and now she is past the 42 day limit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FOOT OPERATION (Had foot surgery and was in the hospital and now she is past the 42 day limit) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day limit interval between the first and second vaccine). At the time of the report, FOOT OPERATION (Had foot surgery and was in the hospital and now she is past the 42 day limit) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Past the 42 day limit interval between the first and second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This report refers to a case of Product dose omission issue for mRNA-1273, lot #066B21A , and an AE of Foot operation. Based on the current available information and temporal association between the use of the product and the start date of the event of Foot operation, a causal relationship cannot be excluded.    .; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot #066B21A , and an AE of Foot operation. Based on the current available information and temporal association between the use of the product and the start date of the event of Foot operation, a causal relationship cannot be excluded.  However based on reporter's causality (is past the 42 day limit) the event is assessed as not applicable to mRNA-1273.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Loss of consciousness, Nausea
Clinical narrative: passed out; Anxiety; right now she has trouble breathing; nauseous; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C2LA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ANXIETY (Anxiety), DYSPNOEA (right now she has trouble breathing) and NAUSEA (nauseous). On 03-May-2021, LOSS OF CONSCIOUSNESS (passed out) and NAUSEA (nauseous) had resolved. At the time of the report, ANXIETY (Anxiety) and DYSPNOEA (right now she has trouble breathing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events at was reported as medic was about to give oxygen. The patient did not know if it was her oxygen or heart rate that was low but she became conscious.  Patient is worry about taking second dose. She asked if something bad will happen if she stopped at first dose.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Critical illness, Loss of consciousness
Clinical narrative: Patient went unconscious for almost 3 hours; Critical until he wasn't critical; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient went unconscious for almost 3 hours) and CRITICAL ILLNESS (Critical until he wasn't critical) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patients had neurological workup and cannot drive for 6 months.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient went unconscious for almost 3 hours) (seriousness criterion medically significant) and CRITICAL ILLNESS (Critical until he wasn't critical) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Patient went unconscious for almost 3 hours) and CRITICAL ILLNESS (Critical until he wasn't critical) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Blood test: blood work clear (normal) Blood work clear. On 24-Apr-2021, Chest X-ray: chest x-ray clear (normal) Chest X-ray clear. On 24-Apr-2021, Computerised tomogram: cat scan clear (normal) CAT scan clear.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient went unconscious for almost 3 hours. the patient almost lift flighted to the hospital but could not and ended up calling an ambulance and brought him to the hospital where they kept him from 7:15 AM to 3:30 PM. After the patient woke up he was completely fine. The reporter disclosed that during the wait for the flight, they had to do continuous sternum rub on him.  Treatment for the events included IV fluids and NS saline.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Lyme disease
Clinical narrative: Lyme disease; She was bit by a tick; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (Lyme disease) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced LYME DISEASE (Lyme disease) (seriousness criterion medically significant) and ARTHROPOD BITE (She was bit by a tick). At the time of the report, LYME DISEASE (Lyme disease) and ARTHROPOD BITE (She was bit by a tick) outcome was unknown.            Treatment included Doxycycline 200 mg.  No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Vision blurred
Clinical narrative: Blood pressure was elevated; right eye is cloudy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure was elevated) and VISION BLURRED (right eye is cloudy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 007A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, LISINOPRIL and AMLODIPINE for Blood pressure high.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was elevated) (seriousness criterion medically significant) and VISION BLURRED (right eye is cloudy) (seriousness criterion medically significant). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure was elevated) and VISION BLURRED (right eye is cloudy) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment:Very limited information regarding this events has been provided at this time. Further information  has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information  has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Pulmonary embolism
Clinical narrative: Subsequential PE; Anemia; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Subsequential PE) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Hypothyroidism, COPD, Asthma, Drug allergy (Sulfa), Drug allergy (Ceftin) and Drug allergy (Cefuroximine). Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis, SALBUTAMOL (ALBUTEROL HFA), DILTIAZEM HYDROCHLORIDE (DILTIAZEM CD) and LEVOTHYROXINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced ANAEMIA (Anemia). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Subsequential PE) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Subsequential PE) and ANAEMIA (Anemia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-029848 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Lethargy, Nausea
Clinical narrative: Lightheaded, naseous, stomach pains, and lethargy.; Lightheaded, naseous, stomach pains, and lethargy.; Lightheaded, naseous, stomach pains, and lethargy.; Lightheaded, naseous, stomach pains, and lethargy.; This is a spontaneous report from a noncontactable consumer. This 31-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number/Expiry date: Unknown) via an unspecified route of administration on 26Jan2021 at 10:00 as a 1st dose single for covid-19 immunization. The past medical history and concomitant medications was not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received 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 26Jan2021, the patient experienced Lightheaded, naseous, stomach pains, and lethargy. It was unknown if the patient received treatment for the adverse events. On an unknown date, the clinical outcome for the events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, External ear pain, Feeling abnormal, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Significant left ear pain that woke me up from sleep 3x last night when I would lay on that side; left ear pain; Right ear pain; Outer ear pain on rest and highly tender on palpation, most severe around the tragus area; left unilateral left axillary lymphadenopathy; Moderate systemic symptoms; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection via an unspecified route of administration in left arm on 23Jan2021 03:30 PM (Batch/Lot Number ELA262) single dose for COVID-19 immunization at hospital. The patient's medical history was none, and concomitant medications were not reported. The patient had no allergic history. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient was not diagnosed with COVID-19 prior to vaccination. 12 hours after the vaccination the patient had moderate systemic symptoms and persisted for 36 hours. 24 hours after the vaccination, the patient developed left unilateral left axillary lymphadenopathy and improved. On 24Jan2021 at 06:30 AM the patient had outer ear pain on rest and highly tender on palpation, most severe around the tragus area. 48 hours after the vaccination the patient had right ear pain (now resolved) and after 72 hours pain started in left side (persisting). It was reported that about 5 days after vaccination, the patient had significant left ear pain woke her up from sleep at night if she lay on that side. No cervical or preauricular lymphadenopathy. Events were not treated. Events resulted in doctor or other healthcare professional office/clinic visit. On 25Jan2021, the patient was tested (Nasal Swab) negative for COVID-19. Outcome of "Outer ear pain on rest and highly tender on palpation, most severe around the tragus area", left ear pain, was not recovered. Outcome of right ear pain and Moderate systemic symptoms was resolved. Outcome of "Significant left ear pain that woke me up from sleep 3x last night when I would lay on that side" was unknown. Outcome of "left unilateral left axillary lymphadenopathy" was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Significant left ear pain that woke me up from sleep 3x last night when I would lay on that side; left ear pain; Right ear pain; Outer ear pain on rest and highly tender on palpation, most severe around the tragus area; left unilateral left axillary lymphadenopathy; Moderate systemic symptoms; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection via an unspecified route of administration in left arm on 23Jan2021 03:30 PM (Batch/Lot Number ELA262) single dose for COVID-19 immunization at hospital. The patient's medical history was none, and concomitant medications were not reported. The patient had no allergic history. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient was not diagnosed with COVID-19 prior to vaccination. 12 hours after the vaccination the patient had moderate systemic symptoms and persisted for 36 hours. 24 hours after the vaccination, the patient developed left unilateral left axillary lymphadenopathy and improved. On 24Jan2021 at 06:30 AM the patient had outer ear pain on rest and highly tender on palpation, most severe around the tragus area. 48 hours after the vaccination the patient had right ear pain (now resolved) and after 72 hours pain started in left side (persisting). It was reported that about 5 days after vaccination, the patient had significant left ear pain woke her up from sleep at night if she lay on that side. No cervical or preauricular lymphadenopathy. Events were not treated. Events resulted in doctor or other healthcare professional office/clinic visit. On 25Jan2021, the patient was tested (Nasal Swab) negative for COVID-19. Outcome of "Outer ear pain on rest and highly tender on palpation, most severe around the tragus area", left ear pain, was not recovered. Outcome of right ear pain and Moderate systemic symptoms was resolved. Outcome of "Significant left ear pain that woke me up from sleep 3x last night when I would lay on that side" was unknown. Outcome of "left unilateral left axillary lymphadenopathy" was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Parosmia
Clinical narrative: A sudden loss of taste; A sudden loss of smell; I smelled oil/gas; This is a spontaneous report from a contactable other hcp (patient).   A 24-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3302) via an unspecified route of administration in Arm Right on 28Jan2021 at 08:00 (at the age of 24-years-old) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL1283) via an unspecified route of administration in Arm Right on 09JAN2021 at 08:00 (at the age of 24-years-old) as SINGLE DOSE for covid-19 immunisation. There were no allergies to medications, food, or other products. The patient didn't received 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 28Jan2021 at 21:00, the patient experienced a sudden loss of taste, a sudden loss of smell and change in smelled oil/gas. Treatment was not received for the adverse events. At the time of this report event outcome was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Feeling numbness and tingling in my right hand ring and pinky finger. Ulnar area.; Feeling numbness and tingling in my right hand ring and pinky finger. Ulnar area.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3248; Expiration Date: unknown) via an unspecified route of administration, administered in Arm Right on 13Jan2021 16:00 (at the age of 35-year-old) as 1st dose single for COVID-19 immunization. COVID-19 vaccine was administered at other. Medical history included diabetic (diabetes mellitus) from an unknown date. Patient had no allergies to medications, food, or other products. Concomitant medications patient received within 2 weeks of vaccination included empagliflozin, metformin hydrochloride (SYNJARDY), venlafaxine (VENLAFAXINE), atorvastatin (ATORVASTATIN), aripiprazole (ARIPIPRAZOLE) taken for an unspecified indication. 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. Since the vaccination, the patient has not been tested for COVID-19. On 25Jan2021 16:30, the patient experienced feeling numbness and tingling in my right-hand ring and pinky finger, ulnar area. Never had this issue before until after having the vaccine. The case was assessed as non-serious as per reporter with no seriousness criteria of Results in death/Life threatening/Caused/prolonged hospitalization/ Disabling/ Incapacitating/ Congenital anomaly/birth defect. No treatment was received for the adverse events. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: High fever 105.4 F; This is a spontaneous report from a contactable consumer reported for (himself). A 36-year-old male received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number & Expiry date not reported) second dose via intramuscular route of administration in left arm on 28Jan2021 12:45 (at age of 36years) as SINGLE DOSE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient had no known allergies to medications, food, or other products. Nasal swab test was performed which was negative in 26Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient previously received first dose of bnt162b2 via intramuscular route of administration in left arm on 02Jan2021 15:30 as single dose for COVID-19 immunization. On 29Jan2021 at 12:45, patient experienced high fever 105.4 F. Treatment received for event was Tylenol. Lab tests performed was: Nasal swab test which was negative on 26Dec2020. The Outcome of event was Recovering.   Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: Red ring and pain surrounding injection site, swelling; Red ring and pain surrounding injection site, swelling; Swelling; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration in right arm dose on 28Jan2021 at 11:15 (at the age of 30 years) as single dose for COVID-19 immunization. The patient's medical history included AVM hemorrhage in 2014 (Arteriovenous malformation and Hemorrhage brain). The patient had no allergies. The patient had not taken any other vaccines within 4 weeks prior to the COVID vaccine and had not taken any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested positive for COVID-19. On 29Jan2021 06:00, the patient had red ring and pain surrounding injection site and swelling. The patient did not receive treatment for events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: brain fog; This is a spontaneous report from a contactable nurse (patient herself). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via intramuscular route of administration on 26Jan2021 at 15:45 (at the age of 29-year-old) as single dose in right arm for COVID-19 immunisation at hospital. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: Unknown), via intramuscular route of administration on an unknown date in Jan2021 at 01:30 PM (at the age of 29-year-old), as single dose in right arm for COVID-19 immunisation. Patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 29Jan2021, the patient experienced brain fog. The patient did not receive any treatment for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not recovered.  Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Diarrhoea, Headache, Movement disorder
Clinical narrative: bone pain thru out the body/pain so bad inability to move without tears; chills; headache; spine pain; nausea; vomiting; diarrhea; bone pain thru out the body/pain so bad inability to move without tears; This is a spontaneous report from a contactable nurse (patient herself). A 44-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EL3249), via intramuscularly, administered in Arm Left on 26Jan2021 at 08:15 (at the age of 44-years-old) as single dose for covid-19 immunisation at hospital. Medical history and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications within 2 weeks of vaccination. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: 5k9231) via intramuscularly, administered in Arm Left on 04Jan2021 at 08:30 as single dose for covid-19 immunisation. On 26Jan2021 at 07:00 PM, the patient experienced bone pain thru out the body/pain so bad inability to move without tears, chills, headache and spine pain, nausea vomiting and diarrhea. Patient was not received any treatment for the events. At the time of report, patient was recovering from the events.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Spinal pain, Vomiting
Clinical narrative: bone pain thru out the body/pain so bad inability to move without tears; chills; headache; spine pain; nausea; vomiting; diarrhea; bone pain thru out the body/pain so bad inability to move without tears; This is a spontaneous report from a contactable nurse (patient herself). A 44-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EL3249), via intramuscularly, administered in Arm Left on 26Jan2021 at 08:15 (at the age of 44-years-old) as single dose for covid-19 immunisation at hospital. Medical history and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications within 2 weeks of vaccination. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: 5k9231) via intramuscularly, administered in Arm Left on 04Jan2021 at 08:30 as single dose for covid-19 immunisation. On 26Jan2021 at 07:00 PM, the patient experienced bone pain thru out the body/pain so bad inability to move without tears, chills, headache and spine pain, nausea vomiting and diarrhea. Patient was not received any treatment for the events. At the time of report, patient was recovering from the events.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Apraxia, Arthralgia, Feeling abnormal
Clinical narrative: brain fog; couldn't keep eyes open; sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: unknown) via an unspecified route of administration, administered in Arm Left on 24Jan2021 16:00 (at the age of 73-year-old) as SINGLE DOSE for covid-19 immunization. Patient not pregnant at the time of vaccination. Medical history included hypothyroid and allergies to latex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin d3; calcium; iron and thyroid meds. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 25Jan2021 at 14:00, 24 hours after shot, the patient experienced brain fog, couldn't keep eyes open, sore shoulder, the runs. The seriousness criteria reported was non-serious. The Patient did not received treatment for the adverse events. The outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm recurrence
Clinical narrative: Within 2 days of vaccine developed recurrent tumor in the left axilla on the same side as the vaccine; This is a spontaneous report from a contactable physician. A 79-year-old male patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date were unknown), via intramuscular, administered in Arm Left on 14Jan2021 12:00 (age at vaccination 79-year-old)  as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included primary cutaneous anaplastic large-cell lymphoma from an unknown date and unknown if ongoing. Patient had no disease for 2-3 years. The patient's concomitant medications were not reported. On 16Jan2021 the patient experienced within 2 days of vaccine developed recurrent tumor in the left axilla on the same side as the vaccine.  This has persisted for nearly 28 days after vaccine. Therapeutic measures were taken as a result of within 2 days of vaccine developed recurrent tumor in the left axilla on the same side as the vaccine. It was unknown if the patient was diagnosed with COVID or if the patient was tested for COVID. The outcome of event was not recovered/not resolved.   Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Lymphadenopathy, Pain in extremity, Pharyngeal swelling
Clinical narrative: Sore arm; Low grade fever (101); Swollen lymps (throat); Swollen lymps (throat); Lethargy; This is a spontaneous report from a contactable consumer (patient). A 31-years-old (non-pregnant) female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EL8982), dose 1 intramuscular in arm left on 28Jan2021 at 15:45 (at the age of 31-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included anxiety. The patient did not had allergies to medications, food, or other products. Concomitant medication(s) included escitalopram 15 mg and pyridoxine hydrochloride (VIT B6) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 at 16:00, the patient experienced sore arm, low grade fever (101), swollen lymph (throat) and lethargy. The patient underwent lab test and procedures which included body temperature 101. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm; Low grade fever (101); Swollen lymps (throat); Swollen lymps (throat); Lethargy; This is a spontaneous report from a contactable consumer (patient). A 31-years-old (non-pregnant) female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EL8982), dose 1 intramuscular in arm left on 28Jan2021 at 15:45 (at the age of 31-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included anxiety. The patient did not had allergies to medications, food, or other products. Concomitant medication(s) included escitalopram 15 mg and pyridoxine hydrochloride (VIT B6) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 at 16:00, the patient experienced sore arm, low grade fever (101), swollen lymph (throat) and lethargy. The patient underwent lab test and procedures which included body temperature 101. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient (at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, in arm left on 30Dec2020 at 12:00 (lot number was EL1284 and expiration date was not reported) as 1st dose single and the dose 2 via an unspecified route of administration, administered in arm left on 20Jan2021 at 12:00 (lot number was EL 8982 and expiration date was not reported) as 2nd dose, single for COVID-19 immunisation. Medical history included mitral valve prolapse (MVP) from an unknown date and unknown if ongoing, atrial fibrillation (Afib) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 at 12:00, the patient experienced vertigo. It was reported that vertigo was more prominent when laying on left side in bed. It also happened if the patient got up too fast. It was gradually subsiding. It was more prominent after first dose however it was still happening occasionally. The patient did not receive treatment for the event. The seriousness of the event was reported as non-serious. The outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Movement disorder, Musculoskeletal chest pain, Pain
Clinical narrative: Headache; Body aches; felt like cracked ribs in the chest; it was painful to breath; patient  could not lie on his side; This is a spontaneous report received from a contactable consumer (patient). A male patient with unspecified units of age 41 received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 27Jan2021 at a 2nd dose, dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) on 06Jan2021. The patient reported that after the second dose of BNT162B2, he felt like a headache and body aches that kind of thing. But then it started later in the afternoon after 2 days, it settled in one area, felt like cracked ribs in the chest, it was painful to breath when the patient was taking a full breath and the patient could not lie on his side. The out-come of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Stomach cramps; Diarrhea; Nausea; Vomiting; Injection site pain in her right arm; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injecton, Lot number and expiry date were not reported) via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunisation. Medical history included covid-19 from 2019. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. On an unspecified date, the patient experienced stomach cramps, diarrhea, nausea, vomiting, injection site pain in her right arm. The patient reports taking a Tylenol to help her pain, pain has not subsided and she was felt heat moving in her body once the injection was given. Patient states that she gets tested frequently for COVID, and she's continued to test negative. Caller reports the symptoms she is feeling feels like when she had COVID in 2019, after she received the injection. The outcome of the events were unknown. Patient had questions: If she can take muscle relaxers or something for stomach pain, Is stomach pain associated with the vaccine, and can the vaccine make COIVD active again.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Stomach cramps; Diarrhea; Nausea; Vomiting; Injection site pain in her right arm; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injecton, Lot number and expiry date were not reported) via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunisation. Medical history included covid-19 from 2019. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. On an unspecified date, the patient experienced stomach cramps, diarrhea, nausea, vomiting, injection site pain in her right arm. The patient reports taking a Tylenol to help her pain, pain has not subsided and she was felt heat moving in her body once the injection was given. Patient states that she gets tested frequently for COVID, and she's continued to test negative. Caller reports the symptoms she is feeling feels like when she had COVID in 2019, after she received the injection. The outcome of the events were unknown. Patient had questions: If she can take muscle relaxers or something for stomach pain, Is stomach pain associated with the vaccine, and can the vaccine make COIVD active again.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Pain, Pyrexia, Taste disorder
Clinical narrative: burning sensation in throat; mouth with a very metallic taste; mild taste distortion; fever; chills; aches; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EK9231) via an unspecified route of administration in left arm on 21Jan2021 at 17:00 as single dose for COVID-19 immunization. Medical history included CKD2, CAD, HBP, and Diastolic Congestive heart failure. The patient had allergies to medications, food, or other products Demerol, all statins was reported. Concomitant medications included Sertraline hydrochloride, valsartan, Ranexa, and Fenofibrate. 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. It was reported that App. 30 min. (21Jan2021 17:30) Post shot, had burning sensation in throat and mouth with a very metallic taste. Metallic taste lasted about day and a half. After that it cleared somewhat, but still have mild taste distortion. About day three did develop some fever, chills, and aches which lasted about three days. Treatment was not received for the adverse events. The events were considered as non-serious. The outcome of events was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: burning sensation in throat; mouth with a very metallic taste; mild taste distortion; fever; chills; aches; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EK9231) via an unspecified route of administration in left arm on 21Jan2021 at 17:00 as single dose for COVID-19 immunization. Medical history included CKD2, CAD, HBP, and Diastolic Congestive heart failure. The patient had allergies to medications, food, or other products Demerol, all statins was reported. Concomitant medications included Sertraline hydrochloride, valsartan, Ranexa, and Fenofibrate. 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. It was reported that App. 30 min. (21Jan2021 17:30) Post shot, had burning sensation in throat and mouth with a very metallic taste. Metallic taste lasted about day and a half. After that it cleared somewhat, but still have mild taste distortion. About day three did develop some fever, chills, and aches which lasted about three days. Treatment was not received for the adverse events. The events were considered as non-serious. The outcome of events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: Extreme fatigue; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 57-years-old non pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1284) intramuscularly administered in right arm on 19Jan2021 at 13:00 (at the age of 57 years) as single dose for COVID-19 immunization. The patient medical history included asthma, osteoporosis, Raynaud's. The patient was allergic to birth control pills, sunscreen. The concomitant medications patient received within 2 weeks of vaccination included meloxicam (MELOXICAM), fluticasone propionate (FLONASE), ciclosporin (RESTASIS). 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. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL0140) intramuscularly administered in left arm on 30Dec2020 at 08:00 as single dose for COVID-19 immunization. On 30Jan2021, the patient experienced extreme fatigue, muscle pain. Since the vaccination, the patient had tested for COVID-19. On 20Jan2021, patient underwent lab tests and procedures which included sars-cov-2 test which resulted negative. The patient did not receive treatment for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysstasia, Overdose, Pain, Pyrexia
Clinical narrative: second dose administered was stronger(0.7); High Fever (102); Achy; hard to stand up; This is a spontaneous report from a contactable consumer or other Non-health care professional.  A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: 1EL9261, expiry date: not reported) via an unspecified route of administration in the region of left arm on 25Jan2021 at 12:00 as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was reported as unknown. The patient had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL0142 expiry date: not reported) via an unspecified route of administration in the region of left arm on 04Jan2021 at 12:00 as SINGLE DOSE for covid-19 immunization. Patient stated that the technician who administered told her that the first dose was 0.4 and second dose administered was stronger (0.7). The reported finds this odd as both doses should be identical. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as unknown. Patient was not pregnant at the time of vaccination. Patients concomitant medications were not reported. On 25JAN2021, the patient experienced high fever, achy, hard to stand up. On 25JAN2021, the patient underwent lab tests and procedures which included body temperature: 102. The treatment received for adverse events was reported as no. The outcome of the events high fever, achy and hard to stand up was reported as recovered and second dose administered was stronger (0.7) was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Moderna vaccine for 1st dose on 3/17/2021. When she returned on 4/14/21 for her 2nd dose, she received the Pfizer vaccine.  No known symptoms or side effects at this time
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Throat irritation, Vomiting
Clinical narrative: A few minutes (about 10) after she received her vaccine, she started with an itchy throat, then a cough, then she vomited and couldn't breath well. She was given some benadryl and some water and she began to feel better. She said her throat was only slightly itchy the next day.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: ?COVID Arm? itchy rash.