chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Noticed edema of lower legs within 24 hours of administration; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Feb2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hypothyroidism, gerd (gastroesophageal reflux disease), asthma, hypertension, obstructive sleep apnea, arthritis and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and loratadine (CLARITIN), All for an unknown indication from an unknown date and unknown if ongoing. On 20Feb2021 at 16:00, the patient experienced edema of lower legs within 24 hours of administration. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of event edema of lower legs was not recovered at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 24Feb2021 at 07:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid and obesity. It was reported "none known" allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 27Jan2021 at 07:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 25Feb2021 at 19:30 (also reported as 18:30), 36 hours later the vaccination, the patient had pain in her armpit, maybe lymph nodes "?" 64 hours later it moved down arm pretty severe pain "in ? fat ?" of arm under the armpit and pain to touch and pain to lifting the arm and maybe called stinging pain. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in her armpit, maybe lymph nodes 64 hours later it moved down arm pretty severe pain in arm under the armpit and pain to touch and pain to lifting the arm and maybe called stinging pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion. Unmixed vaccine was exposed to a temp of 1.3 degrees higher than the recommended storage max range for up to 6 hours prior to administration.; POOR QUALITY VACCINE ADMINISTERED; This is a spontaneous report from a contactable Nurse. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an intramuscular route of administration in the right arm on 24Feb2021 at 07:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient was pregnant at the time of the vaccination. It was unknown whether  the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 24Feb2021 at 07:00, the patient experienced temperature excursion. Unmixed vaccine was exposed to a temperature of 1.3 degrees higher than the recommended storage maximum range for up to 6 hours prior to administration. It was unknown whether the patient received any treatment. The clinical outcome of the events temperature excursion and poor-quality product administered was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, SARS-CoV-2 test
Clinical narrative: Left armpit pain; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient's medical history reported as not applicable. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included citalopram hydrobromide (CELEXA), duloxetine hydrochloride (CYMBALTA), naproxen (MANUFACTURER UNKNOWN), rizatriptan benzoate (MAXALT) and omeprazole (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 06Feb2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 25May2020, the patient underwent COVID-19 test via nasal swab and the result was negative. On 28Feb2021 at 02:00, the patient experienced left armpit pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been not tested for COVID-19. The clinical outcome of the event left armpit pain was resolving at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site erythema
Clinical narrative: Slight pain/discomfort; Redness at injection site on left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration on 20Feb2021 in the left arm (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Feb2021 the patient experienced slight pain/discomfort and redness at injection site on left arm. The events did not result in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight pain/discomfort and redness at injection site on left arm was recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Hypersomnia, Muscular weakness, Nausea
Clinical narrative: Chills; Chills, then hot; Loss of motor skills from weakness; Nausea; Slept almost 24 hours; Some body aches; This is a spontaneous report from a contactable consumer, the patient. An 88-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 25Feb2021 at 15:15 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. The medical history included Atrial fibrillation (afib) and stroke on 15Nov2020 and the patient was recovering from stroke at the time of report. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included apixaban (ELIQUIS), atorvastatin calcium (LIPITOR), escitalopram oxalate (LEXAPRO), losartan potassium (COZAAR), Breo(unspecified), sy (unspecified) and montelukast sodium (SINGULAR). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 04Feb2021 at 15:00 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. On 25Feb2021, the patient experienced chills, then hot, loss of motor skills from weakness, nausea, slept almost 24 hours and some body aches. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, then hot, loss of motor skills from weakness, nausea, slept almost 24 hours and some body aches were resolved on an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills; Chills, then hot; Loss of motor skills from weakness; Nausea; Slept almost 24 hours; Some body aches; This is a spontaneous report from a contactable consumer, the patient. An 88-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 25Feb2021 at 15:15 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. The medical history included Atrial fibrillation (afib) and stroke on 15Nov2020 and the patient was recovering from stroke at the time of report. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included apixaban (ELIQUIS), atorvastatin calcium (LIPITOR), escitalopram oxalate (LEXAPRO), losartan potassium (COZAAR), Breo(unspecified), sy (unspecified) and montelukast sodium (SINGULAR). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 04Feb2021 at 15:00 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. On 25Feb2021, the patient experienced chills, then hot, loss of motor skills from weakness, nausea, slept almost 24 hours and some body aches. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, then hot, loss of motor skills from weakness, nausea, slept almost 24 hours and some body aches were resolved on an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection spot; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Feb2021 at 08:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included "blood Leiden factor V". The patient had no allergies to medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN), ergocalciferol (VITAMIN D) and probiotics; all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021 at 15:00, the patient experienced soreness at injection spot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness at injection spot was resolved on an unknown date in Feb2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in the left arm on 25Feb2021 at 08:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme exhaustion for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administrated in Left arm on 21Feb2021 10:00 (age at the time of vaccination 60-years-old), as a single dose for COVID-19 immunization. The patient medical history included Rheumatoid arthritis. The patient concomitant medications were not reported. Patient took other medications in two weeks was not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 21Feb2021 12:00, the patient experienced Extreme exhaustion for 24 hours. Patient did not received treatment for adverse event. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up (28May2021): Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Insomnia, Lymphadenopathy, Myalgia, Neck pain
Clinical narrative: Body aches; Sore muscles; Sore neck; back arm; Tired; Can't sleep; Swollen lymph nodes same armpit as shot; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included slight asthma, COVID-19 on an unknown date and sulfonamide allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously received clindamycin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), riboflavin (MANUFACTURER UNKNOWN), ergocalciferol (VIT D), tocopherol (VITAMIN E) and ascorbic acid, calcium lactate, copper sulfate, cyanocobalamin, ergocalciferol, ferrous fumarate, nicotinamide, retinol, riboflavin, sodium iodide, sodium molybdate, thiamine mononitrate (NUTREX); all for an unknown indication, from an unknown date and unknown if ongoing.  On  26Feb2021 at 22:00, the patient experienced 24 hours later body aches, sore muscles, sore neck, back arm, was tired, could not sleep and had swollen lymph nodes same armpit as shot. The patient experienced 48 hours sore muscles, swollen lymph nodes same armpit as shot and could not sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, sore muscles, sore neck, back arm, tired, could not sleep and swollen lymph nodes same armpit as shot was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Body aches; Sore muscles; Sore neck; back arm; Tired; Can't sleep; Swollen lymph nodes same armpit as shot; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included slight asthma, COVID-19 on an unknown date and sulfonamide allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously received clindamycin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), riboflavin (MANUFACTURER UNKNOWN), ergocalciferol (VIT D), tocopherol (VITAMIN E) and ascorbic acid, calcium lactate, copper sulfate, cyanocobalamin, ergocalciferol, ferrous fumarate, nicotinamide, retinol, riboflavin, sodium iodide, sodium molybdate, thiamine mononitrate (NUTREX); all for an unknown indication, from an unknown date and unknown if ongoing.  On  26Feb2021 at 22:00, the patient experienced 24 hours later body aches, sore muscles, sore neck, back arm, was tired, could not sleep and had swollen lymph nodes same armpit as shot. The patient experienced 48 hours sore muscles, swollen lymph nodes same armpit as shot and could not sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, sore muscles, sore neck, back arm, tired, could not sleep and swollen lymph nodes same armpit as shot was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Panic attack
Clinical narrative: Body aches; Sore muscles; Sore neck; back arm; Tired; Can't sleep; Swollen lymph nodes same armpit as shot; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included slight asthma, COVID-19 on an unknown date and sulfonamide allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously received clindamycin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), riboflavin (MANUFACTURER UNKNOWN), ergocalciferol (VIT D), tocopherol (VITAMIN E) and ascorbic acid, calcium lactate, copper sulfate, cyanocobalamin, ergocalciferol, ferrous fumarate, nicotinamide, retinol, riboflavin, sodium iodide, sodium molybdate, thiamine mononitrate (NUTREX); all for an unknown indication, from an unknown date and unknown if ongoing.  On  26Feb2021 at 22:00, the patient experienced 24 hours later body aches, sore muscles, sore neck, back arm, was tired, could not sleep and had swollen lymph nodes same armpit as shot. The patient experienced 48 hours sore muscles, swollen lymph nodes same armpit as shot and could not sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, sore muscles, sore neck, back arm, tired, could not sleep and swollen lymph nodes same armpit as shot was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Insomnia, Lymphadenopathy, Myalgia, Neck pain
Clinical narrative: Insomnia; waking up with panic attacks; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient reported that she had already submitted these medications (unspecified) which she had received within two weeks of vaccination and also provided a details of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, the patient experienced insomnia and waking up with panic attacks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with sleeping aid. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events insomnia and waking up with panic attacks was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Insomnia; waking up with panic attacks; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient reported that she had already submitted these medications (unspecified) which she had received within two weeks of vaccination and also provided a details of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, the patient experienced insomnia and waking up with panic attacks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with sleeping aid. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events insomnia and waking up with panic attacks was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Panic attack
Clinical narrative: Insomnia; waking up with panic attacks; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient reported that she had already submitted these medications (unspecified) which she had received within two weeks of vaccination and also provided a details of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, the patient experienced insomnia and waking up with panic attacks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with sleeping aid. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events insomnia and waking up with panic attacks was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Intense Stomach pain; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received bnt162b2 (BNT162B2 formulation; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 18Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Known allergies to Penicillin from an unknown date and unknown if ongoing. Concomitant medication (other medications in two weeks) included sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported and was received within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (BNT162B2 formulation; Solution for injection. Batch/lot number: Unknown) via an unspecified route of administration in Arm Left 26Jan2021 at 10.00 AM as DOSE 1, SINGLE for covid-19 immunisation. 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. The patient was not tested for COVID-19 since the vaccination. The patient experienced intense stomach pain on 19Feb2021 at 19:00. No treatment received for event. The outcome of event reported as not recovered.  Information about Lot/Batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Tremor, Vomiting
Clinical narrative: Headache; Tired; Hands started shaking really bad; Nauseated; Threw up; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6200) intramuscularly, administered in right arm on 21Feb2021 at 10:15 (at the age of 74-year-old) as dose 2, single for COVID-19 immunisation. Medical history included breast cancer (She had breast cancer and did have radiation 2 years ago). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. The patient previously took first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9262) intramuscularly, administered in right arm on 31Jan2021 (at the age of 74-year-old) as dose 1, single for covid-19 immunization and she felt really, really tired like she was fatigued and could hardly go. On an unspecified date in Feb2021 the patient experienced headache, tired, hands started shaking really bad, nauseated and threw up. It was reported that she had her second vaccine yesterday. She had a terrible headache, and she went to bed early because she was really tired. She woke up around 2:30 a.m., and her hands started shaking really bad. The shaking stopped. Then this morning when she woke up again, she was nauseated, and she felt like she was going to throw up. She did in fact in throw up. She still has a little bit of a headache. The event hands started shaking really bad was recovered on unknown date in Feb2021 and headache was not recovered. Outcome of the other events was unknown.   Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Walking disability
Clinical narrative: she felt really, really tired like she was fatigued and could hardly go. She can't remember the other one, but the fatigue got her.; she felt really, really tired like she was fatigued and could hardly go. She can't remember the other one, but the fatigue got her.; This is a spontaneous report from a contactable consumer patient. This 74-year-old female consumer reported herself that:  A 74-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9262), via an intramuscular, administered in right arm on 31Jan2021 (at the age of 74-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Vaccination Facility Type: The patient explained it used to be an old shopping mall, Regency, but now its run by the military she guesses. The  patient medical history included breast cancer and did have radiation 2 years ago from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events was not following prior vaccinations. On an unspecified date in 2021, the patient experienced she felt really, really tired like she was fatigued and could hardly go. She can't remember the other one, but the fatigue got her. It was reported that, the patient was called today to report side effects she was having. She had her second vaccine yesterday. She had a terrible headache and she went to bed early because she was real tired. She woke up around 02:30 and her hands started shaking really bad. The shaking stopped. Then this morning when she woke up again, she was nauseated and she felt like she was going to throw up. She did in fact in throw up. She still has a little bit of a headache. The patient explained she didn't call after the first vaccine she had. She had little side effects then. This time, the side effects were different. For the first vaccine, she felt really, really tired like she was fatigued and could hardly go. She cant remember the other one, but the fatigue got her. Relevant Tests were none. The patient did not require to visit Emergency Room/Physician Office. The patient explained she was supposed to get blood work done this week, but she was kind of wondering if she should or not. The outcome of events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion. Refrigerator Temp of unmixed vaccine vial was out of range for ~ 24 hours and as high as 55 degrees F prior to being administered.; Poor quality vaccine administered; This is a spontaneous report from a contactable nurse. A 61-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an intramuscular route of administration in the arm left on 25Feb2021 at 07:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 25Feb2021 at 07:30, the patient experienced temperature excursion. The refrigerator temp was unmixed vaccine vial was out of range for 24 hours and as high as 55 degrees Fahrenheit prior to being administered. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the event temperature excursion was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Eructation, Faeces soft, Fatigue
Clinical narrative: mucus in her stool; abdominal discomfort and pressure; Diarrhea; stools were passing much easier; tiny bit tired the next day; arm sore; Burping more than usual; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3249, Expiry date: not reported) via an unspecified route of administration, administered in Arm Right on 09Feb2021 14:40 (at the age of 58 years old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. concomitant therapy:None The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm sore on 10Feb2021, stools were passing much easier on 14Feb2021, tiny bit tired the next day on 10Feb2021, diarrhoea on 18Feb2021, mucus in her stool on 20Feb2021, abdominal discomfort and pressure on 19Feb2021, burping more than usual on 2021. Reporter stated, She said that she did not feel the shot and barely had a sore arm the next day. She was a tiny bit tired the next day, but it was barely noticeable. She stated 6 days later however she started to have odd bowel movements, she read the side effects and it stated that this happens to about 8 percent of people in her age group and she is 59-year-old. She wanted to know however, if her bowel movements were apart of the vaccine or something else. it was a bad case of diarrhoea. She said that on Saturday 20Feb2021 and Sunday 21Feb2021 she noticed little pieces of mucus in her stool with abdominal pressure. She has little bit of discomfort in her abdomen and pressure like when you have diarrhoea and it feels like you need to go to the bathroom. She stated that she is also noticing more burping than usual. She said that diarrhoea was mentioned in 8% of people after the shot according to what she read online. she had clear mucus and had a tiny feces with mucus hanging off of it. She said that she has never had this before. diarrhoea happens more in the morning. She said that it was clear mucus in her stool and she does not know what to call it. she is also having pressure is more so in the rectal area like when you have diarrhoea. She said that it is abdominal and rectal discomfort. She said that her second dose is scheduled for 02Mar2021. Arm sore was recovered on 11Feb2021, stools were passing much easier, Diarrhoea, mucus in her stool, abdominal discomfort and pressure was not recovered, tiny bit tired the next day 12Feb2021, Burping more than usual was unknown.   No follow-up attempts are possible. No further information was expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Mucous stools, Pain in extremity
Clinical narrative: mucus in her stool; abdominal discomfort and pressure; Diarrhea; stools were passing much easier; tiny bit tired the next day; arm sore; Burping more than usual; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3249, Expiry date: not reported) via an unspecified route of administration, administered in Arm Right on 09Feb2021 14:40 (at the age of 58 years old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. concomitant therapy:None The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm sore on 10Feb2021, stools were passing much easier on 14Feb2021, tiny bit tired the next day on 10Feb2021, diarrhoea on 18Feb2021, mucus in her stool on 20Feb2021, abdominal discomfort and pressure on 19Feb2021, burping more than usual on 2021. Reporter stated, She said that she did not feel the shot and barely had a sore arm the next day. She was a tiny bit tired the next day, but it was barely noticeable. She stated 6 days later however she started to have odd bowel movements, she read the side effects and it stated that this happens to about 8 percent of people in her age group and she is 59-year-old. She wanted to know however, if her bowel movements were apart of the vaccine or something else. it was a bad case of diarrhoea. She said that on Saturday 20Feb2021 and Sunday 21Feb2021 she noticed little pieces of mucus in her stool with abdominal pressure. She has little bit of discomfort in her abdomen and pressure like when you have diarrhoea and it feels like you need to go to the bathroom. She stated that she is also noticing more burping than usual. She said that diarrhoea was mentioned in 8% of people after the shot according to what she read online. she had clear mucus and had a tiny feces with mucus hanging off of it. She said that she has never had this before. diarrhoea happens more in the morning. She said that it was clear mucus in her stool and she does not know what to call it. she is also having pressure is more so in the rectal area like when you have diarrhoea. She said that it is abdominal and rectal discomfort. She said that her second dose is scheduled for 02Mar2021. Arm sore was recovered on 11Feb2021, stools were passing much easier, Diarrhoea, mucus in her stool, abdominal discomfort and pressure was not recovered, tiny bit tired the next day 12Feb2021, Burping more than usual was unknown.   No follow-up attempts are possible. No further information was expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Vaccination site inflammation, Vaccination site pain
Clinical narrative: injection area became sore; skin around injection has slugged off; burning sensation; This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 00:30 (at the age of 52-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included covid-19. The patient concomitant medications included pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported, esomeprazole sodium (NEXIUM) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient experienced injection area became sore, skin around injection has slugged off and burning sensation on 05Feb2021 12:00. No treatment received for events. Patient was not tested positive after vaccination. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Mildly sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Feb2021 15:00 (age at vaccination 70-years-old) as single dose for COVID-19 immunization. Medical history included asthma, and hypertension. Patient concomitant medication were not reported. The patient had no known allergies. No other vaccine received in four weeks. Patient has taken other medication in two weeks. On 11Feb2021, patient experienced Mildly sore arm. No treatment received for adverse events. The patient stated that she had not been diagnosed with COVID -19 prior to vaccination and since the vaccination, the patient been tested for COVID-19. On 14Feb2021, the patient underwent lab tests and procedures which included Nasal Swab, sars-cov-2 test: negative, Rapid test. The outcome of the event was recovered on an unspecified date.  Follow-up (11May2021): Follow-up attempts completed. No further information expected. Information about lot/batch number is not available.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Mid to Upper back pain between shoulder blades on both the left and right side.; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267) via an unspecified route of administration in arm left on 17Feb2021 10:15 AM (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. Medical history coronary artery disease (CAD). Patient has known allergies: NSAIDS, Artificial Sweeteners. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Patient did not have covid prior vaccination and no covid tested post vaccination. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265) via an unspecified route of administration in Arm Left on 26Jan2021 12:30 PM as dose 1, single dose for COVID-19 immunization. On 20Feb2021 at 8:00 AM patient experienced mid to upper back pain between shoulder bladed on both the left and right sides. Patient didn't received treatment for event. The outcome of the event was not recovered.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Pain in lower back on both sides of spine.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 27Feb2021 at 14:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, double mastectomy on an unknown date in 2013, chemotherapy on an unknown date in 2014, skin cancer, latex allergy, food allergy to mushrooms, shellfish allergy and milk allergy (aged cheeses). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included anastrozole (ARIMIDEX), vitamin d nos (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and nicotinamide (MANUFACTURER UNKNOWN), all from an unknown date, for unknown indication and unknown if ongoing. The patient previously took cefalexin (KEFLEX) for an unknown indication, on an unknown date and experienced drug allergy. On 27Feb2021 at 15:00, the patient experienced pain in lower back on both sides of spine. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in lower back on both sides of spine was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's wife).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The reporter (patient's wife) stated that she felt a sting when the needle went into her arm, but she did not feel anything else stating her husband had a sore arm. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration
Clinical narrative: Above normal level of dehydration while working.; This is a spontaneous report from a contactable consumer (patient).  A 27-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in left arm on 19Feb2021 11:45 (at the age of 27 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history was not reported including no known allergies. The patient's concomitant medications were none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in left arm on 29Jan2021 11:45 (at the age of 27 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not get tested for COVID post vaccination. On 19Feb2021 14:00 after the second dose of vaccination, the patient experienced above normal level of dehydration while working. The patient did not receive treatment for the event. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.