chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: she tested positive for COVID-19 on Monday 27Dec2020; she tested positive for COVID-19 on Monday 27Dec2020; This is a spontaneous report from a contactable nurse (patient herself). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer-Biontech Covid-19 Vaccine, lot/batch number and expiry date not reported), via an unspecified route of administration on 19Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled for her second dose today 09Jan2021. However, she tested positive for COVID-19 on Monday, 27Dec2020. She stated that she has still some of the symptoms of COVID-19 even though she has been declared fit to work. She was asking if she could take the second dose today.  Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported event "she tested positive for COVID-19".
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in jaw
Clinical narrative: tired; headachy; hurting; sore jaw/jaw hurts; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age (reported as age: 46; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 07Jan2021 at 10:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on Thursday (07Jan2021) at 10am from work then experienced a hurting and sore jaw later that evening. On Friday (08Jan2021), she became tired, headachy, had no motivation, and mentioned that her jaw still hurts. She reported the AEs on 09Jan2021, and mentioned that she was feeling better but her jaw hurts. The patient has not recovered from the event 'sore jaw/jaw hurts'. Outcome of the rest of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: slight tingling in the hand, leg, and toes on the administrative side of injection; This is a spontaneous report from a contactable other HCP (patient). A female patient of an unspecified age started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 08Jan2021 15:40 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced slight tingling in the hand, leg, and toes on the administrative side of injection on an unspecified date in Jan2021. Injection was administered on the left side. She wanted to know if this side effect was common. She stated that they reported this to DSU, in which DSU gave them MI's phone number to call. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Death, General physical health deterioration
Clinical narrative: Resident experienced an overall decline in condition on 1/8/21 and continued to decline until he passed away on 1/13/21.
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling, Pruritus, Vaccination site pain
Clinical narrative: left upper shoulder, it was little sore; my face was itching; My eyes puffed up; This is a spontaneous report from a contactable consumer via the Medical Information Team. A 76-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 04Jan2021 to 04Jan2021 at a single dose for an unspecified indication. Medical history included allergy to sweat Bees. The patient's concomitant medications were not reported. It was reported by the patient that after administration on his left upper shoulder, it was a little sore. On the 2nd or 3rd day after that, his face was itching so he took a Benadryl to keep from scratching and itching. The outcome of the events was unknown. He also reported that his eyes puffed up. Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Muscle twitching
Clinical narrative: occasional twitching on the left eye; she had a pain on the eye in a split of a second; This is a spontaneous report from a contactable healthcare professional via the Medical Information Team. A female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 30Dec2020 to 30Dec2020 at a single dose for an unspecified indication.  The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the COVID-19 vaccine on 30Dec2020 and she noticed occasional twitching on the left eye and has been fading away because it has been 10 days now after having her first dose. When she had the COVID-19 vaccine, after a minute or so, she had a pain on the eye in a split of a second. The outcome of the event occasional twitching on the left eye was recovering while unknown for the other event. Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable Physician. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at the first single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Immediately after receiving the first dose of the vaccine, the patient reported having dizziness and tingling throughout her body, she could not feel her hands, the patient was not anxious. After that, her heart began to pound and it was difficult for her to breathe, after a minute she felt her heartbeat begin to normalize. After 30 minutes she began to normalize, but she went to the emergency room and began to feel nausea, her body hurt and her heart rate was 140 bpm, the episode lasted 30 seconds. The outcome of events was unknown.  Information on the Batch/Lot number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable Physician. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at the first single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Immediately after receiving the first dose of the vaccine, the patient reported having dizziness and tingling throughout her body, she could not feel her hands, the patient was not anxious. After that, her heart began to pound and it was difficult for her to breathe, after a minute she felt her heartbeat begin to normalize. After 30 minutes she began to normalize, but she went to the emergency room and began to feel nausea, her body hurt and her heart rate was 140 bpm, the episode lasted 30 seconds. The outcome of events was unknown.  Information on the Batch/Lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: irritated area at injection site about the size fo a golf ball hard red and warm to touch low grade temp 99.6-100 arm had sharp pain and aching
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches; fever; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her most recent COVID-19 vaccine in a hospital. The patient experienced aches and fever on 07Jan2021 22:00. The outcome of the events was recovered in Jan2021. The reporter considered the events as non-serious. The patient received ibuprofen as treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  Information on Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: Lymph edema; This is a spontaneous report from a contactable health care professional nurse, the patient.  A 50-years-old non-pregnant female patient (nurse) received  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE;  on 06Jan2021 as a single dose, for COVID-19 vaccination.  Medical history included asthma, hypothyroidism and known allergy to penicillin. There were no concomitant medications.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 08Jan2021, The patient experienced lymph edema. No treatment was  given for the event. The clinical outcome of lymph edema  was not recovering.    Information regarding lot number  has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chills, Dizziness, Feeling abnormal
Clinical narrative: 12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, and the feeling of dizziness or fogginess for 36 hours. Writer missed 2 days of work due to symptoms.   Continued symptom - injection site is swollen, red, firm, tender to touch, arm sore to lift, and pain noted in arm pit.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, and the feeling of dizziness or fogginess for 36 hours. Writer missed 2 days of work due to symptoms.   Continued symptom - injection site is swollen, red, firm, tender to touch, arm sore to lift, and pain noted in arm pit.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Limb discomfort, Mobility decreased, Pyrexia
Clinical narrative: 12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, and the feeling of dizziness or fogginess for 36 hours. Writer missed 2 days of work due to symptoms.   Continued symptom - injection site is swollen, red, firm, tender to touch, arm sore to lift, and pain noted in arm pit.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 13:00 (lot 121820, expiry date not reported), then second dose on 08Jan2021 15:30 (lot EK9231, expiry date not reported); both intramuscular in the left arm at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The vaccines were administered in a hospital. On 09Jan2021 06:30, the patient experienced pain at shot location, swelling, chills, headache, body aches and fatigue. Post vaccination, patient had COVID test nasal swab (PCR) on 05Jan2021 and the results was negative. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient did not receive any treatments in response to the events reported. The patient was recovering from the events pain at shot location, swelling, chills, headache, body aches and fatigue.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 13:00 (lot 121820, expiry date not reported), then second dose on 08Jan2021 15:30 (lot EK9231, expiry date not reported); both intramuscular in the left arm at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The vaccines were administered in a hospital. On 09Jan2021 06:30, the patient experienced pain at shot location, swelling, chills, headache, body aches and fatigue. Post vaccination, patient had COVID test nasal swab (PCR) on 05Jan2021 and the results was negative. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient did not receive any treatments in response to the events reported. The patient was recovering from the events pain at shot location, swelling, chills, headache, body aches and fatigue.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: Day 1-4 post vaccine: low grade fever up to 100.7, significant fatigue, soreness at site of injection. On Day 5 I was much better. On day 8 I woke up with a large red, swollen and itchy rash on left arm. On day 11. I still have the rash but it is not as itchy or swollen but still large and red. Approximately 6 inches x 4 inches.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Day 1-4 post vaccine: low grade fever up to 100.7, significant fatigue, soreness at site of injection. On Day 5 I was much better. On day 8 I woke up with a large red, swollen and itchy rash on left arm. On day 11. I still have the rash but it is not as itchy or swollen but still large and red. Approximately 6 inches x 4 inches.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills and body aches, low grade fever which lasted x hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Delayed localized reaction 1 week following injection: increased swelling, redness, warm to touch, spread in size over 24 hours
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Eye contusion, Fatigue, Injection site erythema
Clinical narrative: Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia, Syncope
Clinical narrative: Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Flushing, Pain, Pyrexia
Clinical narrative: Whole body aches from head to toes, chills , flushing, diarrhea, low grade fever
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Myalgia; overwhelming fatigue; injection site pain and swelling; injection site pain and swelling; This is a spontaneous report from a contactable physician, the patient.  A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek4176, via an unspecified route of administration on 08Jan2021 at 08:30 (at the age of 30 years old) as a single dose in the right arm for COVID-19 vaccination.  Medical history included attention deficit hyperactivity disorder, gastritis, and hiatal hernia all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included spironolactone, ethinylestradiol, norgestimate (SPRINTEC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), and 'dexylan', all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of  BNT162B2, lot number: Eh9899 on 18Dec2020 at 10:00 AM in the right arm. The vaccine was given at a Public Health Clinic. On 09Jan2021 at 12:00AM, the patient experienced myalgia, overwhelming fatigue, injection site pain and swelling. The patient did not receive treatment for the events. The clinical outcome of myalgia, overwhelming fatigue, injection site pain and swelling was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Tachycardia, Throat tightness
Clinical narrative: Felt hot, Tachycardia, sensation of throat closing
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Body temperature, Chills, Fatigue
Clinical narrative: 30 hours post injection mild weakness and fatigue; Onset began 18 hours after injection. 100.2 fever; chills; body aches; extreme fatigue; Bedridden 8 hours; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable nurse, the patient.  A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via an unspecified route of administration on 07Jan2021 at 15:00 (at the age of 53 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included high blood pressure from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of  BNT162B2, lot number: EJ1685 on 19Dec2020 at 16:15 in the left arm. On 08Jan2021 at 09:00 (reported as onset began 18 hours after injection), the patient experienced 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours. It was reported that 30 hours post injection (08Jan2021 at 21:00) he experienced mild weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours, mild weakness and fatigue was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: 30 hours post injection mild weakness and fatigue; Onset began 18 hours after injection. 100.2 fever; chills; body aches; extreme fatigue; Bedridden 8 hours; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable nurse, the patient.  A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via an unspecified route of administration on 07Jan2021 at 15:00 (at the age of 53 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included high blood pressure from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of  BNT162B2, lot number: EJ1685 on 19Dec2020 at 16:15 in the left arm. On 08Jan2021 at 09:00 (reported as onset began 18 hours after injection), the patient experienced 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours. It was reported that 30 hours post injection (08Jan2021 at 21:00) he experienced mild weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours, mild weakness and fatigue was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: 101.5 (units not reported) fever; Severe body aches; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm from 07Jan2021 to 07Jan2021 at SINGLE DOSE, for covid-19 immunization. The patient 's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 for covid-19 immunization on unspecified date (1st dose). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  On 08Jan2021 about 24 hours post vaccine, the patient experienced a 101.5 (units not reported) fever, severe body aches and chills. The outcome of events was unknown. No treatment was required or given due to the events.  No follow-up attempts possible. No further information expected. Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pain in extremity
Clinical narrative: She has sore arms; Body aches; Inappropriate schedule of product administration; This is a spontaneous report from a contactable consumer. An adult female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Jan2021 as a single dose in the left arm for COVID-19 vaccination.  Medical history and concomitant medications were not reported. Historical vaccination information included receiving the first dose of  BNT162B2 on 17Dec2020 for COVID-19 vaccination. On an unspecified date, the patient experienced sore arms and body aches. It was unknown if the patient received treatment for the events. The clinical outcome of sore arms and body aches, and inappropriate schedule of product administration was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Shot on Thursday (1/7/21h at 1PM) Immediate:  Experienced some light headiness right after shot. 2-3 hours later - Some chest tightness, even up to throat. Resolved evening that day.     Usual soreness in arm, expected resolved after about 48 hours. Around 2 pm 1/14, felt chest tightness return up to throat, looked at arm, hot red and swollen, like a bug bite, itchy.  Did not take antihistamine.   1/15/21 redness and itchiness still at injection site.  Mild itching. Lingering mild chest tightness.  Upon big inhalation, feels like someone squeezing ? numb pain ? in chest and up to throat with a big breath.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Painful respiration, Peripheral swelling, Throat tightness
Clinical narrative: Shot on Thursday (1/7/21h at 1PM) Immediate:  Experienced some light headiness right after shot. 2-3 hours later - Some chest tightness, even up to throat. Resolved evening that day.     Usual soreness in arm, expected resolved after about 48 hours. Around 2 pm 1/14, felt chest tightness return up to throat, looked at arm, hot red and swollen, like a bug bite, itchy.  Did not take antihistamine.   1/15/21 redness and itchiness still at injection site.  Mild itching. Lingering mild chest tightness.  Upon big inhalation, feels like someone squeezing ? numb pain ? in chest and up to throat with a big breath.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: 24 hours after 2nd vaccine, I had one day oh fever to 104; headache; myalgia; chills; This is a spontaneous report from a contactable physician. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 08:00 at a SINGLE DOSE  and second dose via an unspecified route of administration on the left arm on 07Jan2021 04:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none.  There were no concomitant medications. 24 hours after 2nd vaccine, the patient had one day of fever to 104, headache, myalgia and chills on 08Jan2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: This incident was likely a documentation error. During clinic, the vaccinator documented in database that the patient received Moderna for 2nd dose, even though previous records confirmed that the pt received Pfizer for 1st dose. However, pt confirmed that she received a blue sheet of paper (which in our clinic workflow means Pfizer dose) and that her CDC Immunization Card is labeled as Pfizer for 2nd dose. Vaccinator also confirmed that she only provided Pfizer immunizations for the entire day, and that she is not comfortable/experienced with using a tablet. Thus, it is highly likely that this was purely a documentation error and the patient correctly received the Pfizer vaccine for both doses.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination error
Clinical narrative: This incident was likely a documentation error. During clinic, the vaccinator documented in database that the patient received Moderna for 2nd dose, even though previous records confirmed that the pt received Pfizer for 1st dose. However, pt confirmed that she received a blue sheet of paper (which in our clinic workflow means Pfizer dose) and that her CDC Immunization Card is labeled as Pfizer for 2nd dose. Vaccinator also confirmed that she only provided Pfizer immunizations for the entire day, and that she is not comfortable/experienced with using a tablet. Thus, it is highly likely that this was purely a documentation error and the patient correctly received the Pfizer vaccine for both doses.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea within 30 minutes, lasting a few days following; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK921, on 07JAN2021 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization.  Medical history included hypothyroid from an unknown date and unknown if ongoing, hyperlipidemia from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing.  The patient did not have known allergies. Concomitant medication included levothyroxine, atorvastatin, lisinopril, and sertraline hydrochloride (ZOLOFT). The most recent COVID-19 vaccine was administered in the hospital.  No other vaccines were given in 4 weeks. The patient was not pregnant at the time of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19.  On 07Jan2021 12:30 PM the patient experienced diarrhea within 30 minutes, lasting a few days following. The diarrhea within 30 minutes, lasting a few days following did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the event diarrhea within 30 minutes, lasting a few days following. Outcome of the event diarrhea within 30 minutes, lasting a few days following was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Lymphadenopathy, Myalgia
Clinical narrative: whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when  woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when  woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; weak; her middle finger and index finger feel tight; her left shoulder feel really tight but has full sensation; unable to lift her left arm more than 30 degrees; pain in her arm; unable to sleep very well last night; This is a spontaneous report from a contactable nurse (patient) reported that a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 08Jan2021(yesterday morning, Deltoid Left) at single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications was not reported. Historical Vaccine was included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Patient received her second dose and within an hour she started feeling extremely tired, had a severe headache. When she woke up she noticed a large palpable knot on her left upper lateral deltoid in Jan2021. She stated that the injection went well and noticed no problems when she received the shot. At this time she was still very weak, her headache was still severe and she has noticed that her middle finger and index finger feel tight and her left shoulder feel really tight but had full sensation. She stated that she was unable to lift her left arm more than 30 degrees. She does not have a primary care physician at this time as she just relocated to her current residence. She stated that she was so uncomfortable due to the pain in her arm she was unable to sleep very well last night. She was going to seek medical attention at a local urgent care to be safe. The outcome of events, fatigue, knot on her left upper lateral deltoid, finger feel tight, shoulder feel really tight, unable to lift her left arm more than 30 degrees, pain in her arm, unable to sleep very well was unknown.  The outcome of events of severe headache, weak was not recovered.  Information about lot/batch number has been requested.; Reporter's Comments: her symptoms online per the Fact Sheet instructions.   Potential
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Vaccination site movement impairment, Vaccination site nodule
Clinical narrative: feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; weak; her middle finger and index finger feel tight; her left shoulder feel really tight but has full sensation; unable to lift her left arm more than 30 degrees; pain in her arm; unable to sleep very well last night; This is a spontaneous report from a contactable nurse (patient) reported that a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 08Jan2021(yesterday morning, Deltoid Left) at single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications was not reported. Historical Vaccine was included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Patient received her second dose and within an hour she started feeling extremely tired, had a severe headache. When she woke up she noticed a large palpable knot on her left upper lateral deltoid in Jan2021. She stated that the injection went well and noticed no problems when she received the shot. At this time she was still very weak, her headache was still severe and she has noticed that her middle finger and index finger feel tight and her left shoulder feel really tight but had full sensation. She stated that she was unable to lift her left arm more than 30 degrees. She does not have a primary care physician at this time as she just relocated to her current residence. She stated that she was so uncomfortable due to the pain in her arm she was unable to sleep very well last night. She was going to seek medical attention at a local urgent care to be safe. The outcome of events, fatigue, knot on her left upper lateral deltoid, finger feel tight, shoulder feel really tight, unable to lift her left arm more than 30 degrees, pain in her arm, unable to sleep very well was unknown.  The outcome of events of severe headache, weak was not recovered.  Information about lot/batch number has been requested.; Reporter's Comments: her symptoms online per the Fact Sheet instructions.   Potential
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysgeusia, Pain in extremity, Vaccination site pain
Clinical narrative: Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ejko85, intramuscular on 22-DEC-2020 11:45 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization.  Medical history had known allergies to latex. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 01:15AM, the patient experienced metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. The metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers.  Outcome of the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node in Between collar bone and neck on Left side( injection side) .. it?s sore and fluffy
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site hypoaesthesia, Vaccination site pain, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), via an unspecified route of administration from 19Dec2020 11:00 AM at single dose on left arm for COVID-19 immunization. Age at vaccination was reported as 56 years. Patient was not pregnant at the time of vaccination. Medical history included cancer and penicillin allergies. Concomitant medications (received within 2 weeks of vaccination) included Irbesartan, Pantoprazole, Levothyroxine and Calcium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. On 26Dec2020 13:00 (reported as 01:00 PM), patient experienced vertigo, then dizzy-lighted since. Patient also experienced loud hissing sounds in her ears. Patient's arm (site of injection) became sore again, numb to the touch and she felt like she had a sunburn when her clothes touch the skin. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for "vertigo-dizziness". The events were assessed as non-serious. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since the vaccination.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Vomiting
Clinical narrative: nausea; vomiting 3 times; chills/rigors; sore arm; This is a spontaneous report from a contactable physician (patient).  A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0142, via an unspecified route of administration on left arm from 08Jan2021 09:30 to 08Jan2021 09:30 as single dose for COVID-19 immunisation.  Historical vaccine includes first dose of BNT162B2, lot number: EJ1685, on 18Dec2020 at 09:00 AM on left arm. There were no medical history and no concomitant medications. On 08Jan2021 21:30 (12 hours after vaccine), the patient experienced sore arm; on 09Jan2021 at 00:30 (15 hours after vaccine), the patient experienced chills/rigors; on 09Jan2021 at 01:30 (16 hours after vaccine), the patient experienced nausea and vomiting 3 times. The outcome of the events was recovering. No treatment was given to the patient.  No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Feeling hot
Clinical narrative: Impressions Adverse reaction to vaccine, initial encounter   Patient with sensation of generalized body warmth within 15 minutes after receiving first dose of Moderna COVID-19 vaccine No rash noted on exam No associated symptoms including but not limited to itching, chest pain, shortness of breath, difficulty swallowing, or any focal neurologic deficits   We will monitor patient for 1 hour  Patient states that his symptoms continue to improve and that he is feeling well Vital signs have remained stable throughout patient's ED course including oxygen saturation of 100% on room air Patient remains afebrile and nontoxic in appearance   At the time of discharge the patient remained in stable condition.  The patient was counseled to return the emergency department immediately with worsening symptoms.  The patient voiced understanding and agreement with treatment plan.  He is also aware that he may return to the emergency department at anytime for any reason for reevaluation, and should return with worsening or persistent symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Pain
Clinical narrative: severe pain in her lower left side; Abdominal pain that feels like a cramp at first but the pain intensifies when you try to move.; This is a spontaneous report from a contactable health care professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 05Jan2021 at 12:00 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient was not diagnosed of COVID-19 prior to vaccination. The patient did not have any other vaccines in the last four weeks. The patient's concomitant medications were not reported.  The patient experienced severe pain in her lower left side on 07Jan2021. The patient also reported abdominal pain that feels like a cramp at first but the pain intensifies when you try to move on 07Jan2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.  Information about lot and batch number was requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Migraine, Pain
Clinical narrative: Fatigue; Body aches; Migraine; Vomiting; Chills; Sweats; This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 07Jan2021 09:15 at a single dose on Left arm for COVID-19 immunization. Medical history included Chronic back pain, and latex allergy. Concomitant medication included gabapentin, acetaminophen, tramadol, sulindac, methocarbamol. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 17Dec2020 09:30 at a single dose on right arm for COVID-19 immunization. The patient experienced fatigue, body aches, migraine, vomiting, chills, sweats on 07Jan2021 12:30. No treatment received for adverse event. The outcome of the event was recovered on an unspecified date in Jan2021. The events were assessed as non-serious. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fatigue; Body aches; Migraine; Vomiting; Chills; Sweats; This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 07Jan2021 09:15 at a single dose on Left arm for COVID-19 immunization. Medical history included Chronic back pain, and latex allergy. Concomitant medication included gabapentin, acetaminophen, tramadol, sulindac, methocarbamol. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 17Dec2020 09:30 at a single dose on right arm for COVID-19 immunization. The patient experienced fatigue, body aches, migraine, vomiting, chills, sweats on 07Jan2021 12:30. No treatment received for adverse event. The outcome of the event was recovered on an unspecified date in Jan2021. The events were assessed as non-serious. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. 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.