chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: 15 MINUTES AFTER SHOT- DIZZINESS, BLURRY VISION, SHORTNESS OF BREATH, SOME CHEST PAIN, INTENSE ANXIETY
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: COVID VACCINE CLINIC  12/18/2020    Subjective Patient is a 32 y.o. female who was seen at the COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness.  Also c/o tingling in hands and feet. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Review of Systems     Objective   Visit Vitals BP 111/78 Pulse 76 SpO2 100%       Physical Exam HENT:     Head: Normocephalic.     Right Ear: Tympanic membrane normal.     Left Ear: Tympanic membrane normal.     Nose: Nose normal.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: She is alert.  Psychiatric:        Mood and Affect: Mood normal.        Assessment/Plan    Treatment included water, granola bar, and rest. Follow up response to treatment:excellent Patient discharge:  Stable to go home and follow up with PCP   Watch for signs for allergic reaction danger signs:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Patient complained of chest tightness.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Patient experience tongue numbness and tingling of lips and around mouth
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chest X-ray, Chest discomfort, Dyspnoea
Clinical narrative: Right ribcage and right upper back pain. Difficulty breathing  specially lying down on my left side and during inhalation. Feels like something is pressing on my chest. Went to ER on 12/30/20 after midnight. Was given Toradol IM on my right arm. Still feeling pain when I woke up today and difficulty breathing is still the same.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Musculoskeletal chest pain
Clinical narrative: Right ribcage and right upper back pain. Difficulty breathing  specially lying down on my left side and during inhalation. Feels like something is pressing on my chest. Went to ER on 12/30/20 after midnight. Was given Toradol IM on my right arm. Still feeling pain when I woke up today and difficulty breathing is still the same.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Mild fever, chills, and headache.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching and received Benedryl 50mg IM on the right deltoid; vital signs post taken; at 11:40 itching subsided; at 12:10 139/76 heart rate 57; SPO2 97% on R/A; was alert and oriented; itching subsided and associate was discharged home
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: A temperature excursion involving PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an inappropriate storage of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, for prophylaxis (lot # T021302 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 19-DEC-2021) (strength, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were -5° Celsius (C) for 20 hours respectively.  A digital data logger was involved, and there was not previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Report a temperature excursion involving PROQUAD and VARICELLA. Excursion occured on 2 separes dates/ Several patient were administered PROQUAD during this temperature excursion; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not provided.      On 08-DEC-2020, the patient was inadvertently administered with an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 milliliter for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number  T021302, had been verified to be a valid number; expiration date 19-DEC-2021). The  temperature  excursion was at -5 degrees Celsius (C) for 10 hours, for a time frame of  20 hours, and no had the previous temperature excursion. It was reported that the call was due to data logger. Additionally, it was reported a varicella vaccine (manufacturer unknown) with a temperature excursion on 2 separate dates with the exact same temperature condition, however this vaccine was not administered to the patient.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Flushing, Hypoaesthesia, Hypoaesthesia oral, Lymph node pain
Clinical narrative: Bell's palsy; experienced sudden flushing; tachycardia; the left side of my tongue became numb and tight. The numbness and tightness radiated to my left cheek, ear, jaw, and neck; the left side of my tongue became numb and tight. The numbness and tightness radiated to my left cheek, ear, jaw, and neck; the left side of my tongue became numb and tight. The numbness and tightness radiated to my left cheek, ear, jaw, and neck; The numbness lasted for approximately 45 minutes with resulting jaw and ear pain for 3-4 days after injection; The numbness lasted for approximately 45 minutes with resulting jaw and ear pain for 3-4 days after injection; New lymph node tenderness at day 4.; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on left arm at 11:30 AM on 18Dec2020 at single dose for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medication included fluticasone propionate (FLONASE), loratadine (CLARITIN) both for seasonal allergies. The patient had sudden generalized flushing, tachycardia, and the left side of her tongue became numb and tight. The numbness and tightness radiated to her left cheek, ear, jaw, and neck at 11:45 AM on 18Dec2020. She hadn't found any similar reports/reactions documented. Spoke briefly per document below regarding Bell's palsy. The numbness lasted for approximately 45 minutes with resulting jaw and ear pain for 3-4 days after injection. New lymph node tenderness at day 4 in Dec2020. No shortness of breath, dysphagia, or facial drooping associated. All events were reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was unknown. Explained that Pfizer would not be able to provide treatment recommendations and referred to her HCP to discuss the 2nd dose.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in jaw, Skin tightness, Tachycardia, Tongue disorder
Clinical narrative: Bell's palsy; experienced sudden flushing; tachycardia; the left side of my tongue became numb and tight. The numbness and tightness radiated to my left cheek, ear, jaw, and neck; the left side of my tongue became numb and tight. The numbness and tightness radiated to my left cheek, ear, jaw, and neck; the left side of my tongue became numb and tight. The numbness and tightness radiated to my left cheek, ear, jaw, and neck; The numbness lasted for approximately 45 minutes with resulting jaw and ear pain for 3-4 days after injection; The numbness lasted for approximately 45 minutes with resulting jaw and ear pain for 3-4 days after injection; New lymph node tenderness at day 4.; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on left arm at 11:30 AM on 18Dec2020 at single dose for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medication included fluticasone propionate (FLONASE), loratadine (CLARITIN) both for seasonal allergies. The patient had sudden generalized flushing, tachycardia, and the left side of her tongue became numb and tight. The numbness and tightness radiated to her left cheek, ear, jaw, and neck at 11:45 AM on 18Dec2020. She hadn't found any similar reports/reactions documented. Spoke briefly per document below regarding Bell's palsy. The numbness lasted for approximately 45 minutes with resulting jaw and ear pain for 3-4 days after injection. New lymph node tenderness at day 4 in Dec2020. No shortness of breath, dysphagia, or facial drooping associated. All events were reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was unknown. Explained that Pfizer would not be able to provide treatment recommendations and referred to her HCP to discuss the 2nd dose.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test negative
Clinical narrative: headache; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular (left arm) on 18Dec2020 08:00 at a single dose for Covid-19 immunisation. Medical history included asthma, hypertension (HTN), and allergy to latex. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. After receiving the first dose, the patient experienced headache on 18Dec2020 12:00. No treatment was given for the event. The patient underwent lab tests which included nasal swab: negative on 16Dec2020 (Covid test name post vaccination: Binex). Outcome of the event was recovered.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Headache; Swollen lymph nodes in neck; Sore throat; This is a spontaneous report from a contactable healthcare professional. A 30-year-old female patient started to receive bnt162b2 (BNT162B2; unknown lot number and expiration date), intramuscularly left arm on 23Dec2020 12:30 at single dose for COVID-19 immunization. The patient has no medical history. The patient has no known allergies. The patient was not pregnant when the vaccination was given. The patient's concomitant medications were not reported. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced headache, swollen lymph nodes in neck and sore throat on 24Dec2020 02:00 AM. The event was not considered serious, life threatening, caused/prolonged hospitalization, disabling/incapacitating or causes congenital anomaly/birth defect or death. The patient did not received treatment for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not yet been tested for COVID-19 since the vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: Woke up from dead sleep shivering. had chills; muscle ache; a fever of 102.8F; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EH9899 ) intramuscularly at the right arm on 22Dec2020 11:00 at single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 24Dec2020 01:30, the patient woke up from dead sleep shivering, had chills, muscle ache and a fever of 102.8 Fahrenheit. The patient did not receive treatment for the events reported. The patient underwent lab tests and procedures which included nasal swab SARS-CoV-2 test: negative on 24Dec2020. Outcome of the events was recovering.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Night sweats
Clinical narrative: Light headed, dizzy, headache, night sweats; Light headed, dizzy, headache, night sweats; Light headed, dizzy, headache, night sweats; This is a spontaneous report from a non-contactable nurse (patient). A 22-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration in left arm on 23Dec2020 15:45 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient experienced light headed, dizzy, headache, night sweats on 23Dec2020 19:30 with outcome of recovering. No treatment was received.   No follow-up attempts possible. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall, Lethargy, Nausea
Clinical narrative: felt weak; fell out of bed; Felt nauseated; vomiting; chills; Felt lethargic; This is a spontaneous report from a contactable nurse. A 76-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0140), intramuscularly on 22Dec2020 15:15 at a single dose in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient woke up at 06:00 am 23Dec2020, reached for something on their nightstand, felt weak and fell out of bed. Felt nauseated at breakfast table and vomited. Had chills - no fever - temp 97.6 F. Had second episode of nausea/vomiting. Felt lethargic. Took a nap; by evening of same day began to feel better, was able to keep food down. On 24Dec2020, symptoms completely resolved; the patient was back to normal. No treatment received for these events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. This is a non-serious report. The outcome of event was recovered on 24Dec2020.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: felt weak; fell out of bed; Felt nauseated; vomiting; chills; Felt lethargic; This is a spontaneous report from a contactable nurse. A 76-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0140), intramuscularly on 22Dec2020 15:15 at a single dose in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient woke up at 06:00 am 23Dec2020, reached for something on their nightstand, felt weak and fell out of bed. Felt nauseated at breakfast table and vomited. Had chills - no fever - temp 97.6 F. Had second episode of nausea/vomiting. Felt lethargic. Took a nap; by evening of same day began to feel better, was able to keep food down. On 24Dec2020, symptoms completely resolved; the patient was back to normal. No treatment received for these events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. This is a non-serious report. The outcome of event was recovered on 24Dec2020.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Extreme generalized joint and muscle pain lasting 5 days. No serious adverse events. I just felt the need to report the generalized severe pain.; Extreme generalized joint and muscle pain lasting 5 days. No serious adverse events. I just felt the need to report the generalized severe pain.; This is a spontaneous report from contactable nurse (patient). A 43-year-old female patient received her first dose of BNT162B2 (Lot number: EH9899), via an unspecified route of administration on 21Dec2020 05:30 at single dose (dose 1) in the left arm for COVID-19 immunization. Medical history included hypothyroid, migraine, depression and allergies: Sulfa. The patient's concomitant medications were not reported. On 22Dec2020 02:00, the patient experienced extreme generalized joint and muscle pain lasting days. No serious adverse events. She just felt the need to report the generalized severe pain. No treatment received for all the events. The outcome of the events was recovering.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain
Clinical narrative: Headache; Joints hurt; Spot where the injection was is also hurting; fever; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number ELI284), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Medical history included couple of months ago patient had the shingles but he don't know it's been gone. There were no concomitant medications. Patient woke up this morning (24Dec2020) with a headache, he didn't think it's quite a fever and joints that hurt and the spot where the injection was also hurting. Patient didn't received treatment. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Significant metal taste in mouth; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (also reported as COVID-19 Vaccine, lot no. and expiry date was unknown) via an unspecified route of administration in Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine approximately 2 days ago and the patient experienced significant metal taste in mouth on unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Injection site pain
Clinical narrative: high pain level at injection site; exhaustion/fatigue; This is a spontaneous report from a contactable consumer.  A 65-year-old male patient received bnt162b2 (BNT162B2, lot/batch number and expiry date were unknown), via an unspecified route of administration on unknown Dec2020 (last week) at single dose for Covid-19 immunisation. Medical history included obese by medical standards, has heart rhythm issues and diverticulosis. He also was tested positive for COVID and had symptoms over two weeks in the summer of 2020. The patient's concomitant medications were not reported. On unknown date in Dec2020, he experienced the exhaustion and fatigue that he experienced when he had COVID. It lasted about a week and he took two days of sick time. He also reported 12 hours of high pain level at injection site following the shot. He described it as a higher level of pain than he had experienced with other vaccines or injuries. Events took place after use of product. The outcome of events was recovered.  The following information on the batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: inside part of her lip is red; lips inside part of her lip and tip of the tongue feel numb; This is a spontaneous report from a contactable pharmacist.  A 43-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the right arm on 22Dec2020 11:30 at single dose for COVID-19 immunisation.  The patient had no medical history. The patient's concomitant medications were not reported.  The patient stated, "since that night her lips, the inside part of her lip and tip of the tongue feel numb on 22Dec2020. Added she just looked at the inside and it is also red on 24Dec2020. She started to feel the numbness on the inside part of her lips and on the tip of her tongue later that night. The feeling is still the same today. Restates she just looked today and noticed it is red at the place where it feels numb". The outcome of the events were not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: symptoms of flu like illness; This is a spontaneous report from a non-contactable nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunisation. The patient's medical history included having symptoms of covid infection. Concomitant medications were not reported. Patient received covid vaccine 14 days after having symptoms of covid infection. Patient reported significant symptoms of flu like illness for 48 hours after first dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eyelids pruritus, Injection site pain, Swelling, Urticaria
Clinical narrative: Moderate to severe pain at injection site; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids.; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids; This is a spontaneous report from a non-contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 12:00 at single dose for covid-19 immunization. Vaccine location was Right arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Asthma and Ehlers Danlos, and Known allergies: Hives with amoxicillin and anaphylaxis with shellfish. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT), ethinylestradiol/levonorgestrel (QUARTETTE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Moderate to severe pain at injection site, and 2 days after vaccination I had swelling, redness, hives and itching on both eye lids on 25Dec2020. Treatment received for the adverse events included Benadryl 50mg once. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Mild injection site pain and headache; Mild injection site pain and headache; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced mild injection site pain and headache on an unspecified date. Outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Peripheral swelling
Clinical narrative: she experienced a swollen right leg and abdomen after receiving the COVID-19 vaccine; she experienced a swollen right leg and abdomen after receiving the COVID-19 vaccine; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 41-year-old female patient received bnt162b2, via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 immunization. The patient' medical history and concomitant medications were not reported. The patient experienced a swollen right leg and abdomen after receiving the covid-19 vaccine in Dec2020. Outcome of the events was recovered on an unknown date. Patient reported that she had follow-up with her doctor, received lab work that returned normal, and now has no more swelling.   No follow-up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: she is about two months pregnant; She reported that she had very mild muscle pain at injection site; She reported that she had very mild muscle pain at injection site; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A female patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported that she very recently received her first dose of COVID-19 vaccine, and was scheduled for the follow up. She reported that she had very mild muscle pain at injection site. The nurse shared that she was about two months pregnant. She was unaware of any other health issues. The outcome of the events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Soreness at the site of injection; Fever; Headache; Nausea; Vomiting; Shivering; Dizziness; This is a spontaneous report from a contactable Other-HCP (patient herself).  This 49-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685, via intramuscular, at single dose on 23Dec2020 at 13:30 for COVID-19 immunisation. Vaccine location was arm left. The patient was vaccinated at hospital, age at vaccination 49-year-old. The patient was not pregnant. No other vaccine was received in four weeks. Relevant medical history included msg allergy. The patient did not have concomitant medications. The patient is a scientist and works at hospital. On 24Dec2020, the patient experienced soreness at the site of injection, fever, headache, nausea, vomiting, shivering, and dizziness. It felt like a never-ending torture that would have warranted an ER visit. She was not hospitalized. She took anti-nausea/dizziness medication, and ibuprofen (MOTRIN). The patient was recovering from the events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Soreness at the site of injection; Fever; Headache; Nausea; Vomiting; Shivering; Dizziness; This is a spontaneous report from a contactable Other-HCP (patient herself).  This 49-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685, via intramuscular, at single dose on 23Dec2020 at 13:30 for COVID-19 immunisation. Vaccine location was arm left. The patient was vaccinated at hospital, age at vaccination 49-year-old. The patient was not pregnant. No other vaccine was received in four weeks. Relevant medical history included msg allergy. The patient did not have concomitant medications. The patient is a scientist and works at hospital. On 24Dec2020, the patient experienced soreness at the site of injection, fever, headache, nausea, vomiting, shivering, and dizziness. It felt like a never-ending torture that would have warranted an ER visit. She was not hospitalized. She took anti-nausea/dizziness medication, and ibuprofen (MOTRIN). The patient was recovering from the events.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Hypoaesthesia, Influenza like illness
Clinical narrative: I was very tired; Tingling lips; Flu like symptoms; I had the chills; I went to bed and I woke up again with the chills; Hot flashes; Numbness in both feet, both my feet are having a numbing sensation; Fingers are freezing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number looks like EL0140) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient medical history included Asthma, blood pressure and cholesterol. The patient took a blood pressure pill, cholesterol pill, a pill for her stomach and breathing treatment for asthma. On 22Dec2020, the patient received her first COVID Vaccination and started to experience flu like symptoms where she had the chills, hot flashes and numbness in both feet. When she said her fingers were freezing on 22Dec2020, so she went to work this morning, she was not experiencing the numbness or anything but like she had the flu shot, she came home this evening (23Dec2020) but she was very tired so took a bath. She went to bed and woke up again with the chills, her lips tingling and both feet having a numbing sensation. The patient took Tylenol when she came home from work to treat these events. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Peripheral coldness
Clinical narrative: I was very tired; Tingling lips; Flu like symptoms; I had the chills; I went to bed and I woke up again with the chills; Hot flashes; Numbness in both feet, both my feet are having a numbing sensation; Fingers are freezing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number looks like EL0140) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient medical history included Asthma, blood pressure and cholesterol. The patient took a blood pressure pill, cholesterol pill, a pill for her stomach and breathing treatment for asthma. On 22Dec2020, the patient received her first COVID Vaccination and started to experience flu like symptoms where she had the chills, hot flashes and numbness in both feet. When she said her fingers were freezing on 22Dec2020, so she went to work this morning, she was not experiencing the numbness or anything but like she had the flu shot, she came home this evening (23Dec2020) but she was very tired so took a bath. She went to bed and woke up again with the chills, her lips tingling and both feet having a numbing sensation. The patient took Tylenol when she came home from work to treat these events. The outcome of the events was not recovered.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Heart rate increased, Hyperhidrosis, Lymphadenopathy
Clinical narrative: I woke up with swollen lymph node in my neck and my arms pits; Elevated pulse; Sweating; Severe sore throat; weakness; Body ache; I couldn't even function and get out of bed; I am still kind of feeling off; Fatigue; I couldn't swallow; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730 and expiration date Mar2021), intramuscular on 17Dec2020 16:00 at single dose for prevention of COVID-19 at a outpatient clinic. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine on the 17th he got the vaccine around 4 o' clock and later that evening about 11 o'clock at night he woke up with swollen lymph node in his neck and his arms pits, with a elevated pulse and sweating and a severe sore throat where he couldn't swallow and body ache and that subsided in a couple of hours after that. But he was with body ache and weakness for almost three days after that to a point where he couldn't even function and get out of bed still with sore throat and after three days it subsided. But he was still kind of feeling off and general weakness. The patient had had blood work, which he did not know the specific name of test that he had done, it was for a physical, it was just regular laboratory work. The result of the blood work was unknown. No treatment was received for the events. Also reported that for the most of above events improved, just the fatigue was persistent. The outcome of the event fatigue was not recovered, for the rest of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: I woke up with swollen lymph node in my neck and my arms pits; Elevated pulse; Sweating; Severe sore throat; weakness; Body ache; I couldn't even function and get out of bed; I am still kind of feeling off; Fatigue; I couldn't swallow; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730 and expiration date Mar2021), intramuscular on 17Dec2020 16:00 at single dose for prevention of COVID-19 at a outpatient clinic. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine on the 17th he got the vaccine around 4 o' clock and later that evening about 11 o'clock at night he woke up with swollen lymph node in his neck and his arms pits, with a elevated pulse and sweating and a severe sore throat where he couldn't swallow and body ache and that subsided in a couple of hours after that. But he was with body ache and weakness for almost three days after that to a point where he couldn't even function and get out of bed still with sore throat and after three days it subsided. But he was still kind of feeling off and general weakness. The patient had had blood work, which he did not know the specific name of test that he had done, it was for a physical, it was just regular laboratory work. The result of the blood work was unknown. No treatment was received for the events. Also reported that for the most of above events improved, just the fatigue was persistent. The outcome of the event fatigue was not recovered, for the rest of events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hot flush
Clinical narrative: Ache/Pain; Chills; Hot flashes; Light headedness; Nausea; Headache; I have had sore arms; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiration date 21Mar2021) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. Medical history included Cholesterol. Concomitant medications included Atorvastatin for Cholesterol. The patient was called about the side effects from the vaccine (Covid 19 Vaccine). She has had ache, pains, chills, hot flashes, light headedness, nausea, sore arms, headaches, a lot of symptoms is what she had when she had COVID. That, she had symptoms like that when she had COVID. But this vaccine (Covid 19 Vaccine) she was given on the 22nd she did fine until 1 AM and she woke up with all these symptoms and she was still fatigued, Aching, headache and she did not got a text, yesterday she got one asking about her health on 22nd. So, she thought since she didn't got another one she really need to report these side effects. When asked about event start date, it was stated as "So, it's on 1 AM on 23rd and she got the vaccine around 12 O'clock on 22nd, pm". Due date for the next shot: 12Jan2021. Therapeutic measures were taken as a result of events Fatigue, ache, headache included treatment with Tylenol. Outcome of events Fatigue, ache, headache was not recovered, while outcome of other events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Pain
Clinical narrative: Ache/Pain; Chills; Hot flashes; Light headedness; Nausea; Headache; I have had sore arms; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiration date 21Mar2021) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. Medical history included Cholesterol. Concomitant medications included Atorvastatin for Cholesterol. The patient was called about the side effects from the vaccine (Covid 19 Vaccine). She has had ache, pains, chills, hot flashes, light headedness, nausea, sore arms, headaches, a lot of symptoms is what she had when she had COVID. That, she had symptoms like that when she had COVID. But this vaccine (Covid 19 Vaccine) she was given on the 22nd she did fine until 1 AM and she woke up with all these symptoms and she was still fatigued, Aching, headache and she did not got a text, yesterday she got one asking about her health on 22nd. So, she thought since she didn't got another one she really need to report these side effects. When asked about event start date, it was stated as "So, it's on 1 AM on 23rd and she got the vaccine around 12 O'clock on 22nd, pm". Due date for the next shot: 12Jan2021. Therapeutic measures were taken as a result of events Fatigue, ache, headache included treatment with Tylenol. Outcome of events Fatigue, ache, headache was not recovered, while outcome of other events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lymphadenopathy
Clinical narrative: Sore injection site for 48 hrs; Fatigue for 48 hrs; Lower cervical and supraclavicular lymphadenopathy; This is a spontaneous report from a contactable physician (patient herself).  This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via intramuscular, on 22Dec2020 at 10:30 AM at single dose for COVID-19 immunisation.  The patient was vaccinated at hospital, age at vaccination was 39-year-old. Vaccination location was arm left. No other vaccine was received in four weeks. The patient was not pregnant.  Relevant medical history included reflux. Relevant concomitant famotidine (PEPCID) for reflux. No known allergies. The patient did not have congenital abnormality or birth defect. On 22Dec2020, after vaccination, the patient had sore injection site for 48 hrs, fatigue for 48 hrs and lower cervical and supraclavicular lymphadenopathy. Pre-vaccination and Post-vaccination tests for COVID were not performed. The patient was not treated for the events. The patient was recovering from the events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Tongue discolouration, Urticaria
Clinical narrative: Tongue throat tingly; Tongue throat tingly; hives; purple tongue in the back on sides; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old female patient received first dose (BNT162B2, lot number EH9899) , intramuscular at Arm Left on 23Dec2020 12:00 at the 50 years old at single dose for COVID-19 immunization.  Medical history included Angio edema. The patient was not allergic to medications, food, or other products. Concomitant medication included pantoprazole(strength 40 mg), simvastatin (strength 20 mg), colecalciferol (D3, strength 5000iU), ascorbic acid, betacarotene, copper, tocofersolan, zinc (OCUVITE), ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER) , boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN).  The patient experienced Tongue throat tingly, hives, purple tongue in the back on sides on 23Dec2020 18:00. The patient received Benadryl as the treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Sore Arm x48 hours; fatigue; mild nausea; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231, Expiry date unknown), intramuscular in left arm, on 23Dec2020 15:00, at single dose, for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient is not pregnant. The patient experienced "sore arm x48 hours", fatigue and mild nausea all on 24Dec2020 03:00. No treatment was received for the events. The patient did not have COVID prior and post vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the event vaccination site pain was recovered on 26Dec2020 at 03:00 and the outcome of the remaining events was recovered on an unspecified date in Dec2020.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea; lightheaded; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old female patient started to receive her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer lot EK5730), intramuscular from 24Dec2020 12:30 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID and has not been tested for COVID-19. The patient experienced nausea and lightheaded on 25Dec2020. Events were reported as non-serious. No treatment given. The outcome of events was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Major arm soreness at injection site for 2 days; Nausea for 2 days; Intermittent headache; Fatigue for 1 day; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 23Dec2020 14:30 at left arm,  at single dose for covid-19 immunization. The patient medical history was not reported, previously healthy, no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced Major arm soreness at injection site for 2 days, Nausea for 2 days, Intermittent headache, Fatigue for 1 day all from 24Dec2020 07:30 AM. No treatment was received for all events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: her fever is being going up since 5 days; body aches/Hurting most of the days; tired; Arthritis; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as looked like VAC DOD, cannot read whether that is OOD or DOD and then it was 7051 and cannot read the writing), via an unspecified route of administration on 21Dec2020 at single dose for preventive measure for Covid. Medical history included low thyroid, cholesterol, breast cancer surgery, high blood pressure, AFib (atrial fibrillation) incident. Concomitant medication included metoprolol for high blood pressure, tamoxifen after breast cancer surgery, fenofibrate for cholesterol, levothyroxine for low thyroid and unspecified medication for AFib incident. The patient got the first Covid vaccination at the hospital where she volunteer. Every day the patient was having more and more, a higher temperature. This morning in Dec2020, she got up at 102.2 and that was the highest it had been. It was 101 something yesterday (event onset reported as probably ever since the 22Dec20020 but each day the fever got worst). The patient also had the body aches but she had arthritis so it was really hard to tell if it just been a (incomplete sentence), what she was already hurting most of the days so it was hard to tell if the vaccine had to do anything but really tired. The outcome of events was unknown.  Information on the lot/batch number has been requested.