chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Fatigue, body aches
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 5 days post vaccination, patient developed rash on central abdomen. 6 days post vaccination, rash on abdomen resolved and rash appeared on bilateral forearms. Patient took Benadryl and rash subsided by day 8 post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Fever (100.6) chills, very bad body aches, fatigue, dizziness  Lasted for about 18 hours. Woke up the next day feeling fine.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Fever (100.6) chills, very bad body aches, fatigue, dizziness  Lasted for about 18 hours. Woke up the next day feeling fine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Pain from left arm and up to left shoulder Lymph node is enlarged and tender Diarrhea Body Aches
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain from left arm and up to left shoulder Lymph node is enlarged and tender Diarrhea Body Aches
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Pharyngeal swelling, Throat irritation
Clinical narrative: After receiving vaccine about 30 minutes, she felt dizzy.  45-50 minutes after receiving vaccine she felt itchy throat, cough, and swollen throat *Treatment: 50 mg of benadryl, 1 pen of Epipen 0.3 mg. Called EMS
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Disturbance in attention, Dizziness, Dysstasia
Clinical narrative: Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and legs, numbness hands and feet,   hands and feet became ice cold, headache,  joint pain, muscle spasms, feeling drunk and dizzy, loss of consciousness 3x (reported by friend).  confusion, inability to focus and complete thoughts and sentences.  911 called  @12:04 PM by friend.  At time of paramedics evaluation BP 175\100, O2 SAT 100%,  loss of consciousness 2x(reported by friend)  before being transported to University of Alabama at Birmingham (UAB) ER.   No treatment except basic vitals taken,  Held in waiting area for several hours then basic eval by ER doctor (unknown name) asked to attempt to stand, could not.  Moved to ER room for couple hours, second eval by nurse to see of i could stand, had difficulty standing, asked to walk, shuffled feet to move and notified that i could go home
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling drunk, Gait disturbance, Headache, Hypoaesthesia, Loss of consciousness
Clinical narrative: Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and legs, numbness hands and feet,   hands and feet became ice cold, headache,  joint pain, muscle spasms, feeling drunk and dizzy, loss of consciousness 3x (reported by friend).  confusion, inability to focus and complete thoughts and sentences.  911 called  @12:04 PM by friend.  At time of paramedics evaluation BP 175\100, O2 SAT 100%,  loss of consciousness 2x(reported by friend)  before being transported to University of Alabama at Birmingham (UAB) ER.   No treatment except basic vitals taken,  Held in waiting area for several hours then basic eval by ER doctor (unknown name) asked to attempt to stand, could not.  Moved to ER room for couple hours, second eval by nurse to see of i could stand, had difficulty standing, asked to walk, shuffled feet to move and notified that i could go home
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Paraesthesia, Peripheral coldness, Sensory loss
Clinical narrative: Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and legs, numbness hands and feet,   hands and feet became ice cold, headache,  joint pain, muscle spasms, feeling drunk and dizzy, loss of consciousness 3x (reported by friend).  confusion, inability to focus and complete thoughts and sentences.  911 called  @12:04 PM by friend.  At time of paramedics evaluation BP 175\100, O2 SAT 100%,  loss of consciousness 2x(reported by friend)  before being transported to University of Alabama at Birmingham (UAB) ER.   No treatment except basic vitals taken,  Held in waiting area for several hours then basic eval by ER doctor (unknown name) asked to attempt to stand, could not.  Moved to ER room for couple hours, second eval by nurse to see of i could stand, had difficulty standing, asked to walk, shuffled feet to move and notified that i could go home
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Sensation of foreign body, Throat irritation
Clinical narrative: 12:15pm: c/o itching in throat BP: 102/60 P: 68 O2: 100% No rash or other sxs Benadryl 25mg 1 PO given 12:45pm: itching of throat, (L) chin itchiness, small red bumps on (L) side of face forming No SOB BP: 122/80, P: 72 Benadryl 125mg 1 PO given 1:00pm itching of throat, lump in throat, decreased face itching decreased bumps 1:15pm decreased sxs overall BP: 118/62 let got home, ok to drive
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pain, redness and swelling in the injection site, also reporting rash for 3 days and now it has not gone away.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: Pain, redness and swelling in the injection site, also reporting rash for 3 days and now it has not gone away.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: developed systemic hives and itching approx 15 minutes after receiving first dose vaccine
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Full blood count, Metabolic function test, Migraine, SARS-CoV-2 test
Clinical narrative: Severe migraine x10+ days
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Flushing, Injection site erythema
Clinical narrative: Cheeks & forehead flushed. Inj. site with mild erythema. Mom instructed to apply cool compresses & give Benadryl 6 hrs x 3days if itching. May give OTC Motrin/Tylenol x 48 hrs. RTC to ER if gets distressed
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out in office while waiting 15min after shots.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: developed fever 101.0, body ache, fatigue at 0400 1/7, relieved with Tylenol. symptoms improved slightly by 1/8 to mild body ache, fatigue and temp 100.0
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Reported temp.101F Resolved with Tylenol (99.9F)
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Respiratory symptom
Clinical narrative: I received vaccine at 2:50 pm on Wednesday January 6th. I felt upper respiratory symptoms around 3:30 pm the same day. By the second day, I felt the pain in my back. On a scale of 1-10 the pain level has been at a consistent 6.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram, Paraesthesia oral
Clinical narrative: Tingling lips 1100am, mild chest tightening 1115am
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Pt felt very anxious, states initial dizziness that resolved in 30 minutes.  Onset was 15 minutes after vaccination. PT monitored, VS at released from observation area were normal for this patient.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Myalgia, Product administered at inappropriate site, Tearfulness
Clinical narrative: Patient reports left pectoral pain. Patient suspects the injection was given a little higher than it should have been. She has limited ROM of her left shoulder and is tearful during exam. Normal ROM of neck.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Wife called and stated that her husband received the Pfizer vaccine on 01/06/2021 at 4pm and since receiving vaccine has been experiencing possible side effects. Wife states that patient has been excessively throwing up and having diarrhea. Wife has been encouraging husband to go to E.R. or seek medical attention, but he is refusing.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Injection site rash, Injection site urticaria, Ocular hyperaemia, Pruritus
Clinical narrative: swelling and redness around both eyes, rash/hives on left arm, upper chest and abdomid I was given an oral steriod (unknown) given a pepcid, and perscriptions for pepcid, benedryl, and calamine lotion eye swelling was partially reduced, itching could be controled wit benedryl and calamine, as of today 1/8/2021 I still have some redness and swelling around the eyes and also still have the hives and itching
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: swelling and redness around both eyes, rash/hives on left arm, upper chest and abdomid I was given an oral steriod (unknown) given a pepcid, and perscriptions for pepcid, benedryl, and calamine lotion eye swelling was partially reduced, itching could be controled wit benedryl and calamine, as of today 1/8/2021 I still have some redness and swelling around the eyes and also still have the hives and itching
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Posture abnormal
Clinical narrative: Pt. felt dizzy and lightheaded and slumped out of observation chair.  Pt. was arousable, but sluggish in response.  No SOB, LOC, or rashes noted.  Pt. placed supine in trendelenberg position.  Paramedics arrived @ 0853 and transport to hospital was declined by pt.  Pt. continued to be observed and stated she felt 100% better and called lyft to drive her home @  0925.  Pt. was advised to call an acquaintance to drive her home but she was unable to find anyone and chose to call lyft.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Heart rate increased, Hyperventilation
Clinical narrative: dizziness, labored breathing, hyperventilation, increased pulse and blood pressure, O2 sat of 80% briefly passing out. O2 applied per nasal cannula.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: dizziness, labored breathing, hyperventilation, increased pulse and blood pressure, O2 sat of 80% briefly passing out. O2 applied per nasal cannula.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs reported; Varivax was administered during temperature excursion; Information has been received from a nurse concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 28-DEC-2020, the patient was vaccinated with a temperature excursion (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot No. T014309, exp. date 24-APR-2022) (route of administration not reported) for prophylaxis. No adverse evenst reported.  Temperature: 12F Time frame: 30 minutes Previous temperature excursion: No Call because of data logger.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no additional AE; expired MMR-II vaccine was given; This spontaneous report was received from a registered nurse and refers to a 12-month-old, male patient (reported also as a child). His medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 05-JAN-2021, also reported as "today", the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), rHa, 0.5 ml, lot # R028004 (valid lot #), expiration date reported and validated as 01-OCT-2020 (strength, route of administration and anatomical location were not provided) for prophylaxis (expired vaccine used). The nurse was calling to inquire about revaccination or if it was supported. There was no previous temperature excursion reported (no mention about the data logger). No additional adverse event (AE) was reported (no adverse event).
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 57-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 57-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any accompanied AE.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Urticaria
Clinical narrative: he dust that landed on his face caused hives; feeling flushed; started feeling itchy about 2 hours post vaccine; This is a spontaneous report from a contactable nurse.  A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, intramuscular from 23Dec2020 11:00 at a single dose for COVID-19 immunization.  Medical history included patient's known allergies: Only grass, pollen, dust mites; and hives all from unspecified dates. Concomitant medication included naproxen sodium (ALEVE) for " itchy", ibuprofen (MOTRIN) and paracetamol (TYLENOL 8 HOUR). The patient got the COVID vaccine on 23Dec2020 at 11:00. He stayed at vaccination location for 30 minutes and then drove to his destination. Upon arrival at 12:00, he started feeling flushed. No shortness of breath or breathing difficulties. He then started feeling itchy about 2 hours post vaccine. He took an Aleve. At home in the evening, took Benadryl with improvement of symptoms. The following day he also took Benadryl. On 25Dec2020 & 26Dec2020, he still had some itching, but not bothersome enough to take medications. On 27Dec2020 he was working cutting tile and wearing protective eye wear, but the dust that landed on his face caused hives. He has been taking Benadryl since. He said that this has occurred in the past when his body was hypersensitive, the hives. He has seasonal allergies but no allergies to food/medications/vaccines. Patient was not diagnosed with COVID-19 and since the vaccination, he has not been tested for COVID-19.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Pain of skin, Sinus pain, Sinusitis
Clinical narrative: pain in the right maxillary sinus, and upper right molars; pain in the right maxillary sinus, and upper right molars; right fronto-parietal scalp tenderness; numbness of right canines; possible sinus infection; headache; This is a spontaneous report from a contactable physician (patient).  A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730) , intramuscular into the left arm on 17Dec2020,at 17:00 as first single dose for covid-19 immunization.  Medical history included known allergy to dairy from an unknown date.  There were no concomitant medications.  The patient experienced pain in the right maxillary sinus, and upper right molars on 20Dec2020, at 06:00 with outcome of recovering; right fronto-parietal scalp tenderness on 20Dec2020, at 06:00 with outcome of recovering; numbness of right canines on 20Dec2020, at 06:00  with outcome of recovering; possible sinus infection on 20Dec2020, at 06:00  with outcome of recovering; headache on 20Dec2020, at 06:00  with outcome of recovering. Details were as follows: described as possible trigeminal neuralgia,  awoke on 20Dec2020, and noted right eye appeared smaller than the left. Also noted, was pain in the right maxillary sinus, and upper right molars. The patient was afebrile. On 21Dec2020, noted onset of right fronto-parietal scalp tenderness along with numbness of right canines. Patient did not have any skin lesions. Therapeutic measures were taken as a result of the events;  began azithromycin and sinus rinse for a possible sinus. Despite treatment, right scalp pain/tenderness, tooth pain numbness of canines persisted and peaked on 26Dec2020. Symptoms subsided but were still present. Acetylsalicylic acid (ASPIRIN) for headache infection was given with improvement. Symptoms appear to be in the right trigeminal dermatome. Patient had never had chicken pox and had been vaccinated. For varicella,  the patient did not have a rash in the affected dermatome; valacyclovir (MANUFACTURER UNKNOWN), has been started. The events were reported as non-serious. The patient was recovering from the events.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: pain in the right maxillary sinus, and upper right molars; pain in the right maxillary sinus, and upper right molars; right fronto-parietal scalp tenderness; numbness of right canines; possible sinus infection; headache; This is a spontaneous report from a contactable physician (patient).  A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730) , intramuscular into the left arm on 17Dec2020,at 17:00 as first single dose for covid-19 immunization.  Medical history included known allergy to dairy from an unknown date.  There were no concomitant medications.  The patient experienced pain in the right maxillary sinus, and upper right molars on 20Dec2020, at 06:00 with outcome of recovering; right fronto-parietal scalp tenderness on 20Dec2020, at 06:00 with outcome of recovering; numbness of right canines on 20Dec2020, at 06:00  with outcome of recovering; possible sinus infection on 20Dec2020, at 06:00  with outcome of recovering; headache on 20Dec2020, at 06:00  with outcome of recovering. Details were as follows: described as possible trigeminal neuralgia,  awoke on 20Dec2020, and noted right eye appeared smaller than the left. Also noted, was pain in the right maxillary sinus, and upper right molars. The patient was afebrile. On 21Dec2020, noted onset of right fronto-parietal scalp tenderness along with numbness of right canines. Patient did not have any skin lesions. Therapeutic measures were taken as a result of the events;  began azithromycin and sinus rinse for a possible sinus. Despite treatment, right scalp pain/tenderness, tooth pain numbness of canines persisted and peaked on 26Dec2020. Symptoms subsided but were still present. Acetylsalicylic acid (ASPIRIN) for headache infection was given with improvement. Symptoms appear to be in the right trigeminal dermatome. Patient had never had chicken pox and had been vaccinated. For varicella,  the patient did not have a rash in the affected dermatome; valacyclovir (MANUFACTURER UNKNOWN), has been started. The events were reported as non-serious. The patient was recovering from the events.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Exposure to SARS-CoV-2, Fatigue, Pyrexia
Clinical narrative: infection of SARS-COV-2; infection of SARS-COV-2; This is a spontaneous report from a contactable healthcare professional.  A 31-year-old male patient started to receive received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0140), intramuscular into the left arm on 18Dec2020, at 10:30 as single dose for covid-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced infection of SARS-COV-2 on 25Dec2020. Details were as follows: The patient received the first dose of the two dose series. On 20Dec2020, he was exposed to COVID-19. Official positive diagnosis of COVID-19  was made on 25Dec2020. Patient had symptoms of fatigue, joint pain and a small fever on an unspecified date, and had been exposed to SARS-COV-2  on 20Dec2020, and the infection on 25Dec2020.  The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 25Dec2020.  The patient was scheduled to receive second dose of the vaccine; he will be out of quarantine around five to six days before that dose. The outcome of infection of SARS-COV-2 was recovering.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: infection of SARS-COV-2; infection of SARS-COV-2; This is a spontaneous report from a contactable healthcare professional.  A 31-year-old male patient started to receive received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0140), intramuscular into the left arm on 18Dec2020, at 10:30 as single dose for covid-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced infection of SARS-COV-2 on 25Dec2020. Details were as follows: The patient received the first dose of the two dose series. On 20Dec2020, he was exposed to COVID-19. Official positive diagnosis of COVID-19  was made on 25Dec2020. Patient had symptoms of fatigue, joint pain and a small fever on an unspecified date, and had been exposed to SARS-COV-2  on 20Dec2020, and the infection on 25Dec2020.  The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 25Dec2020.  The patient was scheduled to receive second dose of the vaccine; he will be out of quarantine around five to six days before that dose. The outcome of infection of SARS-COV-2 was recovering.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Ear swelling, Lip swelling, Pruritus, SARS-CoV-2 antibody test
Clinical narrative: Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; This is a spontaneous report from a contactable Health Care Professional (patient).   A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK572) in the left arm, on 21Dec2020 at 11:30 AM, at single dose, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks and 2 weeks prior to the BNT162B2 vaccine. The patient experienced in the past an allergy due to amoxicillin. On an unspecified date, the patient experienced hives from her head to her toes, intense itching, painful, swollen ears, swollen lip. Emergency room/department or urgent care required. Treatment was received: prednisone 60 mg for 5 days. The patient recovered from the events on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test post vaccination (nasal swab) was performed on 25Dec2020 and the result was negative. The case was assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; This is a spontaneous report from a contactable Health Care Professional (patient).   A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK572) in the left arm, on 21Dec2020 at 11:30 AM, at single dose, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks and 2 weeks prior to the BNT162B2 vaccine. The patient experienced in the past an allergy due to amoxicillin. On an unspecified date, the patient experienced hives from her head to her toes, intense itching, painful, swollen ears, swollen lip. Emergency room/department or urgent care required. Treatment was received: prednisone 60 mg for 5 days. The patient recovered from the events on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test post vaccination (nasal swab) was performed on 25Dec2020 and the result was negative. The case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: recipient of the covid 19 vaccine received a positive antigen test within 10 days of getting the vaccine; recipient of the covid 19 vaccine received a positive antigen test within 10 days of getting the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of 2 reports. A female patient of an unspecified age (Age: 30, Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received a positive antigen test within 10 days of the vaccine and wanted to know if the vaccine could cause a positive antigen test. There was no mention of exposure to a positive person. Outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 antigen test positive and LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020519946 same reporter, drug, and events; different patients
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Headache, Oropharyngeal pain, Paraesthesia oral, Stomatitis
Clinical narrative: left sided mild case of trigeminal neuritis that persisted beyond 48 hrs after vaccination given (symptom-numbness); headache; gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat; lost taste; burning/tingling on tongue; burning/tingling on tongue; This is a spontaneous report from a contactable physician, the patient. A 38-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK5730), intramuscular in the left arm on 28Dec2020 at 12:30 (at the age of 38-years-old) as a single dose for Covid-19 vaccination. edical history included trigeminal neuritis in the past twice, first from herpes simplex virus (HSV1) and second from flu shot a few years ago; acne and recurrent oral HSV 1, all from an unknown date and unknown if ongoing. The patient was allergic to sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included drospirenone, ethinylestradiol (LORYNA) for OCP; prednisone (MANUFACTURER UNKNOWN), short course completed prior to vaccination; beclometasone dipropionate (QNASL); xylometazonline hychrochloride (SUDAFED) which was stopped before vaccination; valaciclovir hydrochloride (VALTREX); ascorbic acid (VITAMIN C) which was stopped before vaccination and multivitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 12:45, the patient experienced left sided mild case of trigeminal neuritis that persisted beyond 48 hours with symptoms of numbness with decreased sensation on lateral part of V2 trigeminal nerve which started 10-15 mins after vaccination with small spot corner of mouth on left and involved lateral part of entire left side of face from corner of left eye down within 1-2 hours after received vaccine. The patient also experienced headache, borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth, at 12-14 hours after getting vaccine on 28Dec2020; got burning/tingling on tongue and then lost taste 100% for about 1 hour then started to slightly come back-and waxed and waned until later that evening and most was back to normal except sweet taste still gone. The events resulted in a doctor or other healthcare professional office visit. Therapeutic measures were taken for all of the events which included antihistamines and valaciclovir; and for the trigeminal neuritis only, methylprednisolone pack. The clinical outcome of the event trigeminal neuritis was recovering (lasted longer than 48 hours after vaccination); for headache, stomatitis, throat irritation, oropharyngeal pain, ageusia, tongue discomfort and paraesthesia oral was recovered (at 48 hours after vaccination).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tongue discomfort, Trigeminal neuritis
Clinical narrative: left sided mild case of trigeminal neuritis that persisted beyond 48 hrs after vaccination given (symptom-numbness); headache; gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat; lost taste; burning/tingling on tongue; burning/tingling on tongue; This is a spontaneous report from a contactable physician, the patient. A 38-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK5730), intramuscular in the left arm on 28Dec2020 at 12:30 (at the age of 38-years-old) as a single dose for Covid-19 vaccination. edical history included trigeminal neuritis in the past twice, first from herpes simplex virus (HSV1) and second from flu shot a few years ago; acne and recurrent oral HSV 1, all from an unknown date and unknown if ongoing. The patient was allergic to sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included drospirenone, ethinylestradiol (LORYNA) for OCP; prednisone (MANUFACTURER UNKNOWN), short course completed prior to vaccination; beclometasone dipropionate (QNASL); xylometazonline hychrochloride (SUDAFED) which was stopped before vaccination; valaciclovir hydrochloride (VALTREX); ascorbic acid (VITAMIN C) which was stopped before vaccination and multivitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 12:45, the patient experienced left sided mild case of trigeminal neuritis that persisted beyond 48 hours with symptoms of numbness with decreased sensation on lateral part of V2 trigeminal nerve which started 10-15 mins after vaccination with small spot corner of mouth on left and involved lateral part of entire left side of face from corner of left eye down within 1-2 hours after received vaccine. The patient also experienced headache, borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth, at 12-14 hours after getting vaccine on 28Dec2020; got burning/tingling on tongue and then lost taste 100% for about 1 hour then started to slightly come back-and waxed and waned until later that evening and most was back to normal except sweet taste still gone. The events resulted in a doctor or other healthcare professional office visit. Therapeutic measures were taken for all of the events which included antihistamines and valaciclovir; and for the trigeminal neuritis only, methylprednisolone pack. The clinical outcome of the event trigeminal neuritis was recovering (lasted longer than 48 hours after vaccination); for headache, stomatitis, throat irritation, oropharyngeal pain, ageusia, tongue discomfort and paraesthesia oral was recovered (at 48 hours after vaccination).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hot flush, Hyperhidrosis, Nausea
Clinical narrative: Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse.  A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Presyncope, Vision blurred
Clinical narrative: Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse.  A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; This is a spontaneous report from a contactable nurse.  A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in right arm, on 18Dec2020 at 09:00 ( at the age of 40 years-old) as a single dose for COVID-19 immunization. The patient was administered the vaccine at a hospital. Medical history was not reported. Prior to the vaccination the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On approximately 25Dec2020 (reported as one week after vaccination on 18Dec2020), the patient experienced hives and itchy rash. The patient was not hospitalized for the events but received treatment  with  diphenhydramine (BENADRYL), loratadine (CLARITIN) and generic loratadine. clinical outcome of hives and itchy rash was not recovered: the patient reported that the hives and itchy rash continued despite multiple doses of BENADRYL, CLARITIN, and loratadine. Since the vaccination, the patient has not been tested for COVID-19.     Information on lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuropathy peripheral
Clinical narrative: neuropathy/ started acutely in feet bilaterally / persist intermittently in left extremities; One-time episode of upper extremity (UE) numbness; This is a spontaneous report from a contactable health care professional (patient). A 40-year-old female patient (not pregnant) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown) at single dose via an unknown route at left arm on 26Dec2020 for Covid-19 immunization. COVID-19 vaccine was administered in Pharmacy or Drug Store. Medical history was reported as "none". Patient had no COVID prior vaccination, further reported as patient was not diagnosed with COVID-19 prior to vaccination. No known medications, food, or other products allergies. Concomitant drugs (Other-medications-in-two weeks) included levocabastine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL) as needed, ibuprofen (MOTRIN), and multivitamin. No other-vaccine-in-four weeks received.  Patient experienced adverse-event of neuropathy, which started acutely in feet bilaterally and now (as of 02Jan2021) persist intermittently in left extremities (LEs). One-time episode of upper extremity (UE) numbness. No weakness. Patient inquired if 2nd dose should be held. Adverse-event-start-date was 26Dec2020. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received. The event was reported as non-serious. Since the vaccination, patient had not been tested for COVID-19. Outcome of the event was not resolved.    Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of peripheral neuropathy and upper extremity (UE) numbness  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and nerve conduction tests, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Right supraclavicular lymphadenopathy; This is a spontaneous report from a contactable physician reporting for herself. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: not provided), via intramuscular route of administration in the right arm, on 30-DEC-2020 at 11:30 AM (at the age of 29 years old) as a single dose for COVID-19 vaccination. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced right supraclavicular lymphadenopathy - five freely mobile lymph nodes, tender to palpation, roughly 1 cm in size. The patient did not receive treatment for the event right supraclavicular lymphadenopathy. The outcome of the event right supraclavicular lymphadenopathy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Flushing, Paraesthesia
Clinical narrative: Became extremely flushed; tingling in hands and feet; disorientation; This is a spontaneous report from a non-contactable nurse (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date unknown), via intramuscular route of administration, on 28Dec2020 (at the age of 34 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included Gastrooesophageal reflux disease (GERD), Attention deficit hyperactivity disorder (ADD), Generalised anxiety disorder (GAD). The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole sodium (NEXIUM), venlafaxine hydrochloride (EFFEXOR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, at 09:00 PM, the patient became extremely flushed, tingling in hands and feet, disorientation. Treatment was received for the events became extremely flushed, tingling in hands and feet, disorientation included Diphenhydramine 50mg @2200 and again at 0200. The outcome of the events became extremely flushed, tingling in hands and feet, disorientation was recovered on unknown date. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  extremely flushed, tingling in hands and feet and disorientation due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including  chemistry panel and Head CT/MRI, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.