chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Had a horrible reaction / Admitted to the hospital 3 times with tachycardia; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tachycardia (serious criteria hospitalization). On an unknown date, the outcome of the tachycardia was recovered/resolved.   It was unknown if the reporter considered the tachycardia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient took the two vaccine series a year ago from date of reporting and had a horrible reaction. She was admitted to the hospital 3 times with tachycardia.  Emergency room visit required. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cardiac murmur, Chest discomfort, Electrocardiogram, Vision blurred
Clinical narrative: Heart murmur; Increase in her blood pressure 190/105; Tightness in chest when breathing; Blurry vision; A spontaneous report was received concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an increase in blood pressure 190/105, blurry vision, tightness in the chest when breathing and a heart murmur.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately 30 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient received the Moderna vaccine and after 30 minutes, she experienced an increase in her blood pressure (190/105), blurry vision and tightness in the chest when breathing. She remained at the site for an hour for observation and then was brought to the urgent care. An electrocardiogram (EKG) was performed and treatment included oral lisinopril. She was sent home, and she also stated that she had a heart murmur.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, increase in blood pressure 190/105, blurry vision, tightness in the chest when breathing, and a heart murmur, were not reported.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of blood pressure increased, and non-serious unexpected event of chest discomfort, vision blurred, and cardiac murmur. The events occurred 1 day (15 min) after first dose of mRNA-1273, lot # 037K20A. Treatment included lisinopril. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Computerised tomogram abnormal, Cough, Dyspnoea
Clinical narrative: Bronchitis; COVID-19; A spontaneous report was received from a consumer concerning a 63-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and bronchitis.     The patient's medical history, as provided by the reporter, included asthma and unspecified allergies. Concomitant product use included unspecified allergy medication and asthma/bronchitis inhalers.   On 02 Jan 2021, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient experienced coughing, wheezing, shortness of breath, headache, and sinus congestion. The patient tested positive for COVID-19. The patient was taken to the hospital where he was treated with an infusion.  On an unspecified date, a computed tomography scan showed bronchitis. Additional treatment for the events included unspecified antibiotics and steroids.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events COVID-19 and bronchitis was unknown.; Reporter's Comments: This spontaneous report concerns a 63-year-old male patient who experienced the serious events of COVID-19 and bronchitis. The event occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). Treatment administered included antibiotics and steroids. Outcome was unknown. Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported events and mRNA-1273 vaccine administration.  Critical details such as diagnostic test for COVID infection prior to vaccination was not ascertained. Causality is also confounded by the patient's advanced age.  Main field defaults to possibly related'
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test positive, Sinus congestion, Wheezing
Clinical narrative: Bronchitis; COVID-19; A spontaneous report was received from a consumer concerning a 63-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and bronchitis.     The patient's medical history, as provided by the reporter, included asthma and unspecified allergies. Concomitant product use included unspecified allergy medication and asthma/bronchitis inhalers.   On 02 Jan 2021, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient experienced coughing, wheezing, shortness of breath, headache, and sinus congestion. The patient tested positive for COVID-19. The patient was taken to the hospital where he was treated with an infusion.  On an unspecified date, a computed tomography scan showed bronchitis. Additional treatment for the events included unspecified antibiotics and steroids.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events COVID-19 and bronchitis was unknown.; Reporter's Comments: This spontaneous report concerns a 63-year-old male patient who experienced the serious events of COVID-19 and bronchitis. The event occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). Treatment administered included antibiotics and steroids. Outcome was unknown. Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported events and mRNA-1273 vaccine administration.  Critical details such as diagnostic test for COVID infection prior to vaccination was not ascertained. Causality is also confounded by the patient's advanced age.  Main field defaults to possibly related'
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Fall, Lethargy, Muscular weakness
Clinical narrative: Fainted; Disoriented and didn't know what was happening; Feels a little dizzy; Lethargy; Tenderness in the arm; A spontaneous report was received from a consumer who was a 36-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and feels a little dizzy.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 25L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the evening of 14 Jan 2021, the patient had tenderness in the arm and felt lethargic.   On 15 Jan 2021, the patient fainted when he woke up in the morning. The patient's legs gave out and he fell into the wall. The patient was disoriented and didn't know what was happening. The patient reported the event as happening pretty quick and described it as "like he had very low blood sugar". The patient reported that sometimes when he gets up too quickly, he feels a little dizzy. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and sometimes when he gets up too quickly, was unknown. The event, feels a little dizzy, was considered not resolved.; Reporter's Comments: This spontaneous report refers to a case of a 36-year-old male patient who experienced events of fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and feels a little dizzy.  The events developed on the following day after the administration of the mRNA-1273 vaccine (Lot # 25L20A, expiration date-unknown). No treatment was reported, and outcome is resolved for dizziness and unknown for all other events.  Based on the information provided which includes a temporal association, a causal association cannot be excluded
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tenderness
Clinical narrative: Fainted; Disoriented and didn't know what was happening; Feels a little dizzy; Lethargy; Tenderness in the arm; A spontaneous report was received from a consumer who was a 36-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and feels a little dizzy.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 25L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the evening of 14 Jan 2021, the patient had tenderness in the arm and felt lethargic.   On 15 Jan 2021, the patient fainted when he woke up in the morning. The patient's legs gave out and he fell into the wall. The patient was disoriented and didn't know what was happening. The patient reported the event as happening pretty quick and described it as "like he had very low blood sugar". The patient reported that sometimes when he gets up too quickly, he feels a little dizzy. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and sometimes when he gets up too quickly, was unknown. The event, feels a little dizzy, was considered not resolved.; Reporter's Comments: This spontaneous report refers to a case of a 36-year-old male patient who experienced events of fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and feels a little dizzy.  The events developed on the following day after the administration of the mRNA-1273 vaccine (Lot # 25L20A, expiration date-unknown). No treatment was reported, and outcome is resolved for dizziness and unknown for all other events.  Based on the information provided which includes a temporal association, a causal association cannot be excluded
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Deviation from the interval between doses; A report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and receiving the second dose 21 days before the recommended 28 days.    The patient's medical history was not provided. No relevant concomitant medications were reported.    The patient received the first of two planned doses of mRNA-1273 on an unspecified date.   On 04 Jan 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.   The reported stated that the patient received the second shot 21 days before the 28 days recommended at the hospital. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns a female patient of unknown age who received the first of two planned doses of mRNA-1273 on an unspecified date and received the second dose 21 days before the recommended 28 days. There were no reported adverse events after the vaccine was administered.
Sex: M
Vaccine: COVID19
Symptoms: Flank pain, Hyperhidrosis, Road traffic accident, Skin warm, Syncope
Clinical narrative: Syncopal episode while driving; Crash; Became extremely warm; Sweaty; Right flank pain; A spontaneous report was received from a nurse concerning her husband, a 53-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced became extremely warm, sweaty, right flank pain, a syncopal episode while driving, and crash.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, approximately two and a half hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient felt fine for approximately two and a half hours after receiving the vaccine, then became extremely warm, sweaty, developed right flank pain, and had a syncopal episode while driving. The nurse mentioned that the patient was not seriously injured in the crash, nor was anyone else. No treatment information was provided. It was also reported that the patient had followed up with his PCP and seen a cardiologist, some diagnostics were scheduled, and plans to see a neurologist.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, became extremely warm, sweaty, developed right flank pain, syncopal episode while driving, and crash, was unknown.; Reporter's Comments: This case concerns a 53-years-old male patient, who experienced serious unexpected events of syncope and non-serious unexpected event of road traffic accident, feeling hot, hyperhidrosis, and flank pain. The events occurred 1 day (approximately 2.5 hours) after first dose of mRNA-1273, lot # unknown. Treatment details not provided. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccinated on the tricepts and it hit a bone; A spontaneous report was received from a consumer who was also a75-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated on the triceps and it hit a bone.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Jan 2021, the patient felt like the vaccine was not administered correctly. He was vaccinated on the triceps, and it hit a bone.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccinated on the triceps and it hit a bone, was resolved on 25 Jan 2021.; Reporter's Comments: This case concerns a75-years-old male patient who received his first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. and was vaccinated on the triceps and it hit a bone. There were no reported adverse events at the associated with the event of vaccinated on the triceps and it hit a bone.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: second dose of the Pfizer vaccine on 06Jan2021/had an antibody test performed on 14Jan. The results were negative; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization on an unknown date. Patient received the second dose of the Pfizer vaccine on 06Jan2021 (also reported as 06Jan2020) and had an antibody test performed on 14Jan2021. The results were negative for the presence of IGG. Patient asked if this was "normal" and if not, does it mean he do not have protection against SARS COV2. Patient was not immunocompromised nor was taking any immunosuppressive medications.  The outcome of the event antibody test/negative was unknown.   Information on lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 14Jan2021 at 09:00 at a single dose in the hospital for COVID-19 immunization. Medical history included autoimmunity of unknown origin and seafood allergy. The patient is not pregnant at the time of vaccination. Concomitant medication included folic acid, methotrexate, multivitamins (vitamins nos), and fluoxetine hydrochloride (PROZAC). The patient experienced injection site soreness, tiredness, muscle pain, feeling unwell for 30 hours on 14Jan2021 at 12:00. The patient did not receive treatment for the events. Outcome of the events was recovered on 15Jan2021.  Information on batch/lot number was requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Influenza like illness, Oxygen consumption
Clinical narrative: Heart rate from 105 to 120; chills felt like flu; oxygen turned up from 2L to 4L went; chills felt like flu; This is a spontaneous report from a contactable consumer (reporting for himself) from the Pfizer sponsored program.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  Medical history included: chronic obstructive pulmonary disease (COPD) and lung function 37%. The patients concomitant medications were not reported.  On an unspecified date, the patient experienced heart rate from 105 to 120, chills felt like flu and oxygen turned up from 2 liters (L) to 4 L went.  About 3 and a 1/2 days after the vaccination, the patients heart rate was from 105 to 120 and chills felt like flu no fever, so his oxygen was turned up from 2L to 4L.  He went through that for six hours and decided it might be COVID.  The patient took 12mg of Ivermectin (MANUFACTURER UNKNOWN), 10 mg of melatonin (MANUFACTURER UNKNOWN) and alprazolam (XANAX) went to bed and was good 12 hours later. The patient also reported that budesonide formoterol fumarate (SYMBICORT) caused him to be tachy.  The patient underwent lab tests and procedures which included heart rate: 105 to 120 on an unspecified date. Therapeutic measures were taken as a result of the events as aforementioned.  The outcome of the events was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Lymphadenopathy, Nausea
Clinical narrative: Throat was itching and felt very full; Throat was itching and felt very full; hives on arm; hot sweats; Extreme fatigue; lymphadenopathy in armpit and injection site; lymphadenopathy in armpit and injection site; headache; body aches; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 14Jan2021 09:45 at single dose for COVID-19 immunisation. Medical history included seasonal allergies and depression. 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. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the left arm on 24Dec2020 12:00 at single dose for COVID-19 immunisation. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC) and a birth control pill (unspecified). It was reported that 10 minutes after the second dose, on 14Jan2021 09:55, the patient's throat was itching and felt very full, hives on arm, hot sweats, which went away with Benadryl. The patient also experienced extreme fatigue, lymphadenopathy in armpit and injection site, headache, body aches, and nausea. Therapeutice measures were taken as a result of the events. Clinical outcome of the events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Throat irritation, Throat tightness, Urticaria, Vaccination site lymphadenopathy
Clinical narrative: Throat was itching and felt very full; Throat was itching and felt very full; hives on arm; hot sweats; Extreme fatigue; lymphadenopathy in armpit and injection site; lymphadenopathy in armpit and injection site; headache; body aches; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 14Jan2021 09:45 at single dose for COVID-19 immunisation. Medical history included seasonal allergies and depression. 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. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the left arm on 24Dec2020 12:00 at single dose for COVID-19 immunisation. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC) and a birth control pill (unspecified). It was reported that 10 minutes after the second dose, on 14Jan2021 09:55, the patient's throat was itching and felt very full, hives on arm, hot sweats, which went away with Benadryl. The patient also experienced extreme fatigue, lymphadenopathy in armpit and injection site, headache, body aches, and nausea. Therapeutice measures were taken as a result of the events. Clinical outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: swollen supraclavicular lymph nodes/axillary lymph node swelling; first dose of BNT162B2; on 26Dec2020 11:00 AM/second dose of BNT162B2; on 14Jan2021 11:00 AM; This is a spontaneous report from a contactable Nurse (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the left arm on 14Jan2021 11:00 AM at single dose for Covid-19 immunization in a hospital. Medical history was not reported. The patient has no COVID prior vaccination. The patient was not pregnant. Concomitant medications was none. The patient previously took vancomycin and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular at the left arm on 26Dec2020 11:00 AM at single dose for Covid-19 immunization. The patient has no other vaccine in four weeks. On 15Jan2021 11:00 AM, the patient experienced swollen supraclavicular lymph nodes approximately 24 hours after 2nd shot, some very minor axillary lymph node swelling both on left side, shot arm. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the event. The event swollen supraclavicular lymph nodes/axillary lymph node swelling was recovering.  Follow-up activities are possible, information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Peripheral swelling, Skin discolouration
Clinical narrative: inflammation; swelling of his toes; toes are starting to turn purple; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had been experiencing "weird side effects" which included inflammation and swelling of his toes on an unspecified date in Jan2021. He said his toes were starting to turn purple and when he went for a health visit, he was told that it was "Covid toe". He wanted to know if there have been reports regarding "weird side effects" like his. The reporter assessed the events as non-serious. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Swollen lymph nodes in his right armpit; swelling in the lymph node in the armpit, the lymph nodes in the site of injection; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right arm, first dose on 22Dec2020, and second dose on 12Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was reporting the side effect after taking the two doses and wanted to know if this is normal. The patient received both doses of the COVID-19 vaccine (22Dec2020 and 12Jan2021) and had swollen lymph nodes in his right armpit on an unspecified date, the same arm he received both doses of vaccine in. The patient's lymph nodes were swelling where he got injected with the vaccine, specifically his right arm. The patient had swelling in the lymph node, his lymph node in the armpit in the same side (in the right arm) is swelling, the lymph nodes in the site of injection. The patient's concern is that is that something he may expect from the vaccine. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: dizziness; blurred vision; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received first dose bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 14Jan2021 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 16Jan2021, the patient experienced dizziness and blurred vision. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Dizziness, Headache, Pain
Clinical narrative: lightheadedness; Fever 100.2; body aches; Headache; Upset stomach; This is a spontaneous report from a contactable other health professional (patient).  A 59-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL1284), in a hospital intramuscularly on 13Jan2021 at 09:45 at 59-years-old at a single dose for COVID-19 immunization.  Medical history included sarcoidosis from 2006 to an unknown date, breast cancer from 2006 to an unknown date, depression from an unknown date and unknown if ongoing, migraines from an unknown date and unknown if ongoing, reflux from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing.  Concomitant medications included krill oil (MANUFACTURER UNKNOWN), colecalciferol (D3), zinc (MANUFACTURER UNKNOWN), chondroitin sulfate, glucosamine sulfate (MANUFACTURER UNKNOWN), gemfibrozil (MANUFACTURER UNKNOWN) , omeprazol [omeprazole] (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), almotriptan malate (MANUFACTURER UNKNOWN), acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), albuterol [salbutamol] (MANUFACTURER UNKNOWN), prednisone (MANUFACTURER UNKNOWN), senior vitamin (MANUFACTURER UNKNOWN), "tension migraine" (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unspecified date to an unspecified date; "meticore" (MANUFACTURER UNKNOWN) taken for weight loss from an unspecified date to an unspecified date .  The patient previously took nystatin (MANUFACTURER UNKNOWN), cefalexin (KEFLEX), hydrocodone bitartrate paracetamol (VICODIN), LEVOFLOXACIN (LEVAQUIN) and experienced drug allergy from an unspecified date to an unspecified date. The patient previously received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose at 10:00, intramuscularly in the right arm-Lot Number EL1284) for COVID-19 immunization on 22Dec2020 at 59-years-old. On 16Jan2021 at 11:15, the patient experienced: lightheadedness, fever 100.2, body aches, headache, upset stomach. There was no treatment received. The patient underwent lab tests and procedures which included body temperature: 100.2 on 16Jan2021.  The clinical outcome of the events was recovered in Jan2021. The patient did not receive another vaccine within four weeks of the bnt162b2. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lightheadedness; Fever 100.2; body aches; Headache; Upset stomach; This is a spontaneous report from a contactable other health professional (patient).  A 59-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL1284), in a hospital intramuscularly on 13Jan2021 at 09:45 at 59-years-old at a single dose for COVID-19 immunization.  Medical history included sarcoidosis from 2006 to an unknown date, breast cancer from 2006 to an unknown date, depression from an unknown date and unknown if ongoing, migraines from an unknown date and unknown if ongoing, reflux from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing.  Concomitant medications included krill oil (MANUFACTURER UNKNOWN), colecalciferol (D3), zinc (MANUFACTURER UNKNOWN), chondroitin sulfate, glucosamine sulfate (MANUFACTURER UNKNOWN), gemfibrozil (MANUFACTURER UNKNOWN) , omeprazol [omeprazole] (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), almotriptan malate (MANUFACTURER UNKNOWN), acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), albuterol [salbutamol] (MANUFACTURER UNKNOWN), prednisone (MANUFACTURER UNKNOWN), senior vitamin (MANUFACTURER UNKNOWN), "tension migraine" (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unspecified date to an unspecified date; "meticore" (MANUFACTURER UNKNOWN) taken for weight loss from an unspecified date to an unspecified date .  The patient previously took nystatin (MANUFACTURER UNKNOWN), cefalexin (KEFLEX), hydrocodone bitartrate paracetamol (VICODIN), LEVOFLOXACIN (LEVAQUIN) and experienced drug allergy from an unspecified date to an unspecified date. The patient previously received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose at 10:00, intramuscularly in the right arm-Lot Number EL1284) for COVID-19 immunization on 22Dec2020 at 59-years-old. On 16Jan2021 at 11:15, the patient experienced: lightheadedness, fever 100.2, body aches, headache, upset stomach. There was no treatment received. The patient underwent lab tests and procedures which included body temperature: 100.2 on 16Jan2021.  The clinical outcome of the events was recovered in Jan2021. The patient did not receive another vaccine within four weeks of the bnt162b2. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Lethargy, Nasal congestion, Oropharyngeal pain
Clinical narrative: increased congestion; fatigue; sore throat; congestion; extreme Lethargy; Arm pain; This is a spontaneous report from a non-contactable healthcare professional, the patient.  A 38-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Jan2021 at 10:15 as a single dose for COVID-19 immunization.   Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included ethinylestradiol,/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE).  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the influenza vaccine (FLU VACCINE) on an unknown date for immunization and experienced drug allergy. The patient experienced arm pain on 14Jan2021, extreme lethargy on 15Jan2021, congestion on 16Jan2021, sore throat on 16Jan2021, increased congestion on 17Jan2021, and fatigue on 17Jan2021.  On 14Jan2021, the patient had a COVID-19 nasal swab which was negative. The patient did not receive any treatment for the events. The clinical outcomes of the arm pain, extreme lethargy, congestion, sore throat, increased congestion, and fatigue were recovering.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: increased congestion; fatigue; sore throat; congestion; extreme Lethargy; Arm pain; This is a spontaneous report from a non-contactable healthcare professional, the patient.  A 38-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Jan2021 at 10:15 as a single dose for COVID-19 immunization.   Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included ethinylestradiol,/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE).  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the influenza vaccine (FLU VACCINE) on an unknown date for immunization and experienced drug allergy. The patient experienced arm pain on 14Jan2021, extreme lethargy on 15Jan2021, congestion on 16Jan2021, sore throat on 16Jan2021, increased congestion on 17Jan2021, and fatigue on 17Jan2021.  On 14Jan2021, the patient had a COVID-19 nasal swab which was negative. The patient did not receive any treatment for the events. The clinical outcomes of the arm pain, extreme lethargy, congestion, sore throat, increased congestion, and fatigue were recovering.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect from a contactable healthcare professional. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient tested positive for COVID on 17Jan2021.  The patient underwent lab tests and procedures which included a positive COVID  test on 17Jan2021.  The outcome of tested positive for COVID was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the information provided, the positive COVID-19 test is unlikely related to suspect BNT162B2 administration. The available injection date and detailed clinical course would be helpful for further assessment.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Limb mass, Tenderness
Clinical narrative: tennis ball size lump under left arm, only tender; tennis ball size lump under left arm, only tender; This is a spontaneous report from a contactable other hcp (patient). A 57-year-old male patient received first dose of BNT162B2 (lot number: EK9231), intramuscular on 16Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin and environmental. Concomitant medication included allopurinol. The patient experienced tennis ball size lump under left arm, only tender on 17Jan2021 23:00. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: my joints that are affected, my legs and from groin down to my toes; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 21Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). This female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Jan2021, the patient was experiencing side effects. She stated that her husband will have to take her to the emergency room tomorrow if it stays the same. It's her joints that are affected, her legs and from groin down to her toes. This happened shortly after she received the vaccine, it happened around 2 days later. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vein discolouration
Clinical narrative: blue line from where her injection site was going up toward her throat/it looked like a vein; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; expiration unspecified), via an unspecified route of administration on 15Jan2021 09:00 at single dose (left arm) for COVID-19 immunization. The patient had no medical history and no concomitant medications. On 18Jan2021, the patient noticed this morning when she took off the band aid, she has blue line from where her injection site was going up toward her throat. Patient stated that it looked like a vein, but she does not have one on the other side.  The patient wonders if this was a normal side effect or something to be concerned about. Outcome of event was not recovered.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: developed non-resolving significant tinnitus after his second Pfizer Covid on 13Jan; site injection pain; headache; muscle pain; joint pain; nausea without vomiting; fatigue; This is a spontaneous report from a contactable nurse (patient). A 51-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot No. EK9231), via an unspecified route of administration at site of left deltoid on 13Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he had developed non-resolving significant tinnitus after his second Pfizer Covid on 13Jan, sudden onset tinnitus at 11:30am. Stated that he had other symptoms that resolved. Stated that on Friday that the tinnitus was continuing. The other symptoms that resolved were site injection pain, headache, myalgia, muscle and joint pain, queasy stomach, nausea without vomiting and fatigue on 13Jan2021. Stated they were more severe the first day and resolved by Friday night. Stated that the was fine Saturday morning. Stated that they all had acute onset. The outcome of event tinnitus was not recovered. The outcome of rest events was recovered in Jan2021  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: developed non-resolving significant tinnitus after his second Pfizer Covid on 13Jan; site injection pain; headache; muscle pain; joint pain; nausea without vomiting; fatigue; This is a spontaneous report from a contactable nurse (patient). A 51-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot No. EK9231), via an unspecified route of administration at site of left deltoid on 13Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he had developed non-resolving significant tinnitus after his second Pfizer Covid on 13Jan, sudden onset tinnitus at 11:30am. Stated that he had other symptoms that resolved. Stated that on Friday that the tinnitus was continuing. The other symptoms that resolved were site injection pain, headache, myalgia, muscle and joint pain, queasy stomach, nausea without vomiting and fatigue on 13Jan2021. Stated they were more severe the first day and resolved by Friday night. Stated that the was fine Saturday morning. Stated that they all had acute onset. The outcome of event tinnitus was not recovered. The outcome of rest events was recovered in Jan2021  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Palpitations
Clinical narrative: Pounding heart rate; rapid heart rate like it was pounding out of her chest; Felt faint; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), intramuscular in left arm, on 15Jan2021 at 14:15, at 0.3 mL, single, for COVID-19 immunization. The patient's medical history included attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications included amfetamine aspartate monohydrate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (MYDAYIS), buspirone hydrochloride (BUSPAR), and ethinylestradiol/ norethisterone acetate (MICROGESTIN). The patient previously took cefotaxime sodium (OMNICEF) and amoxicillin sodium/clavulanate potassium (AUGMENTIN) and experienced allergies to both drugs. The patient worked on a COVID-19 study. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 18Jan2021 at 03:00 AM, the patient had a pounding heart rate beginning two days after vaccination and had felt faint. The patient received her first dose on Friday and then last night (3 AM; also reported as 2-3 AM) she started having rapid heart rate like it was pounding out of her chest. It woke her up in the middle of the night around 2-3 AM so it was this morning around 2-3 AM. The patient can still feel like her heart is pounding out of her chest, but it is improved a little bit since it began. It is a little better now but is still persistent. No treatment was given for the adverse events. The patient was not sure if that is something that has been reported before. She did not know what to do but she wanted to try to find out if it was because of the vaccine. The patient did report it online already, she did the event reporting, but she would be happy answer more questions. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore arm; Fever up to 101 degrees Fahrenheit; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK4176), via an unspecified route of administration in left arm, on 12Jan2021 at 12:15 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included colecalciferol (VITAMIN D). The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 21Dec2020 at 09:15 AM for COVID-19 immunization (left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 13Jan2021 at 05:00 AM, the patient experienced sore arm, fever up to 101 degrees Fahrenheit (F), and headache. No treatment was administered for the events. The patient underwent COVID-19 nasal swab test that was negative on 07Jan2021. The patient recovered from the events in Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: was asymptomatic but has received a positive test result since receiving the 1st dose of vaccine; was asymptomatic but has received a positive test result since receiving the 1st dose of vaccine; This is a spontaneous report from a contactable Other-HCP.   An HCP patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was asymptomatic but has received a positive test result since receiving the 1st dose of vaccine. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive. The outcome of event was unknown. The reporter queried whether the second vaccine doses have to be administered on the 21st day after the first dose, or whether there is a window of time in which it can be administered. The reporter queried whether this patient can continue with the normal vaccination schedule, or do they need to delay their second shot.   Information on the batch number/lot number has been requested.; Sender's Comments: There is no available injection date of vaccine BNT162B2 or event onset date. Based on the information provided, the Company considers that the asymptomatic carrier with positive COVID-19 is unlikely related to suspect BNT162B2 administration.