chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth, Pain
Clinical narrative: Pain at injection site; Redness at injection site; Swelling at injection site; Warmth at injection site; Continued pain at injection site described as adhesion muscle pain; Continued pain at injection site since vaccination; A 52 year old female patient received MassBiologic's Td Vaccine (Lot # A112A) via IM in her deltoid muscle on 11/07/2019 at Care Center. The patient indicated she immediately experienced pain, redness, swelling, and warmth at the injection site after receiving the Td product and experienced worsening pain  in her muscle at the injection site. The patient initially went to her primary care physician (PCP) for treatment, however the PCP was unable to provide satisfactory treatment for the worsening pain, so the patient sought treatment from her husband since he is a chiropractor. The patient indicated that all adverse events had resolved shortly after the vaccination (date not provided) except for the continued deep muscle pain that she described as "adhesive muscle pain."    During the follow up on, 10/05/2020, the patient confirmed that she is still experiencing the muscle pain and continues to be treated by her chiropractor husband.; Sender's Comments: MassBiologics medical reviewer assessed all adverse events as labelled and non-serious.  All reactions have resolved except for chronic pain and muscle pain at injection site.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pruritus
Clinical narrative: Td administered subcutaneously; Td administered at forearm; Red halo around injection site; Itchiness around injection site; On 03/24/2020 a 31 year old male inadvertently received a subcutaneous injection of TDVAX (Lot # A122A) in the forearm instead of intramuscular in the deltoid.  The correct product and dose (0.5mL) was administered; however it was an incorrect site and route.  On the day of administration, the patient experienced redness (halo) and itchiness at injection site.  The patient's adverse events resolved within two days.  The reporter indicated that the administration error occurred to confusion with TB product and not verifying administration instructions beforehand.; Sender's Comments: The reactions of itchiness and redness were accessed as non-serious and labelled.  The medication error was accessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; A spontaneous report was received from a consumer concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced seizures.  The patient's medical history was not provided. Concomitant product use was not provided.  On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   A social media message was received from a consumer concerning a female patient who developed seizures after receiving the Moderna COVID-19 vaccine. The report stated that the patient was still in this condition more than a week after receiving the vaccine and that she was sent home from the hospital.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, seizures, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of seizure. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided.  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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Muscle twitching, Pallor, Presyncope
Clinical narrative: Felt like might pass out; Proceeded to become limp, pale and sweaty; Proceeded to become limp, pale and sweaty; Hands rhythmically twitched back and forth; A spontaneous report was received from a nurse concerning a 32-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt like he might pass out, became limp, pale, and sweaty, and hands rhythmically twitched back and forth.   The patient's medical history included allergy to penicillin. No relevant concomitant product use was reported.   On 28 Dec 2020, approximately three minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient began to feel like he was going to pass out minutes after receiving the vaccine.  He became more limp, pale, and sweaty and his hands rhythmically twitched back and forth.  His eyes closed and he leaned back in his chair, but he remained upright. The nurse elevated his feet, fanned his face and upper body, and applied wet paper towels to the back of his neck.  After approximately two minutes, the patient's level of consciousness returned to baseline and he felt better after five minutes. He remained seated and sipped water for 30 minutes.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, felt like he might pass out, became limp, pale, and sweaty, and hands rhythmically twitched back and forth, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 32-year-old, male, patient, who experienced a serious unexpected event of presyncope and non-serious unexpected event of pallor, hyperhidrosis This case concerns a 32-year-old, male, patient, who experienced a serious unexpected event of presyncope and non-serious unexpected event of pallor, hyperhidrosis and muscle twitching. The event occurred 15 min after first dose of mRNA-1273, lot # 011J20A. Treatment included no medications, but feet elevation and wet towel on the back of his neck. 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.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Double dose of Moderna's COVID-19 vaccine (1ml) in error; A spontaneous report report was received from a nurse concerning a 60-year-old female patient, who received double dose (1ml) of Moderna's COVID-19 vaccine in error.  The patient's medical history and relevant concomitant medications were not reported.   On 06-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   Nurse reported that, she had double dosed patient in error. Reporter provided consent to follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the event double dose (1ml) of Moderna's COVID-19 vaccine in error was not reported.   The outcome of the event double dose (1ml) of Moderna's COVID-19 vaccine in error was considered to be resolved on an unspecified date.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (lot number 025L20A), where incorrect dose (1 ml) was administered to a 60-year-old, female patient. There were no reported AEs associated with this case of Product administration error.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; A spontaneous report  was received from a site concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed with Bell's Palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, approximately 7 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient was diagnosed with Bell's Palsy. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, Bell's Palsy, was not reported.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of Bell's palsy.  Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and the onset of event, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Fatigue, Headache, Heart rate
Clinical narrative: New onset atrial fibrillation; Shortness of breath; Very tired; Her arm was sore; Headaches; A spontaneous report was received from a nurse concerning a 54-year-old, White, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, headaches, atrial fibrillation, very tired, and shortness of breath.  The patient's medical history was not provided. Concomitant product use was not provided.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021 the patient experienced headaches after vaccination.  On 05 Jan 2021 the patient's arm was sore.  On 14 Jan 2021 at 6:00 am the patient's heart rate started at 136 and went as high as 180. She reported having heart palpitations, shortness of breath, and headaches. The patient went to the emergency room and was hospitalized for 14 hours. She was diagnosed with new onset of atrial fibrillation. While in the hospital she was started on a Diltiazem and Heparin.   On 17 Jan 2021, the patient reported she was now in sinus rhythm but was very tired. Her cardiologist prescribed Rivaroxaban and Metoprolol.   Action taken with mRNA-1273 in response to the events was not provided.   The events, sore arm, headaches, atrial fibrillation, and shortness of breath, were unknown. The event, very tired, was considered not resolved.; Reporter's Comments: This case concerns a 54 years old female patient, who experienced a serious unexpected event of atrial fibrillation and non-serious unexpected event of dyspnea, and non- serious expected event of injection site pain, fatigue and headache. The event of headache occurred 1 days after first dose of mRNA-1273, lot # 039K20A. The event of injection site pain occurred 2 days after first dose of mRNA-1273, lot # 039K20A. The event of atrial fibrillation, dyspnoea, and fatigue occurred 11 days after the first dose of mRNA-1273, lot # 039K20A. Treatment included Cardizem drip, heparin, Xarelto and Lopressor. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: New onset atrial fibrillation; Shortness of breath; Very tired; Her arm was sore; Headaches; A spontaneous report was received from a nurse concerning a 54-year-old, White, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, headaches, atrial fibrillation, very tired, and shortness of breath.  The patient's medical history was not provided. Concomitant product use was not provided.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021 the patient experienced headaches after vaccination.  On 05 Jan 2021 the patient's arm was sore.  On 14 Jan 2021 at 6:00 am the patient's heart rate started at 136 and went as high as 180. She reported having heart palpitations, shortness of breath, and headaches. The patient went to the emergency room and was hospitalized for 14 hours. She was diagnosed with new onset of atrial fibrillation. While in the hospital she was started on a Diltiazem and Heparin.   On 17 Jan 2021, the patient reported she was now in sinus rhythm but was very tired. Her cardiologist prescribed Rivaroxaban and Metoprolol.   Action taken with mRNA-1273 in response to the events was not provided.   The events, sore arm, headaches, atrial fibrillation, and shortness of breath, were unknown. The event, very tired, was considered not resolved.; Reporter's Comments: This case concerns a 54 years old female patient, who experienced a serious unexpected event of atrial fibrillation and non-serious unexpected event of dyspnea, and non- serious expected event of injection site pain, fatigue and headache. The event of headache occurred 1 days after first dose of mRNA-1273, lot # 039K20A. The event of injection site pain occurred 2 days after first dose of mRNA-1273, lot # 039K20A. The event of atrial fibrillation, dyspnoea, and fatigue occurred 11 days after the first dose of mRNA-1273, lot # 039K20A. Treatment included Cardizem drip, heparin, Xarelto and Lopressor. 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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Delirium, Hyperhidrosis, Pyrexia
Clinical narrative: At  night he is really sweating.; that night he got really bad chills; Fever; Came home feeling delirious; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who came home feeling delirious, that night he got really bad chills, fever, and at night he was really sweating.   The patient's medical history was not provided.  Concomitant medications were not provided.   On 13 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient came home feeling delirious after he had received the COVID -19 vaccine.  That night, he developed real bad chills with a fever.  O  On 17 Jan 2021, his temperature worsened and was 100.8 degrees Fahrenheit (F).  At night he was really sweating.   Treatment for the events were not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, came home feeling delirious, that night he got really bad chills, fever, and at night he was really sweating, were not resolved.; Reporter's Comments: This spontaneous report refers to a case of a male patient who experienced a serious event of feeling delirious and non-serious event of he got really bad chills, fever, and was really sweating.  The events developed on the same day after the administration of the mRNA-1273 vaccine (lot # 027L20A, expiration date-unknown). No treatment was reported, and outcome is unknown.  Based on the information provided which includes a temporal association, a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Injection site pain
Clinical narrative: Anaphylaxis; Burning sensation in the arm; This spontaneous report  was received from a consumer who was a 39-years-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced an immediate burning sensation in the arm and anaphylaxis.   The patient's medical history was not provided. Concomitant Medications were not reported.  On 13 Jan 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm (Lot number: 025L20A). She immediately felt a burning sensation in the arm, dizziness, and developed hives on her arm, face and chest. The hives on her face were itchy. She presented to the Emergency Department and was treated for anaphylaxis. Treatment included intravenous diphenhydramine and intramuscular epinephrine.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, burning sensation in the arm and anaphylaxis, were considered resolved on an unknown date.; Reporter's Comments: This case concerns a 39-year old female patient with unknown medical history and concomitant medications. The patient experienced an unexpected event of Anaphylaxis that was considered medically significant. Additionally, the patient experienced expected non-serious event of Burning sensation in the arm. The events occurred immediately after receiving their first of two planned doses of mRNA-1273 (Lot number: 025L20A). Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactoid reaction
Clinical narrative: Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 59-year-old, White, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.  The patient's medical history was not reported. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, after vaccine administration, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 59 year old subject with unknown medical history, who experienced a serious unexpected event of Anaphylactoid reaction. The event occurred after first dose of the study medication administration.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Dysphagia
Clinical narrative: Angioedema of arm, face, and tongue; Difficulty swallowing; A spontaneous report was received from a physician concerning a 46-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed angioedema arm, face, and tongue and difficulty swallowing probably due to swelling.    The patient's medical history, as provided by the reporter, included penicillin allergy, seasonal allergies, dermatological fillers and collagen fillers. Concomitant medications included Redopx and Aloim.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, after receiving the vaccine, the patient had swelling, angioedema of the arm, face and tongue. She also had difficulty swallowing, probably due to the swelling per the reporter. Treatment for the event included prednisone and diphenhydramine.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed angioedema arm, face, and tongue and difficulty swallowing probably due to swelling, were considered resolved on an unknown date.; Reporter's Comments: This case concerns a 46-year-old female patient with relevant medical history of penicillin allergy, seasonal allergies, dermatological fillers and collagen fillers who received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced the serious unlisted event of angioedema of the arm, face, and tongue and serious unlisted event of difficulty swallowing probably due to swelling. Treatment for the events included prednisone and diphenhydramine which resolved the events. Based on the temporal association between the use of the product and the events occurring after receiving the vaccine, a causal relationship cannot be excluded and the events of angioedema of the arm, face, and tongue and difficulty swallowing are possibly related to the product.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Horner's syndrome
Clinical narrative: Horner's syndrome; A spontaneous report was received from a 66-year-old female physician who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Horner's syndrome.    The patient's medical history was not provided. Concomitant product use was not provided.  On 28 Dec 2020, approximately two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported after receiving the vaccine, she developed Horner's syndrome on 30 Dec 2020. She reported having a droopy eye on the left side and her left eye having a small pupil. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, Horner's syndrome, was unknown.; Reporter's Comments: This case concerns a 66-year old female patient. The medical history is not provided. The patient experienced an expected medically significant event of Horner's syndrome approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot 011J20A). Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: arm soreness; headache; fatigue; mild body aches; The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on 17Jan2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer (patient) and another contactable consumer. A 39-year-old patient of an unspecified gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 14Dec2020 at single dose for covid vaccine. The patient's medical history and concomitant medications were not reported. The patient was almost 72hrs in and feel normal. The patient had arm soreness the first day (14Dec2020) followed by headache, fatigue, and mild body aches lasting about 36hrs. The patient was vaccinated in the middle of six emergency room shifts in 7 days so the patient suspected that contributed to some of the fatigue. The patient was able to go for a run yesterday (unspecified date) before night shift and felt fine during shift. So all in all, the side effects for the patient had been mild without needing any Motrin or Tylenol. The outcome of events was recovering.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Blood potassium decreased, Blood sodium decreased, Dizziness, Fatigue, Heart rate increased
Clinical narrative: pulse 128, heart is still beating too fast; took my blood pressure and it was high for me. 167/102/high blood pressure; patient was very tired; I was lightheaded and saw spots before my eyes; My heart pounded in my chest; my pulse erratic; low potassium; high sugar; high thyroid; low sodium; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 04Jan2021 at 12:00 at SINGLE DOSE for COVID-19 immunisation.  Medical history included allergies to latex from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient previously took tetracycline and experienced allergies to tetracycline. It was reported that the evening of the vaccine, the patient was very tired. Patient stated, "I took my blood pressure and it was high for me. 167/102, pulse 128, I was lightheaded and saw spots before my eyes". The patient called the nurse hotline and was sent to the ER. The ER just said that the patient had high blood pressure which patient stated, "I don't, I take it regularly". The patient also stated, I was off work for a week, too tired to get off the couch. My heart pounded in my chest, my pulse erratic. I went to the doctor 2 days later. She said it was from the vaccine. My labs from the ER showed low sodium, low potassium, high sugar and high thyroid. I had no health issues before the vaccine. I am back at work, but my heart is still beating too fast. This morning while doing nothing it was 102". No treatment was provided for the events. Covid test post vaccination (test type: nasal swab) on 07Jan2021 was negative. Outcome of the events was reported as recovering.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Heart rate irregular, Hypertension, Palpitations, SARS-CoV-2 test negative, Thyroid function test abnormal
Clinical narrative: pulse 128, heart is still beating too fast; took my blood pressure and it was high for me. 167/102/high blood pressure; patient was very tired; I was lightheaded and saw spots before my eyes; My heart pounded in my chest; my pulse erratic; low potassium; high sugar; high thyroid; low sodium; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 04Jan2021 at 12:00 at SINGLE DOSE for COVID-19 immunisation.  Medical history included allergies to latex from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient previously took tetracycline and experienced allergies to tetracycline. It was reported that the evening of the vaccine, the patient was very tired. Patient stated, "I took my blood pressure and it was high for me. 167/102, pulse 128, I was lightheaded and saw spots before my eyes". The patient called the nurse hotline and was sent to the ER. The ER just said that the patient had high blood pressure which patient stated, "I don't, I take it regularly". The patient also stated, I was off work for a week, too tired to get off the couch. My heart pounded in my chest, my pulse erratic. I went to the doctor 2 days later. She said it was from the vaccine. My labs from the ER showed low sodium, low potassium, high sugar and high thyroid. I had no health issues before the vaccine. I am back at work, but my heart is still beating too fast. This morning while doing nothing it was 102". No treatment was provided for the events. Covid test post vaccination (test type: nasal swab) on 07Jan2021 was negative. Outcome of the events was reported as recovering.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: pulse 128, heart is still beating too fast; took my blood pressure and it was high for me. 167/102/high blood pressure; patient was very tired; I was lightheaded and saw spots before my eyes; My heart pounded in my chest; my pulse erratic; low potassium; high sugar; high thyroid; low sodium; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 04Jan2021 at 12:00 at SINGLE DOSE for COVID-19 immunisation.  Medical history included allergies to latex from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient previously took tetracycline and experienced allergies to tetracycline. It was reported that the evening of the vaccine, the patient was very tired. Patient stated, "I took my blood pressure and it was high for me. 167/102, pulse 128, I was lightheaded and saw spots before my eyes". The patient called the nurse hotline and was sent to the ER. The ER just said that the patient had high blood pressure which patient stated, "I don't, I take it regularly". The patient also stated, I was off work for a week, too tired to get off the couch. My heart pounded in my chest, my pulse erratic. I went to the doctor 2 days later. She said it was from the vaccine. My labs from the ER showed low sodium, low potassium, high sugar and high thyroid. I had no health issues before the vaccine. I am back at work, but my heart is still beating too fast. This morning while doing nothing it was 102". No treatment was provided for the events. Covid test post vaccination (test type: nasal swab) on 07Jan2021 was negative. Outcome of the events was reported as recovering.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Rash, Sensation of foreign body, Throat clearing
Clinical narrative: Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249), intramuscular (right arm), on 13Jan2021 09:45, at single dose, for covid-19 immunization. Medical history included allergies: sea salt, hypothyroidism, anemia, asthma, and seizures (when younger). Concomitant medications were not reported. The patient previously took tramadol and hydrocodone and experienced allergies to both drugs. The patient experienced full body rash on 13Jan2021 10:15 (also reported as about 30 mins after vaccination). On 13Jan2021 10:15 (also reported as about an hour after receiving vaccination), the patient had trouble clearing throat and felt like there was something stuck in throat. The patient has been taking Benadryl and Motrin for these adverse events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination and, had not been Covid-tested post vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Back pain, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; asymptomatic; tested positive for Covid-19; asymptomatic; Back pain; Cold; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient informed that she received the first dose of the Covid-19 vaccine on 29Dec2020 and her second dose was scheduled on 19Jan2021, but she was tested positive for Covid-19 on unspecified date. The patient informed that she was asymptomatic and only has back pain and cold. The patient wanted to know if she can receive the second dose of the vaccine. The outcome of the events tested positive for Covid-19; asymptomatic, back pain, cold was unknown.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the time association, the lack of efficacy cannot be excluded for vaccine BNT162B2.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: test for COVID-19/Positive; test for COVID-19/Positive; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration in left arm on 22Dec2020 17:00 at single dose for covid-19 immunization. Medical history included High Cholesterol. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. The patient received the Rapid throat swab test for COVID-19 on 30Dec2020, the result was positive. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Computerised tomogram, Ultrasound scan vagina, Urine analysis
Clinical narrative: Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 05Jan2021 at 05:00 at a single dose for COVID-19 immunization.  Medical history included skin auto-immune disease and auto-immune hypothyroidism.  The patient's concomitant medications were not reported.  The patient received the vaccine on 05Jan2021 at 05:00. The next day at 6:30 AM (06Jan2021), the patient started having vaginal bleeding that has not subsided yet and still going strong. The patient had seen a lot of specialist. She went to the ER twice and had CT scan, 3 biopsies taken, internal sonogram, had blood tests and urinalysis done, all with unknown results. The doctor told her if it doesn't stop in a couple of weeks, the patient will undergo a general anesthesia to further analyze the situation. The physician did not have information on vaccination for people with auto-immune issue. The patient had not yet recovered from the event vaginal bleeding.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 05Jan2021 at 05:00 at a single dose for COVID-19 immunization.  Medical history included skin auto-immune disease and auto-immune hypothyroidism.  The patient's concomitant medications were not reported.  The patient received the vaccine on 05Jan2021 at 05:00. The next day at 6:30 AM (06Jan2021), the patient started having vaginal bleeding that has not subsided yet and still going strong. The patient had seen a lot of specialist. She went to the ER twice and had CT scan, 3 biopsies taken, internal sonogram, had blood tests and urinalysis done, all with unknown results. The doctor told her if it doesn't stop in a couple of weeks, the patient will undergo a general anesthesia to further analyze the situation. The physician did not have information on vaccination for people with auto-immune issue. The patient had not yet recovered from the event vaginal bleeding.   Information about lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills
Clinical narrative: She has abdominal cramping now; Chills; she develops joint pain /They were sore and stiff; she develops joint pain /They were sore and stiff; This is a spontaneous report from a contactable consumer patient via a Pfizer-sponsored program. A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685, Lot Expire Date: unknown), intramuscular injection in left deltoid on 30Dec2020 07:15 AM at single dose for COVID-19 immunization (reported as "Why was the patient taking COVID19 Vaccine (Verbatim): healthcare worker "). Medical history included ongoing allergy to sulfa antibiotics since 1998 (diagnosed within her first year of life) and allergic to the cold from 2011 and ongoing. She has an allergy to the cold and people sometimes confuse it with Raynaud's. It is not Raynaud's. Concomitant medication included etonogestrel (NEXPLANON) from May2019 and ongoing for birth control. The patient received the vaccine on 30Dec2020 and developed symptoms 4 days ago (10Jan2021), she was experiencing joint pain and chills, also reported as "just over the last 2 days she develops joint pain and chills". Patient experienced chills on 13Jan2021. Patient just called about possible side effects and she was wondering if she should get the second dose. Her side effects were minor. They were joint pain and chills. Joint Pain started in the hips and felt like something was wrong. They were sore and stiff. She has abdominal cramping now and she was not sure if that is from the joint pain or regular period. She just finished her menstrual cycle and normally she has cramps afterwards. She does not have a fever. Patient has checked her temperature three times. 30Dec2020 was when she received her first dose. Vaccination Facility Type was health center . The events did not require a visit to emergency room and physician office. No prior vaccination within 4 weeks but patient reported that events following prior vaccinations was "the worst was swelling and tenderness with HPV vaccine. HPV vaccine manufacturer: unknown". Outcome of the event chills was not recovered (ongoing) while for other events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, SARS-CoV-2 test positive
Clinical narrative: she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; tested positive for COVID; tested positive for COVID; not feeling very well; feeling dizzy and weak; feeling dizzy and weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included Diabetes which was diagnosed in Apr2020. There were no concomitant medications. The patient received the first dose of the vaccine on 22Dec2020. She tested positive for COVID19 on 08Jan2021. The second dose of vaccine on 12Jan2021 was deferred as the patient was not feeling well on an unspecified date in Jan2021. She asked for guidance/information about receiving the second dose after testing positive. She stated that she was still feeling dizzy and weak on an unspecified date in Jan2021. She said that she heard the people were not feeling too well after the second dose and she will get it as long as it will not kill her. She asked what will happen if she does not take the second dose and will she need to get the series again. She wanted to know if she can take the second dose of vaccine. She clarified that she was supposed to get her second dose on 12Jan2021 but she was not feeling very well so now they were telling her to go on the weekend. She does not feel fine. She asked if it was safe for her to take the second dose or should she wait. She wanted to know if the effect of the first dose is null since she has now delayed it so long. She is the supervisor of ultrasound department. She started having COVID symptoms of 04Jan2021, she was tested on 05Jan2021 and got a positive result on 08Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID19 based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Sex: U
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: significant leakage from the site of injection; This is a spontaneous report from contactable pharmacist. This pharmacist reported similar events for two (2) patients. This is the first of the two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) 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. After administration of the vaccine, two of the doctors had significant leakage from the site of injection. This was a clear fluid leaking out of the site of injection. The pharmacist stated this type of leaking fluid is a common occurrence with the flu vaccine and asked if there is any particular guidance on what should be done in the case of this vaccine. Should the doctors get titers drawn up to determine if they need to get a 3rd dose? Should they go ahead and get the 3rd dose anyways?  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042161 same drug/event, different patients
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Peripheral coldness
Clinical narrative: on left arm, almost immediately after left hand became increasingly cold; This is a spontaneous report from a non-contactable Other-HCP reporting for herself.  A 40-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on arm left from 14Jan2021 07:00 to 14Jan2021 07:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Prolonged QT syndrome. The patient's concomitant medications were not reported. The patient had her first dose of BNT162B2 on 23Dec2020 to 23Dec2020. On 15Jan2021 at 07:00, on left arm, almost immediately after left had became increasingly cold. Right had was ok and did not change in temperature. Area around the shot was not cold, only hand. Coldness lasted for about 15 minutes before slowly getting back to normal temperature. The patient had not received any treatment for the event. The patient was not pregnant at the time of the report. Outcome of the event was recovered on an unspecified date.   No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Type IV hypersensitivity reaction
Clinical narrative: Severe generalized pruritus, likely delayed hypersensitivity; Severe generalized pruritus, likely delayed hypersensitivity; This is a spontaneous report from a contactable physician (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 10Jan2021 at 08:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included seasonal allergies. Patient has no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021, the patient experienced severe generalized pruritus, likely delayed hypersensitivity. Patient was given antihistamines and topical agents for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Very painful stiff neck; Very painful stiff neck; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021 13:15 at single dose (left arm) for COVID-19 immunization. The patient had no medical history. The patient had no known allergies and patient was not pregnant. Concomitant medication included gabapentin, diltiazem hydrochloride (DILT-XR), losartan and ezetimibe (ZETIA). On 14Jan2021 at 22:00, the patient experienced very painful stiff neck and rapid heartbeat. The patient had no therapy for the events. The patient had no other vaccine in 4 weeks, and did not have Covid prior vaccination. The patient was no Covid tested post vaccination. Outcome of events was not recovered.  Information on Lot/Batch has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Muscle tightness
Clinical narrative: Muscle tightness; soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 14Jan2021 13:15 at single dose for Covid-19 immunization. The patient's medical history included Penicillin allergy (reported "known allergies: Penicillin". Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 (20:00), the patient experienced muscle tightness and soreness at the injection site up to 24 hours post injection. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: red circle around the injecting site; injecting site, itchy; injecting site; a hard ball underneath; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El3246 and expiry date unknown) via unspecified route of administration at the left arm on 13Jan2021 09:15 at single dose for Covid-19 immunization in a hospital. Medical history included liver tumors, and allergies to "sulfer", thyroid (disorder), anxiety and blood pressure (abnormal). Concomitant medications included thyroid, anxiety and blood pressure medications. The patient has no other vaccine in four weeks. On 14Jan2021, the patient experienced red circle around the injecting site, itchy and a hard ball underneath. The patient did not receive treatment due to the events. The outcome of the events red circle around the injecting site, itchy and a hard ball underneath was not recovered.