chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Echocardiogram
Clinical narrative: Was in the hospital due to her heart and they had to do a eko gram.; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Patient was supposed to get her 2nd dose of the Covid vaccine on 20Apr2021 but was in the hospital due to her heart and they had to do a ekogram on an unspecified date. She wanted to know what to do and where to go to get her 2nd dose. On unknown date, the patient underwent lab tests and procedures which included ekogram: unknown. The outcome of the event was unknown.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nasopharyngitis, Pyrexia
Clinical narrative: Fever; Cold; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 47 years old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) via an unspecified route of administration in the left arm on 26Apr2021 at 14:00, (at the age of 47 years old) as a single dose of COVID-19 immunisation. The patient had no medical history. Concomitant medications include TYNALOL from unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) (at the age of 47 years old), via an unspecified route of administration in the left arm on 07Apr2021 at 17:00, as a single dose of COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 19:00 the patient experienced fever, cold and dizziness. The clinical outcome of fever, cold and dizziness was not recovered.   No follow-up attempts are possible needed ; information about lot number cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo positional
Clinical narrative: Vertigo - positional; dizziness; nausea; his is a spontaneous report received from a contactable consumer, the patient. A 42-year-old-male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in left arm on 25Mar2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hypertension. The concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 20mg daily. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in left arm on 02Mar2021(at the age of 42-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Apr2021, the patient experienced vertigo -positional, dizziness and nausea. The treatment received for the events included meclizine 25mg three times per day. The clinical outcome of the events vertigo positional, dizziness and nausea was not recovered at the time of reporting.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph gland infection
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 01Apr2021 at 10:30 as 1st dose single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18Apr2021 (3 weeks later), she experienced a large lymph node on the back of her ear. She went to the doctor and was diagnosed with an infection. But the doctor did not ask if she received the vaccine. She was put on Amoxicillin, and it went away with taking the medication. She then stated that on 22Apr2021, 3 days after being prescribed the Amoxicillin, she received her second dose (LOT ER8729, left arm injection) of the vaccine. She had no reaction until 27Apr2021, 3 days ago. She experienced a rash all over her body after second dose. The doctor told her it's a rash caused by the Amoxicillin. She said that she had never been allergic to Amoxicillin in her life, but knows that there was a possibility that you can develop a allergy. However, the patient's mother stated that it may be from the vaccine. Patient would like to verify if a rash is a side effect of the vaccine. Her mom had never seen a rash like it. Patient added hives go away with Benadryl, usually. They were weird dots on her body now and do not know if it is from the vaccine. Patient had never had hives before this. Patient asking is Pfizer vaccine a cause of this. Patient does not remember the exact date that the enlarged lymph node went away. Patient continued to take the Amoxicillin. The outcome of the event was recovered on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Throat tightness
Clinical narrative: trouble breathing; throat felt like it was closing; sternum hurt; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration (patient age at the time of vaccination was 33 year and patient was not pregnant at the time of vaccination), administered in arm right on 30Apr2021 at 14:30 as single dose for COVID-19 immunisation. The patient's medical history included down syndrome. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously took penicillin and experienced allergy. Patient was not received any other vaccine prior four weeks of vaccination. Patient received other medications two weeks prior of vaccination. About 12 hours after the vaccine, on 30Apr2021 at 03:00, the patient began with trouble breathing, throat felt like it was closing, and sternum hurt. The patient visited to emergency room/department or urgent care for the events. Since vaccination patient not tested for COVID-19. Therapeutic measures were taken as a result of the events with oxygen, tyelnol and hydroxyzine. Pfizer have permission to contact your/the patient's healthcare provider about this report. The outcome of the events was reported as recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Headache, Hypersensitivity, Oral pruritus, Stomatitis
Clinical narrative: caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; itching in tongue; back of throat; Itching in mouth, tongue, roof of mouth, back of throat; tightness in throat; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EW0162), via an unspecified route of administration on 17Apr2021 at the age of 53-year-old as single dose for covid-19 immunization. The patient medical history was reported as none. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from 17Apr2021 to 17Apr2021. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number:: EN6199; Expiry Date: Jun2021 ), dose 1 via an unspecified route of administration, administered on 12Mar2021 as single dose for covid-19 immunization. On 17Apr2021 the reporter reported that she has a mild allergic reaction she experienced Itching in mouth, tongue, roof of mouth, back of throat, Tightness in throat and her tongue swelling up "a little bit" after the second dose. Reporter also stated that her headache has ran from cheeks to the back of her neck, lasted for about 5-6 days. Was worst in the mornings as she took migraine medication. The reporter stated that she took Benadryl and a dose of her Inhaler before her second dose of the vaccine and she said she was still having to use her inhaler and take antihistamine daily. As her doctor had recommended that when she got the second vaccine to take the Benadryl beforehand and she could tell that the inhaler and Benadryl helped her after this dose of the vaccine. She was started to feel the symptoms but says she could tell that the medications were helped to fight them. The patient did not visit to Emergency Room or Physician Office. The outcome of events was recovering as reported by reporter.  Follow-up attempts are needed. Further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat irritation, Throat tightness
Clinical narrative: caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; itching in tongue; back of throat; Itching in mouth, tongue, roof of mouth, back of throat; tightness in throat; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EW0162), via an unspecified route of administration on 17Apr2021 at the age of 53-year-old as single dose for covid-19 immunization. The patient medical history was reported as none. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from 17Apr2021 to 17Apr2021. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number:: EN6199; Expiry Date: Jun2021 ), dose 1 via an unspecified route of administration, administered on 12Mar2021 as single dose for covid-19 immunization. On 17Apr2021 the reporter reported that she has a mild allergic reaction she experienced Itching in mouth, tongue, roof of mouth, back of throat, Tightness in throat and her tongue swelling up "a little bit" after the second dose. Reporter also stated that her headache has ran from cheeks to the back of her neck, lasted for about 5-6 days. Was worst in the mornings as she took migraine medication. The reporter stated that she took Benadryl and a dose of her Inhaler before her second dose of the vaccine and she said she was still having to use her inhaler and take antihistamine daily. As her doctor had recommended that when she got the second vaccine to take the Benadryl beforehand and she could tell that the inhaler and Benadryl helped her after this dose of the vaccine. She was started to feel the symptoms but says she could tell that the medications were helped to fight them. The patient did not visit to Emergency Room or Physician Office. The outcome of events was recovering as reported by reporter.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Severe Pain; Headache; Fever; Chills; Blurred vision; Tingling in hands and feet; Shortness of breath; Fatigue; Sweating; Uncomfortable sleeping on left arm; Lack of appetite; Couldn't eat, couldn't drink; Couldn't eat, couldn't drink; Felt like there was inflammation in her stomach; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8435 and expiration date was not reported), via an unspecified route of administration in left arm on 28Apr2021 at 19:00 as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder (reported as 2 years ago she had an ultrasound and was told she had a minor autoimmune). The concomitant medications included unspecified birth control pills and multivitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8131), via an unspecified route of administration in right arm on 07Apr2021 as a single dose for COVID-19 immunisation and experience soreness at the injection site which lasted for about 2 days and she could not sleep on that side of her body. No additional vaccines administered on same date of the Pfizer vaccine. No prior vaccination (within 4 weeks). On 29Apr2021, the patient experienced severe pain, headache, fever, chills, blurred vision, tingling in hands and feet, shortness of breath, fatigue, sweating, uncomfortable sleeping on left arm, lack of appetite, couldn't eat, couldn't drink, felt like there was inflammation in her stomach. The consumer stated that "the symptoms started about 12 hours later of vaccination. She had severe pain, headache, fever, chills, blurred vision, tingling in her hands and feet, shortness of breath, lack of appetite, couldn't eat, couldn't drink, inflammation in her stomach, fatigue, and sweating. Stated most of the symptoms lasted about 5 hours. She did not go to the emergency room/ physician office; she had people around her keeping an eye on her. She took Naproxen, Ibuprofen, Aspirin, and Anti-histamines. She still had fatigue, feels uncomfortable sleeping on her left arm and sweating. The sweating was worse in the morning and kind of feels like when you have a flu or virus and wake up sweating." The patient underwent lab tests and procedures which included ultrasound: minor autoimmune on unspecified date (reported as 2 years ago). Therapeutic measures were taken as a result adverse events. Vaccination facility type: Warehouse event. The outcome of events fatigue, sweating and uncomfortable sleeping on left arm were not recovered whereas the outcome of all other events were recovered on 30Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Fluid intake reduced, Gastritis, Headache, Hyperhidrosis
Clinical narrative: Severe Pain; Headache; Fever; Chills; Blurred vision; Tingling in hands and feet; Shortness of breath; Fatigue; Sweating; Uncomfortable sleeping on left arm; Lack of appetite; Couldn't eat, couldn't drink; Couldn't eat, couldn't drink; Felt like there was inflammation in her stomach; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8435 and expiration date was not reported), via an unspecified route of administration in left arm on 28Apr2021 at 19:00 as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder (reported as 2 years ago she had an ultrasound and was told she had a minor autoimmune). The concomitant medications included unspecified birth control pills and multivitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8131), via an unspecified route of administration in right arm on 07Apr2021 as a single dose for COVID-19 immunisation and experience soreness at the injection site which lasted for about 2 days and she could not sleep on that side of her body. No additional vaccines administered on same date of the Pfizer vaccine. No prior vaccination (within 4 weeks). On 29Apr2021, the patient experienced severe pain, headache, fever, chills, blurred vision, tingling in hands and feet, shortness of breath, fatigue, sweating, uncomfortable sleeping on left arm, lack of appetite, couldn't eat, couldn't drink, felt like there was inflammation in her stomach. The consumer stated that "the symptoms started about 12 hours later of vaccination. She had severe pain, headache, fever, chills, blurred vision, tingling in her hands and feet, shortness of breath, lack of appetite, couldn't eat, couldn't drink, inflammation in her stomach, fatigue, and sweating. Stated most of the symptoms lasted about 5 hours. She did not go to the emergency room/ physician office; she had people around her keeping an eye on her. She took Naproxen, Ibuprofen, Aspirin, and Anti-histamines. She still had fatigue, feels uncomfortable sleeping on her left arm and sweating. The sweating was worse in the morning and kind of feels like when you have a flu or virus and wake up sweating." The patient underwent lab tests and procedures which included ultrasound: minor autoimmune on unspecified date (reported as 2 years ago). Therapeutic measures were taken as a result adverse events. Vaccination facility type: Warehouse event. The outcome of events fatigue, sweating and uncomfortable sleeping on left arm were not recovered whereas the outcome of all other events were recovered on 30Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Pain, Paraesthesia, Pyrexia
Clinical narrative: Severe Pain; Headache; Fever; Chills; Blurred vision; Tingling in hands and feet; Shortness of breath; Fatigue; Sweating; Uncomfortable sleeping on left arm; Lack of appetite; Couldn't eat, couldn't drink; Couldn't eat, couldn't drink; Felt like there was inflammation in her stomach; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8435 and expiration date was not reported), via an unspecified route of administration in left arm on 28Apr2021 at 19:00 as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder (reported as 2 years ago she had an ultrasound and was told she had a minor autoimmune). The concomitant medications included unspecified birth control pills and multivitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8131), via an unspecified route of administration in right arm on 07Apr2021 as a single dose for COVID-19 immunisation and experience soreness at the injection site which lasted for about 2 days and she could not sleep on that side of her body. No additional vaccines administered on same date of the Pfizer vaccine. No prior vaccination (within 4 weeks). On 29Apr2021, the patient experienced severe pain, headache, fever, chills, blurred vision, tingling in hands and feet, shortness of breath, fatigue, sweating, uncomfortable sleeping on left arm, lack of appetite, couldn't eat, couldn't drink, felt like there was inflammation in her stomach. The consumer stated that "the symptoms started about 12 hours later of vaccination. She had severe pain, headache, fever, chills, blurred vision, tingling in her hands and feet, shortness of breath, lack of appetite, couldn't eat, couldn't drink, inflammation in her stomach, fatigue, and sweating. Stated most of the symptoms lasted about 5 hours. She did not go to the emergency room/ physician office; she had people around her keeping an eye on her. She took Naproxen, Ibuprofen, Aspirin, and Anti-histamines. She still had fatigue, feels uncomfortable sleeping on her left arm and sweating. The sweating was worse in the morning and kind of feels like when you have a flu or virus and wake up sweating." The patient underwent lab tests and procedures which included ultrasound: minor autoimmune on unspecified date (reported as 2 years ago). Therapeutic measures were taken as a result adverse events. Vaccination facility type: Warehouse event. The outcome of events fatigue, sweating and uncomfortable sleeping on left arm were not recovered whereas the outcome of all other events were recovered on 30Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder due to a general medical condition, Ultrasound scan, Vision blurred
Clinical narrative: Severe Pain; Headache; Fever; Chills; Blurred vision; Tingling in hands and feet; Shortness of breath; Fatigue; Sweating; Uncomfortable sleeping on left arm; Lack of appetite; Couldn't eat, couldn't drink; Couldn't eat, couldn't drink; Felt like there was inflammation in her stomach; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8435 and expiration date was not reported), via an unspecified route of administration in left arm on 28Apr2021 at 19:00 as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder (reported as 2 years ago she had an ultrasound and was told she had a minor autoimmune). The concomitant medications included unspecified birth control pills and multivitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8131), via an unspecified route of administration in right arm on 07Apr2021 as a single dose for COVID-19 immunisation and experience soreness at the injection site which lasted for about 2 days and she could not sleep on that side of her body. No additional vaccines administered on same date of the Pfizer vaccine. No prior vaccination (within 4 weeks). On 29Apr2021, the patient experienced severe pain, headache, fever, chills, blurred vision, tingling in hands and feet, shortness of breath, fatigue, sweating, uncomfortable sleeping on left arm, lack of appetite, couldn't eat, couldn't drink, felt like there was inflammation in her stomach. The consumer stated that "the symptoms started about 12 hours later of vaccination. She had severe pain, headache, fever, chills, blurred vision, tingling in her hands and feet, shortness of breath, lack of appetite, couldn't eat, couldn't drink, inflammation in her stomach, fatigue, and sweating. Stated most of the symptoms lasted about 5 hours. She did not go to the emergency room/ physician office; she had people around her keeping an eye on her. She took Naproxen, Ibuprofen, Aspirin, and Anti-histamines. She still had fatigue, feels uncomfortable sleeping on her left arm and sweating. The sweating was worse in the morning and kind of feels like when you have a flu or virus and wake up sweating." The patient underwent lab tests and procedures which included ultrasound: minor autoimmune on unspecified date (reported as 2 years ago). Therapeutic measures were taken as a result adverse events. Vaccination facility type: Warehouse event. The outcome of events fatigue, sweating and uncomfortable sleeping on left arm were not recovered whereas the outcome of all other events were recovered on 30Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue
Clinical narrative: Xeljanz and leflunomide is not working; fatigue; This is a spontaneous report from Pfizer sponsored program. A contactable other healthcare professional and consumer (patient) reported that a 54-year-old female started to receive tofacitinib citrate (XELJANZ XR, Prolonged-release tablet, 11mg), oral from 09Dec2020 to ongoing at 11mg, once daily for rheumatoid arthritis; BNT162B2 (Solution for injection), via unspecified route administration from 28Apr2021, single dose for COVID-19 immunization and leflunomide via unspecified route of administration from an unspecified date to ongoing at an unspecified dose and frequency for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. Patient reported "changing plan with MD because combination of Xeljanz and leflunomide is not working; patient will move to Remicade but will keep taking Xeljanz until Remicade is ready to go; rheumatoid arthritis symptoms are constantly moving from joint to joint; patient had her second dose of covid-19 vaccine on Wednesday, 28Apr2021, and has been experiencing fatigue yesterday and today." MD aware. The action taken in response to the events for tofacitinib citrate was dose not changed and leflunomide was unknown. The outcome of the events was unknown.   No follow up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Rash, SARS-CoV-2 test, Skin burning sensation
Clinical narrative: Skin rash; Pins and Needles feelings on skin; Burning feeling; Worse with warm temperatures and exercise; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old female patient received her unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8735) via an unspecified route of administration on the left arm on 22Apr2021 at 9:30 hours (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patients medical history included Afib (atrial fibrillation) and a bad lower back. The patient received unknown medication as concomitant within 2 weeks of vaccination. The past drug history of the patient included penicillin, sulfur drugs and contrast dyes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient was not tested positive for COVID-19. On 23Apr2021 the patient experienced Skin rash, Pins and Needles feelings on skin, burning feeling and worse with warm temperatures and exercise. The clinical outcome of the events skin rash, pins and needles, burning skin and pyrexia were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Derealisation, Headache, Hyperhidrosis, Nightmare
Clinical narrative: Horrible nightmares; Sweating; Sore arm for 3 days; Feeling of unreality; Headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 36 years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0171), via an unspecified route of administration in the left arm on 26Apr2021 at 16:45 (at the age of 36-years-old), as a first single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included Suboxone (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Apr2021 at 13:00, the patient experienced horrible nightmares, sweating, sore arm for 3 days, feeling of unreality, headaches, and chills. The clinical outcome of horrible nightmares, sweating, sore arm, feeling of unreality, headaches, and chills was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Horrible nightmares; Sweating; Sore arm for 3 days; Feeling of unreality; Headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 36 years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0171), via an unspecified route of administration in the left arm on 26Apr2021 at 16:45 (at the age of 36-years-old), as a first single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included Suboxone (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Apr2021 at 13:00, the patient experienced horrible nightmares, sweating, sore arm for 3 days, feeling of unreality, headaches, and chills. The clinical outcome of horrible nightmares, sweating, sore arm, feeling of unreality, headaches, and chills was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: chills; Low grade fever and next day fever of 101.5; feeling fatigue; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received second dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: 0172) via an unspecified route of administration in the left arm on 24Apr2021 at 1700, as a single dose for COVID-19 immunisation. It was reported that patient had no medical history. Concomitant medication included flonase nasal steroid (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 25Apr2021, the patient experienced fatigue. On 26Apr2021, the patient had low grade fever and on 28Apr2021, the patient had fever of 101.5 and chills. On 29Apr2021, the patient started to experience fatigue and fever again. The clinical outcome of the events fatigue, fever and chills were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Night sweats, Pain in extremity, Rash pruritic, Vaccination site pain
Clinical narrative: injection site soreness; night sweats; itchy, hive-like rash on both arms 48 hours after shot; very mild pain during urination for a couple weeks; moderate arm pain the day after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8734), via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 14:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included flax seed oil (MANUFACTURER UNKNWON) and multi vitamin (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced injection site soreness and moderate arm pain the day after injection at 00:00, night sweats from second night and continued for 7 days, itchy hive-like rash on both arms 48 hours after shot (lasted for 2-3 days), no medical attention needed and urination pain for a couple weeks, all on an unknown date in Apr2021. The clinical outcome of vaccination site pain, itchy rash, night sweats, pain in arm and urination pain was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Light pink, mildly itchy rash on left hand and right side of my neck/lower face area.; This is a spontaneous report received from a contactable patient. A 30-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EW0169) in left arm on 28Apr2021 at 18:15 (at the age of 30 years-old) as a single dose for COVID-19 immunisation. The patient's concomitant medications included TRI SPRINTEC and IC PERMETHRIN cream within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021 at 09:00, the patient experienced light pink, mildly itchy rash on left hand and right side of neck/lower face area.  Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. On an unknown date, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the event light pink, mildly itchy rash on left hand and right side of neck/lower face area was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in right arm on 21Apr2021 11:30 (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. Patient was not pregnant. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0150) administered in right arm on 31Mar2021 12:45 AM (at the age of 38-year-old) for COVID-19 immunization. The patient experienced shortness of breath on 25Apr2021. The event was reported as non-serious. Patient did not receive treatment for the event reported. Outcome of event was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Major pain in arm; chills off and on; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 04May2021 at 18:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not take any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 13:00, the patient experienced major pain in arm and chills off and on. The clinical outcome of the events major pain in arm and chills off and on was not recovered at the time of reporting.   No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Malaise, Pain in extremity
Clinical narrative: Excruciating pain to hit my arm; I'm just not feeling good. I started feeling like my body is off; I started having issues with some breathing, my breathing is off, it's not fluent like it usually do; I don't have the energy like I have been; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient).   A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 29Apr2021 as 1st dose, single for covid-19 immunisation. Medical history included allergies from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient Stated, I took the vaccine on Thursday, On 01May2021 I'm just not feeling good, I did good on Friday, but Saturday I started feeling like my body is off, and I started having issues with some breathing, my breathing is off, it's not fluent like it usually do, and the end I just don't feel good in my body in the end yesterday in my right arm that's where they gave me the shot I had this , On 02May2021 excruciating pain to hit my arm and I noticed it was not that head up to here , wasn't there anymore so I don't know what happen with that, but the pain was really bad in my arm yesterday, so I'm not feeling good, On unknown date 2021 I don't have the energy like I have been and like I said, my breathing is off and I had inhaler that I use every now and then for allergies but inhaler didn't help with this, when I used this twice yesterday, still I don't feel any better. When probed for the medication for allergies consumer stated that he was taking clover inhaler which was not clarified appropriately. When paraphrased, Consumer stated, No, I'm not feeling good, I haven't said good since Saturday, I got up this morning for walking and I was afraid to walk too far so I stayed in the neighbourhood and I stopped after hour in walking I usually, I am energetic when I got through but not this morning. Like my energy was not there. Reporter was informed that was needed for the documentation of the safety report. Patient stated, I known whether or not I need to go to the ER. Therapeutic measures were taken as a result as i started having issues with some breathing, my breathing is off, it's not fluent like it usually do. The outcome of the event excruciating pain to hit my arm was reported as unknown and while for others was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Itching and hives; Itching and hives; Muscle aches; Arm soreness; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, in left arm on 29Apr2021 14:30 as single for COVID-19 immunisation. Medical history included of chronic autoimmune hives likely exacerbated by COVID vaccine, limited occurrence of hives since stopping oral contraceptive in Nov2020 and recent urinary tract infection (UTI). No allergies reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: L3247) via intramuscular route of administration, administered in arm left on 08Apr2021 at 12:30 (at the age of 41-year-old) as single dose for COVID-19 immunization. Concomitant medications included within 2 weeks of vaccination ascorbic acid, calcium phosphate, lactobacillus, vaccinium macrocarpon (AZO CRANBERRY), menotrophin (MENOPUR), follitropin beta (FOLLISTIM), nitrofurantoin and MVI (MULTIVITAMINS) all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 29Apr2021, patient experienced arm soreness, fatigue and muscle aches on 30Apr2021. On 02May2021 01:00 the patient experienced itching and hives present on trunk, gluteal region, arms, legs, and scalp 3 days after second vaccine dose. The patient received treatment for the events was Zyrtec. The outcome of the events itching, and hives was not recovered and for all other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Cough, Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: She is still having weakness, coughing, and breathing issues; She is still having weakness, coughing, and breathing issues; She is still having weakness, coughing, and breathing issues; did get the second dose after hospitalization/so she got her second dose yesterday, 05May2021; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's husband) reported for a 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8736, Expiration Date: Jul2021, NDC not known), via an unspecified route of administration on 05May2021 16:00 as 2ND DOSE, SINGLE (age at vaccination: 73 years) for covid-19 immunisation. The patient's medical history included breast cancer, ongoing thyroid disorder, ongoing lung issues, cough, headache, tiredness, sickness from 01Feb2021 (Tested positive for the Covid 19 virus on 03Feb2021. The caller's wife started having symptoms. She had a cough, headache, sinus issues and tiredness.), bronchitis (Gets bronchitis easy). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021, Lot number: EL3246, 1ST DOSE for covid-19 immunisation and had feels like she has a lot of weight on her chest, sinus issues on 01Feb2021 and tested positive for the Covid 19 virus on 03Feb2021. On 05May2021, the patient did get the second dose after hospitalization. She is still having weakness, coughing, and breathing issues. The patient underwent lab test and procedures included COVID-19 virus test positive on 03Feb2021 and Chest X-ray on an unknown date had unknown result. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: She is still having weakness, coughing, and breathing issues; She is still having weakness, coughing, and breathing issues; She is still having weakness, coughing, and breathing issues; did get the second dose after hospitalization/so she got her second dose yesterday, 05May2021; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's husband) reported for a 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8736, Expiration Date: Jul2021, NDC not known), via an unspecified route of administration on 05May2021 16:00 as 2ND DOSE, SINGLE (age at vaccination: 73 years) for covid-19 immunisation. The patient's medical history included breast cancer, ongoing thyroid disorder, ongoing lung issues, cough, headache, tiredness, sickness from 01Feb2021 (Tested positive for the Covid 19 virus on 03Feb2021. The caller's wife started having symptoms. She had a cough, headache, sinus issues and tiredness.), bronchitis (Gets bronchitis easy). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021, Lot number: EL3246, 1ST DOSE for covid-19 immunisation and had feels like she has a lot of weight on her chest, sinus issues on 01Feb2021 and tested positive for the Covid 19 virus on 03Feb2021. On 05May2021, the patient did get the second dose after hospitalization. She is still having weakness, coughing, and breathing issues. The patient underwent lab test and procedures included COVID-19 virus test positive on 03Feb2021 and Chest X-ray on an unknown date had unknown result. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Asthenia, Chills, Dyspnoea
Clinical narrative: Difficulty breathing; Pain at the injection site; Tired; Muscle pain; Chills; Joint pain; feeling very weak; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; She felt a little pain; rash or redness; Got the sweats after the chills; having weakness in her legs, the muscles and joints.; Having weakness in her legs, the muscles and joints.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO162), dose 1 via an unspecified route of administration,  on 22Apr2021 13:00 as 1st dose, single (at the age of 86-years-old) dose on left arm for COVID-19 immunization. Medical history included prosthesis on the right arm 7-8 years ago, that is why she gets everything done on the left arm. And got COVID-19 virus, then she got the antibodies intravenously applied. The patient's concomitant medications were not reported and she would rather not give her list of medications. On 22Apr2021, after vaccination, the  patient had reaction. The  patient also had pain at the injection site injection, site swelling and redness that went down her arm, was tired, had muscle pain, chills, joint pain, difficulty breathing and weakness in joint. After getting the shot she felt a little pain, then a rash or redness that kept growing and growing; she felt it was little swollen. The patient stated that she got so chilled she had to put on 4 layers of clothing and 2 blankets. Then she got the sweats after the chills, so much that you could wring it out of her clothing. She reports feeling very weak and had the chills, then she went to bed and woke up with the sweats. The patient also having weakness in her legs, the muscles and joints. It was reported that everything went away after about a week, gently. At the injection site she had swelling and redness that went down her arm that lasted 2 weeks and went away. The patient furthermore stated that  "she is not going bald but, losing her hair a little and the color of her hair changed from dark brown to all white now, it happens when one gets old they shrink, go bald or lose your hair". The patient was  scheduled to receive second shot on 12May2021 at 11:00. She went to her pulmonary doctor due to having trouble breathing. They increased her medication for her breathing which helped a lot. Therapeutic measures were taken with medications for dyspnea. The patient recovered from all the events.  No follow-up attempts are needed. No further information is expected.