chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Tachycardia, Vaccination failure
Clinical narrative: If covid tested post vaccination: yes, covid test result positive; If covid tested post vaccination: yes, covid test result positive; Tachycardia; elevated d dimer; elevated blood pressure; This is a spontaneous report from a contactable consumer.   A 36-year-old (non-pregnant) female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL8982), via an unspecified route, administered in left arm on 12Jan2021 as dose 2, single for COVID-19 immunization at Hospital. The patient medical history included ongoing hypothyroidism, right bundle branch (block), cardiomegaly and no allergies. Concomitant medications included levothyroxin. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL1284), intramuscularly administered in left arm on 22Dec2020 at 13:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccine. The patient did not have COVID-19 prior vaccination. On 12Jan2021 at 13:30, the patient experienced tachycardia, elevated d-dimer and elevated blood pressure. On 07Mar2021, the patient was diagnosed with Covid-19. The patient underwent lab tests and procedures which included blood pressure: elevated, D-dimer: elevated on 12Jan2021 and nasal swab: SARS CoV-2 test positive on 07Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not treated for the events. The outcome of If covid tested post vaccination: yes, covid test result positive was unknown. The outcome of rest of the events is recovered with sequel.  Follow-up attempts completed. No further information expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event vaccination failure and covid-19 cannot be ruled out.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733) via an unspecified route of administration on 13Apr2021(at the age of 62 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rapid heartbeat on an unspecified date. Reported as, patient got the first Pfizer vaccine on tuesday this week. patient just want to know if there is epinephrine in that vaccine or not because when patient used to go the dentist and get a shot of novocain patient got a rapid heartbeat and the dentist said that was because of the epinephrine and patient said patient dont want that any more. But when patient got vaccine on tuesday patient had a few minutes of a very rapid heartbeat just like epinephrine in her Novocain. patient read the ingredient for Pfizer and patient didnt see epinephrine so patient did not worry about it patient was fine after few minutes but she gonna be getting her second shot in three weeks and she want to know if she going to have that experience again like worse. Patient did not compliant about this, she sat in the observation and waited the 15 minutes and got the rapid heartbeat for the first for five or some minute and then it went down and then it was fine. Next dose was on 06May2021. The patient underwent lab tests and procedures which included heart rate: rapid on an unspecified date. Outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 19Apr2021 07:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunization and experienced a bit of chills, goosebumps, sweating, fever, headache, sweating, and feeling nauseous. The patient received her second dose of Pfizer-Biontech Covid19 vaccine on 19Apr2021 around 7:30. She was reporting AEs of "being able to feel her heartbeat" that started later in the afternoon, after her dose. Then on Tuesday (Apr2021), she started to feel some dizziness and shortness of breath, feeling like she can't get a full breath in. She was most concerned about the shortness of breath. She also reported feeling "normal side effects" after both of her doses which include a fever, headache, sweating, and feeling nauseous after both doses. The patient was directed back to HCP for additional guidance. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 19Apr2021 07:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunization and experienced a bit of chills, goosebumps, sweating, fever, headache, sweating, and feeling nauseous. The patient received her second dose of Pfizer-Biontech Covid19 vaccine on 19Apr2021 around 7:30. She was reporting AEs of "being able to feel her heartbeat" that started later in the afternoon, after her dose. Then on Tuesday (Apr2021), she started to feel some dizziness and shortness of breath, feeling like she can't get a full breath in. She was most concerned about the shortness of breath. She also reported feeling "normal side effects" after both of her doses which include a fever, headache, sweating, and feeling nauseous after both doses. The patient was directed back to HCP for additional guidance. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oral herpes, Pain in extremity, Pruritus, Shoulder injury related to vaccine administration
Clinical narrative: Suspected shoulder injury related to vaccine administration, immobility due to incorrectly placed shot (too high/deep on shoulder); couldn't move for 3 days without intense pain; Suspected shoulder injury related to vaccine administration  immobility due to incorrectly placed shot (too high/deep on shoulder); couldn't move for 3 days without intense pain; Body chills followed by a fever blister developing on the bottom lip; Body chills followed by a fever blister developing on the bottom lip; Single hive on left arm and itchy scalp; Single hive on left arm and itchy scalp; This is a spontaneous report from a non-contactable consumer.   A 34-years-old non- Pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Age at vaccination 34 years), as dose 1, single for covid-19 immunization. Medical history included Mild asthma, Fibromyalgia, depression, anxiety IBS (Irritable bowel syndrome (IBS). Concomitant medications included sertraline hcl (ZOLOFT); gabapentin; levocetirizine dihydrochloride (XYZAL); ethinylestradiol, norgestimate (TRI-PREVIFEM); vitamin d3 (VITAMIN D3). The patient previously took chlorhexidine (cetrimide;chlorhexidine), Wellbutrin (Allergies to medications, food, or other products like Chlorhexidine, Wellbutrin). Most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced suspected shoulder injury related to vaccine administration, immobility due to incorrectly placed shot (too high/deep on shoulder); could not move for 3 days without intense pain; felt as if shoulder was dislocated, body chills followed by a fever blister developing on the bottom lip, single hive on left arm and itchy scalp. Patient did not receive any treatment for reported events. On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Suspected shoulder injury related to vaccine administration, immobility due to incorrectly placed shot (too high/deep on shoulder); couldn't move for 3 days without intense pain; Suspected shoulder injury related to vaccine administration  immobility due to incorrectly placed shot (too high/deep on shoulder); couldn't move for 3 days without intense pain; Body chills followed by a fever blister developing on the bottom lip; Body chills followed by a fever blister developing on the bottom lip; Single hive on left arm and itchy scalp; Single hive on left arm and itchy scalp; This is a spontaneous report from a non-contactable consumer.   A 34-years-old non- Pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Age at vaccination 34 years), as dose 1, single for covid-19 immunization. Medical history included Mild asthma, Fibromyalgia, depression, anxiety IBS (Irritable bowel syndrome (IBS). Concomitant medications included sertraline hcl (ZOLOFT); gabapentin; levocetirizine dihydrochloride (XYZAL); ethinylestradiol, norgestimate (TRI-PREVIFEM); vitamin d3 (VITAMIN D3). The patient previously took chlorhexidine (cetrimide;chlorhexidine), Wellbutrin (Allergies to medications, food, or other products like Chlorhexidine, Wellbutrin). Most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced suspected shoulder injury related to vaccine administration, immobility due to incorrectly placed shot (too high/deep on shoulder); could not move for 3 days without intense pain; felt as if shoulder was dislocated, body chills followed by a fever blister developing on the bottom lip, single hive on left arm and itchy scalp. Patient did not receive any treatment for reported events. On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depressed mood, Fatigue, Influenza like illness, Pain
Clinical narrative: Fatigue; Weak; Achiness; First shot got caller down for a week.; Flu-like symptoms; This is a spontaneous report from a contactable consumer, the patient. This case is for first dose. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200, Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Feb2021 evening, the patient experienced flu-like symptoms. Stated reaction was three to four days. First shot got caller down for a week. Took her down for about a week. It was about five days. She had fatigue and was weak. She clarified as aching all over, joints and muscles too like the flu. Was not running a fever after first dose. On 20Mar2021, she had achiness. Outcome of the event depressed mood, flu-like symptoms was resolved on 03Mar2021; achiness was resolved on 22Mar2021; for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Streptococcal infection
Clinical narrative: daughter received 1st dose and contracted Strep; This is a spontaneous report from a Pfizer. A contactable consumer reported for a female patient (daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), first dose via an unspecified route of administration on 01Apr2021 single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date daughter of reporter received 1st dose (on unspecified date) and contracted Strep - after 21st day and he (Parent) scheduled 2nd is scheduled for Friday 23Apr2021. The mother of patient tried to get in touch with the health department in her area, but could not get in touch with anyone there - suggested that she contact her doctors office. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia after receiving 2nd Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced tachycardia after receiving 2nd pfizer vaccine. Reporter stated he wants to talk to someone regarding tachycardia after receiving 2nd Pfizer vaccine yesterday. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Dysgeusia, Fatigue
Clinical narrative: weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; walked around for 15 minutes and just felt like a heaviness; anxiety; have like a fruity taste in the mouth, not fruity but just some taste lingering in the mouth; feeling flushed; feel swelling in face; dizzy; This is a spontaneous report from a contactable consumer (Reported for herself). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization at grocery store. The patient's medical history and concomitant medications were not reported. The consumer stated that she walked around the store for about half an hour and was okay but when she started driving home, she started experiencing side effects such as weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed. When she drank water, she noticed like a fruity taste in the mouth, not fruity but just some taste lingering in the mouth. She knew her heart rate went up because she saw her Heart rate go up on her exercise watch. Report was not related to a study or programme. The patient underwent lab tests and procedures which included heart rate: increased on an unspecified date. She wanted to know if all of this was normal. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Heart rate increased, Limb discomfort, Nausea
Clinical narrative: weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; walked around for 15 minutes and just felt like a heaviness; anxiety; have like a fruity taste in the mouth, not fruity but just some taste lingering in the mouth; feeling flushed; feel swelling in face; dizzy; This is a spontaneous report from a contactable consumer (Reported for herself). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization at grocery store. The patient's medical history and concomitant medications were not reported. The consumer stated that she walked around the store for about half an hour and was okay but when she started driving home, she started experiencing side effects such as weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed. When she drank water, she noticed like a fruity taste in the mouth, not fruity but just some taste lingering in the mouth. She knew her heart rate went up because she saw her Heart rate go up on her exercise watch. Report was not related to a study or programme. The patient underwent lab tests and procedures which included heart rate: increased on an unspecified date. She wanted to know if all of this was normal. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Taste disorder
Clinical narrative: weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed; walked around for 15 minutes and just felt like a heaviness; anxiety; have like a fruity taste in the mouth, not fruity but just some taste lingering in the mouth; feeling flushed; feel swelling in face; dizzy; This is a spontaneous report from a contactable consumer (Reported for herself). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization at grocery store. The patient's medical history and concomitant medications were not reported. The consumer stated that she walked around the store for about half an hour and was okay but when she started driving home, she started experiencing side effects such as weird taste in mouth, extremely tired, without energy, heartbeat going up, nauseated, feel swelling in face, pressure, heaviness and feeling flushed. When she drank water, she noticed like a fruity taste in the mouth, not fruity but just some taste lingering in the mouth. She knew her heart rate went up because she saw her Heart rate go up on her exercise watch. Report was not related to a study or programme. The patient underwent lab tests and procedures which included heart rate: increased on an unspecified date. She wanted to know if all of this was normal. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pain, Palpitations, Pyrexia
Clinical narrative: Palpitations; First Dose: Shortness of breath; Fever; Dose 1: body aches all over; Dose 1: Pressure in the chest; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733, Expiration date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 07Apr2021 (age at the vaccination 31-year-old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included narcolepsy from 2013 and ongoing. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) via unspecified route from unspecified date at 0.5 mg, once a day for narcolepsy. On 07Apr2021 patient got the first vaccine, she sat in the observation room for the 15 minutes and went home. When patient got home, patient called the location where she had gotten the vaccine. patient was having palpitations and shortness of breath. They told her to relax and that was one of the common side effects. However, patient did not see that listed on anything she was reading. Patient also had the fever and body aches all over and patient also felt like someone run her over, and pressure in chest. Patient did not visit emergency room and Physician office. Patient took Tylenol for the treatment of fever. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Heart rate, Pain
Clinical narrative: Tachycardia (heart rate as high as 182); Fever (as high as 103.2 even on ibuprofen); Body aches; Headache; Injection site pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 11:30 (at the age of 17-year-old) as dose 2, single for COVID-19 immunization. Medical history included, known allergies: Some foods (banana, avocado, almonds, cucumbers, some raw vegetables) from an unknown date and unknown if ongoing and patient did not have other medical history. Concomitant medication(s) included cetirizine hydrochloride (ZYRETIC); pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]); levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported (other medications the patient received within 2 weeks of vaccination). Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot number: unknown), administered in Left arm on 13Apr2021 11:30 AM (at the age of 17-year-old) for COVID-19 Immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03May2021 15:00, patient experienced tachycardia (heart rate as high as 182), fever (as high as 103.2 even on ibuprofen), body aches, headache, injection site pain, joint pain. Patient received 400 mg ibuprofen as treatment for adverse events. The events were assessed as non-serious, did not results in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included Fever: 103.2 on 03May2021 (as high as 103.2), heart rate: 182 on 03May2021 (Tachycardia (heart rate as high as 182)). Therapeutic measures were taken as a result of tachycardia (heart rate as high as 182), fever (as high as 103.2 even on ibuprofen), body aches, headache, injection site pain, joint pain. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Vaccination site pain
Clinical narrative: Tachycardia (heart rate as high as 182); Fever (as high as 103.2 even on ibuprofen); Body aches; Headache; Injection site pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 11:30 (at the age of 17-year-old) as dose 2, single for COVID-19 immunization. Medical history included, known allergies: Some foods (banana, avocado, almonds, cucumbers, some raw vegetables) from an unknown date and unknown if ongoing and patient did not have other medical history. Concomitant medication(s) included cetirizine hydrochloride (ZYRETIC); pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]); levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported (other medications the patient received within 2 weeks of vaccination). Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot number: unknown), administered in Left arm on 13Apr2021 11:30 AM (at the age of 17-year-old) for COVID-19 Immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03May2021 15:00, patient experienced tachycardia (heart rate as high as 182), fever (as high as 103.2 even on ibuprofen), body aches, headache, injection site pain, joint pain. Patient received 400 mg ibuprofen as treatment for adverse events. The events were assessed as non-serious, did not results in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included Fever: 103.2 on 03May2021 (as high as 103.2), heart rate: 182 on 03May2021 (Tachycardia (heart rate as high as 182)). Therapeutic measures were taken as a result of tachycardia (heart rate as high as 182), fever (as high as 103.2 even on ibuprofen), body aches, headache, injection site pain, joint pain. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lethargy, Pain, Rash
Clinical narrative: Partial body rash on left side; Extreme lethargy; Weakness in left side; Dull ache on left side; This is a spontaneous report from a contactable consumer. A 73-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) Dose 2 via an unspecified route of administration, administered in the right arm on 06Apr2021 at 11:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant drugs were not reported. The patient previously received the first dose of BNT162b2 on 13Mar2021 (Lot Number: EN6204) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Apr2021 (starting 6 days post 2nd vaccine), the patient experienced partial body rash on left side, extreme lethargy, weakness in left side, and dull ache on left side. The patient received antivirals for 7 days, and currently on corticosteroids as treatment for the events. The patient had not recovered from the events, partial body rash on left side, extreme lethargy, weakness in left side, and dull ache on left side.
Sex: M
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: That second one reactivated lymphedema; This is a spontaneous report from a contactable consumer (patient's wife) reported for a male patient (reporter's husband). This is the second case out of two cases. A male patient of unknown age received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EN6208, Expiration date: Unknown), via an unspecified route in the left shoulder on 18Mar2021 as a single dose for covid-19 immunization. Medical history included diabetes, cancer, overweight, blood pressure high, thyroid, asthma and glands removed/ skin cancers removed all the time one skin cancer went too deep and went into his glands and they removed that was 3 years ago I believe that is June 13th. Concomitant medications included levothyroxine for thyroid, pioglitazone for diabetes, budesonide, formoterol fumarate (SYMBICORT) for asthma and salbutamol (ALBUTEROL HFA) for asthma. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EN6198, Expiration date: Unknown), via an unspecified route in the left shoulder on 25Feb2021, as a single dose for covid-19 immunization. On an unknown date, patient experienced reactivated lymphedema. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 7 days after severe tinnitus in right ear. Very high pitched tone; This is a spontaneous report from contactable consumer, the patient. This 49-year-old male patient reported that he received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: ER8727) via an unspecified route in the left arm in Mar2021 at 11:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. 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. Concomitant medications included phenytoin (DILANTIN) and atorvastatin. The patient reported that 7 days after, on 27Mar2021, he experienced severe tinnitus in the right ear. He described it as a very high pitched tone occurring constantly 24 hours a day and still there today. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event which included prednisone and a hearing aid. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Iridocyclitis
Clinical narrative: unilateral nongranulomatous anterior uveitis; This is a spontaneous report from a contactable physician. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 15Apr2021(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Patient medical history was reported as none. Concomitant medication was not provided. The patient previously received the 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. It was unknown, if prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Apr2021, the patient experienced unilateral non-granulomatous anterior uveitis. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with topical steroid(unspecified). The clinical outcome of the event unilateral non-granulomatous anterior uveitis was recovered unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Iridocyclitis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Feeling chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 13:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient had no known allergies. Concomitant drugs included vitamins (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. 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. On 06May2021 the patient experienced feeling chills and body aches. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events feeling chills and body aches was unknown at the time of report.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: large red rash that hurt, itched; large red rash that hurt; was hot to the touch on arm where shot was given; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm right on 27Apr2021 at 08:00(at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported she has allergy to several things. Concomitant medications included allergy shot - armsB taken on 17Mar2021and others(Yes, but more than will fit in this space) were reported but name not specified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 06Apr2021 at 08:30(at the age of 76-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 the patient experienced tiredness, headache, muscle and joint pain, fever, feeling unwell, dizziness, large red rash that hurt, itched, and was hot to the touch on arm where shot was given and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events that included treatment with steroid cream, Benadryl. The clinical outcome of the events  tiredness, headache, muscle and joint pain, fever, feeling unwell, dizziness, large red rash that hurt, itched, and was hot to the touch on arm where shot was given and nausea were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: large red rash that hurt, itched; large red rash that hurt; was hot to the touch on arm where shot was given; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm right on 27Apr2021 at 08:00(at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported she has allergy to several things. Concomitant medications included allergy shot - armsB taken on 17Mar2021and others(Yes, but more than will fit in this space) were reported but name not specified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 06Apr2021 at 08:30(at the age of 76-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 the patient experienced tiredness, headache, muscle and joint pain, fever, feeling unwell, dizziness, large red rash that hurt, itched, and was hot to the touch on arm where shot was given and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events that included treatment with steroid cream, Benadryl. The clinical outcome of the events  tiredness, headache, muscle and joint pain, fever, feeling unwell, dizziness, large red rash that hurt, itched, and was hot to the touch on arm where shot was given and nausea were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: large red rash that hurt, itched; large red rash that hurt; was hot to the touch on arm where shot was given; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm right on 27Apr2021 at 08:00(at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported she has allergy to several things. Concomitant medications included allergy shot - armsB taken on 17Mar2021and others(Yes, but more than will fit in this space) were reported but name not specified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 06Apr2021 at 08:30(at the age of 76-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 the patient experienced tiredness, headache, muscle and joint pain, fever, feeling unwell, dizziness, large red rash that hurt, itched, and was hot to the touch on arm where shot was given and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events that included treatment with steroid cream, Benadryl. The clinical outcome of the events  tiredness, headache, muscle and joint pain, fever, feeling unwell, dizziness, large red rash that hurt, itched, and was hot to the touch on arm where shot was given and nausea were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Heavy Heart Palpitations; Chest Pain; Breath Issues- Heavily Breathing; Chest Feels Heavy; High Blood Pressure; Anxiety; Scared for everything/fear; Dizziness; Head revolving; tension; getting irritated; feel like shout and cry a lot; Sweating in legs and hands inside; Feeling tired; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8736) via an unspecified route of administration on 19Apr2021 at 14:30 (at the age of 40-years-old) in left arm as a single dose for covid-19 immunization. The patient previously took Perinorm injection for nausea and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Concomitant medication received within 2 weeks of vaccination included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40) taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: ER8732) on 25Mar2021 at 10:00 in left arm for covid-19 immunization. The patient experienced heavy heart palpitations, breath issues- heavily breathing, chest feels heavy, high blood pressure, sweating in legs and hands inside, scared for everything/fear, feeling tired, dizziness, head revolving, anxiety was coming for everything like crying a lot so that anxiety was reduced, getting anxiety for work pressure/delivery on time/if miss timelines, any noise/sounds, he got irritated, chest pain, tension and she felt like shout and cry a lot on 20Apr2021 at 22:00. The events were assessed as non-serious. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was treated with aspirin tablets. Post vaccination, the patient had been tested for covid-19. The patient underwent lab tests and procedures on 22Apr2021 which included SARS-COV-2 (COVID-19) test and RSV by PCR both nasal swab: negative, Influenza A and B by PCR (nasal swab): negative. The outcome of all the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Fear, Feeling abnormal, Hyperhidrosis, Hypertension
Clinical narrative: Heavy Heart Palpitations; Chest Pain; Breath Issues- Heavily Breathing; Chest Feels Heavy; High Blood Pressure; Anxiety; Scared for everything/fear; Dizziness; Head revolving; tension; getting irritated; feel like shout and cry a lot; Sweating in legs and hands inside; Feeling tired; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8736) via an unspecified route of administration on 19Apr2021 at 14:30 (at the age of 40-years-old) in left arm as a single dose for covid-19 immunization. The patient previously took Perinorm injection for nausea and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Concomitant medication received within 2 weeks of vaccination included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40) taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: ER8732) on 25Mar2021 at 10:00 in left arm for covid-19 immunization. The patient experienced heavy heart palpitations, breath issues- heavily breathing, chest feels heavy, high blood pressure, sweating in legs and hands inside, scared for everything/fear, feeling tired, dizziness, head revolving, anxiety was coming for everything like crying a lot so that anxiety was reduced, getting anxiety for work pressure/delivery on time/if miss timelines, any noise/sounds, he got irritated, chest pain, tension and she felt like shout and cry a lot on 20Apr2021 at 22:00. The events were assessed as non-serious. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was treated with aspirin tablets. Post vaccination, the patient had been tested for covid-19. The patient underwent lab tests and procedures on 22Apr2021 which included SARS-COV-2 (COVID-19) test and RSV by PCR both nasal swab: negative, Influenza A and B by PCR (nasal swab): negative. The outcome of all the events was not resolved.  No follow-up attempts are needed. No further information is expected.