chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pain in extremity, Peripheral swelling, Suicidal ideation
Clinical narrative: I felt like I had blood clots; because of the buzzing feeling going through my body.; my arm hurt very bad; my tongue swelled up; I was extremely ill; I was suicidal for the first time in my life; 10 days after first shot my arm swelled up; This is a spontaneous report from a contactable consumer (patient reported for herself). A 53-year-old no-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 at 12:00 (at the age of 53-year-old) as single for covid-19 immunisation. The patient medical history included asthma and osteoarthritis. The patient had no known allergies. Concomitant medications included Alprazolam (XANAX) and Fluticasone propionate (FLOVENT), all taken for an unspecified indication, start and stop date were not reported. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 as single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 since the vaccination. 06May2021 20:00,10 days after first shot, patient arm swelled up and later that night she was suicidal for the first time in her life and had to call for help. She stated that she had photos and video of a magnet sticking to her arm on 27May2021, 03Jun2021 and 17Jun2021. After 17Jun2021, In Jun2021, the patient arm hurt very bad, her tongue swelled up and she was extremely ill. She stated that she would never do it again. She felt like she had blood clots on 17Jun2021 because of the buzzing feeling going through my body. No treatment was received to treat the events. The reporter assessed the event as non serious. It was reported that the events were not resulted into the seriousness criteria of death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The patient was resolved from all the events on an unspecified date in 2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: I felt like I had blood clots; because of the buzzing feeling going through my body.; my arm hurt very bad; my tongue swelled up; I was extremely ill; I was suicidal for the first time in my life; 10 days after first shot my arm swelled up; This is a spontaneous report from a contactable consumer (patient reported for herself). A 53-year-old no-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 at 12:00 (at the age of 53-year-old) as single for covid-19 immunisation. The patient medical history included asthma and osteoarthritis. The patient had no known allergies. Concomitant medications included Alprazolam (XANAX) and Fluticasone propionate (FLOVENT), all taken for an unspecified indication, start and stop date were not reported. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 as single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 since the vaccination. 06May2021 20:00,10 days after first shot, patient arm swelled up and later that night she was suicidal for the first time in her life and had to call for help. She stated that she had photos and video of a magnet sticking to her arm on 27May2021, 03Jun2021 and 17Jun2021. After 17Jun2021, In Jun2021, the patient arm hurt very bad, her tongue swelled up and she was extremely ill. She stated that she would never do it again. She felt like she had blood clots on 17Jun2021 because of the buzzing feeling going through my body. No treatment was received to treat the events. The reporter assessed the event as non serious. It was reported that the events were not resulted into the seriousness criteria of death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The patient was resolved from all the events on an unspecified date in 2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Herpes zoster, Syncope
Clinical narrative: Shingles requiring medical emergency. Fainting and low heart rate.; Shingles requiring medical emergency. Fainting and low heart rate.; Shingles requiring medical emergency. Fainting and low heart rate.; This is a spontaneous report from a contactable nurse (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206) via an unspecified route of administration, in the left arm on 11May2021 (at the age of 42-years-old) as dose 2, single for covid-19 immunisation. Medical history included IBS (irritable bowel syndrome). Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Known allergies were not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, in the left arm on 16Apr2021 as dose 1, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any vaccines within four weeks prior to the vaccination. On 02Jun2021, the patient experienced shingles requiring medical emergency. Fainting and low heart rate. Patient received treatment for event were medications. Adverse events resulted in emergency room/department or urgent care. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Palpitations, Renal pain
Clinical narrative: Heart Palpitations; severe Angina was completely out of the norms; Heart Palpitations; severe Angina was completely out of the norms; Kidney Problem; This is a spontaneous report from a contactable consumer.   A 42-year- old male patient received  BNT162B2 (sPFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot no: EW0183), via unspecified route as dose 1, single, on on 18Jun2021 for COVID-19 immunisation.The patient had had Covid in Feb2020 and he sustained at the time that he had really severe kidney pain. The patient concomitant medication was not reported. On 18June2021, the patient stated that Within 3 hours of vaccination, he experienced heart palpitations raised, severe Angina because that completely out of the norms for him and he never had a heart problem that kind of result and he was in the Emergency Room of the Hospital  The patient was out of the Emergency Room by 10 o clock (18Jun2021) but now he has same kidney problem that he had half and Year ago, severe kidney pain. He had been experiencing that kidney issue all over again. When probed for any treatment for the problems (events), reporter stated, The local Hospital said to take Ibuprofen, lots of water and bed rest but he has not taken anything yet and also on Pedialyte Electrolyte. He was released from the Hospital at 10 o clock on 18Jun2021 because the heart palpitations and severe Angina resolved itself over about the period of about 4 hours. The outcome of events kidney pain was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart beat little bit fast/at this point he is on 119 and he is on he is been risking all day; This is a spontaneous report received from a contactable consumer (patient's parent).   A 13-year-old adolescent male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 19Jun2021 (at the age of 13-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) received on 28May2021 (at the age of 12-year-old) for covid-19 immunisation. On 20Jun2021, the patient experienced heart beat little bit fast/at this point he was on 119 and he had been risking all day. It was reported that patient was 13 years old just yesterday, he had the second dose of Pfizer for COVID and today he had been feeling the little bit like a with a heartbeat little bit fast. Heartbeat rate was checked and on the day of this report (reported as this afternoon) with 109 and then just checked again increased to 116, so for somebody on his age the range should be in between the 60 and 100 and at this point he was on 119 and he had been risking all day. The patient underwent laboratory tests and procedures which included heart rate: 109 on 20Jun2021 and heart rate: 116 on 20Jun2021. The outcome of event was reported as not re-solved.   Information on the lot/batch number had been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphoedema, White blood cell count, White blood cell count abnormal
Clinical narrative: White blood cells were below 1 on Monday, repeat labs Wednesday they were above 1; Worsening lymphedema since Jan2021 or Feb2021; Joints hurt; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 02Jun2021 (age at vaccination: 57-year-old) as dose number unknown, single for COVID-19 immunization. Medical history of the patient included adhesive tape allergy, iodine tincture allergy, lymphedema (worsening lymphedema since Jan2021 or Feb2021). Concomitant medications included Tocopherol (Vitamin E), naproxen sodium (Aleve), fulvestrant (Faslodex), Levothyroxine, Multivitamin capsule, Vitamin D for unspecified indication, started and stopped on an unspecified date. Patient previously took Macrobid on an unspecified date for an unspecified indication and experienced allergy. On an unspecified date in Jun2021, patient white blood cells were below 1 on Monday and her white blood cells were above 1 on Wednesday, worsening lymphedema since Jan2021 or Feb2021, joints hurt. MD is aware. Outcome of the events were unknown.  Information about lot/batch number has been requested.; Sender's Comments: Limited information of white blood cell count prior to vaccine preclude a comprehensive causality assessment, underlying medical conditons of lymphedema and allergy may be contributory to events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Blood test, Dizziness, Electroencephalogram, Seizure
Clinical narrative: She did have a seizure 3 times Saturday morning. She was admitted to Hospital Saturday, I went to emergency ward with her and she was kept overnight for observation; she felt dizzy; she had 3 auras, auras is very close to having seizures; This is a spontaneous report from a contactable consumer, parent. A 42-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 17Jun2021 19:30 (Thursday night) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included epilepsy from an unknown date and unknown if ongoing. No concomitant medications were reported. Patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 29May2021 as DOSE 1, SINGLE for COVID-19 immunization and experienced no reaction on previous exposure to vaccine. On an unspecified date, patient felt dizzy. On Saturday morning (19Jun2021), patient had 3 auras, auras were very close to having seizures. Patient did have a seizure 3 times Saturday morning. Patient was admitted to Hospital Saturday at night around 8'oclock PM, went to emergency ward and patient was kept overnight for observation the Saturday night and released on 20Jun2021. Patient had epilepsy but nothing major and according the neurologist that was she attending stated it was possible that receiving her second dose brought only auras and the seizures. The patient underwent blood test: unknown results, electroencephalogram: unknown results. The outcome of the events was unknown.  Follow-up attempts are needed. Information on Lot/Batch number was available.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Heart rate increased, Muscle tightness
Clinical narrative: difficulty breathing/had a very difficult time breathing; fast heart rate/rapid heart rate; contraction in the chest near the heart or the abdomen; some muscle tightness/tightness in the chest that was muscle tightness; This is a spontaneous report from a contactable consumer (patient's wife) reported for a patient. This is the first case out of two cases. A 47-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 19Jun2021 in the evening (age at vaccination was 47 years) as 1st dose, single for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. The reporter stated that she was calling because her husband and she went to the (Facility Address), yesterday at 1 O' Clock and got a shot for COVID and she had 2 side effects but she was okay, her husband had some side effects that were not really listed here under severe or more common side effects. On 19Jun2021 at 21:30 pm, last night the patient had tightness in the chest that was muscle tightness difficulty breathing and a rapid heart rate. They give them a paper work after getting the shot which listed some common side effects but not all possible side effects. It just listed few of the severe ones and then some common less severe side effect but it did not mention anything about some muscle tightness, contraction in the chest near the heart or the abdomen and difficulty breathing and a fast heart rate which was what her husband had been experiencing since last night had a very difficult time breathing but he was not allergic, he was not swelling, he didn't have a rash. The reporter confirmed that it was Pfizer COVID 19 Vaccine. No treatment was received for the adverse events. The reporter stated that it has not been resolved and it was still persisting the last time he had checked his heart rate because he was a runner and right now its 101 that was the resting heart which was high for him he normally had very low heart rate like 67 it was 136 about 20 minutes ago, it was raising without exercising. The reporter was informed about the Pfizer Medical Information. The reporter was also advised to visit nearby healthcare profession in the case of emergency. This case LRN W2021388441 was cross linked with LRN W2021388442. The outcome of the event fast heart rate/rapid heart rate was not resolved. The outcome of the other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Headache
Clinical narrative: He is seeing his urine color as red after the vaccine. He is having the problem still today. Every time when he passes urine he sees the color red.; Dose 1: headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 28May2021 at 6:45 pm -7 pm (age at vaccination: 35 years), as a single dose for COVID-19 immunization. The patient took covid 19 vaccine because everybody was getting the vaccine and he might go back to the office. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date in Jun2021, he was seeing his urine color as red after the vaccine. He was having the problem still today. Every time when he passes urine he sees the color red. The patient was not sure if what he was experiencing was a normal side effect of the vaccine. He hasn't seen his experience listed on the list, so he just wanted to check. The patient also stated that he has seen this before when he has had a beet root, but for the past two days he has never had a beet root. He had a headache 3 or 4 days before he received the second vaccine (Dose 1: headache). He took Tylenol for the headache. Headache occurred in the evening on Monday or Tuesday before the vaccine, he was not really sure. He stated maybe 6:14-6:15 pm for onset. Complete recovery the same day. Outcome of the events was recovered on an unspecified date in Jun2021.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure diastolic decreased, Blood pressure measurement, Syncope
Clinical narrative: I was standing up for less than 5 mins, and ended up fainting. I took my blood pressure a few hours later, and my diastolic blood pressure was low: 117/53; I was standing up for less than 5 mins, and ended up fainting. I took my blood pressure a few hours later, and my diastolic blood pressure was low: 117/53; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Jun2021 at 10:45 am (age at vaccination was 36 years) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication the patient received within 2 weeks of vaccination included ethinylestradiol, norethisterone acetate (AUROVELA 1.5/30) taken for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 29May2021 at 11:00 am as 1st dose, single for COVID-19 immunization and did not experience any adverse event. The patient previously took nuts and experienced food allergy. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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. Since the vaccination, the patient has not been tested for COVID-19. On 20Jun2021 at 17:15 pm, the patient was standing up for less than 5 mins, and ended up fainting. She took her blood pressure a few hours later, and her diastolic blood pressure was low: 117/53. The patient underwent lab tests which included blood pressure: 117/53 on 20Jun2021. No treatment was received for the adverse events. The device date was reported as 21Jun2021. The outcome of events was resolved on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Suicidal ideation, Tinnitus
Clinical narrative: Can't take the ringing in her ears any more and is getting a little suicidal; Took the Pfizer Covid-19 vaccine and it gave her ringing in the ears; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she took the Pfizer COVID-19 vaccine, and it gave her ringing in the ears. She couldn't take the ringing in her ears anymore and was getting a little suicidal. The patient also reported that no doctors could help her and that she needed to speak with someone that can tell her what to do. Outcome of the events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Gait disturbance, Joint swelling
Clinical narrative: Joint pain started in her hands, they were painful and swollen/ moved to her right side of her arm/ in her upper arm and was in her feet and toes; Joint pain started in her hands, they were painful and swollen/ moved to her right side of her arm/ in her upper arm and was in her feet and toes; Caller states this is debilitating, she can't even walk up the steps without her toes killing her; This is a spontaneous report from a contactable consumer (patient). A female patient about 49-year-old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18May2021 10:00 (Batch/Lot Number: EW0167) as dose 2, single for covid-19 immunisation. Patient age at vaccination was 48 years old. Medical history included ongoing neck and back pain. Historical vaccine included 1st dose of BNT162B2 (LOT: EW0176) on 27Apr2021 at 10:00 on left arm for covid-19 immunisation. Patient age at 1st dose of vaccination was 48 years old. The patient's concomitant medications were not reported. She experienced joint pain after her second dose and went to her physician and she had several tests. She did blood work to see if she was Lyme's, arthritis and it wasn't. Joint pain began in the end of May2021, beginning of Jun2021. Caller confirmed joint pain had worsened. It was debilitating, she can't even walk up the steps with her toes killing her. It started in her hands, they were painful and swollen. It moved to her right side of her arm and she couldn't use it. It was in her upper arm and was in her feet and toes. Her doctor put her on prednisone. Outcome of the events was not resolved.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Seizure
Clinical narrative: Seizure episodes on the next day of vaccination ( Mother is a physician and took care of her at home); This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in the left arm on 17Jun2021 (at the age of 15 years old) as dose 2, single for COVID-19 immunisation in a Pharmacy/drug store. Medical history included Pollen allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the paitent was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration, administered in the left arm on 27May2021 (at the age of 15 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient experienced seizure episodes on the next day of vaccination on 18Jun2021. The patient's mother is a physician and took care of her at home. The event resulted to Doctor or other healthcare professional office/clinic visit. Treatment was not given in response to the event. Since the vaccination, the patient had been tested for COVID-19 with RT-PCR salivary test on 25Mar2021 which was negative. The outcome of the event was recovering. The consumer assessed the event as non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: breathing issues; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0185) at single dose for COVID-19 immunisation on 04Jun2021 (61-year-old at vaccination). Relevant history included Lyme Disease. Relevant concomitant drug was unknown. The patient previously received the first dose of BNT162B2 (Lot number: EW0176) at single dose for COVID-19 immunisation on 14May2021 with not reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced breathing issues on 04Jun2021. The event caused to Emergency room/department or urgent care visit, and the patient was hospitalized. The outcome of the event was not resolved. Unknown if treatment received or not. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dysphonia, SARS-CoV-2 antibody test
Clinical narrative: AFib; His voice is hoarse today.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Feb2021 19:00 (Batch/Lot Number: EN6201) as dose 2, single for covid-19 immunisation. Patient age at vaccination was 79 years old. Medical history included ongoing COPD (chronic obstructive pulmonary disease), ongoing emphysema, ongoing high blood pressure (he couldn't say, it has to have been a good 15 years he has had it), ongoing high cholesterol (he had it for over 10 years), ongoing Low red blood cell count (depending on his blood count, they give him either a Vitamin B shot or Procrit), ongoing idiopathic pulmonary fibrosis. Both of his parents had type 2 diabetes, and he had type 2 diabetes. Historical vaccine included 1st dose of BNT162B2 (Lot no: EL9263) on 25Jan2021 at 19:00 in left arm for COVID-19 Immunization and flu shot back on October for immunization. Concomitant medications included prednisone (It was for his lungs (unspecific). It was prescribed by his lung doctor. It affected the immune system. He took 10mg. He was taking 5mg then they changed it to 10mg about a month ago. He had taken it for maybe 1 and a half to 2 years); epoetin alfa (PROCRIT) taken for red blood cell count decreased, he only took it as needed when his count was below 10. He had not taken it in 6 months; losartan taken for high blood pressure, from May2021 and ongoing (It was new, he started it about a month ago); amlodipine taken for high blood pressure from May2021 and ongoing (He had been taking it for about a month); atorvastatin taken for blood cholesterol increased from an unspecified start date and ongoing (He had taken it for a couple years); nintedanib esilate (OFEV) taken for idiopathic pulmonary fibrosis from an unspecified start date and ongoing (He had been on it for about a year). The patient experienced AFib on an unspecified date with outcome of recovered. His voice was hoarse today (21Jun2021) with outcome of unknown. He stated he spent 4 days in the hospital and got his rhythm back to normal after 2 days. They put him on apixaban (ELIQUIS), which was a blood thinner. The AFib has resolved, he had no problem with it anymore. The patient underwent lab tests which included COVID-19 antibody test: negative on both 09Jun2021 and 16Jun2021. His HCP told him it was due to prednisone that lowers his immune system.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Muscle spasms, Vaginal haemorrhage
Clinical narrative: Bleeding excessively; It was 4 days early and was the worse period she has experienced in 3 years; Extreme cramps; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female (non-pregnant) patient received 1st dose of BNT162B2 (lot#EW0196) on 30May2021 11:00 AM, vaccine location=Left arm at single dose for COVID-19 immunization. Relevant medical history was Asthma. No any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination included salbutamol (ALBUTEROL), paracetamol (TYLENOL) as needed. It was 4 days early and was the worse period she has experienced in 3 years. She was bleeding excessively and extreme cramps on 02Jun2021. We thought maybe it was a coincidence. She is only 15 yrs old and has had her period for 3 years and has never experienced anything like what she has in the last month. She is due for her next period on 29Jun2021 and I pray it was not as bad as last month after the shot. Outcome of reaction/event at the time of last observation was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow up attempts needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: A patient had a second trimester fetal loss right after getting the Covid vaccine.; A patient had a second trimester fetal loss right after getting the Covid vaccine.; This is a spontaneous report from a contactable physician. An adult female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at an unknown dose on an unknown date via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. Medical history and concomitant drug were not provided. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had 32 weeks gestation period. Patient had a "second trimester" (as reported) fetal loss right after getting the Covid vaccine. The event onset date was Jun2021. Treatment received for the event. It was unknown if the patient diagnosed with COVID-19 prior to vaccination, and unknown if the patient been tested for COVID-19 since the vaccination.   The report was assessed as serious with seriousness criteria of hospitalization.   Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported events miscarriage.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, COVID-19, Chills
Clinical narrative: 103 degree fever; deep cough; chills; body aches; nasal congestion; loss of taste; loss of smell; as well as an earache; Despite receiving both vaccine doses, I tested positive for COVID-19 on 6/16.; Despite receiving both vaccine doses, I tested positive for COVID-19 on 6/16.; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). This 30-year-old male patient received bnt162b2 (brand: Pfizer), dose 1 via an unspecified route of administration, administered in arm left on 27Feb2021 (Batch/Lot Number: EN6205) as dose 1, single; dose 2 via an unspecified route of administration, administered in arm left on 16Mar2021 (Batch/Lot Number: EN6207) as dose 2, single for covid-19 immunisation at the age of 30-year-old. The patient medical history and concomitant medications were not reported. The patient previously took buspirone cox and experienced drug allergy. It was unknown that if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Hospital. Despite receiving both vaccine doses, patient tested positive for COVID-19 on 16Jun2021. Patient had somewhat severe symptoms; 103 degree fever, deep cough, chills, body aches, nasal congestion, and loss of taste and smell, as well as an earache. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: covid test type post vaccination: Nasal Swab on 17Jun2021 (as reported) with result positive. No treatment for events. The outcome of event was recovering.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Ear pain, Inappropriate schedule of product administration, Nasal congestion
Clinical narrative: 103 degree fever; deep cough; chills; body aches; nasal congestion; loss of taste; loss of smell; as well as an earache; Despite receiving both vaccine doses, I tested positive for COVID-19 on 6/16.; Despite receiving both vaccine doses, I tested positive for COVID-19 on 6/16.; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). This 30-year-old male patient received bnt162b2 (brand: Pfizer), dose 1 via an unspecified route of administration, administered in arm left on 27Feb2021 (Batch/Lot Number: EN6205) as dose 1, single; dose 2 via an unspecified route of administration, administered in arm left on 16Mar2021 (Batch/Lot Number: EN6207) as dose 2, single for covid-19 immunisation at the age of 30-year-old. The patient medical history and concomitant medications were not reported. The patient previously took buspirone cox and experienced drug allergy. It was unknown that if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Hospital. Despite receiving both vaccine doses, patient tested positive for COVID-19 on 16Jun2021. Patient had somewhat severe symptoms; 103 degree fever, deep cough, chills, body aches, nasal congestion, and loss of taste and smell, as well as an earache. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: covid test type post vaccination: Nasal Swab on 17Jun2021 (as reported) with result positive. No treatment for events. The outcome of event was recovering.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: 103 degree fever; deep cough; chills; body aches; nasal congestion; loss of taste; loss of smell; as well as an earache; Despite receiving both vaccine doses, I tested positive for COVID-19 on 6/16.; Despite receiving both vaccine doses, I tested positive for COVID-19 on 6/16.; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). This 30-year-old male patient received bnt162b2 (brand: Pfizer), dose 1 via an unspecified route of administration, administered in arm left on 27Feb2021 (Batch/Lot Number: EN6205) as dose 1, single; dose 2 via an unspecified route of administration, administered in arm left on 16Mar2021 (Batch/Lot Number: EN6207) as dose 2, single for covid-19 immunisation at the age of 30-year-old. The patient medical history and concomitant medications were not reported. The patient previously took buspirone cox and experienced drug allergy. It was unknown that if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Hospital. Despite receiving both vaccine doses, patient tested positive for COVID-19 on 16Jun2021. Patient had somewhat severe symptoms; 103 degree fever, deep cough, chills, body aches, nasal congestion, and loss of taste and smell, as well as an earache. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: covid test type post vaccination: Nasal Swab on 17Jun2021 (as reported) with result positive. No treatment for events. The outcome of event was recovering.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myocarditis, Pain, Pyrexia
Clinical narrative: myocarditis; fever; ache; lethargy; This is a spontaneous report from a contactable consumer (patient's grandfather). A 13-year-old male patient received bnt162b2 (BNT162B2), first single dose and second single dose, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation at age of 13-year-old. Medical history concomitant medications were none. Caller stated that he was inquiring for his 13 years old grandson who was very healthy, active, athletic, on no medications, and with no medical problems. He went on to report that when he received the first dose of the vaccine he had a very strong response to it that included; fever, ache, lethargy, and more. When he had the second dose he had a very similar reaction but worse. He stated that the doctors were thinking that his symptoms could be related to possible myocarditis. The caller explained he was encouraged to call by the pediatrician. The caller reported that his grandson just had his second dose of the Pfizer vaccine and with both doses he had, not a terrible one, but a reaction after both doses. His grandson was not on other medications or had any chronic conditions or acute conditions, he was healthy. Outcome of the events was unknown.   Information about batch/ lot number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Sudden hearing loss and tinnitus in my right ear.; Sudden hearing loss and tinnitus in my right ear.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6957), via an unspecified route of administration at the age of 45-year-old administered in arm left on Mar2021 (01:15PM) at single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. There was no Covid tested post vaccination. Concomitant medications were none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications the patient received within 2 weeks of vaccination. The patient had no past drug event. The patient experienced sudden hearing loss and tinnitus in his right ear on 31Mar2021. His hearing has not improved since the onset of the sudden hearing loss. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Disability or permanent damage. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Since the vaccination, the patient hasn't been tested for COVID-19. This report was reported as serious. Seriousness criteria was reported as disabling/Incapacitating. The patient received prednisone shots in his right ear. oral prednisone. The outcome of events was not recovered.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Myocardial necrosis marker, Sinus tachycardia
Clinical narrative: tachycardia the day after the second dose / sinus tachycardia; This is a spontaneous report received from a contactable consumer (patient). A 13-year-old female patient received bnt162b2 (Pfizer COVID-19 vaccine), second single dose via an unspecified route of administration, administered in arm left on 06Jun2021 12:00 (Batch/Lot Number: EW0180) for covid-19 immunisation at age of 13-year-old (non-pregnant). The patient previously received first single dose of bnt162b2 on 14May2021 at 12 :00 PM (lot/Batch: EW9168) at arm left at age of 13-year-old. Medical history included juvenile idiopathic arthritis. Concomitant medication included methotrexate sodium and folic acid. 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. The patient experienced tachycardia the day after the second dose on 07Jun2021 at 12:00 and had constant tachycardia since. She was in the hospital overnight. Cardiac enzymes and chest x-ray and echocardiogram were normal on 07Jun2021. EKGs showed sinus tachycardia on 07Jun2021. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the event was not recovered. Since the vaccination, the patient had not been tested for COVID-19.   Information on Lot/Batch number was available.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: have received the Pfizer vaccine, and have autoimmune disease.; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient reported that she had received the pfizer vaccine and had experienced autoimmune disease. I am concerned about not knowing how effective the vaccine was in people like me. I would like to participate in a study for booster shots. How many visits were required. Please send me information about qualifying for the study and any other information I might need. Outcome of the event was reported as Unknown.   Follow-up attempts are possible. Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: Numbness and tingling head, foot, arm, fingers and face; fatigue; lightheaded ness; foggy brain; Numbness and tingling head, foot, arm, fingers; This is a spontaneous report from a contactable consumer(patient). A 40-year old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8732), via an unspecified route of administration at Arm Left in MAR2021 at 40 years old at single dose for COVID-19 immunization.  The medical history was Hypothyroidism and diagnosed with COVID-19. The concomitant medications were liothyronine sodium(CYTOMEL) for Thyroid and Synthesis. The patient was not pregnant. There was no other vaccine in four weeks. On 22Mar2021 the patient experienced Numbness and tingling head, foot, arm, fingers and face, Foggy brain, fatigue and lightheaded ness 6 periods in 3 months (beginning the day after my first vaccine). Two ER visits to rule out serious medical conditions, two MRIs, blood work, and 2 day hospital stay. All of the events resulted in Emergency Room Visit and Physician Office Visit. All of the events resulted in hospitalized from 2021 to 2021(duration of 2 days). The patient received the treatment Gabapentin for Numbness and tingling head, foot, arm, fingers and face. The patient received the second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0170822021), via an unspecified route of administration at Arm Left 18-APR-2021 11:15 at single dose for COVID-19 immunization. There was covid prior vaccination. The patient underwent lab tests and procedures, which included blood work Unknown result; MRI Unknown Result; MRI Unknown Result; PCR on 07Jun2021: Negative. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Numbness and tingling head, foot, arm, fingers and face; fatigue; lightheaded ness; foggy brain; Numbness and tingling head, foot, arm, fingers; This is a spontaneous report from a contactable consumer(patient). A 40-year old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8732), via an unspecified route of administration at Arm Left in MAR2021 at 40 years old at single dose for COVID-19 immunization.  The medical history was Hypothyroidism and diagnosed with COVID-19. The concomitant medications were liothyronine sodium(CYTOMEL) for Thyroid and Synthesis. The patient was not pregnant. There was no other vaccine in four weeks. On 22Mar2021 the patient experienced Numbness and tingling head, foot, arm, fingers and face, Foggy brain, fatigue and lightheaded ness 6 periods in 3 months (beginning the day after my first vaccine). Two ER visits to rule out serious medical conditions, two MRIs, blood work, and 2 day hospital stay. All of the events resulted in Emergency Room Visit and Physician Office Visit. All of the events resulted in hospitalized from 2021 to 2021(duration of 2 days). The patient received the treatment Gabapentin for Numbness and tingling head, foot, arm, fingers and face. The patient received the second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0170822021), via an unspecified route of administration at Arm Left 18-APR-2021 11:15 at single dose for COVID-19 immunization. There was covid prior vaccination. The patient underwent lab tests and procedures, which included blood work Unknown result; MRI Unknown Result; MRI Unknown Result; PCR on 07Jun2021: Negative. The outcome of the events was not recovered.