chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chills; dizzy; aching all over; fever; felt like she had the flu; joint pain that was quite painful all over/had an attack with pains in her shoulders/joint pain attack; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: and expiry date was not provided) via an unspecified route of administration, on 16Feb2021 (at the age of 85-year-old), as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: and expiry date was not provided) via an unspecified route of administration, on 25Jan2021 (at the age of 85-year-old), as a single dose for COVID-19 immunization. It was reported that the events happened after the second dose of the vaccine. The patient received the second dose of the Pfizer BioNTech COVID 19 vaccine on 16Feb2021. A couple of days after, on 19Feb2021, patient had chills, patient was dizzy, aching all over, had a fever, and it felt like she had the flu. These symptoms resolved within a day, she felt better the next morning when she woke up. A few weeks later, the patient thinks it was 01Mar2021, she began having joint pain that was quite painful all over. The joint pain seems to be worse at night than during the day. Last night the patient had a joint pain attack, it was extreme, the patient wanted to die. It was in the patient's shoulders, knees, and joints. Patient has been prescribed 3 or 4 medications and opioids, none of which have worked.  She took one of the pills last night and 6 hours later, she had an attack with pains in her shoulders, knees and joints. The reporter and patient called 911 but they did not take the patient to the hospital or admit her. The patient took one of her opioids last night- Tramadol HCL 50mg and 6 hours later the joint pain attack happened. The Tramadol did not help the patient's pain, in fact it made it worse. Tramadol HCL 50mg tablet- NDC, lot, expiration date unknown. The medication is in a pharmacy bottle and the print is so small the patient can hardly read it. The patient was following up with her doctor who also prescribed a steroid which she will pick up later today. The reporter and patient completed the VAERS form already on this event. The patient had blood work done yesterday (18May2021), and her doctor said there was no indication of anything wrong with the blood work. Outcome of the events chills, dizzy, aching all over, fever and felt like she had the flu was recovered on 20Feb2021 and joint pain was recovered on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Acute Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (lot number: EW0151), via an unspecified route of administration in left arm on 09Apr2021 12:30 at single dose for COVID-19 immunisation. Medical history included anemia, depression, anxiety, obsessive-compulsive disorder (OCD), endometriosis, and known allergies: Cashews, pecans, and pistachios. Concomitant medications included topiramate (TOPAMAX), bupropion, buspirone, and doxycycline. The patient experienced acute appendicitis on 09Apr2021 20:45. Immediate laparoscopic appendectomy (surgery removed appendix) was required by the emergency room (department or urgent care). The patient was hospitalized for acute appendicitis for 2 days. Patient was recovering. Patient also received the second dose of BNT162B2 (lot number: EW0165), via an unspecified route of administration in left arm on 30Apr2021 12:30 at single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Facial paralysis, Hypoaesthesia
Clinical narrative: CDC is looking into Pfizer being the catalyst for my stroke; I had the droop on right side of my face; my right arm was going numb; This is a spontaneous report from a Non-contactable consumer (patient) via Pfizer sales representative. This consumer (patient) reported that an unknown age and gender patient received 2nd dose of BNT162B2 at single dose for Covid-19 Immunisation. Medical history was diabetic neuropathy. Concomitant drugs were not reported. Historical Vaccine was 1st dose of BNT162B2 for Covid-19 Immunisation. The CDC is looking into Pfizer being the catalyst for my stroke (Life-threatening). It pretty much exacerbated my current diabetic neuropathy problem. Which as why covid is dangerous for diabetic people. So when I got 2nd dose. I started to notice something was wrong the following Friday. My right arm was going numb and I could not understand what I was writing on the computer and it felt like my right hand and my left hand were switching as I typed. Which Is a clear indicator that something was affecting my brain (several strokes happened in the coronata radiata that is on the left side of our brain and it affected my speech and my right side of my body). And then ability to speak was next to go and my reading comprehension. And of course I had the droop on right side of my face that happened on Saturday. Good thing I'm left handed or my writing would have been affected. I should have went to the ER on that Friday. But I ended up thinking I could sleep it Off. I didn't go to the ER until that Sunday. Cause I kept thinking I can sleep it off. Once you notice the sign don't be like me. Go to the ER quickly. They can give you something to reverse it if you catch it on time. It was too late for me if I had gone on Friday they would have saved me. But still I am getting better. So I'm not regretting my decision to take the vaccine. I know if had gotten the more severe variant of the virus I would died. So this complication is nothing. As long as I'm getting better and people can understand me and I will be alight. Something was wrong the following Friday. I wish to return to work once my right hand is up to speed. I'm on leave. They want me back too. I feel like matter at my job. They appreciate me. I don't get paid because it's been less than a year. 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: Cough
Clinical narrative: dry cough; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of Bnt162b2 for covid-19 immunisation. Patient reports he got the second Covid shot a couple days ago and has a dry cough on an unspecified date in May2021. Patient wants to know if that is something regular or valid to have. The outcome of the event was unknown.  Information on batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Dyspnoea, Heart rate abnormal, Heart rate decreased
Clinical narrative: coughing; throat started closing; couldn't breath; my heart rate was going down; shakes; could not swallow; This is a spontaneous report received from a contactable consumer (patient) from Medical Information Team. A female consumer of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: unknown), via an unspecified route of administration on 12May2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the 1st dose of the Pfizer COVID 19 vaccine on 12May2021, and she kept on coughing and her throat started closing, she couldn't breath, her heart rate was going down, she had the shakes. The patient could not swallow. They called the ambulance and took her to the Hospital. The patient received an Epi-pen and Benadryl. She had an IV. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tremor
Clinical narrative: coughing; throat started closing; couldn't breath; my heart rate was going down; shakes; could not swallow; This is a spontaneous report received from a contactable consumer (patient) from Medical Information Team. A female consumer of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: unknown), via an unspecified route of administration on 12May2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the 1st dose of the Pfizer COVID 19 vaccine on 12May2021, and she kept on coughing and her throat started closing, she couldn't breath, her heart rate was going down, she had the shakes. The patient could not swallow. They called the ambulance and took her to the Hospital. The patient received an Epi-pen and Benadryl. She had an IV. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infection; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 13May2021, as a single dose for covid-19 immunization. The patient medical history included asthma. The patient's concomitant medications were not reported. The patient previously took penicillin for Lung stuff and experienced Anaphylaxis. On May2021, the patient experienced bladder infection. It was reported as received her first dose of the vaccine on 13May2021 and started taking antibiotics for a bladder infection on Monday. Her antibiotic regimen will last for 5 days. Reports her reaction to penicillin was a long time ago, she has asthma and was always treated with penicillin for lung stuff, but that was a long time ago. Caller states since then, she never took penicillin, even the pills, she tries to avoid that. Stated earlier she got the first dose of the vaccine and right now she was taking antibiotics and she was scheduled for the second dose on 03Jun2021. Transferring agent states the caller is wondering if that was okay if she can get the second dose. The outcome of the event was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: ulcers in her mouth; This is a spontaneous report from a non-contactable consumer (parent). This consumer reported for the patient (reporter's niece) that A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ulcers in her mouth on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DVT and PE; DVT and PE; This is a spontaneous report from a contactable Physician. This Physician reported that a 54-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot No.unknown) at single dose for COVID-19 immunisation on unknown date. Relevant medical history included Migraines, CAD, CKD III, morbid obesity, and allergy to sulfa. Relevant concomitant drugs included escitalopram oxalate (LEXAPRO), levothyroxine sodium (SYNTHROID), topiramate (TOPAMAX), metoprolol succinate (TOPROL-XL). No other vaccine was admitted in four weeks. The patient experienced DVT (deep vein thrombosis) and PE (pulmonary embolism) on 19May2021. Doctor or other healthcare professional office/clinic was visited. Emergency room/department or urgent care required. The patient was hospitalized for 2 days. Treatment therapy included anticoagulation. The outcome of events was resolving. The events were reported as serious (hospitalization and life-threatening). The patient did not have COVID tested post vaccination.  Information on the lot/batch number has been requested; Sender's Comments: The reported deep vein thrombosis and pulmonary embolism are considered unrelated to BNT162B2 vaccine. No details on the administration date of vaccine were provided. The presence of morbid obesity and chronic kidney disease (CKD) are considered possible contributory factors for the 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.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Blood test, Diarrhoea, Fatigue, Investigation
Clinical narrative: Diarrhea, for 19 days after first vaccine; Tired, after first vaccine; lost 5 pounds; This is a spontaneous report received from a contactable consumer (patient himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number: Unknown, Expiration Date: Unknown), via an unspecified route of administration on 26Apr2021 at 1st dose, single for COVID-19 immunization. The patient's medical history included asthma, chronic bronchitis and congestive heart failure. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included Feces test: no indication that he has any systemic problems, blood test: no indication that he has any systemic problems, Urine sample: no indication that he has any systemic problems on an unspecified date. The patient experienced diarrhea, for 19 days after first vaccine, tired, after first vaccine, lost 5 pounds all are on an unspecified date in 2021. The events assessed as non-serious. The outcome of the events was unknown.  Information about batch/lot number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Diarrhea, for 19 days after first vaccine; Tired, after first vaccine; lost 5 pounds; This is a spontaneous report received from a contactable consumer (patient himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number: Unknown, Expiration Date: Unknown), via an unspecified route of administration on 26Apr2021 at 1st dose, single for COVID-19 immunization. The patient's medical history included asthma, chronic bronchitis and congestive heart failure. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included Feces test: no indication that he has any systemic problems, blood test: no indication that he has any systemic problems, Urine sample: no indication that he has any systemic problems on an unspecified date. The patient experienced diarrhea, for 19 days after first vaccine, tired, after first vaccine, lost 5 pounds all are on an unspecified date in 2021. The events assessed as non-serious. The outcome of the events was unknown.  Information about batch/lot number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Cold sweat, Fatigue, Loss of consciousness
Clinical narrative: cold and clammy; is not energetic like normal; she is feeling a little bit anxious and she feels like her strength is not yet fully recovered.; she is feeling a little bit anxious and she feels like her strength is not yet fully recovered.; passed out; Vomiting; tired; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 04May2021 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was administered as first dose on 12Apr2021. Patient was not ill at the time of vaccination. The patient medical history and concomitant medications were not reported. She says well the first one is just the start, where it has the first dose. She clarifies she received the product so that her husband would be safe since he had his vaccine she figured she would get it too. He has a lot of health issues so she figured she should get it, now she wishes she had not but it is okay. She confirms for COVID 19 prevention. She says she takes no medications other than just Tylenol if she has a headache. On 05May2021 patient experienced passed out at 08:30AM, vomiting at 01:00 and tired. She would say the vomiting stopped at 5 am on 05May2021. This started 05May2021 for sure. The tiredness is ongoing, because last night she went to bed at 7, she is not doing half of what she used to do. It is awkward she does not know what else to blame but the vaccine. She is not energetic like normal, she is a healthy person. The tiredness has improved but she still has it. Also experienced cold and clammy, is not energetic like normal, she is feeling a little bit anxious and she feels like her strength is not yet fully recovered (anxiety and asthenia) on an unspecified date. Time the Vaccination Was Given as her appointment was at 10 so it was within 20 minutes. She would say it was 10:20 AM or so and then she had to wait 15 minutes. Her husband, when she came to, he wanted to call the paramedics she said no, she was fine. He called the Paramedics and they took vitals, they checked blood sugar, checked oxygen, EKG, blood pressure, O2 and everything was okay, all her vital signs were okay. They wanted to take her to the ER but since her vitals were okay she did not want to go into the ER with all the sick people so she had to sign a waver and they told her to follow up with her doctor. She is feeling better than how was but she doesn't feel that she is at 100 percent and she is a healthy person she didn't even want to get the vaccine. The outcome of the event fatigue was recovering and all the other events was unknown.   Follow-up (19May2021): This is a spontaneous report from a Pfizer-sponsored program. A 63-year-old female consumer (patient) reported that, added with event onset date and time.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: cold and clammy; is not energetic like normal; she is feeling a little bit anxious and she feels like her strength is not yet fully recovered.; she is feeling a little bit anxious and she feels like her strength is not yet fully recovered.; passed out; Vomiting; tired; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 04May2021 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was administered as first dose on 12Apr2021. Patient was not ill at the time of vaccination. The patient medical history and concomitant medications were not reported. She says well the first one is just the start, where it has the first dose. She clarifies she received the product so that her husband would be safe since he had his vaccine she figured she would get it too. He has a lot of health issues so she figured she should get it, now she wishes she had not but it is okay. She confirms for COVID 19 prevention. She says she takes no medications other than just Tylenol if she has a headache. On 05May2021 patient experienced passed out at 08:30AM, vomiting at 01:00 and tired. She would say the vomiting stopped at 5 am on 05May2021. This started 05May2021 for sure. The tiredness is ongoing, because last night she went to bed at 7, she is not doing half of what she used to do. It is awkward she does not know what else to blame but the vaccine. She is not energetic like normal, she is a healthy person. The tiredness has improved but she still has it. Also experienced cold and clammy, is not energetic like normal, she is feeling a little bit anxious and she feels like her strength is not yet fully recovered (anxiety and asthenia) on an unspecified date. Time the Vaccination Was Given as her appointment was at 10 so it was within 20 minutes. She would say it was 10:20 AM or so and then she had to wait 15 minutes. Her husband, when she came to, he wanted to call the paramedics she said no, she was fine. He called the Paramedics and they took vitals, they checked blood sugar, checked oxygen, EKG, blood pressure, O2 and everything was okay, all her vital signs were okay. They wanted to take her to the ER but since her vitals were okay she did not want to go into the ER with all the sick people so she had to sign a waver and they told her to follow up with her doctor. She is feeling better than how was but she doesn't feel that she is at 100 percent and she is a healthy person she didn't even want to get the vaccine. The outcome of the event fatigue was recovering and all the other events was unknown.   Follow-up (19May2021): This is a spontaneous report from a Pfizer-sponsored program. A 63-year-old female consumer (patient) reported that, added with event onset date and time.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 test
Clinical narrative: Late miscarriage at 18 weeks gestation. Fetal demise.; This is a spontaneous report from a contactable nurse.  A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced late miscarriage at 18 weeks gestation. fetal demise on 11May2021 12:00.  The mother was 18 weeks pregnant at the onset of the event.  The mother was due to deliver on 10Oct2021.  The mother delivered the pregnancy on 11May2021. Patient had Nasal swab (NP and rapid) on 17May2021 and the result was negative. Treatment: Delivery of fetus, D&C of remaining undelivered placenta. Event resulted to doctor or other healthcare professional office/clinic visit, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event). The outcome of the event was recovering.  Information about the Lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event late miscarriage at 18 weeks gestation. fetal demise cannot be excluded based on temporal association and available information. 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 Authorities, Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Tired; This is a spontaneous report from a Pfizer sponsored program .  This consumer (reporters mother) reported for a male patient (son). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported that her son, the patient, took both doses of the Covid-19 vaccine with very minimal, usual side effects. Caller declined to complete safety report. Caller reported that the patient experienced just the usual, expected side effects. Caller reported that the patient had a headache and was just tired. The event seriousness could not be specified by reporter. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Paraesthesia, SARS-CoV-2 test, Syncope
Clinical narrative: Feeling faint; dizzy; shaky; racing heart began 10 minutes after 1st shot.; Sense of dizziness and vertigo has persisted now; ringing in ears; tingling sensation in back of neck, legs and feet; This is a spontaneous report from a contactable consumer (reported for herself). This 49-year-old not pregnant female received first dose of BNT162B2 (Solution for injection, Lot number was not reported) via an unspecified route of administration in left arm on 03May2021 08:00 AM, as first dose, single for COVID-19 immunization. Medical history included migraine headaches. The patient had known allergies: Doxycycline, latex, sensitivity to Relpax, Minocyclin, aspartame and stevia. Did not receive any concomitant medications within two weeks of suspect. On 03May2021 08:15 AM, the patient experienced feeling faint, dizzy, shaky, racing heart began 10 minutes after first shot, sense of dizziness and vertigo had persisted for 2 1/2 weeks later episodes of racing heart and feeling faint, ringing in ears, tingling sensation in back of neck, legs and feet. She did not receive any treatment for events. She did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. She was tested post vaccination: Saliva pool test on 07May2021 and on 14May2021 was Negative. The outcome of the events of Feeling faint, dizzy, shaky, racing heart began 10 minutes after 1st shot, Sense of dizziness and vertigo has persisted now, ringing in ears, and tingling sensation in back of neck, legs and feet was not recovered.  Information about lot/batch number had been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Tremor, Vertigo
Clinical narrative: Feeling faint; dizzy; shaky; racing heart began 10 minutes after 1st shot.; Sense of dizziness and vertigo has persisted now; ringing in ears; tingling sensation in back of neck, legs and feet; This is a spontaneous report from a contactable consumer (reported for herself). This 49-year-old not pregnant female received first dose of BNT162B2 (Solution for injection, Lot number was not reported) via an unspecified route of administration in left arm on 03May2021 08:00 AM, as first dose, single for COVID-19 immunization. Medical history included migraine headaches. The patient had known allergies: Doxycycline, latex, sensitivity to Relpax, Minocyclin, aspartame and stevia. Did not receive any concomitant medications within two weeks of suspect. On 03May2021 08:15 AM, the patient experienced feeling faint, dizzy, shaky, racing heart began 10 minutes after first shot, sense of dizziness and vertigo had persisted for 2 1/2 weeks later episodes of racing heart and feeling faint, ringing in ears, tingling sensation in back of neck, legs and feet. She did not receive any treatment for events. She did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. She was tested post vaccination: Saliva pool test on 07May2021 and on 14May2021 was Negative. The outcome of the events of Feeling faint, dizzy, shaky, racing heart began 10 minutes after 1st shot, Sense of dizziness and vertigo has persisted now, ringing in ears, and tingling sensation in back of neck, legs and feet was not recovered.  Information about lot/batch number had been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Pyrexia
Clinical narrative: stabbing headache on the upper left side that was like a migraine; Chills; Fever; Coughing straining or bending; This is a spontaneous report from a contactable consumer (patient himself). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration in left arm on an unspecified date at 11:15 (at the age 30-year-old) as a single dose to prevent COVID/ COVID-19 immunization. The patient's medical history and concomitant medications were none. Family history included mother also experienced fever. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration in left arm on 23Apr2021 (at the age of 30-year-old) as a single dose for COVID-19 immunization. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer suspect was none. It was reported that, caller was reporting additional adverse events after getting the second dose of the COVID-19 vaccine on Friday. He had chills the following day on 15May2021. He had to wait 15 minutes after getting the vaccine. He had fever on 15May2021. He took one dose of 500mg Tylenol and felt ok. He had a stabbing headache on the upper left side that was like a migraine on 16May2021. It worsened with coughing straining or bending on an unspecified date in 2021. He was fine when he was relaxed. The headache was still ongoing. The headache started on Sunday. Should he be worried or not. Was there anything additional that he could take or not. Questioned he received the second dose of the vaccine on Friday or not. Was it worth it to call the state health department or not. He had a fever the same date as chills. The fever was a slower onset. No investigation assessment. No relevant tests. The adverse events did not require a visit to emergency room and physician office. The patient was treated with Tylenol 500mg for the events fever and chills. The outcome of the event headache was not recovered, recovered on an unspecified date in 2021 for the event cough and recovered on 15May2021 for the other events.  Description of product complaint: He had a stabbing headache on the upper left side that was like a migraine. He took one dose of 500mg Tylenol and felt ok. It worsened with coughing straining or bending. He was fine when he was relaxed. The headache was still ongoing. Product strength and count size dispensed: Tylenol 500mg.   Follow-up attempts are needed. Further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash
Clinical narrative: The morning after the 2nd shot, I woke up with a rash that looks like a bruise on my chin.; The morning after the 2nd shot, I woke up with a rash that looks like a bruise on my chin.; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 33-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0186) via an unspecified route of administration in Arm Left on 17May2021 13:45 (at the age of 33-years-old) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included norethindrone taken. 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 vaccination. On 18 May 2021 in morning after the 2nd shot, he woke up with a rash that looks like a bruise on his chin. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Poor quality product administered, Product preparation error
Clinical narrative: arm hurting, sore arm; vaccine was mixed with sterile water instead of saline; vaccine was mixed with sterile water instead of saline; felt unwell after her 2nd dose; tired and does not feel great; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 2nd dose, single dose, via an unspecified route of administration on 18May2021 11:45, for covid-19 immunization (at the age of 18-years-old). Medical history included covid-19. It has been a couple of years since patient had not received any other vaccine. There were no concomitant medications. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown), via an unspecified route of administration on 27Apr2021, as single dose for covid-19 immunization at the age of 17-years-old and had really high fever, ears really hurting, Ears got so puffy and filled with fluid. It was stated, that her 18-year-old daughter already received both doses of the Pfizer-BioNTech Covid-19 Vaccine. She said her daughter was 17 years old when she received the 1st dose, but was 18 years old when she had her 2nd dose. She said her daughter had a really bad reaction to the 1st dose, and also felt unwell after her 2nd dose. The reporter stated that on 18May2021 11:45 the patient received second dose of vaccine and stated that someone from pharmacy told that patient's vaccine was mixed with sterile water instead of saline and after receiving the vaccine the patient felt unwell and she was tired and does not feel great on an unspecified date in May2021 and on 19May2021 patient's arm was hurting and had sore arm. Reporter wanted to know if her daughter gets revaccinated or whether she was still fully vaccinated. She was referred to her health care provider for that information. Pfizer has not tested the effects of using sterile water for injection as the diluent for the current formulation of the Pfizer-BioNTech COVID-19 Vaccine. The diluted vaccine using sterile water for injection as the diluent should be appropriately discarded and not used for vaccination. The Pfizer-BioNTech COVID-19 Vaccine has not been tested with sterile water for injection as the diluent. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Full blood count, Thrombocytopenia
Clinical narrative: I do have thrombocytopenia that was down on a CBC; I might be in remission for 3 years and it suddenly ended up coming back; I have been diagnosed with it in the past and I do not know if that has been flared up but I do have thrombocytopenia that was down on a CBC; This is a spontaneous report from a contactable consumer (patient, self-reporting). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included thrombocytopenia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient has been diagnosed with it in the past and patient do not know if that has been flared up but patient do have thrombocytopenia that was down on a CBC but doubt this for years like said that was why it might not be a side effect; it might be in remission for 3 years and it suddenly ended up coming back. Patient was perfectly fine and counts were in comfortable number. Patient see haematologist every 6 weeks anyway was back on blood work within few days. It was nothing bad, just wanted to report any kind of information that patient can help with more than willing to give you guys. patient thank god for this vaccine, it was being a life saviour for everybody and so was just trying to help basically. The patient underwent lab tests and procedures which included full blood count: CBC on unspecified date. The outcome of the events was unknown.   In response to further probing, consumer stated, "I am more than willing to do that, you are breaking up again." Consumer hung up the call abruptly, hence, product details (LOT, expiration date, NDC and UPC) and other details were unknown. Limited information was available over the call.  No follow-up attempts needed, information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: terrible headache; This is a spontaneous report from a contactable consumer (Patient). A female patient with an unknown age received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE, Lot number and expiration date was not provided) via an unspecified route on an unknown date as a single dose for COVID-19 immunization. Medical history included sinus headache and she have problems in the springtime. Concomitant medications were not reported. On an unspecified date, patient experienced terrible headache. Patient states that she is due for the second Pfizer shot tomorrow at 09:45am. She took 2 Advil because she was having a terrible headache. She took it at 6:00 this morning. She enquired if she should get the shot tomorrow or not. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Malaise, Nausea, Pain
Clinical narrative: Fever; Chills; Body aches; No energy; Vomiting; Nauseous; Just don't feel like sitting up; This is a spontaneous report from a contactable consumer (the patient). A 45-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, in left arm on 19May2021 17:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included iron deficiency anemia, migraines and pulmonary embolism (reported as PE's) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to 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 20May2021 03:00, the patient experienced fever, chills, body aches, no energy, vomiting, nauseous, just don't feel like sitting up. The consumer considered events as non-serious. The patient did not receive treatment for adverse events.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever; Chills; Body aches; No energy; Vomiting; Nauseous; Just don't feel like sitting up; This is a spontaneous report from a contactable consumer (the patient). A 45-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, in left arm on 19May2021 17:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included iron deficiency anemia, migraines and pulmonary embolism (reported as PE's) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to 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 20May2021 03:00, the patient experienced fever, chills, body aches, no energy, vomiting, nauseous, just don't feel like sitting up. The consumer considered events as non-serious. The patient did not receive treatment for adverse events.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Caller reports that she is running a fever today in which the fever was 100 degrees Fahrenheit; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, she received the first dose of the Pfizer Covid-19 vaccine yesterday and she is running a fever today in which the fever was 100 degrees Fahrenheit earlier today and is now 100.9 degrees Fahrenheit. Outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: her first dose on 07May2021. On 14May2021 the caller tested positive for the covid virus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07May2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14May2021, the patient tested positive for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14May2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pain in extremity
Clinical narrative: cold symptoms; My arm is sore; feel congested like when I get sick; This is a spontaneous report from a non-contactable consumer (patient) via Medical information team. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 19May2021 (at the age of 29-years-old) at first dose, single for COVID-19 immunization. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that he had cold symptoms. He thought he had allergies before the shot because he would usually get them about this time of year and it would start to act up. The patient's arm was also sore and felt that it was something he had before the shot because they were kind of similar and he just felt congested like when gets sick. Additionally, the patient wanted to know how long he has to wait to take medications like Nyquil or Dayquil. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Implant site pain, Paraesthesia
Clinical narrative: this morning woke up with tingling in her finger tips on the arm that she received the vaccine in; she has a birth control, Nexplanon, implanted in opposite arm and that site has pain in it as well; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route, administered in the arm, on 19May2021, as first dose,single, for COVID-19 immunization.  The patient's medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON) implanted in opposite arm for birth control. On the morning of 20May2021, the patient woke up with tingling in her finger tips on the arm that she received the vaccine in and wanted to know if this was a side effect of the vaccine. She also stated that she had a birth control implanted in opposite arm and that site had pain in it as well, which she has not experienced that before. The outcome was unknown for both the events.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Phlebitis superficial
Clinical narrative: she said she developed superficial phlebitis; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program COVAX US support. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16May2021 as single dose for COVID-19 immunization. Medical history included Blood clots. The patient's concomitant medications were not reported. On May2021, she developed superficial phlebitis. Stated, she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 16May2021. Afterwards, she said she developed superficial phlebitis. She said she previously had issues with blood clots so when she heard that there were reports of blood clots with the Johnson and Johnson vaccine, she specifically selected the Pfizer Covid vaccine. She wants to know if the reaction she had is a known side effect of the vaccine, what she should do, and if there are any protocols on how to treat it. The outcome of the event was unknown.