chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis Flare; 54-years-old male patient received 3rd dose of BNT162B2; 54-years-old male patient received 3rd dose of BNT162B2; This is a solicited report based on information received by Pfizer from a contactable consumer (patient) (Mfr. Control No.: 21K-163-4102312-00). A 54-years-old male patient received bnt162b2, intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single, intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 2, single, intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 3, single for COVID-19 immunisation; adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for moderate to severe rheumatoid arthritis. Solicited report from the a consumer of a 54-year-old adult male with an event of rheumatoid arthritis flare with HUMIRA (adalimumab). There was no reported medical history. The patient's concomitant medications were not reported. On an unknown date, the patient experienced rheumatoid arthritis flare. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer/BioNTech. Primary reporter did not have the lot number information, because the packaging was discarded. The outcome of the event rheumatoid arthritis flare up was recovering/resolving. The reporter's causality for the event of rheumatoid arthritis flare was not provided to Humira, was possible to bnt162b2.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Rheumatoid arthritis and BNT162B2.  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: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: they had a friend who also had shingles after getting the vaccine; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that, on an unknown date, the patient had shingles after getting the vaccine and she was told by her friend not to get the vaccine again since shingle was a common side effects of the vaccine. The reporter knew this patient who got shingles after the vaccine and it went in their ear too. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101317559 same reporter/drug/AE, different patient
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Pain in arm; Shoulder pain; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from regulatory authority, manufacturer report number: 21K-163-4100453-00. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular on 01Apr2021 (Batch/Lot number was not reported; at the age of 56 years old) as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, citrate free for moderate to severe rheumatoid arthritis. Medical history included moderate to severe rheumatoid arthritis. Concomitant medication included methotrexate for unknown indication. The patient previously received first dose of BNT162B2, intramuscular on 01Mar2021 (Batch/Lot number was not reported; at the age of 56 years old) for COVID-19 immunisation. Solicited report from the (country) by a consumer of an adult male with events of non-serious (as reported) flare up of rheumatoid arthritis, sore arm, and shoulder pain with Humira (adalimumab). On an unspecified date in 2021, the patient experienced flare up of rheumatoid arthritis (also reported as rheumatoid arthritis flare up), sore arm, and shoulder pain. Pfizer-BioNTech COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The patient has not recovered from rheumatoid arthritis flare up. The outcome of sore arm and shoulder pain was unknown. The reporter's causality for the events of flare up of rheumatoid arthritis with adalimumab was a reasonable possibility; the reporter's causality for the events of sore arm and shoulder pain with adalimumab was no reasonable possibility.   The reporter's assessment of the causal relationship of the events flare up of rheumatoid arthritis, sore arm, and shoulder pain with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events are assessed as unrelated to BNT162B2, but likely related to the patient underlying rheumatoid arthritis.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Adiposis dolorosa, Contusion, Neoplasm progression, Off label use, Pain
Clinical narrative: Steadily sharp increase in dercum's pain; Steadily sharp increase in dercum's pain; swelling; bruising; Dercums tumors from days 2-7; other vaccine same date product=Flu shot, other vaccine same date vaccine date=26Sep2021; other vaccine same date product=Flu shot, other vaccine same date vaccine date=26Sep2021; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2588) via an unspecified route of administration, administered in Arm Left on 26Sep2021 12:15 (at the age of 58-years-old) as dose 3, booster, single for COVID-19 immunization. The patient received influenza vaccine (FLU VACCINE VII), (Batch/Lot number was not reported) via an unspecified route of administration from 26Sep2021 to 26Sep2021, as dose 1, single for an unspecified indication. Medical history included known allergies: Beef, known allergies: pepper, Dercum's Disease (progressed; a rare progressive connective tissue disorder) by 2 researchers several years ago.), Lipedema, Diabetes 2 and Fibromyalgia. Concomitant medications included duloxetine hydrochloride (CYMBALTA); buspirone (BUSPIRONE). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:00 PM (at the age of 58-years-old) as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm left on 23Mar2021 15:30 PM (at the age of 58-years-old) as dose 2, single for COVID-19 immunization. No COVID prior to the vaccination. COVID not tested post vaccination. On 26Sep2021, the patient received other vaccine same date product=flu shot, other vaccine same date vaccine date=26sep2021. On 27Sep2021 12:00, the patient experienced steadily sharp increase in dercum's pain, swelling, bruising and dercums tumors from days 2-7. There is no reliable treatments for Dercums. No treatment was given for adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Swelling
Clinical narrative: Steadily sharp increase in dercum's pain; Steadily sharp increase in dercum's pain; swelling; bruising; Dercums tumors from days 2-7; other vaccine same date product=Flu shot, other vaccine same date vaccine date=26Sep2021; other vaccine same date product=Flu shot, other vaccine same date vaccine date=26Sep2021; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2588) via an unspecified route of administration, administered in Arm Left on 26Sep2021 12:15 (at the age of 58-years-old) as dose 3, booster, single for COVID-19 immunization. The patient received influenza vaccine (FLU VACCINE VII), (Batch/Lot number was not reported) via an unspecified route of administration from 26Sep2021 to 26Sep2021, as dose 1, single for an unspecified indication. Medical history included known allergies: Beef, known allergies: pepper, Dercum's Disease (progressed; a rare progressive connective tissue disorder) by 2 researchers several years ago.), Lipedema, Diabetes 2 and Fibromyalgia. Concomitant medications included duloxetine hydrochloride (CYMBALTA); buspirone (BUSPIRONE). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:00 PM (at the age of 58-years-old) as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm left on 23Mar2021 15:30 PM (at the age of 58-years-old) as dose 2, single for COVID-19 immunization. No COVID prior to the vaccination. COVID not tested post vaccination. On 26Sep2021, the patient received other vaccine same date product=flu shot, other vaccine same date vaccine date=26sep2021. On 27Sep2021 12:00, the patient experienced steadily sharp increase in dercum's pain, swelling, bruising and dercums tumors from days 2-7. There is no reliable treatments for Dercums. No treatment was given for adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a Spontaneous report received from a contactable other-health care professional, based on the information received by a Regulatory Authority. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 25Apr2021, at dose1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Aug2021,the patient experienced COVID-19. The outcome of the event was recovered on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: My throat immediately started to swell; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration into left arm, at the age of 38-year-old, on unknown date, at dose 2 single for covid-19 immunisation.  Historical vaccine included BNT162B2 (COMIRNATY, solution for injection; lot numbers and expiry dates were not reported) via an unspecified route of administration into left arm, on unknown date, at dose 1, single for covid-19 immunisation. Patient medical history includes shellfish allergy. The patient didn't have any hospitalization.The patient concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have prior COVID vaccination and was not tested post vaccination. The patient experienced throat immediately started to swell. The patient didn't have any treatment in response to the event. The outcome of the event was recovered at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product administered to patient of inappropriate age, SARS-CoV-2 test
Clinical narrative: contracted with Covid-19 (confirmed diagnosis) from vaccinated parents; contracted with Covid-19 (confirmed diagnosis) from vaccinated parents; 7-year-old male received BNT162B2; This is a spontaneous report from a non-contactable consumer via a Representative. A 07-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted with COVID-19 (confirmed diagnosis) from vaccinated parents. The patient was on inhalers and steroids to overcome respiratory symptoms. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urea, Chest pain, Electrocardiogram, Fear, Investigation
Clinical narrative: It was a short pain it made my arm week; Start pain like I am having heart attack and I can''t stop maybe it''s just like a chest pain like some bad spicy food like something pretty serious/I felt the first severe chest pain.; It was a short pain it made my arm week.; I was scared; This is a spontaneous report from a contactable consumer (patient himself). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FC3183, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 25Sep2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 45 years). The patient medical history included nephrolithiasis (He have kidney stone sometimes his kidney stone but kidney stone but not have now, He had over the years or approx.,15 years, no, currently he has no medical condition. It was reported that, patient was healthy before vaccination and did not take any other products before vaccination. The patient's concomitant medications were not reported. On 25Sep2021, the patient experienced start pain like he had a heart attack, and he cannot stop. Maybe it is just like a chest pain like some bad spicy food like something pretty serious/He felt the first severe chest pain (he still having the chest pain and the chest pain continues and does not stop in a while, it was like if he asks his doctor and sit out for like a trying lay down), it was a short pain it made his arm weak, he was scared. Patient visited emergency room as a result of events. The patient underwent lab tests and procedures which included blood urea: normal (kidney function was normal), X-RAY of ribs: normal (does not had crack and my vitals were normal), vitals: normal and EKG: normal on an unspecified date. Therapeutic measures were taken as a result of start pain like he had a heart attack, and he cannot stop. Maybe it is just like a chest pain like some bad spicy food like something pretty serious/He felt the first severe chest pain include Tylenol. The outcome of the events was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, X-ray
Clinical narrative: It was a short pain it made my arm week; Start pain like I am having heart attack and I can''t stop maybe it''s just like a chest pain like some bad spicy food like something pretty serious/I felt the first severe chest pain.; It was a short pain it made my arm week.; I was scared; This is a spontaneous report from a contactable consumer (patient himself). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FC3183, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 25Sep2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 45 years). The patient medical history included nephrolithiasis (He have kidney stone sometimes his kidney stone but kidney stone but not have now, He had over the years or approx.,15 years, no, currently he has no medical condition. It was reported that, patient was healthy before vaccination and did not take any other products before vaccination. The patient's concomitant medications were not reported. On 25Sep2021, the patient experienced start pain like he had a heart attack, and he cannot stop. Maybe it is just like a chest pain like some bad spicy food like something pretty serious/He felt the first severe chest pain (he still having the chest pain and the chest pain continues and does not stop in a while, it was like if he asks his doctor and sit out for like a trying lay down), it was a short pain it made his arm weak, he was scared. Patient visited emergency room as a result of events. The patient underwent lab tests and procedures which included blood urea: normal (kidney function was normal), X-RAY of ribs: normal (does not had crack and my vitals were normal), vitals: normal and EKG: normal on an unspecified date. Therapeutic measures were taken as a result of start pain like he had a heart attack, and he cannot stop. Maybe it is just like a chest pain like some bad spicy food like something pretty serious/He felt the first severe chest pain include Tylenol. The outcome of the events was unknown.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Positron emission tomogram
Clinical narrative: "led vein" was stuck up on 2 stents; First dose of the Pfizer BioNtech Covid-19 Vaccine on 27Feb2021/ second dose of the vaccine on Aug2021; chest pain; arm pains /left shoulder; Increased need to get up and go to bathroom during night; This is a spontaneous report from a contactable consumer (patient). This consumer reported events after two doses of the vaccine. This is the second of two reports. This report is for the second dose. This 66-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number EW0167), via unspecified route of administration in left shoulder (arm) on 02Aug2021 at patient age of 66-year-old as single dose for COVID-19 immunisation. Medical history included blood pressure, diabetes diagnosed 12 years ago and apnea on Cpap breathing machine for 7-8 years. Family history included father died of diabetes 20 years ago. Concomitant medications included blood pressure and diabetes medication, prostate medication. None prior vaccinations within 4 weeks. The patient previously received first dose of BNT162B2 (COMIRNATY, Batch/lot number: EN6198), on 27Feb2021 14:00-15:00 at patient age of 65-year-old as single dose for COVID-19 immunisation and experienced chest pain, arm pain, heart attack and 4 heart blockages. 3-4 days after he took the second vaccine (Aug2021), he started having these chest and arm pains again and it was getting worse. The patient had a PET CT scan and selective coronary arteriogram. The patient stated "led vein" was stuck up on 2 stents (2 more blockages to put a stent in). The patient had 2 stents placed in the LAD on 30Sep2021. The patient was hospitalized from 03Sep2021 to 01Oct2021. The patient stated that prior to getting the vaccine, he had no chest pain or any heart issues. The patient stated that the vaccine might be triggering heart attack or blockages. The patient stated he was hurting. His chest felt like he had been stung by bees. It was a lot of pressure like an elephant had him pinned to ground when he had his heart attack. Now, it feels like bees and sensation goes across chest. His left shoulder was killing him. He does not know if this is because of when they put stents in they went in through left arm and right groin. He was worse now than before he had the 4 bypasses as far as feeling bad. He was almost to the suicidal point, later stated he was not suicidal and would not kill himself, it was just that the pain was bad. The patient had Increased need to get up and go to bathroom 4-5 times a night in either Aug2021 or Sep2021. He at first said it was not relevant and then said he never thought about it. He was already having problems with getting up 1-2 times a night and now it is 4-5 times a night. The outcome of the event chest pain and increased need to get up and go to bathroom was not resolved. The outcome of the event heart blockages was recovered/resolved with sequel. The outcome of the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101317519 same patient, same drug (different dose), different event
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain, Pain in extremity, Seizure
Clinical narrative: I was shivering almost if I had seizures; I was shivering almost if I had seizures; had a cold sensation like If I was cold; it was a little painful but not that bad; at the arm where I got the shot was painful; applying ice pad on my arm to relieve the pain; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Oct2021 14:00 (Lot Number: FF8839) as dose 3 (booster), single (at the age of 69-years-old) for COVID-19 immunization. Medical history included hypertension, diabetes mellitus, visual impairment. The patient's concomitant medications included unspecified medication for blood pressure. The patient experienced, "I was shivering almost if I had seizures", "had a cold sensation like if I was cold", "it was a little painful but not that bad", "at the arm where I got the shot was painful", "applying ice pad on my arm to relieve the pain" on 04Oct2021 2:00. The patient stated, "So the other day it was a little painful but not that bad, but 2 in the morning today I mean, 12 hours later I had a cold sensation like If I was cold and then I was shivering almost if I had seizures. So, yesterday I get the booster shot around 2pm and this morning almost 12 hours later so around 2 in the morning I was, at the arm where I got the shot was painful but not that painful but I was, almost having a seizure. I was shaking a lot in cold and it was not cold so I had to put some covers on top. The anything I can say is that, at the moment I have to apply an ice pad on my arm to see if the pain goes down. I didn't feel the itching only the pain, and then the pain went on little bit to the lower arm and my vein as well. I was shaking a lot, it's almost like I was having seizures I mean I was really really shaking." Therapeutic measures were taken as a result of "it was a little painful but not that bad", "at the arm where i got the shot was painful", "applying ice pad on my arm to relieve the pain". The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I was shivering almost if I had seizures; I was shivering almost if I had seizures; had a cold sensation like If I was cold; it was a little painful but not that bad; at the arm where I got the shot was painful; applying ice pad on my arm to relieve the pain; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Oct2021 14:00 (Lot Number: FF8839) as dose 3 (booster), single (at the age of 69-years-old) for COVID-19 immunization. Medical history included hypertension, diabetes mellitus, visual impairment. The patient's concomitant medications included unspecified medication for blood pressure. The patient experienced, "I was shivering almost if I had seizures", "had a cold sensation like if I was cold", "it was a little painful but not that bad", "at the arm where I got the shot was painful", "applying ice pad on my arm to relieve the pain" on 04Oct2021 2:00. The patient stated, "So the other day it was a little painful but not that bad, but 2 in the morning today I mean, 12 hours later I had a cold sensation like If I was cold and then I was shivering almost if I had seizures. So, yesterday I get the booster shot around 2pm and this morning almost 12 hours later so around 2 in the morning I was, at the arm where I got the shot was painful but not that painful but I was, almost having a seizure. I was shaking a lot in cold and it was not cold so I had to put some covers on top. The anything I can say is that, at the moment I have to apply an ice pad on my arm to see if the pain goes down. I didn't feel the itching only the pain, and then the pain went on little bit to the lower arm and my vein as well. I was shaking a lot, it's almost like I was having seizures I mean I was really really shaking." Therapeutic measures were taken as a result of "it was a little painful but not that bad", "at the arm where i got the shot was painful", "applying ice pad on my arm to relieve the pain". The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Diarrhoea, Eating disorder, Exophthalmos, Facial pain
Clinical narrative: difficult sleeping; light sensitive; trouble eating; sinus infection; her face hurts so bad; Loose stools; almost blinding/vision was so bad; Headache; Nausea; In back of head and front of eyes, feels like it's bulging; Pfizer COVID-19 Booster injection; Pfizer COVID-19 Booster injection; This is a spontaneous case from a contactable nurse (patient). This 68-year-old female patient received the booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 29Sep2021 at 12:00 at patient age of 68-year-old as single dose (Lot Number: FF8839, Expiry Date: 27Oct2021) for COVID-19 immunisation. The patient received the booster dose due to surgery soon, having her hip replaced. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY), dose 1 via unspecified route on 13Feb2021 at patient age of 67-year-old as single dose (Lot Number: EN6201) for COVID-19 immunisation and had no reaction. The patient previously received BNT162B2 (COMIRNATY), dose 2 via unspecified route on 06Mar2021 at patient age of 67-year-old as single dose (Lot Number: EN6198) for COVID-19 immunisation and experienced tired the next day after the dose, which recovered completely. At 4:00AM on 30Sep2021, the patient woke up with intense headache. Next day 01Oct2021, headache was even worse and almost blinding. On 02Oct2021, it continued that way. In back of head and front of eyes, feels like it was bulging. This continued on 03Oct2021. On 04Oct2021, the patient went to doctor thinking she was having a sinus infection and her face hurts so bad. Only time she felt relief was for a few minutes in a really hot shower. Having difficult sleeping because of it. Headache was still there, a little less. It was bothering her enough. Couldn't even fold laundry without having to lay back down. Would say disabling. Regarding headache, the patient also mentioned hard to keep eyes open, very light sensitive. When reading patient record card, the patient stated it was hard to focus, vision was so bad. The patient was also experiencing nausea from 30Sep2021 and loose stools from 02Oct2021. The patient had trouble eating because of the nausea. Nausea was still there. The patient was taking imodium for loose stools, but still ongoing. The patient was put on doxycycline thinking it was an infection. She had three doses of doxycycline and hasn't noticed a difference yet. The patient felt crummy and wants to crawl under a rock. The event headache was reported serious with seriousness criteria disabling/incapacitating. The events nausea and loose stools were reported serious with seriousness criteria medically significant. The reporter assessed the events headache, nausea and loose stools related to vaccine with method of assessment: global introspection. The patient was recovering from the event headache. The patient did not recover from the event nausea and loose stools. The outcome of the other events was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Insomnia, Nausea, Off label use
Clinical narrative: difficult sleeping; light sensitive; trouble eating; sinus infection; her face hurts so bad; Loose stools; almost blinding/vision was so bad; Headache; Nausea; In back of head and front of eyes, feels like it's bulging; Pfizer COVID-19 Booster injection; Pfizer COVID-19 Booster injection; This is a spontaneous case from a contactable nurse (patient). This 68-year-old female patient received the booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 29Sep2021 at 12:00 at patient age of 68-year-old as single dose (Lot Number: FF8839, Expiry Date: 27Oct2021) for COVID-19 immunisation. The patient received the booster dose due to surgery soon, having her hip replaced. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY), dose 1 via unspecified route on 13Feb2021 at patient age of 67-year-old as single dose (Lot Number: EN6201) for COVID-19 immunisation and had no reaction. The patient previously received BNT162B2 (COMIRNATY), dose 2 via unspecified route on 06Mar2021 at patient age of 67-year-old as single dose (Lot Number: EN6198) for COVID-19 immunisation and experienced tired the next day after the dose, which recovered completely. At 4:00AM on 30Sep2021, the patient woke up with intense headache. Next day 01Oct2021, headache was even worse and almost blinding. On 02Oct2021, it continued that way. In back of head and front of eyes, feels like it was bulging. This continued on 03Oct2021. On 04Oct2021, the patient went to doctor thinking she was having a sinus infection and her face hurts so bad. Only time she felt relief was for a few minutes in a really hot shower. Having difficult sleeping because of it. Headache was still there, a little less. It was bothering her enough. Couldn't even fold laundry without having to lay back down. Would say disabling. Regarding headache, the patient also mentioned hard to keep eyes open, very light sensitive. When reading patient record card, the patient stated it was hard to focus, vision was so bad. The patient was also experiencing nausea from 30Sep2021 and loose stools from 02Oct2021. The patient had trouble eating because of the nausea. Nausea was still there. The patient was taking imodium for loose stools, but still ongoing. The patient was put on doxycycline thinking it was an infection. She had three doses of doxycycline and hasn't noticed a difference yet. The patient felt crummy and wants to crawl under a rock. The event headache was reported serious with seriousness criteria disabling/incapacitating. The events nausea and loose stools were reported serious with seriousness criteria medically significant. The reporter assessed the events headache, nausea and loose stools related to vaccine with method of assessment: global introspection. The patient was recovering from the event headache. The patient did not recover from the event nausea and loose stools. The outcome of the other events was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Sinusitis
Clinical narrative: difficult sleeping; light sensitive; trouble eating; sinus infection; her face hurts so bad; Loose stools; almost blinding/vision was so bad; Headache; Nausea; In back of head and front of eyes, feels like it's bulging; Pfizer COVID-19 Booster injection; Pfizer COVID-19 Booster injection; This is a spontaneous case from a contactable nurse (patient). This 68-year-old female patient received the booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 29Sep2021 at 12:00 at patient age of 68-year-old as single dose (Lot Number: FF8839, Expiry Date: 27Oct2021) for COVID-19 immunisation. The patient received the booster dose due to surgery soon, having her hip replaced. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY), dose 1 via unspecified route on 13Feb2021 at patient age of 67-year-old as single dose (Lot Number: EN6201) for COVID-19 immunisation and had no reaction. The patient previously received BNT162B2 (COMIRNATY), dose 2 via unspecified route on 06Mar2021 at patient age of 67-year-old as single dose (Lot Number: EN6198) for COVID-19 immunisation and experienced tired the next day after the dose, which recovered completely. At 4:00AM on 30Sep2021, the patient woke up with intense headache. Next day 01Oct2021, headache was even worse and almost blinding. On 02Oct2021, it continued that way. In back of head and front of eyes, feels like it was bulging. This continued on 03Oct2021. On 04Oct2021, the patient went to doctor thinking she was having a sinus infection and her face hurts so bad. Only time she felt relief was for a few minutes in a really hot shower. Having difficult sleeping because of it. Headache was still there, a little less. It was bothering her enough. Couldn't even fold laundry without having to lay back down. Would say disabling. Regarding headache, the patient also mentioned hard to keep eyes open, very light sensitive. When reading patient record card, the patient stated it was hard to focus, vision was so bad. The patient was also experiencing nausea from 30Sep2021 and loose stools from 02Oct2021. The patient had trouble eating because of the nausea. Nausea was still there. The patient was taking imodium for loose stools, but still ongoing. The patient was put on doxycycline thinking it was an infection. She had three doses of doxycycline and hasn't noticed a difference yet. The patient felt crummy and wants to crawl under a rock. The event headache was reported serious with seriousness criteria disabling/incapacitating. The events nausea and loose stools were reported serious with seriousness criteria medically significant. The reporter assessed the events headache, nausea and loose stools related to vaccine with method of assessment: global introspection. The patient was recovering from the event headache. The patient did not recover from the event nausea and loose stools. The outcome of the other events was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Off label use, Peripheral swelling
Clinical narrative: I had my booster shot on last Friday; I had my booster shot on last Friday; my arm is swollen; I have a big red ring around it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received booster dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 01Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 2, SINGLE and also received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 1, SINGLE both for covid-19 immunisation. The patient had booster shot on last Friday and on an unknown date in Oct2021 had some minor, minor things but they went away and the patient's arm was swollen and it looked like the patient have a big red ring around it. The patient asked if they should be concern about that. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: lack of efficacy. Fully vaccinated/PCR tested 01Oct results reported positive 01Oct; lack of efficacy. Fully vaccinated/PCR tested 01Oct results reported positive 01Oct; This is a spontaneous report from a contactable other health-care professional reporting for a male patient. A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via intramuscularly, administered in right arm on 04Mar2021 (at the age of 37-years-old) as dose 2, and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via intramuscularly, administered in right arm on 11Feb2021 (at the age of 37-years-old) as dose 1 single, for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient had covid prior to vaccination. It was unknown if the patient was diagnosed with COVID-19 Prior to vaccination and has been tested for COVID-19 since the vaccination. It was unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had lack of efficacy. Patient was fully vaccinated. Patient had contact with CV19 person last on 25Sep2021. Patient started with unspecified symptoms from 30Sep2021. On 01Oct2021, patient was tested positive for sars-cov-2 test through nasal swab, PCR test post vaccination. Reporter considered the events as serious. It was unknown if the patient had received treatment for the events. Outcome of the events was recovering. Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure is expected. The case will be reassessed further upon receipt of additional information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: potentially tested positive for Covid after receiving the Pfizer vaccine; potentially tested positive for Covid after receiving the Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced potentially tested positive for covid after receiving the PFIZER vaccine. During the call, the caller mentioned that everyone in house tested positive and they all had the PFIZER vaccine. Everybody tested positive because someone may have been around that did not have the vaccine and got them infected. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test with result positive. The outcome of the events was unknown.   The report is cross referenced to report ID. Caller was calling on patient who tested positive for Covid-19 after receiving both doses of the Pfizer Covid-19 vaccine. During the call, the caller mentioned that everyone in house tested positive and they all had the Pfizer vaccine. Everybody tested positive because someone may have been around that did not have the vaccine and got them infected. This information could not be clarified further. Caller declined to complete report. Full details not obtained or provided.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature abnormal, Headache, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19 after receiving both doses of Covid-19 vaccine; tested positive for Covid-19 after receiving both doses of Covid-19 vaccine; temperature; loss of sense of taste; Headache; This is a follow-up spontaneous report from program. A contactable consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on Mar2021 as a DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine include bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient tested positive for Covid-19 after receiving both doses of Covid-19 vaccine. Also had a temperature, loss of sense of taste and had a headache. Patient underwent laboratory test includes Covid-19 test resulted positive on 24Sep2021, she was sick for like 3 days then she felt better. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: tested positive for Covid-19 after receiving both doses of Covid-19 vaccine; tested positive for Covid-19 after receiving both doses of Covid-19 vaccine; temperature; loss of sense of taste; Headache; This is a follow-up spontaneous report from program. A contactable consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on Mar2021 as a DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine include bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient tested positive for Covid-19 after receiving both doses of Covid-19 vaccine. Also had a temperature, loss of sense of taste and had a headache. Patient underwent laboratory test includes Covid-19 test resulted positive on 24Sep2021, she was sick for like 3 days then she felt better. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Suspected COVID-19
Clinical narrative: feel like I have contract to come down with the COVID since I got the vaccination; lost smell and taste; lost smell and taste; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 23Sep2021 (Batch/Lot Number: FC3184) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient had events reported as "feel like I have contract to come down with the covid since I got the vaccination, lost smell and taste. consumer stated, "No, I haven't had COVID." (Further clarification was unknown). It was reported that after "I got the shot last week, Last Friday or Saturday, I lost taste, smell and taste". The patient was due for the next shot on 14Oct2021. At the time of this report, the outcome of event was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Polymerase chain reaction positive, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with COVID/not only by PCR sent out to lab but I also confirmed it again by Rapid Test; diagnosed with COVID/not only by PCR sent out to lab but I also confirmed it again by Rapid Test; She is still sick; This is a spontaneous report from a contactable consumer or other non hcp. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955; Expiration Date: 30Jun2021) intramuscular on 21Apr2021 (at the age of 43-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955; Expiration Date: 30Jun2021) intramuscular on 31Mar2021 (at the age of 43-years-old) as dose 1, single for COVID-19 immunization. Investigation assessment was performed. No other vaccination within 4 weeks prior to the first administration of the vaccine. On an unspecified date, she is still sick, diagnosed with COVID/not only by PCR sent out to lab but I also confirmed it again by rapid test and vaccination failure. The patient underwent lab tests and procedures on an unspecified date which included polymerase chain reaction positive on tested by LABCORP, SARS-CoV-2 test: positive on tested by LABCORP. The patient was not taking any other treatment medications. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.