chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, COVID-19, Drug ineffective
Clinical narrative: tested positive for COVID-19 after getting the first dose of the Pfizer-BioNTech COVID-19 Vaccine; tested positive for COVID-19 after getting the first dose of the Pfizer-BioNTech COVID-19 Vaccine; hip joints sore; she could not move her body / muscles could not move/ it felt like a magnet was holding her to bed; soreness and pain; Weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "tested positive for COVID-19 after getting the first dose of the Pfizer-BioNTech COVID-19 Vaccine"; ASTHENIA (non-serious) with onset Dec2021, outcome "unknown", described as "Weakness"; ARTHRALGIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "hip joints sore"; MOVEMENT DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "she could not move her body / muscles could not move/ it felt like a magnet was holding her to bed"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "soreness and pain". The patient underwent the following laboratory tests and procedures: body temperature: (Dec2021) 99.8, notes: no unit; sars-cov-2 test: (23Dec2021) positive, notes: mouth swab.  Clinical course: Patient received first dose on 30Nov2021 and had muscle pain and weakness a few days later. On 17Dec2021, patient felt tired, fatigue, muscles and hip joints sore. Patient reported that by the time she got home could only sleep. Patient experienced headache and checked her body temperature for fever and noted it was 99.8. Patient stated that she could not move her body and it felt like a magnet was holding her to bed and muscles could not move and painful. Patient was only able to move, get to the bathroom and go back to bed. Patient never experienced anything like this. Patient experienced soreness and pain. Patient contacted her doctor and suspected Covid and to get a Covid test. Patient was tested on 23Dec2021, by mouth swab, on the side of her jaws. On 26Dec2021, test results showed that patient was tested positive for COVID-19. Patient was scheduled for the second dose on 28Dec2021 and is still not feeling 100. Patient felt like she had a cold and coughed up phlegm, like a productive cough.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 after getting the first dose of the Pfizer-BioNTech COVID-19 Vaccine; tested positive for COVID-19 after getting the first dose of the Pfizer-BioNTech COVID-19 Vaccine; hip joints sore; she could not move her body / muscles could not move/ it felt like a magnet was holding her to bed; soreness and pain; Weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "tested positive for COVID-19 after getting the first dose of the Pfizer-BioNTech COVID-19 Vaccine"; ASTHENIA (non-serious) with onset Dec2021, outcome "unknown", described as "Weakness"; ARTHRALGIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "hip joints sore"; MOVEMENT DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "she could not move her body / muscles could not move/ it felt like a magnet was holding her to bed"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "soreness and pain". The patient underwent the following laboratory tests and procedures: body temperature: (Dec2021) 99.8, notes: no unit; sars-cov-2 test: (23Dec2021) positive, notes: mouth swab.  Clinical course: Patient received first dose on 30Nov2021 and had muscle pain and weakness a few days later. On 17Dec2021, patient felt tired, fatigue, muscles and hip joints sore. Patient reported that by the time she got home could only sleep. Patient experienced headache and checked her body temperature for fever and noted it was 99.8. Patient stated that she could not move her body and it felt like a magnet was holding her to bed and muscles could not move and painful. Patient was only able to move, get to the bathroom and go back to bed. Patient never experienced anything like this. Patient experienced soreness and pain. Patient contacted her doctor and suspected Covid and to get a Covid test. Patient was tested on 23Dec2021, by mouth swab, on the side of her jaws. On 26Dec2021, test results showed that patient was tested positive for COVID-19. Patient was scheduled for the second dose on 28Dec2021 and is still not feeling 100. Patient felt like she had a cold and coughed up phlegm, like a productive cough.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Alice in wonderland syndrome, Hallucination, Headache, Moaning, Speech disorder
Clinical narrative: patient was moaning; hallucinations; he could barely speak/not really talking and not really responding; Alice In Wonderland Syndrome; bad headeache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 14:30 (Lot number: FK5127) at the age of 9 years as dose 1, 10 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HALLUCINATION (medically significant) with onset 15Dec2021, outcome "recovering", described as "hallucinations"; SPEECH DISORDER (non-serious) with onset 14Dec2021 21:00, outcome "recovering", described as "he could barely speak/not really talking and not really responding"; ALICE IN WONDERLAND SYNDROME (non-serious) with onset 14Dec2021 21:00, outcome "recovering", described as "Alice In Wonderland Syndrome"; MOANING (non-serious), outcome "unknown", described as "patient was moaning"; HEADACHE (non-serious) with onset 14Dec2021 21:00, outcome "recovering", described as "bad headeache". The events "hallucinations", "he could barely speak/not really talking and not really responding", "alice in wonderland syndrome" and "bad headeache" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of hallucination, speech disorder, alice in wonderland syndrome, headache. The Clinical course: Had a really bad headache for two days: The patient received the Pfizer Vaccine for kids 5 to 11 on 13Dec2021 and that night went to sleep. The next night, 14Dec2021, later in the night, the patient just laid there and said head hurt and not really talking and not really responding. The caller states caller woke up because the patient was moaning. The headache went away and lasted two days. The caller states the patient did not recover completely.Started to hallucinate and this was called Alice in wonderland syndrome: The patient still has Alice in wonderland syndrome. Everything looks small. The caller clarifies this began on 15Dec2021. The patient's Alice in wonderland syndrome has improved but is still having to check with the patient. The patient still has a spark, will watch something and everything gets small.patient had not received any other vaccines within 4 weeks prior to the COVID vaccine  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 antibody test
Clinical narrative: booster; Received booster shot the same week tested positive for Covid; Received booster shot the same week tested positive for Covid; This is a spontaneous report received from a contactable reporter.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION, outcome unknown, described as booster; DRUG INEFFECTIVE, COVID-19, outcome unknown and all described as Received booster shot the same week tested positive for Covid. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Additional: It was unknown If patient was covid prior vaccination, Patient was tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Losing my hair and its not growing back ,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 14:00 (Lot number: ER873u) at the age of 59 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination and had not tested post vaccination. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 17Mar2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: ALOPECIA (disability, medically significant) with onset 2021, outcome "not recovered", described as "Losing my hair and its not growing back ,"; ALOPECIA (disability, medically significant) with onset 2021, outcome "not recovered", described as "I'm almost bald on the top of my head and have patchy bald spots on the rest of my head". Therapeutic measures were taken as a result of alopecia, alopecia which included Lazer hair follicle treatments, Rogaine, vitamins.  It was reported that Losing hair and it's not growing back! Patient was almost bald on the top of her head and had patchy bald spots on the rest of her head. Afraid to get the booster shot now.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza virus test, Investigation, Musculoskeletal discomfort
Clinical narrative: rash around private area; bad headache; neck hurt; fever/fever went to 102; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: The only thing he has ever had an adverse reaction to is penicillin. There were no concomitant medications. The following information was reported: PYREXIA (medically significant) with onset Dec2021, outcome "unknown", described as "fever/fever went to 102"; RASH (non-serious) with onset 17Dec2021, outcome "recovered" (17Dec2021), described as "rash around private area"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "bad headache"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "neck hurt". The patient underwent the following laboratory tests and procedures: body temperature: (18Dec2021) 102, notes: his fever went to 102 that night; influenza virus test: (Dec2021) negative; investigation: (Dec2021) negative. Therapeutic measures were taken as a result of pyrexia, musculoskeletal discomfort, was treated with Advil and Tylenol.  Clinical Information: within 24 hours of first vaccination, the patient said he had a bad headache, that he had a crack in it, had a fever for the next 3 days, manageable with Advil and Tylenol, states on the second day in the evening, his fever did not go down because he could not take any more of the medication, he was at the maximum dose for each, states his fever went to 102 that night, states she gave him a luke warm bath and that worked to help break his fever. Stated the third day was manageable with Advil and Tylenol again but his neck hurt, states it did not hurt all day, just sporadically, and by fourth day he was okay. Caller state she had no other symptoms. States they went to his pediatrician's office on Monday and was checked at the doctor for flu and strep and was negative for both. Exact height was unknown, it was stated that he was over 3 feet tall.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: rash around private area; bad headache; neck hurt; fever/fever went to 102; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: The only thing he has ever had an adverse reaction to is penicillin. There were no concomitant medications. The following information was reported: PYREXIA (medically significant) with onset Dec2021, outcome "unknown", described as "fever/fever went to 102"; RASH (non-serious) with onset 17Dec2021, outcome "recovered" (17Dec2021), described as "rash around private area"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "bad headache"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "neck hurt". The patient underwent the following laboratory tests and procedures: body temperature: (18Dec2021) 102, notes: his fever went to 102 that night; influenza virus test: (Dec2021) negative; investigation: (Dec2021) negative. Therapeutic measures were taken as a result of pyrexia, musculoskeletal discomfort, was treated with Advil and Tylenol.  Clinical Information: within 24 hours of first vaccination, the patient said he had a bad headache, that he had a crack in it, had a fever for the next 3 days, manageable with Advil and Tylenol, states on the second day in the evening, his fever did not go down because he could not take any more of the medication, he was at the maximum dose for each, states his fever went to 102 that night, states she gave him a luke warm bath and that worked to help break his fever. Stated the third day was manageable with Advil and Tylenol again but his neck hurt, states it did not hurt all day, just sporadically, and by fourth day he was okay. Caller state she had no other symptoms. States they went to his pediatrician's office on Monday and was checked at the doctor for flu and strep and was negative for both. Exact height was unknown, it was stated that he was over 3 feet tall.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood grouping, Immunisation, Mass, Pain in extremity, Thrombosis
Clinical narrative: There was blood clot on her legs/she feel like she does have a blood clot because she started getting like lumps all over legs and it hurts very much. They have lumps; she already got the booster shot; I feel like I do have a blood clot yes because I started getting like lumps all over my legs and it hurts very much/They have lumps; she feels like she do have a blood clot because she started getting like lumps all over her legs and it hurts very much; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient.   A female patient received bnt162b2 (BNT162B2) (Lot number: FF2587) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "There was blood clot on her legs/she feel like she does have a blood clot because she started getting like lumps all over legs and it hurts very much. They have lumps"; IMMUNISATION (non-serious), outcome "unknown", described as "she already got the booster shot"; MASS (non-serious), outcome "unknown", described as "I feel like I do have a blood clot yes because I started getting like lumps all over my legs and it hurts very much/They have lumps"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she feels like she do have a blood clot because she started getting like lumps all over her legs and it hurts very much". The patient underwent the following laboratory tests and procedures: blood grouping: AB positive.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Mouth ulceration, Throat irritation, Tongue disorder
Clinical narrative: Her tongue cracked; her throat was itchy; the roof of her mouth had ulcers; her chest did also get tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TONGUE DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Her tongue cracked"; THROAT IRRITATION (non-serious) with onset Mar2021, outcome "unknown", described as "her throat was itchy"; MOUTH ULCERATION (non-serious) with onset Mar2021, outcome "unknown", described as "the roof of her mouth had ulcers"; CHEST DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "her chest did also get tight".  Additional information: Reporter calling about the Covid 19 vaccine. Stated that she had a reaction last March (Mar2021), within 8 minutes of getting her first dose of the vaccine. Stated that her reaction was all in her mouth. Her tongue cracked, her throat was itchy, and the roof of her mouth had ulcers. Caller then clarified that her chest did also get tight. States that her doctor recommended that she not get the 2nd dose. So she was still unprotected in this very scary time. She was calling to ask about the new pill that was just approved; what are the ingredients? Stated that she would like the list of the ingredients just in case she needs it, so she can give it to her doctor. Stated that she had mast cell, so she has a lot of allergies to different things, and she was just trying to be prepared in case she ever needs to take the new pill. Patient took the covid vaccine back in Mar2021 and had an adverse reaction to it, so patient's doctors advised to patient against the second and booster. Patient was so scared of getting this virus even though patient was very careful. So now that the pill created for covid has given me hope, patient would like to know what the ingredients are since patient had serve allergies to many medicines.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Dysstasia, Loss of personal independence in daily activities, Motion sickness, Vertigo
Clinical narrative: severe vertigo; could not control her bowels, either way; basically couldn't stand; motion sickness; still can't sleep on her right side. If she does, it triggers her./Driving for her, is very minimal and she hardly ever drives anymore. She can't drive at night anymore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: had cancer but that was years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Felt sick". The following information was reported: VERTIGO (hospitalization) with onset Apr2021, outcome "unknown", described as "severe vertigo"; ANAL INCONTINENCE (non-serious) with onset Apr2021, outcome "unknown", described as "could not control her bowels, either way"; DYSSTASIA (non-serious) with onset Apr2021, outcome "unknown", described as "basically couldn't stand"; MOTION SICKNESS (non-serious) with onset Apr2021, outcome "unknown", described as "motion sickness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Apr2021, outcome "not recovered", described as "still can't sleep on her right side. If she does, it triggers her./Driving for her, is very minimal and she hardly ever drives anymore. She can't drive at night anymore". The patient was hospitalized for vertigo (hospitalization duration: 1 day(s)). The event "severe vertigo" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vertigo, anal incontinence, dysstasia, motion sickness, loss of personal independence in daily activities. Clinical information:Clarified that the caller's mother had taken the first two doses of the Pfizer Covid vaccine and the Covid booster. He clarified that the he thinks she had the booster in Aug2021 or Sep2021 but states that when she had the booster, she had nothing.  With her first shot, she felt sick for a day and it was the second one that got her Tests: She didn't really know much, she went to the hospital and was released. She was real low key about everything until the other day. He states that she is now having diarrhea of the mouth, telling everything about what happened to her.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19 on 26Dec2021.; Tested positive for Covid-19 on 26Dec2021.; Currently 37 weeks pregnant and fully vaccinated.; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 22Oct2021 (Lot number: Fh8020) as dose 2, single and intramuscular, administration date 01Oct2021 (Lot number: Ff8839) as dose 1, single for covid-19 immunisation. Date of last menstrual period: 07Apr2021. The patient was 28 weeks pregnant at the time of exposure to bnt162b2. The patient was 37 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12Jan2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu (other vaccine 4weeks product=Flu vaccine). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 26Dec2021, outcome "not recovered" and all described as "Tested positive for Covid-19 on 26Dec2021."; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Currently 37 weeks pregnant and fully vaccinated.". The patient underwent the following laboratory tests and procedures: covid-19: (24Dec2021) negative, notes: Nasal Swab; sars-cov-2 test: (24Dec2021) positive; (26Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, vaccination failure, maternal exposure during pregnancy.  Additional information: The patient did not took other medications in two weeks. The patient did not have Covid prior vaccination. The patient tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Immunisation, SARS-CoV-2 test
Clinical narrative: result was positive; result was positive; Continued feeling ill; Had Pfizer comirnaty booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Batch/Lot number: unknown) at the age of 27 years as dose number unknown (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold like illness", start date: 21Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021, outcome "unknown", described as "Had Pfizer comirnaty booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 25Dec2021, outcome "unknown" and all described as "result was positive"; ILLNESS (non-serious) with onset 25Dec2021, outcome "unknown", described as "Continued feeling ill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) negative, notes: COVID-19 rapid test; (22Dec2021) negative, notes: COVID-19 rapid test; (25Dec2021) positive, notes: COVID-19 rapid test. Began feeling cold like illness 21Dec2021. Took at-home COVID-19 rapid test which was negative on 21Dec2021. Had Pfizer comirnaty booster on 22Dec2021 and took another at home COVID test prior to vaccine that day which was still negative. Continued feeling ill and repeated at home COVID test 25Dec2021 and the result was positive. Event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: result was positive; result was positive; Continued feeling ill; Had Pfizer comirnaty booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Batch/Lot number: unknown) at the age of 27 years as dose number unknown (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold like illness", start date: 21Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021, outcome "unknown", described as "Had Pfizer comirnaty booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 25Dec2021, outcome "unknown" and all described as "result was positive"; ILLNESS (non-serious) with onset 25Dec2021, outcome "unknown", described as "Continued feeling ill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) negative, notes: COVID-19 rapid test; (22Dec2021) negative, notes: COVID-19 rapid test; (25Dec2021) positive, notes: COVID-19 rapid test. Began feeling cold like illness 21Dec2021. Took at-home COVID-19 rapid test which was negative on 21Dec2021. Had Pfizer comirnaty booster on 22Dec2021 and took another at home COVID test prior to vaccine that day which was still negative. Continued feeling ill and repeated at home COVID test 25Dec2021 and the result was positive. Event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Patient got her first covid shot and then got pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NVSC2021US292846 _S.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "Patient got her first covid shot and then got pneumonia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: received the booster vaccine in Oct and two days ago developed COVID.; received the booster vaccine in Oct and two days ago developed COVID.; She received a Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team and product quality group for a Pfizer sponsored program (172086). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single, administration date 21Jan2021 (Lot number: EL3247) as dose 2, single and administration date 31Dec2020 (Lot number: EH9899) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: RITONAVIR; AMLODIPINE. The following information was reported: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "She received a Pfizer booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "received the booster vaccine in Oct and two days ago developed COVID.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  Clinical information: Reporter was a pharmacist and a patient. She developed covid 2 days ago and wants to know how she can obtain the product. She also stated that she received her first Pfizer covid vaccine last New Years Eve (31Dec2020) and her second dose 21 days later. She received a Pfizer booster vaccine in Oct2021. Pharmacist was just trying to find out an additional treatment for this virus that she was very concerned about. She had to get from the health department because the pill, Paxlovid was not available yet. Pharmacist further stated, By the way other two people (further clarifications unknown) were positive and they have got Pfizer shot too but they both are asleep. She became positive from another person who had three shots from Pfizer. She stated, she just knows that yes hopefully she would be okay. She was just worried a lot and she did everything for her mouth and then she got chilled everything (further not clarified).  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Immunisation, Vaccination failure , Covid-19  and suspect drug BNT162B2 cannot be excluded.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: I contracted covid about 5 days ago from a patient despite being triple vaccinated with Pfizer a while ago; I contracted covid about 5 days ago from a patient despite being triple vaccinated with Pfizer a while ago; I contracted covid about 5 days ago from a patient despite being triple vaccinated with Pfizer a while ago; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2), for Covid-19 Immunization; Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown. The physician reported that: I contracted covid 5 days ago despite triple vaccination. By my own PCR my viral load is over 5000 and clinically I am not getting any better. How can I get Paxlovid asap.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2  and immunization cannot be completely excluded.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: have her second dose in July on July 9th, she tested positive for COVID on the 21st of the December; have her second dose in July on July 9th, she tested positive for COVID on the 21st of the December; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 09Jul2021 (Lot number: FA6708) at the age of 17 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no:1, Lot no: EW0217), when the patient was 17 years old, for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021, outcome "unknown" and all described as "have her second dose in July on July 9th, she tested positive for COVID on the 21st of the December". The patient underwent the following laboratory tests and procedures: covid-19: (21Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Advil. Clinical course: This consumer reported that her daughter is the patient who had 2 doses of the Pfizer Covid-19 Vaccine, so she had like her last dosage was 09Jul caller did not provide year and was unwilling to complete this report so unable to clarify further. Caller's question is when is she eligible for the booster of the Pfizer Covid-19 Vaccine relative to her testing positive for COVID; should she wait 90 days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result: Positive; covid test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: EL3247) at the age of 35 years as dose 2, single and administered in arm left, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: NITROFURANTOIN; AMLODIPINE; VITAMIN D3; VYVANSE. Past drug history included: Bactrim, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021 23:00, outcome "recovered" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: body temperature: (19Dec2021) 101.0; Antigen (nasal swab): (Nov2021) negative, (20Dec2021) positive, and (22Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was reported that patient had fever 101.0 and chills >48 hours, severe night sweats - First 3 nights congestion - 3 days on 19Dec2021 11:00PM. The patient also received the third dose of bnt162b2 on 20Dec2021 administered in left arm (lot number: EL3197).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She is calling on behalf of her son (declined to provide his age) who tested positive for covid19.; She is calling on behalf of her son (declined to provide his age) who tested positive for covid19.; This is a spontaneous report received from a contactable reporter. The reporter is the parent.  A male patient received bnt162b2 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She is calling on behalf of her son (declined to provide his age) who tested positive for covid19.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tested positive for covid19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Constipation, Dysgraphia, Electromyogram
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 (Lot number: EW2174) at the age of 59 years as dose 2, single and administered in deltoid right, administration date 07May2021 (Lot number: EW2173) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergy: erythromycin"; Lisinopril, reaction(s): "Known allergy: lisinopril"; Aciphex, reaction(s): "Known allergy: aciphex"; Bactrim, reaction(s): "Known allergy: Bactrim"; Codeine, reaction(s): "Known allergy: Codeine". Vaccination history included: Bnt162b2 (Dose number:1, lot number: EW0162, vaccine location: Right arm), administration date: 16Apr2021, for COVID-19 Immunization. The following information was reported: NEUROMYOPATHY (disability, medically significant) with onset 16May2021, outcome "not recovered", described as "neuromuscular symptoms"; ALOPECIA (disability) with onset 16May2021, outcome "not recovered", described as "Hair loss"; SPEECH DISORDER (disability), MASTICATION DISORDER (disability), DYSGRAPHIA (disability) all with onset 16May2021, outcome "not recovered" and all described as "Trouble talking and chewing and handwriting"; CONSTIPATION (disability) with onset 16May2021, outcome "not recovered", described as "Constipation". The events "neuromuscular symptoms", "hair loss", "trouble talking and chewing and handwriting", "trouble talking and chewing and handwriting", "trouble talking and chewing and handwriting" and "constipation" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown result, notes: AE treatment; electromyogram: (unspecified date) unknown result, notes: AE treatment; magnetic resonance imaging: (unspecified date) unknown result, notes: AE treatment; sars-cov-2 test: (21Nov2021) negative, notes: post vaccination. Therapeutic measures were taken as a result of neuromyopathy, alopecia, speech disorder, mastication disorder, dysgraphia, constipation.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Mastication disorder, Neuromyopathy, SARS-CoV-2 test, Speech disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 (Lot number: EW2174) at the age of 59 years as dose 2, single and administered in deltoid right, administration date 07May2021 (Lot number: EW2173) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergy: erythromycin"; Lisinopril, reaction(s): "Known allergy: lisinopril"; Aciphex, reaction(s): "Known allergy: aciphex"; Bactrim, reaction(s): "Known allergy: Bactrim"; Codeine, reaction(s): "Known allergy: Codeine". Vaccination history included: Bnt162b2 (Dose number:1, lot number: EW0162, vaccine location: Right arm), administration date: 16Apr2021, for COVID-19 Immunization. The following information was reported: NEUROMYOPATHY (disability, medically significant) with onset 16May2021, outcome "not recovered", described as "neuromuscular symptoms"; ALOPECIA (disability) with onset 16May2021, outcome "not recovered", described as "Hair loss"; SPEECH DISORDER (disability), MASTICATION DISORDER (disability), DYSGRAPHIA (disability) all with onset 16May2021, outcome "not recovered" and all described as "Trouble talking and chewing and handwriting"; CONSTIPATION (disability) with onset 16May2021, outcome "not recovered", described as "Constipation". The events "neuromuscular symptoms", "hair loss", "trouble talking and chewing and handwriting", "trouble talking and chewing and handwriting", "trouble talking and chewing and handwriting" and "constipation" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown result, notes: AE treatment; electromyogram: (unspecified date) unknown result, notes: AE treatment; magnetic resonance imaging: (unspecified date) unknown result, notes: AE treatment; sars-cov-2 test: (21Nov2021) negative, notes: post vaccination. Therapeutic measures were taken as a result of neuromyopathy, alopecia, speech disorder, mastication disorder, dysgraphia, constipation.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough covid case; Breakthrough covid case; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 18:00 (Lot number: FC3180) at the age of 36 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies:no, reaction(s): "Drug Allergy", notes: Known allergies:No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 28Mar2021, when the patient was 35 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 07Mar2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Sep2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "Breakthrough covid case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of immunisation. Therapeutic measures were not taken as a result of vaccination failure, covid-19. On 29Sep2021 6:00 PM the patient administered COVID-19 vaccine at Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Birth control medication within 2 weeks of vaccination. The event reported as Breakthrough covid case. Prior to the vaccination the patient does not diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. Device Date was 28Dec2021.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Jun2021 13:00 (Batch/Lot number: unknown) at the age of 21 years as dose 2, single and intramuscular, administered in arm right, administration date 23Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: drug ineffective, COVID-19 (medically significant) all with onset 23Dec2021, outcome recovered (2021). Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: No other vaccine in four weeks. It was unknown if the patient had Covid prior vaccination. Patient had covid tested post vaccination. No Known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.