chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: Could barely move; Breathing felt a little suppressed; Felt Sluggish; Feverish; Slept a lot, which was not normal for her; Exhausted; Feeling discomfort; experienced lethargy; pain  all over the body, pain was extremely intense/Pain magnified a thousand percent/Pain unbearable, like being crushed; felt like being crushed; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Feb2021 14:00 (at the age of 71-year-old) as dose 1, single for covid-19 immunization. Medical history included sleep apnoea, Skeletal muscle disease, fibromyalgia, Chronic pain, arthritis from an unspecified date and unknown if its ongoing. Body aches and Pains from Nov2020 to an unknown date, slight fever maybe around 100 degrees from 2020 to an unknown date. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported, bisoprolol taken for blood pressure measurement, start and stop date were not reported, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for pain, start and stop date were not reported, lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported, ascorbic acid (VITAMIIN C) taken for an unspecified indication, start and stop date were not reported, colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced lethargy, pain all over the body, pain was extremely intense/pain magnified a thousand percent/pain unbearable, felt like being crushed in 2021. Patient was feeling discomfort on 25Feb2021. On 26Feb2021 patient was could barely move, breathing felt a little suppressed, felt sluggish, feverish, slept a lot, which was not normal for her, exhausted. The patient underwent lab tests and procedures in which patient had fever100 fahrenheit on unspecified date. Outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Movement disorder, Pain, Pyrexia, Sluggishness
Clinical narrative: Could barely move; Breathing felt a little suppressed; Felt Sluggish; Feverish; Slept a lot, which was not normal for her; Exhausted; Feeling discomfort; experienced lethargy; pain  all over the body, pain was extremely intense/Pain magnified a thousand percent/Pain unbearable, like being crushed; felt like being crushed; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Feb2021 14:00 (at the age of 71-year-old) as dose 1, single for covid-19 immunization. Medical history included sleep apnoea, Skeletal muscle disease, fibromyalgia, Chronic pain, arthritis from an unspecified date and unknown if its ongoing. Body aches and Pains from Nov2020 to an unknown date, slight fever maybe around 100 degrees from 2020 to an unknown date. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported, bisoprolol taken for blood pressure measurement, start and stop date were not reported, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for pain, start and stop date were not reported, lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported, ascorbic acid (VITAMIIN C) taken for an unspecified indication, start and stop date were not reported, colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced lethargy, pain all over the body, pain was extremely intense/pain magnified a thousand percent/pain unbearable, felt like being crushed in 2021. Patient was feeling discomfort on 25Feb2021. On 26Feb2021 patient was could barely move, breathing felt a little suppressed, felt sluggish, feverish, slept a lot, which was not normal for her, exhausted. The patient underwent lab tests and procedures in which patient had fever100 fahrenheit on unspecified date. Outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Sore arm 4 hours post vaccination so far...; is pregnant: Yes; is pregnant: Yes; is pregnant: Yes; This is a spontaneous report from a contactable consumer or other non hcp.  This is a maternal report. A 34-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 11:30 (at the age of 34-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies The patient received no other vaccine in four weeks. Last menstrual date was provided as 10Nov2020. Concomitant medication included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromium, colecalciferol, copper, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, zinc (PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM; COLECALCIFEROL;COPPER; CYANOCOBALAMIN; FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S); fish oil. On 15Mar2021 at 14:30, the patient experienced sore arm 4 hours post vaccination so far and  "is pregnant: yes." The mother reported she became pregnant while taking bnt162b2.  The mother was 19 Weeks pregnant at the onset of the event. The mother was due to deliver on 04Aug2021. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Outcome of the event sore arm was not recovered.   Follow-up activities closed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Dyskinesia, Groin pain, Hypoacusis, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 67; unit: unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 as dose 2, single for covid-19 immunisation. Medical history included surgery, radical proctectomy, prostate cancer, allergy to contrast iodine dye, autoimmune disorder. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced fever, difficulty getting out of bed, extreme stiffness throughout  the entire the body, loss of coordination, groin and pelvis pain, groin and pelvis pain, extreme general body pain, decrease hearing. Husband had surgery in January - radical proctectomy. Caller reported after second dose on March 10, husband spiked a fever. Husband has taken ibuprofen, Tylenol, and hydrocodone. Caller reported that she has called CDC, but they have not helped much. Caller reported that she had the vaccine and did not have a reaction. Caller would like to know if it could cause this severe of a reaction, and would Pfizer give vaccine if it could have this reaction. Caller mentioned Husband has allergy to contrast iodine dye. Caller reports suggested that her and husband get the vaccine. Caller reported that she has an autoimmune disease and her provider told her that she would not make antibodies to vaccine, but caller does not report any side effects. Caller stated that she would not recommend the vaccine to anyone. Caller stated that doctors do not know enough about the vaccine. Caller reported that she was not able to sign up with v-safe to report side effects post vaccine. Her husband was diagnosed with Prostate cancer in January. Since the 2nd dose her husband has been really sick and had not been able to walk. He was stiff all over. They were not sure if it is the Covid vaccine or if it was the cancer. She wanted to know if this has been reported before. Therapeutic measures were taken as a result of fever, difficulty getting out of bed, extreme stiffness throughout  the entire the body, loss of coordination, groin and pelvis pain, groin and pelvis pain, extreme general body pain, decrease hearing. The clinical outcome of events were unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pelvic pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 67; unit: unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 as dose 2, single for covid-19 immunisation. Medical history included surgery, radical proctectomy, prostate cancer, allergy to contrast iodine dye, autoimmune disorder. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced fever, difficulty getting out of bed, extreme stiffness throughout  the entire the body, loss of coordination, groin and pelvis pain, groin and pelvis pain, extreme general body pain, decrease hearing. Husband had surgery in January - radical proctectomy. Caller reported after second dose on March 10, husband spiked a fever. Husband has taken ibuprofen, Tylenol, and hydrocodone. Caller reported that she has called CDC, but they have not helped much. Caller reported that she had the vaccine and did not have a reaction. Caller would like to know if it could cause this severe of a reaction, and would Pfizer give vaccine if it could have this reaction. Caller mentioned Husband has allergy to contrast iodine dye. Caller reports suggested that her and husband get the vaccine. Caller reported that she has an autoimmune disease and her provider told her that she would not make antibodies to vaccine, but caller does not report any side effects. Caller stated that she would not recommend the vaccine to anyone. Caller stated that doctors do not know enough about the vaccine. Caller reported that she was not able to sign up with v-safe to report side effects post vaccine. Her husband was diagnosed with Prostate cancer in January. Since the 2nd dose her husband has been really sick and had not been able to walk. He was stiff all over. They were not sure if it is the Covid vaccine or if it was the cancer. She wanted to know if this has been reported before. Therapeutic measures were taken as a result of fever, difficulty getting out of bed, extreme stiffness throughout  the entire the body, loss of coordination, groin and pelvis pain, groin and pelvis pain, extreme general body pain, decrease hearing. The clinical outcome of events were unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Bronchitis; lot of congestion in her chest; cough; small fever; This is a spontaneous case received from a contactable consumer (patient) via Pfizer-sponsored program. A 93-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number was not reported), via an unspecified route of administration on 12Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bronchitis, lot of congestion in her chest, cough and fever. Therapeutic measures were taken as a result of the event (lot of congestion in her chest) and included treatment with "Z-pack" therapy. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 21Feb2021 15:30 (Batch/lot number: EL9266), at age 63 years old, as dose 1, single, for COVID-19 immunization, at a hospital. The patient was not pregnant at the time of vaccination. Relevant medical history included high blood pressure, sinus problems and known allergies to trees and grass, all from unknown dates, not reported if ongoing or not. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included lisinopril 20/25 taken for an unknown indication, start and stop dates not reported. The patient did not receive other vaccine in four weeks. On 22Feb2021, the patient experienced cough. Treatment was not given for the event. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number unknown), as dose number unknown, single, for COVID-19 immunisation, at a public health department. Relevant medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 10Mar2021, the patient experienced nosebleed. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Fever 100.7 overnight; Fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 13:15 (lot number: P220395-0060L; expiry date: unknown) as dose 2, single for Covid-19 immunisation. Medical history included known allergies to penicillin. The patient was not pregnant at the time of vaccination. The vaccine was administered in doctor's office/ urgent care. The patient did not receive other vaccines at the time of vaccination. The patient was not diagnosed with Covid-19 prior vaccination. The patient was not taking concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 at 14:00 (lot number: p220395-DD74L) at the age of 60 years old, in left arm, for Covid-19 immunisation. On 09Mar2021, at 11:45 PM, the patient experienced fever 100.7 overnight (approx. 12 hours after vaccine for about 12 hours), fatigue, and headache. The patient did not receive treatment for the events. The patient has not been tested for Covid-19 post vaccination. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: it itched like crazy; it was hives she would guess.; started getting a rash on the back of her neck and head and shoulders; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269, Expiry date: unknown) via an unspecified route of administration on 05Feb2021 (at the age of 79-year-old) as single dose for covid-19 immunisation. The medical history was not reported. There were no concomitant medications. The patient previously took hydrocortisone. On 11Feb2021 the patient experienced a rash on the back of her neck and head and shoulders, it is not quite recovered, it was still a little bit on her tummy and sometimes the back of her neck felt a little like she wanted to scratch it, but she tried not to. It had just been in the last 3-4 days that it was finally clearing up. She was taking Zyrtec, 2 per day with the 10 mg and it itched like crazy, it was hives she would guess. She wanted to know how long she could wait to take the second shot or if she shouldn't take the second shot. She had the bottle of Zyrtec sitting there she was sure the expiration was good because she just bought it. She saw lot number 1801793 expires Sep2023. She did go to her doctor, and he gave her a cream to put on it. She did not know how to pronounce it, but it said Triamcinolone Acetonide, and it is 0.1% he told her to put that on it and she also had used something that she had from before Hydrocortisone USP 2.5%, she used that before she got the prescription. She just got it short time ago imagine it would be good, she did not see anything on that. He gave her a prescription for 4 tubes of that Triamcinolone Acetonide 0.1%. She said she had the box, and it says NDC 52565-056-30. She saw expiration Oct2022 and lot number 16090. Description of Product Complaint included she wanted to know how protected she would be with just one dose of vaccine, should she choose not to get the second dose. She wanted to know if she could receive a different product to potentially avoid another rash. Therapeutic measures were taken as a result of the events. The case assessed as non-serous by the reporter. Therapeutic measures were taken as a result of the events. The outcome of the event rash was recovering and that of itching and hives was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Neck pain, Pain in extremity
Clinical narrative: Shoulder and neck soreness; Shoulder and neck soreness; Dominant arm very painful; Flexibility in range/can't move arm; This is a spontaneous report received from a contactable consumer or other non hcp. A 61-years-old female patient received 1st dose of bnt162b2 (Pfizer covid19 vaccine,Batch/Lot Number: EN6207),via an unspecified route of administration, administered in Arm Right on 13Mar2021 12:30,at the age of 61 years old,as Dose 1,single for covid-19 immunization.Medical history included ongoing overweight Structured information(Patient episode name,Patient Medical comments: Verbatim: Overweight,ongoing hypertension and ongoing asthma.Concomitant medications included hydrochlorothiazide, Irbesartan( HCTZ) taken for hypertension from an unspecified start date and ongoing; montelukast taken for asthma from an unspecified start date and ongoing and naproxen taken for inflammation,start and stop date were not reported.The patient experienced shoulder and neck soreness, dominant arm very painful and flexibility in range/can't move arm on 14Mar2021.Therapeutic measures were taken as a result of shoulder and neck soreness ,dominant arm very painful,flexibility in range/can't move arm.Patient can not raise her arm above her head. It is her dominant arm and it is very painful. It was not bothering her like it is now.Yesterday was 24 hrs ago.The patient was taking advil for the adverse event.The adverse events didn't result in hospital emergency room visit or physician clinic visit.The patient had no prior vaccination within 4 weeks.The outcome of the events was not recovered. Follow-up (15Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that Caller stated daughter filed her own adverse event report through Pfizer Safety Reporting online.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Mass, Pruritus, Urticaria
Clinical narrative: Hives; Itching; Bumps; Thinks it indicates this is an allergic reaction; This is a spontaneous report from a contactable consumer. This 22-year-old female consumer reported for her mother stating that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives, itching, bumps, thinks it indicates this is an allergic reaction. Caller received her first dose of the Pfizer covid on 12Mar2021. Caller stated that her reaction happened the day of, not sure if it was a reaction. My mother had reactions to the vaccine also and called earlier this morning and reported to Pfizer, she had hives and I want to make sure she was okay with what I was experiencing. Caller states 13 minutes into the 15 waiting she was fine and she am fine now, she had severe nausea, felt like she was going to throw up, my heart beat started racing, she felt disoriented, she had difficulty breathing, for only a short time. She thought these because she was panicking because she thought she was going to throw up. She had chills and my hearing went muffled for ten seconds, then I was fine. At the vaccination site she was sitting in the middle of the room, when it happened, I panicked for 60 seconds and then it went away, I think a minute to a minute and a half, She had nothing since then. The caller received her first dose on Friday and she went with her mother. The caller's mother developed hives and itching and bumps which the caller thought it indicated this is an allergic reaction. The clinical outcome of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Malaise, Myalgia, Pyrexia
Clinical narrative: Myalgias; arthralgias; fever; malaise; This is a spontaneous report from a contactable physician. A 64-years-old male patient received Second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot Number: Not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 10:00 as, single for covid-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, the patients had concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced myalgias, arthralgias, fever, malaise. The patient underwent lab tests and procedures which included body temperature: 100 farenite.  As treatment medication naproxen sodium were taken as a result of myalgias, arthralgias, fever, malaise. facility type vaccine Workplace clinic. The outcome of the patient was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Hypoaesthesia, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: vertigo; nausea; vomiting; leg pain; numbness after the first dose of the vaccine; ataxic; off work; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported for a 45-year-old female patient that:  A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EK5730), via an unspecified route of administration on 19Jan2021 as SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced vertigo, nausea, vomiting, leg pain, numbness after the first dose of the vaccine, ataxic, off work on an unspecified date. Caller stated those symptoms went away then came back after the second dose. Patient could not walk from the leg pain for a period of time. Event took place after use of product. Caller stated patient had similar but less severe symptoms. Caller stated had reported those cases already, and in the process of inquiring more information about your question. Caller stated all 3 of these cases we discussed received their Pfizer through 2 hospitals vaccine in Jan and 2 received it within 48hrs of each other. This may be a batch issue. one Lot was FL3247 on 21Jan2021 given at (Hospital Initial). Caller stated can provide more Lot, further details, and contact info for the 3 cases. caller stated with the 2nd patient and lot number EK5730, date of that vaccine 19Jan was, subsequent one was EL1284, caller stated that patient was not improving had ataxic and off work. Medical without had been negative for causes other than the vaccine. Caller stated Since there were reports of polyneuropathy, need to know more about those cases. Ideally how they were treated, did it resolve, what did they learn from their workups regarding the mechanism for this reaction, etc. The outcome of events was unknown.   Follow up (13Mar2021): New information received in response to this follow up spontaneous report from a contactable consumer via Pfizer sales representative.  This consumer reported for a patient included: case narrative.  Follow up (16Mar2021): New information received in response to this follow up spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported for a patient included that: event information and case narrative.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: vertigo; nausea; vomiting; leg pain; numbness after the first dose of the vaccine; ataxic; off work; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported for a 45-year-old female patient that:  A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EK5730), via an unspecified route of administration on 19Jan2021 as SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced vertigo, nausea, vomiting, leg pain, numbness after the first dose of the vaccine, ataxic, off work on an unspecified date. Caller stated those symptoms went away then came back after the second dose. Patient could not walk from the leg pain for a period of time. Event took place after use of product. Caller stated patient had similar but less severe symptoms. Caller stated had reported those cases already, and in the process of inquiring more information about your question. Caller stated all 3 of these cases we discussed received their Pfizer through 2 hospitals vaccine in Jan and 2 received it within 48hrs of each other. This may be a batch issue. one Lot was FL3247 on 21Jan2021 given at (Hospital Initial). Caller stated can provide more Lot, further details, and contact info for the 3 cases. caller stated with the 2nd patient and lot number EK5730, date of that vaccine 19Jan was, subsequent one was EL1284, caller stated that patient was not improving had ataxic and off work. Medical without had been negative for causes other than the vaccine. Caller stated Since there were reports of polyneuropathy, need to know more about those cases. Ideally how they were treated, did it resolve, what did they learn from their workups regarding the mechanism for this reaction, etc. The outcome of events was unknown.   Follow up (13Mar2021): New information received in response to this follow up spontaneous report from a contactable consumer via Pfizer sales representative.  This consumer reported for a patient included: case narrative.  Follow up (16Mar2021): New information received in response to this follow up spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported for a patient included that: event information and case narrative.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: He had cancer and on a treatment program, he had upper respiratory issues, a runny nose then it just went away, and he came back stronger; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. The patient reported that he had his first shot the previous week (from the time of report). He had cancer and on a treatment program, he had upper respiratory issues, a runny nose then it just went away, and he came back stronger after five days (on an unspecified date in Mar2021). He wanted to know if Pfizer wanted to know what is happening to patients after getting the shots. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Muscle spasms, Pain
Clinical narrative: chills; Cramps; achy; feeling feverish/mild fever; achy and it feels like someone punched me in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 65-years-old female patient received second dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via intramuscularly in left bicep (left arm) on 15Mar2021 in after noon (Batch/Lot Number: EP7534) as single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, # EN6201) via intramuscularly, administered in left bicep on 19Feb2021 at 2:40pm as single dose for covid-19 immunisation. The patient has no medical history and concomitant medication were not reported. No additional vaccines administered on same date of the Pfizer suspect. It was reported that after receiving the second dose of vaccine in Mar2021 the patient experienced feeling feverish/mild fever and achy and it feels like someone punched her in her chest. She was achy overnight and started having cramps. Clarified that she noticed over all achiness about 7:00AM this morning. She was achy overall. Her achiness has improved, now it was just in her back and shoulders. Patient stated regarding mild fever as she thinks that it started during the night while she was sleeping. She took her temperature about 8:00 am this morning, she retook her temperature about an hour ago and it was still 99.9. She thinks it has improved but she does not know for sure because she has not retaken it again yet. On 16Mar2021 patient experienced cramps which are acute and on 16Mar2021 at 07:00 in the morning the patient experienced chills. Therapeutic measures were taken as a result of cramps. Treatment included she took a couple of Tylenol yesterday. The outcome of the fever was unknown and was recovering from the events of chest pain and ache and was recovered from the events of chills and cramps on 16Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; Cramps; achy; feeling feverish/mild fever; achy and it feels like someone punched me in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 65-years-old female patient received second dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via intramuscularly in left bicep (left arm) on 15Mar2021 in after noon (Batch/Lot Number: EP7534) as single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, # EN6201) via intramuscularly, administered in left bicep on 19Feb2021 at 2:40pm as single dose for covid-19 immunisation. The patient has no medical history and concomitant medication were not reported. No additional vaccines administered on same date of the Pfizer suspect. It was reported that after receiving the second dose of vaccine in Mar2021 the patient experienced feeling feverish/mild fever and achy and it feels like someone punched her in her chest. She was achy overnight and started having cramps. Clarified that she noticed over all achiness about 7:00AM this morning. She was achy overall. Her achiness has improved, now it was just in her back and shoulders. Patient stated regarding mild fever as she thinks that it started during the night while she was sleeping. She took her temperature about 8:00 am this morning, she retook her temperature about an hour ago and it was still 99.9. She thinks it has improved but she does not know for sure because she has not retaken it again yet. On 16Mar2021 patient experienced cramps which are acute and on 16Mar2021 at 07:00 in the morning the patient experienced chills. Therapeutic measures were taken as a result of cramps. Treatment included she took a couple of Tylenol yesterday. The outcome of the fever was unknown and was recovering from the events of chest pain and ache and was recovered from the events of chills and cramps on 16Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Dyspnoea, Dysuria
Clinical narrative: Headache; burning when she pees; Burning in my chest/burning when she pees; Chest congestion; Urinary symptoms/a little bit of difficulty peeing; Terrible back pain where I couldn't walk; Terrible back pain where I couldn't walk; The pain takes her breath away; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 12Mar2021 02:00 (at the age of 52-years-old) as Dose 1, Single for covid-19 immunization. The medical history included back issues were diagnosed prior to having the Pfizer COVID Vaccine, and back surgeries on 1st was in 1999 and her other surgeries were prior to receiving the Pfizer COVID. The patient's concomitant medications were not reported. Patient did not receive any prior vaccinations within 4 weeks. Patient reported no relevant family medical history. Patient reported that just got her 1st dose on Friday on 12Mar2021 and was fine on Saturday but woke up at 3:00am on Sunday morning on 14Mar2021 and started having some reactions to the Pfizer COVID Vaccine and reported that "I woke up with a mild reaction of a headache, burning in my chest, had burning when pees and a little bit of difficulty peeing as well, chest congestion and urinary symptoms". Patient had "terrible back pain where I couldn't walk". And reported that "it eased up some yesterday but still when I walk even with sitting I'm having difficulty". Patient reported she had not had treatment for the reported events but the last symptom, which was terrible back pain was still going on and was the worst symptom. Terrible back pain to the point of when she got up on Sunday at 3:00am, she could not walk and could not take a step and could not walk; states the back pain has improved some and she could walk but the pain takes her breath away when it happens; states the back pain was straight across the middle of her back and was still there. Patient stated she was home from work today because of the back pain Patient stated that she was used to back pain and handles pain very well but this was severe and was severe compared to what she has had with back surgeries before. The patient did not receive any treatment for events. Patient did not any AE(s) require a visit to emergency room and physician office. No hospitalization. The patient was not recovered from the events headache, back pain, walking difficulty and breathing difficult and was recovered from the events micturition burning, chest burning, chest discomfort on Mar2021 and was recovering from the event urination difficulty at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache
Clinical narrative: Headache; burning when she pees; Burning in my chest/burning when she pees; Chest congestion; Urinary symptoms/a little bit of difficulty peeing; Terrible back pain where I couldn't walk; Terrible back pain where I couldn't walk; The pain takes her breath away; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 12Mar2021 02:00 (at the age of 52-years-old) as Dose 1, Single for covid-19 immunization. The medical history included back issues were diagnosed prior to having the Pfizer COVID Vaccine, and back surgeries on 1st was in 1999 and her other surgeries were prior to receiving the Pfizer COVID. The patient's concomitant medications were not reported. Patient did not receive any prior vaccinations within 4 weeks. Patient reported no relevant family medical history. Patient reported that just got her 1st dose on Friday on 12Mar2021 and was fine on Saturday but woke up at 3:00am on Sunday morning on 14Mar2021 and started having some reactions to the Pfizer COVID Vaccine and reported that "I woke up with a mild reaction of a headache, burning in my chest, had burning when pees and a little bit of difficulty peeing as well, chest congestion and urinary symptoms". Patient had "terrible back pain where I couldn't walk". And reported that "it eased up some yesterday but still when I walk even with sitting I'm having difficulty". Patient reported she had not had treatment for the reported events but the last symptom, which was terrible back pain was still going on and was the worst symptom. Terrible back pain to the point of when she got up on Sunday at 3:00am, she could not walk and could not take a step and could not walk; states the back pain has improved some and she could walk but the pain takes her breath away when it happens; states the back pain was straight across the middle of her back and was still there. Patient stated she was home from work today because of the back pain Patient stated that she was used to back pain and handles pain very well but this was severe and was severe compared to what she has had with back surgeries before. The patient did not receive any treatment for events. Patient did not any AE(s) require a visit to emergency room and physician office. No hospitalization. The patient was not recovered from the events headache, back pain, walking difficulty and breathing difficult and was recovered from the events micturition burning, chest burning, chest discomfort on Mar2021 and was recovering from the event urination difficulty at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swollen upper lip/upper fat lip; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry date: unknown), via an unspecified route of administration on 12Mar2021 as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient got the first Pfizer COVID-19 vaccine on Friday (on 12Mar2021). Two days later (on 14Mar2021), she has woke up with a swollen upper lip/ upper fat lip and it won't go away. She didn't see it as a reported adverse reaction with the vaccine and she called to have that confirmed. The patient has not seen that as a symptom listed anywhere. She has had no other problems, her arm didn't hurt, she had nothing else bother her. Her second dose was scheduled for 02Apr2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: felt a mild itching on his legs; he noticed that he had hives on his back, arms, and chins.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 61-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Mar2021, the patient experienced felt a mild itching on his legs, he noticed that he had hives on his back, arms, and chins. It was further reported that patient was 61-year-old male patient who received that vaccine earlier today. He mentioned that he was fine during the 30 minutes he was made to wait before leaving. On his way home, he felt a mild itching on his legs which he paid no mind to. About an hour and 40 minutes ago, he noticed that he had hives on his back, arms, and chins. He mentioned that there no to slight itching. He is not itching as of the moment. His main concern was if her could take the 2nd dose or not after experiencing these side effects. He stated that, well I have a question. I got the 1st dose of Covid-19 vaccine earlier today. I was at the location and they had me stayed there for 30 minutes and I was feeling fine. About 15 minutes later, on the way home I started noticing some mild itching. So when I got home I still have little itching and about an hour ago, I started noticing hives not the lower, the my upper extremities on my right arm, actually my right forearm on my chin and on my back I am seeing hives. Now they are not, when I say hives, I do not mean all over my body it is just like one here and there, one or two and my arm there was only one, on my upper back I see one and it was not all over, it is just one here and there and there was barely any itching at all but I was concerned about the reaction. Is it safe for me to have the second shot? He stated, let me call you back because I am working on finding what is happening to me right now. He stated that I have a PID number. No I do not see an expiration date. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program Regulatory Authority (CEP 159558). A contactable consumer (patient) reported that, a 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 25Feb2021 (at the age of 59-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included asthma from an unknown date and unknown if ongoing reported as, she is an asthmatic person. Concomitant medications included salbutamol (ALBUTEROL HFA) and salbutamol sulfate (INHALERIN) both taken for an unspecified indication, start and stop date were not reported. The patient experienced developed a little cough on an unspecified date. Patient stated that, "I got the first dose of the Pfizer covid vaccine on 25Feb2021. I'm an asthmatic and take medications every day for my asthma. I developed a little cough after the first dose of the vaccine, and I feel much better now. I use albuterol solution in a breathing machine, and I use some inhalers too.  I'm scheduled for the second dose on 18Mar2021 and want to know if I'll be able to get it. Patient said, my doctor knows about my asthma and wants me to get the vaccine." Further it was reported that, patient received the 1st dose on 25Feb2021 and scheduled to get her 2nd dose on 18Mar2021. However, she mentioned she is an asthmatic person and due to her asthma, she developed a little cough, and was currently taking medications Albuterol solution and few inhalers. She asked, if she is still allowed getting the 2nd dose prior to the medications that she is taking. She clarified that she was fine after receiving the 1st shot. Therapeutic measures were taken as a result of developed a little cough. Outcome of the event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: rash on her upper arms and legs; itchy rash on her upper arms and itchy rash on her legs; This is a spontaneous report from a contactable consumer (reported for herself). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the consumer reported that, she received her second shot on 06Mar2021 had no problems with either the first shot or the second shot. The consumer reported that about a week after receiving the second shot, she developed a itchy rash on her upper arms and itchy rash on her legs. Any reports of this happening a week after the shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.