chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Rash
Clinical narrative: This is a spontaneous report from Pfizer-sponsored program via Regulatory Authority. A contactable consumer (patients wife) reported for a male patient (reporters husband) for a Pfizer sponsored program. A male patient received bnt162b2 (BNT162B2), administration date 28May2021 (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: RASH (non-serious), EAR PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "He back of his ears had a rash and it hurts". Additional information: Patient took 1st dose Pfizer Covid-19 Vaccine on 28May2021. Verbatim and Event Description including that Caller (withheld) (Patient wife) wants to know what is the recommended vaccine for her. She had varicose veins but they are not noticeable. She doesn't have a schedule yet but if it's recommendable she would like to get a schedule. While reading the ISI she mentioned that her husband (withheld) had a reaction when he got the first dose, the back of his ears had a rash and it hurts. He took the first dose 28May, until now he didn't take the second because it might get worse. Caller wants to know if her husband experienced a reaction from the vaccine. She wants to know if her husband will take the second dose or need to start all over again. Provided FAQ When do I receive my second dose. Provided PM number and HOO. Cold transferred. Created AE form. Whereas medical Information unaddressed medical questions referred or forwarded to Medical Information. Reporter a Healthcare Professional was unknown, Reporter's contact information available to you or a sub-contracted party was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Somnolence, Urticaria
Clinical narrative: rash; bumps all over my body, mostly on chest my breast my stomach my back my thigh my wrist; and itchy; slept all day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Aug2021 (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: SOMNOLENCE (non-serious) with onset 28Aug2021, outcome "unknown", described as "slept all day"; RASH (non-serious) with onset 29Aug2021, outcome "unknown", described as "rash"; URTICARIA (non-serious) with onset 29Aug2021, outcome "unknown", described as "bumps all over my body, mostly on chest my breast my stomach my back my thigh my wrist"; PRURITUS (non-serious) with onset 29Aug2021, outcome "unknown", described as "and itchy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Pain
Clinical narrative: developed redness; pain along left nasolabial fold with soreness; nodule and firmness; This is a spontaneous report received from a non-contactable reporter(s) (Physician). Other Case identifier(s): GL-052821-13037 (Galderma).  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "rosacea" (unspecified if ongoing); "skin cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Restylane lyft, start date: 23Apr2021, notes: Patient was injected with 1cc total of Restylane Lyft in both cheeks on 23-Apr-2021. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: ERYTHEMA (non-serious) with onset 2021, outcome "recovered" (24Jun2021), described as "developed redness"; PAIN (non-serious) with onset 2021, outcome "recovered" (24Jun2021), described as "pain along left nasolabial fold with soreness"; NODULE (non-serious) with onset 2021, outcome "recovered" (24Jun2021), described as "nodule and firmness".  Additional information: Patient was injected with 1cc total of Restylane Lyft in both cheeks on 23-Apr-2021. On 26Apr2021, patient developed redness, pain along left nasolabial fold with soreness, nodule and firmness. She was treated with a Vitrase injection, Augmentin and a Prednisone taper. The events resolved on 24Jun2021. Pt received the COVID-19 vaccinations on 16Mar2021 and 13Apr2021 manufacturer unknown. Pt had history of skin cancer the vulva area removed two weeks prior to Lyft injection and had been on antibiotics for a vaginal infection post- surgery. She had a history of rosacea. She had no dental work in the past 6-12 months. It is unknown if patient has had any other vaccinations in the past 6-12 months.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Swelling face
Clinical narrative: whole left side of her face is swollen; Caller states her first dose of the Pfizer Vaccine was on 08Jun2021 and the 2nd dose was yesterday 30Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Caller states her first dose of the Pfizer Vaccine was on 08Jun2021), administration date: 08Jun2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Aug2021, outcome "unknown", described as "Caller states her first dose of the Pfizer Vaccine was on 08Jun2021 and the 2nd dose was yesterday 30Aug2021"; SWELLING FACE (non-serious) with onset 31Aug2021, outcome "not recovered", described as "whole left side of her face is swollen".  Additional Information: Caller stated she was calling about the Pfizer Vaccine and stated she got the 2nd dose of the vaccine yesterday and the whole left side of her face is swollen and she was going to go to the hospital after this call, caller was asked if she needed urgent medical attention at this time and stated she was ok to complete the report but will call after the call is completed. Caller stated she does not have the HCP information with her to provide at this time. Caller stated her first dose of the Pfizer Vaccine was on 08Jun2021 and the 2nd dose was yesterday 30Aug2021 and she has a lab number for the vaccine to provide of 1451-7.2 but stated her patient card and lots, expiry dates or NDC numbers for the vaccine is not with her at this time. She Stated the facial swelling began when she woke up this morning at about 5:30 am and is ongoing and the same as when it began; stated she took the vaccine because she does not want to get sick and has two kids and takes care of them and can't afford to be sick. Caller asked if the shot was life threatening or would kill her if she does not go in; caller aware Pfizer cannot provide treatment recommendations or medical advice but was offered transfer to USMI if she has product questions; caller declined and stated she will go to the hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Nausea, Pyrexia
Clinical narrative: Chills; Nausea; fever; discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Aug2021 15:00 (Lot number: EW0-177) at the age of 49 years as dose 1, single for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 28Aug2021, outcome "recovering", described as "fever"; CHILLS (non-serious) with onset 31Aug2021 21:00, outcome "not recovered", described as "Chills"; NAUSEA (non-serious) with onset 29Aug2021, outcome "not recovered", described as "Nausea"; DISCOMFORT (non-serious) with onset Aug2021, outcome "not recovered", described as "discomfort".  Additional Information: Patient had no other products. Patient had received the first dose of the Pfizer COVID-19 vaccine on Saturday 28AGO, and he got a lot of fever, a few days have passed and he still has a low fever. He also mentioned that he has had nausea and chills. All the doctors have told him to get tested for COVID-19 since he has been told that the side effects only last 1 or 2 days, however it was difficult to perform it since in (City and State Name) there were no appointments available. Had lots of fever. Still experiencing little bit of fever, and a low fever. Had little bit of chills. Had nausea. Lots of fever: That same Saturday, at night. Time: 8PM-9PM around that time. Outcome: The fever was down, still has fever, but just for a while. Before, fever was constant, now is less, but still has that discomfort. Improved a little. Chills: Began the day before yesterday, clarified date as 31Aug2021. Time: at night, thinks 9PM. During the day is fine. When night comes, gets those chills. Nausea: Began same as the fever. Get hungry, but his mouth/body no longer accepts it. Time: Unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Aug 12, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced  dyspnea/issue breathing, onset Aug 2021, with outcome of unknown. Additional information: The reporter said she had an issue breathing after taking the first shot on Aug 12, 2021. She asked for some information and if she would experience the same side effects after taking the second shot. Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Fatigue, Insomnia, Muscular weakness
Clinical narrative: muscle weakness; joint pain; bilateral ear pain that wakes her up; bilateral ear pain that wakes her up; states her arm hurt; fatigue/ she was very tired/ tired all day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 (Lot number: EW0196) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid 19", start date: Jan2021 (unspecified if ongoing), notes: she is a previously recovered Covid patient, states she had Covid in Jan2021. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 05Aug2021, outcome "recovering", described as "fatigue/ she was very tired/ tired all day"; MUSCULAR WEAKNESS (non-serious) with onset 06Aug2021, outcome "recovering", described as "muscle weakness"; ARTHRALGIA (non-serious) with onset 06Aug2021, outcome "recovering", described as "joint pain"; EAR PAIN (non-serious), INSOMNIA (non-serious) all with onset 06Aug2021, outcome "recovering" and all described as "bilateral ear pain that wakes her up"; PAIN IN EXTREMITY (non-serious) with onset 06Aug2021, outcome "recovering", described as "states her arm hurt".  Additional Information: Caller states she wants to report some lasting side effects from Pfizer Covid vaccine, received first dose 5Aug2021, states she tried twice to do the online thing but would not submit. Event Details: Caller states she is a previously recovered Covid patient, states she had Covid in Jan2021, states her doctor recommended one of the vaccines, states she got the vaccine on 5Aug2021 and that first day she expected some kind of reaction, states she was very tired, states she went to bed early and was fine, states the second night, on Friday, 6Aug2021, she was tired all day, states her arm hurt but was bearable, caller states she wanted to explain that when she had Covid in Jan2021, she had this bilateral ear pain, states on that Friday and for a number of nights afterwards she was waking up with that same bilateral ear pain that she had not experienced in months, caller states she is an active person, but is still having some muscle weakness and fatigue and joint pain, states that there is some improvement but she is not back to her pre vaccine self. Caller states her husband has not had any of these reactions, and he had Covid in Jan2021 as well and they received vaccines within minutes of each other. Time the Vaccination was given for Second Dose in 16:30. Anatomical Location of Administration of Pfizer vaccine considered as suspect: LEFT ARM. Patient had no Emergency Room and Physician Office visit. Prior Vaccinations patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: muscle weakness; joint pain; bilateral ear pain that wakes her up; bilateral ear pain that wakes her up; states her arm hurt; fatigue/ she was very tired/ tired all day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 (Lot number: EW0196) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid 19", start date: Jan2021 (unspecified if ongoing), notes: she is a previously recovered Covid patient, states she had Covid in Jan2021. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 05Aug2021, outcome "recovering", described as "fatigue/ she was very tired/ tired all day"; MUSCULAR WEAKNESS (non-serious) with onset 06Aug2021, outcome "recovering", described as "muscle weakness"; ARTHRALGIA (non-serious) with onset 06Aug2021, outcome "recovering", described as "joint pain"; EAR PAIN (non-serious), INSOMNIA (non-serious) all with onset 06Aug2021, outcome "recovering" and all described as "bilateral ear pain that wakes her up"; PAIN IN EXTREMITY (non-serious) with onset 06Aug2021, outcome "recovering", described as "states her arm hurt".  Additional Information: Caller states she wants to report some lasting side effects from Pfizer Covid vaccine, received first dose 5Aug2021, states she tried twice to do the online thing but would not submit. Event Details: Caller states she is a previously recovered Covid patient, states she had Covid in Jan2021, states her doctor recommended one of the vaccines, states she got the vaccine on 5Aug2021 and that first day she expected some kind of reaction, states she was very tired, states she went to bed early and was fine, states the second night, on Friday, 6Aug2021, she was tired all day, states her arm hurt but was bearable, caller states she wanted to explain that when she had Covid in Jan2021, she had this bilateral ear pain, states on that Friday and for a number of nights afterwards she was waking up with that same bilateral ear pain that she had not experienced in months, caller states she is an active person, but is still having some muscle weakness and fatigue and joint pain, states that there is some improvement but she is not back to her pre vaccine self. Caller states her husband has not had any of these reactions, and he had Covid in Jan2021 as well and they received vaccines within minutes of each other. Time the Vaccination was given for Second Dose in 16:30. Anatomical Location of Administration of Pfizer vaccine considered as suspect: LEFT ARM. Patient had no Emergency Room and Physician Office visit. Prior Vaccinations patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Woke up with a stiff neck; sore arm; sore arm at the injection; Started to get the chills; took temp was 99.5 neck getting worse; Feel achey; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 13:15 (Lot number: FC3182) as dose unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: verbatim- Diabetes; "Anyurism" (unspecified if ongoing), notes: verbatim-Anyurism; "Known allergy- Minerals" (unspecified if ongoing); "Covid-19", start date: Jan2021, stop date: Jan2021. Concomitant medication(s) included: FUROSEMIDE; OMEPRAZOLE; FAMOTIDINE; SYNJARDY. Past drug history included: Known allergy- cipro for drug hypersensitivity; Known allergy- srythromiacin for drug hypersensitivity; Known allergy- flexeril for drug hypersensitivity. The following information was reported: MUSCULO-SKELETAL STIFFNESS (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "Woke up with a stiff neck"; PAIN IN EXTREMITY (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "sore arm"; VACCINATION SITE PAIN (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "sore arm at the injection"; CHILLS (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "Started to get the chills"; PYREXIA (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "took temp was 99.5 neck getting worse"; MALAISE (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "Feel achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of musculoskeletal stiffness, pain in extremity, vaccination site pain, chills, pyrexia, malaise.  Additional information: It was reported that patient felt fine after the shot. Woke up with a stiff neck and sore arm at the injection. Started to get the chills, took temp., was 99.5 neck getting worse. patient had Covid in Jan021. Feel achy. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Woke up with a stiff neck; sore arm; sore arm at the injection; Started to get the chills; took temp was 99.5 neck getting worse; Feel achey; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 13:15 (Lot number: FC3182) as dose unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: verbatim- Diabetes; "Anyurism" (unspecified if ongoing), notes: verbatim-Anyurism; "Known allergy- Minerals" (unspecified if ongoing); "Covid-19", start date: Jan2021, stop date: Jan2021. Concomitant medication(s) included: FUROSEMIDE; OMEPRAZOLE; FAMOTIDINE; SYNJARDY. Past drug history included: Known allergy- cipro for drug hypersensitivity; Known allergy- srythromiacin for drug hypersensitivity; Known allergy- flexeril for drug hypersensitivity. The following information was reported: MUSCULO-SKELETAL STIFFNESS (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "Woke up with a stiff neck"; PAIN IN EXTREMITY (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "sore arm"; VACCINATION SITE PAIN (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "sore arm at the injection"; CHILLS (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "Started to get the chills"; PYREXIA (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "took temp was 99.5 neck getting worse"; MALAISE (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "Feel achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of musculoskeletal stiffness, pain in extremity, vaccination site pain, chills, pyrexia, malaise.  Additional information: It was reported that patient felt fine after the shot. Woke up with a stiff neck and sore arm at the injection. Started to get the chills, took temp., was 99.5 neck getting worse. patient had Covid in Jan021. Feel achy. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Urine analysis
Clinical narrative: Urinating blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 13:30 (Lot number: FC 3184) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "If Covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE; LEXAPRO; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Omnicef, reaction(s): "Known allergies: Omnicef". The following information was reported: BLOOD URINE PRESENT (non-serious) with onset 31Aug2021 07:30, outcome "unknown", described as "Urinating blood". The event "urinating blood" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood urine present.  Additional information: Report about Covid vaccine: Yes. Reporting type: AE. Reporter type: Patient. Age group: Adult (18-64 Years). Patient occupation: None of the above. If other vaccine in four weeks: No. Other medications in two weeks: Lexapro, Singular, Flonase, Spironolactone. Adverse event: Urinating blood. Adverse event country:. AE resulted in: Doctor or other healthcare professional office/clinic visit. If patient recovered: Unknown. If treatment AE: Yes. AE treatment: Antibiotics. If Covid prior vaccination: Yes. If Covid tested post vaccination: No. Known allergies: Omnicef. Other medical history: None.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Myalgia, Pain
Clinical narrative: Muscles were really sore; It feels like the arthritis pain that he has in his hip, but all over his body; It feels like the arthritis pain that he has in his hip, but all over his body; It feels like the arthritis pain that he has in his hip, but all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 11:30 (Lot number: EW0183) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis in hip", start date: Mar2021 (ongoing), notes: States he has had arthritis in his hip since Mar2021. The patient took concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 03Sep2021, outcome "unknown", described as "Muscles were really sore"; PAIN (non-serious), ARTHRALGIA (non-serious), ARTHRITIS (non-serious) all with onset 03Sep2021, outcome "unknown" and all described as "It feels like the arthritis pain that he has in his hip, but all over his body".  Additional information: Patient received the first dose of the Pfizer Covid-19 vaccine on 27Aug2021. Caller states when the vaccine was administered, he "didn't even realize he had received the shot because his arm didn't hurt". Caller states his "muscles were really sore," in which the muscle soreness started this morning. Caller was asking if muscle soreness was normal and if it usually takes this long for side effects to appear. Caller asked if he could take ibuprofen for the muscle soreness he was experiencing. Concomitant medications included the unspecified high blood pressure medication from 2000, unspecified heart medication from 2000 and unspecified blood thinner from 2000. Caller states that he was calling about the Pfizer product that was FDA approved. Clarified as the Pfizer Covid 19 Vaccine. Caller states that all of his muscles were sore. Asks if that it normal. States he took the vaccine last friday, does it take that long to have side effects. Caller denies any other medications or medical conditions relevant to events. Then he states he was on high blood pressure medication, heart medication, and blood thinners since 2000. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. Any AE(s) did not require a visit to Emergency Room and Physician Office. Prior Vaccinations (within 4 weeks), patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Maternal exposure during pregnancy
Clinical narrative: Hypertension; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 08:15 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Date of last menstrual period: 02Apr2021. The patient was 16 weeks pregnant at the time of exposure to bnt162b2. The patient was 17 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 07Jan2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical location: Arm right; Administration time: 08:15;), administration date: 08Jul2021, when the patient was 35 years old, for COVID-19 immunisation, reaction(s): "Maternal exposure during pregnancy, second trimester". The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 29Jul2021 08:15, outcome "unknown", described as "Maternal Exposure During Pregnancy, second trimester"; HYPERTENSION (non-serious) with onset 30Jul2021 11:00, outcome "not recovered", described as "Hypertension". The event "hypertension" was evaluated at the physician office visit. Therapeutic measures were taken as a result of hypertension.  Additional information: The patient had no known allergies. The last menstrual period of the patient was 02Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 at 11:00 (also reported as about 24 hours after second dose), the patient had hypertension. At the time of report, hypertension had not yet returned to normal levels. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of hypertension which included treatment with nifedipine (MANUFACTURER UNKNOWN). The clinical outcome of the event hypertension was not recovered at the time of this report.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling hot, Nausea
Clinical narrative: Warm feeling; dizziness; shortness of breath; nausea; This is a spontaneous report from a contactable Nurse. This 37-year-old Female Nurse (Patient) reported for herself that:  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jun2021 16:00 (Lot number: EW0179) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Gastritis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; SPIRONOLACTONE; MULTIVITAMINS [VITAMINS NOS]. The following information was reported: FEELING HOT (non-serious) with onset 27Jun2021 16:15, outcome "recovered" (2021), described as "Warm feeling"; DIZZINESS (non-serious) with onset 27Jun2021 16:15, outcome "recovered" (2021), described as "dizziness"; DYSPNOEA (non-serious) with onset 27Jun2021 16:15, outcome "recovered" (2021), described as "shortness of breath"; NAUSEA (non-serious) with onset 27Jun2021 16:15, outcome "recovered" (2021), described as "nausea". Therapeutic measures were not taken as a result of feeling hot, dizziness, dyspnoea, nausea.  Additional information: Patient did not had covid prior vaccination or tested for covid post vaccination. Patient did not had any other vaccine in four weeks.  Follow-up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Blood thyroid stimulating hormone, Rash, Rash pruritic, Vitamin D
Clinical narrative: I have a rash on my arm and on my chest and they itch; I have a rash on my arm and on my chest and they itch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Aug2021 (Lot number: F08448) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid problems" (unspecified if ongoing), notes: Verbatim: Thyroid problems; "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure; "Glaucoma" (unspecified if ongoing), notes: Verbatim: Glaucoma; "Osteoporosis" (unspecified if ongoing), notes: Verbatim: Osteoporosis; "Arthritic pains" (unspecified if ongoing); "bones" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; CALCIUM; LOSARTAN POTASSIUM taken for blood pressure abnormal; LEVOTHYROXINE taken for thyroid disorder; LATANOPROST taken for glaucoma; HYDROCHLOROTHIAZIDE; ALENDRONATE SODIUM taken for osteopetrosis; IBUPROFEN taken for arthralgia; DORZOLAMIDE + TIMOLOL taken for glaucoma.  The following information was reported: RASH (non-serious), RASH PRURITIC (non-serious), outcome "unknown" and all described as "I have a rash on my arm and on my chest and they itch". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, rash pruritic.  Additional information: Other medication, take general vitamins, I take generic medications like they give for general problems. For lab test go to the doctor and it was done in August around first part of August. Patient will second vaccination on 22Sep2021. Patient received Clobetasol Propionate cream for hands one time. Shot time, "Around 10 am, it was quite a little bit before 10 am, it was like."  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Dizziness, Headache, Pyrexia
Clinical narrative: lower back pain; nerve burning sensation; dizziness; high fever; intense headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 10:00 (Lot number: FC 3180) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FC3180, Lot unknown: False, Administration date: 10Aug2021, Vaccine location: Left arm, Dose number:1), administration date: 10Aug2021, when the patient was 53 years old, for COVID-19 Immunisation, reaction(s): "High fever", "Chills", "Aches".  The following information was reported: BACK PAIN (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "lower back pain"; BURNING SENSATION (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "nerve burning sensation"; DIZZINESS (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "dizziness"; PYREXIA (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "high fever"; HEADACHE (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "intense headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of back pain, burning sensation, dizziness, pyrexia, headache.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient tested COVID post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: lower back pain; nerve burning sensation; dizziness; high fever; intense headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 10:00 (Lot number: FC 3180) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FC3180, Lot unknown: False, Administration date: 10Aug2021, Vaccine location: Left arm, Dose number:1), administration date: 10Aug2021, when the patient was 53 years old, for COVID-19 Immunisation, reaction(s): "High fever", "Chills", "Aches".  The following information was reported: BACK PAIN (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "lower back pain"; BURNING SENSATION (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "nerve burning sensation"; DIZZINESS (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "dizziness"; PYREXIA (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "high fever"; HEADACHE (non-serious) with onset 31Aug2021 11:30, outcome "recovering", described as "intense headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of back pain, burning sensation, dizziness, pyrexia, headache.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient tested COVID post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Sep 1, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient developed pyrexia/fever up to 101.8ºF, onset Sep 2, 2021, with outcome of unknown. Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate irregular, Pain in extremity, Palpitations
Clinical narrative: Sore arm for 2 days; shortness of breath; palpitations; irregular heart beat; chest pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Aug2021 10:00 (Lot number: FC3182) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMOXICILLIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "Sore arm for 2 days"; DYSPNOEA (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "shortness of breath"; PALPITATIONS (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "palpitations"; HEART RATE IRREGULAR (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "irregular heart beat"; CHEST PAIN (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "chest pain". The events "sore arm for 2 days", "shortness of breath", "palpitations", "irregular heart beat" and "chest pain" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, dyspnoea, palpitations, heart rate irregular, chest pain.  Additional Information: Patient did not take any other vaccine in four weeks prior COVID -19 vaccine. If covid prior vaccination was reported as no. Covid test post vaccination: covid test type was Unknown, covid test date was 02Sep2021, covid test result was Negative. Known allergies was reported as no. Other medical history was reported as no. Adverse event: Sore arm for 2 days, then developed shortness of breath with palpitations, 3rd night I developed irregular heartbeat, palpitations, and chest pain and it is still continuing intermittently.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Sore arm for 2 days; shortness of breath; palpitations; irregular heart beat; chest pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Aug2021 10:00 (Lot number: FC3182) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMOXICILLIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "Sore arm for 2 days"; DYSPNOEA (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "shortness of breath"; PALPITATIONS (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "palpitations"; HEART RATE IRREGULAR (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "irregular heart beat"; CHEST PAIN (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "chest pain". The events "sore arm for 2 days", "shortness of breath", "palpitations", "irregular heart beat" and "chest pain" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, dyspnoea, palpitations, heart rate irregular, chest pain.  Additional Information: Patient did not take any other vaccine in four weeks prior COVID -19 vaccine. If covid prior vaccination was reported as no. Covid test post vaccination: covid test type was Unknown, covid test date was 02Sep2021, covid test result was Negative. Known allergies was reported as no. Other medical history was reported as no. Adverse event: Sore arm for 2 days, then developed shortness of breath with palpitations, 3rd night I developed irregular heartbeat, palpitations, and chest pain and it is still continuing intermittently.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Insomnia, Pain
Clinical narrative: flare up in his arthritis in his shoulders, wrists, fingers and legs; Night time pain is worse than day time pain; often wakes patient and makes sleep difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 83 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild arthritis" (ongoing), notes: Patient had mild arthritis in his 20's which disappeared after a couple years.; "gout", start date: Dec2020 (unspecified if ongoing), notes: then in Dec2020, had issues with gout in addition to arthritis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 2021, outcome "not recovered", described as "flare up in his arthritis in his shoulders, wrists, fingers and legs"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Night time pain is worse than day time pain"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "often wakes patient and makes sleep difficult".  Additional information: Description of Event: 83-year-old male patient (withheld), my father, reported to me that he experienced a flare up in his arthritis in his shoulders, wrists, fingers and legs after the 2nd Pfizer Comirnaty vaccine in Mar2021. The arthritis flare has not yet subsided and it is now Sept 3rd. Night time pain is worse than day time pain and often wakes patient and makes sleep difficult. Patient is 5'1" and 150 lbs. Optional Information:  The arthritis worsened after the 2nd vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: She got swelling like her first time; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2020 (Lot number: EK5730) at the age of 62 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: SWELLING (non-serious), outcome "unknown", described as "She got swelling like her first time". Additional Information: Patient received the first dose of the Pfizer covid vaccine in Dec and 2nd dose in Jan. Afterwards she was diagnosed with breast cancer. She went through breast surgery, radiation. She was on a shorter course in Jul that ended in Aug then she went in for her booster dose of the Pfizer covid vaccine on 21Aug2021. She got swelling like her first time and it lingered and got lymphedema. After the 2nd dose of the Pfizer covid vaccine she had lots of fatigue and lots of swelling in the arm. Patient's second injection was in the first week of Jan2021. She got the booster but in between all of that time, she got the Breast Cancer Diagnosis, have to have a mass removed surgery (Further clarification unknown) and then they did what is it called a sentinel node biopsy (Not clarified) and this is on the left side. She had no Lymphedema post-surgery at all and then got the injection on that left side, and then this is on the 21Aug2021 and her arm been swelled up with pretty significant Lymphedema. It's just starting to go away. Patient had no other vaccine within 4 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Maternal exposure timing unspecified, Mobility decreased, Neck pain
Clinical narrative: I am also pregnant; I started getting pain in my shoulder and also in my neck; I cannot  turn my neck.; I started getting pain in my shoulder and also in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (pregnant) received bnt162b2 (BNT162B2), administration date 03Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious) with onset 03Sep2021, outcome "unknown", described as "I am also pregnant"; ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 03Sep2021, outcome "not recovered" and all described as "I started getting pain in my shoulder and also in my neck"; MOBILITY DECREASED (non-serious) with onset 03Sep2021, outcome "not recovered", described as "I cannot turn my neck.".  Additional Information: Reporter seriousness for I am also pregnant; I started getting pain in my shoulder and also in my neck. Now, I cannot turn my neck was Unspecified. Consumer stated, "I have a question. I got the second vaccine today and I am also pregnant(not further clarified, Hence not captured in tab) but I was feeling fine and then, It's about an hour ago, I started getting pain in my shoulder and also in my neck. Now, I cannot turn my neck. I want to know is that normal." Further probing could not be done, As the Consumer was not willing to complete the report. Patient demographics, Product details, Event details, Medical history were unknown. Limited information available over the call. Consumer was informed about Pfizer Medical Information department and provided with the number.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.