chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Influenza like illness, Myalgia
Clinical narrative: More or less, like a little bit towards the bottom of kidney, it hurts in that area. She states it's muscular maybe but its on the right side.; little bit of flu-like symptoms; in the bed the whole week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Lot number: EW0182, Expiration Date: 31Jul2021) at the age of 70 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1, Lot Number: ER8727, Expiry Date: 31Jul2021, She mentions it's kind of small on her vaccine card but she sees the following: Pfizer CV vaccine 0.3mL/mg BUD 8 hours at RT. The caller mentions the expiration is so small, Anatomical Location: Left arm), administration date: 23Mar2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "she had no problem"; Flu vaccines (she all the vaccines required such as shingles, flu, that has been during the year and nothing to do with the Pfizer.). The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "little bit of flu-like symptoms"; BEDRIDDEN (non-serious) with onset Apr2021, outcome "unknown", described as "in the bed the whole week"; MYALGIA (non-serious), outcome "unknown", described as "More or less, like a little bit towards the bottom of kidney, it hurts in that area. She states it's muscular maybe but its on the right side.".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: Feet swollen; I am feeling side effect; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Feet swollen; I am feeling side effect"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath".  Additional information: Patient got the shot last week and 3 days afterwards feet became swollen and patient feeling shortness of breath. Patient want to know, was that one of the side effect of Pfizer shot (vaccine).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching around neck; Redness and itching around neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 75 year-old patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), 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; Bnt162b2 (Second dose), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset Oct2021, outcome "unknown" and all described as "Redness and itching around neck".  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: Gave her the two doses; Did not know that she had to wait three weeks; Went in to get the second dose and she got the two shots within one week after each other; She is feeling really bad/Feels awful/We won''t even know if she is running a fever because she feels so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Gave her the two doses; Did not know that she had to wait three weeks; Went in to get the second dose and she got the two shots within one week after each other"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "She is feeling really bad/Feels awful/We won''t even know if she is running a fever because she feels so bad". Therapeutic measures were taken as a result of feeling abnormal.  Additional Information: This consumer reported for a female patient (reporters daughter). Reporter stated, "I am calling because my daughter received a Pfizer vaccine at a local, a drug store out there and they gave her the two doses. She registered but not showed that appointment. She made a second appointment and they gave her a Covid card and I guess she did not know that she had to wait three weeks, so she got a reminder saying that she needs to come in for the second dose and she went in to get the second dose and she got the two shots within one week after each other and she is feeling really bad not to the point, where she needs to go to the emergency room, I don't think but she just feels awful. So, what should I, should she go even though she has taken Tylenol & Motrin (later clarified as treatment). So, we won't even know if she is running a fever because she feels so bad (event captured as per verbatim since further clarification was unknown). So, that is a reason to have been really concerned or (sentence incomplete)? She got the Pfizer first and the second dose."  Follow-up (26Oct2021): 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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Tenderness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: red swelling at injection site; red swelling at injection site; tenderness; glands swollen and enlarged/swelling under arm; glands painful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 16:00 (Lot number: FE3590) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 08Oct2021. Past drug history included: Yes, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8735, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 30Apr2021, when the patient was 47 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 21May2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 12Oct2021, outcome "unknown" and all described as "red swelling at injection site"; TENDERNESS (non-serious) with onset 12Oct2021, outcome "unknown", described as "tenderness"; LYMPHADENOPATHY (non-serious) with onset 12Oct2021, outcome "unknown", described as "glands swollen and enlarged/swelling under arm"; LYMPH NODE PAIN (non-serious) with onset 12Oct2021, outcome "unknown", described as "glands painful". The events "red swelling at injection site", "red swelling at injection site", "tenderness", "glands swollen and enlarged/swelling under arm" and "glands painful" were evaluated at the physician office visit.  Additional information: It was reported prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: moderate arm pain; mild myalgia; mild fatigue; 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 received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 15Oct2021 (Lot number: EW0217) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 02Oct2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "migraine" (unspecified if ongoing); "chronic allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: ALAVERT; DYMISTA; LEVOXYL; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; RHINOCORT [BUDESONIDE]. Past drug history included: None. Vaccination history included: Comirnaty (pfizer-biontech covid-19 vaccine) (Dose Number: 2, Batch/Lot No: EP6955, Route of Administration: Intramuscular), administration date: 24Mar2021, when the patient was 45 years old, for COVID-19 immunisation, reaction(s): "arm pain", "myalgia", "fatigue"; Comirnaty (pfizer-biontech covid-19 vaccine) (Dose Number: 1, Batch/Lot No: EL3247), for COVID-19 immunisation, reaction(s): "arm pain". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Oct2021 19:00, outcome "recovered" (17Oct2021), described as "moderate arm pain"; MYALGIA (non-serious) with onset 15Oct2021 19:00, outcome "recovered" (16Oct2021), described as "mild myalgia"; FATIGUE (non-serious) with onset 15Oct2021 19:00, outcome "recovered" (16Oct2021), described as "mild fatigue". Therapeutic measures were not taken as a result of pain in extremity, myalgia, fatigue.  Additional information: Patient arm pain was worse than with Dose 1 and Dose 2; all other systemic AEs were mild and less than those following Dose 2. Eligibility for booster dose was based on the underlying medical conditions listed on CDC website and not due to immunosuppression nor occupational exposure.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram
Clinical narrative: with the first one he had like chills and stuff; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 (Lot number: EN6205) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney stones" (unspecified if ongoing), notes: Verbatim: Kidney stones. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "with the first one he had like chills and stuff". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shakes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US084984.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "shakes".  Additional information: Patient mentioned that the shakes was started when she got the COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Headache, Influenza like illness
Clinical narrative: Flu like symptoms; severe headache; Had similar but not quite as severe reaction to dose 2; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 14Feb2021 16:50 (Lot number: EL8982) as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCOS", start date: 1986 (ongoing), notes: History of PCOS; "Penicillin Allergy" (unspecified if ongoing), notes: PCN allergy. Concomitant medication(s) included: ESTRADIOL taken for menopause, start date: 12Sep2021 (ongoing); PROGESTERON taken for menopause, start date: 12Sep2021 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time 7:00 PM, Site and Route of injection: Anatomical site of injection: Left Deltoid, Route of Administration: Intramuscular, Batch/Lot number: EL3249,), administration date: 27Jan2021, for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "severe headache"; ADVERSE EVENT (non-serious) with onset 2021, outcome "recovered" (2021), described as "Had similar but not quite as severe reaction to dose 2". Therapeutic measures were taken as a result of influenza like illness, headache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Blood testosterone decreased
Clinical narrative: low testosterone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD TESTOSTERONE DECREASED (non-serious), outcome "unknown", described as "low testosterone". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller also notes that his son also experienced the same "low testosterone" and he questions it possibly be due to them being "out of shape" or possibly "not eating the right things." Caller states that he is "older" and he knows why his is lower. He had the 1st 2 shots and caught a "mild case" of COVID19 afterwards. He notes that "COVID19 can lower testosterone" and he is "wondering if in the form of the medication to fight it off has the same stuff as COVID 19 to build immunity." He states that maybe it lowers testosterone as COVID 19 can lower testosterone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Dyspnoea, Taste disorder
Clinical narrative: certain taste in my mouth just like egg stinks; I felt a little weird kind of like confusion; my breathing ability was little bit difficulty in breathing their for a while for two days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: TASTE DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "certain taste in my mouth just like egg stinks"; CONFUSIONAL STATE (non-serious) with onset Oct2021, outcome "unknown", described as "I felt a little weird kind of like confusion"; DYSPNOEA (non-serious) with onset Oct2021, outcome "unknown", described as "my breathing ability was little bit difficulty in breathing their for a while for two days". The events "certain taste in my mouth just like egg stinks", "i felt a little weird kind of like confusion" and "my breathing ability was little bit difficulty in breathing their for a while for two days" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of taste disorder, confusional state, dyspnoea.   Additional information: Patient reported that, had not taken any medication or any lab test. The patient felt a little weird kind of like confusion and certain taste in mouth just like egg stinks and breathing ability was little bit difficulty in breathing there for a while for two days but the slight confusion and the certain taste in mouth are still continued.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bradyphrenia, Chest X-ray, Headache, Hyperhidrosis
Clinical narrative: Running a temperature for about 4 days of 100.9; got the sweats/clammy and sweaty; headache; cloudiness; she had shakes that went on for days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 09:30 (Batch/Lot number: unknown) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Obese" (unspecified if ongoing); "Knee replacement" (unspecified if ongoing). Concomitant medication(s) included: FLU, start date: 22Sep2021, stop date: 22Sep2021. Past drug history included: Flu, start date: 22Sep2021, stop date: 22Sep2021, reaction(s): "bump on the arm", notes: AE(s) following prior vaccinations: Caller states besides a bump on the arm. Vaccination history included: Bnt162b2 (1st dose, Anatomical location: left upper arm, Time of administration: 9 am), administration date: 07Mar2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "Pyr"; Bnt162b2 (2nd dose, this is 10 times worse that what she had with the 2nd dose, Lot number:EP7533, Anatomical location: left upper arm, Time of administration: 1:30, Expiry Date: 31Jul2021), administration date: 28Mar2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "worse that what she had with the 2nd dose"; She had typhoid shot (back in the ancient days she had typhoid shot and if there was an epidemic). The following information was reported: TREMOR (non-serious) with onset Oct2021, outcome "unknown", described as "she had shakes that went on for days"; PYREXIA (non-serious) with onset 13Oct2021 07:00, outcome "unknown", described as "Running a temperature for about 4 days of 100.9"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "got the sweats/clammy and sweaty"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "headache"; BRADYPHRENIA (non-serious) with onset Oct2021, outcome "unknown", described as "cloudiness". The event "running a temperature for about 4 days of 100.9" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: Running a temperature for about 4 days of 100.9; got the sweats/clammy and sweaty; headache; cloudiness; she had shakes that went on for days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 09:30 (Batch/Lot number: unknown) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Obese" (unspecified if ongoing); "Knee replacement" (unspecified if ongoing). Concomitant medication(s) included: FLU, start date: 22Sep2021, stop date: 22Sep2021. Past drug history included: Flu, start date: 22Sep2021, stop date: 22Sep2021, reaction(s): "bump on the arm", notes: AE(s) following prior vaccinations: Caller states besides a bump on the arm. Vaccination history included: Bnt162b2 (1st dose, Anatomical location: left upper arm, Time of administration: 9 am), administration date: 07Mar2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "Pyr"; Bnt162b2 (2nd dose, this is 10 times worse that what she had with the 2nd dose, Lot number:EP7533, Anatomical location: left upper arm, Time of administration: 1:30, Expiry Date: 31Jul2021), administration date: 28Mar2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "worse that what she had with the 2nd dose"; She had typhoid shot (back in the ancient days she had typhoid shot and if there was an epidemic). The following information was reported: TREMOR (non-serious) with onset Oct2021, outcome "unknown", described as "she had shakes that went on for days"; PYREXIA (non-serious) with onset 13Oct2021 07:00, outcome "unknown", described as "Running a temperature for about 4 days of 100.9"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "got the sweats/clammy and sweaty"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "headache"; BRADYPHRENIA (non-serious) with onset Oct2021, outcome "unknown", described as "cloudiness". The event "running a temperature for about 4 days of 100.9" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Malaise, Product use issue, Vertigo, Vomiting
Clinical narrative: Blood pressure is really high; When he lays down, he is spinning a lot/ Room is spinning; Throwing up; Doesn''t feel good/ He is not well; Had his second Pfizer shot and at the same time they gave him the flu shot (Unspecified Flu Shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU), administration date 17Oct2021 (Batch/Lot number: unknown) as dose number unknown single for immunisation; insulin (INSULIN) (Batch/Lot number: unknown) for diabetes mellitus. Relevant medical history included: "Diabetic" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset 17Oct2021, outcome "unknown", described as "Blood pressure is really high"; VERTIGO (non-serious) with onset 17Oct2021, outcome "unknown", described as "When he lays down, he is spinning a lot/ Room is spinning"; VOMITING (non-serious) with onset 17Oct2021, outcome "unknown", described as "Throwing up"; MALAISE (non-serious) with onset 17Oct2021, outcome "unknown", described as "Doesn''t feel good/ He is not well"; PRODUCT USE ISSUE (non-serious) with onset 17Oct2021, outcome "unknown", described as "Had his second Pfizer shot and at the same time they gave him the flu shot (Unspecified Flu Shot)". The action taken for insulin was unknown.  Additional information: it was reported that patient was given Insulin twice at the time of report.  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, Fatigue, Headache
Clinical narrative: Slight headache (starting 15 hours post-shot); Fatigue (starting 15 hours post-shot); Chills (starting 24 hours post-shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 17:00 (Lot number: FF2590) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetic" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; HUMALOG; DIOVAN; OMEGA-3 FATTY ACIDS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731), administration date: 10Apr2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534), administration date: 20Mar2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Oct2021 08:00, outcome "recovering", described as "Slight headache (starting 15 hours post-shot)"; FATIGUE (non-serious) with onset 16Oct2021 08:00, outcome "recovering", described as "Fatigue (starting 15 hours post-shot)"; CHILLS (non-serious) with onset 16Oct2021 08:00, outcome "recovering", described as "Chills (starting 24 hours post-shot)". Therapeutic measures were not taken as a result of headache, fatigue, chills.  Additional information: Facility where the most recent COVID-19 vaccine administered was pharmacy or drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; Mild body ache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Lot number: FF2590) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203), administration date: 11Mar2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 18Feb2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2021, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 18Oct2021, outcome "recovering", described as "Mild body ache". Therapeutic measures were not taken as a result of chills, pain. Additional information: No covid vaccination prior vaccination. No covid tested post vaccination No  No follow-up attempts are possible. No further information is expected.  Follow-up (25Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: made me tired for a day; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient in her 60's received bnt162b2 (BNT162B2) (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 (1st Dose), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered" (2021), described as "made me tired for a day". Additional information: Patient experienced fatigue after COVID vaccine. Second shot just made her tired for a day. She was just tired the next day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram abnormal
Clinical narrative: had a mammography and they found something on it; enlarged lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MAMMOGRAM ABNORMAL (non-serious), outcome "unknown", described as "had a mammography and they found something on it"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was vaccinated on the left arm, but the nodes appeared in the right breast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: You can take water and put it in the arm and, and it's going to be sore; This is a spontaneous report received from non-contactable reporter(s) (Other HCP and Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "You can take water and put it in the arm and, and it's going to be sore". Additional information: Action taken: Unknown; Causality: Not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: You can take water and put it in the arm and, and it's going to be sore; This is a spontaneous report received from non-contactable reporter(s) (Other HCP, Consumer or other non HCP and Physician).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "You can take water and put it in the arm and, and it's going to be sore". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine, Blood creatinine increased, Fatigue, Peripheral swelling
Clinical narrative: Second dose: creatinine level went up to 20-25%; After his second dose he felt tired; little bit of swollen arm went away after 2 days.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic kidney disease" (unspecified if ongoing), notes: history of chronic kidney disease (numbers show in the middle of phase 2 to 3), diabetes and immune compromised.; "Diabetes" (unspecified if ongoing), notes: history of chronic kidney disease (numbers show in the middle of phase 2 to 3), diabetes and immune compromised.; "immune compromised" (unspecified if ongoing), notes: history of chronic kidney disease (numbers show in the middle of phase 2 to 3, diabetes and immune compromised. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid 19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "After his second dose he felt tired"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "little bit of swollen arm went away after 2 days."; BLOOD CREATININE INCREASED (non-serious), outcome "not recovered", described as "Second dose: creatinine level went up to 20-25%". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood creatinine increased.  Additional Information: Caller reported history of chronic kidney disease (numbers show in the middle of phase 2 to 3), diabetes and immune compromised. Caller stated that he was fine after the first Pfizer BioNtech covid 19 vaccine. After his second dose he felt tired little bit of swollen arm went away after 2 days. Also reports that he was tired for 3 days after booster shot, also took flu shot at the same time but then felt ok. Also his creatine level went up 20 to 25%, made some medication changes after 2 months kidney levels got better, came back to the number we had before. Caller then got his booster shot 2 weeks ago on 02Oct2021 and his blood test from this Friday showed that his creatine is up about 22% again. He is not feeling tired as he normally is with kidney issues. Caller stated he got the Pfizer Covid, the first shot, and he took the second shot and noticed that his creatinine level went up 20-25% after the second shot. Caller states he went to his kidney doctor and he did nothing, just said to give it a little time. He states after 2 months, it came back, the kidney levels got better, so they think it might have been a side effect of the Pfizer vaccine. He stated he took the booster 2 weeks ago and his creatinine is up 22% again.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (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 (Dose:01), for COVID-19 Immunization. The following information was reported: Fatigue(non-serious), outcome "unknown", described as "tired".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of relaxation
Clinical narrative: relaxed in bed that whole day; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An elderly female patient received bnt162b2 (BNT162B2) (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 (DOSE 1), for COVID-19 immunization. The following information was reported: FEELING OF RELAXATION (non-serious), outcome "unknown", described as "relaxed in bed that whole day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101393021
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Immune system disorder
Clinical narrative: my immune system is a little bit damaged; I felt a little bit in the second one; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 (Dose number: 01), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "my immune system is a little bit damaged"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I felt a little bit in the second one".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101393020
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Genital rash, Pruritus genital
Clinical narrative: My genitals have developed a rash; Itchy response in 24 hours after receiving my covid booster injection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Oct2021 10:00 (Lot number: FF2593) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: All cillins" (unspecified if ongoing), notes: Known allergies: All cillins; "Known allergies: Bee stings" (unspecified if ongoing), notes: Known allergies: Bee stings; "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex; "Known allergies: Seafood" (unspecified if ongoing), notes: Known allergies: Seafood. Concomitant medication(s) included: ALPRAZOLAM; PROPRANOLOL; ESCITALOPRAM; SEQIRUS FLUCELVAX QUAD PF, administration date 06Oct2021. Vaccination history included: Bnt162b2 (Prev dose Product: COVID 19, Prev dose Brand: Pfizer, Prev dose Lot number: ER8727, Prev dose Vaccine location: Right arm, Prev dose Dose number: 1), administration date: 21Mar2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose Product: COVID 19, Prev dose Brand: Pfizer, Prev dose Lot number: EW0153, Prev dose Vaccine location: Right arm, Prev dose Dose number: 2), administration date: 11Apr2021, when the patient was 38 years old, for COVID-19 Immunization.  The following information was reported: GENITAL RASH (non-serious) with onset 17Oct2021, outcome "recovering", described as "My genitals have developed a rash"; PRURITUS GENITAL (non-serious) with onset 17Oct2021, outcome "recovering", described as "Itchy response in 24 hours after receiving my covid booster injection.". Therapeutic measures were not taken as a result of genital rash, pruritus genital. It was reported that prior to vaccination and since the vaccination patient was not diagnosed with Covid 19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Vaccination site pain
Clinical narrative: Soreness at injection site; Elevated temperature; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization; Bnt162b2 (Dose:02), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Elevated temperature"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for the vaccine, [Comirnaty], was not provided and will be requested during follow up.  Follow-up (26Oct2021): 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: Blood creatine, Blood creatine increased, Fatigue
Clinical narrative: tired for 3 days after booster shot; creatine was up about 22% again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 02Oct2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Chronic Kidney Disease" (unspecified if ongoing), notes: numbers show in the middle of phase 2 to 3; "Diabetes" (unspecified if ongoing); "Immune compromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, felt tired little bit of swollen arm went away after 2 days), for COVID-19 Immunization, reaction(s): "Swollen arm"; Bnt162b2 (DOSE 2, SINGLE, his creatine level went up 20 to 25%), for COVID-19 Immunization, reaction(s): "Creatinine level"; Bnt162b2 (DOSE 2, SINGLE, he felt tired), for COVID-19 Immunization, reaction(s): "he felt tired". The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "recovered", described as "tired for 3 days after booster shot"; BLOOD CREATINE INCREASED (non-serious) with onset Oct2021, outcome "unknown", described as "creatine was up about 22% again". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient history of chronic kidney disease (numbers show in the middle of phase 2 to 3), diabetes and immune compromised. Patient was fine after the first Pfizer BioNtech covid 19 vaccine. After his second dose he felt tired little bit of swollen arm went away after 2 days. Also reports that he was tired for 3 days after booster shot, also took flu shot at the same time but then felt ok and his creatine level went up 20 to 25%, made some medication changes after 2 months kidney levels got better, came back to the number we had before. He took booster shot 2 weeks ago on 02Oct2021 and his blood test from this Friday showed that his creatine is up about 22% again. He was not feeling tired as he normally is with kidney issues. Patient seeking information regarding the covid information guide in the document it says, increased endocrine level of 20% from the baseline without any other possible explanation, timeframe of 2 weeks after, back to normal a few months after, do you have any information about this?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101392702 same patient, different vaccine dose/AE
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Trigger finger
Clinical narrative: 6 hrs after the 3rd shot I developed finger locking and swelling in the fingers in my left hand; 6 hrs after the 3rd shot I developed finger locking and swelling in the fingers in my left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 16:30 (Lot number: FF2h93) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing); "L knee arthritis" (ongoing); "Obesity" (ongoing); "erectile dysfunction" (ongoing); "HTN" (ongoing); "HLD" (ongoing); "Urinary Urgency" (ongoing). Concomitant medication(s) included: FLU taken for influenza immunisation; OXYBUTYNIN taken for micturition urgency (ongoing); AMLODIPINE taken for hypertension (ongoing); LISINOPRIL taken for hypertension (ongoing); SILDENAFIL taken for erectile dysfunction (ongoing). Past drug history included: Allergy: statins, reaction(s): "Allergy: statins"; Allergy: erythromycin, reaction(s): "Allergy: Erythromycin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6 (or G) 208, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 72 years old, for COVID-19 Immunization, reaction(s): "had finger joint swelling and locking", "had finger joint swelling and locking"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWG150, Location of injection: Arm Left), administration date: 18Mar2021, when the patient was 72 years old, for COVID-19 Immunization, reaction(s): "had finger joint swelling and locking", "had finger joint swelling and locking". The following information was reported: PERIPHERAL SWELLING (non-serious), TRIGGER FINGER (non-serious) all with onset 15Oct2021 02:00, outcome "recovered" (15Oct2021 11:00) and all described as "6 hrs after the 3rd shot I developed finger locking and swelling in the fingers in my left hand". Therapeutic measures were not taken as a result of peripheral swelling, trigger finger.  Additional information: The swelling and finger locking went away approximately 12 to 18 hours later and returned to pre-shot condition. No relevant Tests performed. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination was Blood Pressure Meds. No specific Relevant Test for thromboembolic events with thrombocytopenia was done. Patient reported swelling in fingers L hand, locking of L 5th and 2nd digit. He was not seen/ examined for reported symptoms.   No follow-up attempts are possible. No further information is expected.