chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Poor quality sleep
Clinical narrative: severe abdominal attack w/ "really bad cramping"; severe abdominal attack w/ "really bad cramping"; bottom lip mild to moderate swell; tired; haven't been able to sleep real well; diarrhea; mild nausea; arm soreness; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. (Duplicate number: 2021134867). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: was not reported), via an unspecified route of administration on 25Aug2021 (at the age of 64 years) as dose number unknown, single for COVID-19 immunization and also received complement c1 esterase inhibitor (HAEGARDA, batch/lot number was not reported), subcutaneous from 09Aug2021 and ongoing, at 6000 iU, q 3-4 days for off label indication. The patient's medical history included kidney infections/issues, Diabetes T2DM, HGD. The patient's concomitant medications were not reported. The patient previously took Takzyhro and reports it really helped her kidneys because she had not had an infection since starting. On 25Aug2021 and 26Aug2021 the patient experienced arm soreness. On 26Aug2021 the patient experienced diarrhea and mild nausea. On an unspecified date the patient experienced severe abdominal attack w/ really bad cramping occurs weekly (down from 2x/week prior to HGD therapy); continues to have occasional bottom lip mild to moderate swell; she was real tired today because she had not been able to sleep real well the past 3 days. Firazyr was taken as a therapeutic measure for events abdominal issues and arm soreness. The patient stated that this treatment took longer "than usual" to work. The outcome of all events was unknown.  Follow-up attempts completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation
Clinical narrative: very sever adrenalin rushing thru my body; patient received other vaccine on same date; patient received other vaccine on same date; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 0938749-02170/Batch number was not reported) via an unspecified route of administration, administered in arm left on 24Sep2021 at 14:00 (at the age of 69-year-old) as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 77867498/Batch number was not reported) via an unspecified route of administration, administered in arm left on 24Sep2021 (at the age of 69-year-old) as dose 2, single; both for COVID-19 immunisation at Pharmacy. Medical history included Cancer multipul myeloma, breast cancer, heavy metal, A flutter, thyroid, art condition a/flutter, thyroid under active and heart a flutter. Concomitant medications included atenolol at a dose of 50 mg; letrozole at 2.5; lenalidomide (REVLIMID) at a dose of 10 mg and thymg, all taken for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient allergies were reported as many. On 24Sep2021, the patient received other vaccine on same date and at 14:30 the patient experienced very sever adrenalin rushing thru my body. Patient did not receive treatment for the events. Outcome of the event very sever adrenalin rushing thru my body was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Disease recurrence, Myocarditis
Clinical narrative: symptoms of myocarditis; COPD flare ups after each dose; COPD flare ups after each dose; The initial safety information received on 28Sep2021 and 20Oct2021 was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 01Nov2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (the patient). This consumer provided information for two reports. This is the first of two reports. This currently 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an intramuscular route of administration on 17Feb2021 (Lot Number: EL9269; Expiration Date: 31May2021) as Dose 1, single for COVID-19 immunisation, and via an intramuscular route of administration on 10Mar2021 (Lot Number: EN6203; Expiration Date: 30Jun2021) as Dose 2, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and ongoing COPD emphysema since 2007, ongoing coronary artery disease since 2014 with open heart surgery cardiac tamponade stent (1st), coronary artery disease from 2018 with Stent in RCA (2nd), weakened immune system, and ongoing hypertension since 2021. Family Medical History Relevant included: heart disease, diabetes, hypertension, and coronary artery disease. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced COPD flare ups after each dose. The flare up lasted 6 months and was treated with oral prednisone for COPD flare ups from an unspecified date in 2021. It took 6 months to get control of COPD after the 1st and 2nd doses. On an unspecified date in 2021, the patient experienced symptoms of myocarditis. As of 01Nov2021, the patient stated, "I believe I have symptoms of myocarditis. I am currently seeking a doctor to give me tests to confirm myocarditis. This is very serious." The clinical outcome of the events "COPD flare up after each dose" was resolved in 2021 while the outcome of the "symptoms of myocarditis" was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-202101284220 same  patient/reporter, different AE/vaccine dose
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity, Vomiting
Clinical narrative: I couldn''t walk this morning; I can''t walk on my feet very well; My feet is, they had the worst, they feel are stabbing them with a knife; My feet hurt so bad, it hurts really bad to walk on them; I threw up; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) as DOSE 3 (BOOSTER), SINGLE via an unspecified route of administration, administered in Arm Left on 28Sep2021 for covid-19 immunisation.  Medical history included diabetes mellitus (I just had diabetes 2 and I used the Cpat at night twice and I guess that was about the worst thing I got) from an unknown date and unknown if ongoing Verbatim: Diabetes II, blood pressure measurement from an unknown date and unknown if ongoing, optic ischaemic neuropathy patient also added that anything that would cause the optical nerve to 'swell' would hurt me because the bone structure can't handle it and it caused about 75 percent of blindness in one eye, that's the worst thing I had I think from an unknown date and unknown if ongoing. Concomitant medication(s) included glimepiride (Januvia), sitagliptin phosphate, metformin taken for diabetes mellitus, start and stop date were not reported; lisinopril taken for blood pressure measurement, start and stop date were not reported; gabapentin taken for neuropathy peripheral, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. This historical vaccine was bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EN6200, Expiration Date: Unknown) as dose 2, single via an unspecified route of administration on 01Mar2021 for covid-19 immunisation and also received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EN6200, Expiration Date: Unknown) as dose 1, single via an unspecified route of administration, administered on an unknown date for covid-19 immunisation. On 29Sep2021  the patient had events reported as: I couldn't walk this morning; i can't walk on my feet very well, my feet is, they had the worst, they feel are stabbing them with a knife; my feet hurt so bad, it hurts really bad to walk on them, on 28Sep2021  i threw up. Therapeutic measures patient stated that since it's like I can't walk on my feet very well if I took, the only thing I have had this morning is 2 Tylenols, but if I took the 'Pension D' (further clarification unknown for the name of the medication hence suspect not captured for MI query) do you think that would help. The outcome of events that I couldn't walk this morning; i can't walk on my feet very well, my feet is, they had the worst, they feel are stabbing them with a knife; my feet hurt so bad, it hurts really bad to walk on them was not recovered. and the outcome of i threw up was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Irritability, Screaming, Sleep disorder
Clinical narrative: breastfeeding mother; slept 5 hours longer than usual; incredibly irritable the entire day; scream; This is a spontaneous report from a contactable consumer. This female consumer (patient mother) reported for baby that:  The patient's mother received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FC3182), on 06Sep2021 11:00 as DOSE 1, SINGLE, And received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 301358A), on 27Sep2021 16:00 as DOSE 2, SINGLE for covid-19 immunization. No known allergies were reported. The patients mother did not received any other medication within 4 weeks of vaccination. The patient's mother received other medications within 2 weeks of vaccination were Prenatal vitamin, magnesium, colace, DHA. Prior to vaccination, was the patients mother was  diagnosed with COVID-19. Since the vaccination, the patients mother had not been tested for COVID-19. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was exposed via breast milk on 28Sep2021 02:00. On 28Sep2021 02:00 the patient slept for 5 hours longer than usual, and was incredibly irritable the entire day following the vaccination. They had to substitute previously pumped milk to feed him, as he would scream immediately upon drinking milk directly from my breast. This lasted for 2 days following the vaccine. At the time of reporting the outcome of the events was recovered on unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101295763 mother/baby case
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Migraine, Pyrexia
Clinical narrative: miserable with his second shot; didn''t feel good and he had a fever; didn''t feel good and he had a fever; occasional headache; had a full blown migraine and he hadn''t had one of those in 10 years; This is a spontaneous report from a contactable consumer (patient's wife) from Pfizer sponsored program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Reporter stated, her husband was miserable with his second shot. He didn't feel good and he had a fever. He was not complaining anymore about anything other than an occasional headache. He had a bad migraine/ severe migraine and didn't know if it was related but it was a full blown migraine and he had not had one of those in 10 years. All the events experienced on an unspecified date. He doesn't know if it was related to the COVID vaccine. He almost went to the hospital for it because he hadn't had one in years but that's about it with him. He has had other injections too and the military forced him to not only take the COVID vaccine but they also forced him to take the shingles vaccine and the flu shot on an unspecified dates. He has had a lot of injections in a short period of time and it could of been from those as well. Outcome of the events was unknown at the time of reporting.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chills, Fatigue, Heavy menstrual bleeding, Pyrexia
Clinical narrative: very heavy menstruation; worsening arthritis pain; fatigue; chills; low grade fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable 41-year-old consumer reported on herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunization. Patient's relevant medical history included immunocompromised with pre lupus, obesity, arthritis and shingles outbreak. The patient's concomitant medications were not reported. It was reported that some of the side effects after first dose included very heavy menstruation, worsening arthritis pain, fatigue, chills and low grade fever on an unspecified date. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Dizziness, Malaise, Nervousness, Vertigo
Clinical narrative: bad vertigo; dizziness; a lot of weakness in her knees; she doesn't feel good; nervous; This is a spontaneous report from a contactable consumer. A consumer reported for 84-year-old female patient (reporter's mother).  A 84-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 29Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that on 30Sep2021 patient experienced vertigo and dizziness a lot of weakness in her knees. She had complained about that last night but she did not have rash or fever and her breathing was good. She was asking if this was normal or if anybody had complained about this before. She was really nervous and upset. Stated she had it two days ago. Caller stated she spoke with her, she was in a different county and she was getting some side effects. Stated that last night she had bad vertigo, dizziness and weakness. Stated that she was 84 and never had this with the first or second doses but she got it with the booster. The outcome for the events was unknown.  Follow-up attempts completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain just like the sore arm; This is a spontaneous report from a contactable other healthcare professional. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (at the age of 32-Years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (at the age of 32-Years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient' s medical history and concomitant medications. On an unspecified date, the patient experienced pain just like the sore arm. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Headache, Immunisation, Pyrexia, Vaccination site vesicles
Clinical narrative: Off-label use; Booster; low fever; headache; breast tenderness; continues with blister at injection site; This is a spontaneous report from a contactable other hcp. A 52-year-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on 07Sep2021 (at the age of 52-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccines include bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number was not reported), dose 1 as DOSE 1 SINGLE and dose 2 as DOSE 2, SINGLE on an unspecified date for COVID-19 immunisation. On 07Sep2021, Off label use and booster. On an unspecified date in 2021, patient experienced low fever, headache, breast tenderness and continues with blister at injection site. The outcome of the event continues with blister at injection site was not recovered and for rest of events was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Immunisation, Off label use
Clinical narrative: booster (pfizer) 21Aug2021; booster (pfizer) 21Aug2021; symptoms of arthritis flare on and off since coronavirus booster (pfizer) 21Aug2021; This is a spontaneous report from a contactable other HCP. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 21Aug2021 (at the age of 54-year-old), as dose 3 (BOOSTER), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced symptoms of arthritis flare on and off since coronavirus booster (pfizer) 21Aug2021 on an unspecified date in 2021. Patient received booster (pfizer) on 21aug2021 as off label use. The clinical outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling drunk, Feeling hot, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: My legs swelled, my feet swelled, my hands swelled everything swelled; my body feels hot; I feel drunk; the pain in my leg and in my neck; the pain in my leg and in my neck; This is a spontaneous report from a contactable consumer (patient) reported for herself. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: not reported) via an unspecified route of administration on 21Sep2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine 21Sep2021 and experienced legs swelled, my feet swelled, my hands swelled everything swelled; feels drunk and my body feels hot; and the pain in the leg and neck, the patient did not understand on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Myalgia, Off label use
Clinical narrative: received a dose of the AstraZeneca Covid-19 Vaccine in JUN2021 and then received a dose of the Pfizer BioNTech Covid-19 Vaccine; I took my first dose in June with COVID-19 Vaccine and I went about two weeks ago to go get the Pfizer vaccine; my muscle is sore; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received COVID-19 VACCINE, dose 1 via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced, received a dose of the covid-19 vaccine in jun2021 and then received a dose of the pfizer biontech covid-19 vaccine, i took my first dose in june with covid-19 vaccine and i went about two weeks ago to go get the pfizer vaccine and my muscle is sore. The patient stated, I am confused as to, should I be getting another second dose of the Pfizer or did I complete my full vaccination process. The outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Localized redness and minor swelling at injection site; Localized redness and minor swelling at injection site; patient received dose_number=3; patient received dose_number=3; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Fe3590 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 06Oct2021 at 11:00 (at the age of 42-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included thyroid cancer from an unknown date and unknown if ongoing. The patient did not have covid prior to vaccination. The patient did not receive other vaccine in four weeks. Concomitant medications included liothyronine (LIOTHYRONINE); levothyroxine (LEVOTHYROXINE); escitalopram (ESCITALOPRAM); buspirone (BUSPIRONE) all taken for an unspecified indication, start and stop date were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was El9262 and expiration date were not reported) via an unspecified route of administration, administered in right arm on 22Jan2021 at 17:00 hours as dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was En6201 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 19Feb2021 at 21:00 as dose 2, single for covid-19 immunization. On 06Oct2021 at 11:00, the patient received third dose of vaccine (coded to off label and booster). On 07Oct2021 at 07:00, the patient also experienced localized redness and minor swelling at injection site. The patient was not tested for covid post vaccination. Therapeutic measures were not taken. The outcome of all the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Immunisation
Clinical narrative: Pfizer booster vaccine; Extreme hair loss/lost like 75% of her hair; This is a spontaneous report from a Contactable consumer (Patient) via Pfizer sales representative.  A female patient of an unspecified age received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. On an unspecified date, patient experienced pfizer booster vaccine, extreme hair loss/lost like 75% of her hair. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: it is hurting a little more than usual to me; I had the booster shot today; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medically history was not reported. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. Consumer stated that, I take an aspirin every day. But they knew that was my other one, provided they did not talk to me about none of that, but I remember in instructions of what to do and what not to. It said something about not taking an Aspirin after the shot and I take one every morning. Now, I am really concerned about because I have had the other 2 shots and I have taken them, but I forgot and now it is hurting a little more than usual to me and I took another Aspirin, and I was wondering if that was going to hurt me. Because I remember that someone was saying something that can cause inflammation was on my appointment thing. I am not sure, if you can pull it back up, it is nothing that I am on. Consumer stated, I have already done that right? And now, there is nobody I can ask I said I have already taken it and there no place I can find out now you said to wait until Monday. When informed the role of Pfizer  and was suggested to call 911 in case of emergency. Reporter type could not be clarified over the call. Hence, captured as Consumer or other non-health professional. Outcome of the event was unknown.   Follow-up (25Oct2021): 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Feeling cold, Lymphadenopathy, Paraesthesia
Clinical narrative: Warm to the touch at injection site (L) upper arm; Coldness and tingling on left arm from the injection site to the fingertips; Swollen lymph nodes under left arm; Coldness and tingling on left arm from the injection site to the fingertips; Coldness and tingling on left arm from the injection site to the fingertips; Fever up to 101.0 F; joint aches; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: PE3950), via intramuscularly administered in left arm on 08Oct2021 19:00 (at the age of 36-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included hypothyroidism, known allergies: oral allergy syndrome and walnuts. Concomitant medication included levothyroxine sodium (SYNTHROID) 100 mcg. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscularly administered in left arm on 23Mar2021 15:00 (Lot Number: EN6205) as dose 2, single for COVID-19 immunization (at the age of 36-year-old) and dose 1 intramuscularly administered in left arm on 02Mar2021 15:00 (Lot Number: EM9810) as dose 1, single for COVID-19 immunization (at the age of 36-year-old). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Oct2021 06:00, the patient experienced warm to the touch at injection site (l) upper arm, coldness and tingling on left arm from the injection site to the fingertips, swollen lymph nodes under left arm, fever up to 101.0 f and joint aches. On 09Oct2021, the patient underwent lab tests and procedures which included fever: 101.0 Fahrenheit. The patient was treated with OTC Acetaminophen 2000 mg as a therapeutic measure of all the events. The clinical outcome of the event received events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site coldness, Vaccination site warmth
Clinical narrative: Warm to the touch at injection site (L) upper arm; Coldness and tingling on left arm from the injection site to the fingertips; Swollen lymph nodes under left arm; Coldness and tingling on left arm from the injection site to the fingertips; Coldness and tingling on left arm from the injection site to the fingertips; Fever up to 101.0 F; joint aches; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: PE3950), via intramuscularly administered in left arm on 08Oct2021 19:00 (at the age of 36-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included hypothyroidism, known allergies: oral allergy syndrome and walnuts. Concomitant medication included levothyroxine sodium (SYNTHROID) 100 mcg. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscularly administered in left arm on 23Mar2021 15:00 (Lot Number: EN6205) as dose 2, single for COVID-19 immunization (at the age of 36-year-old) and dose 1 intramuscularly administered in left arm on 02Mar2021 15:00 (Lot Number: EM9810) as dose 1, single for COVID-19 immunization (at the age of 36-year-old). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Oct2021 06:00, the patient experienced warm to the touch at injection site (l) upper arm, coldness and tingling on left arm from the injection site to the fingertips, swollen lymph nodes under left arm, fever up to 101.0 f and joint aches. On 09Oct2021, the patient underwent lab tests and procedures which included fever: 101.0 Fahrenheit. The patient was treated with OTC Acetaminophen 2000 mg as a therapeutic measure of all the events. The clinical outcome of the event received events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use
Clinical narrative: The booster dose was given in May; The booster dose was given in May; This is a spontaneous report from a contactable nurse. This nurse reported for an unknown (patient).    A 83-year-old female patient received fourth dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: 30145BA, expiry date: Nov2021), via unknown route of administration in Deltoid Left on 07Oct2021 (at the age of 83 years old) as DOSE 4, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported.  Historical vaccines included first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via unknown route of administration on unknown date as dose 1, single, second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via unknown route of administration on unknown date as dose 2, single and dose 3 of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via unknown route of administration on unknown date in May2021 as dose 3 (booster), single for COVID-19 immunization. It was reported that the patient received four doses of Pfizer COVID-19 vaccine instead of three. the patient experienced The booster dose was given in May2021. It was also reported that patient received her first two Pfizer from reporter and she came to get her booster and gave it and she had already received a third Pfizer vaccine back in May at a different 'range' the patient said wasn't aware she got seriously the flu shot they have done it already in her arm, she call them did they she gave receive a Covid shot instead so she receive 4 dosage of the Pfizer instead of three and she wasn't sure if there was anything need to do or the report there she should not do anything. The outcome of the events was unknown.  Follow-up (21Oct2021): 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: temperature elevated 1.5 degrees from normal; headaches; body aches; feeling of nausea; fatigue; 3rd (booster) dose.; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old non pregnant female patient received third dose of (BOOSTER) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2590) via an unspecified route of administration in Arm Right on 12Oct2021 10:00 (age at vaccination 65- years-old) as single dose for covid-19 immunisation.The patient was not pregnant at the time of vaccination. Medical history includes known allergies with slight allergy to raw egg, some pollens, lanolin from an unknown date and unknown if ongoing. Concomitant medication included chlorpheniramine maleate (CHLORPHENIRAMINE MALEATE) taken for an unspecified indication received within 2 weeks of vaccination. The patient historical vaccines includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in Arm Right on 03Apr2021 10:45 as DOSE 2, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199) via an unspecified route of administration, administered in Arm Right on 13Mar2021 11:45 (age at vaccination 65- years-old)as DOSE 1, SINGLE for covid-19 immunisation and No adverse effects from first two doses. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 13Oct2021 at 07:00, patient experienced temperature elevated 1.5 degrees from normal with headaches and body aches and feeling of nausea and fatigue. No treatment received for adverse effect. patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Patient was not affected with Covid prior to vaccination. The patient underwent lab tests and procedures which included body temperature increased:1.5 degree on 13Oct2021 elevated 1.5 degrees from normal. The clinical outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: temperature elevated 1.5 degrees from normal; headaches; body aches; feeling of nausea; fatigue; 3rd (booster) dose.; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old non pregnant female patient received third dose of (BOOSTER) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2590) via an unspecified route of administration in Arm Right on 12Oct2021 10:00 (age at vaccination 65- years-old) as single dose for covid-19 immunisation.The patient was not pregnant at the time of vaccination. Medical history includes known allergies with slight allergy to raw egg, some pollens, lanolin from an unknown date and unknown if ongoing. Concomitant medication included chlorpheniramine maleate (CHLORPHENIRAMINE MALEATE) taken for an unspecified indication received within 2 weeks of vaccination. The patient historical vaccines includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in Arm Right on 03Apr2021 10:45 as DOSE 2, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199) via an unspecified route of administration, administered in Arm Right on 13Mar2021 11:45 (age at vaccination 65- years-old)as DOSE 1, SINGLE for covid-19 immunisation and No adverse effects from first two doses. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 13Oct2021 at 07:00, patient experienced temperature elevated 1.5 degrees from normal with headaches and body aches and feeling of nausea and fatigue. No treatment received for adverse effect. patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Patient was not affected with Covid prior to vaccination. The patient underwent lab tests and procedures which included body temperature increased:1.5 degree on 13Oct2021 elevated 1.5 degrees from normal. The clinical outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation
Clinical narrative: she received a COVID-19 booster vaccine; She had chills last night; She felt Wiped out; This is a spontaneous report from a contactable health care professional, based on information received by Pfizer (manufacturer control number: EC-2021-101432), for bnt162b2.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, (booster) single for covid-19 immunisation. The patient medical history were not reported. Concomitant medication included Lenvima for unspecified indication from an unknown date and unknown if ongoing. The patient received a covid-19 booster vaccine, she had chills last night and she felt wiped out on an unspecified date. Therapeutic measures were taken as a result of she had chills last night and she felt wiped out. The outcome of the events she had chills last night and she felt wiped out was unknown.  The lot number for [bnt162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Dysmenorrhoea, Heavy menstrual bleeding, Mood altered
Clinical narrative: Severe menstrual bleeding and cramps; Severe menstrual bleeding and cramps; Very significant change in mood; Depression; This Spontaneous report from a contactable consumer reported similar events for five patients. This is the second of five reports:  A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe menstrual bleeding and cramps, very significant change in mood and depression on an unspecified date. The outcome of the events was unknown.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101418500 same reporter/drug, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Dysmenorrhoea, Heavy menstrual bleeding, Mood altered
Clinical narrative: Severe menstrual bleeding and cramps; Severe menstrual bleeding and cramps; Very significant change in mood; Depression; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced severe menstrual bleeding and cramps, very significant change in mood, depression on an unspecified date. It was reported that depression symptoms when she have never had an issue before. She did not seek medical attention. No treatment  was received for the events. The outcome of the events was unknown.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101418500 same reporter/drug, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Dysmenorrhoea, Heavy menstrual bleeding, Mood altered
Clinical narrative: Severe menstrual bleeding and cramps; Severe menstrual bleeding and cramps; Very significant change in mood; Depression; This is a spontaneous report from a contactable consumer reporting same events under the same suspect product for 4 patients. This is 4 of 4 reports.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe menstrual bleeding and cramps. Very significant change in mood. Depression symptoms when she never had an issue before. The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101418500 same reporter/drug, different patients.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Pyrexia
Clinical narrative: severe diarrhea; fever; lethargy; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration in right arm on 22Oct2021 12:00 (age at vaccination 75 years) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination Medical history and concomitant medications were not reported. The patient had no known allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. The patient experienced severe diarrhea, fever and lethargy on 23Oct2021 07:00. The patient was not received any treatment for the events. The clinical outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Very strong lower back pain. Left side just above hip; This was a booster. Initial vaccine was J&J.; This was a booster. Initial vaccine was J&J.; booster; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: FF2593, Expiration Date: was not reported), via an unspecified route of administration, administered in right arm, on 22Oct2021 at 16:30 (at the age of 64 year), as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. Historical vaccine included COVID-19 VACCINE JANSSEN (Batch/Lot number: was not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization and COVID-19 VACCINE (unknown manufacturer) as dose 2 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not received other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that bnt162b2 was a booster and initial vaccine was J&J. On the evening of 22Oct2021 at 23:00, the patient experienced very strong lower back pain (left side just above hip). The pain continued as of 26Oct2021 although not as severe it remains. The patient was not received treatment for the adverse event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.