chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: My menstrual cycle has changed. I currently have the paraguard iud implanted and I was due for my period the weekend after I got the 1st shot. I have yet to get my period but I am spotting lightly as; I have yet to get my period but I am spotting lightly; This is a spontaneous report from a contactable Consumer (Patient). A 29-year-old non-pregnant female Patient received first dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: ew0202 and expiry date was not reported), via an unspecified route of administration into left arm on 19Jul2021 at 13:15 (01:15 PM) (at the age of 29 year) as dose 1, single for COVID-19 immunization. Patient did not receive prior vaccinations within 4 weeks of covid-19 vaccine. Medical history was none, and concomitant medications were not reported. The patient had no known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for Covid-19 since the post vaccination. On 24Jul2021, the patient stated that her menstrual cycle was changed. She currently has Para guard IUD implanted and due to her period, the weekend after she got the first shot. She was yet to get her period but spotting lightly as if it was her period, but it has lasted about a week now and she was not sure yet if my period will come or not. Laboratory test on 21Jul2021 included Nasal Swab (Rapid AG) resulted Negative. Patient did not receive any treatment for adverse events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash
Clinical narrative: Rash; Headache; Sore arm; This is a spontaneous report received from a contactable consumer (Patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in the left arm on 16Apr2021 09:30 (at the age of 65 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. No family Medical History Relevant to AE. No other vaccines were given within 4 weeks. No additional vaccines administered on same date of the pfizer suspect. No PQC was present. No investigation assessment was reported. No vaccine administered at private facility. On 16Apr2021, the patient experienced rash, headache, sore arm. Events has not resulted in physician room visit and emergency room visit. The caller stated she had minimal side effects with the first dose Pfizer COVID 19 Vaccine. When the caller received the first dose Pfizer COVID 19 Vaccine it was wonderful and the caller did not feel a thing. Description of complaint reports after receiving first dose Pfizer COVID 19 Vaccine the caller never had a problem with the left arm and the caller felt like she did not get the Pfizer COVID Vaccine. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0182), via an unknown route of administration, administered in Arm Left on 07May2021 09:30 (at the age of 65-years-old) as dose 1, single for COVID-19 immunisation. When patient received the second dose Pfizer COVID 19 Vaccine. The caller clarified her arm was sore with both doses Pfizer COVID 19 Vaccine. After second dose it was jabbed in the arm and felt like an immediate burning sensation and it just felt really unusual. The caller felt relaxed when she received the first dose Pfizer COVID 19 Vaccine and felt relaxed with the second dose Pfizer COVID 19 Vaccine but all of a sudden it was like the caller arm was jabbed and felt this burning sensation when receiving the second. Others who have gotten the Pfizer COVID 19 Vaccine have said they never felt this like the caller did. The caller was hesitant to have another booster. The caller just needs to have this resolved. The caller used her left arm to receive the Pfizer COVID 19 Vaccines and does not want to get in the right arm. The caller was just a little traumatized. The clinical outcome of the events rash, sore arm was reported as unknown and headache was reported as recovered on Apr2021 (lasted four or 5 days).   Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100978816 same patient, different dose vaccine and different event.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Started in the arm pit area and got worse spread to back during the day and got worse on arms, face and neck; Body rash; itching; Redness; Hives; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).  A 14-years-old non-pregnant female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch Lot Number: AW0198), via an unspecified route, administered in left arm on 08Jul2021 at 16:30 (at the age of 14-years-old) as dose 1, single for covid-19 immunization.   Relevant medical history was none. Patient had no allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 29Jul2021 at 12:00 AM, the patient experienced body rash and itching redness and hives. Started in the arm pit area around midnight and got worse spread to back during the day and got worse on arms, face and neck by 4pm the following day. No therapeutic measures were taken as a result of events. The patient received second dose of bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch Lot Number: F97484) via an unspecified route, administered in left arm on 30Jul2021 at 16:30 (at the age of 14-years-old) as dose 2, single for covid-19 immunization. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Head titubation, Hypotension, Tremor
Clinical narrative: Woke up feeling weak; Blood pressure and it is low; Tremors to my whole head and my hands/ Tremble in head and hands; Tremors to my whole head and my hands; This is a spontaneous report from a contactable consumer or other non hcp.   A 80-year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 30Jul2021 13:30 (Batch/Lot Number: FA7485) as Dose 1, Single (age at vaccination:80-Years-old) for Covid-19 immunisation. Medical history included head tremors from an unknown date and unknown if ongoing (I have had head tremors for years, but it has been 5 years since it bothered me last, and underwent surgery on 16Jul2021(She had surgery on 16Jul2021, but she doesn't know if that would've had anything to do with it. There were no concomitant medications. Family medical history relevant to AE(s) was None. On 02Aug2021 the patient experienced woke up feeling weak, blood pressure and it is low, and tremors to my whole head and my hands/ tremble in head and hands. States she woke up feeling weak, and it did not get better so she checked blood pressure and it was low; it usually comes back up, but its staying low, also feeling tremors to whole head and hands. On 02Aug2021 the patient underwent lab tests and procedures which included blood pressure measurement: low. States she doesn't know if they are side effects or not but her blood pressure is really low, and she can't get it to come back up, she also had trembles in her head and hands. Patient was asking are these normal side effects from the vaccine. Case is non-serious. The events not resulted in emergency room visit/ Physician office visit. The patient had not received treatment for all the events. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Myalgia
Clinical narrative: aching in her bones; muscle pain; joint pain; This is a spontaneous report from a contactable consumer (patient) via medical information team from a Pfizer sponsored program. A 73-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA6780, Expiry date: Unknown), via an unspecified route, administered in arm left on 23Jul2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date and experienced Guillain-Barre (about six years ago). On an unspecified date in 2021, reported as for last ten days, the patient experienced aching in her bones/ bone aches. The patient also experienced muscle pain and joint pain. Investigation assessment was not reported. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: I am getting like a rash on my chest, it burns and it itches a lot, like both; I am getting like a rash on my chest, it burns and it itches a lot, like both; I am getting like a rash on my chest, it burns and it itches a lot, like both; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: SA7484), dose 1 intramuscularly administered in left arm on 01Aug2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin taken for diabetes. No prior vaccinations within 4 weeks. On an unspecified date in Aug2021, the patient was getting like a rash on her chest, it burns and it itches a lot, like both. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Had a extremely bumpy itchy rash all over my body; All over my body with welts under my left arm (the arm I received the vaccine in).; she was left with the rash on my left and right thigh; This is a spontaneous report received from a contactable consumer (Patient). A 69-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL8982), via an unspecified route of administration, administered in Arm left on 21Jan2021 at 12:00 (age at vaccination 69-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included ROSUVASTATIN. The patient previously took zinc and experienced allergies. Prior vaccines within 4 weeks were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for COVID-19. Patient received vaccine facility in hospital. On 21Jan2021 at 12:00, the patient reported that she had an extremely bumpy itchy rash all over my body with welts under my left arm (the arm I received the vaccine in). The rash got better but she was left with the rash on her left and right thigh, it was worse on her left thigh. The next morning the pharmacist recommended Benadryl Allergy Diphenhydramine HCI antihistamine which she took for three days. Therapeutic measures were taken as a result of the event which included treatment with cortisone 10 cream with aloe/Benadryl tablets. The outcome of the events was not recovered.   Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Swelling
Clinical narrative: I am having allergic reaction to it;  the kind of reaction that I am having.; I am swelling; I am itching; This is a spontaneous report from a Non-Contactable Consumer (patient). A patient with an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: Unknown) via unknown route of administration on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that, patient had the Pfizer shot (confirmed as Pfizer Covid19 shot) and so, what it was that patient was told to give you all a call because patient had the shot on 29Jul2021 and patient was having allergic reaction to it on an unspecified date. Anyway, before did go by the pharmacist, the pharmacist said, you know, could call this number here, you had to let them know, the kind of reaction that, patient was having." Patient stated that, "And do you recommend. Yeah, because patient was swelling and patient was itching in so, patient was probably would have gone to the doctor or something." It was also reported that patient was go on to the doctor and then, was going to call back cause right now. At the time of this report the outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, SARS-CoV-2 test
Clinical narrative: bronchitis; Persistent cough.; This is a spontaneous report via from a contactable consumer. A 35-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0217) via an unspecified route of administration in right arm on 11Jun2021 16:00 (at age of 35-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available), additional vaccines administered on same date of the Pfizer suspect, all vaccines administered on same date with the Pfizer vaccine considered as suspect, AE(s) following prior vaccinations was none. On 20Jun2021, the patient experienced bronchitis, persistent cough. It was reported that she came down with bronchitis and was unable to receive her second dose of the Pfizer COVID-19 vaccine which she was scheduled to receive on 02Jul2021. She was very angry and was really frustrated at the different pharmacists because they are refusing to vaccinate her and its the third place in city that had refused to vaccinate her and she was begging to get vaccinated and seeked guidance on alternative dosing. States that she got bronchitis 2-3 weeks after the vaccine, so it did not have anything to do with the vaccine. States that she got bronchitis a couple days before she was supposed to get the 2nd dose of the Vaccine. She started had symptoms around 20Jun2021. She had a persistent cough until last week, end of Jul2021. States that she was fine 2 weeks before that, but could not get the vaccine with a persistent cough. The event bronchitis result in physician office visit. The patient underwent lab tests and procedures which included Tested her for Covid: negative on an unspecified date 2021. Treatment received was cough suppressant and a Z-pak received. The outcome of event bronchitis was not recovered and for persistent cough was recovered on Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: Joint pain in  left hand fingers shortly after; Muscle spasms in my upper left arm only; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EX0584 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 03Aug2021 at 11:00 hours (at the age of 33-years old) as dose 2, single for COVID-19 immunisation. The patient medical history included neuropathy peripheral, allergies to sulfa, eggs and dairy and COVID-19 (prior to vaccination) (all from an unknown date and unknown if ongoing). The patient's concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EX0584 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on an unspecified date in 2021 (at the age of 33-years old) as dose 1, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. On 04Aug2021 at 23:00 hours, patient experienced muscle spasms in her upper left arm only and joint pain in left hand fingers shortly after. Patent received no treatment for the events. Patient did not hospitalize for the events. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: my husband just has little swollen in his face.; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife).   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 22Apr2021 (batch or lot Number: EW0172) as dose 1, single dose for covid-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 13May2021 (batch or lot number: EW0172) as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in 2021, the patient experienced little swollen in his face. Patient's wife stated that we took it at the same time but my husband just has little swollen in his face. But like a little grooving in the face but no other thing. Investigation assessment reported as yes. The outcome of the event 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 have been completed and no further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain
Clinical narrative: some pain in chest/severe pain in my chest; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient second dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0171) via an unspecified route of administration, administered in left arm on 04May2021 at 18:00 (at the age of 77-year-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. Medical history reported as none. There were no concomitant/ other medications taken in 2 weeks. No other vaccine administered in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EWD1S3) via an unspecified route of administration, administered in left arm on 13Apr2021 18:00 (at the age of 77-year-old) as dose 1, single for covid-19 immunisation. On 25May2021 09:00, the patient experienced some pain in chest/severe pain in my chest. Patient reported prior to a trip during climbing stairs experienced some pain in chest. The again during a trip to airport while pushing the baggage cart experienced severe pain in his chest. Then he rested for 10 minutes the pain subsided then resurfaced again. He never ever had chest pain in his entire life or received any cardiovascular treatment ever. His blood pressure always has been normal. He was hoping it will go away on its own and waited until he made a cardiovascular specialist doctor appointment on 08Mar2021. He recommended and scheduled whole bunch of tests yet to be performed. He consider himself a very healthy person and has not been taking any medication in his entire life. The patient underwent lab tests and procedures which included blood pressure measurement resulting normal on an unspecified date. Patient didn't had covid prior vaccination and not been tested for covid post vaccination. No treatment was taken for adverse event. Chest pain resulted in doctor/ other healthcare professional office/clinic visit. Outcome of the event was not recovered at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Physical examination, Pyrexia
Clinical narrative: Fever; Muscle spasms or glitching; This is a spontaneous report from a contactable consumer (Patient's parent). A 15-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in left arm on 07Aug2021 at 10:30 (at the age of 15-years) as dose 1, single for covid-19 immunization. The patient medical history included none (Patient History: No). There were no concomitant medications. The patient had not received any other vaccine within 4 weeks prior to Covid-19 vaccination. Following vaccination on an unspecified date in Aug2021, the reporter stated that the patient had fever and muscle spasms or glitching. The reporter queried that whether having muscle spasm as a side effect was normal. The patient underwent lab tests and procedures on an unspecified date after vaccination which included lab work count was done like a physical (unknown). Therapeutic measures were taken as a result of fever, muscle spasms or glitching and included treatment with Ibuprofen. The outcome of the events was not recovered at the time of report.   Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Pain
Clinical narrative: Fever starting overnight that same Saturday at 11 pm into Sun; Subject also had body aches and chills, feeling very tired; Subject also had body aches and chills, feeling very tired; Subject also had body aches and chills, feeling very tired; Feeling still a little lightheaded and dizzy but overall better; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Aug2021 10:15 as dose number unknown, single for COVID-19 immunization (at the age of 17-year-old). The patient medical history and concomitant medications were not reported. On 07Aug2021 23:00, the patient experienced fever starting overnight that same saturday at 11 pm into Sun. On an unspecified date in Aug2021, the patient also had body aches and chills, feeling very tired and feeling still a little lightheaded and dizzy but overall better. The patient underwent lab tests and procedures which included body temperature: 102 (Highest was at 04:30 am) on 08Aug2021 and 99.7 on 09Aug2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever starting overnight that same Saturday at 11 pm into Sun; Subject also had body aches and chills, feeling very tired; Subject also had body aches and chills, feeling very tired; Subject also had body aches and chills, feeling very tired; Feeling still a little lightheaded and dizzy but overall better; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Aug2021 10:15 as dose number unknown, single for COVID-19 immunization (at the age of 17-year-old). The patient medical history and concomitant medications were not reported. On 07Aug2021 23:00, the patient experienced fever starting overnight that same saturday at 11 pm into Sun. On an unspecified date in Aug2021, the patient also had body aches and chills, feeling very tired and feeling still a little lightheaded and dizzy but overall better. The patient underwent lab tests and procedures which included body temperature: 102 (Highest was at 04:30 am) on 08Aug2021 and 99.7 on 09Aug2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Culture, Genital herpes
Clinical narrative: genital herpes; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information Team. A 28-years-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history included a cut in her vulva area from unknown date and unknown if ongoing and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on Jul2021 as dose 1, single for COVID-19 immunisation. On an unspecified date in Jul2021, after receiving second dose Pfizer Covid vaccine, patient was diagnosed with genital herpes. Patient stated that she did not show up as blisters but just had a cut in her vulva area that was swabbed by the doctor and did a culture and was tested positive for herpes. Patient did not have her blood drawn to test for herpes, she asked so how they can say she had genital herpes. Patient reported that she had been with the same person sexually for 5 years, she asked if there had been any form of herpes/shingles reported after receiving Pfizer Covid vaccine and questioned that how likely it would be to receive a false/positive herpes result. The outcome of the event was unknown.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Pyrexia
Clinical narrative: fatigue/feels tired; a mild fever (99.7 degrees); he is not feeling well; This is a spontaneous report from a contactable consumer or other non-health care professional(Parent) via medical information team. A 12-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3180, Expiration date: not reported) via an unspecified route of administration, administered in Arm Right on 09Aug2021 at 16:00 (at the age of 12-years-old) as dose 1, single for COVID-19 immunization. Medical history included developmentally delayed and diabetic, her mother she is diabetic. There were no concomitant medications. On 10Aug2021at 08:00, patient experienced fatigue/feels tired, a mild fever (99.7 degrees) and he is not feeling well. On 10Aug2021, patient underwent lab tests and procedures which included body temperature: 99.7. Additional vaccines administered on same date of the Pfizer Suspect was none and no prior vaccinations within 4 weeks. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Feeling abnormal, Feeling hot, Illness
Clinical narrative: Left upper arm is swollen; hot to touch; very sore/Keep getting random sharp pains in arm; Left upper arm tight; itchy; Feels like the skin is stretched; Was very sick Saturday and Sunday; Fever; body aches; vomiting; diarrhea; Could not get up; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 06Aug2021 at 03:45 PM (Batch/Lot Number: FC3180) as Dose 1, Single for COVID-19 immunization administered in Pharmacy or Drug Store. Medical history included Psoriasis, psoriatic arthritis, anemic, reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported.The patient previously took tetracycline and experienced allergies, humira and experienced allergies. (allergies to Humira and tetracycline). The patient was not pregnant at the time of 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 did not receive any other vaccines within four weeks prior to the vaccination. On 07Aug2021 at 12:30 PM, the patient experienced left upper arm is swollen, hot to touch, very sore/keep getting random sharp pains in arm, left upper arm tight, itchy, feels like the skin is stretched, was very sick saturday and sunday, Fever, body aches, vomiting, diarrhea and Could not get up. The patient not received any corrective treatment for events. The outcome of events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Left upper arm is swollen; hot to touch; very sore/Keep getting random sharp pains in arm; Left upper arm tight; itchy; Feels like the skin is stretched; Was very sick Saturday and Sunday; Fever; body aches; vomiting; diarrhea; Could not get up; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 06Aug2021 at 03:45 PM (Batch/Lot Number: FC3180) as Dose 1, Single for COVID-19 immunization administered in Pharmacy or Drug Store. Medical history included Psoriasis, psoriatic arthritis, anemic, reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported.The patient previously took tetracycline and experienced allergies, humira and experienced allergies. (allergies to Humira and tetracycline). The patient was not pregnant at the time of 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 did not receive any other vaccines within four weeks prior to the vaccination. On 07Aug2021 at 12:30 PM, the patient experienced left upper arm is swollen, hot to touch, very sore/keep getting random sharp pains in arm, left upper arm tight, itchy, feels like the skin is stretched, was very sick saturday and sunday, Fever, body aches, vomiting, diarrhea and Could not get up. The patient not received any corrective treatment for events. The outcome of events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Left upper arm is swollen; hot to touch; very sore/Keep getting random sharp pains in arm; Left upper arm tight; itchy; Feels like the skin is stretched; Was very sick Saturday and Sunday; Fever; body aches; vomiting; diarrhea; Could not get up; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 06Aug2021 at 03:45 PM (Batch/Lot Number: FC3180) as Dose 1, Single for COVID-19 immunization administered in Pharmacy or Drug Store. Medical history included Psoriasis, psoriatic arthritis, anemic, reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported.The patient previously took tetracycline and experienced allergies, humira and experienced allergies. (allergies to Humira and tetracycline). The patient was not pregnant at the time of 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 did not receive any other vaccines within four weeks prior to the vaccination. On 07Aug2021 at 12:30 PM, the patient experienced left upper arm is swollen, hot to touch, very sore/keep getting random sharp pains in arm, left upper arm tight, itchy, feels like the skin is stretched, was very sick saturday and sunday, Fever, body aches, vomiting, diarrhea and Could not get up. The patient not received any corrective treatment for events. The outcome of events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: Immune system is firing on a thousand different cylinders; inflammation; Diarrhea; Cough; Exhausted, all she wants to do is sleep; Zero energy; Nausea; sweating; Sore arm; Headache; Fever; Chills; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: FA7485, expiry date: not reported), via an unspecified route of administration in the left arm on 03Aug2021 17:30 (at the age of 36-years old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis, immunodeficiency, in either 2014 or 2015, she got the Flu shot and about a month later got the worst strain of the Flu a person could get, she was sick with the Flu for a month. The patient has been immune compromised since her mid-twenties. Family history included passed away from the Flu three years ago because her mother was autoimmune compromised. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Aug2021, the patient experienced sore arm, headache, fever, chills, sweating. On 04Aug2021, the patient experienced nausea, exhausted, all she wants to do is sleep, zero energy. On 05Aug2021, the patient experienced diarrhoea, cough. On an unspecified date, the patient had inflammation, immune system was firing on a thousand different cylinders. The day of the vaccine, she came home two hours later, started with sore arm, had a headache right away, managed to finally wake up today finally free of headaches, had fevers, chills, nausea, diarrhoea, not been able to hold food down, experiencing this cough that at this point, is now coughing up clear stuff. She was tested and confirmed she is COVID-19 negative. Exhausted, all wanted to do was sleep, zero energy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on Aug2021. The patient has done a virtual visit to the physician. Therapeutic measures were taken as a result of inflammation (prednisone). The outcome of the events sore arm, headache, fever was recovered. The outcome of the events chills, sweating, nausea, exhaustion, zero energy was not recovered. The outcome of the events diarrhoea, cough was recovering. The clinical outcome of the event immune system was firing, inflammation was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Immune system disorder, Inflammation, Nausea
Clinical narrative: Immune system is firing on a thousand different cylinders; inflammation; Diarrhea; Cough; Exhausted, all she wants to do is sleep; Zero energy; Nausea; sweating; Sore arm; Headache; Fever; Chills; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: FA7485, expiry date: not reported), via an unspecified route of administration in the left arm on 03Aug2021 17:30 (at the age of 36-years old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis, immunodeficiency, in either 2014 or 2015, she got the Flu shot and about a month later got the worst strain of the Flu a person could get, she was sick with the Flu for a month. The patient has been immune compromised since her mid-twenties. Family history included passed away from the Flu three years ago because her mother was autoimmune compromised. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Aug2021, the patient experienced sore arm, headache, fever, chills, sweating. On 04Aug2021, the patient experienced nausea, exhausted, all she wants to do is sleep, zero energy. On 05Aug2021, the patient experienced diarrhoea, cough. On an unspecified date, the patient had inflammation, immune system was firing on a thousand different cylinders. The day of the vaccine, she came home two hours later, started with sore arm, had a headache right away, managed to finally wake up today finally free of headaches, had fevers, chills, nausea, diarrhoea, not been able to hold food down, experiencing this cough that at this point, is now coughing up clear stuff. She was tested and confirmed she is COVID-19 negative. Exhausted, all wanted to do was sleep, zero energy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on Aug2021. The patient has done a virtual visit to the physician. Therapeutic measures were taken as a result of inflammation (prednisone). The outcome of the events sore arm, headache, fever was recovered. The outcome of the events chills, sweating, nausea, exhaustion, zero energy was not recovered. The outcome of the events diarrhoea, cough was recovering. The clinical outcome of the event immune system was firing, inflammation was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Immune system is firing on a thousand different cylinders; inflammation; Diarrhea; Cough; Exhausted, all she wants to do is sleep; Zero energy; Nausea; sweating; Sore arm; Headache; Fever; Chills; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: FA7485, expiry date: not reported), via an unspecified route of administration in the left arm on 03Aug2021 17:30 (at the age of 36-years old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis, immunodeficiency, in either 2014 or 2015, she got the Flu shot and about a month later got the worst strain of the Flu a person could get, she was sick with the Flu for a month. The patient has been immune compromised since her mid-twenties. Family history included passed away from the Flu three years ago because her mother was autoimmune compromised. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Aug2021, the patient experienced sore arm, headache, fever, chills, sweating. On 04Aug2021, the patient experienced nausea, exhausted, all she wants to do is sleep, zero energy. On 05Aug2021, the patient experienced diarrhoea, cough. On an unspecified date, the patient had inflammation, immune system was firing on a thousand different cylinders. The day of the vaccine, she came home two hours later, started with sore arm, had a headache right away, managed to finally wake up today finally free of headaches, had fevers, chills, nausea, diarrhoea, not been able to hold food down, experiencing this cough that at this point, is now coughing up clear stuff. She was tested and confirmed she is COVID-19 negative. Exhausted, all wanted to do was sleep, zero energy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on Aug2021. The patient has done a virtual visit to the physician. Therapeutic measures were taken as a result of inflammation (prednisone). The outcome of the events sore arm, headache, fever was recovered. The outcome of the events chills, sweating, nausea, exhaustion, zero energy was not recovered. The outcome of the events diarrhoea, cough was recovering. The clinical outcome of the event immune system was firing, inflammation was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 0.17
Sex: U
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: had some redness to the leg where it was administered; This is a spontaneous report from a contactable physician. A 2-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11Aug2021 (received at the age of 2-month-old) as DOSE 1, SINGLE for immunization. The patient medical history and concomitant medications were not reported. The patient experienced some redness to the leg where the vaccine was administered on 11Aug2021. The reporter is a pediatrician calling regarding a reaction someone experienced after receiving Prevnar 13. She stated that a 2-month-old baby was receiving the Prevnar 13 for the first time and had some redness to the leg where it was administered, and it went from the leg to the foot. The reporter stated this happened immediately after the vaccine was administered and then resolved in 4 to 5 minutes. There was no swelling, and she doesn't think it was really a reaction. She thinks it was due to the nurse positioning while holding down the baby. The reporter stated that the parent is hesitant to give the vaccine again. The reporter would like to know based on the reaction if the baby should receive the vaccine again or if there are any precautions that need to be taken next time. Outcome of the event was recovered on 11Aug2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Daughters first period started 5 days after first dose of Phizer covid vaccine.; This is a spontaneous report from a contactable consumer (Parent). A 12-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: FC3180) via an unspecified route of administration, administered in right arm on 08Aug2021 15:30 (at the age of 12-year-old) as dose 1, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history and Concomitant medications in 2weeks were none. Patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reporter stated on 13Aug2021 20:30 Daughters first period started 5 days after first dose of Pfizer covid vaccine. Patient did not receive any treatment for the event. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Gastrointestinal disorder, Lip swelling
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.