chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Adnexa uteri pain, Bone pain, Headache
Clinical narrative: Bone pain; Pain in reproductive organs (uterus); Pain in reproductive organs (ovaries); Pain in reproductive organs (lower abdomen); Abdominal cramping; Headache starting the evening of the second vaccine to current date of this report 8/19/2021, still unresolved.; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an intramuscular route of administration in the left arm on 09Aug2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an intramuscular route of administration in the left arm on an unknown date in Jul2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 09Aug2021 at 20:00, bone pain, pain in reproductive organs (uterus, ovaries, lower abdomen), abdominal cramping and headache starting the evening of the second vaccine to current date of this report 19Aug2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bone pain, pain in reproductive organs (uterus, ovaries, lower abdomen), abdominal cramping were resolved with sequelae on an unknown date in Aug2021; while that of the event headache was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine pain
Clinical narrative: Bone pain; Pain in reproductive organs (uterus); Pain in reproductive organs (ovaries); Pain in reproductive organs (lower abdomen); Abdominal cramping; Headache starting the evening of the second vaccine to current date of this report 8/19/2021, still unresolved.; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an intramuscular route of administration in the left arm on 09Aug2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an intramuscular route of administration in the left arm on an unknown date in Jul2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 09Aug2021 at 20:00, bone pain, pain in reproductive organs (uterus, ovaries, lower abdomen), abdominal cramping and headache starting the evening of the second vaccine to current date of this report 19Aug2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bone pain, pain in reproductive organs (uterus, ovaries, lower abdomen), abdominal cramping were resolved with sequelae on an unknown date in Aug2021; while that of the event headache was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: Severe muscle spasms on the left side, arm, thigh and calf the next day; Severe SI joint, hip joint and knee joint for 2 days after the vaccine.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Aug2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. On 08Aug2021, the patient experienced severe muscle spasms on the left side, arm, thigh and calf the next day and severe sacroiliac (SI) joint, hip joint and knee joint for 2 days after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle spasms on the left side, arm, thigh and calf was resolved with sequelae on an unknown date in Aug2021; while of the event severe SI joint, hip joint and knee joint was resolved with sequelae on 10 Aug2021, after the duration of 2 days.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: had got sick; had a knot in my arm that I got the injection in/knot in left arm was reported as worsened; If she touches it, it hurts; The knot was hot and if she touched it, it hurt; This is a spontaneous report from a contactable consumer, the patient.  A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: FC3183), via an unspecified route of administration, in arm left on 20Aug2021 at 12:30 as dose 1, single (age at vaccination 57 years) for covid-19 immunisation. Medical history was diabetic, diagnosed about 8 months ago and ongoing and had bad sinuses since an unknown date and she kept an epi pen, she took covid test and did not have covid, this was prior to the vaccine. The history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient's concomitant medications were not reported. She got her first dose on 20Aug2021, Friday, and the following day she had a knot in her arm that she got the injection in and it had gotten worse on 21Aug2021. The knot was hot and if she touched it, it hurt in 2021. Someone said put some pressure on it but she was scared to do that. She was asking if her left arm was supposed to feel like a knot. She started feeling the knot on Saturday and it started getting bigger and bigger. People told her she may have a blood clot and they were driving her nuts. She reported she had got sick and thought she had it and it was instead an upper sinus infection. The patient did not take any therapeutic treatment for the events. The patient underwent lab tests which included sars-cov-2 test: did not have covid on an unknown date and this was prior to the vaccine. There were no relevant tests. No additional vaccines were administered on same date as that of the pfizer suspect. The events did not require a visit to emergency room or the physician office. There were no prior vaccinations (within 4 weeks). There were no adverse events following prior vaccinations. The patients relevant family medical history was none. The outcome of the event had a knot in my arm that i got the injection in was not recovered and rest of all event outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Myalgia
Clinical narrative: Diarrhea; Intense muscle and joint pain; Intense muscle and joint pain; Severe fatigue - very distinct; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Aug2021 at 01:00, the patient experienced diarrhea, intense muscle and joint pain and severe fatigue - very distinct. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, intense muscle and joint pain and severe fatigue - very distinct was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a noncontactable nurse. A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FC3184), at the age of 61, intramuscularly, in the left arm, on Aug 26, 2021, at 11:30, single dose, for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, patient was diagnosed with COVID-19. Concomitant medications not reported. On Aug 27, 2021, patient had left arm pain that travelled up her shoulder and over to the left-side of her chest. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of left arm pain that travelled up her shoulder and over to the left-side of her chest: unknown (at the time of the report). No follow-up attempts possible. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Malaise, Vaccination site pain
Clinical narrative: Soreness at the site of injection; 'Her' right hand feeling colder than 'her' left hand; Chills; Malaise; Headache; This is a spontaneous report from a non-contactable pharmacist, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via intramuscular route of administration in the right arm on 27Aug2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluocinonide (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D), fish oil (MANUFACTURER UNKNOWN), acetyl cysteine (N-ACETYLCYSTEINE) and prenatal vitamins (MANUFACTURER UNKNOWN) all  for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via intramuscular route of administration in the left arm on 06Aug2021 at 15:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021 at 08:00, the following day of vaccination the patient experienced soreness at the site of injection, patient right hand felt colder than left hand, chills, malaise and a headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness at the site of injection, patient right hand felt colder than left hand, chills, malaise and a headache were recovered on 29Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: stiffness; pain; This is a spontaneous report from a program. A contactable Other HCP and a contactable 71-year-old female consumer (patient) received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on unspecified date as BOOSTER DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Patient medical history and concomitant were not reported. It was reported that patient took XELJANZ XR Manufacturer: Pfizer, Prolonged-release tablet and Strength: 11mg, orally from 13Jun2019 at 11 mg, once a day; for rheumatoid arthritis (RA) as a cosuspect. Patient reported that XELJANZ  held for 7 days before 7 days after receiving COVID-19 booster vaccination shot per md recommendation. On an unspecified date the patient had experienced stiffness and pain during hold interval and as patient had restarted XELJANZ, she could move her fingers on 06Sep2021.Therapeutic measures were taken for the AE for which the patient was patient suffered during hold period and treatment was included prednisone. The clinical outcome of the event were unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  Follow-up on 14Oct2021, This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Eye disorder, Hepatic enzyme abnormal, Hepatic pain, Myalgia
Clinical narrative: kidney hurt; my liver enzyme went up to 535; My muscle hurts; my liver was hurt; eyes are yellow; I have no energy; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation; atorvastatin calcium (LIPITOR), via an unspecified route of administration from 24May2021 (Batch/Lot number was not reported) to an unspecified date, at 18 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. Consumer stated, I am calling to find out what is happening, because the Lipitor has given me a serious side effect, I was on less than six weeks and have taken me to ER. I reported to my doctor that I started felt like medicine was making my kidney hurt, the more I took it, it makes more my kidney hurt and then my liver started to hurt me and did not stop, my liver enzyme went up to 535 and it has been like 5 weeks, and I am still dealing with it. I have no energy, my liver still hurt, eyes are yellow and my doctor still what the heck is doing. So now I am calling because I have missed the opportunity to start a job that I needed, it's really bad time for me. I don't know what cause the problem but my muscle hurts, my liver was hurt, my kidney was hurt, and I am still trying to recover 5 week later. When probed for the medication name as Covid-19 Vaccine, consumer stated, no, Lipitor, I did take the Covid vaccine though, its six week later only time things changed in my life when I got Lipitor and then Covid vaccine. When probed for adverse event from Covid-19 Vaccine, consumer stated, no that I am aware of I think it's from the Lipitor because like I said every day, I took it my kidney hurt more and more. I reported it to my doctor, but I didn't even to make it to 6th week, blood level check like, I was on it less than 6 weeks. I stop taking it for 2 weeks so I called my doctor and tell my doctor quit that medicine because the family member passed away and I have to go out of town in emergency, so I accidently left it here but I told 2 weeks that I didn't have it and felt better but they did get back on it and get them and I took 1 pill and went to emergency room that's all. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: kidney hurt; my liver enzyme went up to 535; My muscle hurts; my liver was hurt; eyes are yellow; I have no energy; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation; atorvastatin calcium (LIPITOR), via an unspecified route of administration from 24May2021 (Batch/Lot number was not reported) to an unspecified date, at 18 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. Consumer stated, I am calling to find out what is happening, because the Lipitor has given me a serious side effect, I was on less than six weeks and have taken me to ER. I reported to my doctor that I started felt like medicine was making my kidney hurt, the more I took it, it makes more my kidney hurt and then my liver started to hurt me and did not stop, my liver enzyme went up to 535 and it has been like 5 weeks, and I am still dealing with it. I have no energy, my liver still hurt, eyes are yellow and my doctor still what the heck is doing. So now I am calling because I have missed the opportunity to start a job that I needed, it's really bad time for me. I don't know what cause the problem but my muscle hurts, my liver was hurt, my kidney was hurt, and I am still trying to recover 5 week later. When probed for the medication name as Covid-19 Vaccine, consumer stated, no, Lipitor, I did take the Covid vaccine though, its six week later only time things changed in my life when I got Lipitor and then Covid vaccine. When probed for adverse event from Covid-19 Vaccine, consumer stated, no that I am aware of I think it's from the Lipitor because like I said every day, I took it my kidney hurt more and more. I reported it to my doctor, but I didn't even to make it to 6th week, blood level check like, I was on it less than 6 weeks. I stop taking it for 2 weeks so I called my doctor and tell my doctor quit that medicine because the family member passed away and I have to go out of town in emergency, so I accidently left it here but I told 2 weeks that I didn't have it and felt better but they did get back on it and get them and I took 1 pill and went to emergency room that's all. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-096728), for BNT162b2.  A female patient of an unspecified age 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 24Sep2021 as dose number unknown (Booster), single for COVID-19 immunisation. Medical history included endometrial cancer from unknown date to unknown if ongoing. The patient previously took Keytruda infusions. Concomitant medication included lenvatinib mesilate (Lenvima) at a dose of 20 mg, once daily, taken for an unspecified indication from 20Jul2021 to an unspecified stop date. On 24Sep2021, after the vaccination, patient was not feeling well and stated that it hit her like a sledgehammer. Patient did stated that she was waiting to receive CT scan. The outcome of the event was unknown.  Lot/Batch number was not provided and will be requested during follow-up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: Intense vomiting; Temperature measured at home with an oral thermometer was 102.2; nausea has continued for for 2 additional days; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 30145BA) via an unspecified route of administration in Arm Left on 26Sep2021 at 10:00 (Age at Vaccination: 67-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration in Left arm from Sep2021 (Batch/Lot number was not reported) to Sep2021, at unspecified dose for immunisation. Medical history included asthma, low thyroid, fibromyalgia, arthritis, high cholesterol and allergies. Concomitant medications the patient received within 2 weeks of vaccination included levothyroxine sodium from Sep2021 to an unspecified stop date; trazodone taken, estradiol, fluoxetine hydrochloride (PROZAC) and sodium fluoride (CREST CAVITY PROTECTION). Prior to vaccination the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. Since the vaccination the patient has not been tested for COVID-19. Patient reported on 27Sep2021 at 6:00 AM, she experienced Intense vomiting starting the morning after the vaccine was administered and which lasted for 5-6 hours required admission to an emergency room. Temperature was measured at home with an oral thermometer was 102.2 and the nausea had continued for 2 additional days. Patient was treated by giving many doses of Zofran and a bag of fluids and the vomiting stopped and she was able to go home. The patient underwent lab test and procedure which included temperature which was 102.2 units unspecified on 27Sep2021. Outcome for fever was resolved on 29Sep2021. The outcome of the event Intense vomiting and nausea has continued for 2 additional days was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Computerised tomogram, Immunisation, Nausea, Off label use
Clinical narrative: vomited; nausea; I got my 3rd booster shot, Pfizer covid shot; I got my 3rd booster shot, Pfizer covid shot; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from regulatory authority (manufacturer control number: EC-2021-096247), for bnt162b2 (BNT162B2).  A 48-year-old female patient received third (booster) 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 27Aug2021 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization; and LENVIMA (LENVATINIB MESILATE), via an unknown route of administration from 09Jul2021 to an unspecified date, as 20 mg for Recurring Thyroid Cancer. The patient medical history included Papillary Thyroid, "Recurring Thyroid Cancer." Diagnosis/ICD code: "Papillary Thyroid Carcinoma C73". The patient concomitant medication was not reported. On 29Aug2021, the patient experienced vomited, nausea, and I got my 3rd booster shot, Pfizer covid shot. On 26Aug2021, the patient underwent lab tests and procedures which included Blood pressure measurement: high, Blood Pressure is "getting better and better" since the dose was decreased; and Computerised tomogram: nodules had decreased, showed 2 of my nodules had decreased, in the right lung. Patient reported "my Blood Pressure was so high", so her doctor reduced her Lenvima, and patient said now her Blood Pressure is "getting better and better" since the dose was decreased. Patient reported she had her Lenvima dose decreased to 20 milligrams daily, about 2 weeks ago, cause was related to Lenvima and occurred while on Lenvima.  Follow up (30Sep2021): The following information was received from regulatory authority.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vomiting
Clinical narrative: vomited; nausea; I got my 3rd booster shot, Pfizer covid shot; I got my 3rd booster shot, Pfizer covid shot; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from regulatory authority (manufacturer control number: EC-2021-096247), for bnt162b2 (BNT162B2).  A 48-year-old female patient received third (booster) 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 27Aug2021 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization; and LENVIMA (LENVATINIB MESILATE), via an unknown route of administration from 09Jul2021 to an unspecified date, as 20 mg for Recurring Thyroid Cancer. The patient medical history included Papillary Thyroid, "Recurring Thyroid Cancer." Diagnosis/ICD code: "Papillary Thyroid Carcinoma C73". The patient concomitant medication was not reported. On 29Aug2021, the patient experienced vomited, nausea, and I got my 3rd booster shot, Pfizer covid shot. On 26Aug2021, the patient underwent lab tests and procedures which included Blood pressure measurement: high, Blood Pressure is "getting better and better" since the dose was decreased; and Computerised tomogram: nodules had decreased, showed 2 of my nodules had decreased, in the right lung. Patient reported "my Blood Pressure was so high", so her doctor reduced her Lenvima, and patient said now her Blood Pressure is "getting better and better" since the dose was decreased. Patient reported she had her Lenvima dose decreased to 20 milligrams daily, about 2 weeks ago, cause was related to Lenvima and occurred while on Lenvima.  Follow up (30Sep2021): The following information was received from regulatory authority.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: neck stiffness; rigors; Severe myalgias; nausea; Pfizer Booster dose administered and experienced events; Pfizer Booster dose administered and experienced events; This is a spontaneous report from a contactable Physician (patient) reported for herself.  A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm left on 29Sep2021 14:15 (Batch/Lot Number: FF8841) (age at vaccination 26-year-old) as Dose 3 (BOOSTER), single for covid-19 immunisation at Hospital; influenza vaccine (INFLUENZA), via an unspecified route of administration at right arm on 29Sep2021 (Batch/Lot number was not reported), at dose number unknown, single for an unspecified indication. The patient had no known allergies. The patient medical history included attention deficit hyperactivity disorder and asthma from an unknown date and unknown if ongoing. The patient received historical vaccine of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose 1 single and dose 2 single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications included Allegra, acetaminophen, bupropion within 2 weeks of vaccination taken for an unspecified indication, start and stop date were not reported. 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 had received Pfizer booster on 29Sep2021, experienced events (Off label use, extra dose administered) ; severe myalgias, neck stiffness, nausea and rigors on 30Sep2021 at 03:30 am. Events were reported as non-significant. The patient did not received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: neck stiffness; rigors; Severe myalgias; nausea; Pfizer Booster dose administered and experienced events; Pfizer Booster dose administered and experienced events; This is a spontaneous report from a contactable Physician (patient) reported for herself.  A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm left on 29Sep2021 14:15 (Batch/Lot Number: FF8841) (age at vaccination 26-year-old) as Dose 3 (BOOSTER), single for covid-19 immunisation at Hospital; influenza vaccine (INFLUENZA), via an unspecified route of administration at right arm on 29Sep2021 (Batch/Lot number was not reported), at dose number unknown, single for an unspecified indication. The patient had no known allergies. The patient medical history included attention deficit hyperactivity disorder and asthma from an unknown date and unknown if ongoing. The patient received historical vaccine of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose 1 single and dose 2 single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications included Allegra, acetaminophen, bupropion within 2 weeks of vaccination taken for an unspecified indication, start and stop date were not reported. 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 had received Pfizer booster on 29Sep2021, experienced events (Off label use, extra dose administered) ; severe myalgias, neck stiffness, nausea and rigors on 30Sep2021 at 03:30 am. Events were reported as non-significant. The patient did not received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Influenza, Nausea
Clinical narrative: she wasn't feeling great/she started feeling bad; fever of 100.3; Aches; chills; thirsty(couldn't drink enough); she was nauseated; Felt "flu-y"; Got Flu shot on the same date of pfizer booster; This is a spontaneous report from a contactable consumer or other non-health care professional. A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 3 via an unspecified route of administration on 28Sep2021 at 12:00 (at the age of 69-year-old) as dose 3 (booster), single for covid-19 immunization administered in pharmacy/drug store, influenza vaccine (INFLUENZA, Batch/Lot number was not reported) via an unspecified route of administration from 28Sep2021 to 28Sep2021, at dose 1, single for Immunization. Medical history included depression, previous mild MI (myocardial infarction) from an unknown date and unknown if ongoing. Allergies reported as unknown. Concomitant therapy was received (received some other medication (Unspecified) in two weeks). Historical vaccine included BNT162B2 (solution for injection) via an unspecified route of administration, administered on an unspecified date as dose 1 single and BNT162B2 (solution for injection) via an unspecified route of administration, administered on an unspecified date as dose 2 single for COVID-19 immunization. Patient was not diagnosed with covid prior vaccination. It was unknown if covid tested post vaccination. It was unknown if patient received other vaccine in four weeks or not. On 28Sep2021 the patient wasn't feeling great/she started feeling bad, fever of 100.3, aches, chills, thirsty (couldn't drink enough), she was nauseated, felt "flu-y" and she got flu shot on the same date of pfizer booster (product use for unapproved combination). The reporter reported that they called there aunt, and she immediately said that she wasn't feeling great. She had gotten her 3rd shot (booster) yesterday (28Sep) at noon, and she started feeling bad during her shift (she works night shift). She c/o of fever of 100.3, aches, chills, and was very thirsty ("couldn't drink enough"). She also said she was nauseated, but that it got better. Felt "flu-y" She also got the flu shot at the same time. She also told reporter that she reported to the CDC, but was unable to edit the field with temperature. The patient underwent lab tests and procedures which included fever: 100.3 fahrenheit on 28Sep2021. No treatment received for the events. Outcome of the events were resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product use issue, Pyrexia, Thirst
Clinical narrative: she wasn't feeling great/she started feeling bad; fever of 100.3; Aches; chills; thirsty(couldn't drink enough); she was nauseated; Felt "flu-y"; Got Flu shot on the same date of pfizer booster; This is a spontaneous report from a contactable consumer or other non-health care professional. A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 3 via an unspecified route of administration on 28Sep2021 at 12:00 (at the age of 69-year-old) as dose 3 (booster), single for covid-19 immunization administered in pharmacy/drug store, influenza vaccine (INFLUENZA, Batch/Lot number was not reported) via an unspecified route of administration from 28Sep2021 to 28Sep2021, at dose 1, single for Immunization. Medical history included depression, previous mild MI (myocardial infarction) from an unknown date and unknown if ongoing. Allergies reported as unknown. Concomitant therapy was received (received some other medication (Unspecified) in two weeks). Historical vaccine included BNT162B2 (solution for injection) via an unspecified route of administration, administered on an unspecified date as dose 1 single and BNT162B2 (solution for injection) via an unspecified route of administration, administered on an unspecified date as dose 2 single for COVID-19 immunization. Patient was not diagnosed with covid prior vaccination. It was unknown if covid tested post vaccination. It was unknown if patient received other vaccine in four weeks or not. On 28Sep2021 the patient wasn't feeling great/she started feeling bad, fever of 100.3, aches, chills, thirsty (couldn't drink enough), she was nauseated, felt "flu-y" and she got flu shot on the same date of pfizer booster (product use for unapproved combination). The reporter reported that they called there aunt, and she immediately said that she wasn't feeling great. She had gotten her 3rd shot (booster) yesterday (28Sep) at noon, and she started feeling bad during her shift (she works night shift). She c/o of fever of 100.3, aches, chills, and was very thirsty ("couldn't drink enough"). She also said she was nauseated, but that it got better. Felt "flu-y" She also got the flu shot at the same time. She also told reporter that she reported to the CDC, but was unable to edit the field with temperature. The patient underwent lab tests and procedures which included fever: 100.3 fahrenheit on 28Sep2021. No treatment received for the events. Outcome of the events were resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Pain, Product use issue, Skin irritation
Clinical narrative: Constant irritating nipples; stomach bloat; sharp pain in Ivorian area; other vaccine 4weeks details: Flu shot date: 13Aug2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administrated in Arm Left on 13Aug2021 13:15 (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization at Pharmacy or Drug Store; and first dose of FLU VACCINE VII (INFLUENZA VACCINE), administrated in arm left on 13Aug2021 for Immunization. The patient's medical history was not reported. Patient had no known allergies. The patient concomitant medications included Latuda, and buspirone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Aug2021 14:30, the patient experienced Constant irritating nipples, stomach bloat, sharp pain in Ivorian area, and other vaccine 4weeks details: Flu shot date: 13Aug2021. The patient also received second dose of BNT162b2 vaccine, (Batch/lot number: Fc3183), administrated in arm left on 03Sep2021 13:00 as a single dose for COVID-19 immunization. Patient did not received treatment for the adverse events. The outcome of the events was not recovered.  Follow-Up (06Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Dyspnoea, Headache, Illness, Lethargy
Clinical narrative: Fever; Nauseous; Headache; broke out with pimples; Lethargic; she got really sick after the second dose; Rash; struggled to breath; This is a spontaneous report from a contactable 53 year-old female consumer (patient) communicated to a Pfizer colleague that reported a 53-year old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF8841), via an unspecified route of administration on 29Sep2021 (at the age of 52 years old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (Lot Number: FC3183) on 08Sep2021 (at the age of 52 years old) for covid-19 immunisation. Reporter a Pfizer employee reporting for his cousin regarding the Pfizer Covid vaccine and who explained that she received both doses. It was reported that with first shot, it was no big deal. It was explained she got really sick after the second dose. Twelve hours after the second dose she developed a rash that looked like ring worms or cigarette burns. It was all over her body but mainly on the arm she received the injection, caller thinks it was the left arm. After that when she went to lay down to sleep, she reported she struggled to breath on 29Sep2021. It felt like someone was crushing her chest. This lasted about 24 hours, the trouble breathing. She also got a fever, was nauseous and had a headache. Her head felt so heavy she couldn't not lift off her pillow. Also, she felt super lethargic, so much so she couldn't get up out of bed. In response to the breathing, she relayed she literally could not breath and this was the first time that had ever happened to her. It was absolutely horrible. She stated she will not get a booster shot. Also it was explained she broke out with pimples. The reporter's sister came over and gave her something and within 30 minutes she was feeling better. It was some herbal treatments, pine needle tea and charcoal to drink. Her sister also made her a drink of zinc mixed with lemon and grapefruit skin. Within 30 minutes of taking all this she started to feel better. It was stated that after taking all this and is getting better, she is able to pull the little blisters off her skin. No testing done. The outcome of struggled to breath was recovered on 30Sep2021, while with other events was unknown.  Follow-Up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash
Clinical narrative: Fever; Nauseous; Headache; broke out with pimples; Lethargic; she got really sick after the second dose; Rash; struggled to breath; This is a spontaneous report from a contactable 53 year-old female consumer (patient) communicated to a Pfizer colleague that reported a 53-year old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF8841), via an unspecified route of administration on 29Sep2021 (at the age of 52 years old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (Lot Number: FC3183) on 08Sep2021 (at the age of 52 years old) for covid-19 immunisation. Reporter a Pfizer employee reporting for his cousin regarding the Pfizer Covid vaccine and who explained that she received both doses. It was reported that with first shot, it was no big deal. It was explained she got really sick after the second dose. Twelve hours after the second dose she developed a rash that looked like ring worms or cigarette burns. It was all over her body but mainly on the arm she received the injection, caller thinks it was the left arm. After that when she went to lay down to sleep, she reported she struggled to breath on 29Sep2021. It felt like someone was crushing her chest. This lasted about 24 hours, the trouble breathing. She also got a fever, was nauseous and had a headache. Her head felt so heavy she couldn't not lift off her pillow. Also, she felt super lethargic, so much so she couldn't get up out of bed. In response to the breathing, she relayed she literally could not breath and this was the first time that had ever happened to her. It was absolutely horrible. She stated she will not get a booster shot. Also it was explained she broke out with pimples. The reporter's sister came over and gave her something and within 30 minutes she was feeling better. It was some herbal treatments, pine needle tea and charcoal to drink. Her sister also made her a drink of zinc mixed with lemon and grapefruit skin. Within 30 minutes of taking all this she started to feel better. It was stated that after taking all this and is getting better, she is able to pull the little blisters off her skin. No testing done. The outcome of struggled to breath was recovered on 30Sep2021, while with other events was unknown.  Follow-Up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Mass, Swelling
Clinical narrative: big painful lump under her armpit; having some pain in the armpit/it was still quite painful; swelling; This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 06Oct2021 as dose 3 (booster), single for COVID-19 immunisation. Family medical history included breast cancer. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single and via an unspecified route of administration on an unspecified date as dose 2, single both doses for COVID-19 immunization. She had third shot, she had it 10 months after having the other doses. Caller was a physician she was calling to report an adverse reaction for herself who received the Pfizer Covid vaccine 2 days ago on 06Oct2021 and noticed then last night on Oct2021 discovered a big painful lump under her armpit. She was wondering if Pfizer had any directions on this. She just wanted to know if Pfizer has any data on how quickly this may go away. She was worried, oh my God do she need to get a mammogram, because she do have a strong family history of breast cancer, she was talking to another colleague, and she said it just hit her, she got the vaccine on wednesday (06Oct2021) and in Oct2021 the swelling, was pretty big she could feel the lump, it was quite tender, and was in the same armpit of the arm she took the vaccine and exactly 24 hours after she took the vaccine it started, 24-36 hours after, so she would like to know how long does it take to resolve. she could feel it and was painful, it was still quite painful. Response received includes in general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response.3. Seriousness of the events was non serious. The outcome of the events was not recovered.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint paint; joint paint; injection site swelling; injection site was very red; nausea; nausea; super tired; arm pain in my right arm same spot from injection on left arm; This is a spontaneous report received from a contactable female consumer reported for herself that:  A 49-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ff2587), via an unspecified route of administration, administered in Arm Left on 20Sep2021 (At the age of 49 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included armour thyroid 90mg taken for an unspecified indication, start and stop date were not reported. The patient had allergy to levothyroxine, synthetic thyroid and Synthroid. On 20Sep2021, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint paint, injection site swelling, injection site was very red, nausea, blurred vision for 3 days, super tired, pain in the right arm same spot from injection on left arm. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were recovering.    Follow-up attempts are completed. No further information is expected.