chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood pressure decreased, Blood pressure measurement, Heart rate
Clinical narrative: Had the same thing-losing weight; Could not taste or smell anything; Could not taste or smell anything; dropping my pulse to 41, 40, 42; blood pressure was 100/60 or 90/55; Fever; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable consumer. This consumer (patient's neighbour) reported for a female patient that a female patient received bnt162b2 (BNT162B2), administration date Apr2020 (Batch/Lot number: unknown) as dose 1, single and administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "Had the same thing-losing weight"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Could not taste or smell anything"; HEART RATE DECREASED (non-serious), outcome "unknown", described as "dropping my pulse to 41, 40, 42"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "blood pressure was 100/60 or 90/55"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate schedule of vaccine administered". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Inappropriate schedule of product administration, Pyrexia, Weight decreased
Clinical narrative: Had the same thing-losing weight; Could not taste or smell anything; Could not taste or smell anything; dropping my pulse to 41, 40, 42; blood pressure was 100/60 or 90/55; Fever; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable consumer. This consumer (patient's neighbour) reported for a female patient that a female patient received bnt162b2 (BNT162B2), administration date Apr2020 (Batch/Lot number: unknown) as dose 1, single and administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "Had the same thing-losing weight"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Could not taste or smell anything"; HEART RATE DECREASED (non-serious), outcome "unknown", described as "dropping my pulse to 41, 40, 42"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "blood pressure was 100/60 or 90/55"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate schedule of vaccine administered". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pyrexia, Weight decreased
Clinical narrative: Had the same thing-losing weight; Could not taste or smell anything; Could not taste or smell anything; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "Had the same thing-losing weight"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Could not taste or smell anything"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional Information: I was losing weight, I could not taste or smell anything, I had a raging fever and it was spiking back and forth and I said I do not get a fever very frequently actually."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Nausea
Clinical narrative: nausea; headache; fever; joint pain; dizziness; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Feb2021 (Lot number: EM9810) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart disease" (unspecified if ongoing); "quadruple bypass", start date: 2008 (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TOPROL (ongoing); CRESTOR taken for blood cholesterol (ongoing); ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (1st Dose, Lot Number : EL3246, Route, Anatomical Location: right upper arm), administration date: 18Jan2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "nausea"; HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "headache"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "fever"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "joint pain"; DIZZINESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "dizziness"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "chills".  Additional information: Patient stated that he called regarding the Pfizer Covid vaccine and just wanted to report his experience with this, and he was a retired scientist from the and around his career, he had taken many different vaccines, including experimental vaccines never4sa had a reaction to anything until taking the Covid vaccine and he took the first dose early in the year. Patient stated that when he took the second dose, he had a very severe reaction to it. He had multiple symptoms from the vaccine, and it was severe and only lasted a few days. Patient stated that the event onset was a little sooner after getting the vaccine and the time, it lasted the same amount of time, about 48 to 72 hours.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: nausea; headache; fever; joint pain; dizziness; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Feb2021 (Lot number: EM9810) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart disease" (unspecified if ongoing); "quadruple bypass", start date: 2008 (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TOPROL (ongoing); CRESTOR taken for blood cholesterol (ongoing); ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (1st Dose, Lot Number : EL3246, Route, Anatomical Location: right upper arm), administration date: 18Jan2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "nausea"; HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "headache"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "fever"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "joint pain"; DIZZINESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "dizziness"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "chills".  Additional information: Patient stated that he called regarding the Pfizer Covid vaccine and just wanted to report his experience with this, and he was a retired scientist from the and around his career, he had taken many different vaccines, including experimental vaccines never4sa had a reaction to anything until taking the Covid vaccine and he took the first dose early in the year. Patient stated that when he took the second dose, he had a very severe reaction to it. He had multiple symptoms from the vaccine, and it was severe and only lasted a few days. Patient stated that the event onset was a little sooner after getting the vaccine and the time, it lasted the same amount of time, about 48 to 72 hours.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Illness, Pyrexia
Clinical narrative: Diarrhea, after booster.; she was feeling ill/she was very sick and has no health conditions/deathly ill.; Fever over 100 degrees, after booster; Dry heaves, after  booster; Headache, after booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 09:30 (Lot number: 30135) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EL3246, Site: left arm), administration date: 25Jan2021, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Lot: EL9262, Site: left arm), administration date: 15Feb2021, when the patient was 65 years old, for COVID-19 Immunization, reaction(s): "chills", "Bad headache", "Ached all over", "felt a little tired". The following information was reported: PYREXIA (non-serious) with onset 15Oct2021 21:30, outcome "recovered" (16Oct2021), described as "Fever over 100 degrees, after booster"; RETCHING (non-serious) with onset 15Oct2021 21:30, outcome "recovered" (16Oct2021), described as "Dry heaves, after  booster"; HEADACHE (non-serious) with onset 15Oct2021 21:30, outcome "recovered" (17Oct2021), described as "Headache, after booster."; DIARRHOEA (non-serious) with onset 16Oct2021, outcome "recovered" (16Oct2021), described as "Diarrhea, after booster."; ILLNESS (non-serious) with onset 15Oct2021 21:30, outcome "not recovered", described as "she was feeling ill/she was very sick and has no health conditions/deathly ill.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient states that she got the booster at 9:30AM and by 9:30 in the evening she was feeling ill. She had a fever over 100, dry heaves, headaches, and diarrhea. And by the next morning, she was still on the bathroom floor. She was not sure she will ever take it again, she was very sick and has no health conditions. Patient stated that she would not take another Covid vaccine in the future.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Diarrhea, after booster.; she was feeling ill/she was very sick and has no health conditions/deathly ill.; Fever over 100 degrees, after booster; Dry heaves, after  booster; Headache, after booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 09:30 (Lot number: 30135) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EL3246, Site: left arm), administration date: 25Jan2021, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Lot: EL9262, Site: left arm), administration date: 15Feb2021, when the patient was 65 years old, for COVID-19 Immunization, reaction(s): "chills", "Bad headache", "Ached all over", "felt a little tired". The following information was reported: PYREXIA (non-serious) with onset 15Oct2021 21:30, outcome "recovered" (16Oct2021), described as "Fever over 100 degrees, after booster"; RETCHING (non-serious) with onset 15Oct2021 21:30, outcome "recovered" (16Oct2021), described as "Dry heaves, after  booster"; HEADACHE (non-serious) with onset 15Oct2021 21:30, outcome "recovered" (17Oct2021), described as "Headache, after booster."; DIARRHOEA (non-serious) with onset 16Oct2021, outcome "recovered" (16Oct2021), described as "Diarrhea, after booster."; ILLNESS (non-serious) with onset 15Oct2021 21:30, outcome "not recovered", described as "she was feeling ill/she was very sick and has no health conditions/deathly ill.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient states that she got the booster at 9:30AM and by 9:30 in the evening she was feeling ill. She had a fever over 100, dry heaves, headaches, and diarrhea. And by the next morning, she was still on the bathroom floor. She was not sure she will ever take it again, she was very sick and has no health conditions. Patient stated that she would not take another Covid vaccine in the future.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersensitivity, Rash erythematous, Swelling face
Clinical narrative: allergic reaction with her first dose; all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face; all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face; all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "surgery" (unspecified if ongoing); "Bell's Palsy" (unspecified if ongoing), notes: on that left side in the past, 3 years before the vaccine. The patient's concomitant medications were not reported.  The following information was reported: HYPERSENSITIVITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "allergic reaction with her first dose"; SWELLING FACE (non-serious), RASH ERYTHEMATOUS (non-serious), BURNING SENSATION (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face". Therapeutic measures were taken as a result of hypersensitivity, swelling face, rash erythematous, burning sensation.  Additional information: The reaction she experienced was all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face. She kept drinking water that day to dilute the reaction. It lasted for about 7 hours. Caller was asking if there is anything she should be doing to receive a second dose, she was trying to do the right thing. She went back on 23Apr2021 for her second dose and the vaccination site would not administer the 2nd dose and advised her to talk to her doctor. Patient had surgery and was given the antibiotic Keflex and she experienced a reaction. Patient was asking if the same ingredients are in both, the Pfizer Covid-19 Vaccine and the Keflex.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101400198 similar report from same reporter
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Oct2021 09:15 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOSARTIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 30Sep2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 19Oct2021 14:45, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 19Oct2021 14:45, outcome "not recovered", described as "Nausea". Therapeutic measures were not taken as a result of pyrexia, nausea.  Additional information: No known allergies. Facility type vaccine was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Losartin 100 mg medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Adverse event resulted in none of the above.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further  information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding approximately 12 days before regular menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 (Lot number: FF2587) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 17Sep2021, outcome "unknown", described as "Vaginal bleeding approximately 12 days before regular menstrual cycle".  Additional information: Facility type vaccine was military base. No other vaccine in four weeks. Patient also received dose 2 of Pfizer covid 19 vaccine on 01Oct2021, lot number: 30145BA, arm left.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash occurred approximately 2 weeks after receiving each dose of vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "Rash occurred approximately 2 weeks after receiving each dose of vaccine.". The event "rash occurred approximately 2 weeks after receiving each dose of vaccine." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of rash.  Additional information: Known allergies was unknown. Other medical history was unknown. Facility type vaccine was unknown. It was unknown whether other vaccine was administered in four weeks. Patient was co-worker of spouse. It was unknown if she had Covid prior vaccination. It was unknown if she was tested for Covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Productive cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; headache; coughing up more phlegm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 18Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "sinus issues" (unspecified if ongoing), notes: she also has a history of sinus issues; "cough" (ongoing), notes: still had a cough with some phlegm yesterday when she took the shot; "phlegm" (ongoing), notes: still had a cough with some phlegm yesterday when she took the shot; "COVID", start date: 23Sep2021, stop date: 2021, notes: she tested positive for COVID on 23Sep2021 and that it lasted for about 14 to 15 days. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 19Oct2021, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 19Oct2021, outcome "unknown", described as "headache"; PRODUCTIVE COUGH (non-serious) with onset 19Oct2021, outcome "unknown", described as "coughing up more phlegm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: she tested positive for COVID on 23Sep2021. She mentioned that it lingered longer like a week later. She mentioned that it lasted for about 14 to 15 days, She mentioned that she still had a cough with some phlegm yesterday when she took the shot. She was advised by her boss to get even though of her condition and she mentioned that it was approved by the primary care, She mentioned that today, she is having a fever, a headache, and is coughing up more phlegm. She mentioned that she also has a history of sinus issues. She is asking if this is normal and for what to do. Response: Mentioned to caller that the general recommendations from the CDC is that people who had COVID can still safely receive the vaccine but would have to wait out isolation and recovered before getting it. Mentioned to caller that the fever and headaches are common side effects of the vaccine. Mentioned to caller that having a cough is not contraindicated with the vaccine but should be mentioned to the HCP before getting the vaccine as a general precaution.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Skin is still discolored on left arm at injection site from 25Mar2021 injection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: EP6955) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Celiac disease" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Generalized Anxiety Disorder" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten/Wheat; "Known allergies: wheat" (unspecified if ongoing), notes: Known allergies: Gluten/Wheat. Concomitant medication(s) included: LORAZEPAM; DESVENLAFAXINE. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset Mar2021, outcome "not recovered", described as "Skin is still discolored on left arm at injection site from 25Mar2021 injection.". Therapeutic measures were not taken as a result of vaccination site discolouration.  Additional information: The patient did not receive any other vaccine within 4 weeks. The patient received Lorazapam, desvenlafaxine, eye fatigue vitamin medications within 2 weeks of vaccination. The patient reported that the events did not cause any serious consequences. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sinus congestion
Clinical narrative: Headache; Sinus congestion; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Mar2021 19:15 (Lot number: EN6198) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Acid Reflux" (unspecified if ongoing). Concomitant medications included: CRESTOR taken for blood cholesterol abnormal (ongoing); NEXIUM taken for gastrooesophageal reflux disease (ongoing).  Vaccination history included: Bnt162b2 (Dose 1; Intramuscular in Right Arm (time at  17:10); Batch/Lot number: EN6201), administration date: 14Feb2021, when the patient was 67 years old, for COVID-19 Immunization, reaction(s): "headache", "nasal congestion", "Sinus congestion", "running nose", "cough". The following information was reported: HEADACHE (non-serious) with onset 05Mar2021, outcome "recovered" (2021), described as "Headache"; SINUS CONGESTION (non-serious) with onset 05Mar2021, outcome "recovered" (2021), described as "Sinus congestion". Therapeutic measures were taken as a result of headache, sinus congestion. Additional information: treatment included TylenolNo follow-up attempts are possible. No further information is expected.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021161110 same reporter/patient/drug, different AE/dose
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Neck pain, Vulvovaginal pain
Clinical narrative: Neck pain; Vaginal pain; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 07:30 (Lot number: ew0170) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: None. The following information was reported: NECK PAIN (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Neck pain"; VULVOVAGINAL PAIN (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Vaginal pain"; CHEST PAIN (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Chest pain". Therapeutic measures were not taken as a result of neck pain, vulvovaginal pain, chest pain.  No follow-up attempts are possible. No further information is expected.  Additional information: 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 COVID-19 vaccine and other medications in two weeks. Since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: broke out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 13:15 (Lot number: FF8841, Expiration Date: 31Dec2021) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing), notes: caught covid before and wanted to make sure. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot EW0182, NDC unknown, expiration date 30Nov2021.), administration date: 21Sep2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 14Oct2021, outcome "not recovered", described as "broke out".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Chills; Sick; Arm pain; Dizzy; Headache; Nauseous; Joint pain; Tiredness; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 15Oct2021 15:30 (Lot number: FF8839) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "Chills"; ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "Sick"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Arm pain"; DIZZINESS (non-serious) with onset Oct2021, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset Oct2021, outcome "unknown", described as "Nauseous"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "Joint pain"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "Tiredness"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Feeling unwell".  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Nausea, Pain in extremity
Clinical narrative: Chills; Sick; Arm pain; Dizzy; Headache; Nauseous; Joint pain; Tiredness; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 15Oct2021 15:30 (Lot number: FF8839) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "Chills"; ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "Sick"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Arm pain"; DIZZINESS (non-serious) with onset Oct2021, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset Oct2021, outcome "unknown", described as "Nauseous"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "Joint pain"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "Tiredness"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Feeling unwell".  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: little fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: EP7534) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "DCIS", start date: Feb2020 (ongoing). Concomitant medication(s) included: ANASTROZOLE taken for intraductal proliferative breast lesion. Vaccination history included: Bnt162b2 (Dose 1, single, Lot: EN6198, Anatomical location: Left arm), administration date: 08Mar2021, when the patient was 67 years old, for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "little fever".  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Pruritus
Clinical narrative: burning; blisters; itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Feb2021 (Batch/Lot number: unknown) at the age of 79 years as dose 2, single for covid-19 immunization.  Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: was scheduled to get radiation for breast cancer; "Radiation", start date: 15Feb2021, stop date: 19Feb2021, notes: Reason for Use: Breast cancer. The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EL9263; Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 03Feb2021, for Covid-19 immunization.  The following information was reported: BURNING SENSATION (non-serious) with onset 25Feb2021, outcome "not recovered", described as "burning"; BLISTER (non-serious) with onset 25Feb2021, outcome "not recovered", described as "blisters"; PRURITUS (non-serious) with onset 25Feb2021, outcome "not recovered", described as "itching". Therapeutic measures were taken as a result of burning sensation, blister, pruritus.  Additional information: The next day of vaccination, caller broke out with blisters, itching, and burning where she got the radiation which reportedly scared the doctor and he gave her silvadine. The caller was set up to get the booster of vaccine but was worried. She stated that it was caused by radiation and it just made the reaction worse. The prior vaccinations within four weeks prior to the first administration date of the suspect vaccine were reported as none. She had radiation for 5 days 15Feb2021 to 19Feb2021  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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Condition aggravated, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: vaginal bleeding on and off/Reoccurring vaginal bleeding; Abdominal cramps; Reoccurring vaginal bleeding was reported as worsened/Abdominal cramps was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 04Apr2021 11:00 (Lot number: ER8733) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sensitivity to Gluten", start date: May2021 (unspecified if ongoing), notes: Illness/AE: Sensitivity to Gluten but does not have Celiac. Concomitant medication(s) included: WELLBUTRIN taken for anxiety, depression, start date: May2020. Vaccination history included: Bnt162b2 (Dose number: 1, Batch number: EN6206, Route, Anatomical Location: injected in right arm in the muscle), administration date: 14Mar2021, when the patient was 22 years old, for Covid-19 immunization; Moderna (When counting back to the date of first dose, she stated Pfizer is 21 and Moderna is 28), administration date: 07Mar2021, when the patient was 22 years old, for Covid-19 Immunization. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 15May2021 09:00, outcome "not recovered", described as "vaginal bleeding on and off/Reoccurring vaginal bleeding"; ABDOMINAL PAIN (non-serious) with onset 15May2021 09:00, outcome "not recovered", described as "Abdominal cramps"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Reoccurring vaginal bleeding was reported as worsened/Abdominal cramps was reported as worsened". The events "vaginal bleeding on and off/reoccurring vaginal bleeding", "abdominal cramps" and "reoccurring vaginal bleeding was reported as worsened/abdominal cramps was reported as worsened" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Chills; fever; headache; body aches; injection site and upper arm soreness; injection site and upper arm soreness; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Oct2021 15:45 (Lot number: ff8839) at the age of 47 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "Migraines" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: RELPAX; ADVIL [IBUPROFEN]; TIZANIDINE.  The following information was reported: CHILLS (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "Chills"; PYREXIA (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "body aches"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 19Oct2021 18:45, outcome "not recovered" and all described as "injection site and upper arm soreness"; FATIGUE (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "extreme fatigue". Therapeutic measures were not taken as a result of chills, pyrexia, headache, pain, vaccination site pain, pain in extremity, fatigue.  Additional information: The patient did not receive any other vaccine in four weeks. She had covid prior to vaccination. She was not tested for covid post vaccination. She had no known allergies.  Follow-up attempts were completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Chills; fever; headache; body aches; injection site and upper arm soreness; injection site and upper arm soreness; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Oct2021 15:45 (Lot number: ff8839) at the age of 47 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "Migraines" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: RELPAX; ADVIL [IBUPROFEN]; TIZANIDINE.  The following information was reported: CHILLS (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "Chills"; PYREXIA (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "body aches"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 19Oct2021 18:45, outcome "not recovered" and all described as "injection site and upper arm soreness"; FATIGUE (non-serious) with onset 19Oct2021 18:45, outcome "not recovered", described as "extreme fatigue". Therapeutic measures were not taken as a result of chills, pyrexia, headache, pain, vaccination site pain, pain in extremity, fatigue.  Additional information: The patient did not receive any other vaccine in four weeks. She had covid prior to vaccination. She was not tested for covid post vaccination. She had no known allergies.  Follow-up attempts were completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash
Clinical narrative: had a rash on the right side of her face; rash on left side of face was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received bnt162b2 (COMIRNATY), administration date 09Oct2021 (Lot number: FE3590) at the age of 65 years as dose 3 (booster), single for covid-19 immunization.   The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, Batch number: EP7334, Anatomical location: left arm), administration date: 19Mar2021, when the patient was 64 years old, for Covid-19 immunization; Bnt162b2 (dose 2, single, Batch number: EN0158, Anatomical location: left arm), administration date: 09Apr2021, when the patient was 64 years old, for Covid-19 immunization.  The following information was reported: RASH (non-serious) with onset 16Oct2021, outcome "not recovered", described as "had a rash on the right side of her face"; CONDITION AGGRAVATED (non-serious) with onset Oct2021, outcome "not recovered", described as "rash on left side of face was reported as worsened".  Additional information: Caller wanted to know if this was a reported side effect from the Pfizer Covid-19 vaccine. Caller received the Pfizer booster shot on 09Oct2021, she stated that she was out on vacations this week and about 4 days ago, clarified on the 16Oct2021 she noticed a rash on the right side of her face only, it was not the left side, she wanted to know if this was a side effect of the booster shot. Caller sated that it progressively got worse and in the last three days it has stayed the same and was not going away.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tired; Sick; Fevers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 44 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Oct2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose of covid-19 vaccine), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired"; PYREXIA (non-serious) with onset 16Oct2021, outcome "not recovered", described as "Fevers"; ILLNESS (non-serious), outcome "unknown", described as "Sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, pyrexia, illness. Caller, who was calling about the Pfizer Covid shot and who explains her son who was in withheld, took the second shot and had a fever since Saturday. It goes up and he takes ibuprofen and then it comes down but still going on right now. It goes up to 103 at night then he takes Ibuprofen and it goes back down. She wants to know what else can he take. No additional information provided for the Ibuprofen taken for the fever that is still ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Mood altered, Vaccination site pain
Clinical narrative: felt achey; felt bad no energy; felt bad no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 11:50 (Lot number: EN6203) at the age of 83 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Influenza (Route: Left arm, Lot number: 274571), administration date: 26Aug2020, when the patient was 83 years old, for Immunization; Prevnar 13 (Date: 08Jul2006, Date: 12Apr2003), administration date: 08Jul2006; Tdap, administration date: 08Jul2016; Bnt162b2 (Dose: 01, Time: 9:50 am, lot number: EI8982, anatomical location: arm left), administration date: 12Feb2021, when the patient was 83 years old, for Covid-19 immunization, reaction(s): "Peripheral swelling", "Side of face was swollen", "felt bad", "Lymphadenopathy", "Fatigue", "Wheezing", "Cough", "Aches", "Pain", "Asthenia". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Mar2021, outcome "unknown", described as "felt achey"; ASTHENIA (non-serious), MOOD ALTERED (non-serious) all with onset 05Mar2021, outcome "unknown" and all described as "felt bad no energy". The events "felt achey", "felt bad no energy" and "felt bad no energy" were evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.