chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Cough, Throat irritation
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing), notes: asthma; allergy (unspecified if ongoing). The patient's concomitant medications not reported. The following patient experienced back pain/backache, cough/bad cough, and throat irritation/scratchy throat, with of outcome unknown. Therapeutic measures were taken as a result of back pain. Additional information: The patient stated a few days after getting the first dose she was hospitalized. Later confirmed patient was not hospitalized because of asthma. Right now, she had a bad cough and currently taking prednisone. She mentioned that tomorrow would be her second scheduled dose. She would like to know if it was ok for her to take the second dose. Again, she confirmed she was not hospitalized. When she got her shot, she was ok. Her only problem was asthma. She wondered because she was taking the prednisone due to a backache (further clarification unknown), as prescribed by her  doctor. She took her last pill on Monday. She was wondering if it would have any effect since. She had cough and asthma/scratchy throat. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Body temperature, Chromaturia, Pyrexia
Clinical narrative: high temperature for 12 hours; dark red color urine for three days; pimples with whitehead all over face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 17:15 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 10Sep2021 07:30, outcome "recovered" (2021), described as "high temperature for 12 hours"; CHROMATURIA (non-serious) with onset 10Sep2021 07:30, outcome "recovered" (2021), described as "dark red color urine for three days"; ACNE (non-serious) with onset 10Sep2021 07:30, outcome "recovered" (2021), described as "pimples with whitehead all over face". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chromaturia, acne.  Additional information: High temperature for 12 hours dark red color urine for three days pimples with whitehead all over face.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: she developed rash on her breast after the first dose of the vaccine; itching; 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 33 year-old female patient received bnt162b2 (BNT162B2), administration date 16Aug2021 (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 17Aug2021, outcome "recovered" (Aug2021), described as "she developed rash on her breast after the first dose of the vaccine"; PRURITUS (non-serious) with onset 17Aug2021, outcome "recovered" (Aug2021), described as "itching".  Additional information: It was reported that caller got the Pfizer Covid vaccine back in 16Aug2021 and the next day she developed a rash on her breast and it was itching. Kind of think it was the vaccine. It died down kind of after 2-5 days. Yesterday she had a visit for the second dose and told the doctor about this and was told she should report this and see if she could go ahead with the second dose or wait.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Postmenopausal haemorrhage
Clinical narrative: I am premenopausal and haven't had a period since 03/2021 at the time that I received my Moderna booster shot. After I received the booster vaccine on 12/15/2021 my period came on 12/27/2021. It was an unusual period because it was very water with very little if not any blood clots. It stayed on for about 5-6 days, which was very usually. My last few years of periods only stayed on for no longer then 2-3 days. Before this period I was without a period for 9 straight months. Since that period I haven't had one again.
Sex: M
Vaccine: COVID19
Symptoms: Breath sounds, Hypersensitivity, Nasopharyngitis, Tinnitus
Clinical narrative: 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 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), BREATH SOUNDS (non-serious), outcome "unknown" and all described as "squeaky noise I have coming from my body, sometimes from ears, lungs, or head"; NASOPHARYNGITIS (non-serious), HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "he has a cold or allergies right now".  Additional information: Caller was a 70 year old male consumer who stated that he has received the first two doses of the Pfizer COVID 19 vaccine - Comirnaty. He wanted to receive the third dose but he has been having a issue and does not know if it was related to the vaccine. He has spoken to his doctors office and tried to schedule an appointment for a check up but when telling them about his problem they suggested calling Pfizer to see if we had any information on this being a side effect from the vaccine before scheduling him an appointment. He stated that he has been experiencing a squeaking noise coming form inside his body. He states that it sounds like its coming from different places at different times. He describes that while he was sleeping it sounds like it was coming from his lungs and other times it comes from his head or his ears. He also stated that he has a cold or allergies right now. He declines to be transferred at this time. Response included Relayed to caller that upon searching through my data there was no information found on this being a side effects from the vaccine. Referred to speak with HCP. Patient was asking can he schedule his second dose. Response received included referred caller to speak with his vaccination site or HCP to schedule the appointment. This consumer reported in response to non HCP telephonic follow up activity which included telephonic conversation to consumer to obtain mailing information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Muscle pain; joint pain; mild fever; feeling unwell; chills; headache; tiredness; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 15:45 (Lot number: 301558A) at the age of 77 years as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Allergic Rhinitis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "known allergies: Sulpha" (unspecified if ongoing), notes: known allergies: Sulpha. Concomitant medication(s) included: LEVOTHYROXINE; SIMVASTATIN. Past drug history included: Tetracycline, reaction(s): "allergies: Tetracycline", notes: known allergies: Tetracycline; Bactrim, reaction(s): "allergies: Bactrim", notes: known allergies: Bactrim; Belladonna, reaction(s): "allergies: Belladonna", notes: known allergies: Belladonna; Mercurochrome, reaction(s): "allergies: Mercurochrome", notes: known allergies: Mercurochrome. Vaccination history included: Flu (Vaccine location: Left arm), administration date: 12Sep2021. The following information was reported: MYALGIA (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "joint pain"; PYREXIA (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "mild fever"; MALAISE (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "feeling unwell"; CHILLS (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "chills"; HEADACHE (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "headache"; FATIGUE (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "tiredness"; VACCINATION SITE PAIN (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "injection site pain". Therapeutic measures were taken as a result of myalgia, arthralgia, pyrexia, malaise, chills, headache, fatigue, vaccination site pain.  Additional information: The patient was treated with Tylenol every 6 hours for events and Rest. The patient was not diagnosed with COVID-19 Prior to vaccination, and not been tested for COVID-19 Since the vaccination. Medications received within 2 weeks of vaccination were Simvastatin, Levothyroxine.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Muscle pain; joint pain; mild fever; feeling unwell; chills; headache; tiredness; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 15:45 (Lot number: 301558A) at the age of 77 years as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Allergic Rhinitis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "known allergies: Sulpha" (unspecified if ongoing), notes: known allergies: Sulpha. Concomitant medication(s) included: LEVOTHYROXINE; SIMVASTATIN. Past drug history included: Tetracycline, reaction(s): "allergies: Tetracycline", notes: known allergies: Tetracycline; Bactrim, reaction(s): "allergies: Bactrim", notes: known allergies: Bactrim; Belladonna, reaction(s): "allergies: Belladonna", notes: known allergies: Belladonna; Mercurochrome, reaction(s): "allergies: Mercurochrome", notes: known allergies: Mercurochrome. Vaccination history included: Flu (Vaccine location: Left arm), administration date: 12Sep2021. The following information was reported: MYALGIA (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "joint pain"; PYREXIA (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "mild fever"; MALAISE (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "feeling unwell"; CHILLS (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "chills"; HEADACHE (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "headache"; FATIGUE (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "tiredness"; VACCINATION SITE PAIN (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "injection site pain". Therapeutic measures were taken as a result of myalgia, arthralgia, pyrexia, malaise, chills, headache, fatigue, vaccination site pain.  Additional information: The patient was treated with Tylenol every 6 hours for events and Rest. The patient was not diagnosed with COVID-19 Prior to vaccination, and not been tested for COVID-19 Since the vaccination. Medications received within 2 weeks of vaccination were Simvastatin, Levothyroxine.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7480), at the age of 47, in left arm, on Aug 18, 2021, at 20:30, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed arthralgia (in right ankle), onset Aug 19, 2021, at 06:30, with outcome of not recovered. Arthralgia in right ankle was evaluated at a physician office visit and emergency room visit. Relevant laboratory tests and procedures available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Treatment received for adverse event was Medrol-dose pack. Event resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications taken in the past two weeks. COVID-19 tested post vaccination. No follow-up attempts possible. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, Headache, Muscular weakness
Clinical narrative: Leg weakness; very tired; body aches; stomach pain; headache; wheezing; shortness of breathe; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 15:45 (Lot number: EW0177) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: Event verbatim: asthma, osteoarthritis, fibromyalgia; "osteoarthritis" (unspecified if ongoing), notes: Event verbatim: asthma, osteoarthritis, fibromyalgia; "fibromyalgia" (unspecified if ongoing), notes: Event verbatim: asthma, osteoarthritis, fibromyalgia. Concomitant medication(s) included: GABAPENTIN, start date: 18Aug2021. Vaccination history included: Bnt162b2 (1st dose, Lot number: 30145BA, Administration time: 15:45), administration date: 18Aug2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "Leg weakness"; FATIGUE (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "very tired"; PAIN (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "body aches"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "stomach pain"; HEADACHE (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "headache"; WHEEZING (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "wheezing"; DYSPNOEA (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "shortness of breathe".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior to and patient was not tested to covid-19 since the vaccination. Patient did not had any allergies. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Wheezing
Clinical narrative: Leg weakness; very tired; body aches; stomach pain; headache; wheezing; shortness of breathe; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 15:45 (Lot number: EW0177) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: Event verbatim: asthma, osteoarthritis, fibromyalgia; "osteoarthritis" (unspecified if ongoing), notes: Event verbatim: asthma, osteoarthritis, fibromyalgia; "fibromyalgia" (unspecified if ongoing), notes: Event verbatim: asthma, osteoarthritis, fibromyalgia. Concomitant medication(s) included: GABAPENTIN, start date: 18Aug2021. Vaccination history included: Bnt162b2 (1st dose, Lot number: 30145BA, Administration time: 15:45), administration date: 18Aug2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "Leg weakness"; FATIGUE (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "very tired"; PAIN (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "body aches"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "stomach pain"; HEADACHE (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "headache"; WHEEZING (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "wheezing"; DYSPNOEA (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "shortness of breathe".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior to and patient was not tested to covid-19 since the vaccination. Patient did not had any allergies. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Loss of personal independence in daily activities, Pain in extremity, Pyrexia
Clinical narrative: has developed chills and fever over 101F and some change; has developed chills and fever over 101F and some change; His arm was unbelievably sore yesterday, and useless today.; His arm was unbelievably sore yesterday, and useless today.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose:, He had the Pfizer BioNtech vaccine both shots earlier in the year.), administration date: 2021, for COVID-19 immunization; Bnt162b2 (2nd Dose:, He had the Pfizer BioNtech vaccine both shots earlier in the year.), administration date: 2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious) all with onset 29Sep2021, outcome "unknown" and all described as "has developed chills and fever over 101F and some change"; PAIN IN EXTREMITY (non-serious) with onset 28Sep2021, outcome "not recovered", LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 29Sep2021, outcome "unknown" and all described as "His arm was unbelievably sore yesterday, and useless today.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller said that his arm is unbelievably sore, and has developed chills and fever over 101F and some change. Caller is asking if he can take ibuprofen for his fever. The patient underwent lab data for Body temperature was 101.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Had mild fever; Chills; Her left leg went numb, swollen, and painful; Her left leg went numb, swollen, and painful; Her left leg went numb, swollen, and painful; Sensitive to cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sciatica", start date: Aug2021 (unspecified if ongoing), notes: She was experiencing sciatica earlier in August and felt recovered prior to the 2nd shot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Had mild fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Her left leg went numb, swollen, and painful"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Her left leg went numb, swollen, and painful"; TEMPERATURE INTOLERANCE (non-serious) with onset 2021, outcome "unknown", described as "Sensitive to cold".  Additional information: Patient was middle aged and healthy but said she was experiencing sciatica earlier in August and felt recovered prior to the 2nd shot. Upon receiving the 2nd injection on 29Aug, she said she had mild fever and chills and that her left leg went numb, swollen, and painful. She said it was sensitive to cold, when she tried icing her leg with the cold causing pain. She said the numbness and pain continue to the present but are much more bearable.   Follow-up (05Oct2021): 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: F
Vaccine: COVID19
Symptoms: Temperature intolerance
Clinical narrative: Had mild fever; Chills; Her left leg went numb, swollen, and painful; Her left leg went numb, swollen, and painful; Her left leg went numb, swollen, and painful; Sensitive to cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sciatica", start date: Aug2021 (unspecified if ongoing), notes: She was experiencing sciatica earlier in August and felt recovered prior to the 2nd shot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Had mild fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Her left leg went numb, swollen, and painful"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Her left leg went numb, swollen, and painful"; TEMPERATURE INTOLERANCE (non-serious) with onset 2021, outcome "unknown", described as "Sensitive to cold".  Additional information: Patient was middle aged and healthy but said she was experiencing sciatica earlier in August and felt recovered prior to the 2nd shot. Upon receiving the 2nd injection on 29Aug, she said she had mild fever and chills and that her left leg went numb, swollen, and painful. She said it was sensitive to cold, when she tried icing her leg with the cold causing pain. She said the numbness and pain continue to the present but are much more bearable.   Follow-up (05Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Blood pressure high; she felt horrible; Shallow breathing; Arm hurt; Felt very tired/exhausted; Chest pain; Light-headed; Headache; 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 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 12:30 (Lot number: FD8448) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPOPNOEA (non-serious) with onset 26Sep2021, outcome "unknown", described as "Shallow breathing"; PAIN IN EXTREMITY (non-serious) with onset 26Sep2021, outcome "unknown", described as "Arm hurt"; FATIGUE (non-serious) with onset 26Sep2021, outcome "unknown", described as "Felt very tired/exhausted"; CHEST PAIN (non-serious) with onset 26Sep2021, outcome "unknown", described as "Chest pain"; DIZZINESS (non-serious) with onset 26Sep2021, outcome "unknown", described as "Light-headed"; HEADACHE (non-serious) with onset 26Sep2021, outcome "unknown", described as "Headache"; HYPERTENSION (non-serious) with onset 29Sep2021, outcome "unknown", described as "Blood pressure high"; FEELING ABNORMAL (non-serious) with onset 26Sep2021, outcome "not recovered", described as "she felt horrible". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypopnoea, pain in extremity, fatigue, chest pain, dizziness, headache, hypertension, feeling abnormal.  Additional information: She felt fine initially, but then she started to have the same events again. She started to have shallow breathing again. She was supposed to be shopping, but she was exhausted again, and she has just been laying in bed.  As she is laying in bed not overexerting herself, she feels she is getting better. She spoke with one of her in-laws who told her to check her blood pressure and she checked it today and it was high, it was 195/92. She thought this was a one-day thing until it started again. This made her want to do more research. She clarified and confirmed all the events, shallow breathing, arm hurt, she felt like she had to take a deep breath to feel better, she felt very tired/exhausted, chest pain, light-headed, and headache started again.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Hypopnoea, Pain in extremity
Clinical narrative: Blood pressure high; she felt horrible; Shallow breathing; Arm hurt; Felt very tired/exhausted; Chest pain; Light-headed; Headache; 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 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 12:30 (Lot number: FD8448) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPOPNOEA (non-serious) with onset 26Sep2021, outcome "unknown", described as "Shallow breathing"; PAIN IN EXTREMITY (non-serious) with onset 26Sep2021, outcome "unknown", described as "Arm hurt"; FATIGUE (non-serious) with onset 26Sep2021, outcome "unknown", described as "Felt very tired/exhausted"; CHEST PAIN (non-serious) with onset 26Sep2021, outcome "unknown", described as "Chest pain"; DIZZINESS (non-serious) with onset 26Sep2021, outcome "unknown", described as "Light-headed"; HEADACHE (non-serious) with onset 26Sep2021, outcome "unknown", described as "Headache"; HYPERTENSION (non-serious) with onset 29Sep2021, outcome "unknown", described as "Blood pressure high"; FEELING ABNORMAL (non-serious) with onset 26Sep2021, outcome "not recovered", described as "she felt horrible". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypopnoea, pain in extremity, fatigue, chest pain, dizziness, headache, hypertension, feeling abnormal.  Additional information: She felt fine initially, but then she started to have the same events again. She started to have shallow breathing again. She was supposed to be shopping, but she was exhausted again, and she has just been laying in bed.  As she is laying in bed not overexerting herself, she feels she is getting better. She spoke with one of her in-laws who told her to check her blood pressure and she checked it today and it was high, it was 195/92. She thought this was a one-day thing until it started again. This made her want to do more research. She clarified and confirmed all the events, shallow breathing, arm hurt, she felt like she had to take a deep breath to feel better, she felt very tired/exhausted, chest pain, light-headed, and headache started again.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Upper-airway cough syndrome
Clinical narrative: First dose: had a ticklish cough; kind of like squeeze in the chest; post nasal drip, it lasted 3 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Aug2021 12:30 (Lot number: FC3183) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: allergic to Sulfur oxide; "allergic to wine" (unspecified if ongoing), notes: allergic to wine; "left ventricular wall leak", start date: Jun2020 (ongoing). There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 31Aug2021, outcome "recovering", described as "First dose: had a ticklish cough"; UPPER-AIRWAY COUGH SYNDROME (non-serious) with onset 2021, outcome "unknown", described as "post nasal drip, it lasted 3 weeks"; CHEST DISCOMFORT (non-serious) with onset 31Aug2021, outcome "recovering", described as "kind of like squeeze in the chest".  Additional Information: The patient had cough, kind of a ticklish cough, assumed it was the vaccine but had also post nasal drip, it lasted 3 weeks, that was why the patient delayed her second shot and waited to get better, she had still a little bit, that was a ticklish cough, kind of like squeeze in the chest, not really major. The patient confirmed it started two days after the shot. It felt like she ate something she was allergic to Sulfur oxide, that was in dried prunes, red wine, it has sulfates, usually the patient had that cough after consuming that.  She took communion, and every time she had that and drink red wine, had coughs. She was just allergic to wine. But she had when laying on the cough and felt like a squeezing ticklish cough. The patient had no prior Vaccinations (within 4 weeks) and no other vaccinations within four weeks prior to the first dose. The patient did not require emergency Room/physician Office for the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Pain, Paraesthesia, Vasodilatation
Clinical narrative: Vein is protruding, enlarged and purple; allergic reaction; her vein was popping out felt a little hard; tingling, numbness and achiness down to her toes; Felt tingling in her legs right behind her knee; tingling, numbness and achiness down to her toes; Vein is protruding, enlarged and purple; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2021, outcome "unknown", described as "allergic reaction"; VEIN DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "her vein was popping out felt a little hard"; PAIN (non-serious), HYPOAESTHESIA (non-serious) all with onset Sep2021, outcome "unknown" and all described as "tingling, numbness and achiness down to her toes"; PARAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "Felt tingling in her legs right behind her knee"; VASODILATATION (non-serious) with onset Sep2021, outcome "unknown", VEIN DISCOLOURATION (non-serious) with onset 29Sep2021, outcome "unknown" and all described as "Vein is protruding, enlarged and purple".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vein discolouration, Vein disorder
Clinical narrative: Vein is protruding, enlarged and purple; allergic reaction; her vein was popping out felt a little hard; tingling, numbness and achiness down to her toes; Felt tingling in her legs right behind her knee; tingling, numbness and achiness down to her toes; Vein is protruding, enlarged and purple; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2021, outcome "unknown", described as "allergic reaction"; VEIN DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "her vein was popping out felt a little hard"; PAIN (non-serious), HYPOAESTHESIA (non-serious) all with onset Sep2021, outcome "unknown" and all described as "tingling, numbness and achiness down to her toes"; PARAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "Felt tingling in her legs right behind her knee"; VASODILATATION (non-serious) with onset Sep2021, outcome "unknown", VEIN DISCOLOURATION (non-serious) with onset 29Sep2021, outcome "unknown" and all described as "Vein is protruding, enlarged and purple".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; 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 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: I had sinus stuff; Swollen lymph nodes under the armpit; Headaches; I have been running a continuous low grade fever; not doing great; 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 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Sep2021 17:00 (Lot number: FC3183) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical depression" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; TRAZODONE taken for sleep disorder; DULOXETINE taken for major depression. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization; Bnt162b2 (Dose no: 2), for COVID-19 immunization. The following information was reported: SINUS DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "I had sinus stuff"; LYMPHADENOPATHY (non-serious) with onset Sep2021, outcome "unknown", described as "Swollen lymph nodes under the armpit"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "Headaches"; PYREXIA (non-serious) with onset Sep2021, outcome "not recovered", described as "I have been running a continuous low grade fever"; MALAISE (non-serious) with onset Sep2021, outcome "unknown", described as "not doing great". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinus disorder, lymphadenopathy, headache, pyrexia, malaise.  Additional Information: The patient that she already reported a possible severe reaction from the booster shot that she received, she was calling back for more information on why swollen lymph nodes under the armpit was not listed as possible side effects of the vaccine, she added that even the pharmacist has not heard of it. She read an article, that swollen lymph nodes under the armpit was likely to have breast cancer which was caused by the vaccine. The patient wanted to report a swollen lymph node under her armpit and that was not commonly shared and of course it scared her and so, in the middle of night she called her daughter and she researched it and said that yeah, it had been reported (further not clarified) but it was just not in regular literature. The other thing and she don't know how unusual it is but she had been running a continuous low grade fever now for which was going on 3 days and she had headaches many times because she had sinus stuff (further not clarified) but she had a headache night before last, that she had to put 3 icepacks on her head, she meant, it was unbelievable it felt like her head was, her whole head was in a vise, worst headache she had in her life, she was not having a fun time with it, she was still very glad she got it but was not doing great.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: I had sinus stuff; Swollen lymph nodes under the armpit; Headaches; I have been running a continuous low grade fever; not doing great; 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 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Sep2021 17:00 (Lot number: FC3183) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical depression" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; TRAZODONE taken for sleep disorder; DULOXETINE taken for major depression. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization; Bnt162b2 (Dose no: 2), for COVID-19 immunization. The following information was reported: SINUS DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "I had sinus stuff"; LYMPHADENOPATHY (non-serious) with onset Sep2021, outcome "unknown", described as "Swollen lymph nodes under the armpit"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "Headaches"; PYREXIA (non-serious) with onset Sep2021, outcome "not recovered", described as "I have been running a continuous low grade fever"; MALAISE (non-serious) with onset Sep2021, outcome "unknown", described as "not doing great". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinus disorder, lymphadenopathy, headache, pyrexia, malaise.  Additional Information: The patient that she already reported a possible severe reaction from the booster shot that she received, she was calling back for more information on why swollen lymph nodes under the armpit was not listed as possible side effects of the vaccine, she added that even the pharmacist has not heard of it. She read an article, that swollen lymph nodes under the armpit was likely to have breast cancer which was caused by the vaccine. The patient wanted to report a swollen lymph node under her armpit and that was not commonly shared and of course it scared her and so, in the middle of night she called her daughter and she researched it and said that yeah, it had been reported (further not clarified) but it was just not in regular literature. The other thing and she don't know how unusual it is but she had been running a continuous low grade fever now for which was going on 3 days and she had headaches many times because she had sinus stuff (further not clarified) but she had a headache night before last, that she had to put 3 icepacks on her head, she meant, it was unbelievable it felt like her head was, her whole head was in a vise, worst headache she had in her life, she was not having a fun time with it, she was still very glad she got it but was not doing great.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood test, Contusion, Epstein Barr virus positive mucocutaneous ulcer, Haematoma
Clinical narrative: she still had a bruise on her left arm from that hematoma; rash; she still had a bruise on her left arm from that hematoma; 7 days after the first dose she got a big itchy rash, states it is called covid arm; 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 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMATOMA (non-serious) with onset 09Feb2021, outcome "recovered" (Mar2021), CONTUSION (non-serious), outcome "unknown" and all described as "she still had a bruise on her left arm from that hematoma"; RASH (non-serious), outcome "unknown", described as "rash"; RASH PRURITIC (non-serious) with onset Feb2021, outcome "unknown", described as "7 days after the first dose she got a big itchy rash, states it is called covid arm". The events "she still had a bruise on her left arm from that hematoma", "she still had a bruise on her left arm from that hematoma", "rash" and "7 days after the first dose she got a big itchy rash, states it is called covid arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of haematoma, contusion, rash, rash pruritic.  Additional information: She thinks part of the issue is she is a tiny person and does not have muscle in her left arm. She thinks they nicked a blood vein when they gave her the first dose since she got a huge hematoma in her left arm that hurt. She does not think it was the vaccine but from the person that administered the vaccine. It got swelled up and got huge. Treatment: She put ice on it. 7 days after the first dose she got a big itchy rash, states it is called covid arm. When she went to go get the second dose she still had a bruise on her left arm from that hematoma that gradually went away.   Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.