chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: HEP
Symptoms: Skin mass, Vitamin B12 increased
Clinical narrative: Experiencing pain that alternated from the left hip, to the left knee, to the right hip, to the right knee / return of  a previous pain in the left shoulder; Hair ceased growing / has only grown one inch since last dose received; Temporary bubble in the left eye; Low blood pressure; Dizziness; Hard lumps have formed on the top of the skin over their knuckles; Being unable to walk for approximately 1 week; Unable to chew for approximately 1 week; This case was reported by a consumer via call center representative and described the occurrence of unable to walk in a 78-year-old female patient who received HBV (Engerix B) for prophylaxis.   The patient's past medical history included shoulder pain. Previously administered products included Engerix B (1st dose received on May 2019) and Engerix B (2nd dose received on June 2019).   In November 2019, the patient received the 3rd dose of Engerix B. In January 2020, 2 months after receiving Engerix B, the patient experienced unable to walk, chewing difficulty, arthralgia multiple, hair growth decreased, eye disorder, low blood pressure, dizziness and skin nodule. On an unknown date, the outcome of the unable to walk, chewing difficulty, eye disorder, low blood pressure and dizziness were recovered/resolved and the outcome of the arthralgia multiple was recovering/resolving and the outcome of the hair growth decreased and skin nodule were not recovered/not resolved.   It was unknown if the reporter considered the unable to walk, chewing difficulty, arthralgia multiple, hair growth decreased, eye disorder, low blood pressure, dizziness and skin nodule to be related to Engerix B.  Additional details were provided as follows: The reporter was the patient. The blood tests had showed high level of B12 in the blood. The patient had received all the three doses of Engerix B. The patient had onset of symptoms as approximately 2 months after receiving last dose.  The patient was unable to walk and unable to chew for approximately 1 week. The patient was experiencing pain that alternated from the left hip, to the left knee, to the right hip, to the right knee. The patient stated that there was a return of a previous pain in the left shoulder Hair had ceased growing after receiving last dose of vaccine and had only grown one inch since the last dose. The patient reported an appearance of a temporary bubble in the left eye. The patient had also experienced low blood pressure that resulted in dizziness.  The patient also had hard lumps that had formed on the top of the skin over the knuckles. The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; A spontaneous report was received from a Consumer regarding his wife who received the first dose of Moderna Covid-19 vaccine and have experienced Bell's palsy.  The patient's medical history was not provided. Her concomitant medication is thyroxine. No information on allergies.   On 04-FEB-2021, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection.   On 11-FEB-2021, patient noticed excessive watering from her right eye, next day on 12-FEB-2021, she felt jaw pain on right side of her mouth and her lip began to droop. On13-FEB-2021, patient was taken to ER where she was diagnosed with Bell's Palsy. She was treated with antivirals and steroids. She is recovering, but still side effects are present.   Action taken with the 2nd dose of vaccine was not reported.  The outcome of the event Bell's Palsy is still recovering at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Urinary tract infection, Vaccination site pain
Clinical narrative: UTI infection; swollen lymph nodes,hard to touch; swollen at site of injection; Headache; Fatigue; Tenderness at site of injection; A spontaneous report was received from a consumer concerning a 54 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lymph nodes near neck are swollen and hard to touch, tenderness at site of injection, swollen at site of injection, Urinary tract infections, tiredness and headache.   The patient's medical history was not provided. Relevant concomitant medications were reported "hidden".   On 04-FEB-2021 approximately a week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number012M2 (or 7) 0A) in left arm for prophylaxis of COVID-19 infection.  On 11-FEB-2021 or 12-FEB-2021, the patient started feeling something on the left area near the neck lymph nodes swollen and hard to touch and headache. On that weekend patient experienced tenderness and swollen at injection site and tiredness.  Treatment for the event included two paracetamol for pain and OTC "Quora" for Urinary tract infections on 17-FEB-2021.   The outcome of the events, lymph nodes near neck are swollen and hard to touch, tenderness at site of injection, swollen at site of injection, Urinary tract infections, tiredness and headache, were unknown.; Reporter's Comments: Based on the information provided which includes a temporal association, and known safety profile  of the vaccine, a causal association between the reported events of lymphadenopathy, injection site tenderness and swelling, tiredness and headache  and the administration of the mRNA-1273 vaccine cannot be excluded. Urinary tract infections is assessed as unlikely related to vaccine use but due to an infection
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: UTI infection; swollen lymph nodes,hard to touch; swollen at site of injection; Headache; Fatigue; Tenderness at site of injection; A spontaneous report was received from a consumer concerning a 54 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lymph nodes near neck are swollen and hard to touch, tenderness at site of injection, swollen at site of injection, Urinary tract infections, tiredness and headache.   The patient's medical history was not provided. Relevant concomitant medications were reported "hidden".   On 04-FEB-2021 approximately a week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number012M2 (or 7) 0A) in left arm for prophylaxis of COVID-19 infection.  On 11-FEB-2021 or 12-FEB-2021, the patient started feeling something on the left area near the neck lymph nodes swollen and hard to touch and headache. On that weekend patient experienced tenderness and swollen at injection site and tiredness.  Treatment for the event included two paracetamol for pain and OTC "Quora" for Urinary tract infections on 17-FEB-2021.   The outcome of the events, lymph nodes near neck are swollen and hard to touch, tenderness at site of injection, swollen at site of injection, Urinary tract infections, tiredness and headache, were unknown.; Reporter's Comments: Based on the information provided which includes a temporal association, and known safety profile  of the vaccine, a causal association between the reported events of lymphadenopathy, injection site tenderness and swelling, tiredness and headache  and the administration of the mRNA-1273 vaccine cannot be excluded. Urinary tract infections is assessed as unlikely related to vaccine use but due to an infection
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: Did not open eyes (Unresponsive); Not speaking; Fever; Positive COVID Test; UTI; A spontaneous report was received from a consumer concerning an 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: did not open eyes (unresponsive)/unresponsive to stimuli, UTI (urinary tract infection), positive COVID test/SARS-CoV-2 test postive, fever (pyrexia) and not speaking (dysphasia).  The patient's medical history included Parkinson's Disease.  On 19-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection.  Treatment included antibiotics, remdesivir IV (intravenous) and rehabilitation.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events did not open eyes (unresponsive), UTI, positive COVID test, fever, and not speaking was unknown.; Reporter's Comments: This case concerns an 89-year-old female who experienced serious unexpected events of COVID-19, pyrexia, urinary tract infection, aphasia, unresponsive to stimuli.  The events occurred 25 days after the first dose of mRNA-1273. Treated with antibiotics and IV remdesivir. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Did not open eyes (Unresponsive); Not speaking; Fever; Positive COVID Test; UTI; A spontaneous report was received from a consumer concerning an 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: did not open eyes (unresponsive)/unresponsive to stimuli, UTI (urinary tract infection), positive COVID test/SARS-CoV-2 test postive, fever (pyrexia) and not speaking (dysphasia).  The patient's medical history included Parkinson's Disease.  On 19-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection.  Treatment included antibiotics, remdesivir IV (intravenous) and rehabilitation.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events did not open eyes (unresponsive), UTI, positive COVID test, fever, and not speaking was unknown.; Reporter's Comments: This case concerns an 89-year-old female who experienced serious unexpected events of COVID-19, pyrexia, urinary tract infection, aphasia, unresponsive to stimuli.  The events occurred 25 days after the first dose of mRNA-1273. Treated with antibiotics and IV remdesivir. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Vision blurred, Vomiting
Clinical narrative: difficulty breathing; vision issues; cloudy and fogginess; vomiting; While in the hospital she was stated to have been on 100% oxygen, couldn't breathe at all; A spontaneous report was received from a 50-year-old female patient.  The patient's medical history included Lupus, and COPD. Products known to have been used by the patient, within two weeks prior to the event, included Salbutamol Sulfate, Alprazolam, Lisinopril, Ezetimibe, and Pantoprazole Sodium Sesquihydrate.  On 31 Dec-2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot unknown) by injection (site not provided) for prophylaxis of COVID-19 infection.   On 31-Dec-2020,  the patient developed difficulty breathing, vision became cloudy/foggy and vomiting. The patient spent New Year's day in the hospital (admission and discharge date and times were not provided), she was treated with 100% Oxygen, Zofran and Morphine. The patient also had nine symptoms while she was in the hospital however details were not reported.   Action taken with mRNA-1273 in response to the events was unknown  The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a UTI on an unspecified date and was prescribed Sulfamethoxazole/Trimethoprim. She read the literature on it which states to not take any vaccines, such as the typhoid vaccine while on this medication unless the doctor tells you to. Patient was asking if it was safe for her to get the second dose of the vaccine while on this medication. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer Sponsored Program. A 70-year-old male patient received his first dose bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE) at unknown vaccination age via an unspecified route of administration on 29Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient received the first dose of the COVID-19 vaccine last Friday (29Jan2021), and he is scheduled to receive his "pain shot" this coming Thursday (unspecified date). She asked if it is ok for her husband to receive this injection between the two doses of the vaccine. She inquired if that's okay to take it prior to the second shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arms; This is a spontaneous report from a contactable nurse (patient). A 39-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the left arm, on 02Jan2021 at 10:30 (at the age of 39-years-old) at a single dose for COVID-19 immunisation. Medical history included hypertension and hypercholesterolemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included losartan (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient experienced rash on arms on 01Feb2021 at 06:00. The event was reported as non-serious. Therapeutic measures were taken as a result of the event, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of rash on arms was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Gastrointestinal disorder, Nausea, Vomiting
Clinical narrative: Severe digestive issues; Nausea; Vomiting; Diarrhea; Upper back pain; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's son explained he has gotten a call from his mother who was 77 years old and received her first vaccine this past Thursday at a Hospital. She was now experiencing vomiting, diarrhea, and upper back pain. He wasn't sure if him and his brother should take her to the emergency room because of her age and her condition. He was not sure if this was a reaction to the vaccine since the vaccine was given so many days ago. He explained he and his mother had the vaccine basically at the same time and he has had no reactions. However, his mother was experiencing digestive issues and lots of diarrhea, vomiting, and nausea. He was trying to determine the best course of action and determine if she should go to the emergency room based on her age and condition. The outcome of the events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypogeusia, Hyposmia
Clinical narrative: his smell and taste was diminished; his smell and taste was diminished; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on 29Jan2021 (at the age of 75 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported on Saturday morning, 30Jan2021, experienced his smell and taste was diminished when he got up. "Now, I do not know what I have gathered, it is not necessarily more of a functional Covid. I just wanted, have you had people reported after having the vaccine?" Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: real bad back problems, back pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a 77-year-old male patient (husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot and expiry not reported), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history included back issues (on and off). The patient's concomitant medications were not reported. It was reported that both consumer (wife) and patient (husband) received the first dose of Pfizer COVID19 vaccine on 23Jan2021. The wife reported that the patient been having real bad back problems, back pain that started 2-3 day afterwards (in Jan2021) and asked if that was one the side effect of the covid-19 vaccine. It comes and goes and was currently ongoing. The event was considered by the wife as non-serious. The patient did have a history of back issues on and off and they planned to discuss this further with his back doctor. Second dose was currently scheduled for 14Feb2021. The wife asked that due to back pain if the patient should get the second dose and/or could it be rescheduled. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural, Vertigo
Clinical narrative: he started experiencing vertigo which lasted 5 or 6 days; only experiencing dizziness when he tries to stand; This is a spontaneous report from a contactable consumer (wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Reporter stated that her husband (patient) received the first dose of the Pfizer COVID-19 vaccine and about 4 days later (date unspecified) he started experiencing vertigo which lasted 5 or 6 days. Patient was now (since an unknown date) only experiencing dizziness when he tries to stand. Patient did speak with his primary care provider to let her know about this reaction after receiving the first dose of the Pfizer COVID-19 vaccine and she prescribed meclizine as a treatment for his vertigo and dizziness. The reporter would like to know if her husband should receive the second dose considering his reaction after the first dose. The reporter would like to know if the two doses of the Pfizer COVID-19 vaccine are the same and would like to know how effective the Pfizer COVID-19 vaccine is after the first dose. The events were reported as non-serious. Therapeutic measures were received in response to the reported events. The outcome of the events vertigo and dizziness was unknown.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Breast swelling, Lymphadenopathy, Muscle spasms
Clinical narrative: burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; charlie horse like cramps in left arm, hand and shoulder.; left breast swelled up; left armpit swelled up; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old female patient received her  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263), via an unspecified route of administration (on left arm) on 27Jan2021 10:00 (at the age of 66 -years-old), single dose for COVID-19 immunization. Medical history included back surgery, knee surgery both on 2018. The patient's concomitant medications were not reported.  Caller received 27Jan2021: 15 min after injection burning down her left arm, left breast and axillary swollen painful, charlie horse like cramps in left arm, hand and shoulder. She is drinking water, taking Tylenol, and using a heating pad but symptoms are persisting. Consumer states she is getting some interesting side effects from the vaccine. Adds she received the vaccine on 27Jan2021 10:00AM. Reports within the first 15 minutes she noticed just some burning down her left arm but then her left armpit swelled up; her left breast swelled up and she started to experience charlie horses in her arm. Adds now the pain has come down a little. She has been drinking water, taking Tylenol, and using a heating pad and that has helped a little. The pain comes and goes. It is worse at night when she lies down. Now it is in her hand, charlie horsing in her hand. She thinks maybe the shot got into her lymph nodes. Mentions the swelling her left armpit and breast has gone down some but the pain is still there. Clarifies patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 at 10:00AM on the left arm. She is scheduled for the second dose 24Feb2021. The outcome of the event Swelling arm, Breast swelling, Axillary pain, Axillary lymph nodes enlarged  was recovering, other events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; charlie horse like cramps in left arm, hand and shoulder.; left breast swelled up; left armpit swelled up; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old female patient received her  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263), via an unspecified route of administration (on left arm) on 27Jan2021 10:00 (at the age of 66 -years-old), single dose for COVID-19 immunization. Medical history included back surgery, knee surgery both on 2018. The patient's concomitant medications were not reported.  Caller received 27Jan2021: 15 min after injection burning down her left arm, left breast and axillary swollen painful, charlie horse like cramps in left arm, hand and shoulder. She is drinking water, taking Tylenol, and using a heating pad but symptoms are persisting. Consumer states she is getting some interesting side effects from the vaccine. Adds she received the vaccine on 27Jan2021 10:00AM. Reports within the first 15 minutes she noticed just some burning down her left arm but then her left armpit swelled up; her left breast swelled up and she started to experience charlie horses in her arm. Adds now the pain has come down a little. She has been drinking water, taking Tylenol, and using a heating pad and that has helped a little. The pain comes and goes. It is worse at night when she lies down. Now it is in her hand, charlie horsing in her hand. She thinks maybe the shot got into her lymph nodes. Mentions the swelling her left armpit and breast has gone down some but the pain is still there. Clarifies patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 at 10:00AM on the left arm. She is scheduled for the second dose 24Feb2021. The outcome of the event Swelling arm, Breast swelling, Axillary pain, Axillary lymph nodes enlarged  was recovering, other events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: headache; chills; muscle pain; tiredness; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3302), via an unspecified route of administration at the left arm from 30Jan2021 3:00 PM at SINGLE DOSE for covid-19 immunization. The patient is not pregnant at the time. The patient was vaccinated at a Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included cancer cured. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that there are other medications the patient received within 2 weeks of vaccination, however it was unspecified.  The patient previously took demerol and experienced allergy. It was reported that the patient experienced headache, chills, muscle pain, tiredness, feeling unwell on 30Jan2021 09:00 PM. The outcome of the events was recovered. No treatment was received for the adverse events. The case/ events were reported to be non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph nodes under left arm; achy; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old non-pregnant female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 at 09:30 AM, in left arm, for COVID-19 immunisation. Medical history included allergies to sulfa and COVID before vaccination. Concomitant medications included calcium, glucosamine/chondroitin and unspecified multivitamin. On 30Jan2021 at 16:00 the patient experienced injection site pain, headache, joint pain, nausea, feeling unwell, tiredness, swollen lymph nodes under left arm and achy. The events got progressively worse the following day. On 01Feb2021 the patient was too tired and achy to go to work. The events did not require any treatment and were resolving at the time of report. COVID was not tested post vaccination.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain
Clinical narrative: injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph nodes under left arm; achy; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old non-pregnant female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 at 09:30 AM, in left arm, for COVID-19 immunisation. Medical history included allergies to sulfa and COVID before vaccination. Concomitant medications included calcium, glucosamine/chondroitin and unspecified multivitamin. On 30Jan2021 at 16:00 the patient experienced injection site pain, headache, joint pain, nausea, feeling unwell, tiredness, swollen lymph nodes under left arm and achy. The events got progressively worse the following day. On 01Feb2021 the patient was too tired and achy to go to work. The events did not require any treatment and were resolving at the time of report. COVID was not tested post vaccination.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: some temporary diarrhea; felt tired; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration on 30Jan2021 (at the age of 83 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on unspecified date at a single dose for covid-19 immunization. On unspecified date in 2021, the patient experienced some temporary diarrhea and felt tired for about 15 hours. Outcome of all the events was recovered on unspecified date in 2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body height decreased, Dizziness, Dry mouth, Fatigue
Clinical narrative: walks with a cane; she has shrunk; tiredness/ extremely tired; vomited twice; lightheadedness/ Very lightheaded; sore throat/ throat is sore; loss of taste/ She has no taste; swollen and puffy mouth/ mouth swollen/puffy; experiencing dry mouth to the point that she cannot talk/ Dry mouth; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), on the left arm, intramuscularly, on 23Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history included mild case of asthma from an unknown date. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient reported that she received her first vaccine a week ago this past Saturday. She didn't feel anything different until 2 days later on 25Jan2021. She became extremely tired and vomited twice, became very lightheaded, has no taste, throat is sore, mouth seems like it is swelling when she wakes up in the morning, her mouth is puffy. Her mouth is getting so dry she can hardly talk. On a unspecified date, the patient reported that she walks with a cane in her own house, she normally doesn't. But since she has had the shot, she has had to use the cane in her own house, she has shrunk. The reporter did not require a visit to a physician's office or emergency room. She mentions she is scheduled for her second vaccine. The patient was vaccinated on an active aging building. The outcome of the events extremely tired and vomited was recovered, for the events very lightheaded, throat is sore, mouth seems like it is swelling/mouth is puffy, mouth is getting so dry she can hardly talk was not recovered, while for the events has no taste, walks with a cane, and has shrunk was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Oropharyngeal pain, Speech disorder, Vomiting, Walking aid user
Clinical narrative: walks with a cane; she has shrunk; tiredness/ extremely tired; vomited twice; lightheadedness/ Very lightheaded; sore throat/ throat is sore; loss of taste/ She has no taste; swollen and puffy mouth/ mouth swollen/puffy; experiencing dry mouth to the point that she cannot talk/ Dry mouth; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), on the left arm, intramuscularly, on 23Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history included mild case of asthma from an unknown date. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient reported that she received her first vaccine a week ago this past Saturday. She didn't feel anything different until 2 days later on 25Jan2021. She became extremely tired and vomited twice, became very lightheaded, has no taste, throat is sore, mouth seems like it is swelling when she wakes up in the morning, her mouth is puffy. Her mouth is getting so dry she can hardly talk. On a unspecified date, the patient reported that she walks with a cane in her own house, she normally doesn't. But since she has had the shot, she has had to use the cane in her own house, she has shrunk. The reporter did not require a visit to a physician's office or emergency room. She mentions she is scheduled for her second vaccine. The patient was vaccinated on an active aging building. The outcome of the events extremely tired and vomited was recovered, for the events very lightheaded, throat is sore, mouth seems like it is swelling/mouth is puffy, mouth is getting so dry she can hardly talk was not recovered, while for the events has no taste, walks with a cane, and has shrunk was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Urticaria, Vaccination site pain
Clinical narrative: Pain; Burning sensation; Hives; Injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el1284 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history included lymphoma from May2020, had chemotherapy for lymphoma from Jun2020 to 08Oct2020, shingles, knee replacement from 2008 and allergic to penicillin. The patient's concomitant medications were not reported. Patient stated she thinks she was having side effects from the Pfizer COVID-19 vaccine she got 19Jan2021, tomorrow 02Feb2020 was two weeks from when she got it. Patient didn't have any side effects to start with, just soreness to the injection site on Jan2021. She says last Wednesday, 27Jan2021, she noticed she had hives, not a rash, on her chest on the left side that are kind of on her breast, the top of her breast, which now spread under her arm up to her shoulder area and back. There was pain along with it, a burning sensation starting last night on 31Jan2021 in the inside area. Since she got her injection on her left side, she doesn't know if this could be a reaction to the injection or not. She had shingles several years ago, this was acting like that, and it looked like one of the side effects listed is lymphadenopathy, which she looked up information about that, but she doesn't know what it was, she doesn't know what else to blame it on. Patient hasn't seen her doctor yet for hives, and has not treated the hives. She got the OK from the nurse who said she didn't see a reason for her not to get the vaccine since she was coming off chemo several months prior. Patient was considered to be in remission right now, and she has an appointment next week with her oncologist for follow up. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting projectile
Clinical narrative: projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, has thrown up in the past, had allergic reactions to things, normally has hives and swelling to those things all from an unknown date. Concomitant medication included methotrexate from an unspecified date for rheumatoid arthritis and an unspecified supplements. On 27Jan2021, the patient was administered her first dose of BNT162B2  vaccine and nothing happened during the shot, it was fine. She took a 2 mile walk as she usually does every day and had lunch. About 6 hours after she got the first dose she had projectile vomiting maybe 5 times in a 15 minute period and that was it; it was over. She had no swelling at injection site or anywhere else after getting vaccine. Just the projectile vomiting. Her Primary Care Physician (PCP) does not think she should take the second dose of the vaccine. Her PCP is worried she will have a worse reaction to the second dose. Her Rheumatologist wants her to take the second dose of the vaccine, he can give her Phenergan. The patient reported that she would rather vomit more and still get the second dose. She did not pass out, did not have any life-threatening effects. She is assuming the second dose will be worse, but that is not life-threatening; COVID is life-threatening, serious like including death. She guesses the projectile vomiting could have been from something else; but she went through everything she ate that day and could not see anything really; most of what she had eaten that day she had also eaten the day before. The only thing unusual was one thing of spinach she ate that day; but because she was leaving town that day she threw it out so she cannot go back and check that. She has thrown up in the past when she has gotten bad food, but not quite as much as she did with this projectile vomiting. She takes a lot of supplements so she thought for the next dose of the vaccine she will not take any supplements. She is getting the second dose in the afternoon so she will have already taken her 2 mile walk before getting the second dose. When she takes her 2 mile walk she walks pretty quick, fast, up hills and down hills; and then when she gets home after the second dose she would rest more and not take any more supplements so she can be super aware if anything occurs. The outcome of the event was recovered on 27Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Musculoskeletal chest pain
Clinical narrative: ribs are better, because they were sore and painful from coughing; coughing; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the covid vaccine first dose last Wednesday, and she felt good all Wednesday. On Thursday night, about 2 am of 29Jan2021, she started coughing and it was horrible. She was growling. Friday morning (29Jan2021), around 7am, patient took a Tylenol and took another one about 1pm and was fine. Her neighbor who was a nurse made the patient call to report her symptoms. Her ribs are better, because they were sore and painful from coughing so much. When she got up and got a sip of water, she raised her mattress (electric bed) and it was better and helped with the coughing, and she fell sleep. Patient was scheduled in 2.5 weeks from now to get the vaccine. She was feeling good now. Outcome of the event " ribs are better, because they were sore and painful from coughing" was recovering, while for the other event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was hurting this morning; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), solution for injection, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included unspecified blood thinner. The patient indicated that she was on a blood thinner and asked what was going to happen to her and if she should get the second dose. Her arm was hurting this morning (01Feb2021). The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Vaccination site pain
Clinical narrative: tired; feeling crummy; chills; Injection site hurt; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) solution for injection, via an unspecified route of administration on 30Jan2021 at 11:00 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her vaccine on Saturday, 30Jan2021 at around 11:00 AM and at about 4:30 PM, she started getting really tired and feeling crummy. She had chills, fatigue, and tiredness. She went to bed and slept the rest of the day. She read that they were side effects and was not too worried about it. On Sunday, 31Jan2021, the patient felt fine and then she had chills and felt crummy again; she took another nap. Today, 01Feb2021, she felt crummy again and had on and off chills. She was asking if this was normal. It was stressing her out. The injection site was also hurting on Saturday (30Jan2021), it was really sore. Other people that she knew did not have these symptoms until the second shot. The patient was concerned about getting her second shot. The outcome of the event fatigue was unknown and not recovered for all other events.   Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait inability, Joint swelling, Pain, Peripheral swelling
Clinical narrative: red blotches; felt sensation at her foot for that she could not walk; experienced chills; hands were shaking; right foot and ankle swelling; right foot and ankle swelling; pain; This is a spontaneous report from a contactable consumer (reporting for herself). An 80-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on her left arm on 30Jan2021 to 30Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL) and experienced allergy as her reaction to those were sometime between 2010 and 2012. On 30Jan2021 after three and a half hours, the patient felt sensation at her foot for that she could not walk, experienced chills, hands were shaking, had a swollen ankle and foot and pain. Around 5 o clock, the patient stated that it was like a strange sensation in her foot and she also got chills. By 7 o clock, she was in pain. The patient stated that she took two Tylenol. The patient stated that at around 9 o clock, she noticed that her ankle and foot were swollen with red blotches on it so she took two Benadryl and then slept until noon. The patient stated that Benadryl actually gave her some relief, although the pain didn't completely subside, but it subsided a little so that it was more tolerable. The patient stated that she had been debating if she should have gone to the emergency room (ER), but she didn't because she has a high pain tolerance. The outcome of the events was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Tremor
Clinical narrative: red blotches; felt sensation at her foot for that she could not walk; experienced chills; hands were shaking; right foot and ankle swelling; right foot and ankle swelling; pain; This is a spontaneous report from a contactable consumer (reporting for herself). An 80-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on her left arm on 30Jan2021 to 30Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL) and experienced allergy as her reaction to those were sometime between 2010 and 2012. On 30Jan2021 after three and a half hours, the patient felt sensation at her foot for that she could not walk, experienced chills, hands were shaking, had a swollen ankle and foot and pain. Around 5 o clock, the patient stated that it was like a strange sensation in her foot and she also got chills. By 7 o clock, she was in pain. The patient stated that she took two Tylenol. The patient stated that at around 9 o clock, she noticed that her ankle and foot were swollen with red blotches on it so she took two Benadryl and then slept until noon. The patient stated that Benadryl actually gave her some relief, although the pain didn't completely subside, but it subsided a little so that it was more tolerable. The patient stated that she had been debating if she should have gone to the emergency room (ER), but she didn't because she has a high pain tolerance. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore arm/arm soreness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of 2 reports.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 to Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced a sore arm/arm soreness. The outcome of the event was unknown.  Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101539 Same reporter, drug and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a sore arm; This is a spontaneous report from a Pfizer-sponsored program,. A contactable consumer (patient) reported that an 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer COVID vaccine and she felt fine but then stated that she had a sore arm. The outcome of the event was unknown.  Information on the lot/batch number has been requested.