chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Whole body muscle aches; headache; fatigue; This is a spontaneous report  received from a contactable other health professional. A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL3247 and expiration date was not reported) via an unspecified route of administration in left arm  on 10Feb2021 at 11:00 AM (42 years at the age vaccination time) as a 2nd single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was never diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and expiry date was not reported) via an unspecified route of administration in left arm  on 20Jan2021 at 11 AM as a 1st single dose for covid-19 immunisation. The patient's concomitant medications included diazepam 5 mg on 08Feb2021, (pseudoephedrine hydrochloride) SUDAFED 30 mg on 06Feb2021 (received within 2 weeks of vaccination). On 11Feb2021 at 02:00 AM, the patient experienced whole body muscle aches, headache and fatigue. The events were lasted for approximately 24 hours. The patient did not receive any treatment for the events. The outcome of the events was recovered in Feb2021.  Follow-up attempts are completed. No further information is expected. .
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen Painful Lymph nodes in L armpit; Swollen Painful Lymph nodes in L armpit; This is a spontaneous report received from a contactable other hcp (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 28Jan2021 (at the age of 25-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient had allergy towards Promethazine HCL. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3246), via an unspecified route of administration, administered in left arm on 09Jan2021 as a single dose for COVID-19 immunization. On 11Feb2021, the patient experienced swollen painful lymph nodes in L armpit. No treatment was received for the event. The patient was not diagnosed with COVID-19, prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was reported as recovering.    Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lymphadenopathy, Pain
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL3248), via intramuscular route, administered in left arm on 10Jan2021 14:45 (at the age of 24-years) as 2nd dose, single for COVID-19 immunization. The patient previously took first dose BNT162B2 Lot Number: EJ1685 via intramuscular route, administered in arm left on 23Dec2020 10:30 as 1st dose, single for COVID-19 immunisation. Patient not pregnant at the time of vaccination. The patient medical history was not reported. The patient had allergic to augmentin. Concomitant medication(s) included Zyrtec, Vienva. The patient received the most recent COVID-19 vaccine at Hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Jan2021, the patient experienced fever of 102, body aches, chills, lymph node swelling under left arm and headache all lasted 24 hours. The patient did not received any treatment for the events. The outcome of the events was recovered on Jan2021. The patient underwent lab tests and procedures which included body temperature: 102 on 11Jan2021. Seriousness reported as non-serious. Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL3248), via intramuscular route, administered in left arm on 10Jan2021 14:45 (at the age of 24-years) as 2nd dose, single for COVID-19 immunization. The patient previously took first dose BNT162B2 Lot Number: EJ1685 via intramuscular route, administered in arm left on 23Dec2020 10:30 as 1st dose, single for COVID-19 immunisation. Patient not pregnant at the time of vaccination. The patient medical history was not reported. The patient had allergic to augmentin. Concomitant medication(s) included Zyrtec, Vienva. The patient received the most recent COVID-19 vaccine at Hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Jan2021, the patient experienced fever of 102, body aches, chills, lymph node swelling under left arm and headache all lasted 24 hours. The patient did not received any treatment for the events. The outcome of the events was recovered on Jan2021. The patient underwent lab tests and procedures which included body temperature: 102 on 11Jan2021. Seriousness reported as non-serious. Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: still laying in bed - lethargic; This is a spontaneous report from a non-contactable consumer. A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 (at the age of 71-years-old) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19 was unknown. On 09Feb2021, the patient was still laying in bed - lethargic. The patient had not received treatment for the adverse event. Batch/lot was unknown as it was not available or not provided to reporter at the time of report completion. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pruritus, Swelling of eyelid
Clinical narrative: Swollen eyelids; face itching; light redness; tiredness; This is a spontaneous report from a contactable consumer (patient).   A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on  '09Feb2021 03:45' (as reported) (Lot Number: EL8982) as single dose for covid-19 immunisation. Medical history included Sjogren's syndrome from an unknown date and unknown if ongoing. Patient had allergy to non-steroid anti-inflammatory drugs. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications included gabapentin, lisinopril , fluticasone, ergocalciferol (VIT D). The patient experienced swollen eyelids on 05Feb2021 09:00, face itching on 05Feb2021 09:00, light redness on 05Feb2021 09:00, tiredness on 05Feb2021 09:00. The events outcome was recovering.  No follow-up attempts are possible. No further information is expected
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Early menstruation; This is a spontaneous report from a non-contactable other health care professional. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), intramuscularly administered in left arm on 23Jan2021 at 12:00 (reported as 12:00 PM) (at the age of 26 years old) as first dose, single for COVID-19 immunisation. Patient's medical history was not reported. Patient previously took Co-trimoxazole (BACTRIM) and experienced allergies on an unspecified date. Patient was not pregnant. Prior to vaccinination, the patient was not diagnosed with COVID-19. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. On 01Feb2021, the patient experienced early menstruation. No treatment was given in response with the event. After vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovered.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old male patient received BNT162B2 (BNT162B2), via an unspecified route of administration on 17 Feb 2021 (Lot Number: EL3247) as single dose (at age of 33-year-old) for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. No known allergies and no COVID-19 prior vaccination. No other vaccines in four weeks. On 17 Feb 2021 patient experienced injection site soreness, mild lethargy. No treatment was required for the events. Patient was not tested for COVID-19 post vaccination. Patient recovered from the events on 17Feb2021. No follow-up attempts are possible; Information about lot/batch number could not be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Malaise
Clinical narrative: Hard of hearing; Not feeling really well; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot number unknown) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter called to ask what needs to be brought on second schedule of Covid-19 vaccine which is on 24Feb on the vaccination card, first dose was given on 27Jan2021 which is past 21 days apart between the first and second dose. He wanted to know the time of appointment. He stated he had his 1st dose (27Jan2021) and 2nd dose (24Feb2021) it was more than the usual 3weeks interval. He was calling earlier to know the exact time for his 2nd dose. He had his vaccination card with him but there was no time showing. He stated he got my first shot of the vaccination (Covid-19 Vaccine) on the 27Jan2021 and then they give a card there and it said next shot would be the 24Feb2021. He got that right in front of him then it doesn't say at what time, so he thought he should call and find out at what time and then the young men that was talking to him said that was too longer period of time. It was supposed to be in 3 weeks and he thought why would he put, why would he do that, you can explain it to. He stated he was hard of hearing, not really, he was not feeling really well, and he didn't feel like doing it. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash erythematous, Skin disorder
Clinical narrative: skin flaked off on checks and around my mouth; Burning sensation; Raised red rash on my face and neck; This is a spontaneous report from a contactable Consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 14:00 (Batch/Lot Number: EL9267; 53-year age at time of vaccination) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported.  There were no concomitant medications. The patient previously took bnt162b2 first dose Left arm on 23Jan2021 02:00 (Lot number= EL0142) for covid-19 immunisation; Allergic to betadine, Balsam. On 19Feb2021 14:00, it was reported raised red rash on my face and neck. burning sensation and skin flaked off on checks and around my mouth. Patient received treatment with steroids. Patient not had covid prior vaccination; covid not tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Skin Disorders, Burning Sensation, Rash Erythematous and the suspect BNT162B2.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dehydration, SARS-CoV-2 test, Sinus disorder
Clinical narrative: On 11Feb2021 he stated the headache, nausea, dehydration and fever started and he tested positive for Covid-19; sinus kind of thing; dehydration; This is a spontaneous report from a contactable consumer or other non hcp. A contactable consumer (patient) reported that a 68-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The caller stated he was scheduled to get his 2nd Pfizer vaccine on 27Feb2021. He stated on 08Feb2021 he developed a sinus kind of thing and hadnot been exposed to anyone with Covid-19 and didnot feel like he had Covid. Caller stated he went to his doctor and received antibiotics for a sinus infection diagnosis. On 11Feb2021 he stated the headache, nausea, dehydration and fever started and he tested positive for Covid-19 (five days later tested positive for covid) and received IVs and antibiotics may be. Callers wife loss of sense of smell around the same time he was diagnosed with Covid 19, although she never was tested. He was asking if he could take the vaccine on the 27Feb2021 since he got positive for Covid-19 after his first dose. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Prolonged and heavier menstrual cycle after first dose.; This is a spontaneous report from a non-contactable other health care professional. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number andExpiration Date: not reported), intramuscularly administered in left arm on 20Jan2021 at  09:15 (reported as 09:15 AM) (at the age of 25 years old) as first dose, single for COVID-19 immunisation in a Nursing Home/Senior Living Facility. Patient was not pregnant and has no known allergies. Prior to vaccine the patient was not diagnosed with COVID-19 and no other medical history was reported. Patient's concomitant medications were not reported. The patient did not receive any other vaccines in 4 weeks and no other medications in 2 weeks. On 21Jan2021, the patient experienced prolonged and heavier menstrual cycle after first dose . No treatment was given as response to the adverse event. After vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: Menstrual cycle changes; Period came 7 days early; This is a spontaneous report from a contactable nurse (patient herself). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the left arm on 05Feb2021 18:00 (at the age of 30-years-old), as first dose, single for COVID-19 immunisation. Medical history included hypothyroidism, autoimmune thyroiditis (Hashimoto), and anxiety. Concomitant medications included levothyroxine sodium (SYNTHROID); and escitalopram oxalate (LEXAPRO) both taken for an unspecified indication and both start and stop dates were not reported. Patient has no known allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient also reported that she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced menstrual cycle changes and her period came 7 days early on 12Feb2021. Patient did not received any treatment for the events reported. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Eye pain, Headache, Pain
Clinical narrative: Eye burns; chills; Pain; headache; eyes hurting; balance problems/balance off/equilibrium was off; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL9262), via an unspecified route of administration, administered in left arm on 17Feb2021 at 14:30 as single dose for covid-19 immunisation. Medical history included covid-19 in Sep2020. There were no concomitant medications. On 18Feb2021 at 11AM, she experienced, chills, pain headache, eyes burning, eyes hurting, balance problems/ balance off, equilibrium was off. She had a bad reaction. It was 3 days of being in bed. She was fine now, she feels great since Sunday afternoon. She had covid in early Sep2020, and in Oct2020 she had 2 tests that came negative, so she knows it was not in her system anymore, but when she got phone the call for covid vaccine thought she should get it. In Dec2020 she did have the covid virus, and asked if this would have any influence on having the vaccine. She does not know that if she had the covid virus in the past, she didn't know if she should have gotten the shot. She called her doctor, and they told her that she should not have gotten the shot, she spoke to a NP, even though she had virus, she shouldn't have gotten it. She was told to rest comfortably as long as she was feeling better. She had 2 negative tests within a week before seeing her doctor. In order to even see the doctor 2 negative tests are required before an appointment can be made. Her second dose was scheduled on 11Mar2021 at 2:30pm. With experiencing these symptoms, she asked if she could get the second dose. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thermal burns of eye
Clinical narrative: Eye burns; chills; Pain; headache; eyes hurting; balance problems/balance off/equilibrium was off; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL9262), via an unspecified route of administration, administered in left arm on 17Feb2021 at 14:30 as single dose for covid-19 immunisation. Medical history included covid-19 in Sep2020. There were no concomitant medications. On 18Feb2021 at 11AM, she experienced, chills, pain headache, eyes burning, eyes hurting, balance problems/ balance off, equilibrium was off. She had a bad reaction. It was 3 days of being in bed. She was fine now, she feels great since Sunday afternoon. She had covid in early Sep2020, and in Oct2020 she had 2 tests that came negative, so she knows it was not in her system anymore, but when she got phone the call for covid vaccine thought she should get it. In Dec2020 she did have the covid virus, and asked if this would have any influence on having the vaccine. She does not know that if she had the covid virus in the past, she didn't know if she should have gotten the shot. She called her doctor, and they told her that she should not have gotten the shot, she spoke to a NP, even though she had virus, she shouldn't have gotten it. She was told to rest comfortably as long as she was feeling better. She had 2 negative tests within a week before seeing her doctor. In order to even see the doctor 2 negative tests are required before an appointment can be made. Her second dose was scheduled on 11Mar2021 at 2:30pm. With experiencing these symptoms, she asked if she could get the second dose. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient had symptomatic Covid-19 diagnosis; Patient had symptomatic Covid-19 diagnosis; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative.  A adult female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had symptomatic COVID-19 diagnosis on Feb2021. The patient visited the doctor or other healthcare professional office. It was unknown whether the treatment was received for the events. The outcome of the event Covid-19 was not recovered and unknown for other event.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Painful swollen lymph nodes in armpit on same side as shot; Aches/pains; headache; low fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN5318) via an unspecified route of administration administered in Arm Left on 19Feb2021 at 11:15 (at the age of 56-years-old) as single dose for covid-19 immunisation. The patient's medical history includes CAD (coronary artery disease) and the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, #lot: EI3302) via an unspecified route of administration administered in Arm Left on 25Jan2021 at 03:00 PM for covid-19 immunisation. The patient underwent lab tests and procedures which included body temperature: 99.4 on 19Feb2021 low fever (maximum orally measured 99.4, on aspirin) for 30 hours. Onset at 10 hours. The patient's concomitant medications included simvastatin, omeprazole, cyanocobalamin, folic acid, pyridoxine hydrochloride (FOLBEE), fish oil and curcuma longa (TURMERIC [CURCUMA LONGA]). On 19Feb2021, the patient experienced aches, pains, headache, and low fever (maximum orally measured 99.4, on aspirin) for 30 hours. Onset at 10 hours. Painful swollen lymph nodes in armpit on same side as shot. Ongoing 3 days after vaccination. Pain mild. The outcome of the events was recovering. Therapeutic measures were taken as a result of low fever.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test
Clinical narrative: body aches; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A 38-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Feb2021 (at the age of 38-year-old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced body aches and on 12Feb2021, the patient was tested positive for covid-19. The patient stated that, her boyfriend tested positive for the covid-19 virus the day after she received her 1st dose of the covid-19 vaccine and then she tested positive for the covid-19 virus on 12Feb2021. The patient had to take off from work for 5 days and bring in a negative covid-19 virus test before she could return to work. She said the whole time she felt fine. She said it was not until after she got the covid-19 virus test that she had only body aches. She said she had no fever or any other symptoms after she tested positive for the covid-19 virus and stated that she was able to get her covid-19 vaccine because she is a caregiver to an elderly patient. The patient was scheduled for the second dose 25Feb2021 and would like to know if she should receive the second dose of the vaccine on 25Feb2021 since she recently had the virus and has developed antibodies. The seriousness of the events was reported as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Dizziness, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Left arm on 19Feb2021 10:00 (at the age of 70 year) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included COVID-19 prior vaccination. The patient had no known allergies and other medical history. The patients concomitant medications were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. The patient was diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 19Feb2021 at 10:00, the patient experienced extreme tiredness, constant headache, extreme muscle pain in left arm, extreme joint pain, these lasting 2 full days lite and off balance for first 10 hours. No treatment was received for adverse events. The outcome of the events, lightheadedness and off balance was recovered on 19Feb2021 at 20:00 and for other events was recovered on 21feb2021. Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Left arm on 19Feb2021 10:00 (at the age of 70 year) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included COVID-19 prior vaccination. The patient had no known allergies and other medical history. The patients concomitant medications were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. The patient was diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 19Feb2021 at 10:00, the patient experienced extreme tiredness, constant headache, extreme muscle pain in left arm, extreme joint pain, these lasting 2 full days lite and off balance for first 10 hours. No treatment was received for adverse events. The outcome of the events, lightheadedness and off balance was recovered on 19Feb2021 at 20:00 and for other events was recovered on 21feb2021. Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: pain in extremity; Knee pain; Limbs stiffness; This is a spontaneous report based on the information received by Pfizer from AbbVie Pharmacovigilance (Mfr Report# 21K-163-3741997-00). A contactable 66-year-old female consumer (patient) reported that:  This is a spontaneous report based on the information received by Pfizer from AbbVie Pharmacovigilance (Mfr Report# 21K-163-3741997-00).  A contactable 66-year-old female consumer (patient) received adalimumab (HUMIRA) subcutaneous from unknown date for moderate to severe rheumatoid arthritis and COVID vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. Patient experienced on unknown date events of non-serious arm, hands, fingers hurt and tight/left leg hurts from knee down sometimes and arm was a little sore/hands and fingers hurt and tight with HUMIRA (ADALIMUMAB). There was no reported medical history. Covid vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Outcome of events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test
Clinical narrative: Cough; Very tired; tested positive 27Jan; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received first dose of bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 22Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 25Jan she started with symptoms. She was told that she could get second shot, but she is hesitant to get it as she still had cough and very tired and just tested negative. She had been unable to get a real answer when she should get it. Her question is should she wait 90 days to get her second shot and will she have to start over or get it now. The patient underwent lab tests which included sars-cov-2 test result as positive on 27Jan2021 and sars-cov-2 test as negative on 23Feb2021. The outcome of the event tested positive was recovered on an unspecified date and cough and very tired was not recovered.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Started getting some Covid symptoms on the 18th and was tested yesterday and am positive; Body ache; pain on the injection site; This is a spontaneous report from a contactable nurse (patient) received from a Pfizer sponsored program CoVax US support. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an unspecified route of administration on 15Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication included vitamins. Nurse stated, I got the Pfizer first dose on the 15Feb2021, then I started getting some Covid symptoms on the 18Feb2021 and I was tested yesterday and I am positive i.e. on 23Feb2021. Now I am supposed to get the second dose on the 08Mar2021. Is there any contraindication for me to not get it on the 08Mar2021? I want to know if it is safe for me to get it on the 08Mar2021. Causality, Nurse stated, Well I do not know because on unspecified date Feb2021 after I received it like 3 days later or 4 days later I had body ache, I had pain on the injection site but then I never had Covid, I do not know if it is the vaccine or the Covid because my mother got the Covid too and my uncle got it too. Treatment, Nurse stated, well after I was feeling really bad I am taking Tylenol flu. Patient wanted to know since she tested positive after her first dose of the covid vaccine is she still able to take the second dose of the covid vaccine. The outcome of events was unknown. The patient underwent lab tests and procedures which included tested positive for COVID: positive on 23Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspepsia, Vaccination site erythema, Vaccination site induration
Clinical narrative: I am chair bound right now, I am recovering from Covid; I am chair bound right now, I am recovering from Covid; heart burns; arm swelled around the injection site; Arm swelled around the injection site and it hurts and burns; her arm swelled around the injection site and it was all red; arm day swell up all around the injection site and it was still hard; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown), via an unspecified route of administration administered in Arm on 19Feb2021 as single dose for covid-19 immunization. Medical history included ongoing hypertension. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number EL3248, expiration date unknown), via an unspecified route of administration as single dose for covid-19 immunization 29Jan2021 and stated that she did not have a reaction after the first dose of the vaccine and she only had a slight rise of temperature after the first dose. The caller stated that after receiving the second dose of vaccine on Friday and on the next day on 20Feb2021 her arm swelled around the injection site and stated that it hurts, it burns, and it was all red and mentioned that it was still hard and red and painful, and she been putting ice on it, but it still was red, hard and it did not seem to have helped. On an unspecified date, she was also experiencing heart burns and further stated that she was chair bound right now and was recovering from Covid (considered as covid-19 and drug ineffective). Patient stated that blood work has not yet been ordered and they are going to come to her house to do it in her house, but they have not come yet. The outcome of events drug ineffective and COVID-19 was recovering, and outcome of the other events were unknown.  Information about batch/lot number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: I am chair bound right now, I am recovering from Covid; I am chair bound right now, I am recovering from Covid; heart burns; arm swelled around the injection site; Arm swelled around the injection site and it hurts and burns; her arm swelled around the injection site and it was all red; arm day swell up all around the injection site and it was still hard; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown), via an unspecified route of administration administered in Arm on 19Feb2021 as single dose for covid-19 immunization. Medical history included ongoing hypertension. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number EL3248, expiration date unknown), via an unspecified route of administration as single dose for covid-19 immunization 29Jan2021 and stated that she did not have a reaction after the first dose of the vaccine and she only had a slight rise of temperature after the first dose. The caller stated that after receiving the second dose of vaccine on Friday and on the next day on 20Feb2021 her arm swelled around the injection site and stated that it hurts, it burns, and it was all red and mentioned that it was still hard and red and painful, and she been putting ice on it, but it still was red, hard and it did not seem to have helped. On an unspecified date, she was also experiencing heart burns and further stated that she was chair bound right now and was recovering from Covid (considered as covid-19 and drug ineffective). Patient stated that blood work has not yet been ordered and they are going to come to her house to do it in her house, but they have not come yet. The outcome of events drug ineffective and COVID-19 was recovering, and outcome of the other events were unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: I still get tiredness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), on 14Feb2021, via unspecified route of administration, at a first dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient still got tiredness and was feeling unwell. The patient stated that she got the vaccine on 14th February and she wanted to know if she still supposed to get a reaction. She still got tiredness and was really feeling unwell. She asked if she was still supposed to get the vaccine. The patient was informed about the role of Pfizer. The patient said that it is said in the paper that if you have any questions about the vaccine or if you have side effects then let us know, that is why I called. In response to question regarding Lot number, she mentioned that she did not see the lot number. Further probing could not be initiated as the patient was unwilling to further answer the questions. Hence, Limited information was available over the call. The outcome of the events was unknown.   No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: This is a spontaneous report from a contactable other hcp. A 29-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 22 Feb 2021 16:30 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient's vaccination history includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE on 01Feb2021. On 23Feb2021 12:00, the patient experienced loss/obscured sense of taste. The patient did not receive any treatment for the event. The patient was not tested positive for Covid prior and post vaccination. The outcome of the event was reported as not recovered. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Diarrhoea, Nausea, Nervousness
Clinical narrative: cataract; nausea; Diarrhea; nervous; This is a spontaneous report from a Pfizer sponsored program. A contactable 78-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on left arm on 04Feb2021 at single dose for COVID-19 immunization. The medical history of the patient included high blood pressure (Caller mentioned this was diagnosed in her late 50s or early 60s, and she was 78 now). She also had history of irritable bowel disease and hiatal hernia which was diagnosed years ago. She said that she did not had any other recent vaccinations or started any new medications. However she takes high blood pressure pills and stomach medicines and a medication for her bowels. It was reported that she had cataract in Feb2021 for which she underwent cataract surgery on 18Feb2021 taking eye drops- Prolensa every morning for 1 and half week. On an unknown date in Feb2021, she was nauseated and had diarrhea. She says she got the shot 04Feb2021 then a few days later she had diarrhea. She mentioned that she was scheduled to get the second shot today i.e. 26Feb2021 Friday, and her son saw on tv some people can get diarrhea, which she did not know before. She said that she had not gotten a temperature, and her BP was fine. She mentioned that she had irritable bowel disease anyway, and usually when she has that it clears in a week. She says that she would like to know if it is safe for her to get the second shot. On an unknown date in Feb2021, she experienced nervousness and it will have repercussions. She said that her son said there was some program on TV that listed all those things, some that were not in the paperwork she got. She had been nauseated or had diarrhea, and she called before, and some people get diarrhea, and she was supposed to check and see if she should get second shot. The outcome of all the events was unknown. Caller mentioned that she called her provider, but they were not going to get back to her in an hour and a half before she would go to get the second dose. She says she got the first dose of the vaccine at (Pharmacy) and says that she thought her diarrhea was better and then it came back the day before yesterday. She mentioned that her vaccine card was handwritten, and she could not read the writing on it. She says it mentioned (Clinic site) and that the handwriting was horrible on the card, and she could not tell if the LOT was E129EG. She says NDC/EXP were not provided on the card. The caller said that she has either got to get the shot or cancel this one, but if she cancels this one she does not know when she would be able to get second since the appointments are all booked up in (State).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythrodermic psoriasis, Fatigue, Lymphadenitis, Pain in extremity
Clinical narrative: Inflamed lymph node left armpit area; 2 days after vaccine developed bruise the size of a quarter (only noticed it the morning; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; Sore arm; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A patient of 38-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration 02Mar2021 01:15 PM in the left arm at single dose for COVID-19 immunisation. The patient age at vaccination was 38 Years. The patient's medical history included psoriasis and underactive thyroid. No allergies to medications, food, or other products. Facility where COVID-19 vaccine was administered was other. The patient was not received any other medications within 2 weeks of vaccination and any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior and after the vaccination. Concomitant medications included vitamin D3 and cyanocobalamin (B12 [CYANOCOBALAMIN]). On 02Mar2021, the patient experienced sore arm, fatigue, 2 days after vaccine developed bruise the size of a quarter (only noticed it the morning), On 03Mar2021, Inflamed lymph node left armpit area. Also, I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my psoriasis flare was barely noticeable. This also happened after the first dose (although it became red a couple of days after). This could be unrelated but thought I'd share anyway since this happened again. I currently do not use any treatment for my psoriasis. No treatment received for the adverse event. Outcome of the events was recovering.  Follow up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238667 Pfizer
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Inflamed lymph node left armpit area; 2 days after vaccine developed bruise the size of a quarter (only noticed it the morning; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; Sore arm; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A patient of 38-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration 02Mar2021 01:15 PM in the left arm at single dose for COVID-19 immunisation. The patient age at vaccination was 38 Years. The patient's medical history included psoriasis and underactive thyroid. No allergies to medications, food, or other products. Facility where COVID-19 vaccine was administered was other. The patient was not received any other medications within 2 weeks of vaccination and any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior and after the vaccination. Concomitant medications included vitamin D3 and cyanocobalamin (B12 [CYANOCOBALAMIN]). On 02Mar2021, the patient experienced sore arm, fatigue, 2 days after vaccine developed bruise the size of a quarter (only noticed it the morning), On 03Mar2021, Inflamed lymph node left armpit area. Also, I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my psoriasis flare was barely noticeable. This also happened after the first dose (although it became red a couple of days after). This could be unrelated but thought I'd share anyway since this happened again. I currently do not use any treatment for my psoriasis. No treatment received for the adverse event. Outcome of the events was recovering.  Follow up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238667 Pfizer