chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Hyperpyrexia, Pyrexia
Clinical narrative: Gave him another Tylenol but he is still shivering because his temperature is still 106.6; Little bit chills; Little bit temperature and he had 99.7; Checked the temperature now and it was a 102; Started shaking; Little bit chest pain; This is a spontaneous report from a contactable consumer. This contactable consumer reported for male patient (reporter's son). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced gave him another tylenol but he is still shivering because his temperature is still 106.6, little bit chills, little bit temperature and he had 99.7; checked the temperature now and it was a 102, started shaking, and little bit chest pain on an unspecified. Reporter stated, this is for his son. He received the second dose which was the Pfizer Vaccine yesterday and what happened was around maybe 7 or 8 o'clock, he was feeling a little bit chills and a little bit temperature and he had 99.7. So, reporter said take a Tylenol and so, he was due for maybe another dose at about 3:15. as he took at 8:15 but reporter checked the temperature now and it was a 102. So, he started shaking and he had a little bit chest pain, so, reporter gave him another Tylenol, but he is still shivering because his temperature is still 106.6. It was reported that should reporter be concerned about that, with his chest pain especially. Reporter was informed about the role of Pfizer Drug Safety and advised to contact the nearest emergency room if required. Reporter further stated, "So, I should just take him to the ER. In response to further probing for safety report, reporter stated, "It would be absolutely no because reporter concerned about his son first and then reporter can get through this later. Further probing could not initiate as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call. The patient underwent lab tests and procedures which included body temperature: 99.7, a little bit temperature and he had 99.7, body temperature: 102, reporter checked the temperature now and it was a 102, body temperature: 106.6 he is still shivering because his temperature is still 106.6. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Gave him another Tylenol but he is still shivering because his temperature is still 106.6; Little bit chills; Little bit temperature and he had 99.7; Checked the temperature now and it was a 102; Started shaking; Little bit chest pain; This is a spontaneous report from a contactable consumer. This contactable consumer reported for male patient (reporter's son). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced gave him another tylenol but he is still shivering because his temperature is still 106.6, little bit chills, little bit temperature and he had 99.7; checked the temperature now and it was a 102, started shaking, and little bit chest pain on an unspecified. Reporter stated, this is for his son. He received the second dose which was the Pfizer Vaccine yesterday and what happened was around maybe 7 or 8 o'clock, he was feeling a little bit chills and a little bit temperature and he had 99.7. So, reporter said take a Tylenol and so, he was due for maybe another dose at about 3:15. as he took at 8:15 but reporter checked the temperature now and it was a 102. So, he started shaking and he had a little bit chest pain, so, reporter gave him another Tylenol, but he is still shivering because his temperature is still 106.6. It was reported that should reporter be concerned about that, with his chest pain especially. Reporter was informed about the role of Pfizer Drug Safety and advised to contact the nearest emergency room if required. Reporter further stated, "So, I should just take him to the ER. In response to further probing for safety report, reporter stated, "It would be absolutely no because reporter concerned about his son first and then reporter can get through this later. Further probing could not initiate as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call. The patient underwent lab tests and procedures which included body temperature: 99.7, a little bit temperature and he had 99.7, body temperature: 102, reporter checked the temperature now and it was a 102, body temperature: 106.6 he is still shivering because his temperature is still 106.6. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Two weeks after the first dose of Pfizer COVID19 vaccine the patient developed generalized rash all over body; This is a spontaneous report form an other HCP, he reported for 70's-year-old patient. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. No medical history and concomitant medications were reported. The patient previously took steroids. It was unknown if any other vaccine in four weeks and no other medications in two weeks. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19. Known allergies were none. It was reported that a licensed acupuncturist and herbalist informed that he had a patient who was in his/her 70's received first dose of Pfizer COVID19 vaccine and other demographics are unknown. On an unspecified date, two weeks after the first dose of Pfizer COVID19 vaccine the patient developed generalized rash all over body. The patient sought medical attention and received steroid injection, however the rash even worsened after the steroids. The patient sought help from this reporting acupuncturist/herbalist and received chinese herbal medication as alternative treatment which was effective, and the rash improved after receiving herbal medication. The clinical outcome of the event was resolved.  Follow up attempts are needed. Further information has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event "Rash" and the suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: heart pain; This is a spontaneous report from a non-contactable consumer or other non healthcare professional.   A 31-years-old female patient received second dose of BNT162B2 ( PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 28Jun2021 18:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunisation (lot unknown reason: Not available/provided to reporter at the time of report completion). Patient did not receive any other vaccination within 4 weeks prior to vaccination. The patient medical history and concomitant medications were not reported. Patient had earlier received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 07Jun2021 18:30 as dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On 29Jun2021 at 07:30 the patient experienced heart pain. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event heart pain was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Loss of consciousness, Syncope
Clinical narrative: I experienced great pain in my head and at approx. 7:55, I awoke after fainting/passing out; I experienced great pain in my head and at approx. 7:55, I awoke after fainting/passing out; I experienced great pain in my head and at approx. 7:55, I awoke after fainting/passing out; experienced severe flu like symptoms all day; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration in arm right on 25Jun2021 at 15:00 (at the age of 58-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Known allergies and medical history was provided as yes (no other detail provided). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0186), via an unspecified route of administration in arm right on 04Jun2021 at 14:15 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was provided as yes. 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 reported on 26Jun2021, she experienced severe flu like symptoms all day. On 27Jun2021 at approx. 7:30 am, while sitting at desk, she experienced great pain in her head and at approx. 7:55, she awoke after fainting/passing out. Patient was alone at home at the time. Throughout that day, she experienced 4 more of these events, but none caused her to lose consciousness. Seriousness was provided as no. The patient did not receive any treatment for the adverse events. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The outcome of the events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: A week later and I have a round hard lump in the vaccination site.; This is a spontaneous report from a contactable other health care professional. A 33-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0185, Expiration date not reported), via an unspecified route of administration in arm left on 18Jun2021 at 15:45 (at the age of 33-year-old) as a single dose for COVID-19 immunization at Doctors office/urgent care. The patient medical history was reported as none. The patient had no known allergies. Prior vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient was not tested with COVID. The concomitant medications included Levothhroxine (MANUFACTURER UNKNOWN), montekulast (MANUFACTURER UNKNOWN) and birth control; both for an unknown indication from an unknown start date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. On 25Jun2021 12:00, a week after the vaccination, the patient had a round hard lump in the vaccination site. The patient did not receive any treatment for the event. The outcome of the event was unknown.  Follow-Up (01JUL2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: An increase of tinnitus in both ears within a week of the vaccination. The tinnitus in my left ear has been increasing in severity since the vaccination and it's almost unbearable.; This is a spontaneous report form a contactable consumer(patient). A 48-year-old non-Pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number ER8734), via an unspecified route of administration on 04Jun2021 into left arm (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medication(s) included levothyroxine sodium (TIROSINT). The patient had allergies to Red dye, penicillin. In Jun2021, the patient experienced an increase of tinnitus in both ears within a week of the vaccination. The tinnitus in my left ear has been increasing in severity since the vaccination and it's almost unbearable. No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not hospitalized for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment medications were received for the adverse event. The outcome of the event was not recovered.  Follow-up (01Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Chest pain, Emotional disorder, Headache, Mental disorder
Clinical narrative: I also had a seizure like episodecat night where I nearly bit my tongue off; 3 minutes after I had an altered mental experience, also twice in the war home. I have since had one a week but they are increasing in frequency I had four yesterday; I also experience some memory loss and sometimes am very emotional or have a headache aftwrwards; I also experience some memory loss and sometimes am very emotional or have a headache aftwrwards; I also experience some memory loss and sometimes am very emotional or have a headache aftwrwards; I have itinerant chest pain in addition; This is a spontaneous report from a contactable consumer (reporting for herself). A 50 year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: En9581), via an unspecified route of administration on 28Jan2021 at 09:15 (at the age of 51-year-old), as dose 1, single in right arm and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EI9826), via an unspecified route of administration on 17Feb2021 at 09:00 (at the age of 51-year-old), as dose 2, single in right arm for COVID-19 immunization. The patient's medical history included nine. Concomitant medications within 2 weeks of vaccination included vitamin D NOS (VITAMIN D), taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021, at 09:15 AM, the patient experienced seizure like episode cat night where she nearly bit her tongue off. 3 minutes after she had an altered mental experience, also twice in the war home. Patient had one a week, but they were increasing in frequency she had four in the previous day. Patient visited the emergency room and neurologist after that. The patient also experienced some memory loss and sometimes was very emotional or had a headache afterwards. Patient had itinerant chest pain in addition. Treatment received for the events included EEG (Electroencephalogram) upon neurology visit. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was reported as not resolved.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I also had a seizure like episodecat night where I nearly bit my tongue off; 3 minutes after I had an altered mental experience, also twice in the war home. I have since had one a week but they are increasing in frequency I had four yesterday; I also experience some memory loss and sometimes am very emotional or have a headache aftwrwards; I also experience some memory loss and sometimes am very emotional or have a headache aftwrwards; I also experience some memory loss and sometimes am very emotional or have a headache aftwrwards; I have itinerant chest pain in addition; This is a spontaneous report from a contactable consumer (reporting for herself). A 50 year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: En9581), via an unspecified route of administration on 28Jan2021 at 09:15 (at the age of 51-year-old), as dose 1, single in right arm and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EI9826), via an unspecified route of administration on 17Feb2021 at 09:00 (at the age of 51-year-old), as dose 2, single in right arm for COVID-19 immunization. The patient's medical history included nine. Concomitant medications within 2 weeks of vaccination included vitamin D NOS (VITAMIN D), taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021, at 09:15 AM, the patient experienced seizure like episode cat night where she nearly bit her tongue off. 3 minutes after she had an altered mental experience, also twice in the war home. Patient had one a week, but they were increasing in frequency she had four in the previous day. Patient visited the emergency room and neurologist after that. The patient also experienced some memory loss and sometimes was very emotional or had a headache afterwards. Patient had itinerant chest pain in addition. Treatment received for the events included EEG (Electroencephalogram) upon neurology visit. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was reported as not resolved.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination error
Clinical narrative: Received 5 Covid Vaccines in the span of a month; Received 5 Covid Vaccines in the span of a month; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 76-years-old-female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID 19 MRNA VACCINE; solution for injection, lot number EN5318 and expiration was unknown), via left deltoid, on 24Jan2021(at age of 76 years old) as a single dose for COVID 19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of COVID-19 vaccine MRNA (MODERNA COVID-19 VACCINE, solution for injection, lot number and expiration was unknown), via unspecified route of administration, on 19Jan2021(at age of 76 years old) as a single dose for COVID 19 immunization. The patient medical history and concomitant medication was not reported. The patient took third dose (Pfizer COVID Vaccine, Lot: EJ1686), via Right deltoid on 28Jan2021 as a single dose for COVID 19 immunization. The patient took fourth dose (Moderna Vaccine, Lot: unknown), via unknown route of administration on 16 Feb2021 as a single dose for COVID 19 immunization. The patient took fifth dose (Pfizer COVID Vaccine, Lot: EL9264), via left deltoid on 19Feb2021 as a single dose for COVID 19 immunization. Lot: EL9264. The caller had a patient who was hospitalized and found the patient received five COVID Vaccines in the span of a month. The caller is asking if Pfizer has case reports or data on this?  The caller states she is going to follow up with the patient today, 29Jun2021 to see how the patient is doing. The patient was in the emergency room and admitted until 19May2021.The patient received the five COVID Vaccines between 19Jan2021 and 19Feb2021, well outside of the window of this being recent.  The patient had been hospitalized since the Vaccines, hospitalized on 12May2021, 19May2021 and 22Jun2021. The caller clarifies, no the patient was transferred to a rehabilitation center on 19May2021 and then looks like she was in the rehabilitation center until 28May2021.    Follow-up attempts are possible. Further information is expected.; Sender's Comments: As per the information provided in the narrative, the relationship between the hospitalisation of the patient and vaccination error cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Glioblastoma
Clinical narrative: The reporter, is spouse of the patient and I know her as a friend. Patient was diagnosed with Glioblastoma (GBM) stage IV on May 31st 2021, few weeks after administering second do; This is a spontaneous report received from a non-contactable consumer (patients' wife) .  A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) age at vaccination of 47-years-old, as single dose, for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date (Batch/Lot number was not reported) age at vaccination of 47-years-old, for covid-19 immunisation. The patient  was diagnosed with Glioblastoma (GBM) stage IV on 31May2021, few weeks after administering second dose of Pfizer-BioNTech COVID-19 Vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit, Hospitalization, Life threatening illness (immediate risk of death from the event). Reporter also believed that "the tumor got rogue/aggravated after the vaccine; her reasoning was: 1) all the GBM symptoms appeared after vaccination and 2) their healthcare provider also suggested COVID vaccination could have made it worst". No treatment was administered. Outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Limb mass, Palpitations
Clinical narrative: Heart palpitations; Chest pain; Lump underarm size of softball (left); This is a spontaneous report from a contactable nurse. This 46-year-old female nurse (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0168, and Expiration date: Unknown), intramuscular, administered in left arm on 14Jun2021 08:00 (at the age of 46-year-old) as dose 2, single for COVID-19 immunization, received at hospital. The patient medical history and concomitant medications. No additional vaccines were administered on same date of the Pfizer suspect. No history of previous immunization with the Pfizer vaccine considered as suspect. No vaccination was given within 4 weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0169, and Expiration date: Unknown), administered in left arm on 24May2021, as single dose for COVID-19 immunization. The patient sated that she received the second dose of the Pfizer vaccine on 14Jun2021 and on 15Jun2021 at 15:00 experienced heart palpitations and chest pain that subsided after a couple of hours. On the same day at same time, she had a "lump underarm size of softball". Stated that she took pictures and sent them to her provider. No treatment was given for the events. The events did not require emergency room visit or physician office visit. No relevant testes were performed. No investigation assessment was done. The patient stated that she made an appointment to see her doctor. The outcome of events heart palpitations and chest pain was reported as resolved on 15Jun2021. He outcome of the event "lump underarm size of softball" was reported as not resolved.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Pyrexia, SARS-CoV-2 test, Salivary gland enlargement, Swelling face
Clinical narrative: 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196), second dose via an unspecified route of administration, administered in left arm on an unspecified date in Jun2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant medical history and concurrent conditions. No known allergies were reported. The patient's concomitant medications were not reported. Historical vaccine given to patient was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), first dose via an unspecified route of administration, administered in left arm on an unspecified date in May2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Reported Event: 10 days after the second dose on 27Jun2021 at 02:00 the patient experienced high fever, hives, and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night. No treatment was received for the event. The events had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. The reporter reported events as non-serious. Adverse events result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jun2021 (Nasal Swab). The outcome of events was reported as resolving and outcome of the event high fever was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196), second dose via an unspecified route of administration, administered in left arm on an unspecified date in Jun2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant medical history and concurrent conditions. No known allergies were reported. The patient's concomitant medications were not reported. Historical vaccine given to patient was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), first dose via an unspecified route of administration, administered in left arm on an unspecified date in May2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Reported Event: 10 days after the second dose on 27Jun2021 at 02:00 the patient experienced high fever, hives, and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night. No treatment was received for the event. The events had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. The reporter reported events as non-serious. Adverse events result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jun2021 (Nasal Swab). The outcome of events was reported as resolving and outcome of the event high fever was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urticaria
Clinical narrative: welts on their legs and back and not near the site of injection; This is a spontaneous report from a contactable pharmacist.  A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular route, administered in Deltoid Left on 18Jun2021 (Batch/Lot Number: EW0180; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for covid-19 immunisation; diphenhydramine hydrochloride (BENADRYL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Pharmacist stated, we are administering the Pfizer COVID Vaccine. One of the patients reported an adverse reaction to the vaccine that we haven't typically seen or have seen as few of the ones we reported. So, reporter just was trying to get more information and see what the correct method of, you know administering the next dose could be. Upon follow-up (29Jun2021) was reported that, the patient received their first dose 11 days ago on 18Jun2021, 3 days after receiving the vaccination (on 21Jun2021), they started forming a 'welt' on both their legs and back, not near the administration site. They have taken over the counter Benadryl in order to try to subdue that just in case there is anything and it looked it helped some, but new welts are still forming even today, 11 days afterwards. And she was concerned about getting her second dose. Therapeutic measures were taken as a result of welts on their legs and back and not near the site of injection. Clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Urticaria cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Skin discolouration
Clinical narrative: I noticed under my breast I have all these brown spot; My arm still kind of hurts me; It improved after the shot because before I couldn't move it for three days; This is a spontaneous report from a contactable Nurse (patient herself). A 70-year-old Nurse (female patient) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8733 and expiration date was 31Jul2021), via left arm, single on 18APR2021 11:00 as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history includes blood pressure high and only took one pill. The patient's concomitant medications included Valsartan 155/2.5 took one pill. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8732 and expiration date was 31Jul2021), via left arm, single on 28Mar2021 11:00 as single dose for COVID-19 immunization and stated I couldn't move my arm for three days and all that was my first. When probed for concern, nurse stated, Well, I took my last Pfizer shot in May2021 but my arm still kind of hurts me and then yesterday I noticed under my breast I have all these brown spot and I was wondering, If they had anything to do with the vaccine. In 2021, she also stated improved after the shot because before she couldn't move it for three days. When probed for treatment for event, nurse stated, No, only thing I do is give an exercise use my arm. The outcome of event (Arm hurt) was recovering, event of (skin discoloration) was unknown and (could not move arm) was recovered on unspecified date May2021.  Nurse was requested to contact Pfizer
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: made her four days late for her monthly menstrual cycle; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reporting for a 14-year-old female patient (reporter's daughter) that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186, Expiry Date, NDC number, UPC number: Unknown), via an intramuscular, administered in left shoulder (Arm Left) on 21May2021 at 12:30PM (vaccinated at the age of 14 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included asthmatic. Concomitant medication included salbutamol sulfate (ALBUTEROL SULFATE) taken for asthma (she was currently not taking any medications. She had an inhaler. She would use it as needed. She had not used it). The patient did not receive any other vaccine 4 weeks prior to COVID shot. no investigation assessment done. For the first dose it made her four days late for her monthly menstrual cycle on an unspecified date in 2021. No treatment received for event. The outcome of event was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (Patient's mother) reported for a unknown female patient that: This case is for reporter's 1st of other two daughters. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 21May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunization. The patient previously took historical vaccine BNT162B2 as Dose 1, single for Covid-19 Immunization. The patient's concomitant medications were not reported. The patient experienced cold on an unspecified date. The outcome of event was unknown  Information about lot/Batch number requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis reactive
Clinical narrative: Developed reactive arthritis.; This is a spontaneous report from a contactable physician. A 27-years-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. (Vaccination facility: Hospital). Medical history included H.pylori infection from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. No known allergies. It was reported that on 15Apr2021 the patient developed reactive arthritis. Unclear if this was due to H.pylori infection or covid vaccination. Patient was not tested for covid-19 post vaccination. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of even with Prednisone, sulfasalazine, diclofenac, indomethacin, Humira, IM Kenalog, IA steroids. The outcome for the event was reported as not recovered.   Information on Lot/Batch information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, reactive arthritis cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphonia, Feeling abnormal, Nausea, Presyncope
Clinical narrative: Just siting and feel like she is going to pass out; "It's a riming in her right ear while she talks; A hoarseness in her throat; Diarrhea; Nausea feeling; Feeling squeamish; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: was not reported; Expiration Date: was not reported), via an unspecified route of administration, administered in Arm on 22Jun2021 (at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. The patient's medical history includes blood pressure. The patient's concomitant medications include blood pressure medication and has been taking Tylenol to keep a fever from coming, so takes 2 Tylenol every morning, every day of the week. Patient previously had first dose of BNT162B2 vaccine, on an unspecified date May2021 (at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. Caller reports that when she had the first shot, in the same arm, she had no symptoms. On around 27Jun2021 or 28Jun2021, the patient experienced Just siting and feel like she is going to pass out; "It's a riming in her right ear while she talks; Diarrhea; Nausea feeling; and Feeling squeamish. Caller declines to complete a safety report at this time. Caller states she wants to know if these symptoms are from the Covid vaccine, or from something else? Caller states after she speaks to Medical Information, she will speak to her primary doctor about what she should do. Caller began to verbalize her frustration with information being provided for transfer to hospital. The outcome for all the events was unknown.  Information about lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Just siting and feel like she is going to pass out; "It's a riming in her right ear while she talks; A hoarseness in her throat; Diarrhea; Nausea feeling; Feeling squeamish; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: was not reported; Expiration Date: was not reported), via an unspecified route of administration, administered in Arm on 22Jun2021 (at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. The patient's medical history includes blood pressure. The patient's concomitant medications include blood pressure medication and has been taking Tylenol to keep a fever from coming, so takes 2 Tylenol every morning, every day of the week. Patient previously had first dose of BNT162B2 vaccine, on an unspecified date May2021 (at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. Caller reports that when she had the first shot, in the same arm, she had no symptoms. On around 27Jun2021 or 28Jun2021, the patient experienced Just siting and feel like she is going to pass out; "It's a riming in her right ear while she talks; Diarrhea; Nausea feeling; and Feeling squeamish. Caller declines to complete a safety report at this time. Caller states she wants to know if these symptoms are from the Covid vaccine, or from something else? Caller states after she speaks to Medical Information, she will speak to her primary doctor about what she should do. Caller began to verbalize her frustration with information being provided for transfer to hospital. The outcome for all the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: Feels like she might die; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as unknown dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient feels like she might die. It was reported that "she got the shot, and they gave her the brochure and it said not to take any other vaccines before getting it and they did not tell her that. Because if she dies someone needs to know". Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased
Clinical narrative: when I took that shot, I couldn't move my arm for three days; I noticed under my breast I have all these brown spot; My arm still kind of hurts me; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732, Expiration Date: 31Jul2021, age at vaccination: 70 years), via an unspecified route of administration, administered in Arm left on 28Mar2021, at 11:00 as dose 1, single for covid-19 immunization. Medical history included blood pressure high. Concomitant medication included valsartan at 155/2.5 taken for blood pressure high. Prior vaccination (within four weeks) were none. The patient reported, she took her last Pfizer shot in May but her arm still kind of hurts me and then yesterday she noticed under her breast she had all these brown spots and was wondering if they had anything to do with the vaccine. After the first dose she couldn't move her arm for three days. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration Date: 31Jul2021, age at vaccination: 70 years), via an unspecified route of administration, administered in Arm left on 18Apr2021, at 11:00 as dose 2, single for covid-19 immunization. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Pharyngeal swelling, Rash, Swelling face
Clinical narrative: swelling of face and throat; swelling of face and throat; bad rash all over body; numbness on her face; allergic reaction from her nose down to her chin; tongue still feels heavy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported for herself.   A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0202, Expiry date: unknown) via an unspecified route of administration in Arm Left on 27Jun2021 14:45 (at the age of 57-years-old) as single dose for covid-19 immunization. Medical history included patient was diagnosed about 10 or 20 years ago for thyroid nodules from an unspecified start date and ongoing. Family medical history includes: Father has high cholesterol, no cancer in her family. Her dad has thyroid conditions. Patient didn't have any other vaccine prior to vaccination (within 4 week) and no adverse event prior vaccination. Concomitant medication included thyroid (ARMOUR THYROID) taken 0.25 one tablet daily for thyroid nodule. Sign of severe allergic reaction include swelling of face and throat, bad rash all over body. Upon follow up on 29Jun2021 patient reported that on 27Jun2021 15:20 patient experienced allergic reaction from her nose down to her chin, her face was numb like she had Novocain. And when patient woke up in morning and recovered (28Jun2021) from numbness in her face but tongue still feels heavy. Patient states she had COVID, and it was not severe and felt like it was not enough to put a vaccine in her body. She felt like with delta strain it may be more severe than the other strain. Patient feel like she was pressured to have it, took it for piece of mind. Patient received treatment for allergic reaction and numbness. The outcome of the event allergic reaction from her nose down to her chin, her face was numb like she had Novocain recovered on 28Jun2021 and tongue still feels heavy unknown.   Referred to HCP for further clinical recommendations.