chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Contracted COVID; Contracted COVID; almost died; antibodies were 1100; This is a spontaneous report from a Pfizer via a Non-contactable female consumer (patient, self-reported).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history included arthritus (she was unable to take Methotrexate for her arthritus). Concomitant medications were not reported. The patient reported that received both vaccines. On an unspecified date, she contracted COVID after first dose and was hospitalized on an unspecified date for 2 months where she was unable to take Methotrexate for her arthritis and stated almost died and antibodies were 1100, refused to get booster shot. The patient underwent lab test and procedure included antibody test on an unspecified date with a result of 1100 and SARS-CoV-2 test on an unspecified date with a result of Contracted COVID. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertension, Myalgia, Nausea
Clinical narrative: extreme fatigue; nausea; daily headaches; muscular pain for 3 months; Later hypertension/ extreme hypertension; SVT; This is a spontaneous report from a contactable physician (patient) reporting for himself. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, at 50 years old, on 16Dec2020 10:00 (batch/lot number: EK5730) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included allergy (Sulfa, H1N1 vaccine) from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication received within 2 weeks of vaccination included allopurinol (ALLOPURINOL) taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 (at 12:00am), the patient experienced extreme fatigue, nausea, daily headaches, muscular pain for 3 months, later hypertension, and svt (supraventricular tachycardia). The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Patient also had treatment for extreme hypertension. The outcome of the events was not recovered. The events were reported as serious, life threatening illnesses (immediate risk of death from the events). Since the vaccination, the patient has been tested for COVID-19 on an unknown date using Nasal Swab test and patient tested negative.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Fatigue, Nausea, Headache, Myalgia, Hypertension, Supraventricular Tachycardia. 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Supraventricular tachycardia
Clinical narrative: extreme fatigue; nausea; daily headaches; muscular pain for 3 months; Later hypertension/ extreme hypertension; SVT; This is a spontaneous report from a contactable physician (patient) reporting for himself. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, at 50 years old, on 16Dec2020 10:00 (batch/lot number: EK5730) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included allergy (Sulfa, H1N1 vaccine) from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication received within 2 weeks of vaccination included allopurinol (ALLOPURINOL) taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 (at 12:00am), the patient experienced extreme fatigue, nausea, daily headaches, muscular pain for 3 months, later hypertension, and svt (supraventricular tachycardia). The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Patient also had treatment for extreme hypertension. The outcome of the events was not recovered. The events were reported as serious, life threatening illnesses (immediate risk of death from the events). Since the vaccination, the patient has been tested for COVID-19 on an unknown date using Nasal Swab test and patient tested negative.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Fatigue, Nausea, Headache, Myalgia, Hypertension, Supraventricular Tachycardia. 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.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Gastrointestinal tract irritation, Heart rate increased, Rash
Clinical narrative: Patient had a lot of anxiety and a high heart rate. Patient stated that yesterday it was bad and they called emergency services and went to the ER; Patient had a lot of anxiety and a high heart rate. Patient stated that yesterday it was bad and they called emergency services and went to the ER; rash; beginning to have GI problems yesterday; This is a spontaneous report from a non-contactable consumer. This consumer (mother) reported for a 31-year-old female patient that: A 31-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jul2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced patient had a lot of anxiety and a high heart rate. Patient stated that yesterday it was bad and they called emergency services and went to the ER and rash. On 29Jul2021 the patient experienced, beginning to have GI problems yesterday. It was reported that, reporter was the mother of the patient who received the Pfizer COVID 19 vaccine dose 1 on Monday 26Jul2021. She stated that she had a rash that she was not sure it was from the vaccine or not. She reported beginning to have GI problems yesterday and again today. She stated that it is not nausea or diarrhea. Described that it was more of a knot in the stomach that was full of anxiety. She was having a lot of anxiety and a high heart rate. She stated that yesterday it was bad and they called# and went to the ER via ambulance. She relays that they did not do anything to help her. They did not give her any medicine or do any tests or bloodwork. We want to get this figured out and don't want to go back to the ER if they were not going to help. She stated that they would like to know if these symptoms have been seen and how long they could last. Reporter did not report, if there a medication that can be given to reverse the vaccine or to counteract it. And can she take Benadryl to help with these symptoms. The patient visited to the emergency room. The patient did not receive treatment for the adverse events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Lip swelling
Clinical narrative: hot flash; top lip puffed up / lip swelling was very slight; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EN5318, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 06Feb2021 (at the age of 79-years-old) as dose 1, single for COVID prevention. The patient has no relevant medical history and concomitant medications. On 06Feb2021, the patient experienced hot flash and top lip puffed up / lip swelling was very slight. The patient stated that the hot flash like a wave that went right through her, started from the shoulders, and spread throughout her body and her top lip puffed up, lip swelling was very slight, it took about an hour to go back down. The patient was wondering if that events were a reaction to the vaccine and if there was a recommendation for her second dose after having these reactions to the first dose. The outcome of the event hot flash was unknown while the outcome of the event top lip puffed up / lip swelling was very slight was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Muscle pain; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH 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 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced muscle pain and flu like symptoms on an unspecified date and wanted to know what to do. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Shortly after receiving the vaccine, within 5 minutes my heart started racing.; This is a spontaneous report from a contactable other healthcare professional (reported herself). A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported), via intramuscular, administered in arm left on 10Feb2021 13:00 (age at vaccination 33-year-old) as dose 1, single for covid-19 immunisation. The facility type vaccine was nursing home/senior living facility. Medical history included covid-19 (prior vaccination the patient had COVID-19). There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. The patient stated that "Shortly after receiving the vaccine, within 5 minutes my heart started racing" on 10Feb2021 13:00. The patient received Benadryl treatment for the event. Post vaccination, the patient was not tested for COVID-19 The outcome of the events was resolved on an unknown date 2021.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Mass, Pain in extremity, Pruritus, Scab
Clinical narrative: Pimples; It is itching so much like the bleedings; It is itching so much like the bleedings; All sores on my arm, on my legs; Bumps that itch/Little bumps all over my legs, all over my arms and itching like hell; Bumps that itch/Little bumps all over my legs, all over my arms and itching like hell; Scab on my arms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 85-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: 100-012-1721), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, hypersensitivity. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, administered in Arm left on 18Feb2021 13:30 as SINGLE DOSE for covid-19 immunization. No other vaccine in four weeks. The patient experienced bumps that itch/little bumps all over my legs, all over my arms and itching like hell, scab on my arms on 28Jan2021 13:15 with outcome of not recovered, pimples, it is itching so much like the bleedings, all sores on my arm, on my legs on an unspecified date with outcome of unknown. Patient stated that she had the shot 2 times and the 2nd time that she had the shot she was all broken up with little bumps all over my legs, all over my arms and itching like hell. Now the doctor gave her prednisone 2 times that didn't help and it helped me itching (Not cleared since there was distortion on line hence captured suspect conservatively). patient asked the pharmacist, what she could give her. She didn't know. So she don't know what to do. It is itching terrible. Patient stated that It is driving her crazy. Her legs, her arms and this happened right after she had the shot. Patient stated Yes. That would be wonderful because this itch is driving me nuts. Itching all the time. Patient stated never had this in her life. Patient stated that he told me to take prednisone, but he only put like 6 pills and she had to take 2 a day. So it is 3 days. When probed as, improved, worsened or persisting, Consumer stated that it was the same way like it was when it started but now that she got more sores. She even asked the pharmacist yesterday and she can't tell me anything she could take and she said No. She didn't know. No covid prior vaccination and no covid tested post vaccination. Therapeutic measures were taken as a result of events with prednisone and Benadryl. The outcome of the events the patient experienced bumps that itch/little bumps all over my legs, all over my arms and itching like hell, scab on my arms was not recovered and for rest all events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Skin haemorrhage
Clinical narrative: Pimples; It is itching so much like the bleedings; It is itching so much like the bleedings; All sores on my arm, on my legs; Bumps that itch/Little bumps all over my legs, all over my arms and itching like hell; Bumps that itch/Little bumps all over my legs, all over my arms and itching like hell; Scab on my arms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 85-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: 100-012-1721), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, hypersensitivity. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, administered in Arm left on 18Feb2021 13:30 as SINGLE DOSE for covid-19 immunization. No other vaccine in four weeks. The patient experienced bumps that itch/little bumps all over my legs, all over my arms and itching like hell, scab on my arms on 28Jan2021 13:15 with outcome of not recovered, pimples, it is itching so much like the bleedings, all sores on my arm, on my legs on an unspecified date with outcome of unknown. Patient stated that she had the shot 2 times and the 2nd time that she had the shot she was all broken up with little bumps all over my legs, all over my arms and itching like hell. Now the doctor gave her prednisone 2 times that didn't help and it helped me itching (Not cleared since there was distortion on line hence captured suspect conservatively). patient asked the pharmacist, what she could give her. She didn't know. So she don't know what to do. It is itching terrible. Patient stated that It is driving her crazy. Her legs, her arms and this happened right after she had the shot. Patient stated Yes. That would be wonderful because this itch is driving me nuts. Itching all the time. Patient stated never had this in her life. Patient stated that he told me to take prednisone, but he only put like 6 pills and she had to take 2 a day. So it is 3 days. When probed as, improved, worsened or persisting, Consumer stated that it was the same way like it was when it started but now that she got more sores. She even asked the pharmacist yesterday and she can't tell me anything she could take and she said No. She didn't know. No covid prior vaccination and no covid tested post vaccination. Therapeutic measures were taken as a result of events with prednisone and Benadryl. The outcome of the events the patient experienced bumps that itch/little bumps all over my legs, all over my arms and itching like hell, scab on my arms was not recovered and for rest all events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: her sister got her shot yesterday and she had ringing in her ears/ringing in her head; This is a spontaneous report from a contactable consumer or other non-HCP (patient sister) via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history included ongoing ascending aortic aneurysm from unspecified date. The concomitant medications were not reported. Investigations were not provided. Sister had been encouraging her to get the vaccine. She stated her sister got her first dose yesterday and called her and said that the caller was not going to believe this but as soon as she got it, there was a ringing in her head on 22Mar2021. She had ringing in her ears immediately upon getting the shot. She stated her sister said an hour after she got the shot, her ringing had stopped. It went away by the time she got home. Stated she wanted her sister to get it because of where she works. She stated that her sister had the exact same aortal aneurysm as she does. It was reported that her sister had the same ascending aortal aneurysms that she had. She stated that she had not talked to her today to see about her symptoms because her sister was going to funeral. Sister stated that she was interested to see if her sister had any permanent stuff going on and she was going to give her the number for the people to report it to. She stated that she had wondered if there was a possibility that has to do with aortal aneurysms. Stated they created circulatory and vascular issues that maybe she had her experience because of her pre-existing condition. Stated that it was funny that she experienced it as well. She stated her sister said it was weird and said it went away. She stated her sister (patient) said she was not sure that she would have alcohol. She stated that she will tell her sister (patient) to call. Stated it was an immediate reaction within a few minutes. She stated that her sister was in so she probably did not have the same batch. She states it was an interesting anecdote. Stated her sister said she was not going to believe this but within a couple minutes her head started ringing so loud and it would not go away and some other person had to drive. Stated she will have her call if it was continual. The reporter asked could this be related. She had researched and found that some people are deciding not to get the second dose. Are we tracking the people who are specifically having hearing difficulties, specifically tinnitus. If she got the second dose will that be permanent.  She did not want a second shot if this could become a 24/7 type of thing. She has heard via news reports based on CDC data that 30 percent of reactions were related to hearing. Some have completely lost their hearing. The outcome of event was resolved on 22Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Rash, Viral test
Clinical narrative: Maternal exposure during pregnancy, second trimester; Rash down the inside of my right leg that started at my groin and ended just about my ankle. I also had some splotches of rash on the exterior of my left leg.; This is a spontaneous report from a contactable consumer, or other non hcp (patient). A 34-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration in the left arm on 22Mar2021 at 11:30 (age at vaccination was of 34-years-old) as dose 1, single for COVID-19 immunization. Medical history included pregnancy and the gestation period was 22 weeks at the time of vaccination. The expected delivery date was reported as 22Jul2021. The patient had her last menstrual period was on 15Oct2020. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for unknown indication from an unknown date. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Mar2021 at 11:30, the patient received the first dose of vaccination when she was pregnant with gestation period of 22 weeks (characterized as maternal exposure during pregnancy, second trimester) and on the same day, the patient experienced a rash down the inside of right leg that started at the groin and ended above the ankle, also had some splotches of rash on the exterior of left leg; the patient noticed the rash about two hours after appointment and it faded before she arrived to her primary care doctor and faintly came back at around 21:00 on the same day. There are now no traces of the rash on 23Mar2021. On 23Mar2021, the patient underwent a nasal swab test, and the result was unknown. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The outcome of the rash both legs was recovered on 23Mar2021, while that of the maternal exposure during pregnancy, second trimester was unknown.  Information on the lot number has been requested
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache
Clinical narrative: Chest feels very tight; Like she cannot breathe; Bad headache; This is a spontaneous report from a contactable consumer.A 19-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 24Mar2021 12:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chest feels very tight, like she cannot breathe, bad headache on 25Mar2021 with outcome of not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Insomnia, SARS-CoV-2 test, Throat tightness
Clinical narrative: Throat tightening can't swallow; Throat tightening can't swallow; 48 hrs no sleep; This is a spontaneous report from a contactable consumer (Patient)or other non health care professional. A 48-years-old non pregnant female patient received first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), via an unspecified route of administration, administered in Arm Right on 27Mar2021 at 11:45 (Age a vaccination: 48 years) as dose 1, single for covid-19 immunisation. Patient did not received any other vaccines within 4 weeks prior to COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccinations. Patient has been tested for COVID-19 since the vaccination. Patient had Allergies to medications, food, or other products: Maybe latex and Bactrian in lg doses. Medical history included patient had 1 kidney/asthma/chronic bronchitis. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTH) 12.5 mg, METOPROLOL 50 mg both taken for unspecified indication. The patient experienced throat tightening can't swallow and 48 hrs no sleep on 28Mar2021 at 04:00. The patient visited emergency room and the patient received Methylprednisolone 4mg for 6days/be banophen 50mg was administered as treatment for the events. The patient under-went lab tests and procedures which included sars-cov-2 test: negative on 28Mar2021. The outcome of the events not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: I'm a severe asthmatic with  diabetes, just started having breathing issues; This is a spontaneous report from contactable consumer. A 47-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 29Mar2021 09:00 (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, diabetes mellitus, osteoporosis, fibromyalgia from an unknown date and unknown if ongoing. Concomitant medication included ipratropium bromide, salbutamol sulfate (DUONEB) taken for an unspecified indication, start and stop date were not reported; venlafaxine hydrochloride (EFEXOR) taken for an unspecified indication, start and stop date were not reported; alendronate sodium (ALENDRONATE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; levocetirizine dihydrochloride (LEVOCETRIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced that I am a severe asthmatic with diabetes, just started having breathing issues on 29Mar2021 20:30 with outcome of unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: joint felt like they would break; fever; Terrible headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 05Apr2021 at 16:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history reported as none. The patient previously received SULPHA on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and carvedilol (MANUFACTURER UNKNOWN) all for unknown indication, from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 2021 at 17:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced headache. On 06Apr2021, the patient experienced joint ache and fever. It was reported that the patient experienced terrible headache by that evening, by the next morning every joint felt liked they would break and she started running a fever that got as high as 102.9. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fever and joint ache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Vision blurred
Clinical narrative: blurred vision in the left eye cleared up; "slowly the blur came back"; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 at 09:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included blurred vision. Concomitant medications were not reported. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, it was reported that the patient was positive, although temporary, and reported that the patient had blurred vision in left eye and after the vaccine shot, her blurred vision in left eye cleared up, but then slowly the blur came back. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event blurred vision in the left eye cleared up was recovered on an unknown date in 2021 while the event blur came back was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in Left Armpit; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications include MULTI-VITAMINS, vitamin c (MANUFACTURER UNKNOWN) , vitamin d nos (VITAMIN D), zinc (MANUFACTURER UNKNOWN) and quercetin (MANUFACTURER UNKNOWN) all taken for unknown indication, from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 the patient experienced swollen lymph node in his left armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse event. The clinical outcome of the event swollen lymph node in left armpit was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling abnormal, Feeling of body temperature change
Clinical narrative: dizziness; hot and cold; diarrhea; extremely tired; feel somewhat disconnected; This is a spontaneous report from a contactable healthcare professional, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 15:30(at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient reported allergy to medications and tended to not take any medications; 1 teaspoon of Robitussin and she could sleep for 2 days. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 04:00 the patient experienced that she woke up dizzy and dizziness was extremely bad until 05Apr2021. She was just slightly dizzy at the time of report. The patient experienced hot and cold still, diarrhea lasted 2 days, extremely tired and she still felt somewhat disconnected. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events feeling hot and cold, tired and still feel somewhat disconnected was not recovered, the outcome of the event dizziness was recovering and the clinical outcome of the event diarrhea lasted two days and was recovered on an unknown date at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: Pain from hand to shoulder - severe; Pain going into back too; Pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 07Apr2021 at 18:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergies to tetanus shot and penicillin. The patient received other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 23:00, the patient experienced pain from hand to shoulder - severe, pain going into back too and pain in arm. The patient reported that she can't lift arm due to pain and can hardly hold anything in left hand. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of pain from hand to shoulder -severe, pain going into back too and pain in arm was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: fatigue; headache; injection site soreness; overall body/joint/muscle pain; overall body/joint/muscle pain; nausea; overall body/joint/muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 06Apr2021 at 14:00(at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 16Mar2021 at 14:00(at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 04:00, the patient experienced fatigue, headache, injection site soreness(vaccination site pain), overall body, joint, muscle pain and nausea. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event fatigue, headache, injection site soreness, overall body, joint, muscle pain and nausea was recovered on Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: fatigue; headache; injection site soreness; overall body/joint/muscle pain; overall body/joint/muscle pain; nausea; overall body/joint/muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 06Apr2021 at 14:00(at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 16Mar2021 at 14:00(at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 04:00, the patient experienced fatigue, headache, injection site soreness(vaccination site pain), overall body, joint, muscle pain and nausea. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event fatigue, headache, injection site soreness, overall body, joint, muscle pain and nausea was recovered on Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Swelling at injection site; Itchy rash at injection site; Lymph node swelling in left armpit near injection site; Nausea; Fatigue; Low grade fever (100.1 F); Muscle soreness (throughout body, worst near injection site); Low energy; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine, hemiplegic migraine, obesity, depression and anxiety. Concomitant medications included fremanezumab (AJOVY) autoinjector on 21Feb2021 and on 21Mar2021 administered in the stomach, levonorgestrel (MIRENA) from unknown date for unspecified indication, paracetamol (TYLENOL) from unknown date for unspecified indication, fluoxetine hydrochloride (FLUOXETINE) from unknown date for unspecified indication, magnesium aspartate (MAGNESIUM) from unknown date for unspecified indication and melatonin (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 16Mar2021 at 09:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. The patient previously took WELLBUTRIN on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 02:00, the patient experienced swelling and itchy rash at injection site, lymph node swelling in left armpit near injection site, nausea, fatigue, chills, low grade fever (100.1 F), muscle soreness (throughout body, worst near injection site), headache and low energy. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 07Apr2021 at 02:00, the patient underwent lab test and procedure which included body temperature and result was shown as 100.1 F. The clinical outcome of the events swelling and itchy rash at injection site, lymph node swelling in left armpit near injection site, nausea, fatigue, chills, low grade fever (100.1 F), muscle soreness (throughout body, worst near injection site), headache and low energy were resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pyrexia, Vaccination site rash
Clinical narrative: Swelling at injection site; Itchy rash at injection site; Lymph node swelling in left armpit near injection site; Nausea; Fatigue; Low grade fever (100.1 F); Muscle soreness (throughout body, worst near injection site); Low energy; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine, hemiplegic migraine, obesity, depression and anxiety. Concomitant medications included fremanezumab (AJOVY) autoinjector on 21Feb2021 and on 21Mar2021 administered in the stomach, levonorgestrel (MIRENA) from unknown date for unspecified indication, paracetamol (TYLENOL) from unknown date for unspecified indication, fluoxetine hydrochloride (FLUOXETINE) from unknown date for unspecified indication, magnesium aspartate (MAGNESIUM) from unknown date for unspecified indication and melatonin (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 16Mar2021 at 09:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. The patient previously took WELLBUTRIN on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 02:00, the patient experienced swelling and itchy rash at injection site, lymph node swelling in left armpit near injection site, nausea, fatigue, chills, low grade fever (100.1 F), muscle soreness (throughout body, worst near injection site), headache and low energy. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 07Apr2021 at 02:00, the patient underwent lab test and procedure which included body temperature and result was shown as 100.1 F. The clinical outcome of the events swelling and itchy rash at injection site, lymph node swelling in left armpit near injection site, nausea, fatigue, chills, low grade fever (100.1 F), muscle soreness (throughout body, worst near injection site), headache and low energy were resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at injection site; Itchy rash at injection site; Lymph node swelling in left armpit near injection site; Nausea; Fatigue; Low grade fever (100.1 F); Muscle soreness (throughout body, worst near injection site); Low energy; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine, hemiplegic migraine, obesity, depression and anxiety. Concomitant medications included fremanezumab (AJOVY) autoinjector on 21Feb2021 and on 21Mar2021 administered in the stomach, levonorgestrel (MIRENA) from unknown date for unspecified indication, paracetamol (TYLENOL) from unknown date for unspecified indication, fluoxetine hydrochloride (FLUOXETINE) from unknown date for unspecified indication, magnesium aspartate (MAGNESIUM) from unknown date for unspecified indication and melatonin (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 16Mar2021 at 09:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. The patient previously took WELLBUTRIN on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 02:00, the patient experienced swelling and itchy rash at injection site, lymph node swelling in left armpit near injection site, nausea, fatigue, chills, low grade fever (100.1 F), muscle soreness (throughout body, worst near injection site), headache and low energy. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 07Apr2021 at 02:00, the patient underwent lab test and procedure which included body temperature and result was shown as 100.1 F. The clinical outcome of the events swelling and itchy rash at injection site, lymph node swelling in left armpit near injection site, nausea, fatigue, chills, low grade fever (100.1 F), muscle soreness (throughout body, worst near injection site), headache and low energy were resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.