chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Tremor, Tryptase, Vertigo
Clinical narrative: Approx 5:55 received vaccine Approx 5:58 after standing up and turning in paperwork to be photocopied at the clinic, the room seemed to turn sideways. Then tingling started in my lips, then tongue, then fingers, then toes; at the same time numbness started in the lips, tongue, fingers and toes, and my heart was pounding fast in my chest.  My breathing became rapid and deep - it was involuntary as if my breathing had to keep up with my heart rate. I was dizzy but not light headed and I did not feel like I needed to remove my mask to get air.  My mouth was extremely dry, I was not hot or cold or sweaty.  My hands and feet started shaking and this progressed to my arms, legs and trunk.  By 6:00 a security guard at the hospital had called a code gray, and the code team tranported me to the ER by 6:05 or 6:10. In triage at the ER, my HR was elevated and so was my blood pressure.  I experienced waves of numbness and tingling followed by episodes of uncontrollable shaking.  I had no tongue swelling, itching, hives or wheezing.  I was given oral benadryl and oral steroids, and because the waves of tingling continued to come and go, I was given a dose of IM epinephrine.   Over the next hour, the waves of tingling became further and further apart and less intense.  At about 7:30 pm it was as if a veil lifted suddenly and my mind felt much more clear. I had no more episodes of tingling and shaking.  I was discharged home with an epi pen at 9pm.   At home, after going to bed, I woke suddenly at 12:20 am with my heart pounding rapidly in my chest.  I had no other symptoms and after a few minutes of breathing deeply my heart rate slowed,  I drifted off to sleep but awoke suddenly again with my heart pounding rapidly. This happened until 4 am when I was able to stay asleep.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Nausea, Pharyngeal swelling, Sensation of foreign body, Tremor
Clinical narrative: Anaphylaxis
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Anaphylaxis
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Intensive care
Clinical narrative: Anaphylaxis
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Dysphagia, Flushing, Nausea, Panic attack
Clinical narrative: Anaphylaxis
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Anaphylaxis
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: 18-year-old patient was administered adult Recombivax HB; This spontaneous report was received from a nurse practitioner concerning to an 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications.  On an unspecified date, the patient was vaccinated with an adult dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1mL dose for prophylaxis (strength, frequency, route of administration and lot number were not reported).   On an unspecified date in November 2020, reported as "a month ago", the patient was vaccinated with a second adult dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1mL dose for prophylaxis (strength, frequency, route of administration and lot number were not reported).  At the reporting time, the patient's outcome was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Sensitive skin
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. In or around August 2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In 2017 (reported as approximately two weeks after the zoster vaccine live (ZOSTAVAX) vaccine was administered), the pt developed a dark rash, which caused such pain that pt could not bear to have anything touching her skin, and which lasted well into the following year, 2018. The pt sought relief, advice, and treatment from doctors. In addition, she presented at the emergency room in search of relief. The pt was diagnosed with shingles by a doctor in 2017. The pt first learned of the link between zoster vaccine live (ZOSTAVAX) and injuries such those from which she suffered, in or about 22-DEC-2018, when a friend shared information found on internet. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her (conflict information, also reported as "his") condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.  The event shingles was considered to be disabling by the lawyer.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion involving PROQUAD / Several patients were administered PROQUAD during this temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 07-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T021302, expiration date: 19-DEC-2020) as prophylaxis, that experienced a temperature excursion (product storage error).  On an unknown date, the vaccine underwent a temperature excursion of minus 5 degrees Celsius (C) for 20 hours, as recorded by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient administered PROQUAD during a temperature excursion.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 10-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter, as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T021302 which has been verified to be valid, expiration date reported and validated as 19-DEC-2021) (product storage error).  The administered dose of the vaccine experienced, on 2 separate dates, a temperature excursion of -5 degrees Celsius (C) for 10 hours, for a time frame of 20 hours, as recorded by a data logger. There was no previous temperature excursion reported. Additionally, it was reported that a varicella vaccine (manufacturer unknown) was involved in the temperature excursion, however, this vaccine was not administered to the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiac failure congestive, Cardiovascular disorder, Cerebrovascular accident, Herpes zoster
Clinical narrative: outbreaks of herpes zoster; postherpetic neuralgia; stroke; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as after receiving the vaccine), the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, stroke, cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, balance disorder, hypoacusis, visual impairment, cardiac failure congestive, cardiovascular disorder, cerebrovascular accident and post herpetic neuralgia was not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, balance disorder, hypoacusis, visual impairment, cardiac failure congestive, cardiovascular disorder, cerebrovascular accident and post herpetic neuralgia were considered as disabling events by the reporter.  Upon internal review, cerebrovascular accident and cardiac failure congestive were considered medically significant events.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoacusis, Post herpetic neuralgia, Visual impairment
Clinical narrative: outbreaks of herpes zoster; postherpetic neuralgia; stroke; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as after receiving the vaccine), the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, stroke, cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, balance disorder, hypoacusis, visual impairment, cardiac failure congestive, cardiovascular disorder, cerebrovascular accident and post herpetic neuralgia was not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, balance disorder, hypoacusis, visual impairment, cardiac failure congestive, cardiovascular disorder, cerebrovascular accident and post herpetic neuralgia were considered as disabling events by the reporter.  Upon internal review, cerebrovascular accident and cardiac failure congestive were considered medically significant events.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: none adverse reaction or side effects experienced; pneumococcal vaccine administered on 17-SEP-2015 and on 26-NOV-2016; This spontaneous report as received from a lawyer refers to a 69-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapy were captured in case MARRS # 2009USA003874.  The patient was vaccinated with pneumococcal vaccine, polyvalent (manufacturer unknown) on 17-SEP-2015 and on 26-NOV-2016 (lot#, expiration date, dose, route of administration and anatomical location were not reported). None adverse reaction or side effects were experienced by the patient.  This is one of 2 reports concerning the same patient.; Sender's Comments:  US-009507513-2009USA003874:
Sex: F
Vaccine: MEN
Symptoms: Meningococcal infection, Vaccination failure
Clinical narrative: Got the vaccine and still got it / hospitalized two months / almost killed her / Suspected vaccination failure; Got the vaccine and still got it / hospitalized two months / almost killed her; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening) and meningococcal infection (serious criteria hospitalization, GSK medically significant and life threatening). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown.   It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to Meningococcal B vaccine.  Additional details were reported as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient received the Meningococcal B vaccine and got meningococcal infection and was hospitalized for two months at the hospital.  Reporter stated that it had almost killed her. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Headache, Lymph node palpable, Lymphadenopathy
Clinical narrative: my left arm and breast were tender with some mild body aches and low grade headache/Arm soreness; my left arm and breast were tender with some mild body aches and low grade headache/ left breast was increasingly painful with swollen palpable lymph nodes; my left arm and breast were tender with some mild body aches and low grade headache/ left breast was increasingly painful with swollen palpable lymph nodes; my left arm and breast were tender with some mild body aches and low grade headache/ left breast was increasingly painful with swollen palpable lymph nodes; my left arm and breast were tender with some mild body aches and low grade headache; body soreness and stiffness; This is a spontaneous report from a contactable healthcare professional.  A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "the day after the injection, my left arm and breast were tender with some mild body aches and low grade headache. Sunday Arm soreness went away but left breast was increasingly painful with swollen palpable lymph nodes, with body soreness and stiffness. Monday left breast is still remarkably tender with palpable lymph nodes" on 19Dec2020 (reported as Seriousness criteria-Caused/prolonged hospitalization: Yes, on an unspecified date in Dec2020). The outcome of the event was not recovered.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Tenderness
Clinical narrative: my left arm and breast were tender with some mild body aches and low grade headache/Arm soreness; my left arm and breast were tender with some mild body aches and low grade headache/ left breast was increasingly painful with swollen palpable lymph nodes; my left arm and breast were tender with some mild body aches and low grade headache/ left breast was increasingly painful with swollen palpable lymph nodes; my left arm and breast were tender with some mild body aches and low grade headache/ left breast was increasingly painful with swollen palpable lymph nodes; my left arm and breast were tender with some mild body aches and low grade headache; body soreness and stiffness; This is a spontaneous report from a contactable healthcare professional.  A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "the day after the injection, my left arm and breast were tender with some mild body aches and low grade headache. Sunday Arm soreness went away but left breast was increasingly painful with swollen palpable lymph nodes, with body soreness and stiffness. Monday left breast is still remarkably tender with palpable lymph nodes" on 19Dec2020 (reported as Seriousness criteria-Caused/prolonged hospitalization: Yes, on an unspecified date in Dec2020). The outcome of the event was not recovered.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: got COVID vaccine from Pfizer, next day got COVID tested with mild symptoms and positive; got COVID vaccine from Pfizer, next day got COVID tested with mild symptoms and positive; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he is a physician and got COVID vaccine from Pfizer, next day got COVID tested with mild symptoms and positive. The patient stated so he got vaccinated probably while having COVID. The patient wanted to know any concerns from the vaccine standpoint efficacy side effects. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Lymphadenopathy
Clinical narrative: asking on how to differentiate between side effects from COVID vs vaccine side effects/also wondered if he needs to quarantine; asking on how to differentiate between side effects from COVID vs vaccine side effects/also wondered if he needs to quarantine; swelling of glands in throat/lymphadenopathy in throat; headache; Feeling a little fluish; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot number and expiry date were unknown), via an unspecified route of administration on 21Dec2020 18:06 at a single dose for COVID-19 vaccination. Medical history included diet controlled Type 2 Diabetic diagnosed 5 years ago in 2015. There were no concomitant medications. The patient previously got Shingles vaccine and it was a two dose vaccine. He felt a little bit like he did now after receiving the second vaccine. He felt fluish for 8-12 hours the day after receiving the vaccine. He has gotten lots of vaccines like Flu and has no responses. The patient does not have prior vaccinations within 4 weeks. The patient received the vaccine yesterday (21Dec2020), and maybe an hour ago on 22Dec2020, he started feeling swelling of the glands in throat or lymphadenopathy in throat and a little bit of headache. He has a question that he cannot find the answer to anywhere. The patient is asking on how to differentiate between side effects from COVID vs vaccine side effects? His temperature was 98.1 on unspecified date. He did not have an exact time frame for when it began. He stated, "you get swelling in glands and then you notice it." He noticed about 2 hours ago and it is getting worse. Now he is feeling like he is sick. He has been volunteering and giving the vaccines over the past two days himself. He is feeling now a little fluish. He doesn't know how to say it other than tired and just doesn't feel good. He would go to work like this and does not feel it is medically significant. He does feel like he is deteriorating but that is only a guess. He felt a little worse than an hour ago. He also wondered if he needs to quarantine because he is signed up to give the vaccines and would not want to do that if he should not. No ER or physician's office required. The outcome of the events was not recovered.  Information on batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: asking on how to differentiate between side effects from COVID vs vaccine side effects/also wondered if he needs to quarantine; asking on how to differentiate between side effects from COVID vs vaccine side effects/also wondered if he needs to quarantine; swelling of glands in throat/lymphadenopathy in throat; headache; Feeling a little fluish; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot number and expiry date were unknown), via an unspecified route of administration on 21Dec2020 18:06 at a single dose for COVID-19 vaccination. Medical history included diet controlled Type 2 Diabetic diagnosed 5 years ago in 2015. There were no concomitant medications. The patient previously got Shingles vaccine and it was a two dose vaccine. He felt a little bit like he did now after receiving the second vaccine. He felt fluish for 8-12 hours the day after receiving the vaccine. He has gotten lots of vaccines like Flu and has no responses. The patient does not have prior vaccinations within 4 weeks. The patient received the vaccine yesterday (21Dec2020), and maybe an hour ago on 22Dec2020, he started feeling swelling of the glands in throat or lymphadenopathy in throat and a little bit of headache. He has a question that he cannot find the answer to anywhere. The patient is asking on how to differentiate between side effects from COVID vs vaccine side effects? His temperature was 98.1 on unspecified date. He did not have an exact time frame for when it began. He stated, "you get swelling in glands and then you notice it." He noticed about 2 hours ago and it is getting worse. Now he is feeling like he is sick. He has been volunteering and giving the vaccines over the past two days himself. He is feeling now a little fluish. He doesn't know how to say it other than tired and just doesn't feel good. He would go to work like this and does not feel it is medically significant. He does feel like he is deteriorating but that is only a guess. He felt a little worse than an hour ago. He also wondered if he needs to quarantine because he is signed up to give the vaccines and would not want to do that if he should not. No ER or physician's office required. The outcome of the events was not recovered.  Information on batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Limb discomfort
Clinical narrative: Chills; Sore arm; Tired; This is a spontaneous report from a contactable consumer.  An adult non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number= EH9899, via an unspecified route of administration on 22Dec2020  (at an unspecified age) as a single dose for COVID-19 immunization.  Prior to the vaccination the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered at a Public Health Clinic/Administration facility. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 22Dec2020, at an unspecified time, the patient experienced a sore arm, chills and was tired. The patient was not hospitalized for the events and it was not known if treatment had been given. The patient recovered from the sore arm, chills and tired on an unspecified date in Dec2020. Since the vaccination, the patient has not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Eye pain
Clinical narrative: Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient (not pregnant) received first dose of BNT162B2 (Lot number: Pcj1685), intramuscularly in left arm on 23Dec2020 18:30 at single dose for COVID-19 immunization. Medical history included anxiety, depression, seasonal allergy all from an unknown date and unknown if ongoing. Concomitant medication included celecoxib (CELEXA), biotin, curcuma longa (TURMERIC), calcium, doxylamine. The patient previously took Levofloxacin (LEVAQUIN) and experienced allergies. The patient experienced bones and joints pain, chills and fever, bad headache, eyes pain, cough all on 24Dec2020 05:00. Treatment (Around the clock Motrin) was received for events. All events were reported as non-serious. Facility type vaccine was administered in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed 5 min after vaccine administered; This is a spontaneous report from a contactable physician, the patient. This 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EH9899), intramuscularly in the left arm on 26Dec2020 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was reported as none. The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 26Dec2020 at 12:05, the patient experienced a nose bleed five minutes after the vaccine was administered. No therapeutic measures were taken as a result of the event. The clinical outcome of the nose bleed was resolved on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: fatigue; not much of an appetite; headaches; chills; dizziness; felt febrile/fever; arm soreness after the injection; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient was social worker who received the Covid 19 vaccine on 22Dec2020. She reported some arm soreness after the injection on 22Dec2020. On Wednesday (23Dec2020), she began having dizziness and felt febrile, On Thursday (24Dec2020) she reported a fever of 100.6, fatigue extreme, not much of an appetite, headaches and chills. She states the fever has gone away for the most part but she isn't always checking. She was alternating Tylenol and Advil. Wanted to know about if these symptoms was normal post vaccination and how long they will last. It's been few days now. Treatment was received for all events. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pyrexia
Clinical narrative: fatigue; not much of an appetite; headaches; chills; dizziness; felt febrile/fever; arm soreness after the injection; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient was social worker who received the Covid 19 vaccine on 22Dec2020. She reported some arm soreness after the injection on 22Dec2020. On Wednesday (23Dec2020), she began having dizziness and felt febrile, On Thursday (24Dec2020) she reported a fever of 100.6, fatigue extreme, not much of an appetite, headaches and chills. She states the fever has gone away for the most part but she isn't always checking. She was alternating Tylenol and Advil. Wanted to know about if these symptoms was normal post vaccination and how long they will last. It's been few days now. Treatment was received for all events. The outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort
Clinical narrative: Sore arm 24 hours; mild head ache; This is a spontaneous report from a contactable nurse.  A 42-year-old female nurse (patient) reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ELO140), at the hospital into the left arm on 24Dec2020 at  06:00 AM as single dose for COVID-19 immunization. The patient did not receive other medications in two weeks. The patient did not report  allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history none. On 24Dec2020 at 07:00 AM the patient started experiencing sore arm 24 hours and mild headache. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Dec2020.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Sore upper right arm; This is a spontaneous report from a contactable Nurse.  A 49-year-old female nurse reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), intramuscular into the left arm ,at single dose for COVID-19 immunization on 21Dec2020 at 11:45 AM in the Workplace clinic. The patient received other medications in two weeks and did not receive other vaccine in four weeks. The patient had known allergies to  medications, food, or other products. Medical history included migraines, depression. On 21Dec2020 starting at 07:00 PM the patient experienced sore upper right arm. Treatment was not received. The outcome of the event was recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Allodynia, Injection site erythema, Injection site pruritus, Pain, Pain in extremity
Clinical narrative: My arm is swelling, painful, and hurts at touch; My arm is swelling, painful, and hurts at touch; Every time I lift my arm I get a severe pain; I have shooting pain; it is itchy and the red mark is getting bigger and bigger; it is itchy and the red mark is getting bigger and bigger; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number/Expiration date: not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. Relevant medical history and concomitant medication were not provided. On an unknown date, the consumer stated that "my arm is swelling, painful, and hurts at touch and every time I lift my arm, I get a severe pain and it is itchy and the red mark is getting bigger and bigger. Every time I lift my arm I have shooting pain". The outcome of the events arm is swelling, painful, and hurts at touch, shooting pain and it is itchy and the red mark is getting bigger and bigger was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: My arm is swelling, painful, and hurts at touch; My arm is swelling, painful, and hurts at touch; Every time I lift my arm I get a severe pain; I have shooting pain; it is itchy and the red mark is getting bigger and bigger; it is itchy and the red mark is getting bigger and bigger; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number/Expiration date: not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. Relevant medical history and concomitant medication were not provided. On an unknown date, the consumer stated that "my arm is swelling, painful, and hurts at touch and every time I lift my arm, I get a severe pain and it is itchy and the red mark is getting bigger and bigger. Every time I lift my arm I have shooting pain". The outcome of the events arm is swelling, painful, and hurts at touch, shooting pain and it is itchy and the red mark is getting bigger and bigger was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash vesicular
Clinical narrative: red spots on some toes which became like blisters.; red spots on some toes which became like blisters.; spot under her toe hurt upon walking; This is a spontaneous report from a contactable pharmacist (patient). A female adult patient of unspecified age received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm single dose for COVID-19 immunization in Dec2020. No other medical history. No known allergies. No allergies to medications, food, or other products. Prior to vaccination, the patient did not diagnose with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Dec2020, 4 days after vaccination, the patient developed red spots on some toes which became like blisters. The spot under her toe hurt upon walking. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored Program Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Unknown, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was upset. She was part of the COVID Trial in and this past week (in Dec2020) she started to get sick and tested positive for COVID. They gave her a diary which she had to fill out weekly, so she filled it out and put that she had COVID. She never heard from anyone. She stated the testing site people and snarky attitudes and when they went no one was wearing masks. She was told by the testing site, they couldn't make people wear them. Relayed that she could do an escalation and have someone reach out to her in regards to this. The patient underwent lab tests and procedures which included Covid test: positive on unspecified date in Dec2020. The event outcome was unknown.  Information on the Batch/Lot number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: I wasn't feeling well at all; Fever; Pain everywhere; Headache; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. Medical history included flu from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient experienced fever, pain everywhere, headache, wasn't feeling well all in Dec2020. Events were reported as non-serious. She received the first dose of COVID vaccine, she was wonder whether it was okay for to wait to get my second dose in 3-4 months. She stated that people and colleagues are saying there could be issues with infertility from getting the vaccine. She received the first dose of COVID vaccine and for 7 days, she wasn't feeling well at all. She had fever, pain everywhere, headache. She had the flu in the past and it was worse than that. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: dizziness; fatigue/tired; chills; irritability; headache; weakness; This is a spontaneous report from a contactable consumer.  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  In Dec2020, the patient experienced dizziness, fatigue/tired, chills, irritability, headache and weakness.  The outcome of dizziness, fatigue/tired, chills, irritability, headache and weakness was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Irritability
Clinical narrative: dizziness; fatigue/tired; chills; irritability; headache; weakness; This is a spontaneous report from a contactable consumer.  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  In Dec2020, the patient experienced dizziness, fatigue/tired, chills, irritability, headache and weakness.  The outcome of dizziness, fatigue/tired, chills, irritability, headache and weakness was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Hiccup; This is a spontaneous report from a contactable physician (patient).   This 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EKS730), intramuscular at single dose in left deltoid on 21Dec2020 15:30 for covid-19 immunisation, dexamethasone sodium phosphate (Exp. date 31Dec2015), via an unspecified route of administration in Dec2020 at 8 mg, daily for an unspecified indication.  Medical history included atrial fibrillation from 2009. There were no concomitant medications.  The patient experienced hiccup on 27Dec2020 12:00 with outcome of not recovered. The action taken in response to the event for bnt162b2 was not applicable, for dexamethasone sodium phosphate was unknown. Therapeutic measures were taken as a result of hiccup. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Pfizer is a marketing authorization holder of dexamethasone sodium phosphate in the country of incidence or the country where the product was purchased. This may be a duplicate report if another marketing authorization holder of dexamethasone sodium phosphate has submitted the same report to the regulatory authorities.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Deafness neurosensory, Ear discomfort, Hyperacusis, Tinnitus
Clinical narrative: Hiccup; This is a spontaneous report from a contactable physician (patient).   This 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EKS730), intramuscular at single dose in left deltoid on 21Dec2020 15:30 for covid-19 immunisation, dexamethasone sodium phosphate (Exp. date 31Dec2015), via an unspecified route of administration in Dec2020 at 8 mg, daily for an unspecified indication.  Medical history included atrial fibrillation from 2009. There were no concomitant medications.  The patient experienced hiccup on 27Dec2020 12:00 with outcome of not recovered. The action taken in response to the event for bnt162b2 was not applicable, for dexamethasone sodium phosphate was unknown. Therapeutic measures were taken as a result of hiccup. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Pfizer is a marketing authorization holder of dexamethasone sodium phosphate in the country of incidence or the country where the product was purchased. This may be a duplicate report if another marketing authorization holder of dexamethasone sodium phosphate has submitted the same report to the regulatory authorities.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: On Day 4 after vaccine,  sudden onset of bilateral fullness in ears, tinnitus, hearing loss, hyperacusis without vertigo.   Weber's test did not lateralize.  Rinne's test  showed Air conduction greater than bone conduction consistent with neurosensory loss.  Started on dexamethasone 8 mg a day for 3 days and symptoms essentially resolved.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Deafness neurosensory, Ear discomfort, Hyperacusis, Tinnitus
Clinical narrative: On Day 4 after vaccine,  sudden onset of bilateral fullness in ears, tinnitus, hearing loss, hyperacusis without vertigo.   Weber's test did not lateralize.  Rinne's test  showed Air conduction greater than bone conduction consistent with neurosensory loss.  Started on dexamethasone 8 mg a day for 3 days and symptoms essentially resolved.