chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Nausea; Fever; Fatigue; Chest pain; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: Er2613) via an unspecified route of administration administered in Arm Right on 24Mar2021 and second dose (#lot: Er8629) via an unspecified route of administration administered in Arm Right on 14Apr2021 as single dose (at the age of 49-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea, fever, fatigue, chest pain and difficulty breathing on an unspecified date. The patient did not report this because he didn't think it was relevant until recent media about myocarditis. He was close 3x to dialing 911 thought was having heart attack. The outcome of all the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, Off label use, Polymenorrhagia, Ultrasound scan
Clinical narrative: My period started 20 days early and had NOT stopped; First dose and second dose administered on 10May2021; First dose and second dose administered on 10May2021; This is a spontaneous report from a contactable consumer (patient) reported that a 43-years-old non-pregnant female patient received first and second dose of bnt162b2 (Pfizer COVID-19, Solution for injection, Lot Number: EW0179), via intramuscular route of administration on 10May2021, 17:00 (at the age of 43-years-old) on left arm as first dose, single then (Lot Number: EW0186), via intramuscular route of administration on left arm on 10May2021 at second dose, single for COVID-19 immunisation. Medical history included allergic to shellfish and penicillin. Other medical history was none. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Concomitant medications were not reported. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient received first and second dose on 10May2021. On 13May2021 at 13:00, 3 days post vaccine, the patient experienced bleeding heavily. Her period started 20 days early and had not stopped. She had been seeking treatment and have no pre vaccine condition to cause this type of bleeding. Patient received treatment for the adverse event. The patient had exam blood work ultrasound. The outcome of the event my period started 20 days early and had not stopped was not recovered and other events was unknown.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Pyrexia
Clinical narrative: Severe chest pain; fever; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179), via an unspecified route of administration in the right arm on 03Jun2021 at 10:00 (at the age of 15-year-old) as single dose for COVID-19 immunisation in public health clinic. Medical history included Tourette's syndrome from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included pimozide taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (Lot number: EW0179), via an unspecified route of administration in the right arm on 13May2021 at 12:15 (at the age of 15-year-old) as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03Jun2021 at 22:00, the patient experienced severe chest pain and two days of fever up to 39.8 degree Celsius. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included fever: 39.8 centigrade on 03Jun2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of severe chest pain was resolved on an unknown date in Jun2021, and fever was resolved on 05Jun2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Paranasal sinus discomfort, Throat irritation
Clinical narrative: Numbness in tongue; Back of throat/sinus irritation; Back of throat/sinus irritation; Mild tingling of lips; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0196), dose 2 via an unspecified route of administration, administered in left arm on 11Jun2021 18:15 (at the age of 57-year-old), as single dose for COVID-19 immunisation in pharmacy or drug Store. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185), administered in left arm on 14May2021 13:00, as single dose for COVID-19 immunisation. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 11Jun2021 at 19:15, the patient experienced mild tingling of lips, numbness in tongue and back of throat/sinus irritation. The patient visit to doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of mild tingling of lips, numbness in tongue, back of throat/sinus irritation, back of throat/sinus irritation and treatment with Benedryl. Outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: feeling like going to pass out; difficulty breathing; chest pain; Moderate headache; fatigue; moderate muscle aches; joint pain; This is a spontaneous report from a contactable consumer.   A 15-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 06Jun2021 at 11:15 (at the age of 15-years-old) as dose 2 single for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), mood disorder, asthma, NKA other than seasonal outdoor allergies and minor lactose intolerance from an unknown date. Concomitant medications included methylphenidate hydrochloride (CONCERTA); oxcarbazepine (TRILEPTAL) and salbutamol sulfate (PROAIR HFA) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0185 and Expiration date: unknown), via an unknown route of administration, in left arm on 16May2021 at 11:00 (at the age of 15-years-old) for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. On 06Jun2021 at 12:00, the patient experienced moderate headache, fatigue, moderate muscle aches, joint pain, chest pain, difficulty breathing and feeling like going to pass out. Lasted for exactly 48 hours. The case was assesses as non-serious. Patient received Ibuprofen and steroid inhaler as treatment for events. On an unspecified date in Jun2021, the events were recovered.  Follow-up attempts are needed. Further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Presyncope
Clinical narrative: feeling like going to pass out; difficulty breathing; chest pain; Moderate headache; fatigue; moderate muscle aches; joint pain; This is a spontaneous report from a contactable consumer.   A 15-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 06Jun2021 at 11:15 (at the age of 15-years-old) as dose 2 single for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), mood disorder, asthma, NKA other than seasonal outdoor allergies and minor lactose intolerance from an unknown date. Concomitant medications included methylphenidate hydrochloride (CONCERTA); oxcarbazepine (TRILEPTAL) and salbutamol sulfate (PROAIR HFA) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0185 and Expiration date: unknown), via an unknown route of administration, in left arm on 16May2021 at 11:00 (at the age of 15-years-old) for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. On 06Jun2021 at 12:00, the patient experienced moderate headache, fatigue, moderate muscle aches, joint pain, chest pain, difficulty breathing and feeling like going to pass out. Lasted for exactly 48 hours. The case was assesses as non-serious. Patient received Ibuprofen and steroid inhaler as treatment for events. On an unspecified date in Jun2021, the events were recovered.  Follow-up attempts are needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Extra dose administered, Flushing, Hyperhidrosis, Nausea
Clinical narrative: wheezing; shortness of breath; flushing; sweating; nauseated; After 3rd infusion, (3rd loading dose) patient experienced shortness of breath, wheezing, flushing, sweating, nauseated; This is a spontaneous report from contactable nurse via Pfizer Sales Representative.   A male patient of age 44 received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 3, single for COVID-19 immunisation. Co-suspect medication included infliximab (INFLECTRA, Formulation: Powder for injection, Lot number: EJ1527), via an unspecified route of administration on an unspecified date as an unknown for an unspecified indication. The patient's medical history included Ankylosis Spond. Historical vaccine included BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in May2021 as a dose 2, single for COVID-19 immunisation, had received 2nd Covid Vaccination at least two weeks prior and the patient received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation, 1st shot of vaccine. The patient's concomitant medications were not reported. It was reported that, after 3rd infusion (3rd loading dose), on an unspecified date, the patient experienced shortness of breath, wheezing, flushing, sweating and nauseated. Used Humira prior switching to Inflectra. (Name) stated that, it was unknown whether it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Inflectra until Covid shot. The patient was not using Methotrexate. Being treated for Ankylosis Spond. No premeds were used prior to infusion. The reporter stated that, the events took place after use of product. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: wheezing; shortness of breath; flushing; sweating; nauseated; After 3rd infusion, (3rd loading dose) patient experienced shortness of breath, wheezing, flushing, sweating, nauseated; This is a spontaneous report from contactable nurse via Pfizer Sales Representative.   A male patient of age 44 received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 3, single for COVID-19 immunisation. Co-suspect medication included infliximab (INFLECTRA, Formulation: Powder for injection, Lot number: EJ1527), via an unspecified route of administration on an unspecified date as an unknown for an unspecified indication. The patient's medical history included Ankylosis Spond. Historical vaccine included BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in May2021 as a dose 2, single for COVID-19 immunisation, had received 2nd Covid Vaccination at least two weeks prior and the patient received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation, 1st shot of vaccine. The patient's concomitant medications were not reported. It was reported that, after 3rd infusion (3rd loading dose), on an unspecified date, the patient experienced shortness of breath, wheezing, flushing, sweating and nauseated. Used Humira prior switching to Inflectra. (Name) stated that, it was unknown whether it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Inflectra until Covid shot. The patient was not using Methotrexate. Being treated for Ankylosis Spond. No premeds were used prior to infusion. The reporter stated that, the events took place after use of product. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Rash; This is a spontaneous report from a Pfizer Colleague.   A non-contactable consumer (Patient) reported that a unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose, the patient developed shingles. Not certain if it was related but my doctor reported it to withheld. After a couple of days, the patient developed a rash (different than shingles) all over my body. At first doctor thought it was poison ivy, but it was quite severe. The patient was treated with vytrex for the event shingles and for the event rash, patient was on steroids (unspecified) for 12 days. It's been more than 5 weeks now; patient still had the rash (it's calming down since this past weekend but still had new rash). Patient did not know if there's any connection to the vaccine, was there other similar incidents.Neither steroids or antihistamine seemed to help much. The outcome of the event shingles was resolved on an unknown date. The outcome of the event rash was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: I have been feeling a real sick; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history was none. The patient concomitant medications were not reported. On an unknown date in Jun2021, the patient has been feeling a real sick and had headache. Reportedly, patient was on day 5 after first shot (Unspecified Shot) here for the Covid thing and had been feeling a real sick. Patient was little better today, just had a headache and was just wondering if that was normal as patient was on day 5. The outcome of the events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a Spontaneous report from a contactable Consumer. This consumer reported for 15-year-old male patient (reporter's son). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0178), dose 2 via an unspecified route of administration, administered in arm left on 12Jun2021 as dose 2, single for COVID-19 immunization, (age at the time of vaccination was 15-year-old). The patient medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered on 22May2021 as dose 1, single for COVID-19 immunization, (age at the time of vaccination was 15-year-old). On an unspecified date the reporter stated, I have the question, my son (consumer) had his second (Pfizer) vaccine (unspecified vaccine) yesterday (12 Jun 2021) and he has headache (overnight). I just wanted to know whether I could give him something worth medicine (treatment) for the headache." The patient did not receive any treatment for the above event. Outcome of the event was reported as unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus, Skin swelling, Skin warm, Vaccination site rash
Clinical narrative: large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0185) via an unspecified route of administration, in right arm on 04Jun2021 at 16:30 (at the age of 61-years-old) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as known allergies to zinc. Concomitant medications in two weeks included multi vitamin, paracetamol (TYLENOL) and ibuprofen (ADVIL). The patient did not receive any vaccines within four weeks prior to the vaccination. On 12Jun2021 at 11:00, the patient experienced large rash around injection site. Skin hot to the touch, swollen, itchy and painful. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Any treatment received for the event was unknown. Outcome of all events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tremor
Clinical narrative: tremors and headache; tremors and headache; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included methotrexate sodium taken for an unspecified indication, start and stop date were not reported; adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; infliximab (REMICADE) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), on an unspecified date as 1st dose, single dose for covid-19 immunisation. On an unspecified date, the patient experienced tremors and headache. After 15th infusion, patient experienced tremors and headache, post 2nd Vaccination for Covid believed to be Pfizers. Patient used Humira, prior to switching to Remicade. Had received 2nd Covid Vaccination at least two weeks prior to their infusion. (Name) said it was unknown if it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Remicade until 2nd Covid shot. Event took place after use of product. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Stabbing pain in abdomen, as if someone was stabbing my abdomen and moving it up and down; This is a spontaneous report from a contactable consumer.   A 19-year-old adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0178), via unspecified route of administration in the left arm, on 13Jun2021, as dose 2, single for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included Spironolactone and Estradiol.  The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0173), via unspecified route of administration in the left arm, on 23May2021, as 1st dose, single for COVID-19 Immunisation. On 14Jun2021 at 13:00, the patient experienced stabbing pain in abdomen, (Reported as: as if someone was stabbing his abdomen and moving it up and down). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Herpes zoster
Clinical narrative: Diagnosed with Shingles; Accidental overdose; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in arm right on 25Mar2021 (at the age of 51-years-old) as dose 1, single and second dose (Batch/Lot Number: EW0158) via an unspecified route of administration, administered in Arm Right on 25Mar2021 as dose 2 single for covid-19 immunisation at the hospital. The patient had no medical history. The patient had no known allergies. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication and unspecified allergy medications and vitamins. The patient had no other vaccine in four weeks. No covid prior vaccination. The patient was not tested for covid post vaccination. On 25Mar2021, the patient experienced accidental overdose. On 10Jun2021, the patient was diagnosed with shingles. As a treatment for diagnosed with shingles the patient received valtrex, topical. The clinical outcome of the diagnosed with shingles was recovering and the outcome of the accidental overdose was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: My period started two days early on 02Jun (which by itself is not an issue) but I have not stopped bleeding since then and am still passing actual tissue/clots almost daily.; I have not stopped bleeding/ am still passing actual tissue/clots almost daily; This a spontaneous report from consumer (Patient).  A 47-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration on 29May2021  (at the age of 47)(at 11:30 AM), as dose 2, single in left arm for covid-19 immunization at vaccine clinic. 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 medical history was not reported and ha d no allergies to medications, food, or other products. Device Date was reported as 15Jun2021. The patient's concomitant medications included lexapro (escitalopram oxalate) and collagen powder(collagen hydrolysate). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) via unspecified route on left arm on 01May2021 01:30 PM for COVID-19 Immunization. On 02Jun2021 (at 12:00PM), patient experienced her period started two days early on 02Jun (which by itself is not an issue) but she has not stopped bleeding since then and still passing actual tissue/clots almost daily. The outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Cutaneous vasculitis, SARS-CoV-2 test
Clinical narrative: leukocytoclastic vasculitis (LCV)/petechial/purpuric lesions on lower legs and feet/crops of lesions/rash; This is a spontaneous report from a contactable health care professional. An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular administered in Arm Left on 09Apr2021 (Lot Number: ER2613) as dose 1, single for covid-19 immunisation in Pharmacy or Drug Store. The patient medical history was not reported. No known drug allergies. Concomitant medication received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient began with petechial/purpuric lesions on lower legs and feet on 19Apr2021. Patient has had continued crops of lesions appear since that time. Has worsened over time. Was diagnosed with leukocytoclastic vasculitis (LCV). A biopsy was collected on 12May2021. The patient was put on an oral prednisone taper, showed improvement on high doses but once tapered down, rash returned worse with no resolution. Visited 3 times and 2 visits to her pediatrician has not resolved. Continued worsening over time. Events resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test type post vaccination: Nasal Swab, SARS-CoV-2, NAA on 11May2021 with Negative result. The outcome of event was not recovered. Event was reported as non-serious and not results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event leukocytoclastic vasculitis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: Gait disturbance, Inflammation, Malaise, Muscular weakness, Pain
Clinical narrative: inflammation & pain have been going on for five months now; inflammation & pain have been going on for five months now; I am not able to walk or grasp items with my hands. I cannot care for myself.; I am not able to walk or grasp items with my hands. I cannot care for myself.; I cannot care for myself.; This is a spontaneous report from a Pfizer sponsored program Pfizer via a contactable consumer (patient, self-reported). A female patient of an unspecified age received a 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 and concomitant medications were not reported. The patient reported that she needed someone to contact her regarding treatment/reversal to her immune systems over reaction to the mRNA from the Covid Vaccine. On an unspecified date, the patient had inflammation and pain have been going on for five months now. She has been to the ER twice now. Her PCP has not been able to help. She was referred to a rheumatologist who has not been able to help her since she did not have RA. She could not take any more steroids because they were damaging her body. She was not able to walk or grasp items with her hands. She could not care for herself. There was no Product quality complaint (PQC) present. Outcome of the event inflammation and pain have been going on for five months now was not recovered and for all other events, it was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injected limb mobility decreased, Magnetic resonance imaging, Neck pain
Clinical narrative: pain in his arm and shoulder; pain in his arm and shoulder; he got the second shot for COVID and he could not move his arm; big bulge under his arm; pain is from the hand, up to the shoulder, neck and head; pain is from the hand, up to the shoulder, neck and head; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation and had no reaction. On 24Apr2021, the patient got the second shot for Covid and he can't move his arm. This was the first time of him feeling bad and then when he got home and began to walk around, he had to sit. For 11 days he had pain on pain on pain and little by little he started to get under his arm, a big bulge. He put ice on it and it went down and he took something for inflammation, but still the pain stayed. Now the past few weeks he had seen his doctor and asked about it and went to Orthopedic doctor about the right shoulder and he told them about the pain in his left arm from the shot and they sent him to do a MRI. He said it's not right because the MRI is expensive and the insurance had to pay. The pain was killing him and no one was doing nothing for him. He did not know what to do once the results come back at the end of this week. Again, mentioned he had MRI of shoulder and left arm. The pain is from the hand, up to the shoulder, neck and head. He stated he was still experiencing pain in his arm and shoulder. Wanted to know what will happen to him because he already went to the doctor and they did not know. Should he see the doctor again. Went to the place he got the vaccine and the nurse had to call him back and was surprised what happened to him. He was having a poor time and now had to stay home. Just wanting to know how long he was going to stay like that. The 24th of this month will be 2 months. How long do side effects last. He had undergone MRI and was currently awaiting results. He asked "How long does it stay like that? This kind of pain. He could have a heart attack. Scared because of his son". Indicated son passed from Sars-COV-2. Outcome of the event pain in his arm and shoulder was not recovered and other events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: pain in his arm and shoulder; pain in his arm and shoulder; he got the second shot for COVID and he could not move his arm; big bulge under his arm; pain is from the hand, up to the shoulder, neck and head; pain is from the hand, up to the shoulder, neck and head; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation and had no reaction. On 24Apr2021, the patient got the second shot for Covid and he can't move his arm. This was the first time of him feeling bad and then when he got home and began to walk around, he had to sit. For 11 days he had pain on pain on pain and little by little he started to get under his arm, a big bulge. He put ice on it and it went down and he took something for inflammation, but still the pain stayed. Now the past few weeks he had seen his doctor and asked about it and went to Orthopedic doctor about the right shoulder and he told them about the pain in his left arm from the shot and they sent him to do a MRI. He said it's not right because the MRI is expensive and the insurance had to pay. The pain was killing him and no one was doing nothing for him. He did not know what to do once the results come back at the end of this week. Again, mentioned he had MRI of shoulder and left arm. The pain is from the hand, up to the shoulder, neck and head. He stated he was still experiencing pain in his arm and shoulder. Wanted to know what will happen to him because he already went to the doctor and they did not know. Should he see the doctor again. Went to the place he got the vaccine and the nurse had to call him back and was surprised what happened to him. He was having a poor time and now had to stay home. Just wanting to know how long he was going to stay like that. The 24th of this month will be 2 months. How long do side effects last. He had undergone MRI and was currently awaiting results. He asked "How long does it stay like that? This kind of pain. He could have a heart attack. Scared because of his son". Indicated son passed from Sars-COV-2. Outcome of the event pain in his arm and shoulder was not recovered and other events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain/ this morning it was about 10 minutes of acute pain in the upper right side of my chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and the patient experienced lymph node swelling. The patient's medical history and concomitant medications were not reported. The patient experienced chest pain/ this morning it was about 10 minutes of acute pain in the upper right side of my chest. It was reported that patient want to know if that was listed as one of the side effect but in the clinical trial has that appeared as the side effect of Pfizer. It was started abruptly. Patient stated that I contact my doctor because I want to know if this is the emergency and if I wait for another half hour that's really not productive if this is the medical. The outcome of the event was unknown.    Information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram thorax, Dyspnoea, Fatigue, Illness
Clinical narrative: she thought she had pneumonia or COVID; she thought she had pneumonia or COVID; lungs were tightening up; couldn't breathe; extremely tired; sick, really sick; (ALBUTEROL), both for asthma.  Patient had been on fluticasone propionate a long time (reported as 6, 7, 8 or 10 years ago), and was on salbutamol just as long as she has been taking the fluticasone propionate. Before she got COVID she barley used her asthma medications; now she had to use everything daily. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations.  A few days afterwards, around 19Mar2021, 20Mar2021, or 21Mar2021. She had a doctors appointment on the 23Mar2021. Patient felt like she experienced a side effect that her lungs were tightening up again.  She was seeing a few doctors right now because she was a "long hauler" because her symptoms were not going away. She was better and then her lungs were tightening up. She was tired all of the time.  She was seeing a Pulmonary specialist, also seeing a heart specialist.  She kept going to the doctor and they kept checking for pneumonia. She said there had been little improvement. She was sick prior and got to feeling better. On 23Mar2021 she got sick and then on 29Mar2021. On 02Apr2021 she got sick and called the doctor because she wasn't feeling good. She went a few times to the doctor and they changed her medicine and things like that. On 08Apr2021 she was sick again and they did an x ray of her lungs and that was better. She stated she was doing therapy and stuff and was getting better. She was followed up for another 6 months. She had a cat scan of her lungs on 11Jun2021 and had ground glass in her lungs. In regards to her lungs, there's another word in there that they can't pronounce. One lobe was clear though. She couldn't breathe, she thought she had pneumonia or COVID, she was extremely tired. The event did not required Emergency Room visit, but resulted in Physician Office visit. Outcome of lungs were tightening up was resolving. Outcome of sick, really sick was not resolved. Outcome of the other events was unknown.  Reporter seriousness assessment for the events was not provided. Patient had not received second dose of COVID (as of 15Jun2021). She stated vaccination card says on there Thursday 2:12 for next one.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder, Pneumonia, Suspected COVID-19
Clinical narrative: she thought she had pneumonia or COVID; she thought she had pneumonia or COVID; lungs were tightening up; couldn't breathe; extremely tired; sick, really sick; (ALBUTEROL), both for asthma.  Patient had been on fluticasone propionate a long time (reported as 6, 7, 8 or 10 years ago), and was on salbutamol just as long as she has been taking the fluticasone propionate. Before she got COVID she barley used her asthma medications; now she had to use everything daily. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations.  A few days afterwards, around 19Mar2021, 20Mar2021, or 21Mar2021. She had a doctors appointment on the 23Mar2021. Patient felt like she experienced a side effect that her lungs were tightening up again.  She was seeing a few doctors right now because she was a "long hauler" because her symptoms were not going away. She was better and then her lungs were tightening up. She was tired all of the time.  She was seeing a Pulmonary specialist, also seeing a heart specialist.  She kept going to the doctor and they kept checking for pneumonia. She said there had been little improvement. She was sick prior and got to feeling better. On 23Mar2021 she got sick and then on 29Mar2021. On 02Apr2021 she got sick and called the doctor because she wasn't feeling good. She went a few times to the doctor and they changed her medicine and things like that. On 08Apr2021 she was sick again and they did an x ray of her lungs and that was better. She stated she was doing therapy and stuff and was getting better. She was followed up for another 6 months. She had a cat scan of her lungs on 11Jun2021 and had ground glass in her lungs. In regards to her lungs, there's another word in there that they can't pronounce. One lobe was clear though. She couldn't breathe, she thought she had pneumonia or COVID, she was extremely tired. The event did not required Emergency Room visit, but resulted in Physician Office visit. Outcome of lungs were tightening up was resolving. Outcome of sick, really sick was not resolved. Outcome of the other events was unknown.  Reporter seriousness assessment for the events was not provided. Patient had not received second dose of COVID (as of 15Jun2021). She stated vaccination card says on there Thursday 2:12 for next one.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Guillain-Barre syndrome, Monoplegia, Nerve injury
Clinical narrative: Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received 2nd dose of BNT162B2 Covid-19 vaccine, at the age of 55 years old, on 24Mar2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face. Ended up in hospital 19Apr2021. Outcome of the event was unknown.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report from a contactable Physician via the company representative. This Physician reported two case for two male patients (one is 25 years old, another one is 27 year old), this report is for the patient who was hospitalized due to the event.   An adult male patient (unknown 25 year old or 27 year old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced pulmonary embolism after the vaccination, and hospitalized due to the event. Outcome of the event was unknown.      Information about lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported event pulmonary embolism and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.   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 RAs, Ethics Committees, and investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021711416 Same reporter/ drug/ event for different patients
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report from a contactable physician via the company representative. This physician reported same events for two male patients (one was 25 years old, another one was 27 year old), this report was for the patient who was not hospitalized due to the event. This is the 2nd of two reports. An adult male patient (unknown 25 year old or 27 year old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced pulmonary embolism after the vaccination (not hospitalized due to the event). Outcome of the event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of pulmonary embolism  due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.,Linked Report(s) : US-PFIZER INC-2021711391 Same reporter/ drug/ event for different patients
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Neuropathy peripheral
Clinical narrative: after a week of second shot neuropathy came back; after a week of second shot neuropathy came back; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: EN6207) as dose 2, single for COVID-19 immunisation. Medical history included anxiety, 2 years ago (2019) patient had chemotherapy and experienced neuropathy in feet and hands. Historical vaccine included 1st dose of BNT162B2 (Lot/batch number: EN6203) on 23Feb2021 for COVID-19 immunization and experienced static electric shock. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for anxiety, start and stop date were not reported. 2 years ago (2019), patient did experience neuropathy in feet and hands. It was almost gone and after patient had the second shot, about after a week of second shot neuropathy came back and it really had gone much better and it started to fade again. It was almost like it was awakened but it was getting better. No treatment was received for the events. Outcome of the events was resolving.  Follow-up attempts are needed. Further information is expected.