chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 screening, Fibrin D dimer, Investigation, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration on 11Jan2021 20:10 (Batch/Lot Number: EK9231, NDC numbe: 59267-1000-01) as 2nd dose, single and first dose (Lot number: EK5730) on 21Dec2020 in the left arm for Covid-19 immunization. Medical history included rheumatoid arthritis from 2007 and ongoing (diagnosed with rheumatoid arthritis when she was 27 years old, in 2007 or 2008) and ongoing immunosuppression which is related to rheumatoid arthritis. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL S); bioflavonoids nos, calcium ascorbate, hesperidin, rutoside, sodium ascorbate, zinc amino acid chelate (VITAMIN C 1000 PLUS ZINC & BIOFLAVONOIDS); zinc chloride; calcium carbonate, colecalciferol (VITAMIN D 2000); naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]); progesterone (PROGESTERONE) all taken for an unspecified indication, start and stop date were not reported. On 07May2021, the patient got Covid-19 after getting Covid-19 vaccine. The patient went to the Emergency Room and got an infusion by Regeneron (endevimir and casevomir) which her symptoms started improving within 5 minutes of receiving the infusion. The patient was not hospitalized/admitted to ICU. The patient did not require supplemental oxygen or receive mechanical ventilation. Patient reported that she got Covid-19 from somebody when she was in an open-air environment and her mask was off. During her Covid-19 infection, she took Benadryl 25 mg at night and Sudafed every 4 to 6 hours throughout the day. She received no sinus relief from the Benadryl or Sudafed prior to receiving the monoclonal antibody infusion. The patient display signs at rest indicative of severe systemic illness which is fever of 102 and symptoms/signs during the Covid-19 illness experience which includes dyspnea, mostly at night and had difficulty breathing due to extreme sinus congestion; diarrhea and nausea; leg pain and thought that she was getting a clot or something which patient started taking blood thinner the day after she was diagnosed with Covid-19; Covid fog where she feels really spacey and out of it and has been experiencing headaches and ears were so full that they felt like they were going to explode. The patient reported that she is still experiencing lingering effects of her Covid-19 infection - fatigue, Covid fog, and headaches. The patient underwent lab tests and procedures which included covid-19 test on 07may2021: positive and D-dimer negative on 07May2021 and basal metabolic rate on unspecified date with unknown result. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The association between the event lack of effect (COVID-19 infection) with BNT162b2 can not be fully excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested Positive for COVID after receiving vaccines/cough, lost her sense of taste and smell, headache, fatigue, and sore throat; tested Positive for COVID after receiving vaccines/cough, lost her sense of taste and smell, headache, fatigue, and sore throat; This is a spontaneous report from a contactable nurse. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (reported as 'injection') on an unspecified date (Batch/Lot number was not reported) as 1st dose, single and via an unspecified route of administration (reported as 'injection') on 22Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included ongoing hypertension, ongoing Raynaud's and recurrent pneumonia two times the year before. The patient is not smoker/former smoker. Concomitant medications included ongoing hydroxychloroquine for Raynaud's and something for high blood pressure. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient got a positive Covid case after receiving the Pfizer, both of the doses. The patient is retired now, but she worked as an RN. The patient received both doses of the Pfizer Covid Vaccine. The patient tested positive for Covid, she believed that Thursday which would have been 22Apr2021. It was stated that the patient also had the antibody treatment. The patient had cough, lost her sense of taste and smell, headache, fatigue, and sore throat. Her symptoms began on that Tuesday, 20Apr2021. The patient has recovered completely from all symptoms except she still has intermittent headaches and the patient has never gotten headaches before. She would say the patient's headaches are improved. The events required physician office visit. The patient had Covid-19 nasal swab PCR on 22Apr2021 which was positive. No antibody testing was done. The reporter had been contacted that she had been exposed to somebody else who also had been immunized. The patient was not hospitalized nor admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness and did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient had no pre-existing diseases worsened during the SARS-COV2 infection. The patient received additional therapies for COVID-19 which included monoclonal antibody infusion, it was a 2 to 3-hour procedure at the hospital. Initiation of new medication or other treatment or procedure was not required. The outcome of the events was recovering; the patient still has the headaches.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Migraine, Myoclonus, Paralysis, Seizure
Clinical narrative: Nightly sleep seizures/spastic seizure lasting 5 minutes of uncontrollable myoclonus only of the left leg; Temporary, passing paralysis; spastic seizure lasting 5 minutes of uncontrollable myoclonus only of the left leg; longer aphasia (inability to speak); severe migraines; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot Ew0179) on 13May2021 at 02:45 PM into left arm for COVID-19 immunisation. Medical history included Hypermobile Ehlers-danlos syndrome, non-epileptic seizures, migraines, mild traumatic brain injury, intractable pain, severe food allergies. Known allergies: Wheat, gluten, eggs, soy, estrogens. Historical vaccine included 1st dose of BNT162B2 (lot Ew0171) on 22Apr2021 at 02:45 PM into left arm for COVID-19 immunisation. Concomitant drugs included Morphine, hydrocodone bitartrate, paracetamol (NORCO), diazepam (VALIUM), Propranolol, Hydroxyzine. The patient had a non-epileptic seizure disorder that was well controlled. After the second dose she began to have nightly sleep seizures, severe migraines, but am writing because of a spastic seizure lasting 5 minutes of uncontrollable myoclonus only of the left leg, with longer aphasia (inability to speak) and temporary, passing paralysis. The symptoms passed in an hour but an epileptic patient could have died. Event onset time was 19May2021 06:30 PM. No treatment was received. The outcome of the event was resolving.
Age: 74.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inflammatory marker test, Investigation, Pericarditis, Pneumonitis, Red blood cell sedimentation rate
Clinical narrative: Red blood cell sedimentation rate: 35; Inflammation in my pericardial sac of my heart, around my heart my lungs; Inflammation in my pericardial sac of my heart, around my heart my lungs; This is a spontaneous report from a contactable consumer (patient). A 74-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202) via an unspecified route of administration, administered in left arm on 27Feb2021 (at the age of 74-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included heart valve replacement and heart surgery. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269) on 06Feb2021 (at the age of 74-year-old) for COVID-19 immunisation. Concomitant medications included prednisone (PREDNISONE) for atrial fibrillation prophylaxis; colchicine (COLCHICINE) for atrial fibrillation prophylaxis; amiodarone (AMIODARONE) for atrial fibrillation prophylaxis; losartan (LOSARTAN) taken for an unspecified indication; metoprolol (METOPROLOL) and  rivaroxaban (XARELTO) taken for an unspecified indication. On an unspecified date after vaccination patient underwent lab test and procedures which included inflammatory marker test that showed the patient's inflammation markers was way up the charts, patient had a lot of laboratory work with unknown result and had a red blood cell sedimentation rate of 35. It was reported that the patient had a huge inflammatory response and experienced inflammation in the pericardial sac of the heart; around the heart and lungs on 09Mar2021. The patient was inquiring if the company has any information on this that could help the situation. Outcome of events was unknown.
Age: 74.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Red blood cell sedimentation rate: 35; Inflammation in my pericardial sac of my heart, around my heart my lungs; Inflammation in my pericardial sac of my heart, around my heart my lungs; This is a spontaneous report from a contactable consumer (patient). A 74-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202) via an unspecified route of administration, administered in left arm on 27Feb2021 (at the age of 74-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included heart valve replacement and heart surgery. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269) on 06Feb2021 (at the age of 74-year-old) for COVID-19 immunisation. Concomitant medications included prednisone (PREDNISONE) for atrial fibrillation prophylaxis; colchicine (COLCHICINE) for atrial fibrillation prophylaxis; amiodarone (AMIODARONE) for atrial fibrillation prophylaxis; losartan (LOSARTAN) taken for an unspecified indication; metoprolol (METOPROLOL) and  rivaroxaban (XARELTO) taken for an unspecified indication. On an unspecified date after vaccination patient underwent lab test and procedures which included inflammatory marker test that showed the patient's inflammation markers was way up the charts, patient had a lot of laboratory work with unknown result and had a red blood cell sedimentation rate of 35. It was reported that the patient had a huge inflammatory response and experienced inflammation in the pericardial sac of the heart; around the heart and lungs on 09Mar2021. The patient was inquiring if the company has any information on this that could help the situation. Outcome of events was unknown.
Age: 74.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Chest X-ray, Chest pain, Computerised tomogram, Echocardiogram
Clinical narrative: Red blood cell sedimentation rate: 35; Inflammation in my pericardial sac of my heart, around my heart my lungs; Inflammation in my pericardial sac of my heart, around my heart my lungs; This is a spontaneous report from a contactable consumer (patient). A 74-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202) via an unspecified route of administration, administered in left arm on 27Feb2021 (at the age of 74-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included heart valve replacement and heart surgery. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269) on 06Feb2021 (at the age of 74-year-old) for COVID-19 immunisation. Concomitant medications included prednisone (PREDNISONE) for atrial fibrillation prophylaxis; colchicine (COLCHICINE) for atrial fibrillation prophylaxis; amiodarone (AMIODARONE) for atrial fibrillation prophylaxis; losartan (LOSARTAN) taken for an unspecified indication; metoprolol (METOPROLOL) and  rivaroxaban (XARELTO) taken for an unspecified indication. On an unspecified date after vaccination patient underwent lab test and procedures which included inflammatory marker test that showed the patient's inflammation markers was way up the charts, patient had a lot of laboratory work with unknown result and had a red blood cell sedimentation rate of 35. It was reported that the patient had a huge inflammatory response and experienced inflammation in the pericardial sac of the heart; around the heart and lungs on 09Mar2021. The patient was inquiring if the company has any information on this that could help the situation. Outcome of events was unknown.
Age: 74.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Endoscopy, Laboratory test, Pericarditis
Clinical narrative: Red blood cell sedimentation rate: 35; Inflammation in my pericardial sac of my heart, around my heart my lungs; Inflammation in my pericardial sac of my heart, around my heart my lungs; This is a spontaneous report from a contactable consumer (patient). A 74-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202) via an unspecified route of administration, administered in left arm on 27Feb2021 (at the age of 74-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included heart valve replacement and heart surgery. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269) on 06Feb2021 (at the age of 74-year-old) for COVID-19 immunisation. Concomitant medications included prednisone (PREDNISONE) for atrial fibrillation prophylaxis; colchicine (COLCHICINE) for atrial fibrillation prophylaxis; amiodarone (AMIODARONE) for atrial fibrillation prophylaxis; losartan (LOSARTAN) taken for an unspecified indication; metoprolol (METOPROLOL) and  rivaroxaban (XARELTO) taken for an unspecified indication. On an unspecified date after vaccination patient underwent lab test and procedures which included inflammatory marker test that showed the patient's inflammation markers was way up the charts, patient had a lot of laboratory work with unknown result and had a red blood cell sedimentation rate of 35. It was reported that the patient had a huge inflammatory response and experienced inflammation in the pericardial sac of the heart; around the heart and lungs on 09Mar2021. The patient was inquiring if the company has any information on this that could help the situation. Outcome of events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted COVID after receiving first dose of Pfizer Covid 19 vaccine; Contracted COVID; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient contracted COVID after receiving first dose of BNT162B2. Outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on the plausible temporal relation between vaccination with BNT162B2 and the onset of Covid 19 in the patient, the association between the two cannot be ruled out. However, Covid 19 mostly is an intercurrent illness.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Cardiac arrest, Heart rate irregular, SARS-CoV-2 test, Speech disorder
Clinical narrative: Heart became irregular; Bad spell; Assistole pause; Atrial flutter; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 11Mar2021 at 09:00 AM. Relevant medical history included atrial fibrillation, spinal stenosis and disk problems. Known allergies: No. Relevant concomitant drug included metoporal, flexinide, alopurinol, hydrocodone bitartrate, paracetamol (NORCO).  The patient previously received the first dose of BNT162B2 for COVID-19 immunisation on 04Feb2021 at 12:00 PM.  After 3 days following the second vaccination, patient's heart became irregular (in spite of medications) on 14Mar2021 at 12:00 PM. The patient was hospitalized after bad spell and had assistole pause, had atrial flutter, had ablation over a period of 2 months. The patient was hospitalized for one day due to the events. Treatment therapy included Medication and pacemaker on later date. The outcome of events was resolving.   Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care needed.  The patient had COVID test (Nasal Swab) on 06Apr2021 and 15May2021, both with negative result. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/ batch number has been requested.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Syncope
Clinical narrative: fainted morning after shot.; Sore arm; Headache all day; tired; This is a spontaneous report from a contactable consumer reported for self. This 14-year-old patient of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: Ew0177) at single dose in left arm on 18May2021 16:00 for COVID-19 immunisation. There was no medical history, no allergies. Concomitant medication 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021 07:30, patient fainted morning after shot, experienced sore arm, headache all day, tired. There was no treatment received for the events. The reporter considered report as non-serious, not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was resolving.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID/infection of the lungs; This is a spontaneous report from a contactable consumer. An 81-Year-Old female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Mar2021 for COVID-19 immunisation. Medical history and concomitant drugs were not provided. The patient was supposed to get the 2nd dose on 25Mar2021 - Patient tested positive for COVID on 14Mar2021 due to exposure to her husband who has COVID infection (husband age: 80 something according to her wife; Tested positive for COVID on 11 Mar2021) - She received an antibody infusion due to infection of the lungs - She was not able to get the 2nd dose since she was advised to wait 90 days before getting the 2nd dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: bells palsy within 72 hrs on same side as injection; This is a spontaneous report from a contactable consumer reporting for self. This 48-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in left arm on 07May2021 02:00 PM (Lot Number: EW0168) at single dose for COVID-19 immunization. The patient is not pregnant. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included OTC cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE). The patient had allergy to famotidine (PEPCID). The patient previously received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in left arm on 16Apr2021 01:15 PM (Lot Number: ER8731) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced bells palsy within 72 hours on same side as injection. The event start date was reported as 09May2021. The event resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The patient was tested nasal swab (Abbott Binax) on 17May2021 with negative result. The patient received prednisone and valacyclovir as treatment. The outcome of event was recovering.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Swelling face, Throat tightness
Clinical narrative: Slight puffiness on her left cheek; Swollen lymph nodes; Light tightness in her throat; Her lymph nodes remain just a little tender but are no longer swollen; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), via an unspecified route of administration in arm left on 14May2021 08:00 at single dose for COVID-19 immunisation. Medical history included triple coronary artery bypass graft (CABG) on 20Apr2019, and deep vein thrombosis (DVT) and pulmonary embolism (PE) blood clots following a surgery 2 years before. Concomitant medications included simvastatin taking for a year and a half at 100 mg one time per day for blood cholesterol, fenofibrate taking for years at 145 mg tablet one time a day by mouth for blood cholesterol, apixaban (ELIQUIS) at 5 mg tablet twice a day by mouth for blood clots from 20Apr2019, alendronate sodium (FOSAMAX) taking for about 6 months or so at 35 mg one tablet on Mondays for bone density abnormal, eicosapentaenoic acid ethyl ester (VASCEPA) at 1VM capsule, 2 capsules in the morning and 2 capsules at night, and a lot of vitamins taking for years. The patient experienced a slight puffiness on her left cheek, very swollen lymph nodes, and light tightness in her throat when she woke up on 15May2021. She said she took diphenhydramine hydrochloride (BENADRYL) which helped make her feel better. She thought she only had a mild reaction since she did not feel the need to call (with held). Patient wanted to know if she should still receive the 2nd dose based on the reaction she had with the 1st dose. They told her if she had a reaction she would have within a few minutes or an hour of getting the vaccine, she was just different, she would have reactions to some things the next day. Within a day the lymph nodes went down and she felt like it had cleared up, her lymph nodes remained just a little tender but were no longer swollen. Outcome of the events was resolving.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, Full blood count, Haemorrhage, Lip swelling
Clinical narrative: Rashes and those rash become swollen; face become swollen; itching; very painful; Lips become swollen; She is bleeding so much of bleeding from there; This is a spontaneous report from a contactable consumer (patient's daughter). A 66-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration on 12May2021 (Batch/Lot Number: EW0172) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, high blood pressure and high cholesterol. Concomitant medications included amlodipine; insulin lispro (HUMALOG), empagliflozin, linaglipin, metformin hcl (TRIJARDY XR) and lovastatin all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on unspecified date for Covid-19 immunization. On 15May2021, 2 days after vaccine administration, it was reported that the patient's body reacted to the vaccine. The side effect which the patient got was in the form of rashes and those rash become swollen and her face become swollen and is very itching and very painful, her lips become swollen. The daughter went to almost all doctors in urgent care and they are giving basically allergy medication but the allergy medications that they are giving is making worse. And the doctor says this is new for them so they don't know why her body is reacting to the vaccine like this. The patient was administered with treatment medications which includes Prednisone, Pepcid, Benadryl, Claritin, she also got Solu-Medrol, which the daughter reported was making the events worse and now the doctors ae not doing anything. Because the patient was given steroids her sugar and WBC came up. The daughter also reported she is bleeding so much of bleeding from there. The patient underwent blood test on 15May2021, 16May2021 and 17May2021 which were normal. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, SARS-CoV-2 test, Swelling face
Clinical narrative: Rashes and those rash become swollen; face become swollen; itching; very painful; Lips become swollen; She is bleeding so much of bleeding from there; This is a spontaneous report from a contactable consumer (patient's daughter). A 66-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration on 12May2021 (Batch/Lot Number: EW0172) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, high blood pressure and high cholesterol. Concomitant medications included amlodipine; insulin lispro (HUMALOG), empagliflozin, linaglipin, metformin hcl (TRIJARDY XR) and lovastatin all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on unspecified date for Covid-19 immunization. On 15May2021, 2 days after vaccine administration, it was reported that the patient's body reacted to the vaccine. The side effect which the patient got was in the form of rashes and those rash become swollen and her face become swollen and is very itching and very painful, her lips become swollen. The daughter went to almost all doctors in urgent care and they are giving basically allergy medication but the allergy medications that they are giving is making worse. And the doctor says this is new for them so they don't know why her body is reacting to the vaccine like this. The patient was administered with treatment medications which includes Prednisone, Pepcid, Benadryl, Claritin, she also got Solu-Medrol, which the daughter reported was making the events worse and now the doctors ae not doing anything. Because the patient was given steroids her sugar and WBC came up. The daughter also reported she is bleeding so much of bleeding from there. The patient underwent blood test on 15May2021, 16May2021 and 17May2021 which were normal. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Rashes and those rash become swollen; face become swollen; itching; very painful; Lips become swollen; She is bleeding so much of bleeding from there; This is a spontaneous report from a contactable consumer (patient's daughter). A 66-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration on 12May2021 (Batch/Lot Number: EW0172) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, high blood pressure and high cholesterol. Concomitant medications included amlodipine; insulin lispro (HUMALOG), empagliflozin, linaglipin, metformin hcl (TRIJARDY XR) and lovastatin all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on unspecified date for Covid-19 immunization. On 15May2021, 2 days after vaccine administration, it was reported that the patient's body reacted to the vaccine. The side effect which the patient got was in the form of rashes and those rash become swollen and her face become swollen and is very itching and very painful, her lips become swollen. The daughter went to almost all doctors in urgent care and they are giving basically allergy medication but the allergy medications that they are giving is making worse. And the doctor says this is new for them so they don't know why her body is reacting to the vaccine like this. The patient was administered with treatment medications which includes Prednisone, Pepcid, Benadryl, Claritin, she also got Solu-Medrol, which the daughter reported was making the events worse and now the doctors ae not doing anything. Because the patient was given steroids her sugar and WBC came up. The daughter also reported she is bleeding so much of bleeding from there. The patient underwent blood test on 15May2021, 16May2021 and 17May2021 which were normal. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Pain in extremity, Wrong product administered
Clinical narrative: Received the Moderna COVID vaccine on Monday and then on Tuesday she was given the Pfizer COVID 19 vaccine; Received the Moderna COVID vaccine on Monday and then on Tuesday she was given the Pfizer COVID 19 vaccine; Experienced a sore arm; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program . A 76-year-old female patient (reporter's aunt) received 1st dose of NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date (reported as "Tuesday") and Moderna COVID vaccine at an unknown dose on an unknown date (reported as "Monday") , both via an unknown route for Covid-19 immunization. Medical history included ongoing dementia that didn't realize how bad it was. It was only little things like forgetting to pat her cable bill. Patient had memory problems before getting Pfizer vaccine and the reporter stated that it was worse than they thought. The patient received the Moderna COVID vaccine on Monday and then on Tuesday she was given the Pfizer COVID 19 vaccine. A family member picked her up on Monday to take get to get her shot and then on Tuesday a different family member picked her up and asked her if she needed to get her shot and she said yes because she didn't remember getting the shot the day before. Patient experienced a sore arm after getting the Pfizer vaccine.  Outcome of the events was unknown. The report was assessed as non-serious.   Information about the lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Had severe side pain; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 16May2021 13:00 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe side pain on 17May2021 00:00 which resulted in hospitalization. Outcome of the event was not recovered. Therapeutic measures were taken as a result of severe side pain.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid virus after the first dose of vaccine; Tested positive for Covid virus after the first dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received her first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration on 29Apr2021 (lot number not provided), at age of 27-year-old, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid at some point after her first dose of the vaccine. She then tested negative for Covid on 14May2021. Her second dose is due 20May2021. She wanted to know if she needed to wait to get the second dose of the vaccine or can she proceed with the second dose as scheduled. The outcome of the event was unknown.  Information about lot/batch number is requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Stridor, Wheezing
Clinical narrative: wheezing; stridor; breathing difficulties; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 16Apr2021 09:30 (Lot Number: EW0169) at the age of 40-year-old, as 2nd dose, single for covid-19 immunisation. Medical history included asthma (Was diagnosed with this when the caller was 2 years old, 38 years ago), familial medullary thyroid cancer (The caller was diagnosed with this 30 years ago). Historical vaccine included first dose of bnt162b2 (lot: ER8733, Route of administration: left arm, appointment time was 1615) on 23Mar2021 and the patient had breathing difficulties, wheezing and coughing. Concomitant medication included salbutamol sulfate (PROAIR HFA) taken for an unspecified indication, start and stop date were not reported. The patient had breathing difficulties after the second dose Pfizer Covid 19 Vaccine: After receiving the second dose Pfizer Covid 19 Vaccine the patient stated roughly the same thing that happened after the first dose Pfizer Covid 19 Vaccine occurred, but it occurred a lot faster. The patient clarified she had breathing difficulties after the second dose Pfizer Covid 19 Vaccine. She had stridor and wheezing and was also injected with an epi pen in the ambulance and they put the patient on other drugs. The breathing difficulties began 15 minutes after the patient received the second dose Pfizer Covid 19 Vaccine. The patient stated the breathing difficulties were not ongoing now. The breathing difficulties subsided mostly, patient not 100% certain, but after the patient was given Benadryl in the ambulance. The patient started to feel better and was given O2 and albuterol through a mask. The patient stated the effects after receiving the second dose Pfizer Covid 19 Vaccine were much worse. The patient was not 100% certain this has gone away. The patient was using her inhaler significantly more often after this occurred. The patient was discharged from the emergency room on both occasions. The outcome of breathing difficulties was recovered, of wheezing and stridor was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Dysphagia
Clinical narrative: She couldn't swallow 30 minutes after receiving the vaccine/difficulty swallowing; light headiness; dry mouth; This is a spontaneous report from a contactable nurse (patient).  A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm at age of 75 years old on 22Jan2021 (Batch/Lot Number: EL1283) as single dose for covid-19 immunization. Medical history included anaphylaxis. The patient's concomitant medications were not reported. After receiving the first dose of the vaccine on 22Jan2021, patient reported extreme dry mouth and light headiness. She couldn't swallow (difficulty swallowing) 30 minutes after receiving the vaccine. She wasn't sure if this was related to the dry mouth or not. It all went away the same day. Patient wanted to know if she can receive the second dose of the vaccine or not. The patient had odd symptoms after the vaccination, after she left the clinic area. The first symptom she experienced was extreme dry mouth. She was slammed with dry mouth. Right after she left her 15 minutes wait period. She also experienced light headedness. Then, on the way home about a half an hour (30min) after the injection (she only stayed 15 min) she couldn't swallow. She went to take a sip of water because of her dry mouth and couldn't swallow. Then, 10 minutes later she was fine. It could of been because of the dry mouth that she couldn't swallow. She stayed light headed at home for an hour. She took Benadryl and went to sleep. This all happened the same day on 22Jan2021. She recovered completely. She hasn't received the second dose because of the odd reaction. It has been 3 months this week from her initial dose. She is not sure whether to go have the second injection or not. This report was provided as non-serious. Therapeutic measures were taken as a result of dry mouth, light headiness, couldn't swallow and included Benadryl. The outcome of the events were recovered on 22Jan2021.  Follow up needed, further information was requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: spike in blood in blood sugar; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single and as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter noticed a spike in blood in blood sugar following first dose of the patient, still manageable with insulin. Following second dose, blood sugar was not manageable with insulin. Said her insulin "acted like water, no effect." Asked to speak with medical professional to see if we have information on vaccine affecting blood sugar. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: immunocompromised; This is a spontaneous report from a contactable consumer (patient caregiver). A 72-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported.  She had a kidney transplant 20 years ago, is immunocompromised after receiving the Pfizer covid vaccine. She has already had both of the COVID vaccines. The outcome of the event is unknown.   Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Feeling abnormal, Paraesthesia, Vision blurred
Clinical narrative: I am freaking out and don't want to be permanently paralyzed.; 25 min ago my left eye became slightly blurred; left side of my face and left my eye were/are tingling/the  left side of my forehead/temple area started tingling; I am freaking out and don't want to be permanently paralyzed.; This is a spontaneous report from a contactable consumer (patient).  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 19May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for Covid-19 immunization. It was reported that the patient received her 2nd Pfizer dose, in her left arm 2 hours ago (on 19May2021) and then she noticed the left side of her face and left her eye were tingling. She stated this started about 1 hour and 40 min after receiving her 2nd vaccine dose, 25 min ago her left eye became slightly blurred and the left side of her forehead/temple area started tingling. She was freaking out and doesn't want to be permanently paralyzed. She asked if these are expected side effects and what she should do. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Further information has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Infection, SARS-CoV-2 test
Clinical narrative: have a Infected abscess and the infection got really bad at the Same time as my vaccination; serious "brain fog"; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 11:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 51-year-old. Medical history included Infected abscess. The patient previously took the bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 51-year-old. The patient received Antibiotics within 2 weeks of vaccination, but no other vaccines within 4 weeks prior to the COVID vaccine. The patient reported I had 12 of the side effects but 2 weeks later, and after missing 2 weeks of work I still have serious "brain fog".  I have an Infected abscess and the infection got really bad at the Same time as my vaccination. The events started on 10May2021 12:00, and result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. The patient was put on antibiotics. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination but tested for COVID-19 on 15May2021 with negative result.  Information on lot number/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased
Clinical narrative: Accelerated heart rate of 135-150bpm; fatigue/tiredness; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's mother). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16May2021 (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of bnt162b2 on 25Apr2021. The patient's medical history and concomitant  medications were not reported. After receiving the second dose, the following day on 17May2021, patient experienced an accelerated heart rate of 135-150 bpm. Her resting pulse is 80 bpm. Patient also experienced fatigue and tiredness. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A 3-decade-old (in her 20s) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Feb2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The pharmacist stated a patient in her 20's had first dose in Feb2021, resulting in anaphylaxis. HCP asking patient to receive an additional dose, followed by a second dose. The pharmacist was doing vaccines with patients and she was getting ready to restart the vaccine for a patient that had the vaccine done at another location and had a reaction back in Feb2021. The pharmacist stated she needed to find out if there has been any instances like that and what she should do. The pharmacist stated the patient had an anaphylactic reaction and had to be taken to the hospital. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile and temporal association, the causal relationship between bnt162b2 and the event anaphylactic reaction cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood lactate dehydrogenase increased, Blood test
Clinical narrative: LDH lab test result came back very high; This is a spontaneous report from a contactable consumer (patient).  A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Mar2021 at the age of 63-years-old (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient received the second dose of the Pfizer Covid-19 vaccine on 31Mar2021. She stated that she had blood work performed on 03May2021, in which her LDH lab test result came back very high. She stated that she had never had this testing performed before and her doctor was referring her to a hematologist. She stated that her doctor believed the vaccine could have affected her LDH lab result. She was asking if the vaccine can elevate the LDH level. The patient underwent lab tests and procedures which included bloodwork: ldh lab test result came back very high on 03May2021, abnormal bloodwork: elevation of LDH, lactate dehydrogenase.  The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Hypertension, SARS-CoV-2 test negative
Clinical narrative: bloody nose/HBP; bloody nose/HBP; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 13Mar2021 at 11:30 (Batch/Lot Number: EN9262, Expiration date: unknown) as the 2nd dose, single for COVID-19 immunization. The patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in the left arm on 19Feb2021 at 10:30 AM at the age of 79 years old (Batch/Lot number: EN6198) for COVID-19 immunization. The vaccine facility type was reported as the urgent care center. Relevant medical history included some digestive issues on an unspecified date in the past, skin cancer (CA) in 1985/1993, and basal cell on an unspecified date with ongoing basal cell on face biopsy from 14Feb2021. There were no concomitant medications. The patient was very healthy and never had any high blood pressure (HBP) and no prescription (Rx) needed or medicine. The patient had no prior vaccination. On 17Mar2021 at 18:30, the patient experienced bloody nose/HBP, which were considered as important medical events. The patient also had bloody nose/HBP on 21Mar2021 at 18:30 and on 28Mar2021 at 19:00. The adverse events (AE) required the patient to visit the emergency room and then to the physician office. The patient underwent lab tests and procedures, which included COVID-19 test: negative on 12Feb2021. Therapeutic measures were taken as a result of HBP, which included Rx for high blood pressure including amlodipine 10 mg. The patient did not receive any treatment for bloody nose. The patient was advised to stop Rx if electrocardiogram (EKG) was abnormal. The patient recovered from the events on an unspecified date in 2021.