chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Urinary tract infection
Clinical narrative: Little bit of sore arm; Pressure in the vaginal area and I think it might be Urinary tract infection; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH 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 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced little bit of sore arm and pressure in the vaginal area and the patient think it might be urinary tract infection and patient thought it probably 99% nothing to do with the vaccine. The patient confirmed that It's 6 days after receive the vaccine, no other complications, no other side effects." The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium test, Diarrhoea, Helicobacter test, Weight decreased
Clinical narrative: having weight issues, probably a little bit because of what was going on. Dropped 10lbs to 12lbs in the past couple months; Severe diarrhea 3 days after that dose that lasted for 2.5 weeks/ diarrhea returned 3 dayts later and is still persisting This is a spontaneous report from Pfizer. A contactable female consumer reported for herself. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 31May2021), dose 1 via an unspecified route of administration on 21Jan2021 as single dose, and dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EK4176; Expiration Date: 31May2021) as dose 2, single (at the age of 62-year-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included famotidine 20 mg taken for stomach pain from 14Jan2021 to an unspecified stop date. Caller reported that she received the first dose of the Pfizer Covid 19 vaccine on 21Jan2021 and experienced severe diarrhea on 24Jan2021, 3 days after first dose that lasted for 2.5 weeks. Started to get better and had two days that were relatively normal. Then she received the second dose on 11Feb2021 and the diarrhea returned 3 days later and was still persisting. It has been five weeks now of diarrhea. She also stated that sometimes the diarrhea would get a little better, but sometimes it would come back really bad. She was having weight issues, probably a little bit because of what was going on. Dropped 10lbs to 12lbs in the past couple months. She was usually between 118-120lbs, but now is about 108lbs. She reported that before the first COVID vaccine, she had been taking Famotidine for a week for stomach pain that she has been having for a long time. Stated maybe that was it. Stopped Famotidine on the 11th day. Was on Famotidine for a full week before symptoms came up. Has stopped the Famotidine and it never went away. Hadn't taken Famotidine for almost five weeks now. The patient underwent lab tests and procedures which included clostridium test (C-diff) and helicobacter test which was negative on an unspecified date. She was taking Imodium to stop it. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Decreased appetite, Dyspnoea, Erythema
Clinical narrative: Panic Attack feeling; Sore to numbness in arm; Sore to numbness in arm; hot from neck down to torso; sharp hot prickly feeling throughout the area; Redness in neck; Tightness of chest; shortness of breath; Disgust of food; loss of appetite; major fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number was not reported) dose 1, via an unspecified route of administration on 26Feb2021 14:45 (at 33-years of age) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, survivor of cancerous ovarian cysts from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (IBUPROFEN) taken for an unspecified indication, IUD, ibuprofen, inhaler, vitamins start and stop date were not reported. The patient previously took caffeine and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient had Known allergies: Sulfa results into violent allergy and caffeine must be kept to a minimum or none at all. It was reported that on 26Feb2021 at 09:00 pm, patient experienced Panic Attack feeling all day following the injection. Sore to numbness in arm, hot from neck down to torso, sharp hot prickly feeling throughout the area. Redness in neck Tightness of chest and shortness of breath...inhaler was needed throughout the day. Disgust of food and loss of appetite with major fatigue throughout the entire day. The outcome of the events was unknown. Therapeutic measures were taken as a result of shortness of breath (dyspnoea).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Food aversion, Hot flush, Hypoaesthesia, Pain in extremity
Clinical narrative: Panic Attack feeling; Sore to numbness in arm; Sore to numbness in arm; hot from neck down to torso; sharp hot prickly feeling throughout the area; Redness in neck; Tightness of chest; shortness of breath; Disgust of food; loss of appetite; major fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number was not reported) dose 1, via an unspecified route of administration on 26Feb2021 14:45 (at 33-years of age) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, survivor of cancerous ovarian cysts from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (IBUPROFEN) taken for an unspecified indication, IUD, ibuprofen, inhaler, vitamins start and stop date were not reported. The patient previously took caffeine and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient had Known allergies: Sulfa results into violent allergy and caffeine must be kept to a minimum or none at all. It was reported that on 26Feb2021 at 09:00 pm, patient experienced Panic Attack feeling all day following the injection. Sore to numbness in arm, hot from neck down to torso, sharp hot prickly feeling throughout the area. Redness in neck Tightness of chest and shortness of breath...inhaler was needed throughout the day. Disgust of food and loss of appetite with major fatigue throughout the entire day. The outcome of the events was unknown. Therapeutic measures were taken as a result of shortness of breath (dyspnoea).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: Panic Attack feeling; Sore to numbness in arm; Sore to numbness in arm; hot from neck down to torso; sharp hot prickly feeling throughout the area; Redness in neck; Tightness of chest; shortness of breath; Disgust of food; loss of appetite; major fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number was not reported) dose 1, via an unspecified route of administration on 26Feb2021 14:45 (at 33-years of age) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, survivor of cancerous ovarian cysts from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (IBUPROFEN) taken for an unspecified indication, IUD, ibuprofen, inhaler, vitamins start and stop date were not reported. The patient previously took caffeine and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient had Known allergies: Sulfa results into violent allergy and caffeine must be kept to a minimum or none at all. It was reported that on 26Feb2021 at 09:00 pm, patient experienced Panic Attack feeling all day following the injection. Sore to numbness in arm, hot from neck down to torso, sharp hot prickly feeling throughout the area. Redness in neck Tightness of chest and shortness of breath...inhaler was needed throughout the day. Disgust of food and loss of appetite with major fatigue throughout the entire day. The outcome of the events was unknown. Therapeutic measures were taken as a result of shortness of breath (dyspnoea).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
Clinical narrative: BP went up 170/90; increased heart rate and pulse; This is a spontaneous report from a contactable nurse (patient). This 55-year-old (non-pregnant) female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL0140, expiration date: not reported) via an unspecified route of administration into the left arm on 19Feb2021 13:30 (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient medical history included hyperthyroid, PSA, rapid pulse, Vit D and magnesium deficiency, headaches. Concomitant medications included atenolol; apremilast (OTEZLA); levothyroxine; vitamin d nos (VITAMIN D); magnesium. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL0140) via an unspecified route of administration into the left arm on 25Jan2021 10:30 AM (at the age of 55-year-old) as single dose for COVID-19 immunisation at Hospital. No other vaccine in four weeks. No COVID prior vaccination nor tested post vaccination. No known allergies. A day after shot, on 20Feb2021, at around 17:30 PM, the patient experienced BP went up 170/90 and increased heart rate (112) and pulse. This continued the day after injection on 21Feb2021 (Saturday) and on 21Feb2021 (Sunday) off and on. This also continued after medications were taken for increased heart rate and pulse. Her BP and heart rate always responded to medication. Currently, it was 22Feb2021 (Monday) and so far, vital signs (V/S) were normal. Unspecified treatment was taken for BP went up 170/90. No other treatments received. Outcome was resolving for both the events. Follow-up attempts completed. No further information expected.; Sender's Comments: Based on temporal relationship, the association between the event BP refractory to medication after vaccination can not be fully excluded. History of hyperthyroid may also be contributory.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: First 48 hours fever(102); Chills; Headache; Vomiting; Fatigue; Diarrhea; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 6203) via an unspecified route, administered in Right Arm on 22Feb2021 at 16:30 (53-year-old of age at vaccination) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, known allergies to amoxicillin. The patient's concomitant medications included Emtricitabine, Tenofovir Disoproxil Fumarate (TRUVADA), propranolol (PROPRANOLOL), Olmesartan (OLMESARTAN) and diltiazem (DILTAZEM). The patient had not received any other vaccine in four weeks prior to covid-19 vaccine. The patient did not have covid prior vaccination. On 22Feb 2021, the patient experienced fever (102) for first 48 hours, chills, headache, diarrhea, vomiting, and fatigue. After day two (unknown date in Feb2021) diarrhea and extreme fatigue through day 6. The patient had not received any treatment medication for the resulted events. The patient was not covid tested post vaccination. The outcome of the events was not recovered.  No follow up attempts are possible. No further information was expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: First 48 hours fever(102); Chills; Headache; Vomiting; Fatigue; Diarrhea; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 6203) via an unspecified route, administered in Right Arm on 22Feb2021 at 16:30 (53-year-old of age at vaccination) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, known allergies to amoxicillin. The patient's concomitant medications included Emtricitabine, Tenofovir Disoproxil Fumarate (TRUVADA), propranolol (PROPRANOLOL), Olmesartan (OLMESARTAN) and diltiazem (DILTAZEM). The patient had not received any other vaccine in four weeks prior to covid-19 vaccine. The patient did not have covid prior vaccination. On 22Feb 2021, the patient experienced fever (102) for first 48 hours, chills, headache, diarrhea, vomiting, and fatigue. After day two (unknown date in Feb2021) diarrhea and extreme fatigue through day 6. The patient had not received any treatment medication for the resulted events. The patient was not covid tested post vaccination. The outcome of the events was not recovered.  No follow up attempts are possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract Infection; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 19Feb2021, as dose 1, single, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021, after the administration of first dose of vaccine, the patient experienced Urinary Tract Infection. The patient was prescribed with an antibiotic for treatment by her physician. But she has not started the prescribed medication. Patient wanted to know whether it was kay to take antibiotics after the first dose or before taking the second dose of BNT162B2. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Insomnia, Pain in extremity
Clinical narrative: couple of nights ago, the pain in her toes; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Lot Number: EL9267) at the age of 73-year-old as DOSE 1, SINGLE for covid-19 immunisation; lidocaine (ASPERCREME [LIDOCAINE]), via an unspecified route of administration from an unspecified date (Lot numbe: 170112 also reported as 17D112, expiry date: Apr2020) to Feb2021, at unspecified dose for pain in her toes. Medical history included neuropathy peripheral, diabetes, pain in her toes, a burning pain like a blister, lung cancer 10 years ago. Concomitant medication included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported (she has been on it 10 years plus). The patient said that 2 weeks prior to receiving the vaccine, she used Aspercreme to treat the pain in her toes, on the middle three toes on her foot. The Aspercreme takes the pain away. It is like a burning pain like a blister. She stopped using Aspercreme after receiving the vaccine and wants to know how long she should wait to use it again. She stopped using anything that she didn't normally use. Aspercreme: she hardly ever uses it. She only uses it for pain like that. She only did it because she was in such pain. She thought she would give it a whirl and it worked. She puts it on once and the pain goes away. She last use Aspercreme two days before getting the vaccine. It has expired, but it worked. The lot number is 170112 or it could be 17D112. She had stopped using it because she read an article. She has been following the COVID vaccine and the article said not to take Tylenol or Advil. She was not sure if the Aspercreme would have similar ingredients and didn't want to interfere. She said she was just concerned since a couple of nights ago, the pain in her toes was so bad she could not sleep. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-years-old female (Non-pregnant) patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 27Feb2021 11:00 as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that the patient had no allergies. The patient did not receive any other vaccine in four weeks. No other medications in two weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that on 6Feb2021 had my first Pfizer vaccine and within 24 hours developed diarrhoea - it lasted about 4 days - received my second vaccine on 27Feb2021 -Again, within 24 hours developed diarrhoea again on 28Feb2021 08:15 once again taking Pepto-Bismol. It has been 48 hours since my second vaccine. The outcome of event not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dysgeusia, Pollakiuria, Urinary tract infection
Clinical narrative: UTI; Frequent urination; amber to brown urine; tasted bitter; This is a spontaneous report from a non contactable consumer reported similar events for herself, her husband and 2 other people. This report is for reporter self. A 66-Year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration into the left arm on 16Feb2021 12:15 PM (at the age of 66-years-old) as dose 2, single for covid-19 immunization. No medical history and concomitant medications were not reported. It was reported that the patient had no allergies and other medical history. The patient previously took historical vaccine dose 1 on an unspecified date for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date patient experienced feeling like she had UTI(urinary tract infection), frequent urination, amber to brown urine. Everything she put into her mouth tasted bitter for a day. Had shot Sunday and everything still tastes bitter. It's Tuesday. The patient did not received any treatment for adverse events. The clinical outcome of the events were not recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225203 same reporter/drug with different patient, similar AE;US-PFIZER INC-2021225201 same reporter/drug with different patient, similar AE;US-PFIZER INC-2021225202 same reporter/drug with different patient, similar AE
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: she had steroid shots a week ago because of her back pain; This is a spontaneous report from consumer (patient) a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 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 medical history and concomitant medications were not reported. It was reported that the patient had steroid shots a week ago because of her back pain. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Mild Fever; chills; Body aches; General Malaise; This is a spontaneous report from a contactable other hcp (patient). This Other HCP reported in response to HCP letter sent in a cross reference case which included. A 36-years-old male patient received first dose bnt162b2 (BNT162B2, Formulation for injection, Batch/Lot Number: EL0140) via intramuscular route of administration in Deltoid Left on 21Dec2020 10:15 (at the age of 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication from 1998 to an unspecified stop date; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported. On 21Dec2020 14:00, the patient had body aches and general malaise. On 21Dec2020 18:00 the patient experienced mild fever and chills. The patient did not receive treatment for events.  AEs did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2020. The outcome of the events mild fever, chills, body aches, general malaise was recovered on 22Dec2020. There was a reasonable possibility that the event is related to suspect product/s.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Ear infection
Clinical narrative: ear infection; ear problem; This is a spontaneous report from a Pfizer (CEP 159558). A contactable consumer reported that, a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that, she received first dose of covid-19 vaccine. Patient had second dose scheduled 4Mar2021. Patient wanted to know if it is okay to take Antibodies if provided, for her ear problem or ear infection (date unspecified). Outcome of both the events were unknown.    Information on lot number/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Infection, Vaccination site pain
Clinical narrative: ct findings may refelect sequelae of atypical infection; Sore left arm; This is a spontaneous report from a contactable consumer or other non hcp. This 83 years old female consumer reported in response to a non-HCP letter sent for a cross reference case that included:  A 83-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 83-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (BNT162B2, solution for injection) via an unspecified route of administration on an unknown date as dose1, single for covid-19 immunisation and experienced not feeling well that evening, chills that night, has developed a cough, heart rate went up. On 16Feb2021, he patient experienced ct findings may refelect sequelae of atypical infection, on an unknown date in Feb2021, patient experienced sore left arm. The patient underwent lab tests and procedures which included computerised tomogram: Mild scattered tree-un-bud nodularity with in the right lower lobe, new as compared to prior on 16Feb2021. Patient had biyearly CT scan of chest. The outcome of the events were unknown.  No follow up attempts are needed. Information on Lot/batch cannot be requested. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Autoimmune disorder, Blood pressure abnormal, Blood pressure measurement, Dizziness
Clinical narrative: Racing heartbeat; Light headedness; I was afraid to stand up; Immunosuppressed, autoimmune problems; Immunosuppressed, autoimmune problems; I have low blood pressure.  Blood Pressure shot up.; Anxiety; This is a spontaneous report from a contactable consumer (patient herself). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE formulation: Solution for injection, Lot number EN6203 and expiration date: 30Jun2021) via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included she was allergic to resin, polymer and fatty acid. Concomitant medications were not reported. Patient previously took epinephrine for which she experienced with allergic. On an unspecified date in Mar2021 patient stared that that she was "Immunosuppressed, autoimmune problems. She was allergic to resin, polymer, fatty acid. She don't have a heart problem. She has low blood pressure. Blood Pressure shot up. She was afraid to stand up. They gave her water. They told her it was anxiety. "Asking if it should receive second dose. States she previously did safety report. When probed about the reaction patient stated "she had a racing heartbeat and light headedness, right five minutes after she got it." On an unspecified date it was reported as treatment was included as consumer stated that "she just sat there. She had to stay. She was afraid to stand up. She thought it was going to be tough. She had to like sit there and they gave her water and just rest until her heartbeat slowed down." Outcome of events was unknown.  Consumer was informed about Pfizer Medical Information and the contact was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Heart rate increased, Immunosuppression
Clinical narrative: Racing heartbeat; Light headedness; I was afraid to stand up; Immunosuppressed, autoimmune problems; Immunosuppressed, autoimmune problems; I have low blood pressure.  Blood Pressure shot up.; Anxiety; This is a spontaneous report from a contactable consumer (patient herself). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE formulation: Solution for injection, Lot number EN6203 and expiration date: 30Jun2021) via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included she was allergic to resin, polymer and fatty acid. Concomitant medications were not reported. Patient previously took epinephrine for which she experienced with allergic. On an unspecified date in Mar2021 patient stared that that she was "Immunosuppressed, autoimmune problems. She was allergic to resin, polymer, fatty acid. She don't have a heart problem. She has low blood pressure. Blood Pressure shot up. She was afraid to stand up. They gave her water. They told her it was anxiety. "Asking if it should receive second dose. States she previously did safety report. When probed about the reaction patient stated "she had a racing heartbeat and light headedness, right five minutes after she got it." On an unspecified date it was reported as treatment was included as consumer stated that "she just sat there. She had to stay. She was afraid to stand up. She thought it was going to be tough. She had to like sit there and they gave her water and just rest until her heartbeat slowed down." Outcome of events was unknown.  Consumer was informed about Pfizer Medical Information and the contact was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Electrocardiogram, Pain in extremity, X-ray
Clinical narrative: The morning after the vaccine, sudden onset of severe left-side chest pains, left arm, and back. Persisted till the next day but gradually got better. No pain after 3rd day.; sudden onset of severe left-side chest pains, left arm,; severe left-side chest pains, left arm, and back.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6202) via an unspecified route of administration (age at vaccination 59-year) in Right Arm on 05Mar2021 15:00 as dose 1, single for COVID-19 immunization. Medical history included Stroke history; early Alzheimers and Diverticulosis from an unknown date and unknown if ongoing. Concomitant medications included Atorvastatin (ATORVASTATIN); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); Gabapentin (GABAPENTIN); famotidine (PEPCID AC) and Tamsulosin (TAMSULOSIN) taken for an unspecified indication, start and stop date were not reported. The patient was having no known allergies. The patient was not tested COVID prior and post vaccination. It was reported that the patient did not received any other vaccine in four weeks. Facility type vaccine was school or student health clinic. On 06Mar2021 08:30 AM in the morning after the vaccine the patient experienced sudden onset of severe left-side chest pains, left arm, and back. persisted till the next day but gradually got better. no pain after 3rd day. The seriousness of the events was serious (medically significant) and AE resulted in visit emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events; AE treatment included: Nitroglycerin, 4 aspirin, lab tests, EKG, X-ray. The clinical outcome of the events was recovered on an unspecified date of Mar2021   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gingivitis, Pain in extremity, Somnolence
Clinical narrative: was very sleepy; pain in his arm; end of the gums at around the wisdom tooth area on the bottom part of the jaw, he noticed white spots that were like pimples. They were infection spots and were painful; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. (Patient, reported for self).  A male patient of (age: 44; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned that he received the 1st dose of the vaccine and experienced side effects. During the 1st day, he was okay. but was very sleepy the day after with a little pain in his arm. About 3-4 days after, he mentioned that at the end of the gums at around the wisdom tooth area on the bottom part of the jaw, he noticed white spots that were like pimples. They were infection spots and were painful. He already consulted his dentist and he cannot determine if this was related to the vaccine. He is due for a follow up in 2 weeks to see if there is improvement. He mentioned that his friends  whose parents also experienced these effects after getting the 2nd dose. He is concerned because he is due for his 2nd dose next week and doesn't want to have any more problems. The clinical outcome of the adverse events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Burning sensation, Chest discomfort, Chills, Decreased appetite
Clinical narrative: Shakes and chills really bad, I couldn't stop shaking; Shakes and chills really bad, I couldn't stop shaking; Sick to the stomach; No appetite; Feeling tired; Have like pressure in my forehead and a little bit in chest; Have like pressure in my forehead and a little bit in chest; burning sensation in my throat and like tightness; burning sensation in my throat and like tightness; neck hurts a lot, just real tight; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient stated, got my second shot on Monday at 10 AM and about 9 PM, got the shakes and chills bad, could not stop shaking, so took two extra strength Tylenol (treatment). I woke up about at 02:45 and was sick to the stomach and again at 03:30, just went up at the sofa with bucket, no appetite, feeling tired, had like pressure in my forehead and a little bit in chest and just like almost burning sensation in my throat and like tightness and my neck hurts a lot, just real tight, had no symptoms after the first shot. Consumer further enquiring about Tylenol, she took oftenly. The outcome of the events was unknown. Therapeutic measures were taken as a result of shakes and chills really bad, could not stop shaking (tremor), shakes and chills really bad, could not stop shaking (chills).  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Neck pain, Throat tightness, Tremor
Clinical narrative: Shakes and chills really bad, I couldn't stop shaking; Shakes and chills really bad, I couldn't stop shaking; Sick to the stomach; No appetite; Feeling tired; Have like pressure in my forehead and a little bit in chest; Have like pressure in my forehead and a little bit in chest; burning sensation in my throat and like tightness; burning sensation in my throat and like tightness; neck hurts a lot, just real tight; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient stated, got my second shot on Monday at 10 AM and about 9 PM, got the shakes and chills bad, could not stop shaking, so took two extra strength Tylenol (treatment). I woke up about at 02:45 and was sick to the stomach and again at 03:30, just went up at the sofa with bucket, no appetite, feeling tired, had like pressure in my forehead and a little bit in chest and just like almost burning sensation in my throat and like tightness and my neck hurts a lot, just real tight, had no symptoms after the first shot. Consumer further enquiring about Tylenol, she took oftenly. The outcome of the events was unknown. Therapeutic measures were taken as a result of shakes and chills really bad, could not stop shaking (tremor), shakes and chills really bad, could not stop shaking (chills).  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: experienced reinfection; experienced reinfection; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced reinfection on an unspecified date. The reporter (daughter) reported that the patient (mother)  experienced reinfection after her first dose of the Covid-19 vaccine. Outcome of the event was unknown.   No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: She had more severe diarrhea; This is a spontaneous report from a contactable consumer. A an 82-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: E29269, NDC number and Expiry Date: Unknown) dose 1 via an unspecified route of administration, administered in the Upper Left Arm on 18Feb2021 (at the age of 82 years old) as a DOSE 1, SINGLE for covid-19 immunisation (it is her best hope for not catching Covid). Patient's medical history included diabetes mellitus from an unknown date and unknown if ongoing Diagnosis date, Reporter stated, "Late 90s, I don't know", hypothyroidism from 1985 to an unknown date, glaucoma from 1988 to an unknown date. Patient also had atrial fibrillation, cardiovascular disorder, urinary incontinence and blood cholesterol abnormal, all from an unknown date and unknown if ongoing. For Other Conditions Diagnosis date was stated by Reporter as, May be 2011 (unspecified).Concomitant medications included insulin lispro (HUMALOG) taken for diabetes mellitus, 6 Units, three times a day before each meal, insulin glargine (LANTUS) taken for diabetes mellitus 8 Units at bed time, atenolol taken for cardiovascular disorder, 50 mg twice a day, dabigatran etexilate mesilate (PRADAXA) taken for atrial fibrillation, 150 mg, twice a day, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, 25 mg, once every other day, losartan taken for an unspecified indication, 100 mg once a day, levothyroxine sodium (SYNTHROID) taken for hypothyroidism, One day 50 mcg and other day 75 mcg, simvastatin taken for blood cholesterol abnormal, 10 mg, once a day, metformin hydrochloride (METFORMIN ER) taken for diabetes mellitus, 500 mg, once a day, brimonidine tartrate, brinzolamide (SIMBRINZA) taken for an unspecified indication, Twice a day and travoprost taken for an unspecified indication, Once a day. All concomitant medications were started on an unspecified date and unknown if was ongoing. The patient experienced she had more severe diarrhea on an unspecified date. She had more severe diarrhea was reported as worsened. Patient had the Pfizer Covid vaccine on the 18Feb that was her first one and she has had problems like diarrhea and her gastro tract (Incomplete sentence). She pretty much had it on and off. Today (date unspecified) she has had more severe diarrhea than before in those days before. She was wondering if that could be attributed to the Covid vaccine." Patient took an antidiarrheal after the last one in the afternoon (date unknown). This was an over the counter, it is called Loperamide HCL soft gelatin capsule, 2 mg and she took 2 of them but they are expired, the expiration date was Jul2020. That all the patient had at home. Outcome of the event was Not Resolved. No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: Diarrhea; Patient received 1st dose on 02Feb2021, and received second dose on 12Feb2021; Patient received 1st dose on 02Feb2021, and received second dose on 12Feb2021; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A 84-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 10:15 (at a age of 84-year-old) as dose 2 single for covid-19 immunisation. Patient received 1st dose BNT162B2 on 02Feb2021 at 12 in right arm with lot number EC-3249 for covid-19 immunization. Patient did not received other vaccines in four weeks. Patient did not had COVID prior vaccination. Patient did not tested COVID post vaccination. The patient medical history was not reported. Patient was not aware of allergies. Concomitant medications included Losartan, Pravastatin and Multivitamin. The patient experienced diarrhea on 13Feb2021 at 02:00 AM. Patient received treatment with dicyclomine. The outcome of event was not recovered. Outcoem of other events were unknown.   No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 69-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 20Feb2021 10:00 (at the time of vaccination 69-years-old) as single dose for covid-19 immunization. Facility type was Doctor's office/urgent care. The patient's medical history included, Ankylosing spondylitis (hlab27 positive) and patient had known allergies with Vicodin, oral prednisone and black-eyed peas. The patient's concomitant medication included levothyroxine sodium (SYNTHROID). Patient previously took first dose of BNT162B2 vaccine, for covid-19 immunization. On 21Feb2021 07:00, the patient experienced diarrhea. Patient visited to doctor or other healthcare professional office/clinic as result of diarrhea. Imodium and Pepto Bismal was taken as therapeutic measures as a result of diarrhea. Patient not diagnosed with covid prior vaccination. Patient did not covid tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension, Investigation, Nasopharyngitis, Weight
Clinical narrative: freezing cold; blood pressure going down; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198, Expiration date was not reported),via an unspecified route of administration, administered in Arm Right on 01Mar2021(at the age of 75 years) as dose 1, single for covid-19 immunisation. Medical history included blood pressure, Vitamin D low, Triglycerides, digest food (Has been taking for 6-7 years). Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCT) taken for blood pressure (100/12.5 mg daily ); atenolol  taken for blood pressure from 2001 and ongoing 25mg daily ; amlodipine besilate taken for blood pressure from 2015 and ongoing(5mg daily); fish oil taken for blood triglycerides from 2006 and ongoing (1000 units daily); vitamin d nos  taken for vitamin d abnormal from 2011 and ongoing(15,000 units per week ); probiotics taken for dyspepsia from an unspecified start date and ongoing. On 01Mar2021 the patient experienced freezing cold, blood pressure going down. Her weight a few months ago was 153 lbs. She has been trying to lose weight. She walks daily. She was unable to state if her blood pressure going down was ongoing or if it has resolved. She read on the internet to drink water to bring the blood pressure up. Should she call the doctor and let her know about effects. Last night she was freezing terribly. It was a 10 on a scale of 1-10. She does not have any soreness. Heart problems run in her family. She will call her doctor. She monitors her blood pressure. She has used her husband monitor to compare. She is scheduled to have a steroid shot in 3 weeks. Can she get it? She is scheduled to get the second Covid vaccine on 24Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement reading was 106/57 (high blood pressure), 108/55, After moving around and having dinner her blood pressure this evening 113/61, (Normally top number is 130), investigation scale it was a 10(Normal low 1 Norm high 10), weight: 153 lbs. The patient received treatment for blood pressure going down (hypotension). She is on four different types of blood pressure medications for high blood pressure. The outcome of vent freezing cold was recovering and blood pressure going down was unknown.  No follow-up attempts are possible. No further information is expected.