chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Fever; fatugue; body aches for 36 hours; swollen and itchy arm for 3 days which later resolved into swollen; swollen and itchy arm for 3 days which later resolved into swollen; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; This is a spontaneous report from a contactable consumer (Patient). A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:15 (at the age of 50-years-old) as dose 2, single for covid-19 immunization. Medical history included allergy to arthropod bite from an unknown date (fire ant allergy). Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (MINASTRIN 24 FE). cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin, amoxicillin, neosporin bacitracin neomycin sulfate polymyxin b sulfate] and experienced allergy. The patient took first dose of bnt162b2 (Lot number: EP6955), via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:15 as dose 1, single for covid-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 14Apr2021, the patient experienced Fever, fatigue, and body aches for 36 hours, swollen and itchy arm for 3 days which later resolved into swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks. The patient did not received treatment for adverse events. Outcome of events was recovered on unspecified date of Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fall, Feeling abnormal, Hot flush, Hyperhidrosis, Malaise
Clinical narrative: I am having major fall outs; I get hot; drip sweat; It feels like someone is pouring hot water over my head and I can't do anything about it until I collapse.; starting to get sick.; went from 160 to 180 pounds and feel puffy, big, and different; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program, Pfizer Oncology Together. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation; and Palbociclib (IBRANCE, Formulation: Capsule), via an unspecified route of administration from 05Feb2021 to an unspecified date, at 125 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient stated, she was having major fall outs, she got hot, and drip sweat. She got a limo and got hot inside, like she was melting with sweat. At the hospital she got a shot of something she could not pronounce (maybe extevia) and the Pfizer vaccine for Covid. It felt like someone is pouring hot water over my head and she could not do anything about it until she collapse. She may have had these problems because of the side effects from the shots. She was blowing up like a blimp, went from 160 to 180 pounds and feel puffy, big, and different. She had not been okay the last couple of weeks. This medicine was putting her in bed, and she was starting to get sick. The patient underwent lab tests and procedures which included weight increased: from 160 to 180 pounds. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Weight increased
Clinical narrative: I am having major fall outs; I get hot; drip sweat; It feels like someone is pouring hot water over my head and I can't do anything about it until I collapse.; starting to get sick.; went from 160 to 180 pounds and feel puffy, big, and different; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program, Pfizer Oncology Together. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation; and Palbociclib (IBRANCE, Formulation: Capsule), via an unspecified route of administration from 05Feb2021 to an unspecified date, at 125 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient stated, she was having major fall outs, she got hot, and drip sweat. She got a limo and got hot inside, like she was melting with sweat. At the hospital she got a shot of something she could not pronounce (maybe extevia) and the Pfizer vaccine for Covid. It felt like someone is pouring hot water over my head and she could not do anything about it until she collapse. She may have had these problems because of the side effects from the shots. She was blowing up like a blimp, went from 160 to 180 pounds and feel puffy, big, and different. She had not been okay the last couple of weeks. This medicine was putting her in bed, and she was starting to get sick. The patient underwent lab tests and procedures which included weight increased: from 160 to 180 pounds. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: sleepy; soreness around the arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 77-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER6955, Expiration Date- Jun2021) via an unspecified route of administration in left arm on 05Apr2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in left arm on 03May2021 as dose 2, single (at the age of 76-years-old) for COVID-19 immunization. Patient medical history included ongoing seasonal allergies, never had an actual diagnosis. He thought there was something wrong with his lungs and said that he was wheezing and the doctor prescribed him something that he did not want to take. Picked up leaves and his throat constricted on him and he said that he diagnosed himself. The concomitant medications were not reported. On an unspecified date in 2021, patient stated he has had both doses of the Pfizer COVID-19 vaccine and reported that the vaccine made him sleepy. He stated he would sleep for 3 to 4 hours after the vaccine. He reported soreness around the arm. He stated he felt great after the nap. He stated he took the Pfizer covid 19 vaccine and feels more at ease now. He stated that his eyes were bad prior to the vaccine and it had no effect on his eyes. He does not like taking medication, but every once in a while would take Benadryl for his allergies. It might have been that he just laid down after the vaccine. He said that he is a old man and can sleep all of the time. The outcome of the events was unknown.   Follow up are attempts needed. Further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in both legs; This is a spontaneous report received from a contactable consumer. This consumer reported for a patient (brother-in-law). A 63- years- old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided; 63-years-old at time of vaccination) via an unspecified route of administration, on 28Mar2021 11:00, at unknown dose single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (on 07Mar2021, unknown arm) for COVID-19 immunization had Numbness in leg (1 week after vaccination of first dose). The reporter stated that the patient received his first vaccine and started to have some side effects. His legs were numb with the first (on an unknown date in Mar2021). He then went back to get the second one and was still experiencing numbness in the legs. The reporter spoke to the patient last night and said that he has seen a doctor but has not gotten any treatment not anything at all. Further stated It happens in the mornings and in the evenings. Started like a week after the first vaccine. Then it started again, a week after the second. He was still experiencing this now, It has not gotten any better and is very concerned. He was not taking any medicine at all as Treatment. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nail discolouration
Clinical narrative: Her finger nails on the left hand are slightly blue; Headache; This is a spontaneous report from a contactable consumer (patient brother). A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 19May2021 (at the age of 23-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient received the Pfizer covid vaccine on 19May2021 and experienced headache and her finger nails on the left hand are slightly blue. The patient had the headache which was normal. Caller reported that today, 20May2021, the patient's fingernails on her left side were slightly blue. Caller wanted to know what do regarding that. Caller stated that he did not know exactly what they need to do. Caller inquired if that was something he needed to take his sister in for. Caller reported that he talked to a relative who suggested that he contact Pfizer. Caller inquired if Pfizer has had any reports of blue fingernails following the Covid-19 vaccine. Caller stated that he wanted to speak in the event that the patient needed to seek urgent medical attention. Outcome of the events was unknown.  Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Postmenopausal haemorrhage
Clinical narrative: I am 55 years old and have not had my menstruation cycle for 1.5 years. After my 2nd vaccination I am currently menstruating with heavy flow and cramping.; I am 55 years old and have not had my menstruation cycle for 1.5 years. After my 2nd vaccination I am currently menstruating with heavy flow and cramping.; I am 55 years old and have not had my menstruation cycle for 1.5 years. After my 2nd vaccination I am currently menstruating with heavy flow and cramping.; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 14:30 PM (Batch/Lot Number: EW0185) (at the age of 55-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 28May2021. There were no concomitant medications. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 27Apr2021 11:45 AM (Batch/Lot Number: EW0175) as DOSE 1, SINGLE for COVID-19 immunization.  Patient reported event: On 25May2021, I am 55 years old and have not had my menstruation cycle for 1.5 years. After my 2nd vaccination I am currently menstruating with heavy flow and cramping. No treatment was received The outcome of events was unknown.    Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Neoplasm progression, Off label use, Pulmonary congestion, Tumour marker test
Clinical narrative: tumor feels bigger; Product use error; lung congestion/ coughing- 30 minutes; lung congestion/ coughing- 30 minutes; i start cough/wheeze; This is a spontaneous report from a non-contactable Healthcare Professional (Clinician/Other HCP). An adult female patient received second dose of BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization, and palbociclib (IBRANCE, Capsule) orally from 01Jun2021 and ongoing at 75 mg daily for breast cancer (off label dosing). The patient's medical history included ongoing asthma, blood pressure, black circles around eyes/bridge of nose, severe dry skin and itchy red rash. Concomitant medication included fulvestrant (FASLODEX, Injection). The patient previously took hydrochlorothiazide for blood pressure and experienced skin cancer, and astaxanthin 12 mg daily. Verbatim and event description or product use error was reported as "Tumor feels bigger, not sure if related to covid vaccine- second one 2 weeks ago. Tumor markers fluctuate. Lab in 2 weeks. MD aware. Current dosing: 75 mg daily for 21 days and off 7 days with FASLODEX injections. Off label dosing. Patient reported that " had huge issues with skin- skin was fine, itchy red rash then resolved. Local pharmacy- organic/homeopathic advised astaxanthin 12 mg daily anti-inflammatory had cleared up the skin. Blood pressure medication hydrochlorothiazide, had side effect skin cancer, so cardiologist switched back to previous medication. She went to dermatologist and was so happy with skin. So with the change in blood pressure medication and astaxanthin. Rash has cleared, black circles around eyes/bridge of nose, then used vita rich serum- sensitive skin, had helped her severe dry skin, wrinkles had helped. Had lung congestion/coughing- 30 minutes after taking dose. She started cough/wheeze, clear throat notice at night when sleeping; she had a history of asthma. Outcome of the events was unknown.  Follow up attempts are needed, Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Wheezing
Clinical narrative: tumor feels bigger; Product use error; lung congestion/ coughing- 30 minutes; lung congestion/ coughing- 30 minutes; i start cough/wheeze; This is a spontaneous report from a non-contactable Healthcare Professional (Clinician/Other HCP). An adult female patient received second dose of BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization, and palbociclib (IBRANCE, Capsule) orally from 01Jun2021 and ongoing at 75 mg daily for breast cancer (off label dosing). The patient's medical history included ongoing asthma, blood pressure, black circles around eyes/bridge of nose, severe dry skin and itchy red rash. Concomitant medication included fulvestrant (FASLODEX, Injection). The patient previously took hydrochlorothiazide for blood pressure and experienced skin cancer, and astaxanthin 12 mg daily. Verbatim and event description or product use error was reported as "Tumor feels bigger, not sure if related to covid vaccine- second one 2 weeks ago. Tumor markers fluctuate. Lab in 2 weeks. MD aware. Current dosing: 75 mg daily for 21 days and off 7 days with FASLODEX injections. Off label dosing. Patient reported that " had huge issues with skin- skin was fine, itchy red rash then resolved. Local pharmacy- organic/homeopathic advised astaxanthin 12 mg daily anti-inflammatory had cleared up the skin. Blood pressure medication hydrochlorothiazide, had side effect skin cancer, so cardiologist switched back to previous medication. She went to dermatologist and was so happy with skin. So with the change in blood pressure medication and astaxanthin. Rash has cleared, black circles around eyes/bridge of nose, then used vita rich serum- sensitive skin, had helped her severe dry skin, wrinkles had helped. Had lung congestion/coughing- 30 minutes after taking dose. She started cough/wheeze, clear throat notice at night when sleeping; she had a history of asthma. Outcome of the events was unknown.  Follow up attempts are needed, Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 3 weeks now; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included known allergies to sulfur. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced diarrhea for 3 weeks now. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of diarrhea. The patient has not recovered from diarrhea.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The patient experienced COVID on an unspecified date.; The patient experienced COVID on an unspecified date.; This is a spontaneous report from a contactable consumer via Pfizer sponsored program Topical LCM US Quant & Qual Follow-Up Study. A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246, Expiry Date: Unknown), via intramuscular in upper arm on 08Jan2021 in AM as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, Expiry Date: Unknown), via intramuscular in upper arm on 29Jan2021 in AM as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were none. Prior vaccination was reported as none. Relevant Test was reported as none. Reporter stated that 9 players and the coaches of the baseball team all came down with COVID. The patient experienced COVID on an unspecified date. The outcome of event was unknown.  Follow up (07Jul2021): This is a follow up-spontaneous report from a contactable consumer. This consumer reported for patient in response to consumer letter sent via follow-up letter which included that: Added dose details (1st and 2nd dose: date, time, route of administration, anatomical site of injection) medical history, relevant test, concomitant drugs and prior vaccination updated as none.
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 antibody test, Urinary tract infection
Clinical narrative: Not sure if it's before or after she got her first dose, she had the COVID 19 Virus; Not sure if it's before or after she got her first dose, she had the COVID 19 Virus; Urinary tract infection; This is a spontaneous report from a Pfizer sponsored program reported by a contactable consumer or other non-health care professional (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration in arm left on 26Apr2021 (at the age of 77-year-old) as single dose for COVID-19 immunization and clarithromycin (MACROBID [CLARITHROMYCIN], Capsule Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at 100 mg for an unspecified indication. Medical history included blood pressure, hypertension, high cholesterol; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient think about lot number and stated that it must be right here D21, she dont know if that is 1 or L and G, this looks like she don't know if its U9J (D21GU9J). On an unspecified date, she was prescribed by her doctor for, to take an antibiotic because she has UTI (Urinary Tract Infection), so she wants to know if it is okay for her to take it or will it interfere with the antibodies that she has in her body. She said, she got the first dose on 26th of April and she is not yet done with the second dose because she was advised by her doctor that it was okay for her not to take it because she already had a lot of antibodies in her body. She also said that she is not sure if it was before or after she got her first dose, she had the COVID 19 Virus. She took the blood, that was it, that's the blood she had done. When confirmed if the reports, patient stated reports were normal. The patient underwent lab tests and procedures which included antibody test resulted as antibodies and sars-cov-2 antibody test resulted as positive; both on an unspecified date. The seriousness of the events was not reported. The clinical outcome of the events was unknown.  Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Chills, Pain
Clinical narrative: Blood in urine; Pain in all of her body/ body ache; Chills; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0186, Expiry Date: unknown), dose 1 via an unspecified route of adminstration, administered in Arm Left on 30Jun2021 at 12:30 (at the age of 42-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history relevant to AE was none. History of all previous immunization with the Pfizer vaccine was not considered as suspect. No additional vaccines administered on same date of the pfizer sus-pect. No other vaccinations was done within four weeks prior to the first administration date of the suspect vaccine. On 01Jul2021, the patient experienced blood in urine, pain in all of her body/ body ache and chills. The events did not cause Emergency Room or physician office visit. It was reported that yesterday the patient woke up with body ache, chills and blood on her urine. Today she has no longer have chills or body ache, but there is still blood in her urine and she wanted to know if it was normal. Blood in her urine is worst in the morning. When she cleans herself she can see the blood. She stated that she has been drinking a lot of water and it is about the same color now. She denied any medical conditions, medications, labs, testing or treatments relevant to events. Upon follow-up 0n 02Jul2021, vaccine information including lot number, start date, anatomical location was provided. This report is not related to a study or programme. Seriousness of the events were unspecified. NDC number of Pfizer Covid 19 Vaccine was unknown. Investigation Assessment was not provided. The patient provided her doctors name but did not provide contact information for her HCP. Vaccine was not administered at military facility. Outcome of the event blood in urine was not recovered and the outcome of the other two events were recovered on 02Jul2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise, Sleep deficit
Clinical narrative: tiredness;Did not feel rested like he should; feeling unwell; feels a little woozy; He explains that he felt like he did not get enough sleep; headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 30Jun2021 17:00 (at the age of 69-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (Had high blood pressure over the years. He started medication in Jan2021), ongoing type 2 diabetes mellitus (diagnosed not longer than 2 years), ongoing cholesterol (It had been a little longer than 2 years, but he did not think much longer. It was along the same line with the blood pressure). Concomitant medications included amlodipine 5 mg taken for High Blood Pressure from Jan2021 and ongoing, metformin hcl 500 mg taken for type 2 diabetes mellitus from an unspecified start date and ongoing, atorvastatin 10 mg taken for cholesterol from an unspecified start date and ongoing. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0176), via an unspecified route of administration, administered in Arm Right on 11Jun2021 13:00 as single dose for COVID-19 immunisation. Additional vaccines administered on same date of the Pfizer suspect was provided as none. Prior vaccinations within 4 weeks and AEs following prior vaccinations was none. Consumer reported that side effects from the last dose of vaccine started on 01Jul2021. Consumer reported tiredness, feeling unwell and feels a little woozy on 01Jul2021. He explained that he felt like he did not get enough sleep. Today is experiencing the same tiredness. He states, "I do not look like it but I feel like it if that makes sense". Consumer disclosed tiredness and headache as of today when referencing the list of side effects on the handout he has access to currently. Caller stated that he would not consider this severe. He was still able to function and do what he needed to do. He was feeling more tired than he normally does. He said he did not feel rested like he should. He was still driving. He did not have any dizziness or anything like that. He had a tiredness feeling. The adverse events did not require a visit to emergency room or physician office. Reporter seriousness for events was unspecified. The outcome of event sleep deficit and headache was unknown and for rest of the events was not recovered.   Information about batch/ lot number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Fever of 101.2 up to and including 5 days after injection; Pin prick rash all over trunk; Nausea; Vomiting; Diarrhea; Shortness of breath; increased fatigue; Muscle aches; stomach pain; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 28Jun2021 12:00 (at the age of 46-years-old) (Batch/Lot Number: EW0196) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient received Meds (unspecified) prescribed by physician within 2 weeks of vaccination. 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 29Jun2021, the patient experienced nausea, vomiting, pin prick rash all over trunk, diarrhea, shortness of breath, fever of 101.2 up to and including 5 days after injection, increased fatigue, muscle aches and stomach pain. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Fever of 101.2 up to and including 5 days after injection; Pin prick rash all over trunk; Nausea; Vomiting; Diarrhea; Shortness of breath; increased fatigue; Muscle aches; stomach pain; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 28Jun2021 12:00 (at the age of 46-years-old) (Batch/Lot Number: EW0196) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient received Meds (unspecified) prescribed by physician within 2 weeks of vaccination. 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 29Jun2021, the patient experienced nausea, vomiting, pin prick rash all over trunk, diarrhea, shortness of breath, fever of 101.2 up to and including 5 days after injection, increased fatigue, muscle aches and stomach pain. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Skin haemorrhage
Clinical narrative: Pounding heart; Blood spots in lower legs. Not bumpy, doesnt itch, doesnt hurt, almost looks like razor burns but all the way around my lower legs; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in Right arm on 23Jun2021 11:00 (Batch/Lot Number: ER8737; Expiration Date: was not reported, Age at vaccination: 46-year-old) as SINGLE for covid-19 immunization and it was administered at doctor's office/urgent care. The patient's medical history included high blood pressure after getting covid. Concomitant medications included alprazolam (XANAX), temazepam, diltiazem hydrochloride (DILTIZEM), acetylsalicylic acid (ASPIRINE) and unspecified vitamins. No other vaccine in four weeks. Covid was present prior vaccination. No covid tested post vaccination. On 28Jun2021, blood spots in lower legs. Not bumpy, does not itch, does not hurt, almost looks like razor burns but all the way around my lower legs, and pounding heart. No treatment received for adverse event. The outcome of all events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Rash, Rash erythematous, Vertigo
Clinical narrative: Pounding heart; Blood spots in lower legs. Not bumpy, doesnt itch, doesnt hurt, almost looks like razor burns but all the way around my lower legs; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in Right arm on 23Jun2021 11:00 (Batch/Lot Number: ER8737; Expiration Date: was not reported, Age at vaccination: 46-year-old) as SINGLE for covid-19 immunization and it was administered at doctor's office/urgent care. The patient's medical history included high blood pressure after getting covid. Concomitant medications included alprazolam (XANAX), temazepam, diltiazem hydrochloride (DILTIZEM), acetylsalicylic acid (ASPIRINE) and unspecified vitamins. No other vaccine in four weeks. Covid was present prior vaccination. No covid tested post vaccination. On 28Jun2021, blood spots in lower legs. Not bumpy, does not itch, does not hurt, almost looks like razor burns but all the way around my lower legs, and pounding heart. No treatment received for adverse event. The outcome of all events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Ear discomfort, Injection site erythema, Insomnia
Clinical narrative: Inability to sleep; Body aches; Skin uncomfortable to touch,; 4 days with a fever; the first two with a fever between 103-104,; Injection site red and swollen to the circumference of a golf ball.; Injection site red and swollen to the circumference of a golf ball.; Severe body chills; On the 4th day after, my left ear(the same side I got the injection on) feels clogged up; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Jul2021 11:30 (at the age of 24-years-old) as dose number unknown, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past Medical history included irritable bowel syndrome (IBS-C) from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, chronic migraine from an unknown date and unknown if ongoing, known allergies for latex from an unknown date and unknown if ongoing. Concomitant medication(s) included cyanocobalamin (B12) supplement taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 01Jul2021, the patient experienced injection site red and swollen to the circumference of a golf ball, 4 days with a fever; the first two with a fever between 103-104, inability to sleep, severe body chills, body aches, skin uncomfortable to touch, on the 4th day after, on unspecified date in Jul2021, her left ear (the same side she got the injection on) feels clogged up like there's water in it. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Body temperature: 103-104 on 01Jul2021. The patient was treated with pain relievers for fever and unspecified treatment for rest all other. The outcome for events was not recovered. Device date was 04Jul2021. Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Skin discomfort, Vaccination site swelling
Clinical narrative: Inability to sleep; Body aches; Skin uncomfortable to touch,; 4 days with a fever; the first two with a fever between 103-104,; Injection site red and swollen to the circumference of a golf ball.; Injection site red and swollen to the circumference of a golf ball.; Severe body chills; On the 4th day after, my left ear(the same side I got the injection on) feels clogged up; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Jul2021 11:30 (at the age of 24-years-old) as dose number unknown, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past Medical history included irritable bowel syndrome (IBS-C) from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, chronic migraine from an unknown date and unknown if ongoing, known allergies for latex from an unknown date and unknown if ongoing. Concomitant medication(s) included cyanocobalamin (B12) supplement taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 01Jul2021, the patient experienced injection site red and swollen to the circumference of a golf ball, 4 days with a fever; the first two with a fever between 103-104, inability to sleep, severe body chills, body aches, skin uncomfortable to touch, on the 4th day after, on unspecified date in Jul2021, her left ear (the same side she got the injection on) feels clogged up like there's water in it. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Body temperature: 103-104 on 01Jul2021. The patient was treated with pain relievers for fever and unspecified treatment for rest all other. The outcome for events was not recovered. Device date was 04Jul2021. Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain, Trigeminal neuralgia
Clinical narrative: My trigeminal neuralgia became more intense with pain to right side of face; My trigeminal neuralgia became more intense with pain to right side of face; pain was too intense; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 2 via an unspecified route of administration in left arm on 08Jun2021 11:30 (age at vaccination was 77-year-old) for covid-19 immunization. The patient had no known allergies. Medical history included heart diabetes, DVT (deep vein thrombosis), PAD (peripheral arterial occlusive disease), trigeminal neuralgia. Patient previously received dose 1 (Lot number and Expiry date was not reported) via an unspecified route administration in left arm on 18May 11.30 AM as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Concomitant medications received within 2 weeks of vaccination was atorvastatin (ATORVASTATIN), cholecalciferol (CHOLECALCIFEROL), gabapentin (GABAPENTIN), glimepiride (GLIMEPIRIDE). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Jun2021 patient experienced trigeminal neuralgia became more intense with pain to right side of face, notified Doctor of pain and made 3 trips to ER 2 by ambulance as the pain was too intense. Treatment received for the events was oxycodone, morpheein, Vicodin. Since the vaccination, patient has not been tested for COVID-19. The outcome of the event was not resolved. Information on the lot/batch number has been requested. Additional information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise, Pain, Pyrexia, Sinusitis
Clinical narrative: Body aches; I had sinus, sinus got infected by it; Fever like; Feeling ill; Sick; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0181) via an unspecified route of administration in Arm Left on 28Jun2021 12:30 as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing, sinusitis from an unknown date and unknown if ongoing I had sinus. The patient's concomitant medications were not reported. The patient experienced he was calling about the symptoms and side effects that occurred after receiving the first dose of the vaccine. It seems that it got him into full Covid reaction, he have had Covid before and he think he have had it twice but once confirmed and the second time it was confirmed, the first time, it was too early, he didn't have all of the symptoms to get checked. After the second day like 2 days after getting it, he started getting body aches, he had sinus, sinus got infected by it, fever like but no fever and that was the same symptoms as the first time when he believe he had it and since then feeling he was feeling ill. So, he feel like he was having Covid all over again and it had been about a week now and he was still sick. The clinical outcome of the event sick was not recovered and other was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Have Hives on stomach and on hands; like three big bumps Hives; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 24Jun2021, as dose 1, single for COVID-19 immunization. The patient's concomitant medications and medical history were not reported. When probed for the concern, consumer stated that he/she received the first dose on 24Jun2021 and on an unknown date in 2021 (on 9th day) he/she had hives on stomach and on hands, consumer thought that hives were like mosquito bites, but they were not mosquito bite, they were like three big bumps hives. The consumer just wanted to know, which antibiotic cream should he/she put on. The second vaccination was due on 15Jul2021. The event outcome was unknown  Information about batch/lot number had been requested
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Friend had it got the most extreme migraine. Sharp stabbing.; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's friend) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporters friend experienced had it got the most extreme migraine. sharp stabbing on an unspecified date. The outcome of event was unknown.  Follow-up (02Jul2021):This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (reporters friend) that: No information was provided for Reporters friend.  Information on the lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fine motor skill dysfunction, Gait inability, Generalised tonic-clonic seizure, Headache
Clinical narrative: Tonic-Clonic seizures; Nausea; Vomiting; Severe body aches; Headache; Moderate - severe neurological events; Tics; Tremors; Confusion; Inability to speak or walk or use restroom on own; Inability to speak or walk or use restroom on own; Fine motor skills deficit; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0876, Expiration Date: not reported), via an unspecified route of administration in left arm on 15May2021 at 15:00(Age at the of 14-years old)as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at time of Vaccination. Medical history was none. Known allergies was Nka. The patient received unspecified medications within 2 weeks of vaccination. The patient did not received 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 17May2021,the patient experienced nausea, vomiting, severe body aches, headache, moderate - severe neurological events, tics, tremors, confusion, inability to speak or walk or use restroom on own, fine motor skills deficit and tonic-clonic seizures. Adverse events resulted in Emergency room/department or urgent care. The patient was hospitalized for 4 days. Hospitalization was not prolonged. The patient received treatment and stopped suspected interacting medicine. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0191, Expiration Date: not reported), via an unspecified route of administration in left arm on 06Jun202114:00 as dose 2, single for COVID-19 immunization. The outcome of the events was recovering. ~~ No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neurological symptom, Pain, Speech disorder, Tic
Clinical narrative: Tonic-Clonic seizures; Nausea; Vomiting; Severe body aches; Headache; Moderate - severe neurological events; Tics; Tremors; Confusion; Inability to speak or walk or use restroom on own; Inability to speak or walk or use restroom on own; Fine motor skills deficit; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0876, Expiration Date: not reported), via an unspecified route of administration in left arm on 15May2021 at 15:00(Age at the of 14-years old)as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at time of Vaccination. Medical history was none. Known allergies was Nka. The patient received unspecified medications within 2 weeks of vaccination. The patient did not received 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 17May2021,the patient experienced nausea, vomiting, severe body aches, headache, moderate - severe neurological events, tics, tremors, confusion, inability to speak or walk or use restroom on own, fine motor skills deficit and tonic-clonic seizures. Adverse events resulted in Emergency room/department or urgent care. The patient was hospitalized for 4 days. Hospitalization was not prolonged. The patient received treatment and stopped suspected interacting medicine. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0191, Expiration Date: not reported), via an unspecified route of administration in left arm on 06Jun202114:00 as dose 2, single for COVID-19 immunization. The outcome of the events was recovering. ~~ No follow-up attempts are possible. No further information is expected.