chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vomiting
Clinical narrative: nauseous; headache; dizzy; vomited on and off/was throwing up bile by 6 am; could not lay down or close my eyes; felt horrible; could not lay down or close my eyes without it getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 18:00 (Lot number: ew0153) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: avocados and apples" (unspecified if ongoing), notes: Known allergies= Avocados and Apples. Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose: 1, Lot no: En6206, Time: 04:00 PM, Anatomical location: Left arm), when the patient was 32 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 08Apr2021 04:00, outcome "not recovered", described as "nauseous"; HEADACHE (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "headache"; DIZZINESS (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "dizzy"; VOMITING (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "vomited on and off/was throwing up bile by 6 am"; SLEEP DISORDER (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "could not lay down or close my eyes"; FEELING ABNORMAL (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "felt horrible"; CONDITION AGGRAVATED (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "could not lay down or close my eyes without it getting worse". The event "nauseous" was evaluated at the physician office visit and emergency room visit. The events "headache", "dizzy", "vomited on and off/was throwing up bile by 6 am", "could not lay down or close my eyes", "felt horrible" and "could not lay down or close my eyes without it getting worse" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, headache, dizziness, vomiting, sleep disorder, feeling abnormal, condition aggravated.  Additional Information: Patient did not taken other vaccine in four weeks. Patient taken other medication in two weeks. Patient taken treatment with Ondansetron. No COVID test was done on post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: mild shoulder/neck stiffness; arm sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 08:45 (Lot number: EN6200) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "severe abd pain" (unspecified if ongoing); "Chia seed allegy" (unspecified if ongoing); "anaphylaxis" (unspecified if ongoing); "Latex" (unspecified if ongoing); "rash" (unspecified if ongoing), notes: known allergies: Sesame seeds, severe abd pain,, allergy verified by blood test. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; LYSINE; VITAMIN D NOS; MULTIVITAMIN [VITAMINS NOS]. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset Mar2021, outcome "unknown", described as "mild shoulder/neck stiffness"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "arm sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of musculoskeletal stiffness, pain in extremity.  Additional information: known allergies: Sesame seeds, severe abd pain,, allergy verified by blood test. Chia Seeds: anaphylaxis. Latex: rash and allergy verified by blood test. It was reported that the facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Levothyroxine, Lysine, Vitamin D, Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination Since the vaccination the patient was not tested for COVID-19. The patient reported Event with 1st dose, mild shoulder/neck stiffness, arm sore, not bad.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chronic obstructive pulmonary disease, Pain in extremity, Pulmonary function test, Pulmonary function test decreased
Clinical narrative: doctor thought she had COPD; asthma; lungs severely compromised; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 13:30 (Lot number: EP969551) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Covid-19", start date: 02Jan2021 (unspecified if ongoing); "Just broke her leg 4 weeks ago" (unspecified if ongoing), notes: On pain medications; "In a wheel chair" (unspecified if ongoing); "Broke 3 ribs/coughing" (unspecified if ongoing); "Broke 3 ribs/coughing" (unspecified if ongoing); "Prednisone raises her sugar" (unspecified if ongoing). Concomitant medication(s) included: DULERA taken for asthma; COMBIVENT taken for asthma; DUONEB taken for asthma; SINGULAIR taken for asthma; PREDNISONE; METFORMIN taken for hyperglycaemia; BENZONATATE taken for cough; XOLAIR taken for asthma, start date: 08Mar2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021 06:00, outcome "recovered" (21Mar2021), described as "sore arm"; ASTHMA (non-serious), outcome "unknown", described as "asthma"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "doctor thought she had COPD"; PULMONARY FUNCTION TEST DECREASED (non-serious), outcome "unknown", described as "lungs severely compromised". The events "asthma", "doctor thought she had copd" and "lungs severely compromised" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthma.  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. Patient mentioned she was taking Prednisone to keep her lungs clear. Patient had to take an allergy shot called XOLAIR however she canceled it because she was about to take her second dose Pfizer COVID-19 vaccine. Now however she was experiencing severe asthma and has to take a nebulizer and she was also advised to take the allergy shot. Patient wanted to verify details as listed above and clarifies hat she was advised that she could get the allergy shot, but now the doctor was telling her to wait a week in between getting her second dose of Pfizer COVID-19 vaccine and the XOLAIR allergy shot. She was already having issues with her asthma that are scaring her and she doesn't want to wait if she doesn't have to. Doctor thought patient had COPD, but he didn't know what he was looking at. Patient stated her lungs were damaged from COVID. Events did not result to emergency room visit.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm soreness after first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Mar2021 14:00 (Lot number: EP7534) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atherosclerosis" (unspecified if ongoing), notes: Atherosclerosis Diagnosed 4-5 years ago; "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing), notes: obesity: none. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Mar2021, outcome "recovering", described as "Left arm soreness after first dose".  Additional information: Left arm soreness took a number of hours before it started to get sore. It was probably 18:00-19:00. It was not excessive where she could not use arm and was much improved by the morning. No ER (emergency room) or physician's office required. Patient had no family medical history and other Products was provided as no. No relevant tests were provided. The Vaccination facility type was hospital not a military facility. As per her, it was explained and answered by the doctors in the facility what happened. When asked about medical conditions, she said she was kind of old and probably has a few things but she does not know of anything.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 16Mar2021 17:30 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Gilbert's syndrome" (unspecified if ongoing); "Familial tremor" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. The patient did not know of any allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: out of work for 2 solid days flat on her back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "out of work for 2 solid days flat on her back".  Additional Information: The patient was not getting the vaccine the second time either, she was out of work for 2 solid days flat on her back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: after 2nd dose I was sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Lot number: EN6201, Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "I had covid" (unspecified if ongoing); "very sick" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (21Jan2021, 13:00, 1st dose:, Route of administration: intramuscular, Batch/Lot number: EL8982), reaction(s): "COVID-19 Immunization". The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "after 2nd dose I was sick". Therapeutic measures were not taken as a result of malaise.  Additional information: Patient had covid by 2 weeks before vaccination patient was very sick for 6 weeks. No prior vaccination (within 4 weeks). After first shot patient was sick for 7days with same as when the patient had covid. After second shot patient was sick for 3 and half days not quite as bad as first shot. He spoke to his family doctor after first shot they said he should have been advised to wait 90 days after recovering from covid before he had first shot.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore in the arm". Additional information: The patient was scheduled to receive the second dose of BNT162B2 and he wanted to know how soon he would be able to donate blood after receiving the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot
Clinical narrative: feels physically warm; tired; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "feels physically warm"; FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Micturition disorder
Clinical narrative: urinary problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MICTURITION DISORDER (non-serious) with onset 04Apr2021, outcome "unknown", described as "urinary problem".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: been sick/sickness/I am pretty ill because I have symptoms; headache; sore throat; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (002191; 159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "been sick/sickness/I am pretty ill because I have symptoms"; HEADACHE (non-serious), outcome "unknown", described as "headache"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He got his first dose on 19Mar, and he was due to take his second dose on Friday. However, he has been sick lately and took a rapid test but the results will come tomorrow. He wanted to know if he still needed to take the second dose if the results came back positive. He was pretty ill because he had symptoms and he was wondering if he takes the second shot; scheduled for rapid test. Dates for she was pretty ill because she had symptoms. Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided. He had the first dose of the Pfizer Vaccine on the 19Mar2021 and due to get the second dose on Friday 09Apr2021. But he was currently experiencing sickness symptoms, headache, sore throat and runny nose. No other side effects appeared. He called for the advice.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: Patient had vivid dreams 12 hours after receiving second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 29 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty, for COVID-19 Immunization. The following information was reported: ABNORMAL DREAMS (non-serious), outcome "unknown", described as "Patient had vivid dreams 12 hours after receiving second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: The arm in which I received the shot feels like it is on fire/feel like I've walked over hot coals/arm feels like from my shoulder to my fingers/laid my arm in a fire; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 08Apr2021 12:45 (Lot number: EWO183) at the age of 42 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "neurapathy in my feet" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TOPIRAMATE; PROPRANOLOL; SIMVASTATIN. Past drug history included: Prednisone, reaction(s): "allergies". The following information was reported: BURNING SENSATION (non-serious) with onset 09Apr2021, outcome "not recovered", described as "The arm in which I received the shot feels like it is on fire/feel like I've walked over hot coals/arm feels like from my shoulder to my fingers/laid my arm in a fire". Therapeutic measures were not taken as a result of burning sensation. Additional information: 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 nor was tested for COVID-19 since vaccination. The event was non-serious; did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, nor led to congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pigmentation disorder
Clinical narrative: discoloration in the pigment of her skin on her hands, particularly on her fingers; pain in my hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 07:45 (Lot number: EN6207) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "low blood platelets" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Graves disease" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE; D3; VITAMIN K [VITAMIN K NOS]; ZINC; VIT C. Past drug history included: Augmentin, reaction(s): "drug allergy". The following information was reported: PIGMENTATION DISORDER (non-serious) with onset 20Mar2021, outcome "recovering", described as "discoloration in the pigment of her skin on her hands, particularly on her fingers"; PAIN IN EXTREMITY (non-serious) with onset 20Mar2021, outcome "recovering", described as "pain in my hands". Therapeutic measures were not taken as a result of pigmentation disorder, pain in extremity. Additional information: Patient's concomitant medication also included "Tr". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: experienced restless leg syndrome for years and she got her 1st dose and last night didn't experience it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "restless leg syndrome" (unspecified if ongoing), notes: she experienced restless leg syndrome for years. The patient's concomitant medications were not reported.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "experienced restless leg syndrome for years and she got her 1st dose and last night didn't experience it.".  Additional information: The patient experienced restless leg syndrome for years and when she got her first dose, and last night (at the time of reporting) she did not experience it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in hands and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 17:15 (Lot number: EP7534) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Concomitant medication(s) included: CELECOXIB. Vaccination history included: Bnt162b2 (First dose, Lot Number: EN6198, administration time: 05:15 PM, vaccine location: right arm), administration date: 27Feb2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 04Apr2021 21:00, outcome "not recovered", described as "Tingling in hands and feet". Therapeutic measures were not taken as a result of paraesthesia.  Additional information: Patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: extreme dizzy spell; arm was hurting; mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "extreme dizzy spell"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was hurting"; HEADACHE (non-serious), outcome "unknown", described as "mild headache".  Additional information: Patient was injected, she had an extreme dizzy spell and had to sit there for 45 minutes. Patient arm was hurting within 5 minutes and now she has a mild headache. Patient wants to know if the second shot going to be too dangerous for her to take.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: actually first all he had was just sore arm and slight warmth that was it; actually first all he had was just sore arm and slight warmth that was it; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious) all with onset 2021, outcome "unknown" and all described as "actually first all he had was just sore arm and slight warmth that was it".  Additional information: The patient was fully vaccinated at the time of reporting. He was not in any study. His second dose he noticed side effects more than first, actually first all he had was just sore arm and slight warmth that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: I was not feeling well; Muscle aches; Dizziness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 77 year-old patient received bnt162b2 (BNT162B2), administration date 07Jan2021 (Lot number: EK9231) as single dose for covid-19 immunisation. Relevant medical history included: "Myopathy" (unspecified if ongoing), notes: Verbatim: Myopathy; "Sleep apnoea", start date: 2006 (unspecified if ongoing), notes: Verbatim: Sleep apnea, Diagnosed 15 years ago; "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol; "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "heart attack", start date: 2010 (unspecified if ongoing), notes: First heart attack in 2010; "Trauma" (unspecified if ongoing), notes: Verbatim: Trauma; "Prostate enlargement" (unspecified if ongoing), notes: Verbatim: Prostate enlargement; "heart attack", start date: 2017 (unspecified if ongoing), notes: second heart attack in 2017; "acoustic neuroma radiated in my brain" (unspecified if ongoing); "dizziness" (unspecified if ongoing). Concomitant medication(s) included: MYOCIN; TOCOTRIENOLS NOS; VITAMIIN C; BUROFIX; MIRAPEX; ASAPRIN; NEOPRIL [LISINOPRIL]; METOPROLOL. The following information was reported: MALAISE (non-serious) with onset Jan2021, outcome "not recovered", described as "I was not feeling well"; MYALGIA (non-serious) with onset Jan2021, outcome "not recovered", described as "Muscle aches"; DIZZINESS (non-serious) with onset Jan2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset Jan2021, outcome "not recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise. Therapeutic measures were taken as a result of myalgia, dizziness, fatigue.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I only had a sore arm with the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "I only had a sore arm with the first dose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Reporter received the first dose the syringe contained a cloudy solution whereas the second dose was clear. The girl didn't even prepare the second shot in front of me. She said she prepare them overnight and keeps them in the fridge. The guy who gave me the first dose prepared it in front of me. I don't know what the young lady gave me. They could've  administered anything. Store should really set a protocol to draw the vaccine from the vial in front of patients. Reporter received second shot of the Pfizer vaccine. Her arm was not sure it just felt like something kind of pinched me. She was sweating in the face. Her cloth masked was full of sweat inside out. The back of her neck and forehead was also wet in sweat. Reporter only had a sore arm with the first dose which lasted a day and the next day everything was fine. Is sweat reported with the vaccine?". Response received was vaccine will be an off-white suspension. After the vaccine is prepared there should be no particulates or discoloration. The stored vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. Upon Follow up (08April2021) information reported by reporter that she had her second shot yesterday. This time around, said she has experienced some soreness in her arm, and a good deal of sweating. Reporter took a couple of aspirins for her soreness. Stated doesn't feel sick though. She also is really concerned if she in fact got the vaccine or not. Said for her first shot, the person loaded the syringe and gave her the shot right there, and it may have been "grayish in color" but she couldn't quite see. For her second shot, the lady just came out of the back with the syringe prefilled already. Reporter said doesn't trust, or know what she got, since the lady is going back and forth to a back room. This caused her great concern.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: One eye was more foggy, little bit more decreased vision then normal; One eye was more foggy, little bit more decreased vision then normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 90 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 90 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Eye condition, Dystrophy" (ongoing), notes: Verbatim: Eye condition, Dystrophy; "mother was about blind in one eye and the other eye she can not see clearly out of." (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset 02Apr2021, outcome "unknown" and all described as "One eye was more foggy, little bit more decreased vision then normal".  Additional information: Caller stated her mother was about blind in one eye and the other eye she can not see clearly out of. Caller stated her mother who is 90 years old had her second vaccine Pfizer the same day as the caller but at a pharmacy because she lives further away. She stated her mother had no reactions and her mother has an eye condition, Dystrophy, that she is about blind in one eye and the other eye she can not see clearly out of. Then the caller stated on the first day after her mother's vaccine, that morning, one of her eyes were more foggy, little bit more decreased vision then normal but now her eyes are back to her normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo/woke up and the room was spinning, like on a carnival ride; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 31Mar2021, outcome "unknown", described as "vertigo/woke up and the room was spinning, like on a carnival ride". Additional information: The patient stated that she never experienced that before and asked if that was normal and if it was safe to receive the second vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Musculoskeletal stiffness
Clinical narrative: Both legs stiffened up and has a hard time walking; Both legs stiffened up and has a hard time walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Apr2021 14:00 (Lot number: EW0151) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lymphoma Cancer", start date: Mar2020 (unspecified if ongoing), notes: Verbatim: Lymphoma Cancer; "6 Vertebrae rubbing together" (unspecified if ongoing), notes: Verbatim: 6 Vertebrae rubbing together, Diagnosed maybe 3 years ago; "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic / chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Immune system low because of Lymphoma Cancer" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN taken for back pain; HYDROCHLOROTHIAZIDE; ALLOPURINOL; ACYCLOVIR [ACICLOVIR]; AMLODIPINE BESILATE; LISINOPRIL. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), GAIT DISTURBANCE (non-serious) all with onset 07Apr2021 15:00, outcome "not recovered" and all described as "Both legs stiffened up and has a hard time walking". Therapeutic measures were taken as a result of musculoskeletal stiffness, gait disturbance.  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as no previous. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks): none. AE following prior vaccinations: None. Family Medical history: none. Relevant test: No test. Investigation Assessment: No. She was calling on behalf of her husband. He has lymphoma cancer, which she confirmed was diagnosed prior to receiving the vaccine.After he got the vaccine, he stiffened up. She clarified that it was both of his legs that stiffened up and he had a hard time walking. When he walks around it improves, but he still has to walk slow because he was still stiff. Adverse event did not result in Emergency or physician office visit. He takes pain medicines. She does not know all of the name. She did not know what his medications were for, but knew that two of them were blood pressure medications, but she does not know which they were.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Lot number: ER8737) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Stomach Acid" (unspecified if ongoing), notes: Verbatim: Stomach Acid. Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal; OMEPRAZOLE taken for gastrooesophageal reflux disease. Vaccination history included: Bnt162b2 (Dose: 1), when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 03Apr2021 07:30, outcome "unknown", described as "Vomiting"; NAUSEA (non-serious) with onset 03Apr2021 07:30, outcome "unknown", described as "Nausea".  Additional information: I have been on Omeprazole for several years. I got it Friday and then Saturday morning I got up after like 7:30.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Illness
Clinical narrative: Illness; high glucose levels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Illness"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "high glucose levels". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information:  It was reported that the patient had his first dose of vaccine on 08Mar2021, and missed his second dose, and would like to reschedule. Patient did not make his second appointment, and stated he was not feeling well as he is diabetic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills ".  Additional information: This consumer reported for her sister. The patient was healthy, had the chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizziness, mostly all at night when I lay down to go to sleep; Weakness; I am always tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Feb2021 (Lot number: EN6201) as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE LOT#EL9265), administration date: 29Jan2021, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness, mostly all at night when I lay down to go to sleep"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "I am always tired".  Additional information : When probed for the concern, consumer stated, "I am not sure, if I am to the right place. I got the second shot on 19Feb2021, Now it was "32" (not clarified) days after my first shot which was 19Feb my first shot. I have been having a problem with some dizziness, mostly all at night when I lay down to go to sleep and after the fact I get the second shot that whatever they are could cause dizziness and weakness, I am always tired, so I don't know what is the weakness would be and I would be concerned about was this dizziness was caused by the shot because it appeared after "32" (not clarified) days of the shot."     No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Moderately sore arm around the injection site; mild fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 13:45 (Lot number: EW0158) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; PHENYLEPHRINE HCL. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Apr2021, outcome "recovered" (Apr2021), described as "Moderately sore arm around the injection site"; FATIGUE (non-serious) with onset 08Apr2021, outcome "recovered" (Apr2021), described as "mild fatigue". Therapeutic measures were taken as a result of vaccination site pain, fatigue. Additional information: Clinical course: Moderately sore arm around the injection site over a 24 hour period, beginning 1-2 hours after the injection and continued for 48 hours after injection; also experience mild fatigue for 6-12 hours, starting the day of the injection. Both symptoms were resolved the by the morning of an unspecified date in Apr2021. Treatment included ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and sore Lymph Nodes under Left Armpit; Swollen and sore Lymph Nodes under Left Armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 12:15 (Lot number: EP6955) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies codine" (unspecified if ongoing), notes: Codine, Chocolate, Strawberries, Nuts; "Known allergies Chocolate" (unspecified if ongoing), notes: Codine, Chocolate, Strawberries, Nuts; "Known allergies Strawberries" (unspecified if ongoing), notes: Codine, Chocolate, Strawberries, Nuts; "Known allergies nuts" (unspecified if ongoing), notes: Codine, Chocolate, Strawberries, Nuts. Concomitant medication(s) included: RELPAX taken for migraine; UBRELVY taken for migraine. Vaccination history included: Bnt162b2 (Dose: 1, lot number: EL3247, administration time: 12:00 PM, vaccine location: Left arm), administration date: 02Mar2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 25Mar2021, outcome "not recovered" and all described as "Swollen and sore Lymph Nodes under Left Armpit". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: Patient reported that she was neither been diagnosed with COVID-19 prior to vaccination and nor been tested for COVID-19 since vaccination. List of any other medications the patient received within 2 weeks of vaccination was reported as Relpax or Ulbrevy as needed for migraine headaches. Patient also reported that she did not received any other vaccines within 4 weeks prior to the COVID vaccine. Seriousness criteria (Results in death/Life threatening/Caused or prolonged hospitalization/Disabling or Incapacitating/Congenital anomaly or birth defect) was reported as No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Secretion discharge
Clinical narrative: Sore Arm/had more prolonged pain in her arm; More Mucous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore Arm/had more prolonged pain in her arm"; SECRETION DISCHARGE (non-serious), outcome "recovered", described as "More Mucous". Additional information: Reporter states his husband actually had more prolonged pain in his arm, his lasted a day and a half longer than his did. States other than arm pain, and more mucous for a couple of days, he is just fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.