chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: This case has been considered invalid as there is no indication that the consumer experienced an event under BNT162B2. This case involves medical inquiry only. This is a spontaneous report from a contactable consumer (herself). A female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date, as single dose for Covid-19 immunisation. Medical history included sinusitis and concomitant medications were not reported.  He had first dose of the Pfizer BioNTech Covid-19 vaccine while she had a sinus infection. Or took the vaccine while she had a sinus infection. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (10May2021): Follow-up attempts completed. No further information expected. Follow-up (22Mar2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: I am fine. No one made or did anything wrong. I were worried that I think. But everything is good. To Pfizer, I do not know why I am receiving all of these papers. I called your company a while back when I received your vaccine, they were very professional and wonderful to me. I am fine was trying to find out if I did something wrong by not realizing I had a sinus problem. I thought I might have done some-thing wrong, I am fine the nurses were great. No need to worry. Thank you but everything is good no mistakes made. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Periorbital disorder
Clinical narrative: Facial numbness around right eye; periorbital migration; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 25Jan2021 07:15 (Lot number: EL1283) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Known allergies: dust" (unspecified if ongoing); "Known allergies: pollen" (unspecified if ongoing); "Known allergies: trees, grasses" (unspecified if ongoing). Concomitant medication(s) included: COQ10 [UBIDECARENONE]; VITAMIN D [ERGOCALCIFEROL]; FEXOFENADINE; ATORVASTATIN; MONTELUKAST; SINGULAIR; ALLEGRA. Vaccination history included: Bnt162b2 (lot number: EH9899; administration time: 07:15 AM; route of administration: intramuscular; vaccine location: left arm; dose number: 1), administration date: 26Dec2020, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Facial numbness around right eye and migrating 11 hours after injection"; Hep b vaccine, administration date: 1984, when the patient was 21 years old, for hepatitis B, reaction(s): "left arm numbness". The following information was reported: HYPOAESTHESIA (non-serious) with onset 25Jan2021 06:00, outcome "recovered", described as "Facial numbness around right eye"; PERIORBITAL DISORDER (non-serious) with onset 25Jan2021 06:00, outcome "recovered", described as "periorbital migration". Therapeutic measures were not taken as a result of hypoaesthesia. Therapeutic measures were taken as a result of periorbital disorder. Additional information: The patient had no other vaccine in four weeks. Other medications in two weeks included multivitamins. It was reported that the patient had facial numbness around right eye and migrating 11 hours after injection. Onset was 12 hours after vaccine, was later, resolved and recovered 3 hours after. Similar sensation 2 weeks after first vaccination was reported. Prior to vaccination, the patient was not diagnosed with COVID- 19. Since the vaccination, the patient has not been tested for COVID-19. The event did not require a visit to the hospital. No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepy; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid.  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 patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Feb2021 09:00 (Lot number: EL9261) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SOMNOLENCE (non-serious) with onset 12Feb2021 15:00, outcome "unknown", described as "sleepy". Therapeutic measures were not taken as a result of somnolence. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Cough, Inappropriate schedule of product administration, Lymphadenopathy, Mammogram
Clinical narrative: URI; Cough; Axillary lymphhadenopathy; second dose on 15Jan2021/first dose on 29Dec2020; This is a spontaneous report from a contactable other HCP reported for herself that a 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 66 years, via intramuscular in right arm on 15Jan2021 04:30 (Lot number: EL3248) as a single dose for COVID-19 immunisation, in hospital. Relevant medical history included: "heart disease" (unspecified if ongoing); "allergies" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hyperlipidaemia" (unspecified if ongoing); "CAD" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE taken for hypertension (ongoing); ZETIN taken for hyperlipidaemia (ongoing); ISOSORBIDE taken for coronary artery disease (ongoing); METOPROLOL taken for hypertension (ongoing); LIVALO taken for hyperlipidaemia, start date: 22Feb2021 (ongoing); ASA taken for coronary artery disease (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient was not pregnant at the time of vaccination. The patient historically received first single dose of BNT162B2 at the age of 66 years via intramuscular in right arm on 29Dec2020 05:00 AM (Batch number: EL0140) for COVID-19 immunisation. Since the vaccination, the patient has not been tested for COVID-19. The patient took Zithromac orally from 17Feb2021 to 21Feb2021 for URI and cough. On 01Mar2021, the patient experienced axillary lymphadenopathy. Event "axillary lymphhadenopathy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, upper respiratory tract infection, cough. CT chest on 01Mar2021 showed right side axillary lymphadenopathy. Diagnostic mammography on 10Mar2021 showed axillary lymphadenopathy and USG right axilla on 10Mar2021 showed mildly enlarged axillary lymph node. On 22Mar2021, it was reported that the patient provided information to the HCP regarding the reported adverse events with the use of product and considered the Pfizer product to have had a casual effect to the adverse event. Outcome of the event axillary lymphhadenopathy was recovering and of the other events was unknown.  Follow up (22Mar2021): This is a follow up-spontaneous report from a contactable other HCP.  Updated information: vaccination details (route of administration and lot/batch number of doses 1 and 2), relevant medical history (HTN, hyperlipidaemia, CAD, and GERD), concomitant medications, laboratory data (CT scan, diagnostic mammography, and USG right axilla), and reaction data (new events axillary lymphadenopathy, URI, and cough).  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Upper respiratory tract infection
Clinical narrative: URI; Cough; Axillary lymphhadenopathy; second dose on 15Jan2021/first dose on 29Dec2020; This is a spontaneous report from a contactable other HCP reported for herself that a 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 66 years, via intramuscular in right arm on 15Jan2021 04:30 (Lot number: EL3248) as a single dose for COVID-19 immunisation, in hospital. Relevant medical history included: "heart disease" (unspecified if ongoing); "allergies" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hyperlipidaemia" (unspecified if ongoing); "CAD" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE taken for hypertension (ongoing); ZETIN taken for hyperlipidaemia (ongoing); ISOSORBIDE taken for coronary artery disease (ongoing); METOPROLOL taken for hypertension (ongoing); LIVALO taken for hyperlipidaemia, start date: 22Feb2021 (ongoing); ASA taken for coronary artery disease (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient was not pregnant at the time of vaccination. The patient historically received first single dose of BNT162B2 at the age of 66 years via intramuscular in right arm on 29Dec2020 05:00 AM (Batch number: EL0140) for COVID-19 immunisation. Since the vaccination, the patient has not been tested for COVID-19. The patient took Zithromac orally from 17Feb2021 to 21Feb2021 for URI and cough. On 01Mar2021, the patient experienced axillary lymphadenopathy. Event "axillary lymphhadenopathy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, upper respiratory tract infection, cough. CT chest on 01Mar2021 showed right side axillary lymphadenopathy. Diagnostic mammography on 10Mar2021 showed axillary lymphadenopathy and USG right axilla on 10Mar2021 showed mildly enlarged axillary lymph node. On 22Mar2021, it was reported that the patient provided information to the HCP regarding the reported adverse events with the use of product and considered the Pfizer product to have had a casual effect to the adverse event. Outcome of the event axillary lymphhadenopathy was recovering and of the other events was unknown.  Follow up (22Mar2021): This is a follow up-spontaneous report from a contactable other HCP.  Updated information: vaccination details (route of administration and lot/batch number of doses 1 and 2), relevant medical history (HTN, hyperlipidaemia, CAD, and GERD), concomitant medications, laboratory data (CT scan, diagnostic mammography, and USG right axilla), and reaction data (new events axillary lymphadenopathy, URI, and cough).  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Slight chills; Slight body aches; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 11:30 (Lot number: EL3247) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies to Sulfer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,  lot number=EL3247, Left Arm), administration date: 23Feb2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 16Mar2021 22:30, outcome "recovered", described as "Slight chills"; PAIN (non-serious) with onset 16Mar2021 22:30, outcome "recovered", described as "Slight body aches"; PAIN IN EXTREMITY (non-serious) with onset 16Mar2021 22:30, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of chills, pain, pain in extremity. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye operation
Clinical narrative: eye surgery; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 79 year-old female 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: EYE OPERATION (medically significant), outcome "unknown", described as "eye surgery". Therapeutic measures were taken as a result of eye operation which included prednisone, ofloxacin and ketorolac.  Clinical course: It was reported that the patient had the eye surgery 2 days after the first dose of the vaccine. She wanted to know if it's okay to take her second dose today (day of report) as she was on prednisone, ofloxacin and ketorolac. She wanted to know about any interaction that will make the vaccine to be not effective.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: increased blood pressure; . This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 10:15 (Lot number: EN6205) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR [ATORVASTATIN] taken for blood cholesterol (ongoing); ULORIC (ongoing). Past drug history included: Lipitor, notes: Started 10 years ago, 5 years ago at a minimum, states let's just say 10 years. Vaccination history included: Bnt162b2 (First vaccine dose received on 14Feb2021, LOT:EL9266, Left Arm), administration date: 14Feb2021, when the patient was 62 years old, for Covid-19 immunisation. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 15Mar2021, outcome "not recovered", described as "increased blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased.  Additional information: Caller states that he is calling about the Pfizer Covid 19 Vaccine. Caller states that first of all he called yesterday and they took his information and he was on hold for 2 hours to get an agent and got cut off. No reference number available. Caller states that is alright, he just wanted to save some time entering information, not a problem. Caller states that he had his second vaccine on Monday 15Mar2021. States his blood pressure normally runs 117/76-77 but since the vaccine on Monday it is running 135/87 and is constantly up. He states the he wants to know if it is from the vaccine, maybe it is his immune system causing it? States the vaccine is the only thing that is different or could be causing it.  Treatment: None, states he doesn't not take blood pressure medication.  Clarifies that Monday evening it started, Tuesday he was taking a reading. States that the reason he took his blood pressure is because he keeps track of it anyway, he was not feeling strange or anything. States that he takes it [blood pressure] in the morning and afternoon and it doesn't change throughout the day. Clarifies that Monday evening the elevated blood pressure started, but he took his blood pressure for the first time on Tuesday morning. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: her left arm is huge and a sack of fluid is hanging from her arm; 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 (005570). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE taken for hypertension. Past drug history included: Lisinopril, reaction(s): "edema", notes: wound up at hospital over night with edema; Lisinopril, reaction(s): "couldn't breath", notes: wound up at hospital over night with couldn't breath. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "her left arm is huge and a sack of fluid is hanging from her arm". Therapeutic measures were taken as a result of peripheral swelling.  Additional information: Patient said her left arm was huge and a sack of fluid was hanging from her arm. It looks like jelly, was out of shape and wobbles. She doesn't know if it was localized or has traveled to other parts of her body, specifically to her heart. She had a previous experience after taking lisinopril and wound up at hospital over night with edema and couldn't breathe. She took 100mg of spironolactone for hypertension. She contacted her hypertension doctor and her primary care physician and a message from her primary physician only said to take Tylenol.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain
Clinical narrative: feels "very achy"; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 12:00 (Lot number: EN6204) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic", start date: Nov1948 (unspecified if ongoing); "Scleroderma", start date: Mar2018 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose was on 25 Feb 2021. Lot EN6198, expiration is unknown. Pfizer COVID vaccine. Injected in left arm in the muscle.), administration date: 25Feb2021, when the patient was 76 years old, for covid-19 immunisation; Flu shot (Reaction to flu shot and was achy the next day), reaction(s): "achy". The following information was reported: PAIN (non-serious) with onset 18Mar2021, outcome "not recovered", described as "feels "very achy""; CONDITION AGGRAVATED (non-serious) with onset 18Mar2021, outcome "not recovered", described as "headache".  Additional information: The reporter reported that She has quite a headache and is achy. She would like to know if she can take a Tylenol for the headache. After the lot number, she stated it had the number 6-21 after it and was unable to confirm if that was the expiration date. There was no prescriber. She did not wish to provide an email address. She confirmed that this occurred after the 2nd dose of the Pfizer COVID vaccine. Her first dose was on 25Feb2021, with Lot EN6198, expiration is unknown. It was also the Pfizer COVID vaccine. She received it as prevention because she is Diabetic and has Scleroderma. She was diagnosed as being Diabetic in Nov 1948, when she was pretty little. Scleroderma was diagnosed Mar2018. All her medications have been steady. She did not think they were relevant. No further details provided. 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). 1st dose was on 25Feb2021. Lot EN6198, expiration is unknown. Pfizer COVID vaccine. Injected in left arm in the muscle.    No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: mild headache; chills; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 10:00 (Lot number: EP6955) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known_allergies" (unspecified if ongoing), notes: known_allergies :PCN. Concomitant medication(s) included: ATORVASTATIN; VIT D. Vaccination history included: Bnt162b2 (Dose number:1, lot number: EP3247, administration time: 10:00AM, vaccine location: Right arm), administration date: 26Feb2021, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 18Mar2021 06:00, outcome "recovering", described as "mild headache"; CHILLS (non-serious) with onset 18Mar2021 06:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 18Mar2021 06:00, outcome "recovering", described as "body ache".Therapeutic measures were not taken as a result of headache, chills, pain.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not diagnosed with COVID prior vaccination and post vaccination. Facility type vaccine was Workplace clinic. other medications the patient received within 2 weeks of vaccination includes Atorvastatin 20mg QD, Vitamin D. Treatment was not received for the adverse event.  Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Moderate Sore Arm; Fatigue; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 17:00 (Lot number: EN6198) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Environmental allergy" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ; LOSARTAN; BUSPAR; ALPRAZOLAM; TRAZODONE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "Moderate Sore Arm"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Fatigue"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Chills". Therapeutic measures were taken as a result of pain in extremity, fatigue, chills.  Additional information: A 56-year-old non-pregnant female patient received first dose via an unspecified route of administration. This is the first of the two case reports. Concomitant medications included BUSPAR, trazodone (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN), PRISTIQ and losartan, (MANUFACTURER UNKNOWN) were received for unknown indications from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Feb2021, the patient experienced moderate sore arm, fatigue lasted for about 36 hours and chills for about 12 hours. The patient called nurse and was advised to apply ice and take ibuprofen. The clinical outcome of pain in arm was unknown while that of fatigue and chills were recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (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, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Serious: No. Patient  told them after the first shot it made me "feel weird". The 2nd shot was on 18Feb2021 (I think it was) and it was normal and don't have anything to tell them. Patient was listening to people like my daughter who won't get the vaccine who's saying it's the mark of the beast; people had me so scared to do this. Patient  just had a sore arm. Patient was still scared ; going to have side effects still have one 29 days away they still scare you people scare you of the shot telling you people have died. Had symptoms but it's not from the shot, it's from a condition she had. Informed her that reported side effects from clinical trials were within 7 days but there were other reported side effects longer than that and they are still being followed 2 years out.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia
Clinical narrative: muscle pain; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Mar2021 10:45 (Batch/Lot number: unknown) at the age of 55 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN 1A PHARMA; GLIPIZIDE; BASAGLAR; VICTOZA; LISINO [LISINOPRIL DIHYDRATE]. The following information was reported: MYALGIA (non-serious) with onset 16Mar2021, outcome "recovering", described as "muscle pain"; DIZZINESS (non-serious) with onset 16Mar2021, outcome "recovering", described as "Dizziness". The events "muscle pain" and "dizziness" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of myalgia, dizziness. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: horrible headache all night, feel like I have the flu; horrible headache all night, feel like I have the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 67 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 1, 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: HEADACHE (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset 21Mar2021, outcome "not recovered" and all described as "horrible headache all night, feel like I have the flu". Therapeutic measures were taken as a result of headache, influenza like illness. Treatment included Tylenol cold and flu medicine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Pain
Clinical narrative: Chills that lasted for hours; Aching from head to feet; severe headache; leg cramps; 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm right, administration date 26Feb2021 18:30 (Lot number: EN6023) at the age of 67 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Allergy".  The following information was reported: CHILLS (non-serious) with onset 27Feb2021 18:15, outcome "recovered" (28Feb2021), described as "Chills that lasted for hours"; PAIN (non-serious) with onset 27Feb2021 18:15, outcome "recovered" (28Feb2021), described as "Aching from head to feet"; HEADACHE (non-serious) with onset 27Feb2021 18:15, outcome "recovered" (28Feb2021), described as "severe headache"; MUSCLE SPASMS (non-serious) with onset 27Feb2021 18:15, outcome "recovered" (28Feb2021), described as "leg cramps". Therapeutic measures were not taken as a result of chills, pain, headache, muscle spasms.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had been taking concomitant medications, but the medication name was not reported. The patient did not receive any other vaccines within four weeks prior to COVID vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: upset stomach; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  An 88 year-old female 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: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "upset stomach".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: diarrhea; Sore Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 10:00 (Lot number: ENU199) as dose 1, single at the age of 69 years for covid-19 immunisation. Relevant medical history included: "Hernia" (ongoing); "sports hernia" (ongoing), notes: First Diagnosis about 11 years ago. She has had several surgeries, the mesh doesn't hold them and she has nothing covering her intestines. Has gotten worse.; "several surgeries" (unspecified if ongoing) and has a lot pf health problems. Family history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications included pain medications but that they have never caused her to have diarrhea with any of the medication that she takes. The following information was reported: DIARRHOEA (non-serious) with onset 07Mar2021, outcome "unknown", described as "diarrhea"; PAIN IN EXTREMITY (non-serious) with onset 07Mar2021, outcome "recovered" (08Mar2021), described as "Sore Arm".   Additional information: the first and second night after the vaccine, she had unbelievable diarrhea. Patient was wondering if that was one of the side effects. She was uncertain if the diarrhea started on 7Mar2021; states that she thinks it did, she was kind of vague on that, but knows that it lasted for 2 nights. She has never had that kind of diarrhea, on the second night it was everywhere. She also had a sore arm starting the day of the vaccine which was hurting; but she kept moving it around, states was better by the next day. It wasn't bothering that bad at all.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: soreness on her left arm; pain the in the injection site; fatigue; headaches; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 12:45 (Lot number: 59267-1000-02) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Mar2021, outcome "not recovered", described as "pain the in the injection site"; FATIGUE (non-serious) with onset 14Mar2021, outcome "not recovered", described as "fatigue"; HEADACHE (non-serious) with onset 14Mar2021, outcome "not recovered", described as "headaches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness on her left arm". The events "pain the in the injection site", "fatigue" and "headaches" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site pain, fatigue, headache. Additional information: The patient has not had COVID prior to vaccination and has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first dose of the vaccine on 07Mar2021. The first week after the vaccine, the patient started to have pain the in the injection site, fatigue, headaches. It was further reported that at first, she felt fine but now she developed soreness on her left arm on an unspecified date which goes on and off, as well as fatigue. She would like to know how long these symptoms will last.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Muscle twitching
Clinical narrative: twitching on my left eyebrow and lid; Facial twitching increased and spread to right eye lid, brow and musclesaround both eyes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 29Jan2021 (Lot number: EL3249) at the age of 36 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hay fever" (unspecified if ongoing); "known allergies: molds" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE.  The following information was reported: BLEPHAROSPASM (non-serious) with onset 01Feb2021, outcome "not recovered", described as "twitching on my left eyebrow and lid"; MUSCLE TWITCHING (non-serious) with onset 01Feb2021, outcome "not recovered", described as "Facial twitching increased and spread to right eye lid, brow and musclesaround both eyes". Therapeutic measures were not taken as a result of blepharospasm, muscle twitching.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not tested for COVID-19. The twitching occurred all day and while the patient was trying to go to sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Tendonitis in my shoulder; 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 (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, siigle for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TENDONITIS (non-serious), outcome "unknown", described as "Tendonitis in my shoulder". The patient reported that shoulder started bothering him. Doctor indicated that he had tendonitis in shoulder and to get rehab.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Illness, Lip blister, Oral mucosal blistering, Pain in extremity
Clinical narrative: Sore arm; blister in nose, lip and mouth; blister in nose, lip and mouth; blister in nose, lip and mouth; sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (Age: 64; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 arm"; BLISTER (non-serious), ORAL MUCOSAL BLISTERING (non-serious), LIP BLISTER (non-serious), outcome "unknown" and all described as "blister in nose, lip and mouth"; ILLNESS (non-serious), outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Feeling abnormal
Clinical narrative: She stated she felt worse after the vaccine than when she had Covid./feeling as bad as she did; After the first dose she had cold sweats, for two nights her hair was wet and her body was wet with sweat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid infection" (unspecified if ongoing), notes: She had the Covid infection the end of May/ first of Jun. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "She stated she felt worse after the vaccine than when she had Covid./feeling as bad as she did "; COLD SWEAT (non-serious), outcome "unknown", described as "After the first dose she had cold sweats, for two nights her hair was wet and her body was wet with sweat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: red marks right below the entry point/2.5 inch red mark on her arm; it is swollen right below the entry point and sore.; it is swollen right below the entry point and sore.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 13:30 (Lot number: ER8727) at the age of 30 years 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: VACCINATION SITE ERYTHEMA (non-serious) with onset 21Mar2021, outcome "not recovered", described as "red marks right below the entry point/2.5 inch red mark on her arm"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 21Mar2021, outcome "not recovered" and all described as "it is swollen right below the entry point and sore.". The events were assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: the strangest feeling washed over me/strange sensation; a really rapid heartbeat for about a minute; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 07:00 (Lot number: ER2613, Expiration Date: 31Jul2021) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 1999 (unspecified if ongoing), notes: diagnosed when she was 44, which was 22 years ago. She says it is an autoimmune thyroid condition.; "a-fib" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing), notes: Caller says this was diagnosed 10 years ago. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 22Mar2021, outcome "recovered", described as "the strangest feeling washed over me"; HEART RATE INCREASED (non-serious) with onset 22Mar2021, outcome "recovered", described as "a really rapid heartbeat for about a minute". Relevant laboratory tests and procedures are available in the appropriate section. She says after about 10 minutes after vaccination, the strangest sensation washed over her and she had a rapid heart beat of about 100 beats for about 60 seconds that went away. She says that she was concerned about when she gets her next shot what may happen. She said that the strange sensation went away after about 60 seconds, it was very fast, she felt like she could feel the vaccine spread through her whole body, it was a really strange sensation. She says she would like to know if this is normal, they waited 5 more minutes before they left and it has been 4.5 hours and she is fine now. She says that her main concern is for the next shot, what will likely happen. She says she guesses that was an adverse effect.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: blotches on her forearm/red spots; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (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: RASH MACULAR (non-serious) with onset 18Mar2021, outcome "unknown", described as "blotches on her forearm/red spots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Food allergy
Clinical narrative: metallic taste; shellfish allergy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A male patient (Age: 59, Unit: Unknown) 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: DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste"; FOOD ALLERGY (non-serious), outcome "unknown", described as "shellfish allergy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: lower back discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 14:05 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tetanus, reaction(s): "no adverse effect". The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 14Mar2021, outcome "not recovered", described as "lower back discomfort".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness
Clinical narrative: experiencing lightheadedness/dizziness; sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Feb2021 (Lot number: EN6200) at the age of 79 years 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 "experiencing lightheadedness/dizziness"; ILLNESS (non-serious), outcome "unknown", described as "sick".  No follow-up attempts are possible. No further information is expected.