chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza virus test, Investigation, Pneumonia viral, SARS-CoV-2 test, X-ray
Clinical narrative: continues cough, visited or office for flu test and X-ray: Result was mild Pneumonia/viral pneumonia; This is a spontaneous report from a contactable consumer (patient). This is second dose report of two reports. A 75-year-old male patient received the second dose of bnt162b2 (lot: EL 9264), via an unspecified route of administration in left arm on 03Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot: EL3249), at the age of 75-year-old, via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization and experienced COVID-19 (Tested positive 22Jan2021. Jan 24-25 experienced Fever, Diarrhea, Dizzy, Hot/cold periods, Headache, weakness and tiredness). The patient experienced continues cough, visited or office for flu test and x-ray: result was mild pneumonia/viral pneumonia on 05Feb2021. On 05Feb2021 patient was tested for flu. Test was negative, however, an X-ray showed some Pneumonia. Dr. indicated No treatment required. The event required a visit to Physician office. The patient underwent lab tests and procedures which included flu test: negative on 05Feb2021, Pneumonia: positive (viral pneumonia) on 05Feb2021, x-ray: mild pneumonia on 05Feb2021, COVID-19 virus test: positive on 22Jan2021. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106774 Same patient, reporter, drug and different event and dose
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Systemic inflammatory response syndrome
Clinical narrative: systemic inflammatory; asymptomatic COVID-19 infection; asymptomatic COVID-19 infection; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed a devastating systemic inflammatory response within 36 hours of receiving his second Pfizer vaccine shot. Patient's deadly inflammatory state followed his vaccination. Administration of the Pfizer vaccine ignited a deadly inflammatory response in patient's body acutely, in a setting where he had a recent asymptomatic COVID-19 infection. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of all events were fatal.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: asymptomatic COVID-19 infection; asymptomatic COVID-19 infection; systemic inflammatory
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction to flu vaccines; Initial information was received on 27-Feb-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional via Social media.  This case involves patient (unknown demography) who experienced severe allergic reaction to flu vaccines (hypersensitivity), while the patient received INFLUENZA VACCINE.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided. Medication Details and reason for taking the medicine: Not Provided The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious severe allergic reaction to flu vaccines (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  Reporter stated that, get yours and you can have mine too. The patient had a severe allergic reaction to flu vaccines. It is unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown.  There will be no information available on the lot number for this case.
Sex: F
Vaccine: PPV
Symptoms: Skin laceration, Syringe issue, Wound treatment
Clinical narrative: when she pushed the plunger down, the cracks in the glass cut her hand through the glove. Patient irrigated the wound and applied a band aid to the wound.; crack in the glass on the finger flange/ SMALL SPOT WITH SHARDS OF GLASS STICKING OUT/ found without finger flange in the blister pack; The medical assistant administered the product with the cracked finger flange/ she noticed and she didn't want to waste the vaccine and she took care to try not to touch the broken part but it still cut her up real good; This spontaneous report was received from an unknown-aged female medical assistant referring to herself via a company representative. Her pertinent medical history, concomitant medication, drug reactions, and allergies were not provided.     On 13-JAN-2021, the medical assistant noticed there was a crack in the glass on the finger flange of one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (lot number T016159, expiration date 28-FEB-2022) further described as a "small spot with shards of glass sticking out of it" and "found without finger flange in the blister pack" (syringe issue). The medical assistant reported that she did not want to waste the vaccine; therefore, she still administered it with the cracked finger flange. She took care to try not to touch the broken part (off label use of device); nevertheless, when she pushed the plunger down, the cracks in the glass cut her hand through the glove (wound) "real good". The medical assistant sought medical attention, irrigated the wound, and applied a band-aid to it. The wound had healed by reporting time.   According to the medical assistant, none of the product leaked out of the barrel. The unspecified patient received the full dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (dose number, route of administration, and anatomical site of vaccination were not provided), and no adverse events occurred to the patient (case # 2102USA007934).   The causal relationship between the wound and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA007934:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; Caller reported that PROQUAD that underwent a temperature excursion was administered.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug or allergy history. No concomitant therapies were reported.      On 22-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027115 and expiration date since it makes match with the autopopulated expiration date 07-FEB-2022) (dose, route, and anatomical location were not reported) for prophylaxis which was stored at temperature excursion. The vaccinemeasles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was exposed to temperatures between -10 to 8 degrees Celsius during 22 hours, detected by a digital data logger. There was not previous temperature excursion.  No additional adverse effect was reported.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Pain, Syncope
Clinical narrative: had fainted on unknown, previous date; GARDASIL 9 injection had hurt at time of GARDASIL 9 administration on unknown, previous date; This spontaneous report as received from  patient's mother regarding a 19-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient confirmed had hurt at time of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administration. Besides, the patient had fainted on an unknown date. The outcome of the events was unknown. The causality assessment between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.    Upon internal review, fainted (PT: syncope) was determined to be medically significant.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2103USA001105:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; Caller reported that VARlVAX that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 05-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme frequency, route of administration, lot number T010313, which has been verified to be valid, expiration date reported and validated as 24-MAR-2022), that underwent a temperature excursion (product storage error). The vaccine administered experienced a temperature excursion of -10 degrees Celsius (C) (-6.7 C), for a time frame of 9 hours and 12 minutes and 0 seconds, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse effects; Patient was given a expired GARDASIL 9; This spontaneous report has been received from a registered nurse referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 04-MAR-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R002429 with expiration date of 18-NOV-2020 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R002429; expirationdate: 18-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The twin boys are now 18 years old and did not complete the series.; No additional AE reported; This spontaneous report was received from a registered nurse, referring to a 18-year-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   In September 2018, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as prophylaxis (formulation, strength, route of vaccination, anatomical site of vaccination, lot number and expiration date were not reported).   At the reporting time, the patient was 18-year-old, and he did not received yet the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No additional adverse event were reported.   This is one of several reports received from the same reporter.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Under age of 18 were inadvertently given their series of Moderna vaccine; A spontaneous report was received from a nurse concerning a 16-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) under the age of 18 (inappropriate age at vaccine administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012L20A) for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 010M20A) for prophylaxis of COVID-19 infection.  The patient under the age of 18 (16  years female) Inadvertently received both doses of Moderna vaccine (inappropriate age at vaccine administration). No adverse reactions were reported.  Treatment details if provided or No treatment information was provided.   Action taken is not applicable  The outcome of the event, patient under the age of 18 was inadvertently given their series of Moderna vaccine was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for  mRNA-1273, who received both doses (batch number: 012L20A and 010M20A) with no associated AEs.  Causality for this medication error is not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 17 year old inadvertently receives the moderna vaccine; A spontaneous report was received from a health care professional concerning a 17-year old patient, unknown gender, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, a 17 year old patient received their first dose of two planned dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events was considered as recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years of age got vaccine administered; A spontaneous report was received from a nurse concerning a 17-year-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, prior to the onset of the events, the patient received a dose of two planned dose of mRNA-1273 (Lot number: 043L20A) intramuscularly for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events is not applicable.   The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 043L20A) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Tachycardia
Clinical narrative: tachycardia; shortness of breath; sweating; A spontaneous report was received from a other health care professional concerning an unspecified age and gender patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tachycardia, shortness of breath/dyspnea, and sweating/hyperhidrosis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date at a pharmacy, within minutes, the patient had shortness of breath, tachycardia and sweating. The events were considered to be life threatening.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies, Computerised tomogram, Splenic infarction
Clinical narrative: Spleen infarct; A spontaneous report was received from a physician concerning a 63-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced spleen infarct/splenic infarction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: unspecified) on first week of January.    On 01-Feb-2021, approximately twenty-two days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unspecified) via an unknown route for prophylaxis of COVID-19 infection.  On 23-Feb- 2021, the patient developed spleen infarct and was hospitalized for 2 days. While in the hospital, the patient had a computerized tomography (CT) scan which showed no malignancy. The patient also had a lupus anticoagulation test which showed a mild elevation.   Treatment for the event included Synthroid (not specified)  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event, spleen infarct, was considered recovered on an unspecified date.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Neck pain
Clinical narrative: Fatigue; achy shoulders and neck; achy shoulders and neck; This is a spontaneous report from a contactable consumer. A female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jan2021 the patient had Fatigue, achy shoulders, and neck. the patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient been tested for COVID-19 was unknown. The outcome of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: dizzy/Dizziness; nausea; This is a spontaneous report from a contactable Other Health Care Professional, the patient.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), via an unspecified route of administration on 02Feb2021 at 07:00 (at the age of 55-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included COVID-19 infection on an unspecified date. The patient was not pregnant at the time of vaccination. Concomitant medications were reported as "No." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021 at 06:00, the patient experienced dizziness and nausea. The reporter commented that she did not think these were side effects from the vaccine because she got it on Tuesday but her husband  pointed out that she normally does not have these side effects, so it has to be from the vaccine. The clinical outcomes of the events dizziness and nausea were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site swelling, redness, pain; injection site swelling, redness, pain; injection site swelling, redness, pain; This is a spontaneous report from a contactable other health professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular, in the right arm, on 05Feb2021 10:00 at SINGLE DOSE for covid-19 immunization. Medical history included allergies (unspecified). 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 hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced injection site swelling, redness, pain on 05Feb2021 10:00. The outcome of event was unknown. Patient did not receive any treatment for the events.  No follow-up attempts possible. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9265, via an unspecified route of administration, in the right arm, on01Feb2021 11:30 at SINGLE DOSE for covid-19 immunization. Medical history included diabetes, high cholesterol, high blood pressure and penicillin allergy. 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 hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced soreness at injection site on 01Feb2021 11:30. The outcome of event was recovered.   No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a little headache; This is a spontaneous report from a contactable consumer (patient). A 92 (units unknown) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a little headache on an unspecified date. The patient stated that she heard on the news not to take anything after having received the vaccine, "do not take anything to counteract". The patient stated that she had a little headache, but she would not consider that an adverse reaction. She stated that she would have had that if she took the flu shot. The patient inquired if what she had heard on the news meant that she could not have any pain medication. She received the second shot of the Pfizer vaccine yesterday. She stated that she heard that on the news and it bothered her. She stated that she would not report this as a side effect/adverse reaction. The clinical outcome of the event a little headache was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Blood test, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; Chest tightness/achiness; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL-9261/expiration date: not provided), via intramuscular route of administration, on 30Jan2021 at 09:00 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was reported as none. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin D, cetirizine hydrochloride (ALLERTEC), and paracetamol (TYLENOL) (a few times after vaccine due to symptoms).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 (also reported as "02Jan2021"), the patient experienced chest tightness/achiness. On 03Feb2021, (also reported as "03Jan2021"), the patient experienced mild/partial loss of smell, headache, and sinus discomfort (pressure, ache). The events required an emergency room visit/physician office visit. The patient did not receive any treatment for these events. The patient was assessed by ER on 02Feb2021: EKG, chest X-RAY and bloodwork looked good. It was assumed COVID due to recent exposure, however, 72 hour COVID test nasal swab PCR on 03Feb2021 and rapid test SARS Antigen FIA on 06Feb were negative. The patient had a post vaccination nasal swab, covid test name unsure - NOT rapid, covid test result pending. The outcome of the events chest tightness/achiness, mild/partial loss of smell, headache, and sinus discomfort (pressure, ache) was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, SARS-CoV-2 test, Sinus pain
Clinical narrative: mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; Chest tightness/achiness; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL-9261/expiration date: not provided), via intramuscular route of administration, on 30Jan2021 at 09:00 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was reported as none. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin D, cetirizine hydrochloride (ALLERTEC), and paracetamol (TYLENOL) (a few times after vaccine due to symptoms).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 (also reported as "02Jan2021"), the patient experienced chest tightness/achiness. On 03Feb2021, (also reported as "03Jan2021"), the patient experienced mild/partial loss of smell, headache, and sinus discomfort (pressure, ache). The events required an emergency room visit/physician office visit. The patient did not receive any treatment for these events. The patient was assessed by ER on 02Feb2021: EKG, chest X-RAY and bloodwork looked good. It was assumed COVID due to recent exposure, however, 72 hour COVID test nasal swab PCR on 03Feb2021 and rapid test SARS Antigen FIA on 06Feb were negative. The patient had a post vaccination nasal swab, covid test name unsure - NOT rapid, covid test result pending. The outcome of the events chest tightness/achiness, mild/partial loss of smell, headache, and sinus discomfort (pressure, ache) was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Dyspnoea, Electrocardiogram, Headache
Clinical narrative: on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; This is a spontaneous report from a contactable consumer, the patient. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: paa156051),  dose 1 , single dose via an unspecified route of administration in the left arm on 27Jan2021 at 12:30 PM for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine.  On Friday, 29Jan2021 at approximately 6pm, the patient had some difficulty with her breathing and again on Sunday 31Jan2021 but not as bad as the 29Jan2021 and again on 02Feb 2021 and 03Feb2021. As of 06Feb2021, she has not had any more breathing problems and had the headache and chills for the first week. She went to urgent care on 01Feb2021 and was given a chest X-ray, bloodwork, electrocardiogram (ECG) and a COVID test all were normal. No treatment was received for difficulty with her breathing, headache and chills. The clinical outcome of difficulty with her breathing, headache and chills was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 05Feb2021 and was negative.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, X-ray
Clinical narrative: on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; This is a spontaneous report from a contactable consumer, the patient. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: paa156051),  dose 1 , single dose via an unspecified route of administration in the left arm on 27Jan2021 at 12:30 PM for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine.  On Friday, 29Jan2021 at approximately 6pm, the patient had some difficulty with her breathing and again on Sunday 31Jan2021 but not as bad as the 29Jan2021 and again on 02Feb 2021 and 03Feb2021. As of 06Feb2021, she has not had any more breathing problems and had the headache and chills for the first week. She went to urgent care on 01Feb2021 and was given a chest X-ray, bloodwork, electrocardiogram (ECG) and a COVID test all were normal. No treatment was received for difficulty with her breathing, headache and chills. The clinical outcome of difficulty with her breathing, headache and chills was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 05Feb2021 and was negative.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Chest X-ray, Chills, Decreased appetite
Clinical narrative: on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; This is a spontaneous report from a contactable consumer, the patient. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: paa156051),  dose 1 , single dose via an unspecified route of administration in the left arm on 27Jan2021 at 12:30 PM for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine.  On Friday, 29Jan2021 at approximately 6pm, the patient had some difficulty with her breathing and again on Sunday 31Jan2021 but not as bad as the 29Jan2021 and again on 02Feb 2021 and 03Feb2021. As of 06Feb2021, she has not had any more breathing problems and had the headache and chills for the first week. She went to urgent care on 01Feb2021 and was given a chest X-ray, bloodwork, electrocardiogram (ECG) and a COVID test all were normal. No treatment was received for difficulty with her breathing, headache and chills. The clinical outcome of difficulty with her breathing, headache and chills was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 05Feb2021 and was negative.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Fibrin D dimer increased, Full blood count, Nausea
Clinical narrative: on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; This is a spontaneous report from a contactable consumer, the patient. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: paa156051),  dose 1 , single dose via an unspecified route of administration in the left arm on 27Jan2021 at 12:30 PM for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine.  On Friday, 29Jan2021 at approximately 6pm, the patient had some difficulty with her breathing and again on Sunday 31Jan2021 but not as bad as the 29Jan2021 and again on 02Feb 2021 and 03Feb2021. As of 06Feb2021, she has not had any more breathing problems and had the headache and chills for the first week. She went to urgent care on 01Feb2021 and was given a chest X-ray, bloodwork, electrocardiogram (ECG) and a COVID test all were normal. No treatment was received for difficulty with her breathing, headache and chills. The clinical outcome of difficulty with her breathing, headache and chills was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 05Feb2021 and was negative.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, SARS-CoV-2 test negative, Scan with contrast, Tremor, Ultrasound Doppler
Clinical narrative: on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; This is a spontaneous report from a contactable consumer, the patient. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: paa156051),  dose 1 , single dose via an unspecified route of administration in the left arm on 27Jan2021 at 12:30 PM for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine.  On Friday, 29Jan2021 at approximately 6pm, the patient had some difficulty with her breathing and again on Sunday 31Jan2021 but not as bad as the 29Jan2021 and again on 02Feb 2021 and 03Feb2021. As of 06Feb2021, she has not had any more breathing problems and had the headache and chills for the first week. She went to urgent care on 01Feb2021 and was given a chest X-ray, bloodwork, electrocardiogram (ECG) and a COVID test all were normal. No treatment was received for difficulty with her breathing, headache and chills. The clinical outcome of difficulty with her breathing, headache and chills was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 05Feb2021 and was negative.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray with contrast
Clinical narrative: on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; This is a spontaneous report from a contactable consumer, the patient. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: paa156051),  dose 1 , single dose via an unspecified route of administration in the left arm on 27Jan2021 at 12:30 PM for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine.  On Friday, 29Jan2021 at approximately 6pm, the patient had some difficulty with her breathing and again on Sunday 31Jan2021 but not as bad as the 29Jan2021 and again on 02Feb 2021 and 03Feb2021. As of 06Feb2021, she has not had any more breathing problems and had the headache and chills for the first week. She went to urgent care on 01Feb2021 and was given a chest X-ray, bloodwork, electrocardiogram (ECG) and a COVID test all were normal. No treatment was received for difficulty with her breathing, headache and chills. The clinical outcome of difficulty with her breathing, headache and chills was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 05Feb2021 and was negative.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Dysuria, Headache, Insomnia, Pain
Clinical narrative: Burning during urination; Headache; body aches and pains; joint fatigue; Very restless and difficult sleep; Very restless and difficult sleep; This is a spontaneous report from a contactable consumer (the patient). A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 04Feb2021 08:30 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma but no food or medicine allergies but seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atorvastatin, losartan, and metoprolol ER (extended release). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 14Jan2021 09:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other vaccine on the same date as the COVID vaccine. On 04Feb2021 22:00, the patient experienced headache, body aches and pains, joint fatigue, very restless and difficult to sleep first night. The patient experienced burning during urination the next morning (05Feb2021). No treatment was received for the events. The clinical outcome of the events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    Information of lot number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: Burning during urination; Headache; body aches and pains; joint fatigue; Very restless and difficult sleep; Very restless and difficult sleep; This is a spontaneous report from a contactable consumer (the patient). A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 04Feb2021 08:30 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma but no food or medicine allergies but seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atorvastatin, losartan, and metoprolol ER (extended release). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 14Jan2021 09:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other vaccine on the same date as the COVID vaccine. On 04Feb2021 22:00, the patient experienced headache, body aches and pains, joint fatigue, very restless and difficult to sleep first night. The patient experienced burning during urination the next morning (05Feb2021). No treatment was received for the events. The clinical outcome of the events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    Information of lot number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Neck pain
Clinical narrative: a bad stiff neck on my left side; one of my lymph nodes were swollen; the pain on my left side of my neck; This is a spontaneous report from a contactable consumer (the patient).  A non-pregnant 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:45 AM (at the age of 82-years) as a single dose for COVID-19 immunization. Medical history included asthma, and hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 at 05:00 AM, the patient woke up with a bad stiff neck on her left side. When she touched her neck, she realized that one of her lymph nodes were swollen, and pain on her left side of my neck. The patient was not sure whether the pain on her left side of her neck had anything to do with this swollen node. After four days, she still had the swollen node and a lot of pain on her left side of her  neck. No treatment was given. The clinical outcome of bad stiff neck on my left side, one of her lymph nodes were swollen, and pain on her left side of my neck was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on lot number was requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Vaccination site pruritus
Clinical narrative: Site is very itchy.; Arm red and hot; Arm red and hot; This is a spontaneous report from a contactable consumer (the patient).  A non-pregnant 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 23Jan2021 at 11:30 AM (at the age of 73 years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, asthma, hypertension. The patient did not have any known allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included levothyroxine sodium, hydrochlorothiazide/losartan potassium. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Feb2021 at 16:00 PM, the patient experienced arm red and hot. On an unspecified date the  patient experienced the injection site is very itchy. No treatment was given for the events.  The clinical outcome of arm red and hot was not recovered. The clinical outcome of injection site is very itchy was unknown. .  It was also reported that since the vaccination, the patient had not been tested for COVID-19.