chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal chest pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme fatigue; Left arm swelling that was the size of a baseball and it hurt/itched; Left arm swelling that was the size of a baseball and it hurt/itched; Left arm swelling that was the size of a baseball and it hurt/itched; Whole body aches for three days after injection; Left upper rib pain that felt like was getting stabbed every time breathed in deep; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 18:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) for an unknown indication and unspecified birth control medication, both from an unknown date and unknown if ongoing. On 11Sep2021 at 20:00, the patient experienced extreme fatigue, left arm swelling that was the size of a baseball and it hurt/itched, whole body aches for three days after injection and left upper rib pain that felt like patient was getting stabbed every time she breathed in deep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event whole body aches was resolved on 13Sep2021, while that of events extreme fatigue, left arm swelling that was the size of a baseball and it hurt/itched and left upper rib pain that felt like patient was getting stabbed every time she breathed in deep were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Extreme fatigue; Left arm swelling that was the size of a baseball and it hurt/itched; Left arm swelling that was the size of a baseball and it hurt/itched; Left arm swelling that was the size of a baseball and it hurt/itched; Whole body aches for three days after injection; Left upper rib pain that felt like was getting stabbed every time breathed in deep; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 18:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) for an unknown indication and unspecified birth control medication, both from an unknown date and unknown if ongoing. On 11Sep2021 at 20:00, the patient experienced extreme fatigue, left arm swelling that was the size of a baseball and it hurt/itched, whole body aches for three days after injection and left upper rib pain that felt like patient was getting stabbed every time she breathed in deep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event whole body aches was resolved on 13Sep2021, while that of events extreme fatigue, left arm swelling that was the size of a baseball and it hurt/itched and left upper rib pain that felt like patient was getting stabbed every time she breathed in deep were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with Covid-19, positive COVID-19 test, an antigen FIA test; diagnosed with Covid-19, positive COVID-19 test, an antigen FIA test; fatigue; cough; This is a spontaneous report from a contactable consumer (patient's wife) and from a Pfizer sponsored program, received from the same contactable consumer (patient's wife). This consumer reported similar events for three patients. This is the second of thee reports.  A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 63 years) (Batch/Lot Number: EP7534) as a single dose and dose 2 via an unspecified route of administration on 08Apr2021 (at the age of 63 years) (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Sep2021 (reported as within the past 4 days), the patient has been diagnosed with COVID-19, had positive COVID-19 test, an antigen FIA test. The patient complained of fatigue and cough on an unspecified date in Sep2021. Patient has been taking Benzonatate 100mg (pearl drops) to stop his cough at 2-3 times a day. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198193 Same reporter, same product, different patient, similar events;US-PFIZER INC-202101200289 Same reporter, same product, different patient, similar events
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with Covid-19; diagnosed with Covid-19; This is a spontaneous report from a contactable consumer (patient's mother/parent) via the Pfizer sponsored program. This consumer reported similar events for different patients. This is the third of 3 reports. This consumer (patient's mother/parent) reported that a 31 year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: EW0158) (at the age of 30 years) as DOSE 2, SINGLE; dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot Number: ER2613) (at the age of 30 years) as DOSE 1, SINGLE  for covid-19 immunisation. The patient medical history and concomitant medications were reported as none. It was reported that within the past 4 days (as reported), patient's mother, father, and patient himself all have been diagnosed with Covid-19. It was stated that all three have complaints of fatigue and that patient had been more tired. The patient medical history and concomitant medications were not reported. It was reported that within the past 4 days, patient's mother, father, and patient himself all have been diagnosed with Covid-19. It was stated that all three have complaints of fatigue and that patient had been more tired. The patient had his COVID test within days and had breakthrough COVID. Patient did the test two days ago (11Sep2021) that came back positive. Patient had a headache and sore throat so knew he had it, he never had COVID until this breakthrough. The outcome of events was unknown. It was unknown if patient has done any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198193 Same reporter/drug, similar event, different patient.;US-PFIZER INC-202101200288 Same reporter/drug, similar event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a Spontaneous report Facilitated Collect based on the information received by Pfizer. A contactable consumer (wife) reported a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications was not reported. The patient experienced passed away on an unspecified date.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Cardiac dysfunction
Clinical narrative: The heart dropped below and is on around 12%; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included a heart working at 18% since the 90s and on medication. Patient was on the donor list for a new heart. The patient's concomitant medications were not reported. On an unspecified date, the patient's heart dropped below and is on around 12% then they took her off from the donor list. Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Nausea, Thrombosis, Vomiting
Clinical narrative: blood clots; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; nausea; vomiting; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. The reporter reported similar events for 2 patients. This is one of the 2 reports. A female patient in her 20s received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter stated issues about the vaccine were being suppressed such as issue with bell's palsy and mentioned that she according to the nurse where her mother was currently admitted; they saw a 50-60% of hospitalization among vaccinated people. The reporter also knew 3 young women in their 20s that have been vaccinated as well. The one was hemorrhaging in the hospital while the two had blood clots on an unspecified date. Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting. There was also one woman suspected to be pregnant has a miscarriage. Outcome of events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101202717 same reporter, drug and event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Nausea, Thrombosis, Vomiting
Clinical narrative: blood clots; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. The reporter reported similar events for 2 patients. This is one of the 2 reports. A female patient in her 20s received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter stated issues about the vaccine were being suppressed such as issue with bell's palsy and mentioned that she according to the nurse where her mother was currently admitted; they saw a 50-60% of hospitalization among vaccinated people. The reporter also knew 3 young women in their 20s that have been vaccinated as well. The one was hemorrhaging in the hospital while the two had blood clots on an unspecified date. Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting. There was also one woman suspected to be pregnant has a miscarriage. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101202716 same reporter, drug and event, different patients
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash erythematous, Rash papular
Clinical narrative: Large, circular, raised, red area; Large, circular, raised, red area; Hurts if accidentally hit arm; Itches; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 11Sep2021 at 14:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, severe allergies and allergy to gold. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ascorbic acid (VIT C), ganoderma lucidum (REISHI MUSHROOM), beclometasone dipropionate (QVAR), zinc (MANUFACTURER UNKNOWN) and sambucus nigra (ELDERBERRY); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 21Aug2021 at 11:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, the patient experienced large, circular, raised, red area and 56 plus hours post injection and had not subsided. The area itched and hurt the patient if she accidently hit her arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large, circular, raised, red area; itches and hurts if accidentally hit arm was not resolved at the time of the report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Rash, Rash pruritic, Urticaria
Clinical narrative: Tired; Horrible itchy hiveish rash on face and under chin and rash on jaw line and a little bit on collarbone; Horrible itchy hiveish rash on face and under chin and rash on jaw line and a little bit on collarbone; Horrible itchy hiveish rash on face and under chin and rash on jaw line and a little bit on collarbone; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 10Sep2021 at 17:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar, anxiety and known allergies to sunscreen and some other topical stuff (multiple allergies). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lithium (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and paracetamol (TYLENOL); all for unknown indications from unknown dates and unknown if ongoing. On 11Sep2021 at 12:00 (Saturday afternoon), the patient experienced horrible itchy hiveish rash on her face and under her chin and nausea. On 13Sep2021 (Monday), after 5:00, the patient saw the rash and it was bad and the rash was on her face underneath the chin and the jaw line and a little bit on the collarbone. The patient was also tired and still nauseous. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible itchy hiveish rash on face and under chin and rash on jaw line and a little bit on collarbone, nausea and tired was not recovered at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Mass, Nausea
Clinical narrative: Nauseous for a week or more; Pain at auxiliary lymph node; Hard Knot in LE; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient felt nauseous for a week or more, experienced pain at axillary lymph node and hard knot in LE. The clinical outcome of the events nauseous, pain at axillary lymph node and hard knot in LE were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 13:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included "high blood" and shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Aug2021 at 16:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. On 26Aug2021, the patient underwent nasal swab test and the result was negative. On 08Sep2021, the patient underwent nasal swab and the result was negative. On 13Sep2021, the patient experienced itchy rash. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event itchy rash was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Pyrexia, Sinus headache
Clinical narrative: Body aches; Congestion; Sore throat; Sinus headache; Fever; This is a spontaneous report from a contactable other healthcare professional, the patient. A 61-year-old male 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 07Sep2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 09Sep2021, the patient experienced fever, body aches, congestion, sore throat, and sinus headache. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, body aches, congestion, sore throat, and sinus headache was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Hypomenorrhoea, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Irregular menstrual cycle; First month heavy and lasted two weeks; Second cycle light and lasted 3 days; Spotting; Mild cramping; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP7533) via an unspecified route of administration in the right leg on an unknown date (also reported on 05Apr2021 at 12:00) as a single dose for COVID-19 immunisation. On 14Jun2021, the patient experienced irregular menstrual cycle, for first month it was heavy and had lasted for two weeks. The patient's second cycle was light and lasted for 3 days. On an unknown date in 2021, the patient experienced spotting and mild cramping. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was unknown. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event first month heavy and lasted two weeks was resolved on 28Jun2021 while that of second cycle light and lasted 3 days was resolved on an unknown date in 2021. The clinical outcome of the events spotting, mild cramping and irregular menstrual cycle were not resolved at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Irregular menstrual cycle; First month heavy and lasted two weeks; Second cycle light and lasted 3 days; Spotting; Mild cramping; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP7533) via an unspecified route of administration in the right leg on an unknown date (also reported on 05Apr2021 at 12:00) as a single dose for COVID-19 immunisation. On 14Jun2021, the patient experienced irregular menstrual cycle, for first month it was heavy and had lasted for two weeks. The patient's second cycle was light and lasted for 3 days. On an unknown date in 2021, the patient experienced spotting and mild cramping. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was unknown. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event first month heavy and lasted two weeks was resolved on 28Jun2021 while that of second cycle light and lasted 3 days was resolved on an unknown date in 2021. The clinical outcome of the events spotting, mild cramping and irregular menstrual cycle were not resolved at the time of this report.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 10Sep2021 at 16:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 12Sep2021, the patient experienced skin rash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of skin rash. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event skin rash was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Varicella Zoster (Shingles) of left arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included esomeprazole magnesium (NEXIUM) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration on 19Dec2020 at 08:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021 at 06:00, about 10 weeks after the second dose of vaccine, the patient experienced varicella zoster (shingles) of left arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the event included treatment with course of VALTREX and NEURONTIN. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event varicella zoster (shingles) of left arm was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Intermenstrual bleeding, Pain in extremity
Clinical narrative: Menstrual spotting; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 13Sep2021 at 14:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid imbalance. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), fexofenadine hydrochloride (ALLEGRA), and vitamin d nos (VIT D); all for unknown indications from unknown dates and unknown if ongoing. On 14Sep2021 at 07:00, the patient experienced menstrual spotting, sore arm, and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events menstrual spotting, sore arm, and fatigue was not recovered at the time of this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dyspnoea, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9W0168) via an unspecified route of administration in the right arm on 11Jun2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included inflamed sinuses/allergies, childhood asthma and mild seasonal allergies, and cold (bronchitis) almost once a year (few days to a week) during winter which resulted in runny nose, nasal congestion, cough and mild infection (yellow/green phlegm). The patient was allergic to theophylline (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included hydroxyzine (MANUFACTURER UNKNOWN) 10 mg, from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 19May2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 17Jul2021, the patient experienced inflamed sinuses or allergies, sinus infection, severe drainage, congestive cough and shortness of breath. The patient had reported that he had mild seasonal allergies in the past, to include childhood asthma and a cold (bronchitis) almost once a year (few days to a week) in the winter, both resulted in runny nose and in the winter, congestion, cough, mild infection (yellow/green phlegm) and sinuses/allergies, which had been in over 20 years, with severe drainage, followed by congestive cough and shortness of breath. This year has been by far the worst as it inflamed on the weekends due to yard work (allergies), subsided over a couple of days, and inflamed the next weekend. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event which included treatment with OTC medication, pseudoephedrine hydrochloride (SUDAFED) and cetrizine hydrochloride (ZYRTEC); from unknown dates and unknown if ongoing. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 13Sep2021 and the result was negative. The clinical outcome of the events inflamed sinuses or allergies, sinus infection, this year has by far, been the worst of her sinuses/allergies have been in over 20 years, severe drainage, congestive cough and shortness of breath was unknown at the time of report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9W0168) via an unspecified route of administration in the right arm on 11Jun2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included inflamed sinuses/allergies, childhood asthma and mild seasonal allergies, and cold (bronchitis) almost once a year (few days to a week) during winter which resulted in runny nose, nasal congestion, cough and mild infection (yellow/green phlegm). The patient was allergic to theophylline (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included hydroxyzine (MANUFACTURER UNKNOWN) 10 mg, from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 19May2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 17Jul2021, the patient experienced inflamed sinuses or allergies, sinus infection, severe drainage, congestive cough and shortness of breath. The patient had reported that he had mild seasonal allergies in the past, to include childhood asthma and a cold (bronchitis) almost once a year (few days to a week) in the winter, both resulted in runny nose and in the winter, congestion, cough, mild infection (yellow/green phlegm) and sinuses/allergies, which had been in over 20 years, with severe drainage, followed by congestive cough and shortness of breath. This year has been by far the worst as it inflamed on the weekends due to yard work (allergies), subsided over a couple of days, and inflamed the next weekend. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event which included treatment with OTC medication, pseudoephedrine hydrochloride (SUDAFED) and cetrizine hydrochloride (ZYRTEC); from unknown dates and unknown if ongoing. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 13Sep2021 and the result was negative. The clinical outcome of the events inflamed sinuses or allergies, sinus infection, this year has by far, been the worst of her sinuses/allergies have been in over 20 years, severe drainage, congestive cough and shortness of breath was unknown at the time of report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nasal congestion, Nausea
Clinical narrative: Chills; Severe headache/headache worse when bending over; Fever; Queasy stomach/nausea; Diarrhea; Severe arm pain; Achiness; Stuffy nose; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 12Sep2021 at 12:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, spinal stenosis, interstitial cystitis, lichen sclerosus and known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medications. On 12Sep2021 at 23:00, the patient experienced chills, severe headache, fever, queasy stomach/diarrhea, severe arm pain, achiness, stuffy nose, sore throat, nausea. It was reported as headache was worse when bending over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, severe headache/headache worse when bending over, fever, queasy stomach/nausea, diarrhea, severe arm pain, achiness, stuffy nose, and sore throat was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills; Severe headache/headache worse when bending over; Fever; Queasy stomach/nausea; Diarrhea; Severe arm pain; Achiness; Stuffy nose; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 12Sep2021 at 12:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, spinal stenosis, interstitial cystitis, lichen sclerosus and known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medications. On 12Sep2021 at 23:00, the patient experienced chills, severe headache, fever, queasy stomach/diarrhea, severe arm pain, achiness, stuffy nose, sore throat, nausea. It was reported as headache was worse when bending over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, severe headache/headache worse when bending over, fever, queasy stomach/nausea, diarrhea, severe arm pain, achiness, stuffy nose, and sore throat was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; Fever; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Sep2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the 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. The patient did not receive any concomitant medications. The patient previously 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 an unknown date as a single dose for COVID-19 immunisation. On 14Sep2021 at 03:00, the patient experienced chills, fever and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever and body aches were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old female patient received first dose of first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: FC3180 and expiry date was not reported), via an unspecified route of administration on 21Aug2021 (age at vaccination 13 years), as dose 1 single for COVID-19 immunization. medical history as none and concomitant medications were not reported. Caller reported on behalf of her daughter who had the 1st dose of the Pfizer COVID vaccine on 21Aug2021 and then tested positive for COVID, the caller was looking to see if and when her daughter will be allowed to get the 2nd dose which should of been given on 11Sep2021. Now the patient was already over the 21 days to receive the 2nd dose. On 02Sep2021, the patient underwent lab tests and procedures on a home kit for covid and tested positive and then they took her for a PCR on 03Sep2021 and that was positive, too. Outcome of the event was unknown.  Follow-Up (16Sep2021): Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Neck pain
Clinical narrative: neck painful; collar bone painful; This is a spontaneous report from a contactable consumer or other non hcp reported for herself. A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: was not reported) via an unspecified route of administration, administered on 12Sep2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date of Sep2021, after the first dose the patient experienced neck painful and collar bone painful. First dose of Pfizer covid vaccine 12Sep2021 and began experiencing a knot in the back of her neck, collar bone that was painful. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pruritus
Clinical narrative: sore arm; itching like poison ivy; slight dull headache; chills; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She noted she never got a flu shot. The caller reported some events but she was not sure if they were an allergic reaction or side effects. On an unspecified date in 2021, the patient experienced the side effects sore arm, itching like poison ivy, slight dull headache and chills. The caller reported on the Pfizer COVID vaccine and explained she got the first shot 3 weeks ago and was due to get the second one but after 3 days, she of course had a sore arm, she incurred a lot of itching like going into poison ivy. The caller explained she was put on 7 days of prednisone for treatment. She had a slight, dull headache for 3-4 days and chills. Everything, after a period of time, went away but she was due to get the second shot tomorrow but wondered if she should, if these things were just side effects or an allergic reaction. The caller asked that if she was allergic to it would she have known after the first one. She received the response stating that they would not be able to say if she would have known about an allergy to the vaccine after the first dose and referred caller to HCP. She was due to receive the second dose tomorrow and she was concerned about getting the second one. She asked if she should get the second dose. The outcome of the events was resolved on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Pain, Peripheral swelling
Clinical narrative: some increased swelling in her hands; feeling numb in her right hand and fingers; but after the shot, it hurts more and swells more than it did; pain; This is a spontaneous report from a contactable consumer(patient). A 83-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 01Sep2021 (at the age of 83-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer and lymphedema (on the left side, which was 23 years ago, and has had no problems) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, on an unspecified date, about 3 days ago (on reporting date), while helping her granddaughter at her wedding, she noticed some increased swelling in her hands. It had gotten worse. Additionally, she was feeling numb in her right hand and fingers, pain and after the shot, breast cancer and lymphedema hurts more and swells more than it did (condition aggravated). It was reported that, on her left side, her arm, hand, and fingers were swollen. She was asking if that would be because of the vaccine. Therapeutic measures were taken as a result of events. She was scheduled for her second dose on 22Sep2021. She reported that she had been taking Tylenol for the pain. She had reached out to her doctor, but could not get a hold of them and was awaiting a callback. Outcome of all events were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Poor quality sleep, Somnolence
Clinical narrative: has not been sleeping well; experiences drowsiness; fatigue; This is a spontaneous report from a contactable consumer reported for herself that. A 31-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 10Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the administration of 1st dose of vaccine, the patient reported not been sleeping well, experiences drowsiness and fatigue on an unspecified date Sep2021. Her main question is, she's not being able to sleep very well and how does sleep affects the ability of the immune system to develop the antibody response required to be immune to Covid. The event outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Sleep disorder
Clinical narrative: has not been sleeping well; experiences drowsiness; fatigue; This is a spontaneous report from a contactable consumer reported for herself that. A 31-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 10Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the administration of 1st dose of vaccine, the patient reported not been sleeping well, experiences drowsiness and fatigue on an unspecified date Sep2021. Her main question is, she's not being able to sleep very well and how does sleep affects the ability of the immune system to develop the antibody response required to be immune to Covid. The event outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.