chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Immediately following injection: rapid heartbeat.; Dizziness/Weakness; Dizziness/Weakness; Flushed feeling; Severe headache that traveled from base of neck to forehead.; Shortness of breath; Difficulty swallowing; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0298) via an unspecified route of administration in the left arm on 05Jul2021(at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin 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 did not receive any medication within two weeks of vaccination. The patient previously received azithromycin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 05Jul2021, immediately after vaccination the patient experienced rapid heartbeat, dizziness, weakness, flushed feeling and severe headache that travelled from base of neck to forehead. On 05Jul2021, 10 min after vaccination the patient experienced shortness of breath and difficulty swallowing. 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 been tested for COVID-19. On an unknown date in 2021, the patient underwent SARS-COV2 test via nasal swab and the result was negative. The clinical outcome of the events rapid heartbeat, dizziness, weakness, flushed feeling, severe headache that travelled from base of neck to forehead, shortness of breath and difficulty swallowing were resolved with sequelae on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid pain, Maternal exposure during pregnancy, Swelling of eyelid
Clinical narrative: Unilateral swelling and soreness of eyelid; Soreness of eyelid; Maternal exposure during pregnancy, second trimester; This is a spontaneous report from a non-contactable consumer. A 25-year-old 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 left deltoid on 2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date as prior to the vaccination, the patient was diagnosed with COVID-19. The patient's gestational period is reported as 22 weeks. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Oct2021, after 5 hours of vaccination, the patient experienced unilateral swelling and soreness of eyelid. 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 unilateral swelling and soreness of eyelid was resolving 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen/painful lymph nodes in left armpit and along left collarbone; Swollen/painful lymph nodes in left armpit and along left collarbone; Fever; 3rd Booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301358A) via an unspecified route of administration in the left arm on 29Sep2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included unspecified vitamins and levothyroxine (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 31-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021, the patient experienced swollen/painful lymph nodes in left armpit and along left collarbone and also had a fever. 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 events swollen/painful lymph nodes in left armpit and along left collarbone and also had a fever was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Peripheral swelling
Clinical narrative: Shortly after the 2nd dose of the vaccine, this person went to an urgent care with a very swollen arm, she referred to it as 'Covid Arm'; She also indicated she was ill for about a month post the 2nd dose; This is a spontaneous report from a contactable consumer, Pfizer colleague. An adult non-pregnant female patient of unknown age 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 as a single dose for COVID-19 immunisation. Medical history included 2 autoimmune disorders, unknown which ones. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, shortly after the second dose of the vaccine, the patient went to an urgent care with a very swollen arm. The patient referred to it as 'COVID arm'. The patient was ill for about a month post the second dose. The event swollen arm resulted in emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events swollen arm and illness were resolved on an unknown date.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes zoster, Skin lesion
Clinical narrative: some of them become crusty for first, she thought they were the shingles; but they would not burst or anything was reported as worsened; bumps on her head, almost like a block blind pimple but they would not burst or anything; This is spontaneous report from contactable nurse (the patient).  A 63 years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, solution for injection, lot number: not reported, expiry date: unknown), via an unspecified route of administration, administered in arm right on 18Mar2021 as dose 2, single (age at the age of 63 years) for covid-19 immunisation. Medical history included ongoing multiple sclerosis from an unknown date and ongoing neuropathy peripheral from an unknown date. Concomitant medication included natalizumab (TYSABRI) for multiple sclerosis from unknown date to unknown date and gabapentin (NEURONTIN) for neuropathy peripheral from unknown date to unknown date. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, solution for injection, lot number: not reported), via an unspecified route of administration on 19Feb2021 as dose 1, single (age at the age of 63 years) for covid-19 immunisation. On an unspecified date in 2021, probably, about a week after, she got her second shot, the patient experienced bumps on her head, almost like a block blind pimple but they would not burst or anything, some of them become crusty for first, she thought they were the shingles, but they would not burst or anything was reported as worsened. The reporter stated that the first two shot and last one was on 18Mar2021 and after that, she started getting all these bumps on her head. She never had it before. She did not know if, it was from that or not. The patient started to see bumps all over her head and they were almost like a block blind pimple but they would not burst or anything but then she wake up in the morning, some of them become crusty for first, she thought they were the Shingles. She went to doctors twice, they warned Shingles and they had ordered antibiotic Prednisolone and it seemed to surprise a little bit this was 2 doses of antibiotics 2 doses of Prednisolone, she had it all over her head again and she did not know it was because of vaccine or not. Therapeutic measures were taken as a result of the events. The patient took an antibiotic called Clindamycin and Prednisolone 2 doses each for the events because events came back. The patient just went for ADC. The patient was still experiencing the event. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Feeling abnormal, Gait disturbance, Headache, Illness
Clinical narrative: I have headache.; I had lump under my armpit; I have been throwing  up.; my body rash real bad. I have from body and the neck and then my armpit. It's bad.; I feel real bad/I feel so horrible; My body hurt bad; I could not walk the pain is so bad ; Under my armpit it hurts real bad.; I left work because I was so sick; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third booster dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 3 (Booster), Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache, had lump under my armpit, have been throwing  up, my body rash real bad. i have from body and the neck and then my armpit. it's bad, i feel real bad/i feel so horrible, my body hurt bad, i could not walk the pain is so bad, under my armpit it hurts real bad and i left work because i was so sick. The patient stated that this going to go away, cause they give me a paper telling me all the symptoms and patient had all the symptoms but patients question was how long this going to be like this. The patient was not recovered from the events headache, I have been throwing up while the outcome of the events I had lump under my armpit, my body rash real bad. I have from body and the neck and then my armpit. It's bad, I feel real bad/I feel so horrible, My body hurt bad, I could not walk the pain is so bad ; Under my armpit it hurts real bad and I left work because I was so sick was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Rash, Vomiting
Clinical narrative: I have headache.; I had lump under my armpit; I have been throwing  up.; my body rash real bad. I have from body and the neck and then my armpit. It's bad.; I feel real bad/I feel so horrible; My body hurt bad; I could not walk the pain is so bad ; Under my armpit it hurts real bad.; I left work because I was so sick; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third booster dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 3 (Booster), Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache, had lump under my armpit, have been throwing  up, my body rash real bad. i have from body and the neck and then my armpit. it's bad, i feel real bad/i feel so horrible, my body hurt bad, i could not walk the pain is so bad, under my armpit it hurts real bad and i left work because i was so sick. The patient stated that this going to go away, cause they give me a paper telling me all the symptoms and patient had all the symptoms but patients question was how long this going to be like this. The patient was not recovered from the events headache, I have been throwing up while the outcome of the events I had lump under my armpit, my body rash real bad. I have from body and the neck and then my armpit. It's bad, I feel real bad/I feel so horrible, My body hurt bad, I could not walk the pain is so bad ; Under my armpit it hurts real bad and I left work because I was so sick was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Fatigue, Immunisation, Off label use
Clinical narrative: Sore throat; Terrible reflexive barking cough; Severe head congestion; Dose received: 3; A FEW HOURS AFTER BOOSTER INJECTION; Mild fever/Low grade fever; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Sep2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic and autoimmune issues. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included insulin (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and unspecified vitamins; all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received varenicline tartrate (CHANTIX) and experienced drug allergy. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 43-years-old) and 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 24Feb2021 at 11:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On  26Sep2021, it started with typical side effects a few hours after booster dose injection. The patient experienced mild fever, aches and fatigue. The symptoms never discontinued; low grade fever continued for a week following injection. The symptoms began to change on 28Sep2021, moving into severe head congestion. On 30Oct2021, the patient experienced sore throat starting day 5. On 01Oct2021, the patient experienced terrible reflexive barking cough on day 6. The events had resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unspecified cough suppressants, antibiotics and steroid nasal spray.  On 03Oct2021, the patient underwent chest X-ray and the result was clear chest. On the same day, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events mild fever, aches, fatigue, low grade fever continued for a week following injection, severe head congestion, sore throat and terrible reflexive barking cough were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test, Upper respiratory tract congestion
Clinical narrative: Sore throat; Terrible reflexive barking cough; Severe head congestion; Dose received: 3; A FEW HOURS AFTER BOOSTER INJECTION; Mild fever/Low grade fever; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Sep2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic and autoimmune issues. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included insulin (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and unspecified vitamins; all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received varenicline tartrate (CHANTIX) and experienced drug allergy. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 43-years-old) and 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 24Feb2021 at 11:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On  26Sep2021, it started with typical side effects a few hours after booster dose injection. The patient experienced mild fever, aches and fatigue. The symptoms never discontinued; low grade fever continued for a week following injection. The symptoms began to change on 28Sep2021, moving into severe head congestion. On 30Oct2021, the patient experienced sore throat starting day 5. On 01Oct2021, the patient experienced terrible reflexive barking cough on day 6. The events had resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unspecified cough suppressants, antibiotics and steroid nasal spray.  On 03Oct2021, the patient underwent chest X-ray and the result was clear chest. On the same day, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events mild fever, aches, fatigue, low grade fever continued for a week following injection, severe head congestion, sore throat and terrible reflexive barking cough were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chest pain, Inflammation, Pain in extremity
Clinical narrative: Left arm hurts; Her inflammation is horrendous today on ankle and hands; A lot of twinge in on the left side between your arm area and near the heart; Her inflammation is horrendous today on ankle and hands; This is a spontaneous report from a contactable consumer, Pfizer colleague. A 60-year-old non-pregnant 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 arm on 04Oct2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and known allergies were reported as unknown. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received other vaccines within four weeks prior to the vaccination. It was unknown whether the patient received any concomitant medication. On 05Oct2021, her left arm hurts and a lot of twinges in on the left side between her arm area and near the heart. Her inflammation was horrendous today (at the time of this report) on ankle and hands. She had dose one injected on 04Oct2021 and the reporter received a text from her today. 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 left arm hurts, a lot of twinges in on the left side between her arm area and near the heart and her inflammation was horrendous today on ankle and hands was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, SARS-CoV-2 test
Clinical narrative: Headache; Stabbing in the back of my right eye; This is a spontaneous report from a contactable consumer, the patient. A 55-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 in the left arm on 22Sep2021 (at the age of 55-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 other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 01Sep2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 26Sep2021, the patient experienced stabbing in the back of his right eye accompanied with a headache. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 24Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events stabbing in the back of right eye accompanied with a 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cyst, Ultrasound scan vagina
Clinical narrative: Ovarian cysts; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, tendonitis and allergy to cashews. 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. Concomitant medications included citalopram hydrobromide (CELEXA), cetirizine hydrochloride (ZYRTEC), guaifenesin (MUCINEX), levonorgestrel (KYLEENA), cyanocobalamin (B12) and probiotics nos (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received cefaclor (CECLOR) and montelukast sodium (SINGULAIR); both for unspecified indication from unknown date and experienced drug allergy and received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the left arm on 22Jan2021 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced ovarian cysts (confirmed by transvaginal ultrasound on same day). The events had resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were not taken as a result of the event. On 01May2021 the patient underwent lab test and procedures which included transvaginal ultrasound and the result was ovarian cysts. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event ovarian cysts was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Vomiting; High Fever; Cough/ Lingering cough; Congestion/  lingering cough/congestion for additional 5 days.; Major Headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 24Sep2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) scleraderma, migraines, rynauds, hoshimotos, allergy to iodine, allergy to bees and allergy to shellfish. 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 etanercept (ENBREL), escitalopram oxalate (LEXAPRO) and propranolol (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date and unknown if ongoing. The patient previously received methotrexate (MANUFACTURER UNKNOWN), ketorolac (MANUFACTURER UNKNOWN) and ciprofloxacin (CIPRO) for unknown indication on an unknown date and experienced drug allergy. On 25Sep2021 at 08:00, the patient experienced vomiting, high fever, cough, congestion, major headache for 7 days and also reported as lingering cough, congestion for additional 5 days. It was reported that the patient missed 5 days of work and doctor wouldn't let go back. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events cough and congestion and included treatment with albuterol sulfate (ALBUTERAL) inhaler. Since the vaccination, the patient had been tested for COVID-19.  On 27Sep2021, the patient underwent SARS-COV2 test via nasal swab and the result was negative. The clinical outcome of the events vomiting, high fever and major headache were resolved with sequelae on 02Oct 2021; while that of the events cough and congestion resolved with sequelae on an unknown date in Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; High Fever; Cough/ Lingering cough; Congestion/  lingering cough/congestion for additional 5 days.; Major Headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 24Sep2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) scleraderma, migraines, rynauds, hoshimotos, allergy to iodine, allergy to bees and allergy to shellfish. 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 etanercept (ENBREL), escitalopram oxalate (LEXAPRO) and propranolol (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date and unknown if ongoing. The patient previously received methotrexate (MANUFACTURER UNKNOWN), ketorolac (MANUFACTURER UNKNOWN) and ciprofloxacin (CIPRO) for unknown indication on an unknown date and experienced drug allergy. On 25Sep2021 at 08:00, the patient experienced vomiting, high fever, cough, congestion, major headache for 7 days and also reported as lingering cough, congestion for additional 5 days. It was reported that the patient missed 5 days of work and doctor wouldn't let go back. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events cough and congestion and included treatment with albuterol sulfate (ALBUTERAL) inhaler. Since the vaccination, the patient had been tested for COVID-19.  On 27Sep2021, the patient underwent SARS-COV2 test via nasal swab and the result was negative. The clinical outcome of the events vomiting, high fever and major headache were resolved with sequelae on 02Oct 2021; while that of the events cough and congestion resolved with sequelae on an unknown date in Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Cardiac disorder, Heart rate increased, Off label use, Pyrexia
Clinical narrative: Heart Complications; dealing with some adverse symptoms; a rapid heartbeat out of proportion to age and level of exertion; fever; Went for their flu shot but instead got the Pfizer Covid vaccine; Went for their flu shot but instead got the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer (parent) and a Pfizer-sponsored program. A 5-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY; Solution for injection; Lot number: Unknown), via an unspecified route of administration as DOSE 1, SINGLE on 04Oct2021 at afternoon time (at the age of 5-year-old) for COVID-19 immunisation at pharmacy. Patient's medical History (including any illness at time of vaccination) included had patient tachycardia. There were no concomitant medications. No history of all previous immunization with the Pfizer vaccine considered as suspect. Caller was a 35-year-old male and wife (29 years old) with 2 children (4 years old male and 5 years old). Caller called because him, his wife, his 4-year-old, and his 5-year-old child all went to get the flu vaccine but were given doses of the Pfizer COVID-19 Vaccine instead on 04Oct2021. Their two children were mistakenly given the COVID-19 vaccine instead of a flu shot a week ago at their local pharmacy and they are now dealing with some adverse symptoms. a rapid heartbeat out of proportion to age and level of exertion. The children have been taken to a paediatric cardiologist, and the family was told both are showing signs of heart issues, since last week, the family now says the patient had developed a fever. Seriousness criteria was assessed as hospitalization for Heart Complications. The caller and his wife had already received both doses last Apr2021 of the Pfizer COVID-19 Vaccine before. Both children, were given full adult doses of the Pfizer COVID-19 Vaccine. Caller declined to provide initials, date of birth, sex, height, weight, or ethnicity of the patient and HCP information. Caller states his wife was better at keeping up with that information than he was. Stated that he just wanted to provide information on the other child due to the other child's symptoms. Caller stated that he has been trying to get the Lot number from the pharmacy. The patient underwent lab tests and procedures which included Heart rate increased as rapid heartbeat out of proportion to age and level of exertion. Caller denied any other medications, medical conditions, labs, testing, or treatments relevant to report for this child. The outcome of events was reported as unknown.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.  Follow-up (12Oct2021, 14Oct2021,18Oct2021): New information received from a contactable consumer. This consumer (Father) reported for a 5-year-old male patient that: Clinical course updated. New event fever was added. Medical history updated (tachycardia). lab tests added.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Heart Complications; dealing with some adverse symptoms; a rapid heartbeat out of proportion to age and level of exertion; fever; Went for their flu shot but instead got the Pfizer Covid vaccine; Went for their flu shot but instead got the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer (parent) and a Pfizer-sponsored program. A 5-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY; Solution for injection; Lot number: Unknown), via an unspecified route of administration as DOSE 1, SINGLE on 04Oct2021 at afternoon time (at the age of 5-year-old) for COVID-19 immunisation at pharmacy. Patient's medical History (including any illness at time of vaccination) included had patient tachycardia. There were no concomitant medications. No history of all previous immunization with the Pfizer vaccine considered as suspect. Caller was a 35-year-old male and wife (29 years old) with 2 children (4 years old male and 5 years old). Caller called because him, his wife, his 4-year-old, and his 5-year-old child all went to get the flu vaccine but were given doses of the Pfizer COVID-19 Vaccine instead on 04Oct2021. Their two children were mistakenly given the COVID-19 vaccine instead of a flu shot a week ago at their local pharmacy and they are now dealing with some adverse symptoms. a rapid heartbeat out of proportion to age and level of exertion. The children have been taken to a paediatric cardiologist, and the family was told both are showing signs of heart issues, since last week, the family now says the patient had developed a fever. Seriousness criteria was assessed as hospitalization for Heart Complications. The caller and his wife had already received both doses last Apr2021 of the Pfizer COVID-19 Vaccine before. Both children, were given full adult doses of the Pfizer COVID-19 Vaccine. Caller declined to provide initials, date of birth, sex, height, weight, or ethnicity of the patient and HCP information. Caller states his wife was better at keeping up with that information than he was. Stated that he just wanted to provide information on the other child due to the other child's symptoms. Caller stated that he has been trying to get the Lot number from the pharmacy. The patient underwent lab tests and procedures which included Heart rate increased as rapid heartbeat out of proportion to age and level of exertion. Caller denied any other medications, medical conditions, labs, testing, or treatments relevant to report for this child. The outcome of events was reported as unknown.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.  Follow-up (12Oct2021, 14Oct2021,18Oct2021): New information received from a contactable consumer. This consumer (Father) reported for a 5-year-old male patient that: Clinical course updated. New event fever was added. Medical history updated (tachycardia). lab tests added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Feeling abnormal, Headache
Clinical narrative: Horrible bad headache; Body aches; Fever; Chills; Nausea; Feeling just awful; Tired; Arm pain & swelling; Arm pain & swelling; Bruised arm; Muscle pain; Slight body rash; Booster; This is a spontaneous report from a non-contactable consumer, the patient. A 66-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWD164) via an unspecified route of administration in the left arm on 27Sep2021 at 11:00 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to lactose, ragweed and molds. 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. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and unspecified vitamins; both for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 65-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 65-year-old); both as a single dose for COVID-19 immunisation. On 28Sep2021 at 09:00, the patient experienced horrible bad headache, body aches, fever, chills, nausea, feeling just awful, tired, arm pain & swelling, bruised arm, muscle pain, and slight body rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included contacting pharmacy to enquire what should be done. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible bad headache, body aches, fever, chills, nausea, feeling just awful, tired, arm pain & swelling, bruised arm, muscle pain, and slight body rash were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Horrible bad headache; Body aches; Fever; Chills; Nausea; Feeling just awful; Tired; Arm pain & swelling; Arm pain & swelling; Bruised arm; Muscle pain; Slight body rash; Booster; This is a spontaneous report from a non-contactable consumer, the patient. A 66-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWD164) via an unspecified route of administration in the left arm on 27Sep2021 at 11:00 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to lactose, ragweed and molds. 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. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and unspecified vitamins; both for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 65-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 65-year-old); both as a single dose for COVID-19 immunisation. On 28Sep2021 at 09:00, the patient experienced horrible bad headache, body aches, fever, chills, nausea, feeling just awful, tired, arm pain & swelling, bruised arm, muscle pain, and slight body rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included contacting pharmacy to enquire what should be done. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible bad headache, body aches, fever, chills, nausea, feeling just awful, tired, arm pain & swelling, bruised arm, muscle pain, and slight body rash were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Horrible bad headache; Body aches; Fever; Chills; Nausea; Feeling just awful; Tired; Arm pain & swelling; Arm pain & swelling; Bruised arm; Muscle pain; Slight body rash; Booster; This is a spontaneous report from a non-contactable consumer, the patient. A 66-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWD164) via an unspecified route of administration in the left arm on 27Sep2021 at 11:00 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to lactose, ragweed and molds. 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. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and unspecified vitamins; both for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 65-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 65-year-old); both as a single dose for COVID-19 immunisation. On 28Sep2021 at 09:00, the patient experienced horrible bad headache, body aches, fever, chills, nausea, feeling just awful, tired, arm pain & swelling, bruised arm, muscle pain, and slight body rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included contacting pharmacy to enquire what should be done. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible bad headache, body aches, fever, chills, nausea, feeling just awful, tired, arm pain & swelling, bruised arm, muscle pain, and slight body rash were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Immunisation, Off label use, Pyrexia
Clinical narrative: Fever; Joint pain; Fatigued; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Oct2021 at 09:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. 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 15Mar2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 05Oct2021 at 22:45, the patient experienced fever, joint pain and fatigued. 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 fever, joint pain and fatigued 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Myalgia, Off label use, Pyrexia
Clinical narrative: Off-label use; Booster / dose received: 3; Slight fever; Chills; Muscle ache; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Oct2021 at 10:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the COVID vaccine. Concomitant medication included influenza vaccine (FLU) for an unknown indication on an unknown date in 2021. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 10:00 (at the age of 65-years-old) and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Feb2021 at 09:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021, the patient experienced slight fever, chills and muscle ache. The events did not result in doctor/other health care 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 events slight fever, chills and muscle ache were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.