chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Illness, Nausea, Pain
Clinical narrative: I am just frustrated with my pain; Fatigue; Nausea; Diarrhea; I am very sick and I had very bad last night because of nausea and diarrhea, it doesn't seem to stop or go away; It just did not stop; This is a spontaneous report from a contactable consumer. This 65-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6206) via an unspecified route of administration on 12Mar2021 (at 65-year-old) on left arm as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7533) via an unspecified route of administration on 01Apr2021 (at This 65-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14Mar2021 patient was very sick and I had very bad last night because of nausea and diarrhea, it did not seem to stop or go away. She was sick every day and it just did not stop. It was because of both the shots or I should say, it never went away after the first shot and She said, she had an adverse event after she got both the Covid shots. She said she had fatigue. On an unknown date she was frustrated with her pain. Also, she said that she does have chronic health problem. Also, she contacted her doctor and they gave her couple of medications but her symptoms were still pretty bad. For treatment of events consumer stated, her medication was changed and it had not improved her situation, they changed the dose in it. One of the medication was Zonisamide, they increased the dosage hoping that it would improve the nausea but it did not. So, the medication that treat chronic health condition they were trying to treat to help me but it was not helping at all, it did not make any sense. The event outcome was unknown.  There was a Product Complaint.  Follow-up attempts were not needed. Further information was not expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthmatic crisis, Cough, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: asthma crisis; cough; shortness of breath; heartbeat also increased significantly; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration, administered in right arm on 09Apr2021 at 15:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included asthmatic. There were no concomitant medications.  The patient previously took quinolone and experienced drug allergy.  On 10Apr2021 around 23 pm, patient suddenly got asthma. That made her cough, and she experienced a shortness of breath. The crisis got away by itself. Patient didn't take any medication. Her heartbeat also increased significantly but that usually the case when she has an asthma crisis. The events were resolved on an unspecified date in Apr2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 43-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0151), at the age of 43, via an unspecified route of administration, in the left arm, on Apr 30, 2021, at 10:15, single dose, for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6206), at the age of 43, via an unspecified route of administration, in the left arm, on Apr 9, 2021, at 16:00, single dose, for COVID-19 immunisation. The patient did not receive other vaccines within four weeks prior to the vaccination. On May 1, 2021, at 21:00, patient experienced sore arm, sore armpit, one episode of nausea, vomiting, generalized body aches, fatigue and tender enlarged supraclavicular lymph node. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of sore arm, sore armpit, one episode of nausea, vomiting, generalized body aches, fatigue and tender enlarged supraclavicular lymph node: resolving (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 43-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0151), at the age of 43, via an unspecified route of administration, in the left arm, on Apr 30, 2021, at 10:15, single dose, for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6206), at the age of 43, via an unspecified route of administration, in the left arm, on Apr 9, 2021, at 16:00, single dose, for COVID-19 immunisation. The patient did not receive other vaccines within four weeks prior to the vaccination. On May 1, 2021, at 21:00, patient experienced sore arm, sore armpit, one episode of nausea, vomiting, generalized body aches, fatigue and tender enlarged supraclavicular lymph node. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of sore arm, sore armpit, one episode of nausea, vomiting, generalized body aches, fatigue and tender enlarged supraclavicular lymph node: resolving (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Myalgia
Clinical narrative: Now there was pressure in "my" chest; Hard to breathe; "I" had slight muscle pain in "my" right arm.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 30Apr2021 at 10:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia which the patient had when he was around six years old. 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. 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: EW0158) via an unspecified route of administration in the left arm on 04Apr2021 at 10:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 02May2021 at 23:00, the patient reported that after he finished cutting the grass and coming inside to have noodles for dinner, he experienced slight muscle pain in his right arm, went to bed for the night.  After waking up today (as reported), there was still a slight muscle pain in his right arm. As the morning passed, the muscle pain in his right arm went away.  However, on 03May2021, there was pressure in his chest and he found it hard to breathe. 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 muscle pain was recovered on 03May2021; while the outcome of the events pressure in my chest and find it hard to breathe were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Constipation, Heart rate
Clinical narrative: Chills; Fever; Elevated resting heart rate; Stomach ache; Partial constipation; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 28Apr2021 at 16:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included stents due to prior heart attack. The patient did not have any 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 atorvastatin (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); both from unknown start date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 at 16:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 09:00, started next day to vaccination, the patient experienced chills, 101 fever, elevated resting heart rate (110+ instead of 75), stomach ache (due to partial constipation) and injection site soreness. The adverse events 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. On 29Apr2021, the patient underwent body temperature test and the result was 101 (unspecified units) and underwent heart rate test and the result was 110+ (unspecified units) instead of 75 (unspecified units). Therapeutic measures were taken as a result of fever and included treatment with 3 acetaminophen (MANUFACTURER UNKNOWN) 500 mg to manage fever from an unknown start date to an unknown stop date. The clinical outcome of the events chills, fever, elevated resting heart rate, stomach ache (due to partial constipation) and injection site soreness was resolved on 30Apr2021, after the duration of 1 day.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Fever; Elevated resting heart rate; Stomach ache; Partial constipation; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 28Apr2021 at 16:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included stents due to prior heart attack. The patient did not have any 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 atorvastatin (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); both from unknown start date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 at 16:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 09:00, started next day to vaccination, the patient experienced chills, 101 fever, elevated resting heart rate (110+ instead of 75), stomach ache (due to partial constipation) and injection site soreness. The adverse events 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. On 29Apr2021, the patient underwent body temperature test and the result was 101 (unspecified units) and underwent heart rate test and the result was 110+ (unspecified units) instead of 75 (unspecified units). Therapeutic measures were taken as a result of fever and included treatment with 3 acetaminophen (MANUFACTURER UNKNOWN) 500 mg to manage fever from an unknown start date to an unknown stop date. The clinical outcome of the events chills, fever, elevated resting heart rate, stomach ache (due to partial constipation) and injection site soreness was resolved on 30Apr2021, after the duration of 1 day.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 56, intramuscularly, on Apr 26, 2021, single dose, for COVID-19 immunisation. Medical history included lupus and asthma. It was unknown if the patient was pregnant at vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On Apr 26, 2021, patient had a very sore arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic/emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of very sore arm and fatigue resolved on an unknown date in 2021. No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: Headache; Fever; Throat soreness; Joint pain; Body aches; Body chills; Severe arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Apr2021 (at the age of 26-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. Concomitant medication was not reported. It was not reported if the patient had received any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient experienced headache, fever, severe arm soreness, throat soreness, joint pain, body aches and body chills. 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. The clinical outcome of the events headache, fever, severe arm soreness, throat soreness, joint pain, body aches and body chills 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache; Fever; Throat soreness; Joint pain; Body aches; Body chills; Severe arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Apr2021 (at the age of 26-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. Concomitant medication was not reported. It was not reported if the patient had received any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient experienced headache, fever, severe arm soreness, throat soreness, joint pain, body aches and body chills. 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. The clinical outcome of the events headache, fever, severe arm soreness, throat soreness, joint pain, body aches and body chills 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Lip swelling, Paraesthesia oral
Clinical narrative: mouth on left side drooped some; my lips started to swell and tingle; my lips started to swell and tingle; the left side of my face, from my jaw to the eye went partially numb; This is a spontaneous report from a contactable consumer (patient).This 48-year-old female patient received dose 2 of BNT162B2 (lot number ER8736) via an unspecified route of administration on 30Apr2021 at 14:15 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient previously received dose 1 of BNT162B2 (lot number ER8731) on 09Apr2021 at 15:30 as a single dose in the left arm for COVID-19 immunization. Approximately 35 minutes after the dose was administered (also reported as 30Apr2021 at 14:45) the patient experienced lips started to swell and tingle and the left side of her face from her jaw to the eye went partially numb. Her my mouth on left side drooped some.  It was similar to the sensation of numbness and drooping after receiving novacain at the dentist. The symptoms largely abated within one hour. The patient did not receive treatment for the events. The outcomes of lips started to swell and tingle, left side of her face went partially numb, and mouth on left side drooped some were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Just wanted to sleep; This is a solicited report based on the information received by Pfizer. (MFR Control No. # 21K-163-3876684-00). A non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via intramuscular on an unspecified 2021 as dose 1, single for COVID-19 immunisation; adalimumab (HUMIRA, Batch/Lot number was not reported), subcutaneous from 2016 to an unspecified date, at unspecified dose for psoriasis. There was no reported medical history. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Social Media report by a consumer of a person with an event of non-serious Just wanted to sleep and drink water after first dose of Covid vaccine with Humira (adalimumab). On an unspecified date in 2021, the patient experienced Just wanted to sleep and drink water after first dose of Covid vaccine. Covid-19 vaccine was also considered suspect. Causality for Humira (adalimumab) and BNT162B2: The reporter's causality for the event of Just wanted to sleep and drink water after first dose of Covid vaccine was not provided. On unknown date in 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the event for adalimumab was unknown. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vulvovaginal rash
Clinical narrative: Rash/hives on right cheek, also near "my" mouth; Hives on right cheek and near "my" mouth and in labia of vagina; Rash in labia of vagina; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 30Apr2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. 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. The concomitant medications included cetirizine hydrochloride (ZYRTEC), daily vitamin (unspecified), ibuprofen (MOTRIN) and duloxetine hydrochloride (CYMBALTA); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 12:00, the patient experienced rash/ hives on right cheek, also near her mouth and in labia of vagina. The adverse 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 reported events and included treatment with prednisone (DELTASONE) and triamcinolone (KENALOG). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash/ hives on right cheek, also near mouth and in labia of vagina were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Vaccination site pain
Clinical narrative: Sore upper arm, to be expected/ arm feels weak and hurts while using.; Injection site still extremely sore; arm feels weak and hurts while using.; This is a spontaneous report from a 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: EW0158) via an unspecified route of administration in the right arm on 26Mar2021 at 15:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known drug allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified regularly prescribed medications. On 26Mar2021 at 15:00, the patient experienced sore upper arm, which patient had expected. However, injection site was still extremely sore, arm felt weak and hurt while using. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore upper arm injection site was still extremely sore, arm felt weak and hurt while using was not resolved at the time of report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 16Apr2021 at 15:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Lymph node pain, Palpitations
Clinical narrative: Lymph sites in pain; Diarrhea; Headache; Heart racing; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 29Apr2021 at 10:15 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS), autonomic malfunction, vasovagal syncope, sulfonamide allergy, calling family allergy, latex allergy and adhesive 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. Concomitant medications included esomeprazole sodium (NEXIUM), topiramate (MANUFACTURER UNKNOWN), pyridostigmine (MANUFACTURER UNKNOWN), levothyroxine sodium (TIROSINT) and bupropion hydrochloride (WELLBEN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received paracetamol; oxycodone hydrochloride (PERCOCET) on an unknown date and experienced drug allergy. On 29Apr2021 at 11:00 (day 1), the patient experienced diarrhea, headache, heart racing. On an unknown date in Apr2021 (Day 2-3), the patient experienced lymph sites in pain. 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 diarrhea, headache, heart racing and lymph sites in pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea, SARS-CoV-2 test
Clinical narrative: Very heavy/longer menstrual cycle; Very heavy/longer menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 30-year-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. Since the vaccination, the patient had been tested for COVID-19. On 26Apr2021, the patient underwent lab tests and procedures which included quest (via nasal swab) and tested negative. On 27Apr2021, the patient experienced very heavy/longer menstrual cycle. 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 events. The clinical outcome of the events very heavy/longer menstrual cycle was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes for about 12 days already; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 08:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included diabetes. 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 vitamins (unspecified products) for unknown indications. On 01Apr2021, the patient experienced swollen lymph nodes for about 12 days already. 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 swollen lymph nodes was not recovered at the time of this report. On 20Apr2021 at 08:30, the patient also 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 (at the age of 60-years-old) as single dose for COVID-19 immunization.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient details (name) was updated, and second dose of BNT162B2 was deleted as suspect dose.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in feet and toes within an hour of vaccine, lasting a couple hours, both doses.; This is a spontaneous report from a contactable pharmacist, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an intramuscular route of administration in the left arm on 30Apr2021 at 08:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The medical history included sjogren's, celiac, chronic kidney disease (CKD) stage III and allergic to sulfonamide and 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 COVID-19 vaccine. The concomitant medications included vitamin d nos (VITAMIN D), curcuma longa rhizome (TURMERIC), probiotic (unspecified), grapeskin extract (unspecified), ubiquinol (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIIN C), all for unspecified indications from unknown dates and unknown if ongoing. The patient previously received thiomersal (THIMEROSAL) on unknown date and experienced allergy. On 30Apr2021 at 09:30,within an hour of vaccine, the patient experienced tingling in feet and toes which lasted a couple of hours on both doses. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tingling in feet and toes was resolved on 30Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Migraine, Pain, Pain in extremity
Clinical narrative: Severe left arm pain and swelling; Severe left arm pain and swelling, Severe leg and feet , stomach swelling; Stomach swelling; Severe migraines; Extreme blurry vision; Severe body and joint pain; Severe body and joint pain; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 11Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, spinal injuries, high blood pressure, hypertension, medical doctors advised the patient not to get flu vaccine because patient's mother was paralyzed from Guillain barre syndrome (possibly from flu vaccine) and known allergies to latex and food allergies but they went away. 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 12Apr2021 at 05:00, the patient experienced severe left arm pain and swelling severe leg and feet, stomach swelling, severe migraines, extreme blurry vision and severe body and joint pain. 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 severe left arm pain and swelling, severe leg and feet, stomach swelling, severe migraines, extreme blurry vision and severe body and joint pain were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vision blurred
Clinical narrative: Severe left arm pain and swelling; Severe left arm pain and swelling, Severe leg and feet , stomach swelling; Stomach swelling; Severe migraines; Extreme blurry vision; Severe body and joint pain; Severe body and joint pain; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 11Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, spinal injuries, high blood pressure, hypertension, medical doctors advised the patient not to get flu vaccine because patient's mother was paralyzed from Guillain barre syndrome (possibly from flu vaccine) and known allergies to latex and food allergies but they went away. 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 12Apr2021 at 05:00, the patient experienced severe left arm pain and swelling severe leg and feet, stomach swelling, severe migraines, extreme blurry vision and severe body and joint pain. 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 severe left arm pain and swelling, severe leg and feet, stomach swelling, severe migraines, extreme blurry vision and severe body and joint pain were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Sensory disturbance
Clinical narrative: chills; fatigue; odd sensation (unsure if related) as if lips were sunburned. (They were not).; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0162) via an unspecified route of administration in the left arm on 21Apr2021 at 09:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any relevant medical history and known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 21:45, 12 hours after vaccination, the patient experienced chills. On an unspecified date in Apr2021, the patient experienced fatigue. On an unspecified date in 2021, the patient experienced odd sensation (unsure if related) as if lips were sunburned. (They were not). Started after vaccine. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 chills was resolved on an unknown date in Apr2021, while that of fatigue was resolved on an unknown date in 2021, and unsure if related, odd sensation as if lips are sunburned. (They are not.)  was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Large rash at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 29Apr2021 at 14:00 (at the age of 63-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. Concomitant medications taken within two weeks of vaccination included magnesium (MANUFACTURER UNKNOWN), vitamin b complex (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12) and calcium (MANUFACTURER UNKNOWN); 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: EW0158) via an unspecified route of administration on right arm on 08Apr2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced a large rash at injection site. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large rash at injection site was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: Period arrived out of cycle and was considerably heavier than usual.; Considerably heavier than usual.; Passed more (and larger) clots than usual and bled much more than usual. This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0161) via an unspecified route of administration in the left arm on 18Apr2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient had known allergies to Ni (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), withania somnifera (ashwagandha) (MANUFACTURER UNKNOWN and omega 3 (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. On 29Apr2021 at 07:45, the patient experienced period arrived out of cycle and was considerably heavier than usual. Patient passed more (and larger) clots than usual and bled much more than usual. In a single day, she used more feminine products than in a usual cycle, and still bled through three times much. The events did not result in doctor or 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 the events period arrived out of cycle and was considerably heavier than usual, passed more (and larger) clots than usual and bled much more than usual was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, SARS-CoV-2 test, Vomiting, Weight decreased
Clinical narrative: Nausea; Vomiting; Lost weight; Diarrhea 5-8 times a day; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 19Apr2021 at 14:15 (at the age of 44-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. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced nausea, vomiting, lost weight and had one week of diarrhea 5-8 times a day. The patient was on day 12 at the time of report and still had nausea and vomiting, lost weight. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021 post vaccination, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event had one week of diarrhea 5-8 times a day was resolved on an unknown date in Apr2021. The clinical outcome of the events nausea, vomiting and lost weight was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Impaired driving ability, Muscle spasms
Clinical narrative: Muscles kept cramping; Severe stomach cramping; I felt loopy and had trouble driving myself home; I felt loopy and had trouble driving myself home; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old, non-pregnant female 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 Apr2021 at 11:30 in the left arm (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and 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. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On an unknown date in Apr2021, at 19:00, immediately after second vaccination the patient felt loopy and had trouble driving home. The patient slept fine that night but the second night muscles kept cramping. The patient was awakened from sleep by severe stomach cramping that was not felt in years. The patient took an Advil and finally after an hour the terrible pain subsided. The next day the patient seemed fine but noticed since then, random muscle cramping. It's been about a week since the patient last had the cramping. 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 muscles cramping and stomach cramping which included ibuprofen (ADVIL). Therapeutic measures were not taken as a result of the events felt loopy and had trouble driving home. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of stomach kept cramping and severe stomach cramping were recovered on an unknown date in Apr2021; while that of the events felt loopy and had trouble driving home were unknown at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Localized pain at injection site; Severe joint pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 04May2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history was not reported. Concomitant medications taken within two weeks of vaccination included lisdexamfetamine mesilate (VYVANSE) for unknown indication from unknown date and unknown if ongoing. The patient previously took neomycin sulfate; polymyxin b sulfate; gramicidin (NEOSPORIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 13Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 21:00, the patient experienced localized pain at injection site and severe joint pain. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN). 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. The clinical outcome of the events localized pain at injection site and severe joint pain was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.