chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in her arm, hands and legs; they thought it was maybe like a hit nerve when they gave me injection but since then it has all traveled down to my hands and legs; This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: EW0180) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the Pfizer COVID-19 Vaccine on 10Jun2021 and after receiving it she experiencing tingling in the arm. The symptoms did not go away when in the patient had to be referred to a neurologist and she still have the symptoms the tingling in her arm, hands and legs and also she is asking if there are any others who experienced the side effect. When paraphrased the concern, consumer stated, yes, thought it was maybe like a hit nerve when they gave me injection but since then it had all traveled down to my hands and legs and it had not just isolated to one arm it spread. When probed if it was the first vaccine, Consumer stated that the patient just had the first vaccine because as far as know it was the adverse reaction and so the patient was concerned with taking the second dose. The patient was still trying to remain a little bit anonymous until got more information to whether was this a normal reaction. Have you guys heard this before and typically how long does it take to go away, ight now, the patient was just trying to fish for some information because concern was whether to have the second vaccination especially with this not going away. Patient was informed about the Medical Information Department for the concern and was provided with the contact for Pfizer Medical Information as Option 3 and was informed that the department was open from Monday to Friday, from 8am to 8pm. Patient stated, If you do not mid transferring her, that would be great. The patient was unwilling to complete the report and requested for transfer. Call was disconnected and transfer was unsuccessful. Hence, limited information was available. The outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After received second injection arm felt sore for a couple days; This is a spontaneous report from a contactable consumer (patient) or other non hcp via a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported) on unspecified date for covid-19 immunisation. The reporter believed that the first dose was given correctly but not the second dose. After received second injection arm felt sore for a couple days on an unspecified date. Reporter was asking if there was a test he can receive (at name withheld) whether he had full protection from receiving both shots. Questionable concern about receiving the first shot. Stated there was a mix-up at the vaccination site, questions whether he actually received first dose due to faulty equipment. Asked vaccination provider, did not seem to provide an appropriate answer. Stated there was no indication that he received an injection. No indication of receiving an injection, no sensation, no indication received injection and no reaction. After received second injection arm felt sore for a couple days. Really doubts he received the first. Asking if there was a test to determine whether her had full protection. Stated he called the county where he resides, stated they have no control over. Reporter received both doses of the Pfizer Covid-19 Vaccine and wants to know if there was a blood test that he can take to confirm that he had the full benefit of the vaccine. The clinical outcome of event was unknown.  Information on the lot/batch number has been requested.  F/U #2 17Aug2021: Follow-up activities closed. Batch/lot number not available.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Nerve injury
Clinical narrative: nerve issues; cold feels in neck, arms and back.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on 21May2021 as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced fatigue. On an unspecified date on 2021, 5 weeks after vaccination, the patient experienced cold feels in neck, arms and back. The patient Describes it as nerve issues. The patient stated "Mint fall" on her arms, neck and back which she never had before while she was walking her dog and was still going through it. The patient wanted to know if this was coincidental. HCP indicated could persist up to six weeks. The outcome of the events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm two or three days; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm two or three days on an unspecified date. The outcome of the event was recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Underdose, Vaccination site pain
Clinical narrative: Soreness on my shoulder where they gave me the shot; I felt liquid down my arm when he pulled it out. Then he was still squeezing liquid out.; I felt liquid down my arm when he pulled it out. Then he was still squeezing liquid out.; I felt liquid down my arm when he pulled it out. Then he was still squeezing liquid out.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in arm on unspecified date in Feb2021 (at the age of 63-years-old) as single dose for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered on an unspecified date in Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Feb2021, the second vaccine a young man gave him the shot and he stuck it in faster than he had ever seen. He felt liquid down his arm when he pulled it out. Then he was still squeezing liquid out (at the time of report). Patient asked if there was a test to see if he received the full dose. Upon follow-up on 23Jul2021, the patient stated that he felt as if the vaccination provider had put in the needle very quickly and felt as if some of the vaccine had dripped out when removing the needle, perhaps didn't receive a full second vaccination and also reported that gave him the shot it was a real quick, when he pulled it out felt some liquid hit his arm, his shoulder, saw some stuff coming out the needle, not confident that he got the full dose on that second shot. On unknown date, patient experienced soreness on his shoulder where they gave the shot. Patient could not provide the date of administration and LOT# as the vaccination card is not with the consumer. Consumer stated regarding concomitant medication as no and he had taken is some over the counter Advil and Tylenol at different points. Patient inquired that whether he need another shot or is it enough which he got already. Outcome of the events were unknown.  Information on lot/batch number has been requested.  Follow-up (23Jul2021): New information received from contactable consumer (patient) via Pfizer-sponsored program includes: patient weight and height, age at time of onset of reaction, event (Soreness on my shoulder where they gave me the shot) added and clinical information updated.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Lymphadenopathy, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Fever; Swollen lymph Nodes; Swollen arm; Painful Arm; Muscle aches; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in left arm on 21Jul2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, it was unknown whether the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient had no known allergies to food, medication or other products. On 22Jul2021, the patient experienced fever, swollen lymph nodes, swollen arm, painful arm, muscle aches and weakness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fever, swollen lymph nodes, swollen arm, painful arm, muscle aches and weakness were recovering at the time of this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Swollen lymph Nodes; Swollen arm; Painful Arm; Muscle aches; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in left arm on 21Jul2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, it was unknown whether the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient had no known allergies to food, medication or other products. On 22Jul2021, the patient experienced fever, swollen lymph nodes, swollen arm, painful arm, muscle aches and weakness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fever, swollen lymph nodes, swollen arm, painful arm, muscle aches and weakness were recovering at the time of this report.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Headache
Clinical narrative: Random headaches; Loss of energy; Stomach pains; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0181) via an unspecified route of administration in the left arm on 24Jun2021 at 11:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. 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 COVID vaccine. The patient did not take any concomitant medications. On 27Jun2021 at 00:30, the patient experienced random headaches, loss of energy and stomach pains. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as the result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events random headaches, loss of energy and stomach pains were unknown at the time of reporting.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Facial spasm
Clinical narrative: Facial muscle spasm; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 21Jul2021 at 14:15 (at the age of 17-year-old) as a single dose and the  second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa6780) via an unspecified route of administration in the left arm on an unspecified date in 2021 as a single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included levocetirizine dihydrochloride (XYZALL) and multivitamins (MANUFACTURER UNKNOWN) for unknown indications, started from unknown dates and unknown if ongoing. The patient was allergic to shellfish, ragweed and mold. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jul2021 at 21:00, the patient experienced facial muscle spasm. It was unknown whether any therapeutic measures were taken as a result of the event facial muscle spasm. The event 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 event facial muscle spasm was unknown at the time of this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: really tired; Chills 7 hours after vaccine; achy including at hips; achy including at joints; This is a spontaneous report from a contactable consumer, the patient. A forty-eight-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FA6780) via an unspecified route of administration in the left arm on 23Jul2021 at 15:00 (at the age of forty-eight-year-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19, allergy to penicillin and sulfas. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included bupropion hydrochloride (WELLBUTRIN) and cetirizine hydrochloride (ZYRTEC), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: 6W0181) via an unspecified route of administration in the left arm on 02Jul2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. On 23Jul2021 at 22:00, 7 hours after vaccination, the patient experienced chills, achy including at hips and joints. On 24Jul2021, next full day, patient was achy and was really tired. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events which included treatment with Tylenol and Advil OTC(over the counter). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, achy at hips and joints and really tired was not recovered at the time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Panic attack
Clinical narrative: Dizziness; Feeling flush; "Feeling as if i were having a panic attack"; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 24Jul2021 at 15:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included panic disorder. The patient had no allergies to medications, food and other products. Concomitant medications were not reported. 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. On 24Jul2021 at 22:30, the patient experienced dizziness, feeling as if she were having a panic attack and feeling flush. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, "feeling as if having a panic attack" and feeling flush were unknown at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vasculitis
Clinical narrative: developed a rash similar to hives; developed a rash similar to hives; This is a spontaneous report from a contactable physician. A 17-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient developed a rash similar to hives in appearance is now being tested for vasculitis. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: 2 menstrual periods in a space of less than 1 month:1st day pf period: June 20 Last day of period: June 271st day of period: July 12 Last day of period: ongoing; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW182) via an unspecified route of administration in the right arm on 28Apr2021(at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history and had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included paracetamol (ACETAMINOPHEN) and docusate sodium (STOOL SOFTENER). The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on an unknown date (age at vaccination unknown) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Jul2021 at 12:00, the patient experienced a shortened menstrual cycle. It was reported that the patient experienced two menstrual periods in a space of less than one month: first day pf period: 20Jun2021 Last day of period: 27Jun2021; first day of period: 12Jul2021 Last day of period: ongoing at the time of report. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event two menstrual periods in a space of less than one month: first day pf period: 20Jun2021 Last day of period: 27Jun2021; first day of period: 12Jul2021 Last day of period: ongoing at the time of report was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eructation, Flatulence, SARS-CoV-2 test
Clinical narrative: Burping; Intestinal gas; Ongoing burping and intestinal gas -since first dose but worse after 2nd; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received 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 18Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included ongoing sinus disorder for decades. 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 COVID-19 vaccine. The patient received other medications within two weeks of COVID- 19 vaccine, names were unspecified. On 20Mar2021, the patient experienced ongoing burping and intestinal gas - since first dose but worse after second. 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 been tested for COVID-19. On 02Jul2021, the patient underwent NACR (SARS COV-2 test; Nasal swab), and the result was Negative. The clinical outcome of the events ongoing burping and intestinal gas was unknown at the time of this report.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose twice; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jul2021 at 13:15 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included bicuspid aortic valve. The patient was allergic to penicillin. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jul2021 at 00:00, the patient experienced bloody nose once and again on the same day at 03:00. The event 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 event. The clinical outcome of the event bloody nose twice was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: Possible enlargement of the lymphatic node (1) due to COVID-19 vaccination. No other abnormalities; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid carcinoma (post thyroid carcinoma/remission since 2016). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 137 mcg for unknown indication received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Jul2021, the patient had a preventative mammogram, called back for additional ultrasound on the left breast and experienced possible enlargement of the lymphatic node (1) due to COVID-19 vaccination. The patient did not have other abnormalities. The event resulted in doctor or other healthcare professional office/clinic visit.  Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event possible enlargement of the lymphatic node was unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vaccination site warmth
Clinical narrative: It still has fever in the injection site; I broke out in hives and it still has fever in the injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO182) via an unspecified route of administration in the left arm on 19Jul2021 at 10:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included heart problems but still waiting on her test results. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (BAYER CHILDREN'S ASPIRIN) from on an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TR8765) via an unspecified route of administration in the left arm on 28Jun2021 at 10:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient also took codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 23Jul2021 at 09:00, the patient experienced broke out in hives and still it had fever in the injection site 4 days after. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with over-the-counter allergy medication. The clinical outcome of events broke out in hives and still had fever in the injection site was recovering at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual bleeding began two weeks ahead of schedule. Have been regular 28 day period for 20 years with no spotting; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the arm right on 20Jul2021 at 15:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN), cold sores, endometriosis and infertility. The patient was allergic to penicillin. Concomitant medication included labatelol (MANUFACTURER UNKNOWN) and famcyclovir (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jul2021 at 08:00, the patient experienced menstrual bleeding began two weeks ahead of schedule. Have been regular 28 day period for 20 years with no spotting. 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. The clinical outcome of the event irregular menstrual cycle was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Headache, SARS-CoV-2 test, Tinnitus
Clinical narrative: Persistent, constant ringing in both ears since the second shot.; Some dizziness; Loss of balance; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 54-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 right arm on 27Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. 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 right arm on 06Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021, since the second shot, the patient experienced persistent constant ringing in both ears, dizziness, loss of balance and headaches. The events resulted in doctor or other healthcare professional office/clinic visit, and the doctor diagnosed it as tinnitus. The patient had mentioned that there was some data on these symptoms after Pfizer second shot and the doctor said there was not enough data. Therapeutic measures were taken as a result of the events and included treatment with prescription medication and over the counter medications. On 10Jul2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events persistent constant ringing in both ears, dizziness, loss of balance and headaches were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and very painful lymph nodes in injected arm/ Occasional lymph node pain; Swollen and very painful lymph nodes in injected arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 02Jul2021 at 17:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy related asthma and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had known allergies to penicillin, dairy and latex. Concomitant medications included centrum vitamins, linum usitatissimum seed oil (FLAX SEED OIL) and loratadine (CLARITIN ALLERGY) from on an unknown date for unspecified indication and unknown if ongoing. The patient took ibuprofen (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Jul2021 at 17:00, the patient experienced swollen and very painful lymph nodes in injected arm for 4 days. Lessened, but continuous pain for 1 week. Occasional lymph node pain for 3 weeks to date. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event swollen and very painful lymph node was not recovered at the time of this report.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Breast tenderness, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; Runny nose; Fatigue; Tenderness/ soreness at injection site; Tenderness/ soreness at injection site and left side of breast; Swollen lymph nodes; Redness near injection site; Pain at armpit area; Left arm warmer, where injection site is on, than the right arm; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old patient of unknown gender 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 21Jul2021 at 10:30 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. 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 salbutamol (ALBUTEROL), allergy pills (MANUFACTURER UNKNOWN) and nasal spray for allergies; all from unknown dates for unknown indications. 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 30Jun2021 at 17:30 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFATURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. On 22Jul2021 at 03:30, the patient experienced fever, runny nose, fatigue, tenderness/ soreness at injection site and left side of breast, swollen lymph nodes, pain at armpit area, redness near injection site that was still visible after 36 hours and left arm warmer, where injection site is on, than the right arm. 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, runny nose, fatigue, tenderness/ soreness at injection site and left side of breast, swollen lymph nodes, pain at armpit area, redness near injection site that was still visible after 36 hours and left arm warmer, where injection site is on, than the right arm 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: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Skin warm, Vaccination site erythema, Vaccination site pain
Clinical narrative: Fever; Runny nose; Fatigue; Tenderness/ soreness at injection site; Tenderness/ soreness at injection site and left side of breast; Swollen lymph nodes; Redness near injection site; Pain at armpit area; Left arm warmer, where injection site is on, than the right arm; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old patient of unknown gender 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 21Jul2021 at 10:30 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. 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 salbutamol (ALBUTEROL), allergy pills (MANUFACTURER UNKNOWN) and nasal spray for allergies; all from unknown dates for unknown indications. 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 30Jun2021 at 17:30 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFATURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. On 22Jul2021 at 03:30, the patient experienced fever, runny nose, fatigue, tenderness/ soreness at injection site and left side of breast, swollen lymph nodes, pain at armpit area, redness near injection site that was still visible after 36 hours and left arm warmer, where injection site is on, than the right arm. 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, runny nose, fatigue, tenderness/ soreness at injection site and left side of breast, swollen lymph nodes, pain at armpit area, redness near injection site that was still visible after 36 hours and left arm warmer, where injection site is on, than the right arm 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.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: trouble breathing; This is a spontaneous report from a contactable consumer (reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced trouble breathing. The outcome of the event was unknow.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Ear swelling
Clinical narrative: Ears swollen inside-no infection anywhere; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 08Mar2021 at 12:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, thyroid, and type 2 diabetes mellitus (controlled) from an unknown date. The patient had an allergy to dust and dog and cat dander. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included unspecified thyroid medication and metformin (MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. On 14Mar2021 at 12:00, the patient had a loss of smell and taste. The ears were swollen inside and there was no infection anywhere. Other than the events reported, the patient actually felt okay and could exercise and live as normal. The patient could only smell or taste the dust. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with montelukast sodium (SINGULAIR). The clinical outcome of the events loss of taste and smell and ears swollen inside-no infection anywhere were not recovered at the time of this report.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia for 3 nights; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA 6780) via an unspecified route of administration in the left arm on 15Jul2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727) via an unspecified route of administration on 18Jun2021 (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 COVID-19 vaccination. On 18Jul2021, the patient experienced insomnia for 3 nights. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event insomnia for 3 nights resolving at the time of this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Persistent headache; This is a spontaneous report from a non-contactable consumer (patient).  A 43-year-old (also the age at time of vaccination) non-pregnant at the time of vaccination female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Jul2021 16:00 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for COVID-19 immunization. The patient had COVID-19 on unknown date prior to vaccination. There were no concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jun2021 (Lot number: EW0186) at 09:45 AM at the age of 43-years-old as COVID-19 immunization. Then, the 2nd dose on 10Jul2021 16:00. On 11Jul2021 08:00 (also reported as two weeks after second injects), the patient experienced persistent headache. The event resulted to emergency room/department or urgent care and was treated with unspecified intravenous (IV) medication. The patient had nasal swab in 2021 with unknown results. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal oedema, Throat tightness
Clinical narrative: She was given her first Pfizer COVID-19 vaccination and within 20 minutes she experienced a tight and swollen throat.; She was given her first Pfizer COVID-19 vaccination and within 20 minutes she experienced a tight and swollen throat; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 23Jul2021 (age at vaccination: 58-years) as dose 1, single for covid-19 immunisation. Patients medical history included anaphylaxis reactions from an unspecified date and un-known if ongoing (has a history of anaphylaxis reactions). Concomitant medications were not reported. On 23Jul2021, within 20 minutes of vaccination, she experienced a tight and swollen throat. She stated the symptoms were mild and that she had experienced anaphylaxis many times in the past and carries an EpiPen. She was observed in the clinic for worsening and she declined steroids. She never used her EpiPen and was sent home. The clinic advised her not to get the second vaccine. No treatment was given for the adverse events. 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.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lacrimation increased, Malaise, Somnolence
Clinical narrative: super sleepy; worst headache; eyes are watering; just feel like absolute trash; I feel exactly how I felt if not worse than when I actually got Covid-19 months ago.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Jul2021 at 16:00 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety, depression, transgender, allergies and COVID-19.  Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included testosterone (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC) and cetirizine hydrochloride (ZYRTEC); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Jul2021 at 01:00, the patient just felt like absolute trash, was super sleepy, had the worst headache, eyes were watering and felt exactly how she felt if not worse than when patient actually got COVID-19 months ago. 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 just felt like absolute trash, was super sleepy, had the worst headache, eyes were watering and felt exactly how she felt if not worse than when patient actually got COVID-19 months ago was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash on arm where shot was at and the chest; Rash on arm where shot was at and the chest; This is a spontaneous report from a contactable consumer or other non HCP (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had rash on arm where shot was at and the chest. The outcome of events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.