chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Swollen, raised , itchy rash/bump at injection site. Approximately 3 inches in circumference.; Swollen, raised , itchy rash/bump at injection site. Approximately 3 inches in circumference.; Swollen, raised , itchy rash/bump at injection site. Approximately 3 inches in circumference; Swollen, raised , itchy rash/bump at injection site. Approximately 3 inches in circumference; This is a spontaneous report from a contactable consumer (patient reported for self). A 41-years-old (non-pregnant) female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 20Feb2021 09:15 (at the age of 41-years-old) (Batch/Lot Number: EL9267) as dose 2, single for COVID-19 immunisation. Medical history included diabetic, high blood pressure,  pcos (polycystic ovarian syndrome), anemia and known allergies to latex, iodine, peanuts, bees, all from an unknown date and unknown if ongoing. Concomitant medication included insulin glargine (TOUJEO), atorvastatin, lisinopril, paracetamol (TYLENOL), iron and ibuprofen (ADVIL [IBUPROFEN]), all drugs were taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (Lot number: EL9265) administered in Left arm on 30Jan2021 14:30 (at the age of 41-years-old) for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. The patient experienced swollen, raised, itchy rash/bump at injection site. approximately 3 inches in circumference on 21Feb2021. The patient had not been tested since the vaccination. Patient did not receive any treatment for the events. Outcome of all events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Vaccination site pain
Clinical narrative: Woke up at approximately 2 am with chills; Felt fine for about 6 hours, then had severe pain at injection site,; Full body weakness; Aches; Severe throbbing headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 13:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included minor high blood pressure and allergies to fish, mushroom and kiwi fruit. 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 metoprolol (MANUFACTURER UNKNOWN), armodafinil (NUVIGIL) and curcuma longa (TURMERIC); all for unknown indication from an unknown date and unknown if ongoing. On 26Feb2021 at 20:00, the patient felt fine for about 6 hours, then had severe pain at injection site, full body weakness, aches, severe throbbing headache and on 27Feb2021 at 02:00 woke up with chills. Symptoms subsided about 16:00 the following day. 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 severe pain at injection site, full body weakness, aches, severe throbbing headache and chills were resolved on 27Feb2021 at about 16:00.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report based on the information received by Pfizer (Case number: 01868196). A non-contactable Nurse reported similar events for two patients (herself and her husband). This is first of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), 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 had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA 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. After their second dose of Pfizer vaccine on an unspecified date, the patient had experienced flu-like symptoms. The outcome of the event was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021222426 same reporter/drug/event & different patient
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report based on the information received by Pfizer. A non-contactable nurse reported similar events for two patients (herself and her husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), 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 previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Reporter states she was speaking to a friend of hers last night, who is nurse who told her that both she and her husband, who is a Physician's assistant, experienced flu-like symptoms after receiving their second dose of Pfizer COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021222420 same reporter/drug/event & different patient
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Sister is having buzzing in both ears after first vaccine; This is a spontaneous case received from a contactable consumer (sister) via from a Pfizer sponsored program database.   A female patient of unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number was not reported), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced buzzing in both ears after first vaccine on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurts; This is a spontaneous report from a program reported by the consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), 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. On an unspecified date, the patient experienced arm hurts. The patient reported that took a second shot. Does it make a difference with stronger reaction, Arm hurts. Hearing nightmares about second shot. Outcome of the event was unknown.    No follow-up attempts are needed, information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Dysphonia, Laryngitis, Malaise
Clinical narrative: chills; malaise; Pain at injection site; bump at the injection site; Swollen pain; Discomfort under the armpit where the injection was given- Left arm; Laryngitis; Swollen pain; laryngitis-Mild case but voice is compromised; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program database.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, about a week and a half ago after vaccination, the patient experienced chills, malaise, pain where injection site, bump at the injection site, swollen pain, and discomfort under the armpit where the injection was given- left arm. It was reported that, 3 days ago patient developed laryngitis, mild case but voice was compromised. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Dec2020, (Caller had Covid on Dec 18 th). 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Swelling, Vaccination site mass, Vaccination site pain
Clinical narrative: chills; malaise; Pain at injection site; bump at the injection site; Swollen pain; Discomfort under the armpit where the injection was given- Left arm; Laryngitis; Swollen pain; laryngitis-Mild case but voice is compromised; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program database.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, about a week and a half ago after vaccination, the patient experienced chills, malaise, pain where injection site, bump at the injection site, swollen pain, and discomfort under the armpit where the injection was given- left arm. It was reported that, 3 days ago patient developed laryngitis, mild case but voice was compromised. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Dec2020, (Caller had Covid on Dec 18 th). 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema
Clinical narrative: Very red and bruised arm at injection site; Very red and bruised arm at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 28-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 in the left arm on 27Feb2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications, food, or other products. 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 omeprazole (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT) and levothyroxine (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 01Mar2021, the patient had very red and bruised arm at injection site. 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 very red and bruised arm at injection site were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 58-year- old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 28Feb2021 at 13:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes type 2 and shellfish allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 07Feb2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced chills and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills and nausea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Asthenia, Chills
Clinical narrative: Severe, debilitating abdominal pain lasting 5+ hours; General weakness; Chills; Pain centered around navel and radiated to lower abdomen; This is a spontaneous report from a contactable consumer, the patient. A 69-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 in the left arm on 26Feb2021 at 15:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder, hernia hiatal and gallstones. The patient was allergic to peanuts. 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 clonazepam (MANUFACTURER UNKNOWN), from an unknown date and for an unknown indication. 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 05Feb2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 27Feb2021 at 23:00, the patient experienced severe, debilitating abdominal pain lasting 5+ hours accompanied by general weakness and chills. Abdominal pain necessitated response by local paramedics. The pain centered around navel and radiated to lower abdomen. The patient did not have vomiting. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken for abdominal pain by local paramedics. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe, debilitating abdominal pain lasting 5+ hours accompanied by general weakness and chills, the pain centered around navel and radiated to lower abdomen was resolving 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight soreness at injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 26Feb2021 at 14:45 (at the age of 51-years old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies. Prior to the vaccination, the patient was 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 concomitant medications. On 27Feb2021 at 08:00, the patient experienced slight soreness at injection site the following day. 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 event slight soreness at injection site the following day was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anxiety
Clinical narrative: Anxious; Hyped up; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a little anxious and hyped up on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This is a spontaneous report from a contactable consumer, the patient. A 45-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 in the left arm on 24Feb2021 at 09:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, sleep apnea, blood pressure high, depression and fish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 03Feb2021 at 09:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation.  On 24Feb2021 at 17:00, the patient experienced blurred vision. Therapeutic measures were not taken as a result of the event. 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 blurred vision was not recovered 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe muscular pain in both lower extremites extending up to hip area starting 3 days after the shot and continueing for11 days, getting less intense towards the end of the  11 days; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration on 17Feb2021 at 09:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, hypertension (HTN), low thyroid, deep vein thrombosis (DVT) and allergic to non steroidal anti inflammatory drugs (NSAIDS). 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 calcium (LIPITOR), amlodipine besilate (NORVASC), vitamin d nos (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), citalopram hydrobromide (CELEXA) and acetyl salicylic acid (ASA); all for unknown indications from an unknown date and unknown if ongoing. The patient previously received ciprofloxacin (CIPRO) for an unknown indication on an unknown date and  experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 20Feb2021, the patient experienced severe muscular pain in both lower extremities extended up to hip area, started 3 days after the shot and continued for 11 days, getting less intense towards the end of the 11 days. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe muscular pain in both lower extremities extended up to hip area, started 3 days after the shot and continued for11 days, getting less intense towards the end of the 11 days was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea 48 hours and going; This is a spontaneous report from a contactable consumer, the patient. A 70-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 in the right arm on 27Feb2021 at 10:00(at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included penicillin allergy. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications within two weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 27Feb2021 the patient experienced diarrhea 48 hours and on going. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was not recovered 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Had some underarm tenderness on the right side. The underarm soreness was much worse on the left side; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19261) via an unspecified route of administration in the right arm on 24Feb2021 at 14:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included surgery, chemo and radiation treatments, breast cancer from 2006 and unknown if ongoing and lymph nodes removed in 2006. 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 COVID vaccine. Concomitant medications included flax seed and calcium (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 25Feb2021, the patient experienced some underarm tenderness on the right side. The underarm soreness was much worse on the left side where the patient have had lymph nodes removed in 2006 and took longer to resolve (about 4 days). 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events some underarm tenderness on the right side. The underarm soreness was much worse on the left side was resolved on an unknown date in 2021.    No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching & redness at injection site started on the 3rd day after injection.; Itching & redness at injection site started on the 3rd day after injection.; Injection site swelling & mild pain the next day after injection.; Injection site swelling & mild pain the next day after injection.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Feb2021 at 13:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included immunoglobulin g4 related sclerosing disease (IgG4-RSD), hypothyroid, polycystic ovarian syndrome (PCOS), migraine, arthritis, asthma, allergies and known allergies to penicillin and nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included loratadine (MANUFACTURER UNKNOWN), cinnamomum cassia (CINNAMON), fish oil (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and beef liver; all from unknown dates for unknown indications and unknown if ongoing. The patient previously received sulfasalazine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, next day after injection, the patient experienced injection site swelling and mild pain. On 28Feb2021 at 15:15, on the third day after injection, the patient experienced itching and redness at injection site, itching still persisted on the fourth day after and mild redness. 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 injection site swelling, mild pain, itching and redness at injection site were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: 48 hours lymph nodes swollen and painful; 48 hours lymph nodes swollen and painful; Jaw ached; within 24  hours, chills aches and fatigued.; Aches; Fatigued; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 27Feb2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 06Feb2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 00:00, within 24 hours, the patient experienced chills aches and fatigued, on 01Mar2021, 48 hours lymph nodes swollen and painful and jaw ached. Therapeutic measures were not 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills aches and fatigued, 48 hours lymph nodes swollen and painful and jaw ached was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: 48 hours lymph nodes swollen and painful; 48 hours lymph nodes swollen and painful; Jaw ached; within 24  hours, chills aches and fatigued.; Aches; Fatigued; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 27Feb2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 06Feb2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 00:00, within 24 hours, the patient experienced chills aches and fatigued, on 01Mar2021, 48 hours lymph nodes swollen and painful and jaw ached. Therapeutic measures were not 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills aches and fatigued, 48 hours lymph nodes swollen and painful and jaw ached was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Some pimples in the back.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 11:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. 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 medications within 2 weeks of vaccination. On 01Mar2021 at 00:00, the patient experienced some pimples in the back and had no pain. No therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event some pimples in the back was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experiencing a very bad headache today.; This is a spontaneous report from a contactable consumer reported for a male patient (husband). A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a very bad headache on 22Feb2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Caller had Lumps in his armpits after he received the 2nd dose of Vaccine; This is a spontaneous report from a Pfizer-sponsored program. A male contactable Consumer or other non HCP (patient) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced caller had lumps in his armpits after he received the 2nd dose of vaccine on an unspecified date. Outcome of event was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness 48 hrs after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6203) via an unspecified route of administration in the left arm on 26Feb2021 at 19:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. 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 lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 01Mar2021 at 07:00 the patient experienced dizziness 48 hours after vaccine. It was unknown whether any therapeutic measures were taken as a result of the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness 48 hours after vaccine was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in jaw, Swelling face
Clinical narrative: Not being able to sleep; Swollen right jaw cannot bite down and hurts to open mouth; hurts to open.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 25Feb2021 at 08:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), etanercept (ENBREL), metoprolol (MANUFACTURER UNKNOWN) and telmisartan (MANUFACTURER UNKNOWN); all for an unknown indication and start date. The patient had no known allergies to medications, food, or other products. On 26Feb2021 at 12:00, the patient experienced swollen right jaw, could not bite down and hurt to open mouth. Patient further stated that she went to urgent care because of pain and not being able to sleep for the same. The events resulted in doctor/other health care professional office/clinic visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified antibiotics and naproxen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events not been able to sleep, swollen right jaw could not bite down and hurts to open mouth and pain in jaw were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: About an hour and a half-two hours after receiving the first dose of the Pfizer Vaccine, began to feel very energized; The heightened energy was noticeable for about 2 days after the initial vaccine date.; This is a spontaneous report from a contactable consumer, the patient. A 21-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 23Feb2021 at 09:15 at the age of 21-year-old, as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, and rotator cuff tendinitis (right side, rarely noticeable). Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included SERTRALINE and VYVANSE, both were taken for an unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 11:00, about an hour and a half-two hours after receiving the first dose of the Pfizer vaccine, the patient began to feel very energized. The patient compared it to the feeling of pre-workout without the physical tingle effects but increments of 15-20 minutes his energy started to go more and more up. By late afternoon, the patient felt really good, he would weight-lift 4 times a week, do yoga 3 times a week, and box 2 times a week. The day of vaccine was a weightlifting day. The patient's workout both that day and the following two days was much better than usual. The heightened energy was noticeable for about 2 days after the initial vaccine date and third day the effect was entirely gone, with no lasting positive or negative effects. It was in some ways similar to an adrenaline rush. The patient thought it was simply unusual. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heightened energy was recovered on an unknown date in 2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a Pfizer sponsored program (contactable female consumer (wife)). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced headache. Patient stated that "My husband and I had vaccine 15Feb in (place name) last Monday, my husband started not feeling well on Tuesday with a lot of Covid side effects, our next schedule is 08Mar, do you think we need to get the Covid test before we get the next dose, I also had a little bit of headache." Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder, Vaccination site pain, Vaccination site swelling
Clinical narrative: Extremely sore injection site, swollen and hard to touch, difficulty using arm for normal tasks like picking up dinner plate.; Extremely sore injection site, swollen and hard to touch, difficulty using arm for normal tasks like picking up dinner plate.; Disturbed sleep; Difficulty using arm for normal tasks like picking up dinner plate; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 23Feb2021 at 10:15 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included scapular humeral muscular dystrophy. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid/retinol/tocopherol (OCUVITE) from an unknown date for an unknown indication and unknown if ongoing. 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 02Feb2021 at 10:15 (at the age of 84-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 25Feb2021, at 00:00, the patient experienced extremely sore injection site, swollen and hard to touch, difficulty using arm for normal tasks like picking up dinner plate and disturbed sleep. 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 extremely sore injection site, swollen and hard to touch, difficulty using arm for normal tasks like picking up dinner plate and disturbed sleep were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: started not feeling well on Tuesday with a lot of Covid side effects; This is a spontaneous report from a contactable consumer (patient's wife) via a male patient (reporter husband) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient started not feeling well on Tuesday with a lot of COVID side effects. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Stomach ache; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 57-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 22Feb2021 at 08:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. 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 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 22Feb2021 at 22:00, the patient experienced stomach ache and vomiting. 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 stomach ache and vomiting was recovering 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen left lymph node; Fatigue; Chills; Minor headache; Minor stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Feb2021 at 12:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. 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 07Feb2021 at 12:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021 at 09:30, the patient experienced swollen left lymph node, fatigue, chills 24 hours after shot, minor headache and minor stomach ache. 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 swollen left lymph node, fatigue, chills, minor headache, and minor stomach ache were resolving 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.