chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hiccups, Pain, Pyrexia, Somnolence
Clinical narrative: hiccups; fever; body pain; tiredness; sleepiness; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old male patient received 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 20Jun2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced hiccups, fever, body pain, tiredness and sleepiness. Consumer calls in requesting information about symptoms management related to second dose administration of Pfizer's COVID-19 vaccine. Consumer reports that her 21-year-old son received first dose on Sunday 20Jun2021 and presented hiccups, fever and body pain. Consumer reports that after first dose her son only had tiredness and sleepiness. The outcome of the events was unknow.  Information about Lot/Batch number requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Throat irritation, Vaccination site pain
Clinical narrative: Pain at the site; Hot flashes; burning in the throat; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jun2021 at 13:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. 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 23Jun2021 at 14:00, after 30 minutes of vaccination, the patient experienced burning in the throat; and on same day at 14:45, the patient experienced pain at the site and hot flashes. 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 pain at the site, burning in the throat and hot flashes were unknown at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Tachycardia (HR 130s) despite extensive workup; This is a spontaneous report from a contactable physician. An adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no known allergies. Concomitant medications included metoprolol (Manufacturer unknown), paracetamol (TYLENOL) and lorazepam (ATIVAN). The patient did not received any other vaccine within four weeks of the BNT162B2 vaccine. The patient experienced tachycardia (HR 130s) despite extensive workup on an unspecified date. The tachycardia self-resolved the following day. The tachycardia resulted in an emergency room/department or urgent care visit.  Treatment included Metoprolol, 3L IV fluids, Tylenol and Ativan. The outcome of event tachycardia was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product \BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported event tachycardia cannot be completely excluded. This case will be re-assessed should additional information becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphocyte count, Lymphocyte count decreased, Monocyte count, Monocyte count increased
Clinical narrative: lymphocytes were low/lymphocyte percentage was low, 0.81 units; monocytes were high/monocytes were 11.8%; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 (between 10:00-12:00) (at the age of 74-years-old) as single for COVID-19 immunization. Medical history included diabetes from on an unspecified date in Jan2017 and ongoing (last diabetes checkup was on 29Apr2021) and AFib (atrial fibrillation) from on an unspecified date in Jan2016 and ongoing. The family history included diabetes. The patient's concomitant medications included flu vaccine. The patient's previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 (around 11:00) as single for COVID-19 immunization. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on same date of the Pfizer suspect or within four weeks prior to the first administration date of the suspect vaccine. The patient reported that he received flu vaccine every year. There was no adverse event following prior vaccinations and reported that he had a bunch, working overseas. On 29Apr2021 at 09:53, the patient experienced lymphocytes were low/lymphocyte percentage was low, 0.81 units and monocytes were high/monocytes were 11.8%. The events did not require a visit to emergency room or physician office. On 29Apr2021, the patient underwent lab tests and procedures which included Bloodwork showed lymphocyte count: 0.81 /10^3/uL (normal range: 0.9-3.40), lymphocyte count: 15.9% (normal range: 16.2-45.9) and monocyte count: 11.8 % (normal range: 4.2-11.6). The patient reported that this was abnormally high according to the report. The patient wanted to know if the Pfizer COVID vaccine had anything to do with lymphocytes being low or his monocytes being high and what were the repercussions. The patient asked whether this was related to the vaccine and what were the ramifications. He asked whether he was more susceptible to diseases. The patient further reported that he has not had anymore blood work done so he was not sure if it was ongoing. The outcome of all the events was unknown.  Follow-up attempts have been made. Case will be update upon receipt of further information.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Malaise, Oropharyngeal pain
Clinical narrative: Arms pain/soreness to his arms; Sinus pressure; Headache; Sore throat/Throat hurt really bad; A super runny nose; Sneezing; A little tired; Really sick; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after receiving the first dose of vaccine on an unspecified date the patient experienced the sore arms for the following day or so and was a little tired. For the next 5-6 days the caller had sinus pressure and headaches. Today (on unspecified date) was the two-week mark, and the first week it was the arms pain, sinus pressure and headaches. That past week the patient was really sick and was feeling unwell with sneezing, a super runny nose and had sore throat and his throat hurt really bad. The Patient had been taking Dayquil, Nyquil, and cough drops. The Reporter could not find anything online about people having these side effects for this long. Patient asked how long this will last and will the symptoms go away. The patient was looking online and couldn't find anything about people having a runny nose. Caller asked if he should take the second shot. Mentally the patient felt better so he was hoping he is getting better. The patient's throat was really hurting ask is this something that has been reported. Weather the patient should see a doctor. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paranasal sinus discomfort, Rhinorrhoea, Sneezing
Clinical narrative: Arms pain/soreness to his arms; Sinus pressure; Headache; Sore throat/Throat hurt really bad; A super runny nose; Sneezing; A little tired; Really sick; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after receiving the first dose of vaccine on an unspecified date the patient experienced the sore arms for the following day or so and was a little tired. For the next 5-6 days the caller had sinus pressure and headaches. Today (on unspecified date) was the two-week mark, and the first week it was the arms pain, sinus pressure and headaches. That past week the patient was really sick and was feeling unwell with sneezing, a super runny nose and had sore throat and his throat hurt really bad. The Patient had been taking Dayquil, Nyquil, and cough drops. The Reporter could not find anything online about people having these side effects for this long. Patient asked how long this will last and will the symptoms go away. The patient was looking online and couldn't find anything about people having a runny nose. Caller asked if he should take the second shot. Mentally the patient felt better so he was hoping he is getting better. The patient's throat was really hurting ask is this something that has been reported. Weather the patient should see a doctor. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymph node pain, Lymphadenopathy, Ultrasound scan
Clinical narrative: Painful swollen lymph nodes near collar bone on left side (injection side); Painful swollen lymph nodes near collar bone on left side (injection side); This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the arm left on 01Apr2021 at 14:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation and the patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the arm left on 04May2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 20 milligrams two times a day and naproxen sodium (ALEVE); both since an unknown date and for unknown indications. 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 COVID vaccine. On 02Apr2021 at 13:00, the patient experienced painful swollen lymph nodes near collar bone on left side (injection side). The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 18Jun2021, the patient underwent blood work and the result was unknown. On 18Jun2021, the patient underwent ultrasound and the result was unknown. No therapeutic measures were taken for the reported events. The clinical outcome of the event painful swollen lymph nodes near collar bone on left side (injection side) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Swelling
Clinical narrative: Experienced swelling in the neck, lymph nodes and under her arms; Experienced swelling in the neck, lymph nodes and under her arms; Experienced swelling in the neck, lymph nodes and under her arms; This is a spontaneous report received from a contactable pharmacist. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 03Jun2021 (age at vaccination 32 year) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling in the neck, lymph nodes and under her arms on an unspecified date. Outcome of the events was unknown. PQC Details: Request Name: REQ- Product: PFIZER-BIONTECH COVID-19 VACCINE. Question: Callback attempt #1 performed on 24Jun2021 at 05:32 PM because caller preferred a callback than to be placed on hold for the information. Caller warm transferred to (withheld) of DSU with NTID and reportum #. Upon warm transfer, caller got disconnected from the call. DSU agent mentioned "she'll take care of it." E-transmitting AE report for review. Potential AE duplicate. (32 years old, female). Caller has a 32-year-old female patient who had the first dose of the Pfizer BioNTech COVID-19 vaccine last 03Jun2021 and experienced swelling in the neck, lymph nodes and under her arms which was reported. Caller asked if it was appropriate for the patient to get the second shot of the vaccine. Proposed response: Provide disclaimer. Speak from attached document and mention Interim Clinical Considerations for the Use of COVID-19 Vaccines from ACIP. Response: Provide disclaimers. Spoke from attached document and mentioned "Interim Clinical Considerations for the Use of COVID-19 Vaccines from ACIP". PSCC Communication: After MI provided information, MI agent attempted to bring caller onto the line. MI agent returned to call handler and stated that the caller had remotely disconnected the call. All information provided is as reported by the MI agent. No additional details provided.  Follow up activities closed: No follow up activities are required for non-serious AEs reported in spontaneous/other solicited sources, no follow-up assessment to be made by DSU at initial case entry per EXCEPTION ICSRs FOLLOW-UP PROCESS DURING PANDEMIC.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lymphadenopathy
Clinical narrative: Diarrhea for 1.5 weeks (as of 6/24); swollen lymph node; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 20-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Jun2021 10:15 (at the age of 20-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included eczema and ginger allergy. Concomitant medications included methotrexate (METHOTREXATE) and folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. The patient not received other vaccine in four weeks. The patient not had COVID prior vaccination and not tested COVID post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 unspecified route of administration on 25May2021 10:15 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. On 15Jun2021, 11:00 the patient experienced diarrhea for 1.5 weeks (as of 6/24) and swollen lymph node. The clinical outcome of the events were not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: fatigue; myalgia; headache; sore arm; This is a spontaneous report from a contactable Other HCP. This Other HCP (female patient) reported for herself in response to consumer letter that the. A female patient of unspecified age ,the patient had received second dose of Pfizer/BioNTech Covid-19 Vaccine solution for injection,(Batch/Lot number: EW0186) via intramuscular route on 26May2021;16:00 as dose 2 single for covid-19 immunuzaion.The patient had taken previously first dose of Pfizer/BioNTech Covid-19(solution for injection) Batch/Lot number: EN0167 on 05May2021;16:00.The patient medical history Illness/AE: HTN onset date: 2014 stop date ongoing,Illness/AE: Hypothyroidism onset date 1997,stop date: ongoing, Hypercholesterolemia ,onset date: 2019 stop date: ongoing.The patient concomitant medication were HCTZ ,Reason for use: HTN Route: Oral Start time: 2018 Ongoing, Levothyroxin ,Reason for use: Hypothyroidism Route: Oral Start date: 1997 Ongoing. Lisinopril reason for use HTN ,route Oral,Start date: 2015 ,Ongoing Rosuvastatin, Hypercholesterolemia route Oral Start date: 2019 Ongoing. After administration of second dose the patient had developed sore arm both times, no biggie. got up next morning 6May, felt ok but by around 11AM started with achy legs, not hungry, mild stomach upset, mild H/A developed and kind a sudden onset fatigue. Slept for 3 hours 6May afternoon. felt lousy woke up with improving,increase appetite etc. By evening pretty much better. After the 2nd vaccine had no such symptoms. On 06May2021, the patient had experienced Fatigue, Myalgia and Headache. This events was considered as non-serious. The clinical outcome of the events was resolved. No therapeutic measures were taken. Follow-Up 21Jul2021: Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lip swelling
Clinical narrative: flu like symptoms; lips were a little swollen on the side where she received her shot; This is a spontaneous report from a contactable physician (patient) via a sales representative.     A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on Jun2021 (a day or two ago) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On Jun2021, patient experienced flu like symptoms and lips were a little swollen on the side where she received her shot. The outcome of both the events was unknown.  Information on lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Urticarial rash with warmth; erythema at site of injection approximately 2 days after the injection; swelling at site of injection approximately 2 days after the injection; This is a spontaneous report from a non-contactable consumer, the parent. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 21Jun2021 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. The patient previously 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 27May2021 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021, the patient experienced urticarial rash with warmth, erythema and swelling at site of injection, approximately 2 days after the injection. Therapeutic measures were taken as a result of the urticarial rash with warmth and included treatment with oral diphenhydramine (MANUFACTURER UNKNOWN) and topical steroid cream (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events urticaria, erythema and swelling at site of injection was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pain in extremity
Clinical narrative: Chest pain; Sore on the arm; Hard to breathe; This is a spontaneous report received from a contactable consumer. This 61-year-old male consumer(patient) reported for himself that he received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (61-years at the age of vaccination). Medical history was none. There were no concomitant medications. Prior Vaccinations (within 4 weeks), AE(s) following prior vaccinations, Patient's Medical History (including any illness at time of vaccination), Family Medical History Relevant to AE, and Relevant Tests was none. The Historical Vaccine include BNT162B2 for COVID-19 (dose: 01, Anatomical Location: Injection, left arm Time: 18:00) Immunization (61-years at the age of vaccination).The patient experienced chest pain, sore on the arm and hard to breathe on an unspecified date. He took the two vaccines lately. Yesterday he felt chest pain. It had happened two times before for a minute or so. Yesterday it took about 15 minutes. He was driving. He had to pull over. Caller said that he started stretching. It was hard to breathe. He had pain on the chest. It was like something was pushing on him. It was like something heavy was on him. Caller stated again that it was hard to breathe and he started stretching. It took awhile. He explained that he stretched his arms to see if he could get more air. He stretched from the pain. Therapeutic measures were taken as a result of chest pain. The outcome of the events Chest pain was not resolved, and other events was unknown.   Follow up attempts are needed; information about lot/batch number cannot be obtained
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nausea, Night sweats, Pain
Clinical narrative: Nausea; Body aches; Chills; Night sweats; Sore joints; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 18-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 22Jun2021 at 15:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) from an unknown date and for an unknown indication. 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 left arm on 01Jun2021 at 11:00 (at the age of 18-year-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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 21:00, the patient experienced nausea, body aches, chills, night sweats, sore joints and vomiting. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, body aches, chills, night sweats, sore joints and vomiting was 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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Body aches; Chills; Night sweats; Sore joints; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 18-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 22Jun2021 at 15:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) from an unknown date and for an unknown indication. 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 left arm on 01Jun2021 at 11:00 (at the age of 18-year-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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 21:00, the patient experienced nausea, body aches, chills, night sweats, sore joints and vomiting. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, body aches, chills, night sweats, sore joints and vomiting was 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: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm x2 days; This is a spontaneous report from a non-contactable other healthcare professional. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Apr2021 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Apr2021 the patient experienced a sore arm for 2 days. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm was recovered on 24Apr2021.  No follow-up attempts are possible. No further information is expected
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report from a contactable consumer (patient's girlfriend) via Medical Information Team. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (76-year-old at vaccination) as a Dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter mentioned that her girlfriend (76-year-old) got dizzy since three days after getting the Pfizer shot. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm x12 hours; This is a spontaneous report from a non-contactable other healthcare professional. A 32-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced sore arm for 12 hours. The event did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event sore arm was unknown at the time of this report.  No follow-up attempts are possible; no further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm x24-48 hours; This is a spontaneous report from a non-contactable healthcare professional. A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Apr2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Apr2021 the patient experienced sore arm x24-48 hours. 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 sore arm x24-48 hours was recovered on 24Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Arm muscle soreness x1 day; Fatigue x1 day; This is a spontaneous report from a non-contactable other healthcare professional. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Apr2021 at 11:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. On 20Apr2021, the patient experienced arm muscle soreness and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events arm muscle soreness and fatigue were resolved on 21Apr2021 after a duration of 1 day.   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore L arm at injection site; This is a spontaneous report from a non-contactable other healthcare professional. A 19-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 20Apr2021, the patient experienced sore L arm at injection site x1 day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore L arm at injection site was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: sore arm x1 day; swelling and redness x2 days; swelling and redness x2 days; This is a spontaneous report from a non-contactable healthcare professional. A 36-year-old patient with unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 20Apr2021 at 11:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 20Apr2021, the patient experienced sore arm for one day and swelling and redness for two days. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm was recovered on 21Apr2021 and that of swelling and redness was recovered on 22Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on right forearm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on the left arm on 17Jun2021 at 15:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. It was reported that the patient received other medications within 2 weeks of vaccination but the medication was not specified. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported allergies which was unspecified. Prior to the vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Jun2021 the patient experienced rash on the right forearm. The patient did not receive any treatment for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash was recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore L arm for a few hours; This is a spontaneous report from a non-contactable healthcare professional. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK8729) in the arm left on 21Apr2021 at 09:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date the patient experienced sore L arm for a few hours. 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 sore L arm for a few hours was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Heart rate increased, Lymph node pain, Lymphadenopathy
Clinical narrative: lymph node in left armpit swollen and very tender; lymph node in left armpit very tender; very bad body aches; felt really cold; slightly nauseous; headache; fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 22Jun2021 at 14:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 01Jun2021 at 15:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 23Jun2021, at 06:45 the patient experienced very bad body aches and felt really cold. The patient tried to get warm to herself and also felt slightly nauseous and had a headache, as well as a fast heartbeat. On 25Jun2021, the patient noticed the lymph node in left armpit was swollen and very tender. 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 of very bad body ache, felt cold, slightly nauseous, headache and fast heartbeat was recovered on 23Jun2021, after the duration of 14Hours and that of swollen and tender lymph nodes in left armpit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: lymph node in left armpit swollen and very tender; lymph node in left armpit very tender; very bad body aches; felt really cold; slightly nauseous; headache; fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 22Jun2021 at 14:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 01Jun2021 at 15:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 23Jun2021, at 06:45 the patient experienced very bad body aches and felt really cold. The patient tried to get warm to herself and also felt slightly nauseous and had a headache, as well as a fast heartbeat. On 25Jun2021, the patient noticed the lymph node in left armpit was swollen and very tender. 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 of very bad body ache, felt cold, slightly nauseous, headache and fast heartbeat was recovered on 23Jun2021, after the duration of 14Hours and that of swollen and tender lymph nodes in left armpit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm x1 day at injection site; This is a spontaneous report from a non-contactable healthcare professional. A 31-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Jun2021 at 10:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. It was unknown whether the patient was pregnant. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 22Jun2021, the patient experienced sore arm for one day at injection site. 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 sore arm for one day at injection site was resolved on 23Jun2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a non-contactable healthcare professional. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 20Apr2021 at 09:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sore arm was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm x2 days; This is a spontaneous report from a non-contactable other healthcare professional. A 25-year-old (unknown if pregnant) female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 22Apr2021, the patient experienced sore arm for 2 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 event. The clinical outcome of the event sore arm was recovered on 24Apr2021 after duration of 2 days.   No follow-up attempts are possible. No further information is expected
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 24 hours; This is a spontaneous report from a non-contactable other healthcare professional. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Apr2021 at 09:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021 the patient experienced sore arm for 24 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sore arm for 24 hours was recovered on an unknown date in April2021.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Neck pain
Clinical narrative: stiffness of muscle; Neck pain same side as shot from Jaw to Collar bone every time I eat or drink anything; Uncomfortable feeling in neck; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in left arm on 13May2021 (at the age of 45-years-old) as single dose for covid-19 immunization. The patient's medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 16May2021, the patient experienced neck pain same side as shot from jaw to collar bone every time she eats or drink anything, uncomfortable feeling in neck and stiffness of muscle. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered, still continues after 5 weeks passed the last vaccine.  Information about batch/lot number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: This is a spontaneous report from a noncontactable healthcare professional. A 25-year-old female patient (unknown if pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8729), at the age of 25, via an unspecified route of administration, left arm, on Apr 22, 2021, at 12:30, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On Apr 22, 2021, patient experienced soreness in left arm and swelling for two days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The outcome of the soreness in left arm and swelling recovered on Apr 24, 2021 after duration of two days. No follow-up attempts needed. No further information expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 102.1 at 30 hours post injection; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 23Jun2021 at 11:15 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included ADHD. The patient previously took augmentin (MANUFACTURER UNKNOWN) and experienced drug allergy on an unknown date. 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 amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), sertraline (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN); all since unknown dates for unspecified indications. On 24Jun2021 at 17:30, 30 hours post vaccination, the patient experienced fever of 102.1 unspecified units. On 24Jun2021 at 17:30, the patient's body temperature was measured and the result was 102.1 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event fever 102.1 (unspecified units) at 30 hours post injection was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.